chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 15-MAR-2011, 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.
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-JUN-2009, patient received VARIVAX dose 1, from lot # 663709/0193Y expiry date: 06-FEB-2011. On 31-JUL-2009, the patient received second dose of improperly stored VARIVAX from lot # 663709/0193Y expiry date: 06-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 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 received vaccinations with improperly stored VARIVAX dose number 1 on 06-MAR-2008 and dose number 2 on 21-APR-2008, both from lot# 658023/0824U with expiry date of 25-MAY-2009 (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: 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. On 21-MAY-2012 the patient was vaccinated with improperly stored VARIVAX lot # 671861/1907AA, 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 practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 28-JUN-2011, patient received improperly stored (Oka/Merck) VARIVAX  dose 1 from batch/lot# 669223-1564Z (expiry date, dose units, route and anatomical location were not specified), on 02-AUG-2011, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # 669601/0138AA (incorrect product storage).  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 provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.  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 as 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. On 04-MAY-2012, the patient was vaccinated with improperly stored dose of VARIVAX lot # 1273AA 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 practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-AUG-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 669601/0138AA (expiry date, dose units, route and anatomical location were not specified (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: HPV4
Symptoms: Seizure
Clinical narrative: This solicited report received from the consumer and refers to 2 children of unknown age and gender enrolled in Market Research Program. The consumer reported that the another parent's children were extremely healthy and without any seizures. On an unknown date, the children were vaccinated with a doses of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date (reported as shortly thereafter), the children riddled with seizures. The outcome of the seizures was not reported. The reporter felt that seizures were related to the GARDASIL. Upon internal review the event of seizure was considered to be medically significant. This is one of 2 reports from the same reporter. Additional information is not expected because the reporter did not want his doctor to be contacted.
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 patient's concurrent condition, medical history and concomitant medications were not reported. On 10-MAR-2009, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # 61445/0525X (expiry date, dose units, route 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 provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain in upper right arm.
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 26-NOV-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # H018451 (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 10-FEB-2012, patient received improperly stored VARIVAX dose 2, from batch/lot # 669842/0931AA ( 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 were 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 06-JUL-2009, patient received improperly stored VARIVAX dose 1, from batch/lot # 663709/0193Y and on 13-AUG-2009, dose 2 of improperly stored VARIVAX 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 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 nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unspecified date in August 2016 (reported as between 15-AUG-2016 and 26-AUG-2016), the patient might have been vaccinated with an improperly stored dose of GARDASIL 9 (lot # L043214, expiration date 30-AUG-2017; exact dose, site and route of administration were not reported. The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 28.6 Fahrenheit (F) degrees for 258.45 hours before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via a sales rep and described the occurrence of injection site swelling in a adolescent patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection sited swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to BEXSERO. Additional details were provided as follows: The exact age at vaccination was not reported. The reporter from vaccine service center reported that, a healthcare professional from office stated that three of four adolescent patients experienced bumps and redness at the injection site lasting more than one week after administrations. The reporter had no patient or product information.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable 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 (Oka/Merck) VARIVAX, dose route and frequency unknown. On 12-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # H018451, dose 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Mom noticed (L) leg was swollen, red and warm that night. the next day the leg was very warm, hard, swollen and hurt. Patient also started with a fever. Mom went to urgent care and was told it was cellulitis and put on an antibiotic. Redness is down and no fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Mom noticed (L) leg was swollen, red and warm that night. the next day the leg was very warm, hard, swollen and hurt. Patient also started with a fever. Mom went to urgent care and was told it was cellulitis and put on an antibiotic. Redness is down and no fever.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocation Nurse (LVN) referring to a 7 weeks old male patient who had no relevant medical history, concomitant medications or drug allergies. On 07-JUL-2016, the patient received his first dose of ROTATEQ (2 ml, oral, lot # L029615, expiration date 15-MAY-2017) which was exposed to a temperature excursion. There was no relevant laboratory data. After the vaccination, no adverse events had been reported thus far. 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 VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-JUN-2008, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 658023/0824U with expiry date of 25-MAY-2009. 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 31-MAR-2015, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from batch/lot # K007982(expiry date, dose units, route 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 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 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 29-APR-2014, the patient was vaccinated with second dose of VARIVAX from lot # H018451 with expiry date of 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 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 24-NOV-2015 the patient was vaccinated with first dose of (Oka/Merck) VARIVAX lot # L015045 which was improperly stored. 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 practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-NOV-2013, patient received improperly stored VARIVAX dose 2, from lot # H018451 (dose and 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 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 an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 21-SEP-2011 the patient was vaccinated with an 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 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 09-MAR-2015, patient received improperly stored VARIVAX dose 2, from lot # K007982 (dose and 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 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 (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 01-DEC-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2,(dose unknown)  from lot # 669601/0138AA with expiry date of 26-JAN-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 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 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 19-JUL-2010, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 6668512/0280Z 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 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 15-MAY-2009, patient received improperly stored VARIVAX dose 2, from lot # 663710/0219Y expiry date: 13-FEB-2011. No adverse effects 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 the several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Pharmacist (R.Ph.) referring to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 14-AUG-2016, the patient was vaccinated with an unspecified improperly stored dose of ZOSTAVAX, at a dose of 0.65 ml, (lot number M019645 with expiration date of 18-JUL-2017 or lot number M020071 with expiration date of 18-JUL-2017, the reporter was not sure which lot was given to the patient) (strength, route of administration and anatomical location were not reported). Concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of 26 Fahrenheit (F) for 60 hours. Furthermore, no product quality complaint was involved. 