chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M011116, expiration date 17-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of VAQTA were stored in the temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four 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 pharmacist concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In October 2016 (reported as "between 12-OCT-2016 and 19-OCT-2016"), the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # M028553, expiration date 07-JUN-2018, (route and anatomical location of administration were unknown). The temperature excursion reported was 15 C for 72 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to a patient of unknown age and gender. No relevant medical history or concomitant conditions were reported. On 28-NOV-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M031944,expiration date 27-DEC-2017; dose and route were not reported). No adverse effects were reported. It was reported that there was no previous temperature excursion and a data logger was involved. The vaccine was exposed to -10.7 Celsius degree for 1 hour and 46 minutes. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On28-NOV-2016, the patients were vaccinated with 2 doses of improperly stored VARIVAX (lot # M027885, expiration date 03-JUN-3028; doses and routes were not reported) (it was unspecified if the two doses of vaccines were administered to the same patient or two patients). No adverse effects were reported. It was reported that there was no previous temperature excursion and a data logger was involved. The vaccines were exposed to -10.7 Celsius degree for 1 hour and 46 minutes. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 with lot number M003659 and expiration date of 20-SEP-2017 (strength, route of administration, anatomical location and dose were unknown), which were stored at a maximum of 60 Fahrenheit degrees (degrees F) for 24 hours and a minimum of 29.3 degrees F for 1.5 hours (14 cycles below 32 degrees F). There was a previous temperature excursion described as below 32 degrees F off and on for a week, several occasions stated as 50 minutes, 45 minutes, 40 minutes, 55 minutes, 1 hour and 15 minutes, 50 minutes, 35 minutes, 35 minutes, 1 hour and 35 minutes, 2 hours and 15 minutes, 45 minutes, 30 minutes and 55 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unspecified date in 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, lot number and expiration date were not reported). Then on 28-NOV-2016, the patient was vaccinated with the second dose of GARDASIL (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. No symptoms were reported. No product quality complaint was involved. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L048848 with expiration date: 09-AUG-2018; lot # M010671 with expiration date: 02-JUN-2018; lot # M000442 with expiration date: 31-MAR-2018; lot # L048848 with expiration date: 04-FEB-2018; lot # L040458 with expiration date: 04-FEB-2018; (strength, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75 hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB lot # M039201 with expiration date 04-NOV-2018 and lot # M032653 with expiration date 31-MAY-2018 (dose and route of administration were not reported). The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 lot # L037339 with expiration date 09-FEB-2016 (dose and route of administration were not reported). The doses were exposed to 59 degrees Fahrenheit for 12 hours. The temperatures were not recorded with a data logger and there were no previous excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a 3 year old patient. The patients' pertinent medical histories and concomitant therapies were not reported. On 26-AUG-2016, the patient received a dose of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017)(dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of 5 reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L037554, expiration date 25-DEC-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of GARDASIL 9 were stored in a temperature of 13.98 degrees Celsius for 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure via eye contact, Eye irritation, Product container issue, Product quality issue
Clinical narrative: This spontaneous report as received from a physician on an unknown age refers to herself. The patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medication. The physician reported that on 11-NOV-2016, the solution of (Oka/Merck) VARIVAX (lot # and expiry date were not reported) squirted into her eye due to the vial having some pressure irregularity and it has caused her some irritation around her on the same day. There was no treatment given for the event. She did not have any laboratory test performed and did not seek any medical attention. Product quality complaint was reported. The outcome of the event of some irritation around the eye was reported as not recovered. The reporter considered irritation around eye to be related to (Oka/Merck) VARIVAX. Additional information is not expected because there was no consent to contact physician.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 11-AUG-2015, 20-OCT-2015, 16-FEB-2016 and 27-OCT-2016, the patient was inadvertently vaccinated with 4 doses of GARDASIL 9 (dose and route unknown for all doses) (lot# for first dose: K011562 which is invalid; lot# for second dose: L013429; lot# for third dose: L0183511 which is invalid; lot# for the fourth dose: M018810; expiration date for all doses were unknown) (Extra dose administered). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug dose omission, No adverse event, Product colour issue
