chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose: 0.25 ml) (lot # expiry date and route were not reported). The reporter stated that an unspecified patient experienced an "anxiety attack" during administration of ZOSTAVAX resulting in delivery of a partial dose. Also stated that "the patient could not tolerate the dose and she only got about 0.25ml of the vaccine" (anxiety and underdose). The outcome of the event anxiety was not reported. The reporter did not provide the causality assessment between the event anxiety and ZOSTAVAX. 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 registered nurse 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 PNEUMOVAX 23 (lot # L012215, expiration date: 13-JAN-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact with the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse 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 VAQTA (lot # M009786, expiration date: 26-MAY-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact with the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager 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 VAQTA (lot # L018499, expiration date: 25-FEB-2017; lot # L041676, expiration date: 15-MAR-2017 and lot # L023232, expiration date: 05-FEB-2017) (dose and route of administration were not reported). There was no adverse effect reported. 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: This spontaneous report as received from an office manager 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 GARDASIL 9 (lot# L037554, expiration date: 25-DEC-2017; lot# L044475, expiration date: 31-MAY-2017; reported lot# L048337, expiration date: 08-MAY-2017; lot# L048237, expiration date: 08-MAY-2017; lot# L016428, expiration date: 30-JUL-2016, and lot# L014415, expiration date: 25-JUL-2017) (doses and route of administration were not reported). There was no adverse effect reported. 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 licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # reported as K011562 and M023169 with expiration dates 08-APR-2017 and 13-JUN-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Lot # K011562 is not valid for hpv rl1 5 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of (wistar ra 27-3) M-M-R II lots # L034730, L019989,  M010426 and L041456 with expiration dates 09-SEP-2017,  01-JUN-2017, 01-MAR-2018 and 22-OCT-2017 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of (wistar ra 27-3), M-M-R II were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 25-OCT-2015, the patient was vaccinated with one improperly stored dose of RECOMBIVAX HB 2.5/0.5 (units not provided), which had a lot # of L014878, an expiration date of 17-JAN-2018 (route and anatomical place of vaccination were not provided). The storage detail for the RECOMBIVAX HB was a temperature excursion of 20 F for 24 hours, 24 F for 8 hours, and 27 F for 15 hours. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis C antibody negative
Clinical narrative: This spontaneous report was received from a physician concerning a a 7 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with 6 doses of RECOMBIVAX HB (route of administration, lot # and expiration date were not provided). On an unknown date, the patient was found to have not seroconverted (hepatitis B antibody negative). The outcome of hepatitis B antibody negative was unknown. This is one of two reports received from the same reporter (MARRS # 1611USA004289). 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 Nurse and refers to 41 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot # M002254 with expiration date on 15-NOV-2016; however, dosage number and route of administration were not reported). No adverse effects were reported. The vaccines experienced the following temperature excursions during 3 hours and 45 minutes: 50.5 grades Fahrenheit. Reportedly, previous temperature excursions on 26-SEP-2016, during 2 hours and 30 minutes of 47.4 grades Fahrenheit, on 27-SEP-2016, during 1 hour of 47.6 grades Fahrenheit, on 05-OCT-2016, during 15 minutes of 46.2 grades Fahrenheit, on 06-OCT-2016, during 1 hour and 15 minutes of 48 grades Fahrenheit, on 12-OCT-2016, during 1 hour of 46.5 grades Fahrenheit, on 17-OCT-2016, during 1 hour 15 minutes of 49.2 grades Fahrenheit and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored doses of VARIVAX lot # M027347, 01-JUN-2018 and M-M-R II, M032153 22-APR-2017. 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 medical assistant professional, referring to multiple unspecified patients of unknown age and gender. Information about patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # L013428, expiration date 03-FEB-2017) that were exposed to temperature of 49F and 48F each one, during an hour. This excursion was detected with a digital data logger. No adverse effects were reported. This is one of the 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: Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 12-SEP-2016, the patient was administered an improperly stored dose of GARDASIL 9 (lot # L037554 with expiration date 25-DEC-2017; dose and route were not reported). The vaccine was exposed to 31.7 degree Fahrenheit for 15 hours 15 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a physician referring to herself, a female patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated subdermally with PNEUMOVAX 23 (dosage, dose number and lot number were unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse concerning an unspecified patient. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On an unknown date an improperly stored dose of VARIVAX (lot # M005974, expired date 02-FEB-2018) (dose and frequency were unknown) was subcutaneously administered to the unspecified patient. The VARIVAX was exposed to -14 C for a time frame of 1 hour and 0.3 C for a time frame of 12 hours. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (wistar ra 27-3) M-M-R II (lot #, expiration date, dose and route not reported. The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. 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 as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients' were vaccinated with improperly stored doses of ROTATEQ (lot # M016238, expiry date 07-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The vaccine underwent temperature excursion of 1.6 degree Celsius for 2 hours and 1.7 degree Celsius for 1 hour 30 minutes. Data logger involvement was unknown. There were no previous temperature excursions. No product quality complaint was involved. This report is linked with case # 1611USA006564, due to same reporter source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot #, expiration date and dose not reported) orally. The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. 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
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot #, expiration date, dose and route not reported). The doses of vaccine were improperly stored at 8.5 degrees Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a refers to a 16 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 24-OCT-2016, the patient was vaccinated with an improperly stored doses of VARIVAX lot # M024683, 18-MAY-2018 and M-M-R II , L037356, 28-SEP-2017. 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 nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot #, expiration date, dose and route not reported). The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since 28-OCT-2016, on multiple unspecified dates, these patients' were vaccinated with improperly stored doses of VARIVAX (lot # M027342, expiry date 01-JUN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 13-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 18 minutes. On 28-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 57 minutes. There were no previous temperature excursions. The temperature excursions were recorded by a data logger. No product quality complaint was involved. This report is linked to case# 1611USA004361, due to same reporter source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and unit unknown). The next day after receiving the vaccination, patient complained of "a swollen arm that was warm to touch and that could not be moved without pain." At unspecified time after vaccination, the patient went to primary physician. The patient was prescribed ibuprofen and "three days later was cleared up." The causality between the event and PNEUMVOAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
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 demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since 28-OCT-2016, on multiple unspecified dates, these patients' were vaccinated with improperly stored doses of M-M-R II (lot # M004063, expiry date 25-JAN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 13-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 18 minutes. On 28-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 57 minutes. There were no previous temperature excursions. The temperature excursions were recorded by a data logger. No product quality complaint was involved. This report is linked to case # 1611USA007950, due to same reporter source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: This spontaneous report was received from a nurse referring to a currently 20 year old female patient. Information about concurrent condition and medical history was not provided. The patient had no drug reactions/allergies. On an unknown date ("sometime before 2012"), the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not reported). After the dose was administered, the patient had a "vagal responses". No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the outcome of the event was recovered. The causality was not provided. Additional information is not expected as no consent to contact the HCP.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On 03-NOV-2016 and on unknown dates in 2016 (reported as "unspecified dates since 29-SEP-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # L036301, expiration date 20-DEC-2017 (dose and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of min. 69.2 to 74.1 degrees Fahrenheit for 131 hours and the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. 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 healthcare worker (also reported as a radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L026602 and expiration date 19-OCT-2017) and (lot # L036301 and expiration date 20-DEC-2017) (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. This information was from a digital data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
