chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 02-NOV-2017, the patient was vaccinated with the dose of ZOSTAVAX (lot #, expiration date, dose, schedule and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent. The patient did not experience any adverse event. The product quality complain (PQC) was not involved.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not reported. On an unspecified date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection (dose and route of administration were not reported; lot#M039318 with expiration date 20-SEP-2018; lot# N015476 with expiration date 18-MAY-2019; lot# M025867 with expiration date 24-MAY-2018), ZOSTAVAX subcutaneous injection (dose and route of administration were not reported; lot # N009777 with expiration date 03-APR-2018) and PROQUAD subcutaneous injection (dose and route of administration were not reported; lot# N016113 with expiration date 21-NOV-2018). Vaccines were reconstituted with properly stored sterile diluent. On an unspecified date, the vaccines experienced temperature excursion of 37 degrees Fahrenheit (F) for 45 minutes. There were no adverse effects reported. The reporter stated that there were no previous temperature excursions for administered doses of vaccine. The data logger was involved. There was no product quality complaint involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # M013156, expiration date: 15-OCT-2017, intramuscularly (dose, site of administration were not provided) for prophylaxis. On the same day, reported as immediately after first vaccination, the patient received an additional dose of PNEUMOVAX 23 intramuscularly (dose, site of administration, lot#, expiration date were not reported) for prophylaxis, which was not expired. No adverse effect was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on an unspecified date, the patient was vaccinated with a dose of an improperly stored VARIVAX lot # N008077, with expiration date 09-MAR-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). No adverse effect was reported. The temperature of excursion was reported as 20.5 degree Fahrenheit (°F). The time frame was reported as 2 hours. There was no previous temperature of excursion was not reported. There was a digital data logger involved. This is one of several reports received from the same reporter Sender's Comments: US-009507513-1711USA002760: US-009507513-1711USA002761: US-009507513-1711USA002762.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on an unspecified date the patient was vaccinated with a dose of an improperly stored VARIVAX lot # N008077, with expiration date 09-MAR-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). No adverse effect was reported. The temperature of excursion was reported as 20.5 degree Fahrenheit (°F). The time frame was reported as 2 hours. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter Sender's Comments: US-009507513-1711USA002762: US-009507513-1711USA002761: US-0095075131711USA002444.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous initial report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter informed that on an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N008077, with expiration date 09-MAR-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK). No adverse effect was reported. The temperature of excursion was reported as 20.5 degree Fahrenheit (°F). The time frame was reported as 2 hours. There was no previous temperature of excursion was not reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002444: US-009507513-1711USA002760: US-009507513-1711USA002761.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-OCT-2017, the patient was administered ZOSTAVAX 19400 plaque-forming units (PFU) vial, lot # M039453 with expiration date on 19-DEC-2017, subcutaneously in the left arm (dose was not reported), for prophylaxis recommended by physician. Other suspect therapies included sterile diluent for injection (strength, dose, route of administration, indication, lot # and expiration date were not reported). On 26-OCT-2017, the patient experienced a rash on her left arm. The pharmacist reported that rash looked like an injection site reaction that was red in color and not raised. The patient did not seek medical attention. It was unknown if any treatment was given for the events. The outcome of the events was unknown. The relatedness between the events, ZOSTAVAX and sterile diluent was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA002012: US-009507513-1711USA004383: US-009507513-1711USA004384: US-009507513-1711USA004385: US-009507513-1711USA004386: US-009507513-1711USA004387: US-009507513-1711USA004388: US-009507513-1711USA004389: US-009507513-1711USA004390: US-009507513-1711USA004391: US-009507513-1711USA004392: US-009507513-1711USA004393: US-009507513-1711USA004394: US-009507513-1711USA004395: US-009507513-1711USA004396: US-009507513-1711USA004397: US-009507513-1711USA004398: US-009507513-1711USA004399: US-009507513-1711USA004400: US-009507513-1711USA004401: US-009507513-1711USA004402: US-009507513-1711USA004403: US-009507513-1711USA004382: US-009507513-1711USA004381: US-009507513-1711USA004379: US-009507513-1711USA004380.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA002012: US-009507513-1711USA004383: US-009507513-1711USA004384: US-009507513-1711USA004385: US-009507513-1711USA004386: US-009507513-1711USA004387: US-009507513-1711USA004388: US-009507513-1711USA004389: US-009507513-1711USA004390: US-009507513-1711USA004391: US-009507513-1711USA004392: US-009507513-1711USA004393: US-009507513-1711USA004394: US-009507513-1711USA004395: US-009507513-1711USA004396: US-009507513-1711USA004397: US-009507513-1711USA004398: US-009507513-1711USA004399: US-009507513-1711USA004400: US-009507513-1711USA004401: US-009507513-1711USA004402: US-009507513-1711USA004403: US-009507513-1711USA004382: US-009507513-1711USA004381: US-009507513-1711USA004379: US-009507513-1711USA004380.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unknown patient of unknown age and gender. Medical history, concomitant therapies and concurrent conditions were not reported. On 09-SEP-2017, the patient received an expired first dose of ZOSTAVAX, 19400 PFU, subcutaneously, Lot# M035696 and expiration date 07-SEP-2017, for profilaxis (Route of administration and anatomical location were not provided). No adverse events occurred.
