chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297 and expiry date 18-AUG-2017) (strength, dosing details, anatomical location were unknown). The vaccine was exposed to the temperature of 48 degree Fahrenheit for 14 hours. No previous temperature excursion was reported. No adverse effects were reported. The temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-NOV-2013, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-NOV-2012, the patient was vaccinated with the first dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). Subsequently on 16-AUG-2016, the patient was vaccinated with the second dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). It was reported that, the patient was not indicated for a 2nd dose of PNEUMOVAX 23 to be administered. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in September 2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route of administration, lot # and expiration date were not reported). Since that, the patient had been administered three doses of GARDASIL 9 (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The last doses was administered on 16-AUG-2016. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a nurse via a field representative refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as "sometime in June"), the patient was vaccinated with his third dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as "sometime in July"), the patient was vaccinated with his fourth dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported as a result of the extra injection. The patient sought medical attention by seeing his physician, but he did not require any treatment. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 17 years old female patient. No information on patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 12-OCT-2015, the patient was vaccinated with the first dose of PROQUAD, subcutaneously (dose, albumin status, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (lot #, dose, route and site of administration were not reported). On 22-AUG-2016, the patient was vaccinated with an improperly stored second dose of VARIVAX lot # M000998, expiration date 07-JAN-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Second dose of vaccine experienced the temperature excursion of -13.2 degrees Celsius for 3.5 hours and -12.1 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX, (lot number: L013067 expiry date: 14-APR-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. The vaccines went to -5.1 degree of Celsius for 2 hours. Data logger was involved. The vaccines were back in range and did not have any prior excursions. This is one of several report 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 was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD, lot number: M007963 expiry date: 05-AUG-2017 and L042817, expiry date: 26-APR-2017, (dose, route of administration were not reporter). Concomitant therapy was not reported. No adverse effect was reported. The vaccines went to -5.1 degree of Celsius for 2 hours. Data logger was involved. The vaccines were back in range and did not have any prior excursions. This is one of several report from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Injection site pain, Tenderness
Clinical narrative: Prolonged, intermittent pain in deltoid at site of injection. Tenderness to touch (interm.) and subjective wkness (intermittent). Normal exam in office 8/30/16.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Red rash from top of deltoid to elbow on outer surface of arm, started 6 weeks after vaccine and has persisted several days. Possible fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 18-DEC-2013, the patient was vaccinated with first dose of VARIVAX lot # H018451 which was improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 18-OCT-2010, the patient was vaccinated VARIVAX dose1, lot # 666851/0280Z, expiry date 12-FEB-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated VARIVAX, lot # L015045 (dose, dose number, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a field employee referring to a 13 year old male patient. The patient's pertinent medical history, concomitant medication or drug allergies/drug reactions were unknown by the reporter. On an unknown date, the patient was vaccinated with a second dose of GARDASIL 9 (dose, lot # and expiration date unknown; intramuscularly to prevent anal cancer and genital warts) and had a syncopal episode following the administration of the vaccine. The physician stated he kept the patient in the office for 30 minutes after the syncopal episode to monitor the patient and unspecified treatment was given for the event. The patient recovered before he left the office. The causality assessment was not reported. Additional information is not expected since the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 12-MAY-2014, patient received improperly stored VARIVAX dose 2, from batch/lot # H018451 (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypoaesthesia, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: This spontaneous report has been received from a 62 year old female patient with high blood pressure and allergies with sulfa based medicines. Concomitant therapies included generic COZAAR, vitamin D and a baby aspirin. On 02-AUG-2016 the patient was vaccinated with ZOSTAVAX (lot # was reported as 038926 and was not valid, expiration date: 06-JAN-2016) in left arm. On the same day, while vaccination, the patient experienced numbness in the left arm and left hand. The patient's left arm was swollen and there were clusters of blisters on her left arm near the injection site. Her left arm itched and was hot. The patient also had a dark patch of flaky skin near the injection site at the time of reporting. The patient visited the doctor and unspecified treatment was given to the patient. No lab test was performed. The outcome of the events was reported as not recovered. Additional