chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: F
Vaccine: MMR, MMR
Symptoms: Allergy test, Urticaria, Vomiting projectile
Clinical narrative: Within 5 minutes of receiving the vaccine, before I'd made it up the street, and barely out of the parking lot, my daughter projectile vomited 4 to 5 times in the car while I was driving. After then vomiting three more instances (with about an hour to hour and a half in between), she then developed hives on her face and neck. The hives came and went in the next few days regularly. They have ceased for the time being while we are using an antihistamine to keep them at bay.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Generalised tonic-clonic seizure, Laboratory test, Lumbar puncture, Resuscitation
Clinical narrative: Fever and generalized tonic-clonic seizures the evening following immunizations.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: X-ray
Clinical narrative: Fever and generalized tonic-clonic seizures the evening following immunizations.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Fever and generalized tonic-clonic seizures the evening following immunizations.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Burning sensation, Computerised tomogram head normal, Pain in extremity, Scan with contrast
Clinical narrative: I had a bad reaction to the flu shot that was given to me at the hospital. I was doing a work program and was required to get a flu shot I was told. I got it on November 28th on Monday and started to feel pain in my hands and feet on Tuesday. Wednesday my mom took me to the doctor at that point my feet were swollen and were burning terribly. The doctor told me it could be GBS and that sometimes people get this from a bad reaction to the flu shot. I was taken 3 times to the ER room, 2 neurologists and a rheumatologist. I'm currently on steroids and pain killers. I had to purchase a wheelchair because I could not walk and I'm seeking some help to come and stay with me while my parents are at work. I had to have a CT scan of my brain and bloodwork. I'm slowly recovering from this terrible ordeal that I have had to endure because of the flu shot. My life has been put on hold since because my hands are better but my feet have not recovered fully. I can't walk very well and have not been out only for doctors appointments.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Abasia, Activities of daily living impaired, Blood test, Burning sensation, Computerised tomogram head
Clinical narrative: I had a bad reaction to the flu shot that was given to me at the hospital. I was doing a work program and was required to get a flu shot I was told. I got it on November 28th on Monday and started to feel pain in my hands and feet on Tuesday. Wednesday my mom took me to the doctor at that point my feet were swollen and were burning terribly. The doctor told me it could be GBS and that sometimes people get this from a bad reaction to the flu shot. I was taken 3 times to the ER room, 2 neurologists and a rheumatologist. I'm currently on steroids and pain killers. I had to purchase a wheelchair because I could not walk and I'm seeking some help to come and stay with me while my parents are at work. I had to have a CT scan of my brain and bloodwork. I'm slowly recovering from this terrible ordeal that I have had to endure because of the flu shot. My life has been put on hold since because my hands are better but my feet have not recovered fully. I can't walk very well and have not been out only for doctors appointments.
Age: 22.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity, Peripheral swelling, Vaccination complication, Wheelchair user
Clinical narrative: I had a bad reaction to the flu shot that was given to me at the hospital. I was doing a work program and was required to get a flu shot I was told. I got it on November 28th on Monday and started to feel pain in my hands and feet on Tuesday. Wednesday my mom took me to the doctor at that point my feet were swollen and were burning terribly. The doctor told me it could be GBS and that sometimes people get this from a bad reaction to the flu shot. I was taken 3 times to the ER room, 2 neurologists and a rheumatologist. I'm currently on steroids and pain killers. I had to purchase a wheelchair because I could not walk and I'm seeking some help to come and stay with me while my parents are at work. I had to have a CT scan of my brain and bloodwork. I'm slowly recovering from this terrible ordeal that I have had to endure because of the flu shot. My life has been put on hold since because my hands are better but my feet have not recovered fully. I can't walk very well and have not been out only for doctors appointments.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This solicited report was received from a 66 year old male patient referring to himself enrolled in a Market Research Program. The patient's concurrent conditions included diabetes and high blood pressure. Concomitant therapies were not reported. On an unspecified date in September 2016, reported as Fall 2016, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the arm (unspecified) (dose, route of administration, lot number and expiration date were not provided) for pneumonia. In Fall 2016, the patient experienced a little bit of swelling in the arm after getting the pneumonia shot (injection site swelling). After 2 days, reported as lasted a day or 2, the patient recovered from injection site swelling. The reporter considered injection site swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Incorrect route of drug administration
Clinical narrative: Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2016 the patient was vaccinated with an expired dose of ZOSTAVAX administered intramuscularly, lot # L036454 and expiration date on 22-DEC-2016 (strength, dose and anatomical location were not reported) for prophylaxis. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, referring to patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date, the patient was vaccinated with a dose of an improperly stored with PROQUAD (route of administration, dose and frequency were not provided) for prophylaxis  lot # M001152, expiration date 05-JUL-2017. The reporter stated that the current temperature range of the vaccine was 15 Fahrenheit (F) and the time frame was 8 hours. On 06-OCT-2016, the previous temperature excursion was 31 Fahrenheit (F) during 3 hours, this information was registered in a data logger. No adverse effect was reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008613.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates since 01-AUG-2016, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K011562 with expiration date 08-APR-2017 for prophylaxis (dose and route were not reported). It was stated that the temperature excursion was between 32 and 36 Fahrenheit degrees for 4 days. No previous temperature excursion was reported. No adverse effect had been reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA004137: US-009507513-1701USA004138.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given. Sender's Comments: US-009507513-1701USA009558: US-009507513-1701USA009559.
Age: 39.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-JAN-2017, the patient was vaccinated with an expired dose of PROQUAD lot # L024125, expiration date on 30-DEC-2016 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 injection (lot# M032650, expiration date 31-MAR-2019 and lot # reported as M021407, expiration date 30-APR-2018) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered : between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA008579: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 3 unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Since 08-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX Lot#: M025870, expiration date on 24-MAY-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 40 minutes: between -15°C (grades Celsius) and -10°C (grades Celsius). The aforementioned ones were identified due to a data logger. There was a previous temperature excursion between -15°C and -10°C for 40 minutes. Furthermore, no product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fatigue, Nasopharyngitis, Respiration abnormal
Clinical narrative: This spontaneous report was received from a 68 year old male consumer referring to himself. The patient's pertinent medical history was not reported. Concurrent conditions included hypertension and diabetes mellitus. Concomitant therapies included high blood pressure and diabetes medication. Drug/allergies reactions included allergy to penicillin (unspecified). On 14-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prevention of pneumonia. On 18-DEC-2016,  the patient experienced cold symptoms (nasopharyngitis), extreme fatigue and severe breathing when walking (respiration abnormal). No treatment was given for the events, no laboratory diagnostics were performed. The patient did not seek medical attention and no product quality complaint was involved. The outcome of nasopharyngitis, fatigue and respiration abnormal was reported as not recovered. The relationship between the aforementioned events and PNEUMOVAX 23 was not established or mentioned by the reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest scan, Dyspnoea, Gait disturbance, Productive cough, Respiratory symptom
Clinical narrative: This spontaneous report was received from a 68 year old male consumer referring to himself. The patient's pertinent medical history was not reported. Concurrent conditions included hypertension and diabetes mellitus. Concomitant therapies included high blood pressure and diabetes medication. Drug/allergies reactions included allergy to penicillin (unspecified). On 14-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, route, lot # and expiration date were not reported) for prevention of pneumonia. On 18-DEC-2016,  the patient experienced cold symptoms (nasopharyngitis), extreme fatigue and severe breathing when walking (respiration abnormal). No treatment was given for the events, no laboratory diagnostics were performed. The patient did not seek medical attention and no product quality complaint was involved. The outcome of nasopharyngitis, fatigue and respiration abnormal was reported as not recovered. The relationship between the aforementioned events and PNEUMOVAX 23 was not established or mentioned by the reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 20 year old male patient. The patient's medical history, concurrent conditions, drug reactions, allergies, and concomitant therapies were not reported. On 05-JAN-2016 (also reported as "one year ago"), the patient was vaccinated with one dose of GARDASIL 9 for the first time, intramuscular, for prophylaxis (lot # and expiration date were unspecified). No adverse effects were reported. The reporter stated that, at the time of reporting, the patient was at the pharmacy to receive the second dose. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unspecified date in January 2017 (reporter as  "from 01-JAN-04-JAN-2017"), the patients were vaccinated with a dose of improperly stored GARDASIL 9 intramuscularly (batch/lot # reported: L040054 with expiration date: 24-DEC-2017; however, dosage number was not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of maximum 1 C (Centigrade) for a time frame of 18 hours. Data logger was involved and there was no previous temperature excursion reported. Furthermore, there was no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient. The patient's historical condition included wrist pain. The patient's had no concomitant medication or drug reaction/allergies. On 07-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot #: M024261 with expiration date 30-JUL-2018 (route was not reported). Then, on 02-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M032650 with expiration date 31-MAR-2019 (route was not reported), both therapies as prophylaxis. On approximately 16-DEC-2016 (reported as "approximately 2 weeks after the vaccine was administered"), the patient had complaint of slight itching (injection site pruritus) with a ring like lesion (injection site reaction). The patient did not receive treatment for the injection site pruritus or the injection site reaction. The outcome of injection site pruritus and injection site reaction was reported as unresolved. There was no product quality complaint (PQC) involved. The reporter did not assess causality between the injection site pruritus, injection site reaction and the use of GARDASIL 9. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 month old male patient with no known drug allergies, gastrooesophageal reflux disease, autism spectrum disorder (ASD), pulmonary valve stenosis and ventricular septal defect (VSD). Concomitant therapies included ZANTAC. On 06-JAN-2017, the patient was vaccinated with a dose of ROTATEQ, oral for prophylaxis (Lot No reported as: M038728; expiration date: 25-APR-2018). The registered nurse reported that on 06-JAN-2017 the patient vomited the dose of ROTATEQ after administration. No further side effects were noted after the incident. There was no treatment given for the event. In January 2017, the patient recovered/resolved from vomiting. There was no product quality complaint involved. The primary reporter did not assess the causality between vomiting and ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unspecified dates, multiple number of patients were vaccinated with doses of improperly stored VARIVAX for prophylaxis, dose, route, anatomical location were not reported (valid lot # M006729, expiration date 8-FEB-2018). No adverse effects reported. The temperature registered was of more than 5° Fahrenheit (F) but less than 14°F with a time frame of 337 hours. No previous temperature excursion was reported. No digital data logger, nor Product Quality Complaint (PQC) were involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA005395.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Deafness unilateral, Gingival pain, Hypoacusis, Noninfective gingivitis
Clinical narrative: This spontaneous report was received from a currently 62-year-old male patient reporting on himself. The patient was thyroid cancer survivor with allergy to regional anesthesia. On 12-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prevention (dose, lot # and expiration date were not reported). Concomitant therapies included mirtazapine (manufacturer unknown), alprazolam and hydrogen peroxide. On an unknown dates, the patient experienced severe gum pain with inflammation, sore throat, crust illusion in his right ear, hearing loss also in the right ear, changing in the hearing in his left ear, and he was also starting to go deaf. The symptoms occurred at different unspecified time. The patient contacted his physician and would meet with her on the reporting day. The patient received unspecified treatment for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient considered the events to be related to ZOSTAVAX as he reported the events as adverse events for ZOSTAVAX. Upon internal review the event of deafness was determined to be medically significant. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Scab
Clinical narrative: This spontaneous report was received from a currently 62-year-old male patient reporting on himself. The patient was thyroid cancer survivor with allergy to regional anesthesia. On 12-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prevention (dose, lot # and expiration date were not reported). Concomitant therapies included mirtazapine (manufacturer unknown), alprazolam and hydrogen peroxide. On an unknown dates, the patient experienced severe gum pain with inflammation, sore throat, crust illusion in his right ear, hearing loss also in the right ear, changing in the hearing in his left ear, and he was also starting to go deaf. The symptoms occurred at different unspecified time. The patient contacted his physician and would meet with her on the reporting day. The patient received unspecified treatment for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient considered the events to be related to ZOSTAVAX as he reported the events as adverse events for ZOSTAVAX. Upon internal review the event of deafness was determined to be medically significant. 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 registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K018986, expiration date: 03-APR-2016; and lot # M001578, expiration date: 21-NOV-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time, data logger was involved . There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007899: US-009507513-1701USA007900.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bladder catheterisation, Muscular weakness, Paraplegia, Urinary retention
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as a nurse prescriber) via a company representative and refers to a 60-year-old female patient. The patient's pertinent medical history included colon cancer (unknown date). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 19-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot # M034765) (dose, route of administration, injection site and expiration date were not provided). On 21-DEC-2016, the patient complained of "weakness in the lower extremity - paraplegia and urinary retention, which required self catheterization". On the same day, she was hospitalized for these symptoms and discharged on 22-DEC-2016. The outcome of paraplegia was reported as recovered/resolved on an unknown date, as the patient's sensation in the lower extremities was restored and she was using her walker (which she had used prior to this incident). The outcome of urinary retention was not reported. The relatedness between the events of paraplegia and urinary retention and ZOSTAVAX was not provided. Upon internal review, the events of paraplegia and urinary retention were considered to be medically significant. 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 registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, since 15-DEC-2016, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M017348, expiration date: 06-APR-2018; lot # reported as M035144, and expiration date: 30-JAN-2018; lot # M026879, expiration date: 27-NOV-2017; lot # M017334 and expiration date: 05-OCT-2017 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >5 °F to <14°F, for a time frame of 50 minutes and >14 °F to <46°F, for a time frame of 5 hours, the cumulative time frame was 5 hours and 50 minutes. There were no previous temperature excursions. The call was  because of a data logger (reported as log tag in use). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003204.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # K016966, expiration date: 10-MAY-2017 and lot # L040460, expiration date: 27-MAY-2017 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time; data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006775: US-009507513-1701USA007900.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042257, expiration date: 17-AUG-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time; data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006775: US-009507513-1701USA007899.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 07-DEC-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 1.5
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150: US-009507513-1701USA007922: Original Case : 1701USA007906: US-009507513-1701USA007881: Original Case : 1701USA007910: US-009507513-1701USA007913: Original Case : 1701USA007910: US-009507513-1701USA007882: Original Case : 1701USA007910: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly stored dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150: US-009507513-1701USA007912: Original Case : 1701USA007906: US-009507513-1701USA007922: Original Case : 1701USA007910: US-009507513-1701USA007881: Original Case : 1701USA007910: US-009507513-1701USA007882: Original Case : 1701USA007910: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 1.17
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case: 1701USA004150; US-009507513-1701USA007912: Original Case: 1701USA007906; US-009507513-1701USA007922: Original Case: 1701USA007910; US-009507513-1701USA007881: Original Case: 1701USA007910; US-009507513-1701USA007913: Original Case: 1701USA007910; US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 1.42
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was also vaccinated with improperly stored doses of  MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) and VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for the same indication. The vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: Original Case : 1701USA007910 US-009507513-1701USA007881: Original Case : 1701USA007910 US-009507513-1701USA007913: Original Case : 1701USA007910 US-009507513-1701USA007882: Original Case : 1701USA007916 US-009507513-1701USA004150: Original Case : 1701USA007916 US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007848: US-009507513-1701USA007849:
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was vaccinated with an improperly dose of MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for the same indication. Both vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912:Original Case : 1701USA007906; US-009507513-1701USA007922:Original Case : 1701USA007910; US-009507513-1701USA007881:Original Case : 1701USA007910; US-009507513-1701USA007913:Original Case : 1701USA007910; US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot numbers M018957, expiration date 22-NOV-2017; M018958, expiration date 03-MAR-2018; M035455, expiration date 22-APR-2018) for prophylaxis. The temperature was between 0°C and 2°C, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions:  1. between 0°C and 2°C for 32 hours; 2. between 0°C and 2°C  for 30 hours; 3. between 0°C and 2°C for 29 hours; 4. between 0°C and 2°C for 36 hours. Data logger was reported as yes. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA008609: Original Case : 1701USA008041 US-009507513-1701USA008611: Original Case : 1701USA008041 US-009507513-1701USA008608: Original Case : 1701USA008041 US-009507513-1701USA008610: Original Case : 1701USA008041
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered nurse concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 05-FEB-2015, the patient was vaccinated with GARDASIL intramuscularly (lot number K006960, dose and expiration date were not reported), and on 23-JAN-2016, the patient was vaccinated with GARDASIL 9 (lot number L027282, dose, route and expiration date were not reported) (inappropriate schedule of vaccine administered). No adverse effects reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Bursitis
Clinical narrative: Information has been received from a nurse via Pfizer (manufacturer control number# 2017001485) referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number not provided) for prophylaxis. On an unknown date, the patient experienced severe bursitis after PNEUMOVAX 23. The outcome of bursitis was unknown. The causality between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.