chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot #L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 13-OCT-2016, the patient was inadvertently administered expired single dose of PNEUMOVAX 23 lot # K021577, expiry date 22-JUN-2016, intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No information on patient's pertinent medical history, drug reactions or allergies was provided. On 01-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiry date were not provided). On 11-AUG-2016 and 13-OCT-2016, the patient was intramuscularly vaccinated with the second and third dose of GARDASIL 9 (dose, lot # and expiry date were not provided), respectively. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number M022077 with an expiration date of 19-MAR-2019) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no previous excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 328 hours, with the lowest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-MAR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the lowest recorded temperature of 1 degrees Fahrenheit (1 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Local reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number 43HB3, expiry date 19th May 2018). In August 2016, the patient received KINRIX .5 ml. In August 2016, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The patient received a dose of KINRIX at an age of 4 months, which led to an inappropriate age at vaccine administration. No side effects were reported. Follow up information was received from other health professional on 17th October 2016: The reporter's contact details were updated. It was reported that the dose of KINRIX was given in the office. The medication was combo in which the patient needed both the vaccines, but did not realize that the medication was for specific age group. The patient's mother was called and she advised that the patient had local reaction (injection site reaction) that lasted for 1 day and otherwise doing well. The patient's mother talked with GlaxoSmithKline and was advised that amount of vaccines (each present in combo) would be the same as if given separately (not in combo vaccine). The VAERS details were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-JUN-2016, the patient received dose of improperly stored RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-JUN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 02-JAN-2000 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 464 hours, with the highest recorded temperature of 1 degrees Fahrenheit (1degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Irritability
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-day-old female patient who received HAVRIX pediatric. On an unknown date, the patient received HAVRIX pediatric at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The patient inadvertently received a paediatric dose of HAVRIX at an age of 21 days, which led to an inappropriate age at vaccine administration. The healthcare professional did not have product or patient information. Follow up information was received from nurse on 18th October 2016: The medication error was not done at the reporter's facility, so she did not have information on the product. An employee at a physician's office called to ask what she should do. The nurse told her to ask the doctor and call the medical department at GlaxoSmithKline. The patient's mother stated that the patient was fussy after vaccination, but no fever, redness or swelling occurred. The VAERS details were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M013156, expiration date: 15-OCT-2017, dose and injection site were not provided). No adverse effects were reported. Complete temperature excursion details were unknown, at the time of the report. The vaccines were exposed to below recommended temperatures for an unspecified period of time. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 years old female patient. The patient's medical history and concurrent conditions were not reported. On 19-OCT-2016 at 12:00, the patient was vaccinated with PNEUMOVAX 23, lot # M020521, expiry date: 17-NOV-2017, (strength, dose, route and anatomical location of administration were unknown). Concomitant therapies were not reported. On the same date at an unspecified time after injection, the patient experienced soreness in her arm (pain in extremity) and also shortness of breath (dyspnoea). The patient's daughter took her to the emergency room, but it was not specific if the patient was actually admitted to the hospital. No product quality complaint (PQC) was involved. At the time of reporting, the patient was recovering from the pain in extremity and the dyspnoea (reported as "patient now felt better but still had some arm soreness"). The causality assessment between the pain in extremity, the dyspnoea and PNEUMOVAX 23 was not provided. Additional information is not expected, no permission for further contact was provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 29 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 828 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the second time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the third time was 792 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Friday evening 10-21-16 pt. shot area was firm-by Saturday 10-22-16 Quarter size red spot and by Sunday bright red "baseball" size red spot-firm to touch with white ring around shot area-area also slightly swollen as reported by mother.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Induration, Pain
Clinical narrative: Patients arm immediately turned red. Patient went to MD on Monday w/hard, itchy, painful, red site irritation. Patient came into pharmacy showed site and had Rx for cephalexin 500 mg TID times 7 days for treatment of cellulitis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin irritation