information is not expected as there is no consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report has been received from a 62 year old female patient with high blood pressure and allergies with sulfa based medicines. Concomitant therapies included generic COZAAR, vitamin D and a baby aspirin. On 02-AUG-2016 the patient was vaccinated with ZOSTAVAX (lot # was reported as 038926 and was not valid, expiration date: 06-JAN-2016) in left arm. On the same day, while vaccination, the patient experienced numbness in the left arm and left hand. The patient's left arm was swollen and there were clusters of blisters on her left arm near the injection site. Her left arm itched and was hot. The patient also had a dark patch of flaky skin near the injection site at the time of reporting. The patient visited the doctor and unspecified treatment was given to the patient. No lab test was performed. The outcome of the events was reported as not recovered. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07-APR-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 03-JUN-2010, the patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y, expiry date 07-AUG-2011 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07- JUN-2013, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 03-JUN-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, lot number and expiration date were unknown). On an unknown date, the patient got the shingles after she received ZOSTAVAX. The outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 28 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular, lot no. M014924/ expiration date- 27-MAY-2017, (drug administered to patient of inappropriate age). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX, "1 vial given intramuscularly", which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging from 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX, "1 vial given intramuscularly" (Incorrect route of drug administration), which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging from 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 12-APR-2011, the patient was vaccinated VARIVAX dose 1, lot # 0552Z (dose, route, vaccination site, expiry date unknown). On 01-JUN-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, route, vaccination site, route unknown). No adverse effects were reported. The reporter started that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016,the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX, "1 vial given intramuscularly" (Incorrect route of drug administration), which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging form 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). On 10-AUG-2016, the patient was inadvertently administered the second dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). On 10-AUG-2016, following the administration of the second dose, the patient experienced sore arm. The primary reporter confirmed that the third dose in the series of three of GARDASIL 9 was not administered. The patient outcome was not reported. The relatedness between the adverse event of sore arm and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding to multiple unspecified patients of unknown age and gender. No concurrent conditions or pertinent medical history were reported. The registered nurse reported that on unspecified dates between 01-AUG-2016 and 23-AUG-2016, multiple unspecified patients received improperly stored doses of VARIVAX, lot number M015735, expiration date 30-MAR-2018, lot number M004663, expiration date 27-JAN-2018 and lot number M008173, expiration date 16-FEB-2018, (dose, frequency and route not reported). No adverse effects were reported. The registered nurse confirmed that the excursion temperature was 8F for a time frame of 552 hours. The temperature went back in range and there were no previous excursions. It was unknown if the report was part of a data logger, and no product quality complaint was involved. This is one of two reports 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 nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot # M019691, expiration date: 02-NOV-2017 and lot# L048854, expiration date: 31-AUG-2017). There was no adverse effects reported. Administered doses of ROTATEQ experienced the temperature excursion of 38 degrees Fahrenheit for 16 hours. The outcome of the event was not reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 19-JUL-2016 from a registered nurse. The nurse reported that a patient received an improperly stored dose of (Oka/Merck) VARIVAX (lot # L019124, expiry 27-MAY-2017) (dose and injection site not reported) on 24-JUN-2014. The temperature of the vaccine was 21.6 F for 204 hours and 30 minutes. There were no adverse effects reported. Additional information had been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Information was received on 21-JUL-2016 from a nurse practitioner (who is also the patient) via a company employee. The female patient is of unknown age. No medical history or concomitant medications were reported. Approximately one year ago, the patient received a dose of ZOSTAVAX (dose, lot, route and location not specified). Three days after receiving the ZOSTAVAX, her arm was extremely hot and swollen from elbow to shoulder. Then, three days later where she received a dose of PNEUMOVAX 23 (dose, lot, route and location not reported) in the opposite arm, she experienced her arm being hot and swollen from elbow to shoulder. Treatment was given for the adverse events (treatment not specified). The patient spoke with a physician. The outcome was recovered on an unknown date. The relatedness was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 VARIVAX lot # L039092, expiration date 06-OCT-2017; lot # M009764, expiration date 23-FEB-2018 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect 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 as received from a licensed practical nurse to 2 unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. Since 15-AUG-2016, these two patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M018810 and expiry date: 28-MAY-2018). No adverse effects reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 23 year old female patient reporting on herself. The patient had no known pertinent medical history and drug reactions or allergies. On approximately 25-MAY-2016, while she was 3 weeks and 4 days pregnant, the patient was vaccinated with a dose of GARDASIL 9 injection (exact dose, anatomical location, dose number, lot # and expiration date were not provided). There were no concomitant medications provided. At the time of the report, the patient was 17 weeks and 4 days pregnant. Last menstrual period was on approximately 16-APR-2016, estimated date of conception was on 30-APR-2016 and estimated date of delivery (EDD) was on approximately 21-JAN-2017. The patient pregnancy outcome was pending. Fetal outcome was unknown. The outcome of exposure during pregnancy was unknown. The patient did not seek medical attention. Following laboratory diagnostic studies were performed: glucose monitoring, ultrasound, pap smear and unspecified test for pregnancy, however the results and details were not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 23-NOV-2010, the patient received improperly stored VARIVAX dose 2, from lot # 666869/0469Z, expiry date 31-MAR-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 23-AUG-2016, the patient was vaccinated with an expired dose of M-M-R II injection (therapy type RHA, lot # K011317, expiration date 13-AUG-2016; dose and route were unknown). No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date/s, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846 and expiry date: 16-JUN-2016) and M-M-R II. It was reported that the GARDASIL 9 was stored at 32.7 Fahrenheit (F) temperature for 6 hours and 5 minutes. Also M-M-R II was stored as 33.0 F for 3 hours and 56 minutes. There was no previous temperature excursion and data logger was reported for both the vaccines. No adverse effects were reported. No product quality complaint was reported for both the vaccines. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 29-APR-2010, patient received improperly stored VARIVAX dose 2, from batch/lot # 665413/1128Y (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient pertinent medical history and drug allergies were not reported. Approximately on 10-AUG-2016 (reported as at the time of this call), the patient was vaccinated with third dose of GARDASIL 9 series about one year after the second dose was administered. No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Lethargy, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field employee, refers to a 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 26-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L038503 and lot # L0038506, intramuscularly, (dose and frequency were unknown). On 26-MAY-2016, the patient became "very lethargic and did not want to eat" after receiving GARDASIL 9. Unspecified lab work was performed. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other adverse event information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-NOV-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669601/0138AA, expiry date 26-JAN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated VARIVAX dose 1, lot # L015045 (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of an unknown age and gender. The patient's pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 injection, lot # M004116, expiration date 12-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This solicited report has been received from a consumer (also reported as received from the patient' mother) referring to her niece, a female patient of unknown age. The patient enrolled in a Market Research. On an unknown date, a few years ago the patient was vaccinated with her first dose of GARDASIL (route, dose and lot number were unknown). On an unknown date the patient experienced a bad reaction. The reporter could not recall offhand what the reaction was, but the patient's mother said she was not giving her the second shot. The patient's mother told the reporter to say away from the vaccine. It was at that point that the reporter decided she would not give it to any of her children. The patient's doctor never informed her of any possible side effects nor did he indicate that the patient should keep an eye out for any thing unusual. Just gave her the shot and told her to come back at a specified time for the second dose. Therapy with GARDASIL was discontinued. The outcome of adverse event was unknown. The causality between the event and the suspect drug was not reported. Additional information is not expected as there is no consent to follow-up.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational nurse referring to a 3 month old female patient. The patient had no relevant medical history, concomitant medications, or drug history. On 07-JUL-2016, the patient started ROTATEQ orally at a 2 ml dose at an unknown frequency. On 12-JUL-2016 the patient received ROTATEQ (lot # L029615, expiration date of 15-MAY-2017, 2 ml, oral) that was exposed to a temperature excursion. After receiving ROTATEQ, no adverse events had been reported thus far. The patient had not relevant laboratory data. As of 25-AUG-2016, it was unknown if the patient would continued to ROTATEQ and the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with dose 2 of VARIVAX 2 weeks early. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 26 year old female patient. Information on patient's pertinent medical history was unknown. On an unspecified date in June 2016, the patient was vaccinated with GARDASIL 9 injection (strength, dose and lot number not reported). Information on concomitant medication was unknown. On an unspecified date in 2016, the patient experienced swollen lymph node in her neck (lymphadenopathy). The patient sought medical attention. It was unknown if any treatment or if any lab diagnostic tests were performed. The outcome of lymphadenopathy was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Information has been received from an unspecified reporter via a company representative referring to a 1 day old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 18-AUG-2016, the newborn was vaccinated with a dose of expired ROTATEQ (dose unknown, lot#: K022990, expiration date unknown) orally (product use issue). Additional information is not expected as there was no consent to request follow up.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Patient reports subjective fever, headache, body aches, severe fatigue and weakness which started minutes after her 1st HPV vaccine. Was evaluated by PCP about 4 hours later. Normal exam, was improving slowly.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter - a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient was vaccinated with her first and second dose of GARDASIL 9, intramuscularly (does, lot # and expiration date were not reported). In June 2016, the patient was supposed to receive her third dose of GARDASIL 9 but she missed it. There was no adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, HEPA, MENB
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of neck pain in a female patient who received BEXSERO. Concomitant products included HAVRIX pediatric. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced neck pain (serious criteria other: as per reporter). On an unknown date, the outcome of the neck pain was unknown. The reporter considered the neck pain to be almost certainly related to BEXSERO. Additional details were reported as follows: The physician stated about two female patients that after being administered BEXSERO vaccine, they ended up in the emergency room. Both the patients experienced severe neck pain and one of the patient's had migraine as well. This case concerned the patient who had experienced severe neck pain after vaccination. The sales representative had extremely limited information. One female patient was 18 years old and the other female patient was 16 years old. One of the patients were administered HAVRIX with BEXSERO, but the sales representative did not know which patient.
Age: 17.0
Sex: F
Vaccine: MENB, HEPA, MENB
Symptoms: Neck pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of neck pain in a female patient who received BEXSERO. Concomitant products included HAVRIX pediatric. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced neck pain (serious criteria other: as per reporter). On an unknown date, the outcome of the neck pain was unknown. The reporter considered the neck pain to be almost certainly related to BEXSERO. Additional details were reported as follows: The physician stated about two female patients that after being administered BEXSERO vaccine, they ended up in the emergency room. Both the patients experienced severe neck pain and one of the patient's had migraine as well. This case concerned the patient who had experienced severe neck pain after vaccination. The sales representative had extremely limited information. One female patient was 18 years old and the other female patient was 16 years old. One of the patients were administered HAVRIX with BEXSERO, but the sales representative did not know which patient.
Age: 0.33
Sex: M
Vaccine: 6VAX-F
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, fussy, swollen at injection site.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain
Clinical narrative: Strong fatigue, upset stomach, strong aches, headache.
Age: 0.5
Sex: F
Vaccine: 6VAX-F, PPV, RV1
Symptoms: Head titubation, Infantile spasms
Clinical narrative: Head dropping (diagnosed as infantile myoclonic spasms).
Sex: U
Vaccine: HPV4
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. The physician reported that she reviewed an unspecified article that described the patients, who, on unknown dates, were vaccinated with doses of GARDASIL (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On unknown dates, an unspecified amount of time after the doses were administered, the patients were diagnosed with Guillain-Barre Syndrome and there were 44 deaths associated with GARDASIL. The outcome of Guillain-Barre syndrome was reported as unknown. The reporter considered death to be related to GARDASIL. The relatedness between Guillain-Barre syndrome and GARDASIL was not reported. Upon internal review, the events of Guillain-Barre syndrome and death were considered to be medically significant. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Death, Diarrhoea, Pyrexia, Screaming, Vomiting
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) via social media on 22 August 2016. This case is linked with case 2016SA157332 and 2016SA157340 (same social medica report). This case involves a two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed high pitch screaming, a high fever, vomiting and diarrhea. The patient also developed additional symptoms. Patient's mother contacted the pediatrician and decided to take her son to the emergency room. On an unknown date, patient died in the arms of mother on their way to the emergency room. It was not reported whether autopsy was performed or not. Laboratory investigations and corrective treatment were not reported. List of documents held by sender: none. Sender's Comments: This is poorly documented social medical case where patient died after administration of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). No medical history, concomitant medications, lab/diagnostic or autopsy results accompany the case to help identify the cause of death. Investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.; Reported Cause(s) of Death: diarrhea; high fever; high pitch screaming; vomiting.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient stated she has a sore arm and went to the hospital.