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 date unknown). On 17-NOV-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2, (dose unknown) from lot # 669601/0138AA with expiry date of 26-JAN-2016. 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 an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-MAY-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: 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 07-JUN-2010, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot #665413/1128Y expiry date: 07-AUG-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 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 21-FEB-2011, patient received improperly stored VARIVAX dose 2, from lot # 666869/0469Z expiry date 31-MAR-2012.  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 condition, medical history and concomitant medications were not reported. On 07-JUN-2007, the patient was vaccinated with improperly stored VARIVAX dose 1, (dose unknown), from lot # 656078/0169U with expiry date of 17-JAN-2009. No adverse effects 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 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 registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration and frequency were unspecified). The improperly doses of VARIVAX corresponded to the following lot number: K021487, expiration date: 03-NOV-2016; L030158, expiration date: 11-AUG-2017 and M010482 (lot# reported as), expiration date: 01-MAR-2018, which were exposed to a temperature of 8.8 Fahrenheit degrees for a time frame of 40 minutes due to a digital data logger, then the vaccines were put back in range. No adverse effects were reported. This is one of several reports from the same reporter (linked case: 1608USA014330). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia, Rash vesicular
Clinical narrative: Information had been received on 18-JUL-2016 from a nurse practitioner regarding a 55 year old female with high blood pressure, depression and allergies to BIAXIN and sulfa drugs. On 15-JUL-2016, patient had been administered an unspecified dose of ZOSTAVAX (lot# M001747, expiration date 07-APR-2017) subcutaneous at an unknown pharmacy. Concomitant medications included multiple unknown medications. Nurse practitioner reported that on 16-JUL-2016, patient developed an area of 16 cm by 7 cm of redness and warmth and in the central area of the rash there was a vesicular type rash which was located on the back of the patient's right arm. Patient also had an unknown fever. Nurse practitioner reported that from 16-JUL-2016 to 17-JUL-2016, the patient got worse as she had the fever both days and more vesicles showed up on the patient's arm. On 18-JUL-2016, patient presented for follow up on the administration of ZOSTAVAX and she did not have any fever and no new vesicles developed on her arm. No additional information was provided in regards to this adverse event. During the conversation, nurse practitioner also reported that multiple unknown patients were administered an unspecified dose of ZOSTAVAX (unknown lot#/expiration date) on multiple unknown dates (MARRS# 1608USA014081). The nurse practitioner reported that on multiple unknown dates following the administration of ZOSTAVAX the multiple unknown patients then developed a "small injection site reaction or rash". No additional information was provided in regards to this adverse event and no further details were provided regarding these patients. This is one of two reports from the same reporter. Additional information is not expected.
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, medial history and concomitant medications were not reported. On 16-NOV-2015, the patient was vaccinated with improperly stored VARIVAX dose 1, 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 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: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant reporting a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-AUG-2016, the patient was vaccinated with M-M-R Ii injection, lot # K011317, expiration date 14-AUG-2016 (strength, dose and route of administration were not provided). There were no concomitant medications reported. No adverse events were reported and no product quality complaint was involved. Additional information is not expected as the reporter did not consent for new follow up attempts.
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 15-DEC-2015, patient received improperly stored VARIVAX dose 2, 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 conditions, medical history and concomitant medications were not reported. On 27-OCT-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 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 VARIVAX dose 1, (dose, lot # and expiry date unknown). On 11-NOV-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 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: 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 02-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: 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 VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-MAY-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2017 (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 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 21-OCT-2009, patient received improperly stored VARIVAX dose 2, from lot # 664468/0684Y expiry date 15-MAY-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 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 conditions, medical history and concomitant medications were not reported. On 22-MAY-2012, patient received improperly stored VARIVAX dose 1, from batch/lot # 671861/1907AA ( 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 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 09-JUN-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-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 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 14-DEC-2015, patient received improperly stored VARIVAX dose 1, 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 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 condition, medical history and concomitant medications were not reported. On 30-MAR-2009, patient received improperly stored VARIVAX dose 1, from lot # 661445/0525X expiry date 27-MAR-2010. On 20-MAY-2009, the patient received VARIVAX from lot # 663710/0219Y expiry date 13-FEB-2011 (dose # 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 several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Genital rash, Irritability, Oral mucosal eruption, Rash, Rash generalised
Clinical narrative: Received PROQUAD (MMRV) 8/15/16 in office. Returned 8/18/16. the chief complaint is: c/o: rash on mouth and body and venous lead. This is a 1.0 year old male with the following history: He presents with a rash around the mouth and spots on the hands, feet and genitalia for the last few days since getting his vaccines. He has not had fever. He is fussy. he is eating normally.
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. On 08-MAR-2010 the patient was vaccinated with improperly stored dose of VARIVAX lot # 665413/1128Y dose number 2. No adverse effects reported. This is one of several reports received from the same source. 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 a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-AUG-2016, the patient was vaccinated with improperly stored dose of PROQUAD (lot # M007960, expiry date: 15-AUG-2017) (route: subcutaneous). The vaccine was stored at a temperature of -7.9 C for 5 hours, 31 minutes. Digital data logger was involved and the vaccine was back in range. There was no previous temperature excursions. No adverse effects reported. 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 12-JUN-2013, 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: 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 30-JAN-2012, the patient received improperly stored VARIVAX dose 2, from lot # 669842/0931AA, expiry date 13-JUN-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 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 08-JAN-2016, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y (dose and 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 the same reporter. Additional information has been requested.