Clinical narrative: Patients arm immediately turned red. Patient went to MD on Monday w/hard, itchy, painful, red site irritation. Patient came into pharmacy showed site and had Rx for cephalexin 500 mg TID times 7 days for treatment of cellulitis.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Red mark on left arm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route were not reported) lot # L016427 and expiry date: 13-APR-2017. The vaccine was exposed to a temperature of 15 degrees centigrade for 12 hours. There were no previous temperature excursions. A data logger was involved. Stability questions were also asked during the call about VAQTA and PEDVAXHIB, however no doses of improperly stored VAQTA and PEDVAXHIB were administered to patients. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 16 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 13-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, subcutaneously (lot# reported as M033219 with expiration date 18-AUG-2017; dose not reported). On an unknown date in October 2016, the patient began experiencing "local irritation, a lump and swelling" at the injection site. The patient did not seek medical attention. There was no treatment given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-MAY-2016 the patient was vaccinated  with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: The patients arm was warm to the touch, swollen, and hard. There was also redness to the inside of the arm. The patient was referred to her doctor. Per the patient the doctor told her to take BENADRYL.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ administered orally (lot number M004508 with an expiration date of 29-JUN-2017 and lot number M019708 with an expiration date of 25-OCT-2017) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no pervious excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of PEDVAXHIB (lot number L051123 with an expiration date of 13-OCT-2018) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The doses of the vaccine experienced a temperature excursion of 1 Celsius (C) for 48 hours. The aforementioned temperature was identified due to a data logger. There were no previous excursions reported. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JUL-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 09-FEB-2018 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-APR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 09-FEB-2018 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M012495 with exp. 09-OCT-2017; lot # M025563 exp. 06-NOV-2017), orally, (dose was not provided). "Since the first excursion occurred of 14 degrees C for 2 hours on an unspecified date" on multiple unspecified dates. The pharmacist reported no adverse effects. There was a data logger issue involved. Temperature: 0 degrees C to 1 degrees C. Time frame: 10 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-MAR-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-JUN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL (strength: 0.5 ml) lot # L020162 and expiration date: 23-JUL-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 120 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint 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: This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 03-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degree F (1.11 degree C), and for a sum of 24 hours at a highest temperature recorded of 47 degree F (8.33 degree C). No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Nerve injury
Clinical narrative: On Feb 4-2015 at 9:30 AM I receive a vaccine call PCV 13 by 4:00 then I was receiving the following reaction listed in sheet=1A. On Feb. 4, 2015 they decided to give me PC-13-pneumonia shot they had been testing my blood for 6 weeks. They then at 9:30 ad. the vaccine to me. By 4:00 I was very sick. I am including a vaccine information sheet talking about the risks and what if there is a serious reaction. That would start a few minutes to a few hours after vaccination. Well after that I experience everything listed plus more and they have never went away. Then on April of this year my pain doctor had me started taking gabapentin 100 mg. capsule for pain. By first week of May it was worse and never has gone away.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Blood test, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016422868) on 10 Oct 2016. This case involves a 16 year old female patient who was vaccinated with 0.5 ml dose one of TRUMENBA (Batch number: M74089, expiry date: 30 Jun 2017) intramuscularly in deltoid left on 22 Jul 2016 at 11:42:00 am and dose two of MENACTRA (batch number: U5259AA, expiry date was not reported) intramuscularly in deltoid right and GARDASIL (Batch number: M005714, expiry date was not reported) intramuscularly in deltoid left on 22 Jul 2016. The patient medical history includes possible anxiety and the patient was previously vaccinated with a dose one of GARDASIL and MENACTRA vaccines on an unknown date. The patient concomitant drug include HYDROXYZINE 50 mg tablets three times a day from 17 Aug 2016. On 22 Aug 2016, one month after vaccination the patient had seizure. The patient was seen at the emergency department on an unknown date. The patient lab tests were not reported. The patient corrective treatment was not reported. The outcome of the event was not recovered at the time of this report (reported as ongoing). Upon internal review, the case was considered as serious due to important medical event (seizure). The reporter assessed the causal relationship with suspect Trumenba as reasonable possibility. List of documents held by sender: none. Sender's Comments: Seizure is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016422868) on 