chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 150 hours, with the recorded temperature of -1-66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 712 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the recorded temperature of -1.66 to 1.11 degrees   degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 376 hours, with the recorded temperature of -1.66 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator refers to unspecified patients (ages and gender unknown). The immunization coordinator reported that unspecified patients, on unspecified dates, were vaccinated with improperly stored PEDVAXHIB, GARDASIL 9 and GARDASIL. No adverse effects were reported. Vaccines involved that were stored at temperature 29.9F, time frame: 273 hours 35 minutes: PEDVAXHIB (Lot number M014927, Expiration date 2/18/2019), PEDVAXHIB (Lot number M025192, Expiration date 3/21/2019), GARDASIL 9 (Lot number M013636, Expiration date 2/15/2018), GARDASIL 9 (Lot number M016193, Expiration date 4/24/2018), GARDASIL 4 (Lot number L035105, Expiration date 5/14/2017). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt received RECOMBIVAX September 2011, November 2011, February 2012 and March 2012. Information was received on 24-OCT-2016 from a consumer/mother regarding her child. Medical history, concurrent conditions and concomitant medications were not reported. On September 2011, November 2011, February 2012 and March 2012 the patient was given a dose of RECOMBIVAX HB (specific dated were not reported). The patient's mother explained that in September 2011 the patient was actually supposed to receive GARDASIL instead of RECOMBIVAX HB which was administered (due to clerical error). The patient did not have an adverse reaction to RECOMBIVAX HB. It was unspecified if the patient ever received his intended GARDASIL vaccinations. No further information was provided. Additional information is not expected as contact information was not provided.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: Vaccine syringe malfunctioned.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from Pfizer, Inc. (manufacturer control # 2016488291) on 08-NOV-2016, which was originally received from a pharmacist referring to a 73 year old male patient. Information about concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with first dose of PNEUMOVAX 23 (strength, dose, lot #, expiration date and route were not provided). One year later, the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23 instead of PREVNAR 13. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, warm to touch, itchy below one injection site, no pain.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Skin reaction, Sleep disorder
Clinical narrative: Patient had skin reaction that kept him up at night.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site urticaria
Clinical narrative: Big red welt, circle over pneumonia shot entrance.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 20-OCT-2016 from a medical assistant. The Medical assistant reported that a patient received the first two dose of the GARDASIL series with GARDASIL (lot numbers and expiration dates unknown) on unspecified dates. Now the patient was back in the office to receive the third dose in the series with GARDASIL 9 (lot number M023169, expiration date 13-JUN-2018). No adverse effects reported. No additional information provided. It is unclear if the patient received GARDASIL 9. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 18-year-ild female patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injection site swelling, injection site erythema, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. Additional details were provided as follows: The age at both the vaccination was not reported. The patient received the 1st dose of BEXSERO and her arm was red and swollen. She was given the 2nd dose and redness and swelling returned. The patient had bulls eye at injection size both the times. There was no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD, M026879 27-NOV-2017, M031944 27-DEC-2017, M032497 02-JAN-2018, M017335 05-OCT-2017, M031945 27-DEC-2017. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX lot # M027886 30-JUN-2018, M027347 01-JUN-2018, M025871 24-MAY-2018. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a pharmacist referring to a 69 years old female patient. The patient's medical history, concomitant therapy and concurrent condition were not provided. On approximately 29-SEP-2016, the patient received an injection of PNEUMOVAX 23 (dose was unknown; lot number M036161 with expiration date 06-MAY-2018) on her right arm. On 30-SEP-2016 (reported as one day after receiving the injection), the patient developed a warm red raised rash on the back of her arm behind the injection site. The patient called her doctor (contact information not specified) and was given a prescription for an unnamed antibiotic, which she "filled on 10-OCT-2016". At the time of reporting, the patient was recovering from the events. The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information is not expected as there is no consent to contact the pharmacist.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown dates, the patients were administered improperly stored doses of VAQTA (lot# and expiration date, strength, dose, frequency and route were not reported). 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 was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # L048848 with expiry date 09-AUG-2018 and lot# M018625 with expiry date 11-AUG-2018) (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were rerpoted in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of adult 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 their first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). Two to three months after receiving their first dose, on unknown dates, the patients received their second dose of RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. 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 healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 0.65ml, subcutaneously, lot # M013377, expiration date 27-MAY-2017 (also reported as 25-MAY-2017). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit for 26 hours and -0.1 degrees Celsius for 70 hours. Data logger was not involved. There were no previous excursions reported. 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 nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored M-M-R II (lot # L029266; expiry date: 04-AUG-2017) (route: subcutaneous). The vaccine was stored at a temperature of -136.6 degrees C for 48 hours. There was no previous temperature excursion. Data logger excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 17-OCT-2016 from an office administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. The administrator is reporting a dose of PROQUAD (possible lot# L044055 expiration 02-MAY-2017, M010478 expiration 01-SEP-2017 or M021731 expiration 29-OCT-2017) and a dose of VARIVAX (possible lot # M010484 expiration 01-MAR-2018, M024702 expiration 18-MAY-201 expiration 18-MAY-2018, M004328 expiration 26-JAN-2018 or M009766 expiration 23-FEB-2018), that had been improperly stored, were inadvertently administered on 14-OCT-2016. No adverse effects reported, No further information provided. On the same day, the administrator has reported that after further review that only one dose of VARIVAX (M010484 expiration 01-MAR-2018) was administered to the patient on 14-OCT-2016. No other improperly stored vaccines were administered. No adverse effect reported. No additional information was available. 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 nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored PNEUMOVAX 23 (lot # M006141; expiry date: 28-MAY-2017) (incorrect product storage) The vaccine was stored at a temperature of -13.6 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Injury
