chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative and refers to a male patient in his 80's. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first dose (reported as "once") of ZOSTAVAX "one shot", (route and site of administration, dose, strength, lot # and expiry date were not reported). On an unknown date, reported as "about one week" after administration of ZOSTAVAX, the patient experienced "shingles-like rash" on his shoulder and the top of his chest. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. The patient sought medical attention by contacting the physician assistant. Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a health care worker refers to multiple unspecified patient of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Lot# L044058, Expiry: 02-MAY-2017; Lot# L05098, Expiry: 14-JUN-2017, Lot#M001152, Expiry: 05-JUL-2017). The vaccine was stored at 16 F for a duration of 1 hour and 11 minutes. 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: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to multiple unspecified patients of unknown demographics. The concurrent condition and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (Lot # L039126, Expiry: 08-JAN-2017; Lot # L044529, Expiry: 09-FEB-2016). The vaccine was stored at 16 F for a duration of 1 hour and 11 minutes. 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: F
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, Interchange of vaccine products, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner an adult female patient of unknown age. There was no information regarding concomitant medications and historical medication. On an unknown date the patient was vaccinated with 2 doses of GARDASIL 4 and 1 dose of GARDASIL 9 (interchange of vaccine products and wrong drug administered. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Reporter did not provided the age of the patient but stated that she was well over the age of 26 years. This is one of several reported received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, Pain in extremity, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an 11 year old female patient. There was no information regarding concomitant medication and historical medication. On an unknown date in August 2015, the patient was vaccinated with GARDASIL dose 1 and dose 2 in mid-October 2015. Approximately on 12-APR-2016, 3 days ago patient was vaccinated with GARDASIL 9 in the left arm (interchange of vaccine products and wrong drug administered) and also got vaccinated with tetanus toxoid was administered. The outcome of pain in extremity was reported as recovered/resolved. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter dose not wants to get contacted.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX, lot # K015308 with expiry date on 17-DEC-2015, (dose, strength and anatomical site were not reported). No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) lot # L013068 with expiration date on 14-APR-2017 and PROQUAD lot# L031602 with expiration date on 18-FEB-2017 (dose, strength and anatomical site were nor reported). No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an 18 year old patient of unknown gender. On 30-AUG-2007, the patient was vaccinated with a pediatric dose of VAQTA (Lot #/exp. date, dose and route of administration were not provided) and then on 12-MAY-2016, the patient was vaccinated with an adult dose of VAQTA (Lot# L004745; exp. date: 28-APR-2017) (dose and route of administration not provided). No adverse effects were reported and no PQC was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. In October 2015, the patient was vaccinated with the first dose of ZOSTAVAX (lot number and expiration date were not provided). Then, on 19-APR-2016, the patient was vaccinated with the second dose of ZOSTAVAX lot # L040445, expiration date 15-JAN-2017. Concomitant therapy information was not provided. On 19-APR-2016, there was an extra dose administered as the pharmacist stated that the patient did not remember that he received a first dose of ZOSTAVAX and had a second dose. No adverse event was reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram, Excessive eye blinking, Eye movement disorder, Grimacing, Muscle tightness
Clinical narrative: Seizure like event, grimace tight jaw, eyes flickering rolling back, tensing up shoulders and neck, come in few second clusters of 3-5 at a time, 4-5 times a day every day since, rx phenobarbital 2x a day.
