chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Olfactory test abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 34/40 which was not suggestive of malingering (<6). The patient was diagnosed with mild mircosmia (20th percentile). The PEA (phenyl ethyl alcohol) test scores were -5.25 left, -5.75 right and -5.70 bilateral. The Whole-Mouth test identification test score was 73% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness, Laboratory test, Malaise, Microsomia, Olfactory test abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 34/40 which was not suggestive of malingering (<6). The patient was diagnosed with mild mircosmia (20th percentile). The PEA (phenyl ethyl alcohol) test scores were -5.25 left, -5.75 right and -5.70 bilateral. The Whole-Mouth test identification test score was 73% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Parosmia, Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 34/40 which was not suggestive of malingering (<6). The patient was diagnosed with mild mircosmia (20th percentile). The PEA (phenyl ethyl alcohol) test scores were -5.25 left, -5.75 right and -5.70 bilateral. The Whole-Mouth test identification test score was 73% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hyposmia, Influenza like illness, Laboratory test, Malaise, Olfactory test abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 23/40 which was not suggestive of malingering (<6). The patient was diagnosed with severe mircosmia (5th percentile). The PEA (phenyl ethyl alcohol) test scores were -6.38 left, -5.50 right and -6.00 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 23/40 which was not suggestive of malingering (<6). The patient was diagnosed with severe mircosmia (5th percentile). The PEA (phenyl ethyl alcohol) test scores were -6.38 left, -5.50 right and -6.00 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anosmia, Influenza like illness, Laboratory test, Malaise, Microsomia
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 23/40 which was not suggestive of malingering (<6). The patient was diagnosed with severe mircosmia (5th percentile). The PEA (phenyl ethyl alcohol) test scores were -6.38 left, -5.50 right and -6.00 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Olfactory test abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 48 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 23/40 which was not suggestive of malingering (<6). The patient was diagnosed with severe mircosmia (5th percentile). The PEA (phenyl ethyl alcohol) test scores were -6.38 left, -5.50 right and -6.00 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Blood ethanol, Hyposmia, Influenza like illness, Malaise, Olfactory test abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 44 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 16/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -5.36 left, -3.31 right and -5.10 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that the smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 44 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 16/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -5.36 left, -3.31 right and -5.10 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that the smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Anosmia, Influenza like illness, Laboratory test abnormal, Malaise, Olfactory test abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 15 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 18/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -2.00 left, -2.75 right and -2.75 bilateral. The Whole-Mouth test identification test score was 98% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 15 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 18/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -2.00 left, -2.75 right and -2.75 bilateral. The Whole-Mouth test identification test score was 98% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Muscle atrophy
Clinical narrative: Information has been received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose, strength and route unknown). On an unknown date after the vaccination the patient experienced muscle atrophy. The field representative did not know whether the patient received GARDASIL or GARDASIL 9 therefore the event was being taken for GARDASIL. The field representative also reported that the physician said it was debilitating and that the patient used to be a swimmer, and he/she guessed the patient didn't or couldn't swim anymore so the field representative would consider that there was significant disability/incapacity. The outcome of the event was unknown. The reporter considered muscle atrophy was attributed to GARDASIL. Additional information is not expected as the physician refused to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a company representative who was informed by a physician regarding 12 unspecified patients. Concurrent conditions, medical history and concomitant medications were not provided. An unspecified neurologist informed the physician that 12 different unspecified patients developed Postural Orthostatic Tachycardia Syndrome or seizures within six months of receiving GARDASIL (dose, route, vaccination site, #lot unspecified). No further information was provided. Product quality complaint (PQC) was not reported. The outcome of the events and causality was not reported. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 5 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: RV5, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 4 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 years ols female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 9 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. Additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MA-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 24 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dos and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 7 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 2 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: RV5, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: M
Vaccine: RV5, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 10 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 18 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.9
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 1.4
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # K026246, expiration date 28-JAN-2017, dose, frequency and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 23 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 12-MAR-2010 the patient was vaccinated with the first dose of VAQTA (25/0.5 (united unspecified); lot#, dosage, frequency and route unspecified). On 03-AUG-2010, a second dose of VAQTA (25/0.5 (unit unspecified); lot#, dosage, frequency and route unspecified) was administered (inappropriate schedule of vaccine administration). No adverse events were reported. Additional information has been requested.