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 24-NOV-2015, patient received improperly stored VARIVAX 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.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Vaccines administered 8/6/16. Presented to office 8/19/16. Mother notice bumps all over body this morning. Also has fever on and off.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (dose, lot #, expiry date, anatomical location and route of administration 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 29-JUN-2009, the patient received improperly stored VARIVAX dose 2, from lot # 663710/0219Y, expiry date 13-FEB-2011 (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 02-DEC-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 09-JUL-2010, the patient received improperly stored VARIVAX dose 2, from lot # 666851/0280Z, expiry date 12-FEB-2012 (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 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 19-MAY-2014 the patient was vaccinated with improperly stored VARIVAX lot # H018451, 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 and refers to a patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 29-MAY-2009, the patient was vaccinated with improperly stored VARIVAX lot # 663710/0219Y 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 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 08-MAR-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 666869/0469Z (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 several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-MAR-2016, the patient was vaccinated with first dose of PEDVAXHIB (lot unknown, expiry date unknown) (route: intramuscular). On 08-JUN-2016, patient received second dose of PEDVAXHIB (lot unknown, expiry date unknown). On 19-AUG-2016, patient was inadvertently received third dose of PEDVAXHIB (lot #M001813, expiry date: 14-OCT-2018). No adverse effect 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 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 12-JUN-2013, 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 several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: Information had been received on 18-JUL-2016 from a nurse practitioner regarding a case for ZOSTAVAX (MARRS# 1607USA007642). Nurse practitioner reported that multiple unknown patients were administered an unspecified dose of ZOSTAVAX (unknown lot#/expiration date) on multiple unknown dates. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients (unknown ages and genders). The patients pertinent medical histories and concurrent conditions were not provided. The medical assistance reported that from 09-JUL-2016 through 09-AUG-2016, the patients were vaccinated each with a dose of improperly stored PROQUAD lot # M001150, expiration date 05-JUL-2017 (concentration, dosage and therapy route were not informed). No adverse effects were reported. Concomitant therapies were not provided. No product quality complaint (PQC) was involved. 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 14-MAR-2012, the patient was vaccinated with improperly stored VARIVAX lot # 0931AA, 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: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot # L028285 and expiry date: 28-OCT-2016, instead of VARIVAX. No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria (fine) ears, trunk, extremities. No mucosal involvement.
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 07-MAY-2012, the patient was vaccinated VARIVAX dose 1, lot # 1273AA (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 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: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 33 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-AUG-2016, the patient was inadvertently received a dose of PROQUAD (lot # L051101, therapy type rHA, route, dose and expiration date not reported) (drug administered to patient of inappropriate age. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 12-NOV-2010, the patient was vaccinated with improperly stored VARIVAX lot # 666851/0280Z, 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 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 12-MAY-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 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. The patient received improperly stored VARIVAX dose number 1 on 16-MAY-2012 and dose number 2 on 10-JUL-2012, both from lot # 671861/1907AA with expiry date of 05-DEC-2013 (dose 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 01-APR-2014, patient received improperly stored VARIVAX dose 1, 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 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 02-DEC-2009, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 665413/1128Y with expiry date of 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 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 06-JUN-2008, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 658023/0824U with expiry date 25-MAY-2009. 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 and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose VARIVAX, dose route and frequency unknown. On 24-JUN-2009, the patient was vaccinated with improperly stored dose of VARIVAX lot # 663710/0219Y. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-AUG-2016, the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU, lot # L0124771/expiration date- 1-JUL-2016. No adverse event was reported. The outcome was unknown. No PQC (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 or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-FEB-2015, the patient was vaccinated with VARIVAX lot # K007982 dose 1 (dose and expiry date unknown). On 30-MAR-2015, the patient was vaccinated with second dose of VARIVAX from lot # K007982 (dose and 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 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 28-MAY-2014, patient received improperly stored VARIVAX dose 1, from batch/lot # H018451 (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: 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 21-FEB-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 666869/0469Z (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 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 10-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 02-FEB-2015, the patient was vaccinated VARIVAX dose 1, (dose, lot # K007982, expiry date unknown). On 06-APR-2015, patient received improperly stored VARIVAX dose 2, from (lot # K007985 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 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 11-APR-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 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 07-APR-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 the several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site extending to entire upper arm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. came to pharmacy 8/26 stating arm was hurting, swollen, red at injection site, warm to touch. Pt is pregnant so called her OB/GYN.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Computerised tomogram head normal, Diplopia, Disturbance in attention, Fatigue, Gaze palsy
Clinical narrative: AUG 4 - fatigue, diplopia, loss of OD medial gaze. AUG 5,6 - photosensitivity, headache, problems focusing. AUG 7 - left eye drifting, loss of OD medial gaze -> to ER; normal CT/MRI head. AUG 9 - ophtho consult - OD 3rd nerve palsy, OD exotropia hypertropic.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Hypertrophy, IIIrd nerve paralysis, Nuclear magnetic resonance imaging brain normal, Photosensitivity reaction
Clinical narrative: AUG 4 - fatigue, diplopia, loss of OD medial gaze. AUG 5,6 - photosensitivity, headache, problems focusing. AUG 7 - left eye drifting, loss of OD medial gaze -> to ER; normal CT/MRI head. AUG 9 - ophtho consult - OD 3rd nerve palsy, OD exotropia hypertropic.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Strabismus
Clinical narrative: AUG 4 - fatigue, diplopia, loss of OD medial gaze. AUG 5,6 - photosensitivity, headache, problems focusing. AUG 7 - left eye drifting, loss of OD medial gaze -> to ER; normal CT/MRI head. AUG 9 - ophtho consult - OD 3rd nerve palsy, OD exotropia hypertropic.