Age: 37.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an Office Manager referring to a 37 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 31-OCT-2017, the patient was inadvertently vaccinated with an expired dose of PROQUAD (route, dose, frequency, and anatomical location were unknown) with lot # M021729 and expiration date 29-OCT-2017 for prophylaxis, reconstituted with sterile diluent (MERCK). No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9-week-old patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies was provided. On 10-NOV-2017 at 10:30 in the morning, the patient inadvertently received RECOMBIVAX HB 10/1.0 micro-g/ml injection, 0.5 ml (route of administration was not reported) adult formulation for prophylaxis instead of the intended pediatric formulation. No information about concomitant therapies was provided. No adverse effects were reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with VARIVAX lot # N017701; expiry date 09-Jun-2019 (dose, route of administration were not provided). On an unknown date (reported as "about 10 days later), the patient was brought back to the office because had a red, swollen, warm to the touch, quarter size bump at the injection site which looked like cellulitis. Unspecified antibiotics was prescribed for the events. The outcome of the events was not unknown (reported also as "ongoing"). The causality assessment was not provided. Sender's Comments: US-009507513-1711USA011751:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with VARIVAX lot # N017701; expiry date 09-Jun-2019 (dose, route of administration were not provided). On an unknown date (reported as "about 10 days later), the patient was brought back to the office because had a red, swollen, warm to the touch, quarter size bump at the injection site which looked like cellulitis. Unspecified antibiotics was prescribed for the events. The outcome of the events was not unknown (reported also as "ongoing"). The causality assessment was not provided. Sender's Comments: US-009507513-1711USA011751:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician and refers to a twins of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in November 2017 (reported as 9-10 days ago), the patients were vaccinated with VARIVAX lot # N017701; expiry date 09-Jun-2019 (dose, route of administration were not provided). On 10-NOV-2017, the patients were brought back to the office with a red, swollen, warm to the touch, quarter size bump at the injection site which more looked like cellulitis. The outcome of the events was not unknown (reported also as "ongoing"). The causality assessment was not provided.; Sender's Comments:  US-009507513-1711USA005027:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a twins of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date in November 2017 (reported as 9-10 days ago), the patients were vaccinated with VARIVAX lot # N017701; expiry date 09-Jun-2019 (dose, route of administration were not provided). On 10-NOV-2017, the patients were brought back to the office with a red, swollen, warm to the touch, quarter size bump at the injection site which more looked like cellulitis. The outcome of the events was not unknown (reported also as "ongoing"). The causality assessment was not provided.; Sender's Comments:  US-009507513-1711USA005027:
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dry skin, Injection site dryness, Injection site paraesthesia, Paraesthesia, Throat irritation
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender with drug hypersensitivity to Astelin, Astepro, Augmentin, cephalexin clindamycin, erythromycin, MACROBID, penicillin, prednisone (reported in MARRS case #1712USA000871) Flagyl, Bactrim, rhinitis and hypercholesterolaemia as concurrent conditions.  On 06-NOV-2017, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. Concomitant therapies included influenza virus vaccine (unspecified), rosuvastatin calcium (CRESTOR), levothyroxine sodium (LEVOXYL), omega-3 marine triglycerides and cholecalciferol. The reporter stated that approximately on an unspecified date in November 2017 (reported as after administration of ZOSTAVAX), the patient experienced injection site "tingling and dryness" (injection site paresthesia)(injection site dryness), also experienced tingling in her arms and through the rest of her body (paresthesia). Furthermore, the reporter stated that the patient experienced dryness of skin (dry skin) and itching of throat (throat irritation). The outcome of injection site paresthesia and injection site dryness was unknown. The outcome of paresthesia was reported as recovering. The outcome of throat irritation and dry skin was reported as not recovered. At the time of this report, the causality between the events and ZOSTAVAX was not reported.; Sender's Comments:  US-009507513-1712USA000871:
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Rash
