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 a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) GARDASIL 9 lot # M042853 expiration date:17-JUL-2019 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effect was unknown. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1707USA009369: US-009507513-1707USA009371: US-009507513-1707USA009370:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JUL-2017, the patient received expired dose of ROTATEQ oral liquid, lot # M004508, expiration date 29-JUN-2017 (dose and frequency were not reported) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concomitant medications, pertinent medical history, drug reactions and allergies were not reported. On 18-JUL-2017, the patient was vaccinated with VAQTA (dose, concetration, route of administration, frequency, lot #, expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a 24 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, (reported as "in her teens") the patient complete the three-dose series of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced pap smear which was abnormal. Further unspecified testing determined that the patient was positive for human papillomavirus (HPV) type 16 infection (papilloma viral infection). At the time of reporting, the outcome of pap smear and papilloma viral infection was unknown. Additionally, the reporter did not provide causal relationship between the events and therapy with GARDASIL.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 15 months old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 07-JUL-2017, the patient was vaccinated with an expired dose of MMRII lot number L024268 and expiration date of 01-JUL-2017 for prophylaxis (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse effects were reported. This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1707USA006499:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referred to an unspecified patient of an unknown age. The patient's past medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency route, lot # and expiry date were unknown) for prophylaxis. On an unknown date about 10 months later the patient received a second dose of PNEUMOVAX 23 (lot and expiration unspecified) (extra dose administered). No adverse effects reported. Additional information is not expected as no consent to follow up.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pharyngitis streptococcal, Pyrexia, Streptococcus test positive, Vomiting
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 2 and a half year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. Patient had no allergies. On 19-JUN-2017 the patient was vaccinated with M-M-R II, lot # M047302 with expiration date: 30-NOV-2018 (dose and route were not reported), for prophylaxis. On 24-JUN-2017, in the early morning, the patient vomited once and developed a fever of 102 Fahrenheit (pyrexia). The patient was given Tylenol and within 24 hours, had recovered from her fever. On 30-JUN-2017, the patient experienced another fever that ranged from 100-103 Fahrenheit. The fever would decreased when the patient was administered Tylenol, however she did not recover from her fever until 03-JUL-2017. On 03-JUL-2017, the patient had an unspecified strep throat test administered and the test came back positive for strep throat (Pharyngitis streptococcal). The patient was then put on antibiotic amoxicillin, but as of 05-JUL-2017, the patient did not recovered. The outcome of vomiting was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 17 weeks old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-JUL-2017, when the patient was 17 weeks and 4 days old, was vaccinated with the first dose of ROTATEQ, orally, lot # N003396 and expiration date on 21-OCT-2018 (dose was not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date (reported as two weeks after receiving VARIVAX), the patient became pregnant (exposure during pregnancy). She further explained that she did "have her period" a few days after VARIVAX and then after "her period" became pregnant. At the time of reporting, the last menstrual period (LMP) and estimated delivery date (EDD) were not known. The pregnancy outcome was pending. The outcome of exposure during pregnancy was unknown. Additional information is not expected because the reporter did not provide the permission to be contacted.
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 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 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: RV5
Symptoms: No adverse event, Product storage error
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 ROTATEQ orally, lot# M006112 with expiration date :16-NOV-2017, lot# M041815 with expiration date: 20-JUN-2018, lot# M045546 with expiration date: 12-JUN-2018, lot# M035828 with expiration date: 28-MAY-2018 (dose was not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date were not reported). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 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-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
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 ZOSTAVAX lot# M044220 with expiration date: 31-JAN-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. 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-009507513-1707USA009056:
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a other health professional refers to a 5 year old male patient with seasonal allergy, mite allergy, allergy to animal, drug hypersensitivity, food allergy and mycotic allergy. On 03-JUL-2017 the patient was vaccinated with PROQUAD lot # M042500 dose 1 in the right thigh for prophylaxis (route of administration was not provided). On 04-JUL-2017, 8 hrs 30 min after onset of therapy the patient experienced large golf ball swelling on right thigh. A physician advised to apply ice to side and take BENADRYL as directed. The outcome of vaccination site swelling was reported as recovering/resolving. The causal relationship was not provided. Additional information is not expected as all relevant information has already been received.
Sex: U
Vaccine: MMR
Symptoms: Dehydration, Pneumonia, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors in a published literature article, concerning to three patients of unknown age (reported as median patient age was 21 months) and gender. On an unknown dates, the patients were vaccinated with two doses of M-M-R II (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. Among the 65 confirmed cases and during April 10 - May 31, confirmed measles patients were identified in five schools, 12 child care centers, three health care facilities, and numerous households; an estimated 8,250 persons were potentially exposed to measles in these settings. Rash onset dates ranged from March 30 - May 27, 2017. Sixty Two (95%) cases were identified in unvaccinated persons, including 50 (77%) in children aged >=12 months (i.e., age-eligible for M-M-R II vaccination). Specific ethnic children accounted for 55 (85%) of the cases. Among the three patients with a history of measles vaccination, all had received 2 M-M-R II doses before illness onset (measles post vaccine and vaccination failure). As of May 31, 20 (31%) patients had been hospitalized, primarily for treatment of dehydration or pneumonia; no deaths had been reported. The outcome of measles post vaccine and vaccination failure was unknown. The reporter considered vaccination failure and measles post vaccine to be related to M-M-R II. Upon internal review, measles post vaccine was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-OCT-2016, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Then, on 01-JUN-2017, the patient was vaccinated with another dose of M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided), also for prophylaxis. Subsequently, on 21-JUL-2017, the patient was vaccinated again with a dose of M-M-R II (lot number reported as N008366 with expiration date of 13-MAR-2019; strength, dose, route and anatomical location were not provided), also for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse effects were reported.
Sex: U
Vaccine: HEPA
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 14-JUL-2017 the patient was vaccinated with VAQTA lot # L031196 for prophylaxis. On 14-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 VAQTA.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age.  On 28-JUN-2017 the patient was vaccinated with ZOSTAVAX lot # M035148, single dose for prophylaxis. On an unknown date in 2017, the patient experienced injection site pain and injection site discomfort. The outcome of injection site discomfort and injection site pain is unknown.      The causal relationship between the ZOSTAVAX and the events was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No concomitant medications or medical history was reported. On 11-JUL-2017, while the pharmacist was administering a dose of ZOSTAVAX (lot # N013289, expires 04-JUL-2018) (dose, route and site not reported) reconstituted with sterile water diluent (lot L033143, expires 16-APR-2018), the pharmacist stated that "the tip of the plastic syringe and the needle separated while administering [the vaccine] and the ZOSTAVAX vaccine splashed into my eyes, mouth and face and I am 13 weeks pregnant" (MARRS# 1707USA004607). The pharmacist confirmed that the full dose was not administered to this patient. No adverse effect reported. No further information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No concomitant medications or medical history was reported. On 11-JUL-2017, while the pharmacist was administering a dose of ZOSTAVAX (lot # N013289, expires 04-JUL-2018) (dose, route and site not reported) reconstituted with sterile water diluent (lot L033143, expires 16-APR-2018), the pharmacist stated that "the tip of the plastic syringe and the needle separated while administering [the vaccine] and the ZOSTAVAX vaccine splashed into my eyes, mouth and face and I am 13 weeks pregnant" (MARRS# 1707USA004607). The pharmacist confirmed that the full dose was not administered to this patient. No adverse effect reported. No further information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) RECOMBIVAX HB of lot/batch #M040423, expiration date:03-JUL-2019 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effect was unknown. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1707USA006260: US-009507513-1707USA009371:US-009507513-1707USA009370:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) VAQTA  of lot/batch# M005274, expiration date:03-APR-2018 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effects was unknown. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1707USA009369: US-009507513-1707USA006260: US-009507513-1707USA009371:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# N008825, expiry date: 12-SEP-2018 and lot# M035690, expiry date: 06-FEB-2018) for prophylaxis. Nurse reported that the vaccine underwent a temperature exposure at -14 to -10 degrees Celsius, for 3 hours and 9 minutes. There were not previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA009610). Additional information has been requested.; Sender's Comments: US-009507513-1707USA009610:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M03478 and expiry date: 15-APR-2019 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009637: US-009507513-1707USA009636:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
Sex: U
Vaccine: MMR