Clinical narrative: This spontaneous social media report as received from a consumer (patient's mother) refers to a male patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose, lot#, expiration date and route of administration were not reported. On an unknown date, the patient had an unspecified injury that led to a scary year. The patient's mother reported that then he was fine and "put right back on the schedule". The outcome of the event was recovered on an unknown date. The relatedness between the event and M-M-R II was not provided. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medial histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There is no information regarding patient's concomitant medications, pertinent medical history, drug reactions, or allergies provided. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX, 19400 PFU, lot # M001747, expiration date: 07-APR-2017 (dose and route of administration were not provided). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 16 degrees Fahrenheit for 1 hour and 30 minutes (and back in range). Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received on 28-OCT-2016 from a pharmacist referring to a patient of unknown age and gender. The pharmacist reported that on unknown date the patient inadvertently received a dose of ZOSTAVAX (dose, route, and lot number not reported) instead of VARIVAX. No adverse effects had been reported. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced extreme swelling at the injection site, almost like a cellulitis. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. 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 refers to unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown, the patient was vaccinated with a dose of M-M-R II lot # M022408, 02-MAY-2018, M032153, 22-APR-2017, M008588 16-FEB-2018, M002419 12-JAN-2018. No adverse symptoms reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored VARIVAX (lot #L048462l; expiry date: 02-DEC-2017 (route: subcutaneous) (incorrect product storage). The vaccine was stored at a temperature of -13.7 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the 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 a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ lot # M019708 with expiry date 25-OCT-2017 (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored PROQUAD (lot # M018635; expiry date: 11-OCT-2017) (route: subcutaneous). The vaccine was stored at a temperature of -13.7 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the 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 pharmacy technician 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 M-M-R II (lot #, expiration date, albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion for 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored ROTATEQ (lot # L048854; expiry date: 31-AUG-2017) (route: oral). The vaccine was stored at a temperature of -13.6 C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M026306, expiry date 30-APR-2018 (dose, route of administration and anatomical location were not specified). The administered doses of GARDASIL 9 underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. 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: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received improperly stored doses of PROQUAD (recombinant human albumin, rHA) (lot # M031944 with expiration date: 27-DEC-2017, lot # M031568 with expiration date: 24-DEC-2017 and lot # M015698 with expiration date 26-SEP-2017) (dose and route of administration were not reported). The administered doses of vaccine were exposed to a temperature of 27 Fahrenheit (F) degrees for 30 minutes. No previous temperature excursions were reported. It was unknown if data logger was used to track the temperature. No adverse effects were reported. No product quality compliant (PQC) was involved. 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: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M017335, expiry date 05-OCT-2017 (therapy type, dose, route of administration and anatomical location were not specified). The administered doses of PROQUAD underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Concurrent conditions, concomitant medication and medical history were not provided. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB (lot# and expiration date, strength, dose, frequency and route were not 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
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown dates, the patients were administered improperly stored PNEUMOVAX 23 (lot# and expiration date, strength, dose, frequency and route were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a male consumer referring to himself of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 and PREVNAR 13 concomitantly. No adverse experience was reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with VAQTA, lot # M022924 with expiry date 24-JAN-2018 (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius(C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9, (lot # L036301 with expiry date 20-DEC-2017 and Lot# M026306 with expiry date 30-APR-2018) (dosing details, route of administration and anatomical location unknown), that were exposed to a temperature excursion of 1.1 Celsius (C) for 6 hours. No adverse effects were reported in any patients. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician 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 #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Injection site induration