Clinical narrative: Information has been received from an unknown age female pharmacist via a company representative referring to herself. The pharmacist was currently 8 months pregnant, and her medical history and concomitant medications were not reported. The pharmacist developed a rash in an unspecified location on an unknown date, an unspecified amount of time after she administered a dose of ZOSTAVAX (route, lot # and expiration date unknown) diluted with sterile diluent to an unspecified patient on an unknown date (secondary transmission and exposure during pregnancy). No adverse effect was reported for the unspecified patient. The pharmacist's last menstruation period (LMP) was approximately in 10-MAR-2017, the estimated due date was 15-DEC-2017. The pregnancy outcome was pending and fetal outcome was unknown.  The outcome of the events was unknown. The causality between the events and ZOSTAVAX was unknown.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in March 2017, the patient was vaccinated with the first dose of GARDASIL and on an unknown date in May 2017, the second dose of GARDASIL (both doses, routes of administration, lot # and expiration dates were not reported). The pharmacist reported that the patient would receive the third dose of GARDASIL 9 on an unknown date in November 2017 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No causality assessment was provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance and refers to patient of unknown age and gander. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-NOV-2017, the patient was vaccinated with 1 dose of improperly stored ROTATEQ, orally, lot # N009962, expiration date 15-NOV-2018, for prophylaxis. The vaccine underwent a temperature excursion between 47 to 77 Fahrenheit degrees for 20 minutes. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 30-OCT-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915:
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Information has been received from a registered nurse reporting on a 37 year old male patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 14-NOV-2017, the patient received an expired dose of M-M-R II lot # L043702, expiration date 03-NOV-2017, subcutaneous for prophylaxis (dose and dose number were not reported) that was reconstituted with a sterile diluent (STERILE DILUENT).
Sex: M
Vaccine: RV5
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On unknown dates, the patient was vaccinated with the first and second doses of ROTATEQ dose 1, (strength, dose,  frequency, indication, lot# and expiration date were not provided) for prophylaxis. The physiscian reported that the patient received his first 2 doses of ROTATEQ via gastric tube (g-tube). No adverse symptoms were reported and no product quality complains was reported. No further information provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA013951: US-009507513-1711USA013953: US-009507513-1711USA013954: US-009507513-1711USA013955: US-009507513-1711USA013958: US-009507513-1711USA013959: US-009507513-1711USA013960: US-009507513-1711USA013963: US-009507513-1711USA013964: US-009507513-1711USA013965: US-009507513-1711USA013967:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. On 16-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II (rHA)lot # N010495, expiration date 31-MAR-2019 (dose and route were not reported) for prophylaxis; reconstitute with sterile diluent which was properly stored. No adverse effects reported. The temperature involved was 9 degrees Celsius to 25 degrees Celsius for 3 hours and 8 minutes. Previous temperature excursion was not reported, and a data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a female adolescent patient (specific age was not reported). No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date (reported as a couple of months ago), the patient was vaccinated with GARDASIL 9 injection (dose number, dose, route of administration, lot# and expiration date were not reported) for prevention of Human Papilloma Virus. After vaccine administration, the patient's mother did not want to wait 15 minutes before leaving. As the patient's mother was leaving with the patient, the patient fainted at the front desk and hit her head. The reporter stated that the staff looked at the patient's head and determined that there was no serious injury or medical attention needed. No treatment was given for the adverse events. The outcome of the adverse events was not reported. Causality assessment was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 16-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N001533, expiration date 16-OCT-2019 (dose and route were not reported) for prophylaxis. No adverse effects reported. The temperature involved was 32 degrees Fahrenheit up to 35 degrees Fahrenheit (33 degrees Fahrenheit) for 15 hours 30 minutes. A previous temperature excursion was reported as below 32 degrees Fahrenheit (30 degrees Fahrenheit) for 10 minutes. A data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 17-NOV-2017, the patient was vaccinated with an improperly stored dose of VAQTA lot # N023954, expiration date 31-AUG-2018 (dose and route were not reported) for prophylaxis. No adverse effects reported. The temperature involved was 9 degrees Celsius to 25 degrees Celsius for 6 hours. A previous temperature excursion was not reported. A data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 32-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with PROQUAD injection, (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug allergies/reactions and concomitant medications were not reported. On 30-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis, reconstituted with sterile diluent. On an unknown date in 2017, the patient experienced significant pain near the injection site. The outcome of the event was unknown. Causality assessment was not provided.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. No information on the patient's pertinent medical history, concomitant medications, drug reaction or allergies was reported. On 20-NOV-2017, the patient was vaccinated with PROQUAD injection (strength, frequency, route of administration were not reported) lot # M041084, expiration date: 04-APR-2018 for prophylaxis and on the same date VARIVAX injection (strength, frequency were not reported) lot# M002063, expiration date: 12-JAN-2018, subcutaneously for prophylaxis, instead of M-M-R II, due to new medical assistant. No adverse effects were reported and no additional information was given. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: DTAP, FLUX, HPV9, MEN
