chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: This spontaneous report was received from a patient's mother friend referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not provided). On an unknown date, the patient had some reaction in the office after receiving the vaccine, which included her passing out and sweating profusely. The outcome of loss of consciousness and hyperhidrosis is unknown. The reporter considered the events to be related to GARDASIL. The reporter considered the events as medically significant. This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, via subcutaneous route in the abdomen instead of the recommended subcutaneous route in the deltoid area of the non-dominant arm as recommended in the prescribing information (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported and no further information was provided. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a certificated medical assistant also reported as "Office Supervisor", referring to 8 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as "from June 1, 2017 through June 30, 2017"), the patients were administered with improperly stored vaccines of ROTATEQ administered orally, lot # M038724 with expiration date on 24-APR-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The vaccines has a temperature excursion of 35.1 Fahrenheit (F) during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred or a digital data logger was involved. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1707USA008450:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were administered improperly stored doses of VARIVAX lot # M004662 with expiration date on 27-JAN-2018 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The reporting medical assistant stated that the vaccines were reconstituted with sterile diluent (manufacturer unknown), however the sterile diluent (manufacturer unknown) was not involved in the temperature excursion. The vaccines had a temperature excursion between 15 Fahrenheit (F) to 46 F during a time frame of 43 hours. It was also reported that the vaccines had previous temperature excursion between 15°F to 46°F for 6 hours. And no digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 11-OCT-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 10-MAY-2013, the patient was seen by a physician at a dermatology facility for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as Herpes Zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JUN-2015, the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 31-MAY-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 28-JUN-2016, at the medical center the patient was  treated for ongoing and worsening symptoms, at which time he was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to shingles outbreaks. The patient was prescribed gabapentin (NEURONTIN) for management of his painful conditions.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular, Scar
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-DEC-2010 at a family medical practice, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-OCT-2016, patient was treated at an urgent care clinic for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 09-MAR-2017, patient was treated again at a medical clinic for ongoing and worsening symptoms, accompanied by scarring and residual pain from shingles. Patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information had been received on 19-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX in 2013 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2016, patient was treated by a physician for the onset of a painful vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient had no drug reactions/allergies and no pertinent medical history. Concomitant medications included bupropion hydrochloride (WELLBUTRIN). On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dosing details unspecified). On 19-JUL-2017, the patient had a "1 inch blister at the injections site". No treatment was provided for the event. The outcome of the event was reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint (PQC) was not involved. No further information has been provided.           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 medical assistant refers to unspecified number of patients of unknown age and gender. No information about patients, medical history, concomitant medication and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses VARIVAX from lot # M024702 with expiry: 18-MAY-2018, for prophylaxis which were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects reported. The temperature excursion was -14 degree C to -10 degree C (-13.3C) for 3 hours. The temperature excursion was detected by digital data logger. It had no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M042853 with expiry: 17-JUL-2019, for prophylaxis. The vaccine lot was exposed to temperature of 0° C to 1° C for 30 hours and  -1° C or colder (-2°C) for 225 minutes (15 Cycles). The temperature excursion was detected by digital data logger. It had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA008567: US-009507513-1707USA008568:
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Condition aggravated, Myalgia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 year old female patient. The patient's medical history included myalgia. On 2017 the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal conj vaccine (unspecified). On an unknown date the patient experienced myalgia. The outcome of myalgia is unknown. Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a 26 year old female patient. There was no information about the patient's concur en conditions, concomitant therapies or medical history provided. On 10-JAN-2017 the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot# and expiration date were not reported. On 07-FEB-2017 the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis(dose, route of administration, lot# and expiration date were not reported. Not adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and 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 an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M045204 with an expiration date 11-NOV-2018 for prophylaxis (dose and route of administration were not reported) reconstituted in properly stored sterile diluent (STERILE DILUENT) (lot# reported as N004801 with an expiration date 09-JUL-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature  excursion from 9 to 25 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1707USA008767:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 77 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, 1 year after vaccination the patient experienced shingles. The outcome of the event and the causality were not reported.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to a 4 year old patient. Medical history and concurrent conditions were not provided. On 03-JUL-2017, the patient was vaccinated with one dose of ZOSTAVAX lot# reported as M042854, the expiration date: 18-JAN-2018 (dose and route were not reported) instead of one dose of VARIVAX for prophylaxis (wrong drug administered). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).    No adverse effects reported. No further information provided.