Clinical narrative: Information has been received on 19-OCT-2016 from a female consumer (mother of patient) 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 received vaccination with a dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported). The mother of the patient reported that the patient developed a hard lump after receiving GARDASIL 9. Treatment and outcome of the adverse event was not reported. No further adverse event information was provided as the reporter declined to participate in answering questions within this adverse event report. No consent to contact reporter or physician. No contact details provided. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as no consent was given for further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as Licensed Practical Nurse) refers to an unknown number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were vaccinated with improperly stored doses of VAQTA (lot # M018644, expiry date 20-SEP-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported in any patient. The vaccine was exposed to the temperature of -0.1 degree Celsius for 1 hour 9 minutes; 1.5 degree Celsius for 23 minutes; 1.5 degrees Celsius for 25 minutes; 1.7 degree Celsius for 21 minutes; 0.7 degree Celsius for 50 minutes; and -0.3 degree Celsius for 1 hour 25 minutes. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as Licensed Practical Nurse) refers to an unknown number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M006708, expiry date 02-JUN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported in any patient. The vaccine was exposed to the temperature of -0.1 degree Celsius for 1 hour 9 minutes; 1.5 degree Celsius for 23 minutes; 1.5 degree Celsius for 25 minutes; 1.7 degree Celsius for 21 minutes; 0.7 degree Celsius for 50 minutes; and -0.3 degree Celsius for 1 hour 25 minutes. No product quality complaint was involved. This is one of 3 reports received from the same reporter source. Additional information is not expected as the reporter did not wish 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 (also reported as Licensed Practical Nurse) refers to an unknown number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were vaccinated with improperly stored doses of ROTATEQ (lot # M004542, expiry date 18-OCT-2017 and lot # M014753, expiry date 11-OCT-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported in any patient. The vaccine was exposed to the temperature of -0.1 degree Celsius for 1 hour 9 minutes; 1.5 degree Celsius for 23 minutes; 1.5 degree Celsius for 25 minutes; 1.7 degree Celsius for 21 minutes; 0.7 degree Celsius for 50 minutes; and -0.3 degree Celsius for 1 hour 25 minutes. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of VARIVAX lot # M017290, expiry date: 07-APR-2018 and lot # M027343, expiry date: 01-JUN-2018 (dose and route were not reported). The details of the storage were temperature excursions of -12.4 C for 22 hours, 29 minutes, -12.5 C for 13 hours 26 minutes, -10.2 C for 19 hours 45 minutes and -10.6 C for 4 hours 11 minutes. No adverse events were reported. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information is not expected as the physician cannot be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other licensed nurse practitioner refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored doses of PROQUAD lot # M031566, expiry date: 04-DEC-2017 and lot # M017335, expiry date: 05-OCT-2017 (dose and route were not reported). The details of the storage were temperature excursions of -12.4 C for 22 hours, 29 minutes, -12.5 C for 13 hours 26 minutes, -10.2 C for 19 hours 45 minutes and -10.6 C for 4 hours 11 minutes. No adverse events were reported. There were no product quality complaint involved. This is one of the two reports from the same reporter. Additional information is not expected as the physician cannot be contacted.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Fall, Fatigue, Injection site pain
Clinical narrative: Information has been received from a consumer referring to his spouse, a 76 year old female patient with heart rate irregular, coagulation time shortened and arthritis. In June 2016 the patient had a severe case of pneumonia that led to a prolonged hospital stay, heart failure, stroke and a compromised immune system, in which case, the physician recommended PNEUMOVAX 23 once she recovered. The patient had no drug reactions or allergies. Concomitant medication included heart regulator medication, blood thinner medication, vitamins and arthritis medication. On 02-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date and dose were unknown, intramuscular). On 03-NOV-2016, the patient experienced extreme fatigue, swollen, injection site pain, labored breathing and extreme dizziness which led to her falling. It was reported that therapy was not discontinued. The patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events. Causality was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a consumer referring to his spouse, a 76 year old female patient with heart rate irregular, coagulation time shortened and arthritis. In June 2016 the patient had a severe case of pneumonia that led to a prolonged hospital stay, heart failure, stroke and a compromised immune system, in which case, the physician recommended PNEUMOVAX 23 once she recovered. The patient had no drug reactions or allergies. Concomitant medication included heart regulator medication, blood thinner medication, vitamins and arthritis medication. On 02-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date and dose were unknown, intramuscular). On 03-NOV-2016, the patient experienced extreme fatigue, swollen, injection site pain, labored breathing and extreme dizziness which led to her falling. It was reported that therapy was not discontinued. The patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ orally (lot # M016238, expiration date 07-DEC-2017) (dose not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. 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 licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored GARDASIL 9 (lot # M023169, expiration date 13-JUN-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degrees Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. 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: Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M020926, expiration date 11-AUG-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal episode post HPV vaccination. B/P 105/71, P. 84 with possible brief loss of consciousness.
Age: 80.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site mass
Clinical narrative: Lump on left arm after pheumo vaccine.
Age: 36.0
Sex: U
Vaccine: TYP
Symptoms: Immunisation, No adverse event, Syringe issue
Clinical narrative: Syringe came apart from syringe contents. No vaccine administered to pt. No AE from injection. Pt. was revaccinated later on.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Biopsy site unspecified abnormal, Injection site nodule, Injection site reaction, Lipoma excision
Clinical narrative: Pt. stated that after receiving ZOSTAVAX in 7/2013 she felt a "knot" that never went away. Pt. saw PCP and then followed up with surgeon who removed Lipoma from same area shot was given.