chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (also reported and "medical assistant") refers to 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 (Oka-Merck) PROQUAD injection (dose, lot # expiry date, route of administration and anatomical location were not specified). No adverse reactions 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-APR-2008, the patient received improperly stored VARIVAX dose 2, from lot # 658023/0824U, expiry date 25-MAY-2009 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-JUN-2011, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from batch/lot # 1564Z (expiry date, dose, units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effect were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was sufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling and redness at both injection site. the right leg had 6" by 8.5" reaction with some induration. the left leg had a red and swollen area that was slightly bigger than a half dollar. They were both hot to touch. She was placed on antibiotics.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot number and expiration were: L026407/15-JUL-2017, L008272/11-MAR-2017, L016124/06-MAY-2017). No adverse effects reported. The temperature excursion was 6.8 degree Fahrenheit for 45 minutes. There was no previous temperature excursion. This report was for data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-AUG-2012, the patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA, expiry date 05-DEC-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 17-FEB-2014, the patient was vaccinated with second dose of VARIVAX (dose unknown) from lot # H018451 with expiry date: 09-OCT-2014 which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 29-NOV-2010, patient received improperly stored VARIVAX dose 1, from batch/lot # 666869/0469Z (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 17-OCT-2011, the patient was vaccinated with improperly stored dose of VARIVAX lot # 669601/0138AA dose 1. On 22-NOV-2011, the patient was vaccinated with second improperly stored dose of VARIVAX, lot#: 669601/0138AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-OCT-2015, the patient was vaccinated VARIVAX, lot # L015045 (dose, dose number, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 09-DEC-2010, the patient was vaccinated with improperly stored VARIVAX, dose number 2, lot # 666869/0469Z. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1m (dose, lot # and expiry date unknown). On 05-MAY-2014, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014,. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 26-AUG-2008, patient received improperly stored VARIVAX dose 1, for lot # 661445/0525X expiry date: 27-MAR-2010. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 04-JUN-2009, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 663710-0219Y expiry date: 13-FEB-2011. No adverse effect were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-MAY-2011, patient received improperly stored VARIVAX dose 2, from lot # 0552Z (expiry date not reported). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 25-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 30-MAY-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 02-MAY-2012, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 1273AA (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 27-MAY-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 0552Z (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. 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 medical assistant regarding possibly 3 patients of unknown age and gender. The RECOMBIVAX HB vaccines were exposed to temperatures between 32F and 34F for 10 days on 02-MAY-2016, 09-MAY-2016, 10-MAY-2016, 13-MAY-2016, 17-MAY-2016, 19-MAY-2016, 20-MAY-2016, 24-MAY-2016, 25-MAY-2016 and 28-MAY-2016. There was no previous temperature excursion reported. On an unknown date approximately in 2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L004754 expiry 10-NOV-2016 and L040458 expiry: 04-FEB-2018). No adverse effects were reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 13-OCT-2011 the patient was vaccinated with improperly stored dose of VARIVAX lot # 669601/0138AA, dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age gender. On an unknown date the patient was vaccinated with first dose of VARIVAX, dose route and frequency unknown. On 15-AUG-2011, the patient was vaccinated with improperly stored dose of VARIVAX lot # 669601/0138AA. No adverse effect reported. This is one 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 practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose (Oka/Merck) VARIVAX  dose, route and frequency unknown.  On 10-FEB-2010, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, lot# 665413/1128Y. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 22-APR-2011, patient received improperly stored VARIVAX dose 1, from lot # 0552Z (dose and expiry date unknown). On 10-JUN-2011, the patient received second dose of VARIVAX from (lot #669223/1564Z expiry date: 11-NOV-2012) which was improperly stored. No adverse effects were reported. The reported stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-FEB-2009, patient received improperly stored VARIVAX dose 2, from batch/lot # 661445/0525X (dose and expiry date unknown) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-JAN-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 1 (dose unknown), from lot # H018451 with expiry date of 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 14-JUN-2017, the patient was vaccinated with the first dose of improperly stored VARIVAX, lot#656078/0169U. On 15-JUL-2008, the patient was vaccinated with second dose of improperly stored VARIVAX lot#:661445/0525X. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown for prophylaxis. On 18-MAY-2012, the patient was vaccinated with improperly stored VARIVAX lot # 671861/1907AA dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report had been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccination VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JAN-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 medical assistant referring to 3 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route were unknown, lot # L050788, expiration date 12-OCT-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative 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 an unknown date, the patients were vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On unknown dates, the patients experienced a local rash at the injection site. The patients were treated with BENADRYL and cortisone. Product quality complaint (PQC) was not involved. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 03-AUG-2016 the patients were vaccinated with improperly stored GARDASIL lot # K010215/expiration date-05-JUN-2016, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The call was because of digital data logger. Temperature/Time frame: 8.9C for 1 hour and 1 minute and previous excursion was 10.4C for 6 hours 18 minutes. The outcome of event was unknown. No PQC (product quality complaint was involved). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-MAY-2014, patient received improperly stored VARIVAX dose 2, from lot # H018451 expiry date: 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07-MAR-2012, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 669842/0931AA with expiry date of 13-JUN-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 11-MAY-2009, patient received improperly stored VARIVAX dose 1, from lot # 663710/0219Y expiry date: 13-FEB-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was vaccinated with improperly stored VARIVAX dose number 1 on 10-DEC-2013 and dose number 2 on 16-JAN-2014, both from lot # H018451 with expiry date of 09-OCT-2014 (dose unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 27-JUL-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 (dose and route were unknown, lot # L050788, expiration date on 12-OCT-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX  dose 1 (dose, lot # and expiry unknown). On 15-DEC-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, from lot L015045 (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-JUL-2010, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 666851/0280Z with expiry date of 12-FEB-2012. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 23-MAR-2007, patient received improperly stored VARIVAX dose 1, from batch/lot # 656078/0169U (expiry date, dose units, route and anatomical location were not specified) and on 23-APR-2007, dose 2 of VARIVAX from batch/lot # 656078/0169U (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus generalised
Clinical narrative: This spontaneous report was received from a 86 year old female patient concerning herself. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, strength, dosage schedule, lot # and expiration date were not reported). On an unknown date, the patient experienced herpes zoster (reported as "shingles", generalized pain and pruritus (reported as "my body still itches and hurts"). There was no product quality complaint (PQC) involved. At the reporting time, the patient did not recover from the herpes zoster, generalized pain and pruritus. The reporter did not assessed causality between the events and the use of ZOSTAVAX. Additional information is not expected as the reported denied consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 05-OCT-2010, patient received improperly stored VARIVAX dose 1, from lot # 666851/0280Z expiry date: 12-FEB-2012. On 06-MAY-2011, the patient received second dose of VARIVAX from lot # 0552Z (dose an expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-NOV-2010, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not provided). On 11-JAN-2011, the patient was vaccinated with the second dose of RECOMBIVAX HB (the second dose was administered later than it should be according to the vaccine schedule) and on 01-MAR-2011, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route of administration, injection site, lot# and expiration date were not provided) (the second and the third dose were administered too close together). No known adverse effects were reported. Product quality complaint was not involved. Additional information is not expected, as there was no consent to contact with the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 17-OCT-2011 the patient was vaccinated with improperly stored dose VARIVAX lot # 669601/0138AA dose 1. On 07-DEC-2011, the patient was vaccinated with the second improperly stored dose of VARIVAX lot # 669601/0138AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 30-SEP-2009, the patient was vaccinated VARIVAX dose 1, lot # 664468/0684Y, expiry date 15-MAY-2011 (dose, route, vaccination site unknown). On 01-FEB-2010, the patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y, expiry date 07-AUG-2011 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-SEP-2009, patient received improperly stored VARIVAX dose 2, from batch/lot # 664468/0684Y (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 01-DEC-2008, patient received improperly stored VARIVAX dose 2, from lot # 661445/0525X expiry date: 27-MAR-2010. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding possibly 3 patients of unknown age and gender. The GARDASIL vaccines were exposed to temperatures between 32F and 34F for 10 days on 02-MAY-2016, 09-MAY-2016, 10-MAY-2016, 13-MAY-2016, 17-MAY-2016, 19-MAY-2016, 20-MAY-2016, 24-MAY-2016, 25-MAY-2016 and 28-MAY-2016. There was no previous temperature excursion reported. On an unknown date approximately in 2016, the patients were vaccinated with improperly stored GARDASIL (lot # M004116 expiry: 12-OCT-2017). No adverse effects were reported. This is 1 of 2 reports 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 has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 03-MAR-2015, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # K007982 (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-NOV-2013, the patient received improperly stored VARIVAX dose 1, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 01-AUG-2008, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 1 , (dose unknown) from lot # 661445/0525X with expiry date of 27-MAR-2010. No adverse effect were reported.  The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that the vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # M007763, expiration date 15-SEP-2017), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-NOV-2015, patient received improperly stored VARIVAX dose 1, from batch/lot # L015045 (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-JUN-2012, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # 671861-1907AA (expiry date, dose units, rout and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 20-NOV-2015, the patient was vaccinated with improperly stored VARIVAX lot # L015045 dose number 1. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.