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Arthropathy, Muscle disorder, Musculoskeletal disorder, Musculoskeletal pain, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a physician referring to a currently 80 year old male patient. The patient's drug reactions included penicillin allergy and rash caused by TAMIFLU. The patient's medical history was reported as "nothing relevant". Concomitant therapies were reported as "yes". On an unknown date, during the same visit to an unspecified pharmacy, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) (route reported as "injections"; dose, anatomical location, lot number and expiration date were not reported), for shingles and pneumonia prevention, and a dose of PREVNAR 13 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (dose, route, lot number, expiration date and indication were not reported). Later, on the same day at night, the patient experienced sciatica in the right leg, which developed into neuritis of both legs and then progressed to include upper extremity pain of the shoulders. It was also reported that the patient experienced agony in all their muscles and joints and had night sweats. Therefore, the physician treated the patient with tramadol hydrochloride for pain and 2 courses of prednisone (manufacturer unknown). Accordingly, the patient felt much better, but the physician could not keep the patient on the prednisone (manufacturer unknown) forever. No lab diagnostics were performed. At the time of reporting, the outcome of sciatica, night sweats, musculoskeletal disorder and musculoskeletal pain was reported as "gotten worse". The causal relationship between all above mentioned events and the suspect products was not reported. This case was considered as serious because the physician stated that the patient had significant disability.
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Night sweats, Sciatica
Clinical narrative: This spontaneous report was received from a physician referring to a currently 80 year old male patient. The patient's drug reactions included penicillin allergy and rash caused by TAMIFLU. The patient's medical history was reported as "nothing relevant". Concomitant therapies were reported as "yes". On an unknown date, during the same visit to an unspecified pharmacy, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) (route reported as "injections"; dose, anatomical location, lot number and expiration date were not reported), for shingles and pneumonia prevention, and a dose of PREVNAR 13 (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (dose, route, lot number, expiration date and indication were not reported). Later, on the same day at night, the patient experienced sciatica in the right leg, which developed into neuritis of both legs and then progressed to include upper extremity pain of the shoulders. It was also reported that the patient experienced agony in all their muscles and joints and had night sweats. Therefore, the physician treated the patient with tramadol hydrochloride for pain and 2 courses of prednisone (manufacturer unknown). Accordingly, the patient felt much better, but the physician could not keep the patient on the prednisone (manufacturer unknown) forever. No lab diagnostics were performed. At the time of reporting, the outcome of sciatica, night sweats, musculoskeletal disorder and musculoskeletal pain was reported as "gotten worse". The causal relationship between all above mentioned events and the suspect products was not reported. This case was considered as serious because the physician stated that the patient had significant disability.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age.  No pertinent medical history, concurrent conditions, drug reactions allergies or concomitant therapies were provided. On 19-JUL-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, intramuscular for prophylaxis in an unspecified arm (strength, dosage, lot number and expiration date were not reported). On 20-JUL-2017, the patient contacted the pharmacy in order to report that he developed in approximately July 2017, redness, swelling and soreness that started on his shoulder and was now going further down his arm (erythema, pain in extremity and peripheral swelling) and his arm is warm to the touch (skin warm). The outcome of erythema, skin warm, pain in extremity and peripheral swelling was unknown. The causality assessment between the adverse events and the suspect therapy was  not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a certificate medical assistant also reported as "Office Supervisor", referring to 8 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as "from June 1, 2017 through June 30, 2017"), the patients were administered with improperly stored vaccines of LIQUID PEDVAXHIB lot # N000237 with expiration date on 25-OCT-2019 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines has a temperature excursion of 35.1 Fahrenheit (F) during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred or a digital data logger was involved. This is one of several reports received from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA004031:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA004031:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included sterile diluent lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA004031.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA004031:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA004031:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner referring to multiple unknown patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II lot # M010426, expiration date: 01-MAR-2018; lot # L040961, expiration date: 19-OCT-2017; lot # L037356, expiration date: 28-SEP-2017; lot # L036851, expiration date: 23-SEP-2017; dose and route unknown) for prophylaxis. It was reported that the M-M-R II improperly stored vaccines from lot # L040961 were administered on 15-FEB-2017, 16-FEB-2017, 21-FEB-2017 and 22-FEB-2017. The lot # M010426 was administered on 23-FEB-2017. The M-M-R II was stored under temperature between 33.44 Fahrenheit (also reported as 32°F) and 36 Fahrenheit for 44 hours. There was no previous temperature excursion. It was unknown if there was a digital data logger involved. No adverse effects reported. No product quality complaint was involved. This is one of several cases received from the same source. Sender's Comments: US-009507513-1703USA002539: US-009507513-1702USA012115.