Clinical narrative: This spontaneous report received from the medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient missed dose of M-M-R II 0.5 ml subcutaneously (lot number not reported, expiry date: 06-APR-2018 and 18-MAY-2018) because the reconstituted product did not have the normal color. No adverse effects reported. PQC has been filed. The patient had been rescheduled for vaccination. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were administered an unspecified umber of improperly-stored doses of RECOMBIVAX HB 10/1.0 microgram/ml (lot # M032649 with expiration date 11-NOV-2018, lot # L048848 with expiration date 09-AUG-2018; dose unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # M031802 with expiration date: 09-NOV-2017; lot # M019691 with expiration date: 02-NOV-2017; lot # M019707 with expiration date: 25-OCT-2017; lot # L044476 with expiration date: 07-SEP-2017; lot # M018957 with expiration date: 22-JUL-2017; (strength and dosage unspecified) via oral route. Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75 hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant and refers to 15 year old patient of unknown gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On 26-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # M017982, expiration date 13-SEP-2017; dose, frequency and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of VAQTA lots # M016191 and  M09377 with expiration dates 26-MAY-2017 and 17-JUN-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for 1 hour and 30 minutes and then was also exposed to a temperature fo48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL (dose, frequency, route, lot number and expiry date were not reported) or GARDASIL 9 (dose, frequency, route, lot number and expiry date were not reported). The vaccines were exposed to a temperature frame of 32 Fahrenheit to 34 Fahrenheit for an unspecified duration. Reporter stated that consumer asked pharmacist's advice on how to decide on the possible need for revaccination, as the unspecified physician who administered the vaccines did not provided any guidance to her. There was no product quality complaint involved. Additional information is not expected as the reporter has not provided consent to contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VAQTA lot # L015460, 20-JUL-2017 exposed to 0.4'C for 231 hours, L015460 20-JUL-2017 exposed to 30F for 684hours, M017982 13-SEP-2017 exposed 30F for 325 hours. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # L027067, 04-JUN-2017 exposed to 0.4 degree centigrade for 344 hours, L029617 19-MAY-2017 exposed to 0.3 degree centigrade for 326 hours, lot L033545 30-MAY-2017 exposed to 34.1F for 132 hours, L027076 25-MAY-201 exposed to 0.7 degree centigrade for 177 hours, M004508 29-JUN-2017 exposed to 30F for 408 hours, M014318 30-SEP-2017 to 30F for 210 hours. No adverse effects were reported. There was no prior excursions. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Herpes simplex test positive
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unknown dates, the patient was vaccinated with series of GARDASIL (dose and route unknown). On an unspecified date, the patient had positive herpes simplex virus (HSV) titers that lasted an unspecified amount of time. The outcome of the event was unknown. The causal relationship between the event and GARDASIL was unknown. Additional information is not expected as the reporter did wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unknown number of patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 (indication, dose, frequency and dose number were not provided) (Lot # K026246 with an expiration date in 28-JAN-2017). No adverse effects were reported. The vaccines were exposed to a temperature excursion of 15.6 Celsius degrees for 1 hour and 59 minutes. Concomitant medication information was not provided. This is one of two reports from the same reporter. Additional information is not expected as no consent for follow up was provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 RECOMBIVAX HB lot # L048848, expiration date 09-AUG-2018 and lot# M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # M015931 with expiration date: 22-JAN-2018; lot # M007277 with expiration date: 09-FEB-2018; lot # L047134 with expiration date: 24-NOV-2017; lot # L039613 with expiration date: 08-OCT-2017; lot # L036853 with expiration date: 24-SEP-2017; (strength, therapy type, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75  hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. 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 medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M017983 with expiration date: 30-MAY-2018; lot # M016193 with expiration date: 24-APR-2018; lot # M013636 with expiration date: 15-FEB-2018; lot # L026602 with expiration date: 19-OCT-2017; (strength, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75 hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M002268 with expiration date: 20-SEP-2017; lot # M017982 with expiration date: 13-SEP-2017; lot # M022924 with expiration date: 24-JAN-2018; (strength, dosage and route unspecified). Temperature excursion details are as follows: temperature of 53.2F for time frame of 4.75 hours (285 minutes). There was no previous temperature excursion. Call was because of a data logger. No adverse effect reported. No product quality complaint involved. No additional information available. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.83
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 11-NOV-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K016153, expiration date: 24-SEP-2016 (dose, strength and route were not reported), furthermore, no previous temperature excursions and no adverse effects were reported. No Product Quality Complaint was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 64-year-old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not provided. On 10-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot# L028284, expiration date: 28-OCT-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lot # L024993, expiration date 17-OCT-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for 1 hour and 30 minutes and then was also exposed to a temperature of 48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistance concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # L031459, expiration date 30-APR-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for hour and 30 minutes and then was also exposed to a temperature of 48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lots # L048208 and L048849 with expiration dates 15-SEP-2017 and 04-FEB-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The medical assistant reported that the vaccine was exposed to a temperature of 51F for 1 hour and 30 minutes and then was also exposed to a temperature of 48F during an hour and that this information was obtained with a digital data logger. Finally, no product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as no consent for follow up was given.
Sex: U
Vaccine: HEP
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. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Since 12-AUG-2016 to 16-AUG-2016, the RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017) was stored in 9 Celsius degrees for 5 days. In September 2016, (excursion day unspecified), the RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017) was stored in 8.1 Celsius degrees for 45 minutes. Total time out of range was 120 hours, 45 minutes. There were no previous excursions. The excursions were detected by a data logger. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017) (dose, route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-JUL-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at 8.33 Celsius Degrees for 416 hours, 9.44 Celsius Degrees for 168 hours, 15 Celsius Degrees for 56 hours, -3 Celsius Degrees 1172 hours, -1.11 Celsius Degrees for 80 hours and 8.88 for 24 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases 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 medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX lot # L040421 15-OCT-2017, L043624 03-NOV-2017 exposed to 5.8F for 114 hours, L049532 08-DEC-2017 exposed to 5.8 F for 114 hours, M006156 05-FEB-2018 exposed to 6.8F for 24 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, L039269 05-APR-2017, M015699 26-SEP-2017 exposed to -13 degree centigrade for 65 hours for. There were no prior excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unknown number of patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 (indication, dose, frequency and dose number were not provided) (Lot # L014458 with an expiration date in 11-FEB-2017 and Lot # reported as M029681 with an expiration date in 22-JAN-2018). No adverse effects were reported. The vaccines were exposed to a temperature excursion of 15.6 Celsius degrees for 1 hour and 59 minutes. Concomitant medication information was not provided. This is one of two reports from the same reporter. Additional information is not expected as no consent for follow up was provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Severe injection site reaction noticed the morning after vaccine received- approximately 2 in. diameter red, hard induration, hot to touch. Diffuse pink, warm rash on entire upper left arm. Improvement in symptoms over the next 48 hours. Patient reported to pharmacy to alert pharmacist of the reaction on 11/28/16 at approximately 8 pm.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Discomfort, Hypoaesthesia, Radiculopathy
Clinical narrative: (L) arm - nerve, irritation down to hand between thumb and forefinger; onset 5-10 secs post IM administration of Hep. A vaccine; discomfort followed by numbness; 20 mins showed increase in comfort.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial and follow up information was received from a Registered nurse concerning to a patient (age and gender not reported). On an unknown date the patient was vaccinated intramuscularly (outside the recommendations per prescribing information) with a dose of ZOSTAVAX (Lot no. L035506 exp. 16-DEC-2016). The nurse reported that also a dose of PNEUMOVAX 23 (Lot no. L017406, exp. 26-FEB-2017) in the other arm. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M010212, expiration date 21-JAN-2019 (dose was not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of RECOMIBVAX HB were stored in the temperature of 13.98 degrees Celsius of 10 minutes and in the temperature of 10.58 degrees Celsius for 10 minutes. Data logger was involved. There were no previous temperature excursions reported. At the time of reporting, there was no further information to provide. This is one of four reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dryness, Injection site rash
Clinical narrative: Patient presented with rash and very dry skin on area of injection. Patient took.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Rash
Clinical narrative: Patient presented with rash and very dry skin on area of injection. Patient took.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Pt reports raised, fire bump red rash that began on trunk - spread to legs - on 11/22; went to urgent care center 11/25 2 hours itching and no improvement with topical antihistamine cream; TX with steroid taper - trunk rash resolved - now on back and remains on legs - no other symptoms reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-NOV-2016, the patient was inadvertently vaccinated with an improperly stored dose of ZOSTAVAX injection, subcutaneously, lot # M035146, expiration date 26-JUL-2017 (dose and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered dose of ZOSTAVAX was stored in the temperature of 55 degrees Fahrenheit for 4 hours. Data logger was not involved. There were no previous temperature excursions reported. Additional information is not expected as no consent for contact was given.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Vomiting, Wheezing
Clinical narrative: Vomiting, diarrhea, wheezing. 1 vial of albuterol administered. 0.1 ml of epinephrine of 1:1000 (1mg/mL) administered.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Urticaria
Clinical narrative: Patient developed local reaction. Presented as a large, red, egg shaped welt on the back of her arm. It also itched. On 11/10/16, the patient reported that the welt is more pink in color, and is starting to get better. Patient did not seek medical treatment.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Flushing, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed itchy red rash after Hepatitis B vaccine and Tdap vaccines on 11/23/16. Also developed a second rash/hives on 11/28/16 that was more severe. Also had facial redness/flushing.