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 M-M-R II (M044351 with expiration date 04-NOV-2018; M034387 with expiration date 19-JUL-2018 and M008588 with expiration date 26-FEB-2018; 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-009507513-1707USA009616: US-009507513-1707USA009615:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. On 20-JUL-2017, the patient was administered an improperly stored M-M-R II (lot # reported as M045402, exp date: 14-NOV-2018), that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# M015993, exp. date: 03-DEC-2018) for prophylaxis. The improperly stored information for M-M-R II this time was reported: temperature of 12.2 Celsius degrees with time frame of 53 hours. A digital data logger was involved. There was no previous temperature excursion for M-M-R II. It was also verified that diluent (MERCK STERILE DILUENT) did not undergo an excursion. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Pharmacy Technician refers to unspecified patients of unknown age and gender. The Pharmacy Technician reporting that improperly stored doses of RECOMBIVAX HB (lot # N002202, Expiration Date 04-NOV-2019, dose, frequency and route were not provided) were administered to unspecified patients from  21-JUN-2017 to 21-JUL-2017. No adverse effects. The RECOMBIVAX HB was stored between 47 Fahrenheit to 77 Fahrenheit for 1 hour and 45 minutes. No previous temperature excursion occurred. The data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Lot# M044020 with expiration date 01-MAY-2018, Lot# reported as M013865 with expiration date 31-OCT-2018, Lot# M044575 with expiration date 04-MAY-2018, Lot# M049122 with expiration date 13-JUN-2018) for prophylaxis which were reconstituted with diluent. On an unknown date the patients were vaccinated with the vaccines that were improperly stored between 6F to 14F (9F) with the time frame of 3 hours and 45 minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. Diluent was not involved in the temperature excursion. This is one of several reports received from the same source.  Sender's Comments: US-009507513-1707USA009490: US-009507513-1707USA009511:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot# N009167 with expiration date 02-FEB-2018, Lot# reported as N012492 with expiration date 17-MAR-2018) for prophylaxis which were reconstituted with diluent. On an unknown date the patients were vaccinated with the vaccines that were improperly stored between 6F to 14F (9F) with the time frame of 3 hours and 45 minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. Diluent was not involved in the temperature excursion. This is one of several reports received from the same source. Sender's Comments: US-009507513-1707USA009510: US-009507513-1707USA009490.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple patients of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored VAQTA lot#N005796 with expiry date of 26-MAY-2018 for prophylaxis (dosing details not reported). Temperature was 47F to 77F (46.8 F). Time frame of the excursion was 62 hours 45 minutes. There was no previous excursion. The call was because of data logger. No adverse effects were reported. This case is linked to 1707USA009781 due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# N000682, expiry date: 06-JAN-2019, lot# M040138, expiry date: 28-SEP-2018 and lot# M010484, expiry date: 01-MAR-2018) for prophylaxis. Nurse reported that the vaccine underwent a temperature exposure at -14 to -10 degrees Celsius, for 3 hours and 9 minutes. There were not previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA009377). Additional information has been requested.; Sender's Comments: US-009507513-1707USA009377:
Sex: U
Vaccine: RV5
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 ROTATEQ (M042169 with expiration date 22-JUN-2018; M044395 with expiration date 31-MAY-2018; 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-009507513-1707USA009616: US-009507513-1707USA009417:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M040004 and expiry date: 20-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009404: US-009507513-1707USA009637:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route were not reported) lot # M03478 and expiry date: 24-OCT-2019 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009404: US-009507513-1707USA009636:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients.  On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding multiple patients of unknown demographics. Information on pertinent medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored RECOMBIVAX HB lot# N006321 with expiry date of 08-NOV-2019 for prophylaxis (dosing details not reported). Temperature was 47F to 77F (46.8 F). Time frame of the excursion was 62 hours 45 minutes. There was no previous excursion. The call was because of data logger. No adverse effects were reported. This case is linked to 1707USA009603 due to the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Discomfort, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable certified chemical medical assistant (CCMA) and a non-contactable consumer. A 17-year-old male patient received, on 14Jul2017, TRUMENBA (Lot. R56659, Expiration date: Jan2019, NDC number: 005010005) at 10:15 AM, intramuscularly, in left arm, at 0.5 ml, single dose; and the second dose of meningococcal vaccine (Lot. U5751AA, Expiration date: 12Nov2018, NDC-4928158905, Manufacturer: Sanofi Pasteur) intramuscularly, in right arm, both for immunization. Relevant medical history and concomitant medications were none. The patient received previously a dose of meningococcal vaccine for immunization at the age of 11 years. On 15Jul2017, the patient experienced migraine, body weakness, swelling and pain at injection site, and he was not able to get out of bed. On an unspecified date, the patient developed also headache, and he was not able to move arm over the head and felt heavy. No treatment was received. The patient did not recover from the events, swelling and pain at injection site; clinical outcome of the events, headache, vaccination site movement impairment and heavy feeling in arms & legs was unknown; while clinical outcome of the other events was recovering.