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB from lot # N000237 with expiry: 25-OCT-2019, prophylaxis. The vaccine lot was exposed to temperature of 0° C to 1° C for 30 hours and  -1° C or colder (-2°C) for 225 minutes (15 Cycles). The temperature excursion was detected by digital data logger. It had no previous temperature excursion. This is one of three reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, from lot # M041184 with expiry: 31-MAY-2018, prophylaxis. The vaccine lot was exposed to temperature of 0° C to 1° C for 30 hours and  -1° C or colder (-2°C) for 225 minutes (15 Cycles). The temperature excursion was detected by digital data logger. It had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007928:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug allergies were not reported. On 17-JUL-2017 the patient was vaccinated with both VARIVAX, 1 dose unit (Lot # M029918, Expiry date :28-SEP-2018) and PROQUAD 1 dose unit (Lot # N013865, Expiry date : 31-OCT-2018) for prophylaxis (inappropriate schedule of drug administration). Concomitant therapies included sterile diluent(STERILE DILUENT), lot # and expiry date was unknown. No adverse effects were reported. There was no product quality complaint involved. This is 1 of the 2 reports from the same reporter.; Sender's Comments:  US-009507513-1707USA008871:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M041990, expiry date : 28-JUN-2019) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments: US-009507513-1707USA008761: US-009507513-1707USA008760: US-009507513-1707USA008762:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Their medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, an unspecified number of patients received improperly stored doses of VARIVAX (lot # M006731-valid [expiration date 09-FEB-2018], lot # M012990-valid [expiration date 14-MAR-2018], and lot # M049125 [expiration date 15-DEC-2018]) (dose and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature was reported as 15 degrees Fahrenheit (F) to 46 degrees F (15.3 degrees F) for a time frame of 40 minutes. Previous temperature excursion was 15 degrees F to 46 degrees F (15 degrees F) for 3 hours and this was reported as a data logger. This is one of the multiple reports from the same reporter (US-009507513-1707USA006549 and US-009507513-1707USA008650). Additional information has been requested.; Sender's Comments:  US-009507513-1707USA008650: US-009507513-1707USA006549:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Their medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, an unspecified number of patients received improperly stored doses of ZOSTAVAX (lot # M037654-valid [expiration date 29-NOV-2017]) (dose and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature was reported as 15 degrees Fahrenheit (F) to 46 degrees F (15.3 degrees F) for a time frame of 40 minutes. Previous temperature excursion was 15 degrees F to 46 degrees F (15 degrees F) for 3 hours and this was reported as a data logger. This is one of the multiple reports from the same reporter (US-009507513-1707USA006549 and US-009507513-1707USA008649). Additional information has been requested. Sender's Comments: US-009507513-1707USA006549: US-009507513-1707USA008649.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # M039642, Expiry date : 03-JUL-2019) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments:  US-009507513-1707USA008614:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (Lot # N004274, Expiry Date : 03-APR-2018) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.; Sender's Comments: US-009507513-1707USA008614:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, route of administretion, frequency) lot # M034780 with expiration date of 15-APR-2019, for prophylaxis. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 32 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA008774: US-009507513-1707USA006516:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant  referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, frequency, route of administration were not provided) lot # M036458 with expiration date of 02-MAR-20178 for prophylaxis. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 16 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006516: US-009507513-1707USA008773:
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Stock of vaccine was received in summer 2016. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L051100 with expiration date of 17-JUN-2017 (dose, route and frequency were not reported) for prophylaxis. The vaccine was purchased with private funds. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 3 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 7 year old male patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 04-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13 month old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 16-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 135 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 12-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 04-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 7 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 18 week old patient of unknown gender. On 20-JUL-2017, the patient was administered with a dose of ROTATEQ (lot # M045545, exp. date: 10-JUN-2018, oral) for prophylaxis (product use in unapproved population). No adverse effects were reported. No additional information was provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. the patient's medical history, current conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with ZOSTAVAX (batch# N015628, expiry date: 30-JUL-2018) for prophylaxis. On 14-JUL-2017, the patient experienced injection site pruritus and injection site erythema which were resolved on 17-JUL-2017 without any treatment.  On an unknown date in July 2017 (reported as 2 weeks after receiving the vaccination), the patient experienced head and neck itchiness which was ongoing. The causality was not reported.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 55 year old male consumer regarding himself. The patient did not have any pertinent medical history or allergies. On 18-JUL-2017, the patient was vaccinated with ZOSTAVAX, 1 DF in the triceps area of left arm for prophylaxis. Concomitant therapies included escitalopram. On 18-JUL-2017, the patient experienced injection site swelling and injection site warmth. Treatment was given for the events and no medical attention was sought. The outcome of injection site swelling and injection site warmth was reported as not recovered. Causality was not reported. No further information was provided.        Additional information is not expected as there are contact details .
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen warm right upper lateral arm. Slightly warm to touch. To give Compresses when necessary. Ibuprofen 8 mL every 6 hours if needed for pain or fever. Monitor closely and call for worsening.