Age: 0.62
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Nuclear magnetic resonance imaging, Seizure like phenomena
Clinical narrative: Seizure like event, grimace tight jaw, eyes flickering rolling back, tensing up shoulders and neck, come in few second clusters of 3-5 at a time, 4-5 times a day every day since, rx phenobarbital 2x a day.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site. Difficulty moving or raising the left arm of injection site because of pain. Warmth, red, and swelling in the whole upper left arm. Feeling feverish and generally weak. Occasional headache. These symptoms continued but improved during the next day except the swelling and redness in the upper left arm. These symptoms finally resolved on 05/14/2016.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pain at injection site. Difficulty moving or raising the left arm of injection site because of pain. Warmth, red, and swelling in the whole upper left arm. Feeling feverish and generally weak. Occasional headache. These symptoms continued but improved during the next day except the swelling and redness in the upper left arm. These symptoms finally resolved on 05/14/2016.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site urticaria, Injection site warmth, Pain in extremity
Clinical narrative: Headache, welt at injection site, warm to touch, arm sore.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swelling in the arm extending from the elbow to the shoulder. Redness, soreness, warmth, and mild fever.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Disorientation, Dizziness, Dysarthria, Seizure
Clinical narrative: Patient was given a Td vaccination and as he was sitting on bench for 20 minute wait after vaccine was given, he had a seizure. It lasted maybe 30 seconds, I can't be for  sure. I tried to offer supportive care as 911 was called by my technician. My other technician also helped keep me keep him from falling onto the floor as 911 arrived and took over. He was alert but very dizzy and disoriented and was slurring words. He was taken to the hospital for further observation.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Pain at injection site and surrounding muscle starting 05/11/2016. Swollen lymph nodes in neck starting 05/12/2016.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Large area (about 5 inches) red rash area with swelling and soreness.
Age: 28.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: 5/13/16-SORE ARM 7:00 PM PT TOOK IBUPROFEN. 5/14/2016- 10:00 PM ARM SWOLLEN 5/14/16- 3:00 PM ARM WENT LIMP WHILE DRIVING
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: One inch diameter rash at administration site. Administered 1% hydrocortisone cream with no relief on 5/8 in am. Administered clobetasol 0.05% ointment which cleared rash.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Chills, Condition aggravated, Dehydration, Diarrhoea
Clinical narrative: 3/24/16 5:00 PM - pain at the injection site;  9:00 PM - nausea; 3/25/16 4:00 AM - nausea, chills, weakness; 6:00 AM - severe weakness (difficult to stand up), extreme nausea; 8:00 AM - 9:00 AM diarrhea 3 x, severe weakness/feeling faint; 10:00 AM - vomiting, diarrhea, hives, fever; 11:00 AM - 8:00 PM - nausea, diarrhea 10 x; treatment - ice chips throughout day, could not tolerate food (tried jello at 5 PM and had nausea/diarrhea); 3/26 - nausea but beginning to tolerate food (rice, banana), extremely weak/dehydrated from vomiting/diarrhea on 3/25; 3/27 - 3/29 nausea persists but able to tolerate food (BRAT diet)
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dysstasia, Food intolerance, Injection site pain, Nausea
Clinical narrative: 3/24/16 5:00 PM - pain at the injection site;  9:00 PM - nausea; 3/25/16 4:00 AM - nausea, chills, weakness; 6:00 AM - severe weakness (difficult to stand up), extreme nausea; 8:00 AM - 9:00 AM diarrhea 3 x, severe weakness/feeling faint; 10:00 AM - vomiting, diarrhea, hives, fever; 11:00 AM - 8:00 PM - nausea, diarrhea 10 x; treatment - ice chips throughout day, could not tolerate food (tried jello at 5 PM and had nausea/diarrhea); 3/26 - nausea but beginning to tolerate food (rice, banana), extremely weak/dehydrated from vomiting/diarrhea on 3/25; 3/27 - 3/29 nausea persists but able to tolerate food (BRAT diet)
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: 3/24/16 5:00 PM - pain at the injection site;  9:00 PM - nausea; 3/25/16 4:00 AM - nausea, chills, weakness; 6:00 AM - severe weakness (difficult to stand up), extreme nausea; 8:00 AM - 9:00 AM diarrhea 3 x, severe weakness/feeling faint; 10:00 AM - vomiting, diarrhea, hives, fever; 11:00 AM - 8:00 PM - nausea, diarrhea 10 x; treatment - ice chips throughout day, could not tolerate food (tried jello at 5 PM and had nausea/diarrhea); 3/26 - nausea but beginning to tolerate food (rice, banana), extremely weak/dehydrated from vomiting/diarrhea on 3/25; 3/27 - 3/29 nausea persists but able to tolerate food (BRAT diet)
Age: 77.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right lower deltoid swelling, Erythema, tenderness.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Nausea, Vomiting
Clinical narrative: Side pain in lower right quadrant, nausea, vomiting; ER diagnosis appendicitis- had appendectomy on Dec. 1, 2015.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Fatigue, Muscle swelling, Myalgia, Rash, Rash erythematous
Clinical narrative: Pt. had a red rash covering the anterior upper arm. He complained of muscle ache. Muscle was a little swollen. Pt. also complained of feeling tired. No redness or any kind of reaction at injection site. Told pt. to take BENADRYL and ADVIL before bed time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Small rash at injection site 5/13, vaccine adm 5/5/16.