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 demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients' were vaccinated with improperly stored doses of PEDVAXHIB (lot # M027882, expiry date 14-APR-2019) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The vaccine underwent temperature excursion of 1.6 degree Celsius for 2 hours and 1.7 degree Celsius for 1 hour 30 minutes. Data logger involvement was unknown. There were no previous temperature excursions. No product quality complaint was involved. This report is linked with case# 1611USA007953, due to same reporter source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 24-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334, 05-OCT-2017. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2016 the patient was vaccinated with improperly stored ZOSTAVAX lot # M020071/expiration date-18-JUL-2017. No adverse event was reported. Temperature excursion of -5C, Time frame of 75 days as of 11-NOV-2016. There was no previous temperature excursion and call was not because of the data logger. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concomitant conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lots # M004890 and L037924 with expiration dates 10-NOV-2017 and 22-JUN-2017 respectively,orally, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of ROTATEQ were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate decreased, Hypoaesthesia, Laboratory test, Nausea, Seizure like phenomena
Clinical narrative: Patient was given HPV9 vaccination at 2:55 pm on 11/16/16 in left deltoid. Patient was instructed to lay down on bed after injection in case of any adverse reaction. After documenting injection and visual examine of patient I left the exam room. Less than 1 minute after leaving the exam room the patients sister yelled for help. Myself and another employee ran into patients room to find patient demonstrating seizure like activity on table. Father was at bedside talking to patient. Patient stopped shaking and knew who she was and who father was. Patient stated she felt nausea and numbness in hands. Pulse ox was done O2 was 100 percent, heart rate was 40. I ran to get Physician. Doctor assessed patient. Heart rate dropped to 39 and patient started to shake again. Doctor informed RN to draw up EPI and Oxygen was started on patient, 911 called per Doctor. After starting oxygen on patient her heart rate started to rise and EPI was not given per Doctor. Staff and family talking to patient explaining what we were doing and why. Patient responsive and answering Doctor's questions. Mother was at patients side at this time. Ambulance arrived, patient was transported to Hospital for further evaluation.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: Patient was given HPV9 vaccination at 2:55 pm on 11/16/16 in left deltoid. Patient was instructed to lay down on bed after injection in case of any adverse reaction. After documenting injection and visual examine of patient I left the exam room. Less than 1 minute after leaving the exam room the patients sister yelled for help. Myself and another employee ran into patients room to find patient demonstrating seizure like activity on table. Father was at bedside talking to patient. Patient stopped shaking and knew who she was and who father was. Patient stated she felt nausea and numbness in hands. Pulse ox was done O2 was 100 percent, heart rate was 40. I ran to get Physician. Doctor assessed patient. Heart rate dropped to 39 and patient started to shake again. Doctor informed RN to draw up EPI and Oxygen was started on patient, 911 called per Doctor. After starting oxygen on patient her heart rate started to rise and EPI was not given per Doctor. Staff and family talking to patient explaining what we were doing and why. Patient responsive and answering Doctor's questions. Mother was at patients side at this time. Ambulance arrived, patient was transported to Hospital for further evaluation.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a company field representative who refers to a female patient of unknown age. The patient's medical history and/or concurrent conditions were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23, (lot # and expiration date unknown). Concomitant medication was not provided. On an unknown date the patient developed redness and swelling at the injection site. The patient did not seek medical attention. Treatment was provided to the injection site in the form of an ice pack. The patient's symptoms resolved "within 24 hours". A PQC was not involved. No other information is available. Additional information is not expected.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding her three child sons of unknown age. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with the first and second doses of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were unspecified for both vaccines). On an unknown date, the patients were vaccinated with the third dose of GARDASIL 9, Lot # reported as L040459 (dose, route, anatomical location, and expiration date were unspecified). Following the third administration of the third dose, the reporter received a letter from her children's physician stating that all the three last doses of GARDASIL 9 that were administered to her three sons were improperly stored. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information is not expected because no contact information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician regarding an unspecified number patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced syncope. The outcome of syncope was unknown. Causality was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334. No adverse effects were reported. 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 nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot# M027879, expiration date 24-JAN-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. 