chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
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. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # reported as L04884, expiry date 04-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Lot number L04884 is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L035510 with expiry date: 13-MAY-2017, (dosing details not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date a couple of years ago, the patient was vaccinated with ZOSTAVAX (dosing details not provided). Physician reported that an unspecified time after vaccination, the patient developed a small rash on an unspecified location of the body, which might had been shingles. It was reported that the patient healed from the small rash. Outcome of the event was reported as recovering. Reporting physician had not assessed the causality of the event with respect to ZOSTAVAX. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 15 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. At 03:21 PM on 04-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother refers to a female patient of an unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported) too early. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 22-AUG-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, intramuscularly, 0.5 ml, lot # L037339, expiry date 09-FEB-2018 (anatomical location was not specified). The administered dose of GARDASIL 9 was stored at 90 Fahrenheit degrees for 14 days. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose and route were unknown, lot # L015460 with expiration date 20-JUL-2017, and lot # M011116 with expiration date 17-JUN-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were unknown, lot # M011117 with expiration date 07-DEC-2017, and lot # L026602 with expiration date 19-OCT-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-JUN-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB lot # L048849, expiration date 04-FEB-2018 (dose and route of administration not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medication, drug reactions/allergies and concomitant medication were not reported. On 25-MAY-2010, the patient was vaccinated with the first dose of VAQTA (dose and lot# were not reported), intramuscularly. On 08-NOV 2010 the patient was vaccinated with the second dose of VAQTA, intramuscularly (dose and lot# were not reported). The reporter stated that the second dose was too soon after the first dose. No known adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Seizure like phenomena
Clinical narrative: Pt tensed up like a seizure was happening and fell towards me out of chair. Pt then went to the ground and regained awareness. EMS was called and she was released by the medics.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical 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 histories provided. On unknown dates, the patients were vaccinated with improperly stored dosed of GARDASIL 9 lot # L006547, expiration date 04-MAR-2017 (dose and route of administration 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 was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored GARDASIL 9 (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 17 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. At 10:12 AM on 03-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a female patient of unknown age concerning herself via other company Pfizer. The patient was allergic to iodine contrast dye which was used 10 years ago with a CAT scan, the patient had huge hives and facial swelling on an off 4 months after. Concomitant therapies included levothyroxine sodium since 10 years. Approximately in 2013 (3 years ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the patient experienced sore muscles. The outcome of sore muscle was unknown. The reporter did not assess the causality of the event with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a 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 20-JUL-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported).  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a 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 11-JUL-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a healthcare professional via Pfizer (case # 2016382414) referring to a female patient of unknown age. The patient's medical history included fibromyalgia, chronic fatigue/malaise, mild hypertension, anxiety, asthma (mild), high cholesterol, migraines/stress headaches, lower lumbar spine (LS) pain, sleep apnea, hysterectomy, biopsy breast, cervical spinal fusion, carpal runnel release, radial tunnel release, lumbar vertebral fracture L1, ischemic colitis, spinal cord stimulator (SCS) implant. The patient's historical drug included cortisone. On unknown date in January 2012 the patient was vaccinated with PNEUMOVAX 23. On an unknown date the patient was allergy to the vaccine. The outcome was unknown. This is one of several reports received from the same reporter concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a 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 03-AUG-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not 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 medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L037554 with expiry date: 25-DEC-2017, (dose and route not reported). No adverse effects and no product quality reported. No further information provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old non-pregnant female patient. The patient did not have any pertinent medical history and drug reactions or allergies. The patient did not have any concomitant medications. On 14-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, anatomical location, lot # and expiration date were not reported) subcutaneously. On 21-AUG-2016, the patient developed 2 inch, round, red area at the injection site injection and, on the same day, called the pharmacy back to report that. There was no treatment for the adverse event given. No laboratory tests were performed. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not 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 Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to 120 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unspecified dates since 10-JUL-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M006708, expiry date 02-JUN-2018 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 14 year old male patient. There was no information about the patient's pertinent medical history or medical history and drug reactions or allergies provided. Concomitant therapies included VAQTA. On 21-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 (exact dose and anatomical location were not reported, lot # M005714, expiry date: 03-OCT-2017) intramuscularly. On an unknown date in 2016, the patient experienced syncope and fainted. There was no treatment for the adverse event given. The patient did not seek medical attention. The outcome of syncope was reported as recovered/resolved on an unknown date in 2016. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to 15 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. At 11:49 on 04-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored PROQUAD (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 48 year old female patient. Information regarding patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details were not provided) via intramuscular route. Physician reported that two days after vaccination, on 24-AUG-2016, the patient developed pain, swelling, and warmth in her arm (unspecified arm and also it was unknown if it was same arm where the vaccine was administered). It was unspecified if the patient required medication attention or not. The patient received unspecified treatment for the adverse events. Outcome of the events were unknown. Reporting physician did not provide the causality of the events with respect to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical 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 histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as AK006960, expiration date 19-FEB-2017 (dose and route of administration 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical 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 histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L010595 expiration date 12-NOV-2016 (dose and route of administration 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: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical 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 histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M001811, expiration date 04-NOV-2018 and lot # reported as M014925, expiration date 16-FEB-2019 (dose and route of administration 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses VAQTA which had lot # M003011 with expiry date: 15-NOV-2017, (dose and route not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored inactivated VAQTA (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. 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 Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date the multiple patients were vaccinated with improperly stored ROTATEQ (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursion reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an 11 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 23-AUG-2016, at the age of 11 months, the patient was vaccinated with ROTATEQ (lot # L035511, expiration date 21-MAY-2017, orally, dose was not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reaction or allergies were not reported. On 13-AUG-206, the patient was vaccinated twice with PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported) due to a human error. Concomitant therapy was not reported. No adverse effects were reported. No 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 and refers to a patient of unknown age and gender. There was no information about the patient's current conditions, concomitant therapies or medical history provided. On 16-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M009768 with an expiration date: 23-FEB-2018. (Dose and route of administration were not reported). Administered dose of VARIVAX experienced temperature excursion of 13 degree Fahrenheit for 90 minutes, on an unknown date. Digital data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored GARDASIL (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 15-AUG-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route were not reported). No adverse reactions were reported. This is one of the two 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 Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccine with improperly stored VARIVAX (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 02-SEP-2016 the patient was vaccinated with expired ROTATEQ with lot number L0044554 and expiration date of 07-AUG-2016. No concomitant medications were reported. No adverse effects were reported. The lot number L0044554 with expiration date of 07-AUG-2016 has been verified to be a non valid lot number for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Licensed practical nurse refers to multiple patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored RECOMBIVAX HB (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a clinician via field representative refers to a patient of unknown gender and age. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-SEP-2016, the patient was inadvertently vaccinated with a fourth dose of GARDSIL 9 (dosing details not provided) extra dose administered. Physician reported that the patient received dose 1, 2 and 3 on 14-JUN-1999, 31-AUG-2010 and 09-FEB-2011, respectively (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain, Chills, Disturbance in attention, Dizziness
Clinical narrative: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016008857) as a part of a business agreement on 06-SEP-2016. Case received from a physician via HA on 01-Sep-2016 under reference numbers DK-DKMA-WBS-0004375 / DK-DKMA-ADR 23625530. A 24-year-old female adult patient received GARDASIL, (batch number Not available, Dose 1) via intramuscular route on 14-Jul-2010, GARDASIL, (batch number Not available, Dose 2) via intramuscular route on 15-Oct-2010, GARDASIL, (batch number Not available, Dose 3) via intramuscular route on 23-Aug-2011. The patient experienced Abdominal pain on 04-Sep-2011 12 days Post Administration, Headache on 04-Sep-2011 12 days Post Administration, Dizziness on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Skin disorder on an unknown date, Fatigue on an unknown date, Concentration loss on an unknown date, weakness of leg / weakness of arms on an unknown date, Bloated feeling on an unknown date, Irritable colon on an unknown date, Neuropathic pain on an unknown date, Influenza like illness on an unknown date, Chills on an unknown date, Difficulty focusing eyes on an unknown date, Palpitation on an unknown date, Lactose diarrhea on an unknown date, Light sensitivity on 04-Sep-2011 12 days Post Administration and Fever on 04-Sep-2011 12 days Post Administration. The patient reports that the first symptoms started 14 days after the third vaccination, with fever, abdominal pain, headache, sensitivity to light. Also flu-like symptoms. These episodes are continuous and occur periodically. Can last 3 days, morning and evenings are the worst - 3 day break - 3 days with symptoms and so on. In Autumn and Winter, she is almost constantly sick. Before the vaccines she ran 3 times a week and did strength training. Was employed as a junior producer in the film industry, but had to stop due to her diseases. The tilt table test showed that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines: No. Other medicines: No. The patient's outcome was reported as Not Recovered/Not Resolved.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Influenza like illness, Irritable bowel syndrome, Lactose intolerance
Clinical narrative: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016008857) as a part of a business agreement on 06-SEP-2016. Case received from a physician via HA on 01-Sep-2016 under reference numbers DK-DKMA-WBS-0004375 / DK-DKMA-ADR 23625530. A 24-year-old female adult patient received GARDASIL, (batch number Not available, Dose 1) via intramuscular route on 14-Jul-2010, GARDASIL, (batch number Not available, Dose 2) via intramuscular route on 15-Oct-2010, GARDASIL, (batch number Not available, Dose 3) via intramuscular route on 23-Aug-2011. The patient experienced Abdominal pain on 04-Sep-2011 12 days Post Administration, Headache on 04-Sep-2011 12 days Post Administration, Dizziness on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Skin disorder on an unknown date, Fatigue on an unknown date, Concentration loss on an unknown date, weakness of leg / weakness of arms on an unknown date, Bloated feeling on an unknown date, Irritable colon on an unknown date, Neuropathic pain on an unknown date, Influenza like illness on an unknown date, Chills on an unknown date, Difficulty focusing eyes on an unknown date, Palpitation on an unknown date, Lactose diarrhea on an unknown date, Light sensitivity on 04-Sep-2011 12 days Post Administration and Fever on 04-Sep-2011 12 days Post Administration. The patient reports that the first symptoms started 14 days after the third vaccination, with fever, abdominal pain, headache, sensitivity to light. Also flu-like symptoms. These episodes are continuous and occur periodically. Can last 3 days, morning and evenings are the worst - 3 day break - 3 days with symptoms and so on. In Autumn and Winter, she is almost constantly sick. Before the vaccines she ran 3 times a week and did strength training. Was employed as a junior producer in the film industry, but had to stop due to her diseases. The tilt table test showed that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines: No. Other medicines: No. The patient's outcome was reported as Not Recovered/Not Resolved.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Muscular weakness, Nausea, Neuralgia, Palpitations
Clinical narrative: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016008857) as a part of a business agreement on 06-SEP-2016. Case received from a physician via HA on 01-Sep-2016 under reference numbers DK-DKMA-WBS-0004375 / DK-DKMA-ADR 23625530. A 24-year-old female adult patient received GARDASIL, (batch number Not available, Dose 1) via intramuscular route on 14-Jul-2010, GARDASIL, (batch number Not available, Dose 2) via intramuscular route on 15-Oct-2010, GARDASIL, (batch number Not available, Dose 3) via intramuscular route on 23-Aug-2011. The patient experienced Abdominal pain on 04-Sep-2011 12 days Post Administration, Headache on 04-Sep-2011 12 days Post Administration, Dizziness on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Skin disorder on an unknown date, Fatigue on an unknown date, Concentration loss on an unknown date, weakness of leg / weakness of arms on an unknown date, Bloated feeling on an unknown date, Irritable colon on an unknown date, Neuropathic pain on an unknown date, Influenza like illness on an unknown date, Chills on an unknown date, Difficulty focusing eyes on an unknown date, Palpitation on an unknown date, Lactose diarrhea on an unknown date, Light sensitivity on 04-Sep-2011 12 days Post Administration and Fever on 04-Sep-2011 12 days Post Administration. The patient reports that the first symptoms started 14 days after the third vaccination, with fever, abdominal pain, headache, sensitivity to light. Also flu-like symptoms. These episodes are continuous and occur periodically. Can last 3 days, morning and evenings are the worst - 3 day break - 3 days with symptoms and so on. In Autumn and Winter, she is almost constantly sick. Before the vaccines she ran 3 times a week and did strength training. Was employed as a junior producer in the film industry, but had to stop due to her diseases. The tilt table test showed that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines: No. Other medicines: No. The patient's outcome was reported as Not Recovered/Not Resolved.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Pyrexia, Skin disorder, Tilt table test positive, Vision blurred
Clinical narrative: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016008857) as a part of a business agreement on 06-SEP-2016. Case received from a physician via HA on 01-Sep-2016 under reference numbers DK-DKMA-WBS-0004375 / DK-DKMA-ADR 23625530. A 24-year-old female adult patient received GARDASIL, (batch number Not available, Dose 1) via intramuscular route on 14-Jul-2010, GARDASIL, (batch number Not available, Dose 2) via intramuscular route on 15-Oct-2010, GARDASIL, (batch number Not available, Dose 3) via intramuscular route on 23-Aug-2011. The patient experienced Abdominal pain on 04-Sep-2011 12 days Post Administration, Headache on 04-Sep-2011 12 days Post Administration, Dizziness on an unknown date, Nausea on an unknown date, Diarrhea on an unknown date, Obstipation on an unknown date, Skin disorder on an unknown date, Fatigue on an unknown date, Concentration loss on an unknown date, weakness of leg / weakness of arms on an unknown date, Bloated feeling on an unknown date, Irritable colon on an unknown date, Neuropathic pain on an unknown date, Influenza like illness on an unknown date, Chills on an unknown date, Difficulty focusing eyes on an unknown date, Palpitation on an unknown date, Lactose diarrhea on an unknown date, Light sensitivity on 04-Sep-2011 12 days Post Administration and Fever on 04-Sep-2011 12 days Post Administration. The patient reports that the first symptoms started 14 days after the third vaccination, with fever, abdominal pain, headache, sensitivity to light. Also flu-like symptoms. These episodes are continuous and occur periodically. Can last 3 days, morning and evenings are the worst - 3 day break - 3 days with symptoms and so on. In Autumn and Winter, she is almost constantly sick. Before the vaccines she ran 3 times a week and did strength training. Was employed as a junior producer in the film industry, but had to stop due to her diseases. The tilt table test showed that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines: No. Other medicines: No. The patient's outcome was reported as Not Recovered/Not Resolved.
Sex: M
Vaccine: HPV4
Symptoms: Central nervous system inflammation, Endotracheal intubation, Paralysis
Clinical narrative: Information has been received from an unspecified person via a company employee referring to a male patient of unknown age, who was perfectly healthy. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot #, expiration date and route not reported). On an unknown date, the patient was paralyzed after getting the GARDASIL shot. The patient was hospitalized for 88 days and had to be intubated. The patient's spinal cord remained inflamed and he needed to wear 15 pounds (lbs) breathing apparatus at all times. The outcome of the events was unknown. The doctors at the hospital had reported the events to Vaccine Adverse Event Reporting System (VAERS). The reporter considered the GARDASIL caused the events. Upon internal review, the events of "paralyzed and spinal cord remained inflamed" were considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Was dizzy and headache "like knife" after TRUMENBA vaccine-right after vaccine. Did TYLENOL and symptoms improved within 40 minutes.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Nausea
Clinical narrative: Was dizzy and headache "like knife" after TRUMENBA vaccine-right after vaccine. Did TYLENOL and symptoms improved within 40 minutes.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Was dizzy and headache "like knife" after TRUMENBA vaccine-right after vaccine. Did TYLENOL and symptoms improved within 40 minutes.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient had none pertinent medical history and drug reactions or allergies. On 19-AUG-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L046893, expiration date 23-FEB-2017), once. The patient did not have any concomitant therapy. On unspecified time on Sunday 20-AUG-2016, the patient experienced an adverse event described as the following: "raised and swollen, redness, warm down to elbow, no pain". The patient sought medical attention by coming into the pharmacy on 22-AUG-2016, to speak with the pharmacist. The pharmacist stated that she told the patient to take an unspecified dosage of BENADRYL for treatment of the adverse event. No lab diagnostic studies were performed. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness between the ZOSTAVAX and the adverse event was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient had none pertinent medical history and drug reactions or allergies. On 19-AUG-2016, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L046893, expiration date 23-FEB-2017), once. The patient did not have any concomitant therapy. On unspecified time on Sunday 20-AUG-2016, the patient experienced an adverse event described as the following: "raised and swollen, redness, warm down to elbow, no pain". The patient sought medical attention by coming into the pharmacy on 22-AUG-2016, to speak with the pharmacist. The pharmacist stated that she told the patient to take an unspecified dosage of BENADRYL for treatment of the adverse event. No lab diagnostic studies were performed. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness between the ZOSTAVAX and the adverse event was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 52 year old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with a dose of PREVNAR one year ago, in approximately 2015. Concomitant medications were reported as 'there was nothing new in her current medication therapy'. On 21-AUG-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot# reported as L022262; expiry date: 05-NOV-2016) subcutaneously. Other suspect vaccine included AFLURIA. Following vaccination, on an unknown date, in approximately 2016, patient experienced a red swollen arm. Patient was seen by a nurse practitioner at a physician's office. The nurse practitioner thought that it 'might be a Staphylococcus cellulitis infection but was some kind of a bacterial infection' that the patient received unspecified antibiotic shots for. Patient had recovered from the event in approximately 2016. Causality assessment was not provided. No Product Quality Complaint (PQC) was involved. Upon internal review, Staphylococcus cellulitis infection was considered to be medically significant. This is one of the two reports from the same source. Additional information has been requested.