Age: 3.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Child has had two VARIVAX vaccines on 9/30/10 and 9/27/12. Child presented in the office today with varicella.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of VAQTA 50/1.0 U/ML (which had the lot number of K001296 with expiration date of 15-JAN-2016) (dose, route and anatomical site were not reported). Information regarding concomitant medication was not provided. However no adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12-month-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12-month-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker professional referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot #L027070 with expiration date of 30-APR-2017 (dose number was not provided). The patient's concomitant medications were not reported. The healthcare worker stated, that ROTATEQ was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. It was called due to a data logger. Additionally it was stated, that the vaccine was not involved in previous temperature excursions. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist 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 11-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX that was not expired (dose, route of administration, lot # and expiration date were not reported). ZOSTAVAX was mixed with an expired STERILE WATER DILUENT lot # L001646, expiration date 20-DEC-2015 (wrong solution used in drug reconstitution and expired product administered. There was no adverse effect reported. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2015 , the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 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 unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 20-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX  lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. 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 Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 (therapy type digital data logger) (lot # L029073, expiry date 19-APR-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 degrees Fahrenheit (10 cycles) in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. The outcome of temperature excursion was reported as not supported. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 1-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 6-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit of 72 hours. 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 Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (therapy type digital data logger) (lot # L043213, expiry date 28-AUG-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 F to 35 F in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three 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 Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (therapy type digital data logger)(lot # L043213, expiry date 28-AUG-2016) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 F to 35 F in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three options received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours.  Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. 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: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 26-APR-2016 the patient was inadvertently vaccinated with an expired dose of VARIVAX (dosing details were not reported) (lot # K002912 with expiry date of 26-FEB-2016). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There was no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified 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 (Oka/Merck) PROQUAD lot # L011080 with expiration date 10-OCT-2016 or lot # L023114 with expiration date 24-DEC-2016 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 0.5 degrees Celsius for 12 hours. A digital data logger was  involved. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 9-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13-month-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare workers refers to a 17 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.13
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Adverse event, Pyrexia
Clinical narrative: This spontaneous report as received from a physician vie a company representative refers to a 70 year old male patient. The patient had no pertinent medical history, concomitant therapy and drug reactions or allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX23, "one injection", subcutaneous (site of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced unspecified adverse event. Within 24 hours of receiving the injection, the patient developed a fever with a temperature of 102 degrees (exact units not provided). No treatment was given for the adverse events. There were no lab diagnostic studies performed excluding body temperature. The patient sought medial attention by visited doctor's office. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 13-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.16
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.19
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 8 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 1.26
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact does and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were not previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 15 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose, site and route of administration were unknown), more than 2 months after her first dose which was GARDASIL (dose, site and route of administration, lot and expiration date were unknown) vaccinated on an unknown date in 2015 (date unspecified). There was no adverse events reported. No product quality issue was involved. Additional information has been requested.
Age: 1.19
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a 14-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was not adverse effect reported. Administrated dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. 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.
Age: 66.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 19-APR-2016, the patient was vaccinated inadvertently with pediatric dose of VAQTA, K012457, expiry date 04-JUN-2017, 0.5 ml instead of an adult dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a newborn patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated concomitantly with two doses of RECOMBIVAX HB (strength, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse concerning multiple unspecified patients of unknown age or gender. The patients' concurrent conditions, medical history or allergy/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses (24 hours) of ROTATEQ (Lot # L013203, exp. 28-JAN-2017) (dose and frequency were not provided). There was no concomitant medications reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.