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Migraine, Mobility decreased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable certified chemical medical assistant (CCMA) and a non-contactable consumer. A 17-year-old male patient received, on 14Jul2017, TRUMENBA (Lot. R56659, Expiration date: Jan2019, NDC number: 005010005) at 10:15 AM, intramuscularly, in left arm, at 0.5 ml, single dose; and the second dose of meningococcal vaccine (Lot. U5751AA, Expiration date: 12Nov2018, NDC-4928158905, Manufacturer: Sanofi Pasteur) intramuscularly, in right arm, both for immunization. Relevant medical history and concomitant medications were none. The patient received previously a dose of meningococcal vaccine for immunization at the age of 11 years. On 15Jul2017, the patient experienced migraine, body weakness, swelling and pain at injection site, and he was not able to get out of bed. On an unspecified date, the patient developed also headache, and he was not able to move arm over the head and felt heavy. No treatment was received. The patient did not recover from the events, swelling and pain at injection site; clinical outcome of the events, headache, vaccination site movement impairment and heavy feeling in arms & legs was unknown; while clinical outcome of the other events was recovering.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse, via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site, after the use of the product on an unspecified date. The patient was reported as ok but the outcome of the event pain at the injection site was unknown.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Local reaction, Rash
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA (Lot # WAL-R9416, Exp. Date: 01Jan2019), at single dose via an unspecified route of administration in one arm on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included booster shot of MENACTRA, administered in the other arm, with a small quarter sized local reaction. The patient previously took meningococcal vaccine a/c/y/w conj (dip tox) for immunisation at the age of 11 years, and she did not had a reaction. Patient had also a known allergy to sulphur. The patient experienced a reaction that night that covered entire arm and rash on the stomach. The outcome of both events was unknown.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac pacemaker evaluation, Chest discomfort, Dyspnoea, Feeling jittery, Paraesthesia
Clinical narrative: Patient experienced shortness of air, chest pressure, tingling in arms, jittery feeling.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Injection site erythema
Clinical narrative: Information was received on 13-JUL-2017 from a 63 year old female consumer regarding herself.  Medical history/concurrent conditions included osteoporosis, rheumatoid arthritis, Epstein Barr virus, allergies to Codeine, Naproxen, FELDENE, Sulfur, Tramadol and latex. Concomitant medications were reported as none. On 10-JUL-2017, the patient was vaccinated with ZOSTAVAX (dose, route, site of administration and lot number not reported) for the prevention of shingles. She reported that "since she got the ZOSTAVAX vaccine she has been experiencing hair loss and also has a red spot around the injection site 2-3 inches wide and 5 inches long." She has not sought medical attention. No additional information was provided. The relationship between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received 30-JUN-2017 via a phone call from a nurse practitioner who reported that an unspecified patient possibly received VARIVAX and PROQUAD during the same appointment which was "4 days ago". No symptoms were reported. Lot numbers, expiration dates for the VARIVAX, PROQUAD and sterile diluent were unknown. No further information was provided regarding the patient. The nurse also reported that another unspecified patient had received VARIVAX and PROQUAD during the same appointment, but that incident had occurred "a long time ago". No symptoms had been reported and the nurse practitioner stated she had already reported this incident to Merck. The nurse practitioner did not wish to answer further questions and reported she did not wish to be contacted. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with PROQUAD, (route: subcutaneous) that was improperly stored. No adverse effects reported. The vaccine underwent multiple unspecified excursions due to defrost cycles and the call was because of the data logger. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA009799.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with VARIVAX, (route: subcutaneous) that was improperly stored (incorrect product storage). No adverse effects reported. The vaccine underwent multiple unspecified excursions due to defrost cycles and the call was because of the data logger. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA009505:
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, joint pain, headache
Age: 21.0
Sex: M
Vaccine: ANTH, HPV9
Symptoms: Fall, Head injury, Loss of consciousness, Presyncope
Clinical narrative: Patient vasovagal reaction on his way out of the immunizations room, he fell forward and hit left side of head on wall and then was caught by other service member and myself, he was helped to the grown, laying flat on back, pillow provided. Patient was unconcious for about 3 seconds. Patient was A&O  X3 after coming to. States this has only happened once in his past. Patient denies eating lunch today. Patient left laying for about 5 minutes, VSS. Moved to sitting position. Patients states feeling fine. Water and snack Provided. Employeee notified and in room assessing. Patient notified to report to ER if he notices visual distturbances or severe HA, patient verbalized understanding.
