chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA006643: US-009507513-1707USA008799: US-009507513-1707USA008831: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834:US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA00885.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008817: US-009507513-1707USA008818: US-009507513-1707USA008819: US-009507513-1707USA008862: US-009507513-1707USA008863: US-009507513-1707USA008793: US-009507513-1707USA008820: US-009507513-1707USA008821: US-009507513-1707USA008839: US-009507513-1707USA008864: US-009507513-1707USA008865: US-009507513-1707USA008794: US-009507513-1707USA008822: US-009507513-1707USA008823: US-009507513-1707USA008840: US-009507513-1707USA008866: US-009507513-1707USA008867: US-009507513-1707USA008795: US-009507513-1707USA008824: US-009507513-1707USA008825: US-009507513-1707USA008841: US-009507513-1707USA008868: US-009507513-1707USA008869: US-009507513-1707USA008796: US-009507513-1707USA008826: US-009507513-1707USA008827: US-009507513-1707USA008828: US-009507513-1707USA008842: US-009507513-1707USA008870: US-009507513-1707USA008797: US-009507513-1707USA008829: US-009507513-1707USA008830: US-009507513-1707USA008843: US-009507513-1707USA008798: US-009507513-1707USA006643: US-009507513-1707USA008831: US-009507513-1707USA008832: US-009507513-1707USA008844: US-009507513-1707USA008845: US-009507513-1707USA008800: US-009507513-1707USA008833: US-009507513-1707USA008801: US-009507513-1707USA008802: US-009507513-1707USA008834: US-009507513-1707USA008846: US-009507513-1707USA008803: US-009507513-1707USA008804: US-009507513-1707USA008835: US-009507513-1707USA008847: US-009507513-1707USA008848: US-009507513-1707USA008805: US-009507513-1707USA008806: US-009507513-1707USA008849: US-009507513-1707USA008850: US-009507513-1707USA008807: US-009507513-1707USA008808: US-009507513-1707USA008851: US-009507513-1707USA008852: US-009507513-1707USA008853: US-009507513-1707USA008789: US-009507513-1707USA008809: US-009507513-1707USA008810: US-009507513-1707USA008854: US-009507513-1707USA008855: US-009507513-1707USA008790: US-009507513-1707USA008811: US-009507513-1707USA008812: US-009507513-1707USA008836: US-009507513-1707USA008856.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported), for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office supervisor  medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 (also reported as "since March 2017,") the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office supervisor  medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 (also reported as "since March 2017,") the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. The vaccine was exposed from 32°F to 35°F for 1 hour. There was no previous temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug allergies were not reported. On 17-JUL-2017 the patient was vaccinated with both VARIVAX, 1 dose unit (Lot # M029918, Expiry date: 28-SEP-2018) and PROQUAD 1 dose unit (Lot # N013865, Expiry date: 31-OCT-2018) for prophylaxis (inappropriate schedule of drug administration). Concomitant therapies included sterile diluent, lot # and expiry date was unknown. No adverse effects were reported. There was no product quality complaint involved. This is 1 of the 2 reports from the same reporter. Lot N013865 is a valid lot number for PROQUAD and has been added to the lot number field. Lot M029918 is an invalid lot number for VARIVAX. Sender's Comments: US-009507513-1707USA008603.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot# M031567 with expiration date: 24-DEC-2017, lot# M035143 with expiration date: 30-JAN2017 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not provided). The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F for 54 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053:US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009057.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old male patient with hypertension. On JUN-2017 the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis. Concomitant therapies included atenolol. On 07-JUL-2017 the patient experienced injection site pain. The outcome of injection site pain is unknown.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 20-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010013: US-009507513-1707USA010014: US-009507513-1707USA010015: US-009507513-1707USA010017: US-009507513-1707USA010018: US-009507513-1707USA010019: US-009507513-1707USA010012: US-009507513-1707USA010016.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 64 year patient of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUL-2017, the patient received VARIVAX reconstituted with sterile diluent for prophylaxis (dosing details not reported). The pharmacist reported that the patient received VARIVAX in error rather than ZOSTAVAX (Wrong drug administered). No side effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to multiple unspecified patients of unknown age and gender. Information about current condition, concomitant medication and medical history were not provided. On unspecified dates, unspecified patients were vaccinated with unspecified number of doses of improperly stored PEDVAXHIB (lot# reported as N003536 with expiration date 02-NOV-2019; M046133 with expiration date 26-SEP-2019; concentration, dose, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at 47 degrees Fahrenheit (F) to 77F (51F) for 1 hour 20 minutes, and 32F to 35F (34F) for 3 hours and 46 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009417: US-009507513-1707USA009615.