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 pharmacist referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. The reporter stated that a dose of GARDASIL 9 was drawn up from the vial and stored for two hours in a plastic syringe. On an unknown date, the patient was vaccinated with a dose of improperly storaged GARDASIL 9 lot # M018810 with expiration date: 28-MAY-2018 (route, dosage schedule, lot # and expiration date were not reported). No adverse event was reported. There was no product quality complaint (PQC) involved. 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 nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# M026317, expiration date 11-JAN-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a Nurse Practitioner who refers to a 18 year old unspecified patient. The patient's medical history and/or concurrent conditions were not provided. On an unknown date the patient was vaccinated with RECOMBIVAX HB dose 1, 10/1.0 mcrg/ml, intramuscular (lot # and expiration date not provided). Concomitant medication was not provided. The Nurse Practitioner reported that on an unspecified date, an unspecified 18 year old patient received RECOMBIVAX HB adult dose. No adverse effect reported. A PQC was not involved. No further information was provided. Follow up information was received on 24-OCT-2016 from a nurse. The nurse stated that the unknown patient was serologically tested on an unknown date for hepatitis B immunity, and tested seronegative for hepatitis B immunity on an unknown date. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-JAN-2015, the patient was vaccinated with a dose of improperly stored of GARDASIL (dose, concentration, route of administration were not provided) (lot # K002740, expiration date 06-AUG-2015). Concomitant medications were not reported. The vaccine had temperature excursions of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)). The storage criteria and the storage type were reported as "refrigerator (R)". The vaccine status was reported as "in excursion" No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 82 year old female patient. The patient's concurrent conditions included allergy to bacitracin, naproxen, neomycin, penicillin, vitamin B and pramoxine hydrochloride. No pertinent medical history was reported. Concomitant therapies included FLONASE, unspecified vitamins and an unspecified thyroid medicine. On 10-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (lot # M032635 with an expiration date of 05-MAY-2018). Other suspect medications were not reported. On an unspecified date in 2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and he was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from the cellulitis. The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: After 1 and 1/2 days, itching, red + swollen and hard, no fever, 3" long 1 1/12" wide. Took 3 weeks to resolve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Local reaction to Zoster noticed by family 24 hours after vaccine. Patient came in to me 48 hrs after vaccine because I asked her to if got worse. Red, raised area below vaccine administration site, warm to touch about 3 inches in diameter.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Right deltoid rash (large hive) over area of injection. Treated with triamcinolone cream.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Aerophagia, Anxiety, Dyskinesia, Excessive eye blinking, Grimacing
Clinical narrative: Child started to exhibit motor tics one week after vaccine including shoulder shrugging, eye blinking, air swallowing, facial grimace, and involuntarily raising arms. Exhibited increased anxiety and had sleep issues. Treating with supplements.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Sleep disorder, Tic
Clinical narrative: Child started to exhibit motor tics one week after vaccine including shoulder shrugging, eye blinking, air swallowing, facial grimace, and involuntarily raising arms. Exhibited increased anxiety and had sleep issues. Treating with supplements.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling and itching in the arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Postural orthostatic tachycardia syndrome
Clinical narrative: Near syncopal event at the time and followed by weeks of prolonged dizziness. Seen by Cardiology and dx with POTS syndrome after Holter and ECHO.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Presyncope
Clinical narrative: Near syncopal event at the time and followed by weeks of prolonged dizziness. Seen by Cardiology and dx with POTS syndrome after Holter and ECHO.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored VARIVXA lot # M027347 01-JUN-2018 and M-M-R II, M032153 22-APR-2017. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp 100.9 after vaccines. 24 hours later no redness or discomfort.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Lethargy, Rash, Tremor
Clinical narrative: Chills, lethargy, tremor 11/15/16. 11/17/16 Broke out in a rash. She saw Dr. and they told her the worst was behind her.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hypoaesthesia oral, Nausea
Clinical narrative: Patient left exam room after the vaccine, waiting about 5 minutes post injection. Came back about 5 minutes later feeling nauseated and warm, numb lips developed within 5 more minutes. Declined request to return to exam room, remained in waiting area. Declined need for EMS. Ambulated from area without assistance.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Adverse reaction, Urticaria