Symptoms: Fall, Loss of consciousness, Pain
Clinical narrative: This spontaneous report was received from a physician via company employee, regarding a 11 year old female patient. The patient's medical history included an unspecified "immune disorder" and the historical or concomitant medications were unknown by the reporter. On an unspecified date (reported as "a couple of weeks ago") the patient was administered GARDASIL 9 on her left arm for prevention of Human Papilloma Virus (HPV); the product Lot # was reported as A013698 and expiration date as 19-DEC-2019. The patient was also administered with an influenza virus vaccine (reported as "unspecified flu vaccine") in her left arm and unspecified meningococcal and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid vaccines in her right arm. Upon receiving the GARDASIL 9, the patient complained about the pain. It was reported that an unspecified Medical Assistant and the patient's father "thought she was standing up, but she was not and she passed out and fell to the floor". The patient woke up once her father picked her up. The patient did not sought medical attention for the events. The recovery status from pain by the time of the reporting and the association between the events and GARDASIL 9 were unknown.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare professional regarding a 6 month old female patient. The patient's concurrent condition was reported as seasonal allergy. On 06-OCT-2017, the patient was vaccinated with an inappropriately stored ROTATEQ lot # M044399 (expiry date: 25-JUN-2018), dose 3 via oral route for prophylaxis (dosage unspecified). Concomitant therapies included PEDIARIX, PEDVAXHIB and PREVNAR 13. No adverse event reported. Temperature excursion occurred and a Digital Data logger was involved. Sender's Comments: US-009507513-1711USA001950.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Memory impairment
Clinical narrative: This spontaneous report was received from an elderly (over 65-year-old) female patient, who was reporting on herself. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date in approximately 2012, reported "as about 5 years ago", the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, route of administration, lot # and expiration date were not reported). The patient said that within the past 5 years, she received a ZOSTAVAX vaccination, 19400 plaque-forming units (PFU) vial (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified condition and at the time of reporting she was taking an unspecified new medication for this condition. On an unknown date, the patient had trouble remembering her phone number. The outcome of the events was not reported. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy
Clinical narrative: This retrospective pregnancy spontaneous report was received from a currently 32-year-old female patient reporting on herself. The patient's concurrent conditions included high blood pressure. On an unknown date (reported as "when they were very young"), the patient was vaccinated with VARIVAX subcutaneously (dose, anatomical location, lot# and expiration date) as an active immunization for the prevention of varicella in individuals. The patient has been vaccinated "when they were very young". On unknown dates (reported as "in the last few years") the patient was pregnant multiple times and had multiple miscarriages. The last menstrual period date and estimated conception date were not reported and could not be calculated. The patient sought medical attention and visited physician. The outcome of the event of multiple miscarriages was reported as recovered. The causality between the event and VARIVAX was not reported. Upon internal review, the event of multiple miscarriages was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a female patient who was a nurse of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2017, the nurse "got a splash" of the GARDASIL 9 in her eyes while administering GARDASIL 9 to an unspecified patient for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA003941.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 06-JAN-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccines was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013914: US-009507513-1711USA013915: US-009507513-1711USA006083:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 06-JAN-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013915:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 06-JAN-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 30-OCT-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 01-NOV-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013918:  US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 03-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccines was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Fahrenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA006632.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA006632: