chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a practitioner nurse and a medical assistance, concerning a 17 year-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 08-MAR-2017, the patient was vaccinated with a dose of PROQUAD (dose, frequency and route were not reported) lot # M040141 with expiration date of 27-MAR-2018; the PROQUAD dose was reconstituted with sterile diluent (lot # reported as M029027 and expiration date of 14-MAR-2019). Then, on 05-APR-2017, the patient received a dose of M-M-R II (dose, frequency, route, lot # and expiration date were not reported) and a dose of VARIVAX (dose, frequency, route, lot # and expiration date were not reported); the diluent information used to reconstitute these two vaccines were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was supposed to be vaccinated with a dose of PNEUMOVAX 23 for prophylaxis but instead was inadvertently administered with another dose of PREVNAR 13.  Other suspect therapies included PREVNAR 13. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse via Poison and Drug Centre refers to an unknown number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates in 2017, multiple unspecified patients were vaccinated with GARDASIL. Dosing details, route of administration, lot number and expiry date were unknown. On an unknown date, in the beginning of 2017, the vaccine was reported to have been out of range. It was reported that "the other employees who record the temperature never reset the button". On 03-JAN-2017, for example, the "min/max" temperature was "33/47" (units unspecified) and "she didn't reset the button". The temperature was observed to be 43 (units unspecified) when she arrived at the office and when she left, it was 47 (units unspecified). It was never observed to be out of that range. It was also reported that "on the 3rd, 4th, 5th, and 7th, everything was in the same range and was 43, 38, 35, 45, 43, or 45" (units unspecified). As of 06-MAY-2017, it was not known if the patients were still administered the GARDASIL. This report is one of three reports that are linked via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741.
Sex: U
Vaccine: HPV9
Symptoms: Oxygen therapy
Clinical narrative: This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration, indication, lot # and expiration date were not reported). On an unknown date, the patient was "sent to the hospital" after receiving the GARDASIL 9 vaccine due to unspecified reason. On an unknown date, the patient was on an oxygen therapy because of what the GARDASIL 9 did to them. The outcome of the events and the relatedness between the events and GARDASIL 9 were not reported. Upon internal review, the event of oxygen therapy was considered to be medically significant. Additional information is not expected due to lack of the reporter's contact details.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-MAR-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomival location, lot number and expiration date were not provided), for prophylaxis, reconstituted with sterile diluent. The patient became pregnant with last menstrual period (LMP) of 15-MAR-2017 and expected date of delivery (EDD) of 20-DEC-2017. On 10-MAY-2017, the patient reported to the clinic that she was 8 weeks pregnant and "had been approximately 2 weeks pregnant" when she received the dose of M-M-R II. The patient did not received any treatment and no adverse reactions were reported. At the time of reporting, the outcome of exposure during pregnancy was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Antibody test abnormal, Blood immunoglobulin M decreased, Flow cytometry
Clinical narrative: This literature marketed report as received from the authors of a published abstract, titled as stated below, refers to a 53 year old male patient. Selective IgM deficiency (sIgMD) was a rare primary immunodeficiency that was associated with autoimmunity and atopy. Autoimmune polyglandular syndrome type 3 (APS3) was also a rare disease that presents with autoimmune thyroiditis with one or more of the following: diabetes type I, pernicious anemia, and vitiligo. The authors described a patient found to have selective IgM deficiency and concurrent APS3. The patient presented with an extensive history of multiple autoimmune conditions with sudden onset decades prior (diabetes type I, pernicious anemia, vitiligo, hypogonadism, sicca syndrome, chronic urticaria). He also had a history of significant infections (pneumonia, chronic sinusitis and sepsis). He was recently diagnosed with brain cancer and had post-operative Streptococcus pneumoniae meningitis, and an isolated abnormal IgM was identified upon quantitative immunoglobulin screening. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and site of administration were not reported). On an unspecified date, immune work-up revealed a low IgM (9 mg/dL), 3/23 protective pneumococcal titers despite recent pneumococcal polysaccharide vaccination, normal flow cytometry and undetectable isohemaglutinins. SIgMD was associated with impaired specific IgG response to pneumococcal polysaccharide vaccine and undetectable natural IgM antibodies. Although the relationship between sIgMD and autoimmunity was well established, the autoimmune diseases in this case were not typically seen in sIgMD but were consistent with the clinical diagnosis of APS3. Additional information has been requested.
Sex: F
Vaccine: HPV9, TD
Symptoms: Intervertebral disc degeneration, Muscle spasms, Muscle tightness, Nuclear magnetic resonance imaging spinal abnormal, Paralysis
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a 41 year old female patient. The patient concurrent conditions and medical history was not reported. Historical drug included extreme flu influenza vaccine (manufacturer unknown). On 08-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M037770) intramuscularly in the left arm for prophylaxis. On the same day, she was also vaccinated with a dose of TENIVAC (lot number A093AJ) intramuscularly in the left arm. Concomitant therapies included dabigatran etexilate mesylate (PRADAXA).  On 08-FEB-2017, the patient experienced cramping muscles, tense muscles and muscle spasms. On 17-FEB-2017, reported as 9 days later, the patient experienced partial paralysis. On 20-FEB-2017, Magnetic Resonance Imaging (MRI) was performed and L3-4 and L5-S1 was found with active degenerative change and the patient experienced nuclear magnetic resonance imaging spinal abnormal and intervertebral disc degeneration. The outcome of the events was not reported. The relationship between the events and GARDASIL 9 and TENIVAC was not reported. The events were considered to be life threatening. Upon internal review, the event of paralysis was determined to be medically significant.     Additional information has been requested.
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 an unknown number of patients of unknown age and gender. On 23-NOV-2016, 20-JAN-2017, 06-MAR-2017 and on 10-MAR-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot # L048456, expiration date: 25-MAY-2017) (dosage and route of administration were not reported) for prophylaxis. From 06-APR-2016 to 08-MAR-2017, the doses were stored outside of recommended temperature (from 36 to 46 degrees of Fahrenheit). The lowest temperature was 33 degrees of Fahrenheit and the highest temperature was 73 degrees of Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008959:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender.     On an multiple unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L030865, expiration date was not reported) (dosage and route of administration were not reported) for prophylaxis. The temperature excursion, time frame and the temperatures were not reported. No adverse effects was reported. This is one of several reports from the same reporter.       Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008959:
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 an unknown number of patients of unknown age and gender. On 06-JAN-2017 and on 10-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiration date: 25-MAY-2017) for prophylaxis. From 06-APR-2016 to 22-MAR-2017, the doses were stored outside of recommended temperature (36-46 degrees Fahrenheit). The lowest temperature was 47 and the highest was 73 degrees Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008959.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. On 12-SEP-2016, 16-SEP-2016, 03-OCT-2016, 07-OCT-2016, 21-OCT-2016, 04-NOV-2016, 11-JAN-2017, 08-FEB-2017 and on 22-FEB-2017, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L012481, expiration date was not reported) (dosage and route of administration were not reported) for prophylaxis. Concomitant therapy included properly stored sterile diluent. From 04-MAR-2016 to 22-MAR-2017, these doses were stored in the temperatures between 48 to 73 degrees Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008959.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown gender and age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB, 40 micrograms dialysis dose, (route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The physician reported that the patient was not a dialysis patient. No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to an 2-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with M-M-R II (lot # M035388) albumin status unknown (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis. It was reported that, in the period from 01-MAR-2017 to 23-MAR-2017, the M-M-R II was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007311: US-009507513-1705USA007310.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse via Poison and Drug Centre refers to an unknown number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates in 2017, multiple unspecified patients were vaccinated with PEDVAXHIB for prophylaxis. Dosing details, route of administration, lot number and expiry date were unknown. On an unknown date, in the beginning of 2017, the vaccine was reported to have been out of range (incorrect product storage). It was reported that "the other employees who record the temperature never reset the button". On 03-JAN-2017, for example, the "min/max" temperature was "33/47" (units unspecified) and "she didn't reset the button". The temperature was observed to be 43 (units unspecified) when she arrived at the office and when she left, it was 47 (units unspecified). It was never observed to be out of that range. It was also reported that "on the 3rd, 4th, 5th, and 7th, everything was in the same range and was 43, 38, 35, 45, 43, or 45" (units unspecified). As of 06-MAY-2017, it was not known if the patients were still administered the PEDVAXHIB. This report is one of three reports that are linked via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1705USA007741: US-009507513-1705USA004287.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse via Poison and Drug Centre refers to an unknown number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates in 2017, multiple unspecified patients were vaccinated with ROTATEQ for prophylaxis. Dosing details, route of administration, lot number and expiry date were unknown. On an unknown date, in the beginning of 2017, the vaccine was reported to have been out of range (incorrect product storage). It was reported that the other employees who record the temperature never reset the button. On 03-JAN-2017, for example, the "min/max" temperature was "33/47" (units unspecified) and she didn't reset the button. The temperature was observed to be 43 (units unspecified) when she arrived at the office and when she left, it was 47 (units unspecified). It was never observed to be out of that range. It was also reported that "on the 3rd, 4th, 5th, and 7th, everything was in the same range and was 43, 38, 35, 45, 43, or 45" (units unspecified). As of 06-MAY-2017, it was not known if the patients were still administered the ROTATEQ. This report is one of three reports that are linked via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA004287.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness and swelling of site. Also headache and fever. Next day patient left work early. Went to the Dr. Took IBU and Tylenol #3.  Returned to Dr. 5/12/2017. Was administered steroids. Patient still had a fever.  Went back to the Dr on 5/14/2017 complaining of worsening swelling down to the elbow. Patient was given Keflex. Today patient is feeling better and has no fever, but can still feel a 'knot' at the site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and swelling of site. Also headache and fever. Next day patient left work early. Went to the Dr. Took IBU and Tylenol #3.  Returned to Dr. 5/12/2017. Was administered steroids. Patient still had a fever.  Went back to the Dr on 5/14/2017 complaining of worsening swelling down to the elbow. Patient was given Keflex. Today patient is feeling better and has no fever, but can still feel a 'knot' at the site.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Seizure
Clinical narrative: Had GARDASIL on 5/10/17, started having cold chills and convulsions that evening.  Went to  ER, dx with seizures.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This was a vaccine administration error. No adverse effects noted.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Cyanosis, Dyspnoea, Hypotonia, Lethargy, Pallor
Clinical narrative: Child started screaming. Went limp, turned white, labored breathing them quit breathing. Lips and breast turned blue. Very lethargic, non responsive.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Respiratory arrest, Screaming, Unresponsive to stimuli
Clinical narrative: Child started screaming. Went limp, turned white, labored breathing them quit breathing. Lips and breast turned blue. Very lethargic, non responsive.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was referring to herself. There was no information regarding patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (exact dose, route of administration, lot number and expiration date were not provided) for prevention of pneumoccocal disease. On an unknown date, the patient experienced severe swelling for three days, redness, pain and itchiness. The patient sought medical attention by visiting a physician, who treated her with antihistamine's on unspecified dates. The outcome of the adverse events was reported as not recovered at the time of the report. The relatedness between adverse events and vaccination with PNEUMOVAX23 was not reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patient received three doses of PNEUMOVAX23 (route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient came to the office to receive the fourth dose of PNEUMOVAX23. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report was received from a currently 75 year old female patient who was referring to herself. The patient's concurrent conditions included chronic migraines and allergy to "Sulfa". In approximately April 2013 (reported as 3-4 years ago), after having the shingles virus previously, the patient was vaccinated with ZOSTAVAX, 19400 plaque-forming units (PFU) subcutaneously for prophylaxis (exact dose, lot number and expiration date were not provided). Concomitant therapies included zolmitriptan (ZOMIG). On 17-APR-2017, the patient's elbow started tingling and it was difficult for her to sit in a chair. The patient sought medical attention, as she saw the physician who diagnosed her with shingles again. The patient received a treatment of an unspecified antiviral, an unspecified pain medication and unspecified medicated lotion. The patient also stated that her shingles helped her in relieving the pain from her chronic migraines. There was no lab diagnostic studies performed. There was no product quality complaint involved in this case. The outcome of adverse events was reported as not recovered. The relatedness between adverse event and suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reaction, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of M-M-R II (doses and routes of administration were not provided) lot # M032485 (albumin status rHA), expiration date: 06-JUL-2018; lot # M032487 (albumin status recombinant human albumin (rHA)), expiration date: 05-JUL-2017. No adverse effects were reported. The vaccines were stored for 2 hours and 30 minutes in the temperature between 9 and 25 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA013231: US-009507513-1704USA013229: US-009507513-1704USA012451.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II injection, lot # L007217, expiration date on 03-MAR-2017 (dose route and site of administration were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 28-APR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # L014458, expiry date 11-FEB-2017, dose and route of administration were not provided). No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored  M-M-R II, for prophylaxis (dose, units, lot number and expiration date were not provided). Concomitant therapy included (STERILE DILUENT) (lot number and expiration date were not provided) used for reconstitution of M-M-R II. Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007629: US-009507513-1705USA007630:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # M037770 with expiration date of 01-JUN-2019, for prophylaxis. The temperature of the GARDASIL 9 was between 47 °F and 77 °F for a time frame of 16 hours. No previous temperature excursion occurred, and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source.   Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007816: US-009507513-1705USA007814:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history was not reported. The reporter stated that on 05-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, (strength, route, dose, lote number and expiration date were not provided) for prophylaxis. In addition, it was reported that on the same date, "five minutes after receiving that expired dose, the patient also received a non-expired dose of ZOSTAVAX. The patient's concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of ROTATEQ orally, lot number M017514, expiration date 07-NOV-2017 (dose was not reported) were administered to the patients. No adverse effects were reported. On unknown dates, the doses were stored in the temperature 33.6 degrees Fahrenheit (F) for 19.5 hours which was detected by a digital data logger. No previous temperature excursion was reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000218:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, from 01-FEB-2017 to 28-FEB-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot# M029230, expiration date: 08-JUN-2018; lot# M008588, expiration date: 16-FEB-2018; lot# M035935, expiration date: 09-AUG-2018; lot# M037096, expiration date: 23-AUG-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. The nurse stated that the reason for temperature excursion was due to the refrigerator needing service. It was also added that there were no other temperature excursions once the service was completed. Reporter also stated that she would call back with the information regarding patients who received improperly stored vaccines. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007278: US-009507513-1705USA007277: US-009507513-1703USA005900.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers 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 M-M-R II lot # M029919 with expiration date 13-JUN-2018 and lot # M000768 with expiration date 05-JAN-2018 (dose and route of administration were not reported), which were reconstituted with sterile diluent. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007304: US-009507513-1705USA007308: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1704USA014902: US-009507513-1705USA007305.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 1-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with M-M-R II albumin status unknown (lot # M035388) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis. It was reported that in the period from 01-MAR-2017 to 23-MAR-2017, the M-M-R II was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007311: US-009507513-1705USA007309.
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to a 17-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-MAR-2017, the patient was vaccinated with M-M-R II albumin status unknown (lot # M035388) (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis. It was reported that, in the period from 01-MAR-2017 to 23-MAR-2017, the M-M-R II was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007309: US-009507513-1705USA007310.
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 an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored GARDASIL 9, for prophylaxis (dose, units, lot number and expiration date were not provided). Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002132: US-009507513-1705USA007630.
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 an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored ROTATEQ for prophylaxis (dose, units, lot number and expiration date were not provided). Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007629: US-009507513-1705USA002132.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were orally vaccinated with an improperly stored dose of ROTATEQ (dose and frequency were not reported) lot # M038846 with expiration date of 26-APR-2018, for prophylaxis. The temperature of the ROTATEQ was between 47 °F and 77 °F for a time frame of 16 hours. No previous temperature excursion occurred, and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003118: US-009507513-1705USA007814:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient describes pain at injection site, some times radiating down. Hard to carry heavy objects.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Hypoaesthesia, Mobility decreased, Nuchal rigidity, Pain
Clinical narrative: Extreme pain and rigid neck, numbness and tingling shooting down on right arm where injection was given. Unable to move extremity.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Extreme pain and rigid neck, numbness and tingling shooting down on right arm where injection was given. Unable to move extremity.
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, X-ray normal
Clinical narrative: ? SIRVA. Chronic pain/soreness at injection site. Tried NAPROSYN and meloxicam with no relief. Pain has persisted > 6 months.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site swelling
Clinical narrative: Patient experienced swelling in elbow and shoulder joint of left arm.  Patient also reported having chills.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-APR-2017, the patient was vaccinated with an expired dose of VAQTA (formulation, dose, frequency, route of administration and anatomical location of administration were not reported) lot # L031196, expiration date 20-MAR-2017, for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 21 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml (frequency, route of administration and anatomical location of administration were not reported) lot # M039202, expiration date 11-MAR-2018, for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a a medical assistant refers to a 5 year old patient of an unknown gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II, recombinant human albumin (rHA), lot# M001200, expiration date: 28-AUG-2016 subcutaneusly. The sterile diluent used for reconstitution was not expired. The patient experienced no adverse reactions. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA000210:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a a medical assistant refers to a 4 year old patient of an unknown gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 27-APR-2017, the patient was vaccinated with an expired dose of M-M-R II recombinant human albumin (rHA), lot# M001200, expiration date 28-AUG-2016, subcutaneously. The sterile diluent used for reconstitution was not expired. The patient experienced no adverse reactions. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000202:
Age: 0.5
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 22-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 13 weeks old patient of unknown gender. Om 26-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916:
Age: 0.58
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No symptoms reported; Patient received improperly stored vaccine (RECOMBIVAX); This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 7 months old patient of unknown gender. Om 23-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 29-AUG-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 8 weeks old patient of unknown gender. On 29-AUG-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 29-AUG-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:Original Case : 1608USA012794.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to unspecified 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 ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 4 months old patient of unknown gender. On 08-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794: