chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a public health nurse and refers to a 23-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 24-MAY-2017, the patient was vaccinated with an expired dose of VARIVAX injection (lot # L012038, expiration date: 07-APR-2017; dose and route of administration were not reported). Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the physician via a company representative and refers to a 71 year old female patient. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 25-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, single dose (route and site of administration, lot # and expiration date were not reported) for prevention of shingles. On unknown date (reported as after vaccination), the patient experienced shingles. The physician prescribed valacyclovir hydrochloride (VALTREX) for the shingles. The outcome of the event was reported as recovered. Causality assessment was not provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a nurse and refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-MAY-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU), subcutaneously, lot # M042851, expiration date 18-JAN-2018 (dose was not reported) and also with VARIVAX injection, lot # M044347, expiration date 04-NOV-2018 (dose and route of administration were not reported) due to human error. The reporter stated that she was going too quickly with the checking" prior to administration of the doses. The vaccines were reconstituted with sterile diluent (DILUENT MRK) lot # N07932, expiration date 06-MAY-2018 (dose and route of administration were not reported). The patient had not experienced an adverse effect. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concomitant therapies, medical history and drug reactions or allergies provided. On 13-APR-2017, the patient was vaccinated with improperly stored dose of VARIVAX 0.5 ml, once, subcutaneously, lot# M038857, expiration date: 14-SEP-2018 (site of administration was not reported). Sterile diluent (manufacturer unknown), lot number reported as M033585, expiration date: 21-APR-2019 was used to reconstitute the dose of improperly stored VARIVAX received by the patient. No temperature excursion was identified for the sterile diluent. No adverse effects were reported. Administered dose of VARIVAX was stored at temperature between 15 Fahrenheit degrees to 46 Fahrenheit degrees (the range was 35.5 degrees Fahrenheit) for 3 hours. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007776: US-009507513-1705USA015679: US-009507513-1705USA015681: US-009507513-1705USA015682: US-009507513-1705USA015683.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed vocational nurse (L.V.N) and refers to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions, and allergies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 16-MAY-2017, one patient was vaccinated with an improperly stored dose of PROQUAD, on 17-MAY-2017, other patient was vaccinated with an improperly stored dose of PROQUAD, and on 18-MAY-2017, two patients were vaccinated with improperly stored doses of PROQUAD, all for prophylaxis (doses and routes of administration were not reported). It was unknown by the nurse which specific vaccine lot numbers were administered on each specific date of administration. Lot #M044720 with expiration date 07-MAY-2018 (which was reconstituted with sterile diluent (manufacturer unknown) lot #L025372 with expiration date 20-MAR-2018) and Lot # M043310 with expiration date 24-APR-2018 (which was reconstituted with sterile diluent (manufacturer unknown) lot # N003192 with expiration date 05-JUL-2019). The sterile diluent (manufacturer unknown) used to reconstitute the vaccines was properly stored. No symptoms were reported. The doses of the vaccine were exposed to a temperature of 8.8 degree Fahrenheit (°F) for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Lot number M044720 has been verified to be a valid lot number for PROQUAD and lot number L025372 has been verified to be a valid lot number for sterile diluent (manufacturer unknown). Additional information has been requested. Sender's Comments: US-009507513-1706USA002919.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of VAQTA lot number M022924, expiration date 24-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a "data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004337: US-009507513-1706USA004338: US-009507513-1706USA004336: US-009507513-1706USA004335:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored GARDASIL 9 lot # M028323 and expiration date of 26-SEP-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA001767: US-009507513-1706USA001765: US-009507513-1706USA001766.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse, concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 30-MAY-2017 the patient was vaccinated with a expired dose of VAQTA (dose and route of administration were not provided) (lot # M031695, expiration date 26-MAY-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 6 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 doses of GARDASIL 9 (dose and route of administration were not reported) (lot # M032650 and expiration date 31-MAR-2019) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccines experienced a previous temperature excursion of 34.9 degrees Fahrenheit for 12 hours and the last temperature excursion was 31 degrees Fahrenheit for 6 hours. Data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA (dose, route and anatomical location were not reported), strength of 25/0.5 (units not reported), lot # reported as M043731 with expiration date on 22-MAY-2019 and lot # N005274 with expiration date on 03-APR-2018, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Lot number M043731 is an invalid lot number for VAQTA. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001034: US-009507513-1705USA008599: US-009507513-1706USA001033:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) concerning a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-JUN-2017, the patient was vaccinated with an expired dose of VAQTA injection lot # L036449, expiration date: 26-MAY-2017 (dosing details not reported) intramuscularly for prophylaxis (expired product administered). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a pharmacy intern referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The intern reported that on 01-JUN-2017, an expired dose of PNEUMOVAX 23 (unknown lot, expiration 10-MAY-2017) was administered (expired product administered). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an 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(s), the patients were vaccinated with improperly stored doses of PROQUAD from lot #s M064719 with expiry date: 07-MAY-2018; M037010 with 21-FEB-2018; and M037011 with expiry: 21-FEB-2018, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -13.6 degree Celsius for 3.5 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. The lot # M064719 has been verified to be not valid for PROQUAD. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002051: US-009507513-1706USA002056: US-009507513-1706USA002053: US-009507513-1706USA002054: US-009507513-1706USA002055: US-009507513-1706USA002056.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dosing details and route of administration unknown) (lot # M033209 with expiry date 09-JAN-2018; lot # M038228 with expiry date 06-MAR-2018; lot# M049123 (RHA) with expiry date 13-OCT-2018) for prophylaxis, which reconstituted with sterile water diluent that was not involved in the temperature excursion. Medical assistant did not know which of vaccine lot numbers were administered. The administered doses experienced a temperature excursion of 6 degree Fahrenheit(F) to 14 degree Fahrenheit(F) for a time frame of 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1706USA001442: Original Case: 1706USA001442.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ, (dosing details unknown) (lot # M019707 with expiry date 25-OCT-2017; lot # M014755 with expiry date 30-OCT-2017; lot # M041814 with expiry date 27-JUL-2018) orally for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of ROTATEQ experienced a temperature excursion of 47 degree Fahrenheit(F) to 77 degree Fahrenheit(F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001442: Original Case : 1706USA001442
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # L030868 and expiration date of 09-JUN-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015824: US-009507513-1706USA001767: US-009507513-1706USA001766:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored ROTATEQ lot # M019707 and expiration date of 25-OCT-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32°Fahrenheit degrees to 35°Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes).  No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015824: US-009507513-1706USA001767: US-009507513-1706USA001765:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an 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(s), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB from lot # M047666 with expiry: 24-OCT-2019 and lot# M034187 with expiry:17-MAY-2019, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Back disorder, Colonoscopy, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: This spontaneous report was received from a 24 year old female patient (currently 32 year old), who was reporting on herself. The patient had no known drug reactions or allergies. The patient's concomitant therapies included valacyclovir hydrochloride and zolpidem tartrate (AMBIEN). On 19-FEB-2010, the patient was vaccinated with the third dose of GARDASIL injection for prevention of human papillomavirus (route of administration, lot number and expiration date were not provided). On approximately 21-FEB-2010 (reported as 2 days after the third injection), the patient had a reaction, as her nerve endings became hypersensitive to the point that even air hurt her skin. The hypersensitivity was all over her body and felt like "fire ants". The patient reported that her unspecified physician could not determine if the reaction was from the vaccine or the carrier. The patient sought medical attention by visiting her general practitioner, dermatologist, neurologist, rheumatologist, orthopedic specialist, obstetrician-gynaecologist (reported as OB-GYN) and a pain management physician. The patient also visited emergency room a couple of times, with no hospital admission yet. The performed laboratory diagnostic studies included a full blood work-up a couple of times, 24-hour urinalysis, endoscopy, colonoscopy, electroencephalogram, electrocardiogram, magnetic resonance imaging and computed tomography scan, all on unknown dates. It was also reported that it took five months to determine the way to treat the hypersensitivity. On unknown dates, the patient underwent nerve burning (radio frequency), steroid injections and physical therapy as a treatment. The patient was still being treated for the hypersensitivity with anti-depressants, pain medication and nerve blockers (all unspecified) at the time of this report. It was also reported that when the patient had been stressed the symptoms came back. On an unknown date in 2017 (reported as "earlier this year"), the patient underwent a back surgery for an unspecified back disorder (the reason of the surgery was not reported). The outcome of the hypersensitivity and the air hurting skin was considered as not recovered. The outcome of the unspecified back disorder which required back surgery was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of unspecified back disorder which required a back surgery was considered to be medically significant and the events of hypersensitivity and the air hurting skin have been upgraded to medically significant, as they required nerve burning (radio frequency), steroid injections and physical therapy. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Endoscopy, Full blood count, Hyperaesthesia, Nuclear magnetic resonance imaging, Peripheral nerve destruction
Clinical narrative: This spontaneous report was received from a 24 year old female patient (currently 32 year old), who was reporting on herself. The patient had no known drug reactions or allergies. The patient's concomitant therapies included valacyclovir hydrochloride and zolpidem tartrate (AMBIEN). On 19-FEB-2010, the patient was vaccinated with the third dose of GARDASIL injection for prevention of human papillomavirus (route of administration, lot number and expiration date were not provided). On approximately 21-FEB-2010 (reported as 2 days after the third injection), the patient had a reaction, as her nerve endings became hypersensitive to the point that even air hurt her skin. The hypersensitivity was all over her body and felt like "fire ants". The patient reported that her unspecified physician could not determine if the reaction was from the vaccine or the carrier. The patient sought medical attention by visiting her general practitioner, dermatologist, neurologist, rheumatologist, orthopedic specialist, obstetrician-gynaecologist (reported as OB-GYN) and a pain management physician. The patient also visited emergency room a couple of times, with no hospital admission yet. The performed laboratory diagnostic studies included a full blood work-up a couple of times, 24-hour urinalysis, endoscopy, colonoscopy, electroencephalogram, electrocardiogram, magnetic resonance imaging and computed tomography scan, all on unknown dates. It was also reported that it took five months to determine the way to treat the hypersensitivity. On unknown dates, the patient underwent nerve burning (radio frequency), steroid injections and physical therapy as a treatment. The patient was still being treated for the hypersensitivity with anti-depressants, pain medication and nerve blockers (all unspecified) at the time of this report. It was also reported that when the patient had been stressed the symptoms came back. On an unknown date in 2017 (reported as "earlier this year"), the patient underwent a back surgery for an unspecified back disorder (the reason of the surgery was not reported). The outcome of the hypersensitivity and the air hurting skin was considered as not recovered. The outcome of the unspecified back disorder which required back surgery was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of unspecified back disorder which required a back surgery was considered to be medically significant and the events of hypersensitivity and the air hurting skin have been upgraded to medically significant, as they required nerve burning (radio frequency), steroid injections and physical therapy. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal operation, Urine analysis
Clinical narrative: This spontaneous report was received from a 24 year old female patient (currently 32 year old), who was reporting on herself. The patient had no known drug reactions or allergies. The patient's concomitant therapies included valacyclovir hydrochloride and zolpidem tartrate (AMBIEN). On 19-FEB-2010, the patient was vaccinated with the third dose of GARDASIL injection for prevention of human papillomavirus (route of administration, lot number and expiration date were not provided). On approximately 21-FEB-2010 (reported as 2 days after the third injection), the patient had a reaction, as her nerve endings became hypersensitive to the point that even air hurt her skin. The hypersensitivity was all over her body and felt like "fire ants". The patient reported that her unspecified physician could not determine if the reaction was from the vaccine or the carrier. The patient sought medical attention by visiting her general practitioner, dermatologist, neurologist, rheumatologist, orthopedic specialist, obstetrician-gynaecologist (reported as OB-GYN) and a pain management physician. The patient also visited emergency room a couple of times, with no hospital admission yet. The performed laboratory diagnostic studies included a full blood work-up a couple of times, 24-hour urinalysis, endoscopy, colonoscopy, electroencephalogram, electrocardiogram, magnetic resonance imaging and computed tomography scan, all on unknown dates. It was also reported that it took five months to determine the way to treat the hypersensitivity. On unknown dates, the patient underwent nerve burning (radio frequency), steroid injections and physical therapy as a treatment. The patient was still being treated for the hypersensitivity with anti-depressants, pain medication and nerve blockers (all unspecified) at the time of this report. It was also reported that when the patient had been stressed the symptoms came back. On an unknown date in 2017 (reported as "earlier this year"), the patient underwent a back surgery for an unspecified back disorder (the reason of the surgery was not reported). The outcome of the hypersensitivity and the air hurting skin was considered as not recovered. The outcome of the unspecified back disorder which required back surgery was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of unspecified back disorder which required a back surgery was considered to be medically significant and the events of hypersensitivity and the air hurting skin have been upgraded to medically significant, as they required nerve burning (radio frequency), steroid injections and physical therapy. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA lot number reported as M005274, expiration date 03-APR-2018 (dose was not reported) for prophylaxis. The temperature reported was 33 grades Fahrenheit for 22 hours. It was not prior temperature excursion, and a data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002271: Original Case : 1706USA002271.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported) for prophylaxis. The storage temperature was reported as 9 to 25 degrees Celsius (°C) for a time frame of 32 hours and 19 minutes. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports received from the same source. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1706USA003747:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on an unspecified date, the patient might have received an improperly stored dose of GARDASIL 9 (lot: M007464, expiry date: 30-JAN-2018) or ROTATEQ (lot: M033338, expiry date: 15-APR-2018) (Incorrect product storage). But she was not sure which of the vaccines the unspecified patient received. The vaccine was exposed to the temperature range of 32°F to 35°F for 8 hours. There was no previous temperature excursion. No adverse events were reported. This is one of the two reports associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001350:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant 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 06-JUN-2017, the patient was vaccinated with expired dose of M-M-R II injection, lot # L009212, expiration date 17-MAR-2017 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK) (dose, route of administration, lot # and expiration date were not reported). No symptoms were reported. No product quality complaint was involved. The reporter did not want to provide a physician's name but said that a follow-up form can be sent to the office and did not want to identify to whose attention the follow-up form should be sent to. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received via medical records from a licensed practical nurse and refers to a 4 year old White male patient. On 06-OCT-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot# and expiration date were not reported). This is one of two reports concerning the same patient. Additional information is not expected. All available medical records will be provided upon request. Sender's Comments: US-009507513-1704USA001524:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-APR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
Age: 1.75
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-APR-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2017, the patient was vaccinated with the improperly stored (between 6 and 14 degrees Fahrenheit for 30 minutes) dose of VARIVAX (for prophylaxis, lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009837:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (from 47 to 77 degrees Fahrenheit for 14 hours) doses of PROQUAD (lot # L050910, expiration date 14-JUN-2017; dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with the properly stored sterile diluent. No adverse effect and previous excursion were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1705USA009034.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VAQTA (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported) for prophylaxis. The storage temperature was reported as 9 to 25 degrees Celsius (°C) for a time frame of 32 hours and 19 minutes. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports received from the same source. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1706USA002365:
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a first, second and third dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, after receiving the third dose of the vaccine, the patient experienced a lump at injection site. The outcome of a lump at injection site was unknown. The relatedness between the event of lump at injection site and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of RECOMBIVAX HB lot number L029631, expiration date 14-AUG-2017; and lot number L000717, expiration date 14-APR-2017(strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004337: US-009507513-1706USA004336: US-009507513-1706USA004338:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of ROTATEQ lot number M019690, expiration date 02-NOV-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004337 : US-009507513-1705USA015783: US-009507513-1706USA004338:  US-009507513-1706USA004335:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of GARDASIL 9 lot number L036301, expiration date 20-DEC-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a "data logger". No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested. Sender's Comments: US-009507513-1705USA015783: US-009507513-1706USA004336: US-009507513-1706USA004338: US-009507513-1706USA004335.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of PNEUMOVAX23 lot number M029681, expiration date 22-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004337: US-009507513-1706USA004336: US-009507513-1706USA004335: US-009507513-1705USA015783:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain, Injection site rash, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) on behalf of the practice. A 69-year-old female patient received PREVNAR 13, (Lot # R28322, Expiry Date 30Mar2018, NDC #0005-1971-01) intramuscular at 0.5ml, single at left deltoid on 25May2017 approximately 11:30am for immunization, for prophylactic vaccination against pneumonia, at physician office. Medical history included vitamin D deficiency from Nov2016 and ongoing, nicotine dependence from Nov2016 and ongoing, anxiety from Mar2016 and ongoing, dyslipidaemia from Mar2016 and ongoing, hypertension from 20Mar2016 and ongoing, ongoing atrial tachycardia, constipation treated with Glycoax. Concomitant medication included ongoing ALPRAZOLAM 0.5 mg, as needed (0.5mg BID PRN tablet) for anxiety, ongoing AMLODIPINE 5 mg, 1x/day (5mg 1 tablet QD) for hypertension, ongoing ASPIRIN 81 mg, daily (81mg daily tablet) for atrial tachycardia, ongoing GLYCOLAX 17g per dose oral powder daily for constipation. No history of all previous immunizations with PREVNAR 13. No additional vaccines administered on same date of PREVNAR 13. No prior vaccinations within 4 weeks. The patient's last vaccine was the influenza in Nov2016 for immunisation. On 25May2017 the patient experienced lump at injection site and soreness at injection site. On 30May2017 she experienced rash at the injection site, a couple inches from the injection site that started 5 days after the vaccination. The patient thought she had shingles because the rash was away from the injection site. She had been applying AVEENO cream to the area. No event required a visit to Emergency Room, but Rash and lump required a visit to physician office. The outcome of rash and soreness was unknown, of lump at injection site was not recovered.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Eye pain, Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 67 year-old female patient of other race received the first single dose of PREVNAR 13 via an unspecified route of administration on 09May2017 at 4 pm in left arm for immunisation. Medical history included allergy from an unknown date and unknown if ongoing. The patient was concomitantly taking some other unspecified medications. No family medical relevant history was present. No other vaccines were administered the same day or within four weeks prior. The patient experienced injection hurt real bad on 09May2017. The evening of the next day, on 10May2017, she noticed pain in her left arm, generalized to the shoulder area. She rubbed her arm in ASPERCREME, and then iced it because the cream didn't do any good. Because she was still having pain and weakness in her left arm up to the shoulder area, she started taking ADVIL, that evening as well. On 11May2017, she went to work and was still icing her left arm and taking 2 ibuprofen per day. She also started feeling very sleepy, had muscle aches and pains, and fatigue. That continued for 11May2017 and 12May2017. On 13May2017, she started having headaches behind her right eye. She described them as funny kind of headaches but not migraines. On 14May20017 she was tired and lethargic, and just laid around and slept all day. She went to work the next day even though she was still tired and lethargic, and her co-workers told her that she needed to go to the doctor. She stated that she also noticed, on that day, that her arm was very red and irritated. On 15May2017 or 16May2017 she went to the doctor due to the events. The doctor measured the area on her left arm that was red and irritated, and it was about 3 inches. It was also really itchy. The doctor prescribed a 4 day dose of prednisone. The redness and itching resolved a couple of days after she finished prednisone on an unspecified day in May2017. She had also stopped the trolamine salicylate by this time because it wasn't working. She was still having headaches behind her right eye, but since last week, the headaches were getting better. They were still there, but they were intermittent. She also still had the weakness in her left side up in the should area. It was bad the first week, but it has improved. She could feel the pain going up the left side of her neck if she raised her left arm. On 26May2017 she felt like the whole thing was coming on her again. She clarified that she felt like she did the day that she went to the doctor. It lasted into the evening, about 4-5 hours. She has never had that feeling before in her life, so she recognized it immediately. The patient recovered from redness and itching on an unspecified day in May2017, she was recovering from weakness in her left arm up to the shoulder area and headache, she was not recovered from pain in her left arm, generalized to the shoulder area and pain going up the left side of her neck if she raised her left arm, outcome of the other events was unknown.