Age: 5.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the adult tdap (BOOSTRIX) instead of the dtap child dose. Contacting GSK today to find out what interval to wait before giving her the dtap to complete primary series. No physical reactions noted in the office.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Hand-foot-and-mouth disease, Immunoglobulin therapy, Infantile spitting up, Insomnia
Clinical narrative: My son was almost a month premature. The pediatrician chose to vaccinate him on schedule. He received all 6 vaccination all in one visit. When we got home that night he started spitting up an extreme amount and continued spitting up for the next week and a half. He was inconsolably crying very frequently and waking very frequently at night for about a week. About 10 days after getting vaccinated he started running a fever, broke out in a rash all over his body and had swollen hands and feet. The pediatrician diagnosed him with hand, foot, mouth. 5 days later he was still running a fever and symptoms were worse. He also had what appeared to be blisters on his penis and his testicles were swollen. We took him to the hospital. He got admitted to hospital and was diagnosed with Kawasaki disease the next day. He spent almost 3 weeks in the hospital and received 2 IVIG treatments, two treatments of REMICADE, steroids and aspirin.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Kawasaki's disease, Middle insomnia, Penile blister, Peripheral swelling, Pyrexia
Clinical narrative: My son was almost a month premature. The pediatrician chose to vaccinate him on schedule. He received all 6 vaccination all in one visit. When we got home that night he started spitting up an extreme amount and continued spitting up for the next week and a half. He was inconsolably crying very frequently and waking very frequently at night for about a week. About 10 days after getting vaccinated he started running a fever, broke out in a rash all over his body and had swollen hands and feet. The pediatrician diagnosed him with hand, foot, mouth. 5 days later he was still running a fever and symptoms were worse. He also had what appeared to be blisters on his penis and his testicles were swollen. We took him to the hospital. He got admitted to hospital and was diagnosed with Kawasaki disease the next day. He spent almost 3 weeks in the hospital and received 2 IVIG treatments, two treatments of REMICADE, steroids and aspirin.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash generalised, Testicular swelling
Clinical narrative: My son was almost a month premature. The pediatrician chose to vaccinate him on schedule. He received all 6 vaccination all in one visit. When we got home that night he started spitting up an extreme amount and continued spitting up for the next week and a half. He was inconsolably crying very frequently and waking very frequently at night for about a week. About 10 days after getting vaccinated he started running a fever, broke out in a rash all over his body and had swollen hands and feet. The pediatrician diagnosed him with hand, foot, mouth. 5 days later he was still running a fever and symptoms were worse. He also had what appeared to be blisters on his penis and his testicles were swollen. We took him to the hospital. He got admitted to hospital and was diagnosed with Kawasaki disease the next day. He spent almost 3 weeks in the hospital and received 2 IVIG treatments, two treatments of REMICADE, steroids and aspirin.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nodule, Peripheral swelling
Clinical narrative: Mom calls and reports that Patient developed a knot and swelling to the right arm on 7/15/17.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Middle insomnia, Pain, Pain in extremity, Rash
Clinical narrative: Extreme right upper arm pain with middle of night onset, vas 7/10. Took nsaids for one week. Continue to have pain to right bicep area with adduction of arm and lifting of objects 7 weeks posts vaccine. Vas varies from day to day and amount of movement.  Continues to cause nighttime wakefulness. Vas on good day 3/10. On bad day 5/10. No pain when vaccine administered. Did have rash 4 days post.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient presented to the pharmacy on 7/25/17 a raised red lump on her right arm that was continuing to get bigger per the patient from the BOOSTRIX Immunization.