Age: 31.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Urticaria
Clinical narrative: Developed itchy red rash after Hepatitis B vaccine and Tdap vaccines on 11/23/16. Also developed a second rash/hives on 11/28/16 that was more severe. Also had facial redness/flushing.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant mediations were not reported. On 14-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 Plaque Forming Unit, lot #L017165 and expiration date 13-AUG-2016. (The route of administration was not reported). No adverse effect reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient presented with redness, warmness and itching at injection site. Noted 2 blisters also present, not directly on but around injection site swelling. Tx included BENADRYL for itching and ice at least 3x daily. F/u if no improvement.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This solicited report was received from the mother of a 15 year old male patient who enrolled in a Market Research study. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1 (strength, dose details, lot/batch #: unspecified). The patient's mother told that "I heard he may only need 2 shots instead of 3. I was waiting to hear from the Doctor what it would be and when we would get the second shot". Action taken was not applicable. Outcome was unknown. Causality was reported as related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Nausea, Wrong drug administered
Clinical narrative: Information has been received from a nurse via a company representative referring to a 17 years old female patient who was not pregnant. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-OCT-2016, also reported as last Monday, the patient was to be given an unspecified meningococcal vaccine and instead was administered GARDASIL 9, (patients specific history with GARDASIL 9 was unspecified, therefore it was unknown if the patient had received prior doses within the series). It was reported that "over the weekend (29-OCT-2016 and 30-OCT-2016)", the patient was having "nausea and abdominal pain". The patient called to physician to seek medical attention. The outcome of the events was unknown. The causal relationship between GARDASIL 9 and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 15-OCT-2012 the patient was vaccinated first dose of GARDASIL (dose and route were not reported, lot # 0652AE). On 05-AUG-2016, the patient was vaccinated the second dose of GARDASIL 9 (dose and route were not reported, lot # M007764). No adverse event was reported. Additional information has been requested.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a 19 month old patient of unknown gender. The patients' pertinent medical histories and concomitant therapies were not reported. On 30-AUG-2016, the patient received a dose of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of 5 reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a 7 year old patient of unknown gender. The patients' pertinent medical histories and concomitant therapies were not reported. On 26-AUG-2016, the patients received a dose of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017)(dose and route of administration were not provided). No adverse symptoms were reported. No product quality (PQC) was involved. This is one of 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 with lot number M006141 and expiration date of 28-MAY-2017 (strength, route of administration, anatomical location and dose were unknown), which were stored at a maximum of 60 Fahrenheit degrees (F) for 24 hours and a minimum of 29.3 degree F for 1.5 hours (14 cycles below 32 degree F). There was a previous temperature excursion described as below 32 degree F off and on for a week, several occasions stated as 50 minutes, 45 minutes, 40 minutes, 55 minutes, 1 hour and 15 minutes, 50 minutes, 35 minutes, 35 minutes, 1 hour and 35 minutes, 2 hours and 15 minutes, 45 minutes, 30 minutes and 55 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not provided. On 03-NOV-2016, the patients were administered improperly stored doses of M-M-R II (therapy type: RHA) (lot # L047134, expiration date 24-NOV-2017) (strength, dose, frequency and route were not reported), which was exposed to a temperature of 14.3 Celsius degree (C) for 10 hours and 42 minutes. It was reported that the vaccine was also exposed to the temperature excursions as following: 14.3 C for 164 minutes on 10-NOV-2016, 12.4 C for 270 minutes on 11-NOV-2016, 11.3 C for 134 minutes on 12-NOV-2016, 8.9 C for 20 minutes on 13-NOV-2016 and 8.7 C for 74 minutes on 17-NOV-2016. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA with lot number M011116 and expiration date of 17-JUN-2017 (strength, route of administration, anatomical location and dose were unknown), which were stored at a maximum of 60 Fahrenheit degrees (F) for 24 hours and a minimum of 29.3 degree F for 1.5 hours (14 cycles below 32 degree F). There was previous temperature excursion described as below 32 degree F off and on for a week, several occasions stated as 50 minutes, 45 minutes, 40 minutes, 55 minutes, 1 hour and 15 minutes, 50 minutes, 35 minutes, 35 minutes, 1 hour and 35 minutes, 2 hours and 15 minutes, 45 minutes, 30 minutes and 55 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal pain
Clinical narrative: Severe shoulder pain. aggravated with use, but persistent.  Disturbed nighttime rest with pain. treated with otc meds and physical therapy.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Severe shoulder pain. aggravated with use, but persistent.  Disturbed nighttime rest with pain. treated with otc meds and physical therapy.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Food allergy, Vomiting
Clinical narrative: Stomach pain and vomiting intermittently over the next few weeks.  He seems to have suddenly developed a food allergy, most likely to peanuts.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Patient vaccinated with 0.25 mL of FLULAVAL QUADRIVALENT vaccine. Vaccine only licensed for 3 years old & older.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Left arm pain.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Patient received 0.25mL of FLULAVAL QUADRIVALENT vaccine which is only licensed for those 3 years old and older.