chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB single dose (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 12-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2007). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient reports left upper is puffy, red and sore. Reports that area of concern was the size of a quarter 7/14/15, but today is the size of a fifty cent piece &/15/15). Reports "has to be MMR or varicella because it was once given at 45 degree angle").
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 13-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On 12-MAY-2015, 13-MAY-2015, 18-MAY-2015, 27-MAY-2015 and 9-JUN-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 16-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 23-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 10-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2007). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report was received from a consumer refers to her daughter, a currently 17 year old female patient with hay fever. There was not pertinent medical history. On 25-JUN-2015, the patient was vaccinated with the first dose of GARDASIL, (dosage, route, lot# and expiration date were not reported). There were not concomitant therapy. The patient's mother reported that on an unknown date her daughter was pregnant after received GARDASIL. At the time of this report there were not laboratory diagnostic studies performed and the patient did not seek medical attention. The patient's mother explained that her daughter would be seen by her physician on an unspecified date. The last menstrual period (LMP) at the estimated date of delivery (EDD) were not reported. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-MAR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # H020901, expiration date: 05-JUL-2015), dose and route were not reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a male patient of unknown age. Concurrent conditions, pertinent medical history, drug reactions or allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date the patient experienced bumps/spots on his arm that then traveled to the other arm. Treatment given for the adverse event and laboratory diagnostic studies performed were unspecified. It was unknown if the patient sought medical attention. The outcome of mass was reported as resolved on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of VARIVAX (Merck) (lot numbers and expirations dates were reported as "L001324" exp. "13-JAN-2017" and lot # "L004651" exp. "11-FEB-2017") (route and doses were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # reported as "L008355" with expiration date on "09-SEP-2016"), (route and doses were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX, HPVX, MEN
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Dysgeusia, Flushing
Clinical narrative: This spontaneous report as received from an unknown source refers to an 12 year old female patient. The patient's medical history included vaccination with DTAP (unspecified), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), influenza virus vaccine (unspecified), M-M-R vaccine, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and varicella virus vaccine (unspecified). On 02-DEC-2014, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) vaccine (manufacturer unknown) (dose, anatomical location and lot# was not reported), influenza virus vaccine (unspecified) (4th dose, dose, anatomical location and lot# was not reported), meningococcal vaccine (unspecified) (1st dose, dose, anatomical location and lot# was not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (1st dose, dose, anatomical location and lot# was not reported). On an unknown date the patient experienced lethargy, fever like symptoms (chills, flushed face but temperature equal to 1 degree lower than 97, absence seizures, tendon aches, headache, stomach ache, nausea, leg numbness from knee to down, tingling, sore throat (with a taste of blood) and itchy/tingly skin. The outcome the events was unknown. The causal relationship between the events and the suspect therapies was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX, HPVX, MEN
Symptoms: Headache, Hypoaesthesia, Lethargy, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from an unknown source refers to an 12 year old female patient. The patient's medical history included vaccination with DTAP (unspecified), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), influenza virus vaccine (unspecified), M-M-R vaccine, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and varicella virus vaccine (unspecified). On 02-DEC-2014, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) vaccine (manufacturer unknown) (dose, anatomical location and lot# was not reported), influenza virus vaccine (unspecified) (4th dose, dose, anatomical location and lot# was not reported), meningococcal vaccine (unspecified) (1st dose, dose, anatomical location and lot# was not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (1st dose, dose, anatomical location and lot# was not reported). On an unknown date the patient experienced lethargy, fever like symptoms (chills, flushed face but temperature equal to 1 degree lower than 97, absence seizures, tendon aches, headache, stomach ache, nausea, leg numbness from knee to down, tingling, sore throat (with a taste of blood) and itchy/tingly skin. The outcome the events was unknown. The causal relationship between the events and the suspect therapies was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX, HPVX, MEN
Symptoms: Paraesthesia, Petit mal epilepsy, Pruritus, Tendon pain
Clinical narrative: This spontaneous report as received from an unknown source refers to an 12 year old female patient. The patient's medical history included vaccination with DTAP (unspecified), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), influenza virus vaccine (unspecified), M-M-R vaccine, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and varicella virus vaccine (unspecified). On 02-DEC-2014, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) vaccine (manufacturer unknown) (dose, anatomical location and lot# was not reported), influenza virus vaccine (unspecified) (4th dose, dose, anatomical location and lot# was not reported), meningococcal vaccine (unspecified) (1st dose, dose, anatomical location and lot# was not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (1st dose, dose, anatomical location and lot# was not reported). On an unknown date the patient experienced lethargy, fever like symptoms (chills, flushed face but temperature equal to 1 degree lower than 97, absence seizures, tendon aches, headache, stomach ache, nausea, leg numbness from knee to down, tingling, sore throat (with a taste of blood) and itchy/tingly skin. The outcome the events was unknown. The causal relationship between the events and the suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL Single-Dose (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of ROTATEQ (dose and lot # not reported) orally that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of PEDVAXHIB (dose, route and lot # not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was administered with GARDASIL 9 (strength, dose, route and lot number unspecified), which underwent a supported temperature excursion. No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a licensed vocational nurse via a company representative concerning a female patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with the second dose of GARDASIL (strength, dose, frequency, lot number and expiration date were unspecified). The patient immediately fainted after vaccination. Treatment was not given for the faint. On an unknown date, the patient recovered from faint. At the time of reporting, the causality between faint and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with VAQTA (strength, dose, route and lot number unspecified), which underwent a supported temperature excursion. No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients might have received doses of GARDASIL (dose, route and lot # not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to an 8 year old male patient. The patient's concurrent conditions and medical history were not reported. On 07-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (Lot #, expiration date, dose and route were not provided). Concomitant therapies included DURA-TAP/PD and MENVEO. The reporter stated that at the age that the patient was vaccinated was other than indicated in the prescribing information. It was also reported that no treatment was given. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were inadvertently administered RECOMBIVAX HB (lot#, dose, route not reported, strength 5/0.5 mcg/ml) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient. There are no pertinent medical history and drug reactions/allergies reported for the patient. On 08-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown), lot # L000449, expiration date 08-MAR-2016, subcutaneously in the right arm and a dose of PNEUMOVAX 23 (dose, lot# and expiration date were unknown) intramuscularly in the left arm. There is not concomitant drug. On 08-JUL-2015, the patient developed warmth, redness, and swelling at the injection site of the ZOSTAVAX in the right arm. The patient did not develop an adverse reaction at the injection site of the PNEUOMVAX 23. The patient came to pharmacy for medical attention. The pharmacist suggested the patient apply ice packs to the area of reaction in right arm and the patient followed the advice. No lab diagnostics studies was performed. At the time of reporting, the patient was not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route and lot number unspecified), which underwent a supported temperature excursion. No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown gender and age. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. On unknown dates the patients experienced injection site reaction. At the time of reporting, the outcome of injection site reaction and the causality were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Protein total normal
Clinical narrative: Initial unsolicited report received from literature on 7 July 2015. Abstract: Blastic plasmacytoid dendritic cell neoplasms (BPDN) are exceeding rare T-cell neoplasms that carry a dismal prognosis. Today, the exact etiology of the disease is unclear, and to our knowledge, no cases of BPDN have been reported at the site of vaccination injection. Additionally, all currently described cases described have dismal prognosis, and, to our knowledge, there are no reports of such lesions responding to topical steroid treatment. Herein, we present an unusual case of BPDN occurring at an influenza vaccination site that subsequently resolved after high-potency topical steroid treatment. A 71-year-old male patient, with no significant medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On an unspecified date, seven days after vaccination, the patient presented with a 5.0 cm nontender, erythematous, and scaling plaque with an indurated border on the left upper arm. The lesion appeared at the site of an influenza vaccination. The patient denied systemic symptoms and any such reaction with previous vaccinations in the past. A topical high-potency steroid, diflorasone diacetate 0.05 percent, was prescribed and radiation therapy was delivered at the site as corrective treatment. The laboratory investigation was reported as biopsy found an atypical dense lymphoid infiltrate in the papillary and reticular dermis. A grenz zone was present. The infiltrate shows prominent perivascular distribution. The individual lymphocytes had hyperchromatic nuclei with irregular nuclear contour and nucleoli crush artefact was present at the periphery of the biopsy section. Immuno histochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesion cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD791 B Cells. Tests for myeloperoxidase, CD34, MUM1, PAX5, CD3, CD10, CD21, kappa, and lambda were negative. Epstein Barr virus in situ hybridization results were also negative. In addition to these markers, an outside hospital found that our lesion was TCL11 and CD117 and muramidase negative. After histologic and immune profiling of CD4, CD56, TCL1, and CD123, a diagnosis of BPDN was rendered. Differential diagnosis included extramedullary myeloid sarcoma and an acute leukemia with ambiguous lineage. Absence of myeloperoxidase excluded myeloid sarcoma, and absence of CD34, myeloperoxidase, CD117, and muramidase ruled out acute leukemia. This diagnosis was confirmed by a senior hematopathologist and at major cancer center. At the time of this report outcome of the event was recovered on an unspecified date. Upon medical review, the case was considered as serious due to important medical event: Blastic Plasmacytoid Dendritic Neoplasm (BPDN). Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site reaction, Light chain analysis normal, Skin lesion
Clinical narrative: Initial unsolicited report received from literature on 7 July 2015. Abstract: Blastic plasmacytoid dendritic cell neoplasms (BPDN) are exceeding rare T-cell neoplasms that carry a dismal prognosis. Today, the exact etiology of the disease is unclear, and to our knowledge, no cases of BPDN have been reported at the site of vaccination injection. Additionally, all currently described cases described have dismal prognosis, and, to our knowledge, there are no reports of such lesions responding to topical steroid treatment. Herein, we present an unusual case of BPDN occurring at an influenza vaccination site that subsequently resolved after high-potency topical steroid treatment. A 71-year-old male patient, with no significant medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On an unspecified date, seven days after vaccination, the patient presented with a 5.0 cm nontender, erythematous, and scaling plaque with an indurated border on the left upper arm. The lesion appeared at the site of an influenza vaccination. The patient denied systemic symptoms and any such reaction with previous vaccinations in the past. A topical high-potency steroid, diflorasone diacetate 0.05 percent, was prescribed and radiation therapy was delivered at the site as corrective treatment. The laboratory investigation was reported as biopsy found an atypical dense lymphoid infiltrate in the papillary and reticular dermis. A grenz zone was present. The infiltrate shows prominent perivascular distribution. The individual lymphocytes had hyperchromatic nuclei with irregular nuclear contour and nucleoli crush artefact was present at the periphery of the biopsy section. Immuno histochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesion cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD791 B Cells. Tests for myeloperoxidase, CD34, MUM1, PAX5, CD3, CD10, CD21, kappa, and lambda were negative. Epstein Barr virus in situ hybridization results were also negative. In addition to these markers, an outside hospital found that our lesion was TCL11 and CD117 and muramidase negative. After histologic and immune profiling of CD4, CD56, TCL1, and CD123, a diagnosis of BPDN was rendered. Differential diagnosis included extramedullary myeloid sarcoma and an acute leukemia with ambiguous lineage. Absence of myeloperoxidase excluded myeloid sarcoma, and absence of CD34, myeloperoxidase, CD117, and muramidase ruled out acute leukemia. This diagnosis was confirmed by a senior hematopathologist and at major cancer center. At the time of this report outcome of the event was recovered on an unspecified date. Upon medical review, the case was considered as serious due to important medical event: Blastic Plasmacytoid Dendritic Neoplasm (BPDN). Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Laboratory test abnormal, Light chain analysis normal, Skin lesion, Vaccination site reaction
Clinical narrative: Initial unsolicited report received from literature on 7 July 2015. Abstract: Blastic plasmacytoid dendritic cell neoplasms (BPDN) are exceeding rare T-cell neoplasms that carry a dismal prognosis. Today, the exact etiology of the disease is unclear, and to our knowledge, no cases of BPDN have been reported at the site of vaccination injection. Additionally, all currently described cases described have dismal prognosis, and, to our knowledge, there are no reports of such lesions responding to topical steroid treatment. Herein, we present an unusual case of BPDN occurring at an influenza vaccination site that subsequently resolved after high-potency topical steroid treatment. A 71-year-old male patient, with no significant medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On an unspecified date, seven days after vaccination, the patient presented with a 5.0 cm nontender, erythematous, and scaling plaque with an indurated border on the left upper arm. The lesion appeared at the site of an influenza vaccination. The patient denied systemic symptoms and any such reaction with previous vaccinations in the past. A topical high-potency steroid, diflorasone diacetate 0.05 percent, was prescribed and radiation therapy was delivered at the site as corrective treatment. The laboratory investigation was reported as biopsy found an atypical dense lymphoid infiltrate in the papillary and reticular dermis. A grenz zone was present. The infiltrate shows prominent perivascular distribution. The individual lymphocytes had hyperchromatic nuclei with irregular nuclear contour and nucleoli crush artefact was present at the periphery of the biopsy section. Immuno histochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesion cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD791 B Cells. Tests for myeloperoxidase, CD34, MUM1, PAX5, CD3, CD10, CD21, kappa, and lambda were negative. Epstein Barr virus in situ hybridization results were also negative. In addition to these markers, an outside hospital found that our lesion was TCL11 and CD117 and muramidase negative. After histologic and immune profiling of CD4, CD56, TCL1, and CD123, a diagnosis of BPDN was rendered. Differential diagnosis included extramedullary myeloid sarcoma and an acute leukemia with ambiguous lineage. Absence of myeloperoxidase excluded myeloid sarcoma, and absence of CD34, myeloperoxidase, CD117, and muramidase ruled out acute leukemia. This diagnosis was confirmed by a senior hematopathologist and at major cancer center. At the time of this report outcome of the event was recovered on an unspecified date. Upon medical review, the case was considered as serious due to important medical event: Blastic Plasmacytoid Dendritic Neoplasm (BPDN). Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Laboratory test normal, Light chain analysis normal, Skin exfoliation, Skin lesion
Clinical narrative: Initial unsolicited report received from literature on 7 July 2015. Abstract: Blastic plasmacytoid dendritic cell neoplasms (BPDN) are exceeding rare T-cell neoplasms that carry a dismal prognosis. Today, the exact etiology of the disease is unclear, and to our knowledge, no cases of BPDN have been reported at the site of vaccination injection. Additionally, all currently described cases described have dismal prognosis, and, to our knowledge, there are no reports of such lesions responding to topical steroid treatment. Herein, we present an unusual case of BPDN occurring at an influenza vaccination site that subsequently resolved after high-potency topical steroid treatment. A 71-year-old male patient, with no significant medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On an unspecified date, seven days after vaccination, the patient presented with a 5.0 cm nontender, erythematous, and scaling plaque with an indurated border on the left upper arm. The lesion appeared at the site of an influenza vaccination. The patient denied systemic symptoms and any such reaction with previous vaccinations in the past. A topical high-potency steroid, diflorasone diacetate 0.05 percent, was prescribed and radiation therapy was delivered at the site as corrective treatment. The laboratory investigation was reported as biopsy found an atypical dense lymphoid infiltrate in the papillary and reticular dermis. A grenz zone was present. The infiltrate shows prominent perivascular distribution. The individual lymphocytes had hyperchromatic nuclei with irregular nuclear contour and nucleoli crush artefact was present at the periphery of the biopsy section. Immuno histochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesion cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD791 B Cells. Tests for myeloperoxidase, CD34, MUM1, PAX5, CD3, CD10, CD21, kappa, and lambda were negative. Epstein Barr virus in situ hybridization results were also negative. In addition to these markers, an outside hospital found that our lesion was TCL11 and CD117 and muramidase negative. After histologic and immune profiling of CD4, CD56, TCL1, and CD123, a diagnosis of BPDN was rendered. Differential diagnosis included extramedullary myeloid sarcoma and an acute leukemia with ambiguous lineage. Absence of myeloperoxidase excluded myeloid sarcoma, and absence of CD34, myeloperoxidase, CD117, and muramidase ruled out acute leukemia. This diagnosis was confirmed by a senior hematopathologist and at major cancer center. At the time of this report outcome of the event was recovered on an unspecified date. Upon medical review, the case was considered as serious due to important medical event: Blastic Plasmacytoid Dendritic Neoplasm (BPDN). Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Mom presented to clinic with reddened area approximatrely one inch below the injection site, smaller than the size of the patien's palm.  The area was marked with a marker and mom instructed to bring the patient back if the size increased or if swelling/pain occurred.  Mom returned to the clinic today (7/16/15) and the area inside the marked boundary was discolored, but not red.  The reddened area spread outside the marked area with warmth that was not noted yesterday. Pt denies pain or discomfort. The patient was assessed by the pediatrician who treated the patient for cellulitis.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of GARDASIL (Lot # K011325, expiration date 08-APR-2017 and; Lot # K009482, expiration date 06-MAR-2017) (doses and route were not specified), which were exposed to temperatures outside of the recommended range on 16-JUN-2015. No concomitant medications were reported. No adverse experience has been observed or reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 that were exposed to temperatures outside of the recommended range during an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K00, expiration date 17-NOV-2016). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 24-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of GARDASIL lot # K006960 that was exposed to temperatures outside of the recommended range during an unknown number of hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 24-APR-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 24 years old male patient. No information on patient's medical history, concurrent conditions or concomitant medication was provided. On an unknown dates (reported as "as a child"), the patient was vaccinated with undocumented, unspecified doses of M-M-R II (strength, dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient performed unspecified blood test with the result of negative titers. The outcome of negative titers and the causality between negative titers and M-M-R II were not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abnormal behaviour, Cough, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: Immediately after HPV-9 inj. developed runny nose, went with family to lunch approx 20 min later developed dry cough/tickle to the back of throat lasting approx 45 min, no issues with breathing, sob, swelling of lips, nose, mouth, tongue, eyes, nose, throat.  Ate lunch and went home approx 1 1/2 hrs after vaccine told mom he just didn't feel well, felt 'shaky on the inside', HA, clingy, requesting mom to lay down with him/sitting on mom's lap-totally out of character for patient.  Mom phoned to report this concerns, discussed with Dr. requested pt be brought for evaluation.  Pt seen by Dr. currently stable with only c/o of HA, foggy headedness, sniffles, and some nausea.  Instructed to take Benadryl every 4-6 hrs X24 hrs, return in the am if still foggy headed or no improvement. If new/worse or further concerns bring to ER STAT.  Family voiced understanding. Stable at d/c 5:30pm.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Malaise, Nausea, Nervousness, Rhinorrhoea, Throat irritation
Clinical narrative: Immediately after HPV-9 inj. developed runny nose, went with family to lunch approx 20 min later developed dry cough/tickle to the back of throat lasting approx 45 min, no issues with breathing, sob, swelling of lips, nose, mouth, tongue, eyes, nose, throat.  Ate lunch and went home approx 1 1/2 hrs after vaccine told mom he just didn't feel well, felt 'shaky on the inside', HA, clingy, requesting mom to lay down with him/sitting on mom's lap-totally out of character for patient.  Mom phoned to report this concerns, discussed with Dr. requested pt be brought for evaluation.  Pt seen by Dr. currently stable with only c/o of HA, foggy headedness, sniffles, and some nausea.  Instructed to take Benadryl every 4-6 hrs X24 hrs, return in the am if still foggy headed or no improvement. If new/worse or further concerns bring to ER STAT.  Family voiced understanding. Stable at d/c 5:30pm.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever spiked while sleeping and he had a febrile seizure lasting for about one minute.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse regarding multiple different unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (dose strength, route and lot was unknown). No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with ROTATEQ (strength, dose and lot number unspecified) orally, which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was vaccinated with the first dose of ZOSTAVAX (strength, lot#, expiration date, dose and route were unknown). On approximately 10-JUL-2015 (reported as "about 40 days" after the first dose), the patient was inadvertently administered a second dose of ZOSTAVAX (strength, lot#, expiration date, dose and route were unknown). No adverse effects were reported. Follow up information has been received from the registered nurse on 13-JUL-2015. The registered nurse reported that the patient had not been administered a second dose of ZOSTAVAX "about 40 days" after the first dose. The patient had not been administered any doses of ZOSTAVAX on 01-JUN-2015 or 10-JUL-2015. The patient had been administered the first and second doses of RECOMBIVAX HB (strength, lot#, expiration date, dose and route were unknown) on 01-JUN-2015 and on 10-JUL-2015, respectively. The second dose of RECOMBIVAX HB was administered more than one month after the first dose. There was no product quality complaint (PQC). Additional information has been requested. Product information, event information and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. No pertinent medical history or drug reaction/allergies was reported. On unknown dates since 07-MAY-2015 the patients were vaccinated with VARIVAX (Merck) (lot# L006386, expired date 25-FEB-2017; lot# L000454, expired date 06-JAN-2017, lot# K020760, expired date 31-OCT-2016; lot# K016128, expired date 23-SEP-2016). These vaccines were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. No pertinent medical history or drug reaction/allergies was reported. On unknown dates since 07-MAY-2015 the patients were vaccinated with PROQUAD (Merck) (lot# L003222, expired date 30-JUL-2016; lot# K023861, expired date 25-MAY-2016, lot# L009209, expired date 17-SEP-2016, dose, frequency were unknown). These vaccines were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. on an unknown date the patient was vaccinated with ROTATEQ (strength, dose and lot number unspecified) orally, which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Information has been received from a pharmacist via company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX to prevent shingles. Concomitant therapies included unspecified influenza virus vaccine. On an unknown date the patient experienced Bells Palsy. The outcome of Bells Palsy was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB (strength, dose, route and lot number unspecified) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.