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 26-JUL-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 condition, medical history and concomitant medications were not reported. On 06-OCT-2011, the patient was vaccinated VARIVAX dose 1, lot # 669601/0138AA, expiry date 26-JAN-2013 (dose, route, vaccination site unknown). On 08-NOV-2011, the patient received improperly stored VARIVAX dose 2, from the same lot # 669601/0138AA, expiry date 28-JAN-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 12-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 conditions, medical history and concomitant medications were not reported. The patient received vaccinations with improperly stored VARIVAX dose number 1 on 14-MAY-2012 from lot # 1273AA (dose and expiry date unknown), and dose number 2 (dose unknown) on 15-JUN-2012 from lot # 671881/1907AA with expiry date of 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 several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Asthma, Condition aggravated
Clinical narrative: This spontaneous report was received from a physician referring to a currently 85 year old female patient. The patient had allergies to seafood, iodinated contrast media-intravenous dye, penicillin's, sulfanilamide, theophylline, odine, albumin human, tetracycline, sulfamethoxazole, metoclopramide, egg, REGLAN, PLAVIX, acetaminophen, LORTAB, FLUZONE, FLUVIRIN, erythromycin base, CIPRO, ZELNORM, XIFAXAN, THEO-DUR, VIOXX and hydrocodone. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported). On an unknown date, the patient experienced allergy to PNEUMOVAX 23 with a symptom of asthma. At the time of reporting, the outcome of the events was unknown. This is one of several reports concerning the same patient. 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 30-MAY2012, the patient was vaccinated with an improperly stored dose of VARIVAX lot # 671861/1907AA (dose 2). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report 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 27-JAN-2011, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 666869/0469Z with expiry date of 31-MAR-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 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 31-MAY-2011, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 0552Z, (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 VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-MAY-2012, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 671861/1907AA with expiry date of 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 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 26-MAY-2011, the patient was vaccinated with improperly stored 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 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 11-APR-2012, the patient received improperly stored (Oka/Merck) 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 and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 17-MAR-2014, the patient was vaccinated VARIVAX dose 1, lot # H018451, expiry date 09-OCT-2014 (dose, route, vaccination site unknown). On 30-APR-2014, the patient received improperly stored VARIVAX dose 2, from the same 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 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-MAR-2009, 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 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 date unknown). On 23-JUL-2010, the patient was vaccinated with  improperly stored (Oka/Merck) VARIVAX dose 2, (dose unknown) from lot # 666851/0280Z with expiry date: 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: 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-MAY-2012, the patient was vaccinated with the first dose of improperly stored VARIVAX, dose, route and frequency unknown, lot#671861//1907AA. On 21-JUN-2012, the patient was vaccinated with second dose of improperly stored VARIVAX lot # 671861/1907AA. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from certified medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date in August 2016, the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot number L010598 and expiration 06-AUG-2016; strength, dose, frequency and route were unknown). No adverse effects were reported. Additional information is not expected as the reporter did not consent to be contacted.
Sex: U
Vaccine: HEPA
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 inactivated VAQTA (dose and route were unknown, lot # M011839, expiration date 13-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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly PNEUMOVAX 23 injection (lot # L019836, expiration date 24-MAR-2017; strength dose, frequency and route were unknown), which was exposed to temperature excursion of 31.1 degrees Fahrenheit for 2 hours (1 cycle). There were no previous temperature excursion. It was unknown if data logger involved. No adverse effects were reported. No product quality complaint (PQC) 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 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 06-JUN-2011, patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z expiry date: 11-NOV-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: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 18-AUG-2016, the patient was vaccinated an expired dose of oral ROTATEQ (dose unknown, lot # K022990, expiration date 26-JUN-2016 orally. No known adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 18-AUG-2016, the patient was vaccinated an expired dose of oral ROTATEQ (dose unknown, lot # K022990, expiration date 26-JUN-2016 orally. No known adverse effect 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 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 14-FEB-2014 and dose number 2 on 09-MAY-2014, both from lot # H018451 with expiry date on 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: 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 11-JUN-2013, 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. 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 15-NOV-2011 the patient was vaccinated with second dose of VARIVAX lot # 669601/0138AA which was improperly stored. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.