chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information about the patient's medical history and concomitant therapy. On 05-DEC-2015, the patient was vaccinated with an expired dose of M-M-R II (lot # J014876 with expiration date on 21-NOV-2015, dose and route unknown) (expired product administered). No adverse effects were reported. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Feeding disorder, Fluid intake reduced, Insomnia, Restlessness
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of decreased appetite in a 6-month-old male patient who received PEDIARIX (batch number N2LK2, expiry date unknown). Co-suspect products included PREVENAR 13. Concomitant products included PREVENAR 13. On 18th November 2015, the patient received PEDIARIX (intramuscular) .5 ml and the 2nd dose of PREVENAR 13. In 2015, less than a month after receiving PEDIARIX, the patient experienced fluid intake reduced and restlessness. In November 2015, the patient experienced weight loss. On 18th November 2015, the patient experienced decreased appetite and sleep decreased. On an unknown date, the outcome of the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss were recovering/resolving. It was unknown if the reporter considered the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss to be related to PEDIARIX. Additional details were received as follows: On 5th November 2015, the patient received a dose of PREVENAR 13. On 5th November 2015, the patient could not eat and sleep for about a week and a half and both the events were completely resolved. The reporter clarified that her son could eat but his appetite was decreased to a fraction of what he normally ate. The patient was sleeping might be for 30 minutes and was very restless. On 18th November 2015, the patient received a dose of PEDIARIX and accidentally again received a dose of PREVENAR 13 (13 days after 1st dose of PREVENAR 13). On 18th November 2015, less than a day after receiving a dose of PEDIARIX and PREVENAR 13, the patient experienced decrease in appetite and decrease in sleep. Both decreased appetite and decreased sleep were getting worse and worse. Patient was only sleeping for 30 minutes and was restless. In November 2015, less than a month after receiving PEDIARIX and PREVENAR 13, the patient lost some weight, about half a pound in a week and a half. In 2015, the patient experienced fluid intake reduced and restlessness and was not drinking bottles very well. The reporter stated that, on the day of reporting it was 1st morning that the patient ate a decent breakfast and he had dinner last night. So, might be that was the start of slight improvement. At the time reporting, the patient was still not drinking very well and the reporter had coaxed him to drink a 4 ounce bottle. The patient did not have other medical conditions and no other investigations. The reporter wanted to know if there was an antidote she could give the patient because 6 weeks of events was too much.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Weight decreased
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of decreased appetite in a 6-month-old male patient who received PEDIARIX (batch number N2LK2, expiry date unknown). Co-suspect products included PREVENAR 13. Concomitant products included PREVENAR 13. On 18th November 2015, the patient received PEDIARIX (intramuscular) .5 ml and the 2nd dose of PREVENAR 13. In 2015, less than a month after receiving PEDIARIX, the patient experienced fluid intake reduced and restlessness. In November 2015, the patient experienced weight loss. On 18th November 2015, the patient experienced decreased appetite and sleep decreased. On an unknown date, the outcome of the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss were recovering/resolving. It was unknown if the reporter considered the decreased appetite, fluid intake reduced, sleep decreased, restlessness and weight loss to be related to PEDIARIX. Additional details were received as follows: On 5th November 2015, the patient received a dose of PREVENAR 13. On 5th November 2015, the patient could not eat and sleep for about a week and a half and both the events were completely resolved. The reporter clarified that her son could eat but his appetite was decreased to a fraction of what he normally ate. The patient was sleeping might be for 30 minutes and was very restless. On 18th November 2015, the patient received a dose of PEDIARIX and accidentally again received a dose of PREVENAR 13 (13 days after 1st dose of PREVENAR 13). On 18th November 2015, less than a day after receiving a dose of PEDIARIX and PREVENAR 13, the patient experienced decrease in appetite and decrease in sleep. Both decreased appetite and decreased sleep were getting worse and worse. Patient was only sleeping for 30 minutes and was restless. In November 2015, less than a month after receiving PEDIARIX and PREVENAR 13, the patient lost some weight, about half a pound in a week and a half. In 2015, the patient experienced fluid intake reduced and restlessness and was not drinking bottles very well. The reporter stated that, on the day of reporting it was 1st morning that the patient ate a decent breakfast and he had dinner last night. So, might be that was the start of slight improvement. At the time reporting, the patient was still not drinking very well and the reporter had coaxed him to drink a 4 ounce bottle. The patient did not have other medical conditions and no other investigations. The reporter wanted to know if there was an antidote she could give the patient because 6 weeks of events was too much.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL (dose and route not reported, lot# L006549, expiration date: 26-APR-2017, lot# K011562, expiration date: 28-APR-2017). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Pharyngitis streptococcal