Clinical narrative: Delayed reaction. Hives.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Paraesthesia, Sensation of foreign body
Clinical narrative: After administration of GARDASIL in left arm, patient experiences numbness and tingling extending from neck down entire arm. Arm felt weak, difficult to lift. She described a "lump" in her throat. BENDARYL and ibuprofen were administered.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Mobility decreased, Muscular weakness
Clinical narrative: After administration of GARDASIL in left arm, patient experiences numbness and tingling extending from neck down entire arm. Arm felt weak, difficult to lift. She described a "lump" in her throat. BENDARYL and ibuprofen were administered.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Paraesthesia, Sensation of foreign body
Clinical narrative: After administration of GARDASIL in left arm, patient experiences numbness and tingling extending from neck down entire arm. Arm felt weak, difficult to lift. She described a "lump" in her throat. BENDARYL and ibuprofen were administered.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Swelling
Clinical narrative: Really sore arm and swollen shoulder and neck.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Depressed level of consciousness, Drug screen positive, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from a medical assistant referring to an 18 month old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-NOV-2016 the patient was vaccinated with a dose of VAQTA (lot #M018644, expiration date 20-SEP-2017, intramuscular; dose unknown). The patient did not take concomitant medication. Later that same day, the patient became "difficult to rouse from sleep," and the patient was taken to the emergency room. Magnatic Resonance Imaging (MRI) was performed on the patient's brain which was found to be normal. A urine test was also performed which "found that the patient had an opioid overdose." The patient was sent home from the emergency room that same night (on 03-NOV-2016). No treatment was given for the events. The patient was recovering. A lot check was requested. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot # L032181, expiration date: 25-AUG-2017; lot # L041455, expiration date: 22-OCT-2017; lot # L04370, expiration date: 03-NOV-2017; dose and route unknown). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3, HEP, HEPA, HPV9, IPV, MMR, MMRV, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event, Tuberculin test, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included GARDASIL 9, HAVRIX (manufactured by GlaxoSmithKline (GSK)), ENGERIX (manufactured by GSK), FLUZONE (manufactured by Sanofi), IPV (manufacturer unknown), MENACTRA (manufactured by Sanofi) and TDaP vaccine (manufacturer unknown). The patient also received an Mantoux test. On an unknown date, the patient inadvertently received a dose of PROQUAD (lot # M015700, expiration date 26-SEP-2017, rHA (recombinant human albumin); dose and route were unknown) instead of VARIVAX (wrong vaccine administered). The patient also received M-M-R II (lot #, expiration date, dose and route were unknown) (overdose). All suspect therapies and concomitant therapies were give during the same visit. No adverse effect had been reported in the patient. Additional information is not expected as there is no consent for follow up.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: 2.5 cm nodule at injection site; hard but not fluctuant, minimal redness; tender.
Age: 21.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Induration, Pain, Swelling, Urticaria
Clinical narrative: Sore, red, swollen, hives, hard to the touch.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling (R) arm distal to site of the injection. Evaluation by MD who advised OTC BENADRYL as well as KEFLEX 250mg 1 QID x7 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection given on 11-15-16 at 3:32 pm. Pain in right upper arm started around 6pm 11-15-16, radiating into her shoulder. Pain increased with movement chilled. 11-16-16 Pain slightly improved but continue to have limited movement of right arm due to pain. Temp 99.8. 11-17-16 Mobility of right arm better today, less discomfort.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Injection given on 11-15-16 at 3:32 pm. Pain in right upper arm started around 6pm 11-15-16, radiating into her shoulder. Pain increased with movement chilled. 11-16-16 Pain slightly improved but continue to have limited movement of right arm due to pain. Temp 99.8. 11-17-16 Mobility of right arm better today, less discomfort.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness and pain, decrease in range of motion for 3 weeks after shot.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: Rash on wrist and forearm on arm with injection. Arm was itchy and tingling.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M011840, expiration date 01-FEB-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site inflammation
Clinical narrative: Pt received ZOSTAVAX 11/4/16. Developed injection site inflammation over the next couple of days. 11/7/16-Primary doctor diagnosed as cellulitis, cephalexin prescribed. 11/8/16-Primary doctor administered penicillin injection. Condition improved as pt continued antibiotics. As of 11/17/16, pt reports that condition is approaching normal. No further treatment is required.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Extreme soreness in arm, decreased range of motion. Popping.  Fever--prescribed antibiotics, then fever went away.