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and a nurse refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# M049123, expiration date 13-JUN-2018; lot# M048201, expiration date 05-JUN-2018 and reported as lot# N012490 expiration date 17-OCT-2018 (requires lot# verification) and reported as lot# N002325, expiration date 19-JUL-2018 (requires lot# verification) (doses and routes of administration were not reported for all) reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 16 hours. Data logger was not involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002187.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. Additional information has been requested. Sender's Comments: US-009507513-1707USA009810: US-009507513-1707USA009900.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age.   On 11-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M014310, expiration date 26-MAY-2017, for prophylaxis.No adverse effect.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 20-JAN-2017 and 20-MAR-2017, the patient was vaccinated with the first and second dose of GARDASIL (lot#, expiration date, route, concentration and dose were unknown), and then on 24-JUL-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot#, expiration date, route, concentration and dose were unknown), all three doses for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 17-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 14-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 10-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown).    No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 06-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender.  On 28-JUN-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown).     No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender.      On 05-JUN-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 20-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009387.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender.      On 29-JUN-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M037015, expiration date 22-NOV-2017; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown).    No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient concurrent condition, medical history and concomitant medications were not reported. On 04-JUL-2017, the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). On 22-JUL-2017, the patient started therapy with oral Keflex and ophthalmic Polycin ointment for an unknown reason (adverse event). The patient sought medical attention and consulted the Pharmacist. It was reported that the patient received unspecified treatment for the adverse event. The outcome of adverse event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rash, Rash erythematous, Urticaria
Clinical narrative: Red rash and hives beginning on face and spreading to torso, joint pain.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient received PEDIARIX instead of KINRIX.
Age: 6.0
Sex: F
Vaccine: DTAP, FLU4, MMR
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Mom spoke with nurse 7/25/17, at clinic to get vaccines. Mom reported with last round of vaccines 3/27/17 daughters left arm swelled up. Daughter had high fever. Patient was taken to emergency room. Was administered Clindamycin. Language barrier mom could not recall why Clindamycin was given. Mom reports once daughter received antibiotic swelling went away she felt better.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a certified medical assistant who was reporting on a patient of unknown gender. No medical history or concomitant medications were reported. On an unspecified date 6 years ago, the patient was 10 years of age and received the first dose of GARDASIL (no lot, expiration, dose or site reported) for prophylaxis. On 11-JUL-2017, the patient was administered dose two in the serious with a dose of GARDASIL 9 (no lot, expiration, dose or site reported) six years later. No adverse effects reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a licensed practical nurse who was reporting on an unspecified patient (age and gender unknown). No medical history or concomitant medications reported. On 11-JUL-2017, the patient received a dose of ZOSTAVAX (lot # M017294, expired 28-JUN-2017). The nurse reported that the sterile diluent (lot N015631, expires 18-MAR-2019) (dose not reported) used to reconstitute ZOSTAVAX was not expired. No adverse effect reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug dose omission, No adverse event, Product availability issue
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was scheduled to complete a vaccination series with GARDASIL, for prophylaxis. On an unknown date the patient experienced drug dose omission, no adverse event and product availability issue. Additional information is not expected, as there was no consent to contact the reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 19-JUL-2017 the patient was vaccinated with M-M-R II lot # L023385, subcutaneous for prophylaxis. On 19-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with VARIVAX from lot # M048200 with expiry 07-DEC-2018,  for prophylaxis, that might have been exposed to 47 degree Fahrenheit to 77 degree Fahrenheit (56F) for 12 hours. The vaccine was diluent used to reconstitute the vaccine was properly stored.  The temperature excursion was noted by digital data logger. It had no previous temperature excursion.
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: Cardiac function test, Computerised tomogram head, Glassy eyes, Seizure, Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a pharmacist on 17-Jul-2017. This case involves a 68-year-old male patient who was vaccinated with a dose of TENIVAC (batch number, expiry date, dose, dose in series, route, site of administration not reported) on 12-Jul-2017 at 9 am. Patient's medical history includes stroke and heart disease (Unspecified). Patient's concomitant vaccine was not reported. On 12-JUL-2017 at 6 pm, 9 hours post-vaccination, patient began to experience seizures described as "eyes glossing over", "unresponsive", the patient was taken to the hospital and was admitted. On 16-Jul-2017, the patient got discharged from the hospital. On an unknown date, after the vaccination, Heart CT scan and heart test (unspecified) were performed. Patient's corrective treatment was not reported. On an unknown date, patient was recovered from all of the events. List of documents held by sender: none. Sender's Comments: The patient experienced seizures, his eyes glossing over and was unresponsive post vaccination with TENIVAC. Time to onset is compatible but the events are not listed with the vaccine. The patient had medical history of heart stroke and heart disease. There is a possibility of underlying alternate etiology which needs to be investigated and ruled out before the role of the vaccine is assessed. Patient's medical condition at the time of vaccination including any untoward experience with regards to his heart condition should also be looked into. Based upon reported information the role of the vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Croup infectious, Radioallergosorbent test, Urticaria
Clinical narrative: Hives on the face next morning. Some croupy cough lasting 5 days.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Generalised tonic-clonic seizure, Laboratory test
Clinical narrative: Developed epilepsy. Began having tonic clonic seizures. started on medicine. Seizures have yet to be controlled.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Developed epilepsy. Began having tonic clonic seizures. started on medicine. Seizures have yet to be controlled.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Hyperhidrosis, Joint warmth, Nausea
Clinical narrative: PAIN IN THE RIGHT ARM THAT RADIATED, WHOLE BODY ACHE, TEMP 101, NAUSEA AND VOMITING, JOINTS (ELBOWS,ANKLES, SHOULDER, KNEE) BECAME SORE, HOT & SWEATY AND CALMY.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: PAIN IN THE RIGHT ARM THAT RADIATED, WHOLE BODY ACHE, TEMP 101, NAUSEA AND VOMITING, JOINTS (ELBOWS,ANKLES, SHOULDER, KNEE) BECAME SORE, HOT & SWEATY AND CALMY.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient was given vaccine with wrong diluent; mother contacted and brought patient in for revaccination on 7/11/2017.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, MMRV, PPV
Symptoms: Rash generalised
Clinical narrative: Allergic rash all over body.
Age: 53.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient reported that his arm hurt immediately after the vaccine but didn't start worring about it until 1 week had past. He claimed trouble moving his arm and mostly hurt when at work trying to lift heavy objects. He went to the doctor after 3 weeks, and was told it is normal and will go away on its own then was given an rx for Ibuprofen. He came to us after another week and told me he had an appointment with his regular dr and would let me know what they had to say. He called us this week saying it still hurts and the doctor told him again that it was normal and should go away on its own.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Hospitalisation, Pneumonia
Clinical narrative: Hospitalized with pneumonia 6 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-07-24.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cough, Feeling abnormal, Nausea, Sneezing, Wheezing
Clinical narrative: Patient developed coughing, sneezing, nausea about 15 - 20 minutes after vaccines. She told her mom "I feel like I am having an allergic reaction", as she has a Hx of food allergies. She had a slight wheeze upon auscultation.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient's mom stated he ran a fever of 103.9 last night and was nauseated. The fever came down with Ibuprofen and Tylenol but he was still nauseated this AM, got up and threw up and then went back to bed. She hasn't checked his temp this AM but he did say he felt better.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: Client's mother called clinic and reported that within 24 hours of receiving vaccinations the child developed redness in the right upper arm and a hive-like rash that extended into the child's right armpit area. She reported that she called the child's doctor and they advised her to give the child a dose of BENADRYL. She reports that the symptoms disappeared after the child took the BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Pruritus, Rash, Vomiting
Clinical narrative: Vomiting, abdominal pain, rash, itching. Patient was taken to ER by ambulance from office. Reaction started occuring within 5 minutes after administration of vaccines.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a nurse who reported that on 10-JUL-2017, an unspecified patient (unknown age or gender) was administered a dialysis formulation of RECOMBIVAX HB, 40 mcg (lot #N007395, expiration date 13-OCT-2019; route of administration not provided). No adverse effects reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 13-JUL-2017 from a registered nurse who was reporting on an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that on 13-JUL-2017. the patient was administered a dose of VARIVAX (lot L025207, expired 07-JUL-2017)(dose and route not reported) that was expired. The nurse reported that the sterile diluent (lot L001533, expires 24-OCT-2017) used to reconstitute VARIVAX was not expired. No adverse effect reported. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 13-JUL-2017 from a medical assistant who was reporting on a female patient of unknown age. No concomitant medications or medical history was reported. On 13-JUL-2017, the patient received a dose of MMR II (lot L024268, expired 01-JUL-2017) (dose, route and site not reported) for prophylaxis, that was expired and was reconstituted with sterile diluent (lot M028330, expires 24-FEB-2019) that was not expired. No adverse effects reported. No other information was provided. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 16 year old patient of unknown gender. On 28-JUN-2017, the patient received an expired GARDASIL (lot # K016966, expiration date: 10-MAY-2017). 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 an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot # N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with a dose of incorrect product storage GARDASIL 9 lot # M036059 for prophylaxis. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age.    On an unknown date the patient was vaccinated with ROTATEQ lot # N000172, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 24-JUL-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L026405, expiration date: 15-JUL-2017, as prophylaxis (Strength, dose, and route were not reported). The patient's concomitant therapies included sterile diluent lot # L039104, expiration date : 09-MAY-2018. No adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who was also the office manager and refers to an unknown number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II lot number reported as M040412, expiration date 30-JUN-2019 (strength, dose, frequency, route of administration, and anatomical location were not reported), were administered to an unknown number of patients on an unknown date for prophylaxis. The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 300 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse reactions reported. There was no product quality complaint involved.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 29-Jun-2017. This case involves a 76-year-old female patient, who was vaccinated with first dose of ADACEL via intramuscular route (batch number, expiry date, dose not reported) in left deltoid on 20-Apr-2017. Patient's illness at time of vaccination was unknown and pre-existing physician diagnosed allergies birth defects, medical conditions were reported as Viox, Vicodin, Coumadin, Codeine, PCN, Valium, Sulfa drugs. Concomitant medications were not reported. On 22-Apr-2017, within 2 days following the vaccination, the patient's her legs were swollen and she has pain with movement in the left arm which continues to date. Patient required ER/doctor visit. Lab test and corrective treatment was not reported. Patient did not recovered form events'. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patients reported hives (rash all over the body) after vaccines were administered.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria
Clinical narrative: Patient developed 2 hives medical to injection site. BENADRYL was given and patient observed.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site urticaria, Injection site warmth
Clinical narrative: LEFT DELTOID EDEMATOUS, ERYTHEMA, AND HOT TO TOUCH. LARGE WELT THAT WAS 1.5X1.5 INCHES.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of pain in L shoulder on 7/11/17. Shoulder/deltoid was red, hot to touch and swollen. Father marked area with marker. Notified doctor of event. Doctor recommend BENADRYL, IBU and ice. Followed Dr. orders. On 7/12/17, patient's arm was still hot to touch and redness and swelling increased in size. Dr. ordered son Cephalexin 500mg 1 capsule PO four times a day. Redness and swelling has started to decrease 7/13/17.
Age: 1.33
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Blood test normal, Febrile convulsion, Influenza virus test negative, Muscle spasms, Pyrexia
Clinical narrative: Fever 7 days later. A higher fever with muscle spasms another 8 days later. And fever with febrile seizure the next evening.
Age: 1.33
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Streptococcus test negative, Urine analysis normal
Clinical narrative: Fever 7 days later. A higher fever with muscle spasms another 8 days later. And fever with febrile seizure the next evening.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Blisters and rash both hands, chest and trunk. Required high dose of steroids and ER visits.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: 9:15 AM  PATIENT RECEIVED HEP A, THEN MENACTRA. THE MEDICAL ASSISTANT SAID SHE NOTICED THE PATIENT SLUMP FORWARD AND SHE THOUGHT THE PATIENT WAS STARTING TO CRY. SHE ASKED HER IF SHE WAS OK AND THE PATIENT STATED SHE WAS FINE SO THE MEDICAL ASSISTANT THEN GAVE THE TRUMENBA. THE PATIENT STOOD UP AND STARTED TO COLLAPSE SO THE MEDICAL ASSISTANT HELPED THE PATIENT TO SIT DOWN. PATIENT FAINTED FOR A FEW SECONDS AND CAME TO. SHE STATED SHE HAD NOT EATEN BREAKFAST. SHE DRANK A GATORAID AND AFTER 1/2 HOUR REST SHE STATED SHE FELT FINE AND LEFT THE OFFICE.
Age: 17.0
Sex: F
Vaccine: HPV9, HEPA, HPV9
Symptoms: Dizziness, Injection site pain, Mydriasis, Pupil fixed, Seizure like phenomena
Clinical narrative: Patient walked out to waiting room after vaccination and stated she felt light headed. I suggested she sit down in a vacant chair next to me, which she promptly did. In the chair while seated, she had an episode of fainting/syncope with a brief jerking motion suggestive of seizure. Her pupils were dilated and fixed during the episode, as her eyes were open but she was not responding to verbal prompts. I signaled for nursing assistance and patient was moved from the chair safely to the floor, in a supine position. Juice boxes were given to patient in an attempt to increase her blood pressure. She drank two juice boxes and then immediately vomited three times. She was then moved back into an examination room where she laid down for 10 minutes and recovered. Her left arm is sore at the injection site.