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's drug reactions/allergies included amoxicillin hypersensitivity. Concurrent conditions were not provided. On unspecified date in 2002, the patient was vaccinated with VARIVAX (Merck), first dose, (frequency was not provided). Concomitant therapies were not reported. Afterward the vaccination, the registered nurse stated that the patient was treated with amoxicillin for an unknown reason, later, on an unknown date, the patient was diagnosed with "strep throat", and after the event, the patient had an anaphylactic reaction. At the time of the report the outcome of the events was unknown. The relatedness between pharyngitis streptococcal and suspect therapy was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant referring to female patient in her late 30's. The patient's had no pertinent medical history. In approximately November 2015, reported as month ago, the patient was vaccinated with VARIVAX (Merck), I shot (strength, dose, route, lot number and expiration date were not provided). Concomitant medications were not reported. On an unspecified date, in November 2015, after 7 to 10 days of vaccination the patient experienced herpes zoster, reported as shingles. Patient sought medical attention and she was treated with antivirals. The patient recovered with no longer effects on an unspecified date. At the time of the report, relatedness between herpes zoster, reported as shingles and vaccination with VARIVAX (Merck) was not provided. Additional information is not expected as no contact information from the physician was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of ROTATEQ (dose and route not reported, lot# L008996, expiration date: 01-DEC-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with improperly stored doses of GARDASIL (lot# K010215 with expiration date 05-MAY-2017; lot# was reported as "L030864" with 07-JUL-2018, strength, dose and route were unknown). The patient's concomitant medications was not reported. No adverse effects have been reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: 5cm x 5cm induration localized, redness, pain.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates since 06-NOV-2015, the patients were vaccinated with PEDVAXHIB lot # L014429, expiration date 15-MAR-2018 (dose, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot# L014426 with expiration date 08-MAR-2017, strength, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects have been reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an 84 year old female consumer with high cholesterol, thyroid disorder and allergy to lidocaine reporting on herself. On 09-APR-2008, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported) subcutaneously. Concomitant therapies included an unspecified thyroid medication and CRESTOR. The consumer reported that on 20-DEC-2015, she experienced shingles. The patient visited her doctor and received an unspecified antiviral medication as treatment. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. 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 licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # L000568 expiration date 10-JUL-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were unknown). No concomitant therapy was reported. On an unknown date (reported as "several months ago") the patient experienced rash. Then on an unknown date the patient had to go to an unspecified physician because of the development of cellulitis. The outcome of the events was unknown. 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 registered nurse refers to a multiple patients of unknown age and gender. No medical history or concurrent conditions were reported. On 11-DEC-2015, it was discovered that on unknown dates (reported as since that day), multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) (doses and routes of administration were not provided; lot #:L031069, expiration date: 18-AUG-2017; lot# L009206, expiration date: 17-MAR-2017). No adverse effects were reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, frequency and route of administration were not reported), L014429 with expiration date: 15-MER-2018). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported . On 13-NOV-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provide. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple patients of unknown age and gender. No medical history or concurrent conditions were reported. On 11-DEC-2015, it was discovered that on unknown dates (reported as since that day), multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (doses and routes of administration were not provided, lot# L030586, expiration date: 10-FEB-2017). No adverse effects were reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 21-DEC-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L014427, expiration date 09-MAR-2018 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 7 unspecified patients of unknown age and gender. No concomitant medication, medical history and allergies were reported for these patients. On an unknown date, the patients were vaccinated either with RECOMBIVAX HB (lot number and expiry date unknown) or VAQTA (lot number and expiry date unknown) series with a longer than recommended intervals between the doses on unspecified dates. Concomitant medications of the patient were not provided. No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare student, who is also a female patient of unknown age and was reporting on herself. Her last menstrual period (LMP) was on 27-OCT-2015 and estimated delivery date (EDD) was 02-AUG-2016, based on the information provided by the reporter that she was 6 weeks pregnant on 09-DEC-2015. There was no information about the patient's concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with her second dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not reported). On 07-DEC-2015, the patient was vaccinated with a dose of VAQTA (strength, dose, route of administration, lot # and expiration were not reported). There was no adverse effect reported. The patient sought medical attention by scheduling an appointment with an obstetrician / gynecologist to discuss the administration of both vaccines. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose and route not reported, lot# K022265, expiration date: 22-OCT-2016, lot# J007299, expiration date: 03-FEB-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L007560 with expiration date 15-JUN-2017; lot# L016429 with 09-AUG-2017, strength, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects have been 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 Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (dose and route not reported, lot# L027287, expiration date: 21-JUL-2017) (incorrect product storage). No adverse event. This is one of several reports 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 has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of PNEUMOVAX23 (dose and route not reported, lot# K008410, expiration date: 26-FEB-2016) (incorrect product storage). No adverse event. This is one of several reports 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 has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with an improperly stored dose of MMRII (dose and route not reported, lot# K001231, expiration date 27-JAN-2016, lot # L012479, expiration date: 10-APR-2017, lot# K024035, expiration date 26-NOV-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were unknown). No concomitant therapy was reported. On an unknown date (reported as "several months ago") the patient experienced rash. The rash had scabbed over and was healing up when the patient came into the pharmacy several months ago. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 (dose, frequency and route of administration were not reported; lot# L016428, with expiration date 30-JUL-2017). No adverse event was 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: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose, frequency and route of administration were not reported, lot#L035686 with expiration date 16-FEB-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a female patient of an unknown age, who was also an emergency medical technician reporting on her self. The patient's conditions, medical history and concomitant therapy were not reported. On an unknown date in September 2015, the patient was vaccinated with an unspecified dose of M-M-R II (dose, route of administration and lot# were not reported). On an unspecified date, after the administration of M-M-R II, the patient stated she developed "joint pain in the knuckles on both her right and left hands, as well as in her right wrist and right elbow". The outcome of the event was reported as not recovered. The relatedness between "joint pain in the knuckles on both her right and left hands, as well as in her right wrist and her right elbow" and M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates since 06-NOV-2015, the patients were vaccinated with ROTATEQ orally, lot # L013193, expiration date 20-JAN-2017 and lot # K022990, expiration date 26-JUN-2016 (dose and site of administration were not reported), which were exposed to temperatures outside of the recommended range. There was no adverse effects reported. No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Rash and arm pain/itching.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medication was reported. In June 2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot # and expiry date were not specified). On 15-NOV-2015, the patient received the second dose of GARDASIL 0.5 ml, intramuscularly (lot # and expiry date were not specified). On 15-DEC-2015, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscularly (lot # and expiry date were not specified). No adverse effects were reported. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report was received from an 86-year-old female patient who was reporting on herself. No information about the patient's medical history was reported. The patient's concurrent conditions included high blood pressure. On 14-DEC-2015, after physician's suggestion, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly (exact dose, lot # and expiry date were not specified). Concomitant therapies included "a lot of medication". On 16-DEC-2015, after receiving the PNEUMOVAX 23, the patient developed a head cold, the cold was treated with unspecified decongestant. The outcome of the event was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-MAY-2012, the patient was subcutaneously vaccinated with dose of ZOSTAVAX (dose, lot# and frequency were not reported). On 10-DEC-2015 (reported as "today"), the patient received another dose of ZOSTAVAX (dose and frequency were not reported, lot # L020482 with expiration date: 02-SEP-2016, subcutaneously). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-DEC-2015, the patient was vaccinated with an expired dose of LIQUID PEDVAXHIB lot # J003720 and exp date on 05-MAY-2015, dose and route were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a patient of unknown age and gender, refers to herself/himself. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (site and route of administration, dose, lot number and expiration date were not reported). On an unknown date in October 2015, the patient came down with shingles. The outcome of the event was not recovered (reported as dealing with the pain at the time of the report). The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to approximately 15 to 20 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiry date were not reported). On unknown dates ,the patients were vaccinated with an additional dose of GARDASIL 9 (dose, route, lot # and expiry date were not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The relatedness between interchange of vaccine products and GARDASIL and GARDASIL 9 was not reported. 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 healthcare worker refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates since 06-NOV-2015, the patients were vaccinated with GARDASIL 9 lot # L016429, expiration date 09-AUG-2017 (dose, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. There was no adverse effects reported. No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F for 492.6 hours for a total of 839.3 hours (35 days); in November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # J006236, exp. date: 25-FEB-2016) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October 0f 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 Registered Nurse refers to multiple patients of unknown age and gender. No concomitant medications were reported. No medical history was provided. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (dosage schedule was not provided) (lot # L005298, expiration date: 17-FEB-2017; lot # K007783, expiration date: 28-MAY-2016). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This initial spontaneous report was received from a patient's relative concerning a 68 year-old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, lot# and expiration date were not provided). There was no concomitant medication reported. On an unknown date reported as "while on vacation", the patient developed a "lesions" on her forehead and over her right eye; she went to see an unknown ophthalmologist, who stated "it was a rash", then saw her own ophthalmologist, who stated, "it appeared as though she had shingles". The ophthalmologist then treated her with unspecified medications. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events was not recovered. The relatedness between the events to the suspect drug was not reported. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 nurse and refers to unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 21-DEC-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # L018499, expiration date 25-FEB-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L008034, expiration date 05-AUG-2016 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.