10 Oct 2016. This case involves a 16 year old female patient who was vaccinated with 0.5 ml dose one of TRUMENBA (Batch number: M74089, expiry date: 30 Jun 2017) intramuscularly in deltoid left on 22 Jul 2016 at 11:42:00 am and dose two of MENACTRA (batch number: U5259AA, expiry date was not reported) intramuscularly in deltoid right and GARDASIL (Batch number: M005714, expiry date was not reported) intramuscularly in deltoid left on 22 Jul 2016. The patient medical history includes possible anxiety and the patient was previously vaccinated with a dose one of GARDASIL and MENACTRA vaccines on an unknown date. The patient concomitant drug include HYDROXYZINE 50 mg tablets three times a day from 17 Aug 2016. On 22 Aug 2016, one month after vaccination the patient had seizure. The patient was seen at the emergency department on an unknown date. The patient lab tests were not reported. The patient corrective treatment was not reported. The outcome of the event was not recovered at the time of this report (reported as ongoing). Upon internal review, the case was considered as serious due to important medical event (seizure). The reporter assessed the causal relationship with suspect Trumenba as reasonable possibility. List of documents held by sender: none. Sender's Comments: Seizure is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Tremor
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016422868) on 10 Oct 2016. This case involves a 16 year old female patient who was vaccinated with 0.5 ml dose one of TRUMENBA (Batch number: M74089, expiry date: 30 Jun 2017) intramuscularly in deltoid left on 22 Jul 2016 at 11:42:00 am and dose two of MENACTRA (batch number: U5259AA, expiry date was not reported) intramuscularly in deltoid right and GARDASIL (Batch number: M005714, expiry date was not reported) intramuscularly in deltoid left on 22 Jul 2016. The patient medical history includes possible anxiety and the patient was previously vaccinated with a dose one of GARDASIL and MENACTRA vaccines on an unknown date. The patient concomitant drug include HYDROXYZINE 50 mg tablets three times a day from 17 Aug 2016. On 22 Aug 2016, one month after vaccination the patient had seizure. The patient was seen at the emergency department on an unknown date. The patient lab tests were not reported. The patient corrective treatment was not reported. The outcome of the event was not recovered at the time of this report (reported as ongoing). Upon internal review, the case was considered as serious due to important medical event (seizure). The reporter assessed the causal relationship with suspect Trumenba as reasonable possibility. List of documents held by sender: none. Sender's Comments: Seizure is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016422868) on 10 Oct 2016. This case involves a 16 year old female patient who was vaccinated with 0.5 ml dose one of TRUMENBA (Batch number: M74089, expiry date: 30 Jun 2017) intramuscularly in deltoid left on 22 Jul 2016 at 11:42:00 am and dose two of MENACTRA (batch number: U5259AA, expiry date was not reported) intramuscularly in deltoid right and GARDASIL (Batch number: M005714, expiry date was not reported) intramuscularly in deltoid left on 22 Jul 2016. The patient medical history includes possible anxiety and the patient was previously vaccinated with a dose one of GARDASIL and MENACTRA vaccines on an unknown date. The patient concomitant drug include HYDROXYZINE 50 mg tablets three times a day from 17 Aug 2016. On 22 Aug 2016, one month after vaccination the patient had seizure. The patient was seen at the emergency department on an unknown date. The patient lab tests were not reported. The patient corrective treatment was not reported. The outcome of the event was not recovered at the time of this report (reported as ongoing). Upon internal review, the case was considered as serious due to important medical event (seizure). The reporter assessed the causal relationship with suspect Trumenba as reasonable possibility. List of documents held by sender: none. Sender's Comments: Seizure is listed with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case. More over patient received more than one vaccine hence role of a particular vaccine cannot be assessed.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Initial unsolicited report received from a Pharmacist on 17 October 2016. This case was linked to 2016SA191742 (same reporter, same product and same event). This case involves a female patient (65 plus year old) who was vaccinated with a dose of FLUZONE HD (batch number: UI620AD, expiry date, dose and dose in series were not reported) intramuscularly in the right deltoid on 05 September 2016. Patients illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy (NKA). On 06 September 2016, one day following the vaccination, the patient developed "red spots all over body, itching". Patient's Lab data was not reported. It was unknown if patient had received any corrective treatment. On unknown date patient recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Initial unsolicited report received from a Pharmacist on 17 October 2016. This case was linked to 2016SA191742 (same reporter, same product and same event). This case involves a female patient (65 plus year old) who was vaccinated with a dose of FLUZONE HD (batch number: UI620AD, expiry date, dose and dose in series were not reported) intramuscularly in the right deltoid on 05 September 2016. Patients illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy (NKA). On 06 September 2016, one day following the vaccination, the patient developed "red spots all over body, itching". Patient's Lab data was not reported. It was unknown if patient had received any corrective treatment. On unknown date patient recovered from the events. List of documents held by sender: none.