chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a health professional (medical assistant) refers to unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/ allergies of the patients were unspecified. Reporting medical assistant stated that on an unknown date, an unspecified number of doses of GARDASIL (lot # K006960, expiry date: 19-FEB-2017; lot # K008931; expiry date: 04-MAR-2017) and/or ROTATEQ (lot # K015816, expiry date: 29-MAY-2016; lot # K005273, expiry date: 23-FEB-2016) were administered to these patients. Concomitant medications were not reported. No adverse experiences were reported. This is one of the two reports received from the same source (MARRS # 1506USA012861). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a health professional (medical assistant) refers to unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies of the patients were unspecified. Reporting medical assistant stated that on an unknown date, an unspecified number of doses of oral, ROTATEQ (lot # K025816, expiry date: 29-MAY-2016; lot # K005273, expiry date: 23-FEB-2016) and/or GARDASIL (lot # K006960, expiry date: 19-FEB=2017; lot # K008931; expiry date: 04-MAR-2017) were administered to these patients. Concomitant medications were not reported. No adverse experiences were reported. This is one of the two reports received from the same source (MARRS # 1507USA002313). Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old female patient. The patient did not have any drug reactions and allergies. On 30-JUN-2015, the patient was vaccinated with the first dose of VARIVAX (Merck) Lot# L004650, expiry date: 11-FEB-2017 (dose and route were not reported) and the first dose of M-M-R II Lot# L004658, expiry date: 05-FEB-2017 (dose and route were not reported). The patient did not take any concomitant medication. On 30-JUN-2015, less than a minute after vaccines administration, the patient experienced seizure. She was administered an oxygen and was taken by ambulance to the hospital. The patient was admitted to the hospital on 30-JUN-2015 and still remained there at the time of this report. The outcome of seizure was reported as recovering. Causality assessment was not provided. The reporting nurse considered the seizure as life threatening, disabling and medically significant as it required oxygen administration. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age. Patients' drug reaction and medical history were not reported. On an unknown date the patients experienced doses of ROTATEQ (lot # K013868, exp 27-MAY-2016; lot # K020182, exp 25-JUN-2016), which has been exposed to temperatures outside of the recommended range. There was no concomitant medication reported. At the time of the report, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a 12-year-old female patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 1 ml. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced injection site hemorrhage, injection site erythema, inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the injection site hemorrhage, injection site erythema, inappropriate age at vaccine administration and accidental overdose were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site erythema to be related to HAVRIX 1440. Additional details were provided as follows: A 12 year-old patient experienced slight bleeding and redness at the injection site after receiving by mistake an adult dose of HAVRIX and led to inappropriate age at vaccine administration and accidental overdose.
Sex: U
Vaccine: HEPA
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 (gender/age unknown). The patient's concurrent/historical conditions or concomitant therapies were not reported. Since 20-APR-2015 the patients were vaccinated with VAQTA (lot # K008254, exp. date 12-NOV-2015) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been 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 was received from a medical assistant referring to an unspecified number of patients. On an unknown date, the patients were vaccinated with VARIVAX (Merck) that were improperly stored (lot  # J009004; Expiration date 19-JUL-2015) (lot # K005176; Expiration date 10-APR-2016) (lot # J009987; Expiration date 12-AUG-2015) (lot # K011799; Expiration date 21-AUG-2016) (lot # K011082; Expiration date 08-AUG-2016) (lot # K016130; Expiration date 23-SEP-2016) (lot # K021936; Expiration date 10-NOV-2016) dose and route of vaccination were unknown. No adverse events reported. This is one of two reports from the same reporter (1507USA001059). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients. On an unknown date, the patients were vaccinated with ZOSTAVAX that was improperly stored (lot# K014835; Expiration date 14-DEC-2015) (lot# K016324; Expiration date 24-DEC-2015) (lot# K018172; Expiration date 02-DEC-2015) (lot# K020186; Expiration date 27-JAN-2016) (lot# K023622; Expiration date 02-FEB-2016) (lot# L000450; Expiration date 09-MAR-2016) (lot# L006379; Expiration date 25-MAY-2016) (lot# L011535; Expiration date 03-JUL-2016) dose and route of vaccination were unknown. No adverse events reported. This is one of two reports from the same reporter (1507USA001144). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient was vaccinated with a dose of PREVNAR 13 instead of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The healthcare provider reported that no adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 71 year old male patient. No pertinent medical history was reported. Approximately on 17-JUN-2015 (reported as 5 days ago) the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). Approximately on June 2015 (also reported as a couple of days later) after the injection, the patient experienced a limited eruption of a varicella like rash that itched in an unspecified area. Patient sought medical attention, saw physician. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of limited eruption of a varicella like rash that itched in an unspecified area was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date were not provided). One year later, on an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not provided). On an unknown date, there was an inappropriate schedule of drug administration as the patient received the first and the second doses of GARDASIL one year apart. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The patient's medical history and concurrent conditions were not reported. On 16-JUN-2015 the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscular, lot # K010465 expiration date 23-MAR-2016. The patient's concomitant therapies were not reported. On approximately on 16-JUN-2015, reported as after receiving the vaccine the patient experienced redness, mild but visible swelling, down to the elbow and soreness at the injection site. The patient sought medical attention by saw the pharmacist and no treatment was given for the adverse events. The reporter stated that the patient was ambulatory, alert and had no fever or systemic complaints. No laboratory diagnostic test were performed. At the time of the report, the outcome of redness, erythema, peripheral swelling and injection site pain was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. 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 Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (dose was not reported), lot # L003774, expiration date 04-FEB-2015. The patient's concomitant therapies were not reported. No adverse effects were reported. Lot number L003774 has been verified to be a valid lot number for VARIVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a female patient of unspecified age (older than 65 years). The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot numbers and expiration date were not provided). No concomitant therapies were reported. On that same date, Three hours after vaccination, the patient called the pharmacist and reported a rash on her knee which the patient thought was spreading. The outcome of rash was unknown at the time of the report. The reporter did not provide a causality assessment for the event. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2015US059969, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 564873) website on 12 May 2015 with a follow up information received from the quality assurance department (QA reference number: 1000418) on 21 May 2015 with a follow up information received from the quality assurance department on 22 Jun 2015. This report refers to a 29 years old female patient. She was vaccinated with FLUVIRIN (batch number: 1414201A) into left arm on an unknown date. Post vaccination, the patient experienced redness and soreness at the site of injection. The patient went to an urgent care center where they said she had cellulitis. Outcome of the events was reported as not recovered. The events were assessed as non-serious, but the event cellulitis was upgraded based on the NVS-IMS list. Causality of the events was not reported. Based on the documents review performed, it was concluded that the FLUVIRIN batch 1414201A was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from the quality assurance department on 21 May 2015: QA reference number updated. Follow up information received from the quality assurance department on 22 Jun 2015: Batch summary updated.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Loss of appetite; swelling and pain for 1 week where shot given mild fever, headache; fatigue; pain for 4 days; weakness, dizziness for over 24 hrs; lack of sleep 2 nights; low energy-2 days unable to walk without falling.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Loss of appetite; swelling and pain for 1 week where shot given mild fever, headache; fatigue; pain for 4 days; weakness, dizziness for over 24 hrs; lack of sleep 2 nights; low energy-2 days unable to walk without falling.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: Loss of appetite; swelling and pain for 1 week where shot given mild fever, headache; fatigue; pain for 4 days; weakness, dizziness for over 24 hrs; lack of sleep 2 nights; low energy-2 days unable to walk without falling.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Headache, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Loss of appetite; swelling and pain for 1 week where shot given mild fever, headache; fatigue; pain for 4 days; weakness, dizziness for over 24 hrs; lack of sleep 2 nights; low energy-2 days unable to walk without falling.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Loss of appetite; swelling and pain for 1 week where shot given mild fever, headache; fatigue; pain for 4 days; weakness, dizziness for over 24 hrs; lack of sleep 2 nights; low energy-2 days unable to walk without falling.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Cold sweat, Excessive eye blinking, Hyperacusis, Insomnia, Muscle contractions involuntary
Clinical narrative: Hyperactivity, agitation occurred from day 1-6 after vaccine, improving with time. Also noted to have possible eye blinking tic following vaccine that has persisted.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Psychomotor hyperactivity, Pyrexia
Clinical narrative: Hyperactivity, agitation occurred from day 1-6 after vaccine, improving with time. Also noted to have possible eye blinking tic following vaccine that has persisted.
Age: 1.92
Sex: M
Vaccine: MMR, MMR
Symptoms: Agitation, Psychomotor hyperactivity, Tic
Clinical narrative: Hyperactivity, agitation occurred from day 1-6 after vaccine, improving with time. Also noted to have possible eye blinking tic following vaccine that has persisted.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection. Visited another facility on 7/4/15, treated with Rocephin 250 mg IM x 1 dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Rash, hives at site and surrounding area of injection.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, PNC13, TDAP
Symptoms: Anaphylactic reaction, Cough, Eye swelling, Lip swelling, Sneezing
Clinical narrative: Patient is a 15 Y male presenting with concern for allergic reaction.  The patient has a history of Neonatal hemochromatosis status post liver transplant ×2, eosinophilic gastroenteritis.  He was seen in the transplant clinic today and given for immunizations around 4:30 PM.  Less than 30 minutes later, he developed swelling of his bilateral eyes, lips, coughing, sneezing, and throat tightness.  The mother gave the patient 50 mg of Benadryl and 2 puffs of albuterol.  She called the transplant clinic who recommended that the patient return to the emergency department for further evaluation.  No nausea, vomiting, abdominal pain, dizziness/presyncope, or other complaints.  Patient states that he is feeling much better at this time, although he still has some mild throat tightness still.  He has multiple allergens, but denies any exposures to them. 15-year-old male with complex past medical history presenting with symptoms concerning for anaphylaxis given involvement of multiple organ systems, normal exam here.  However given anaphylaxis diagnosis, we'll treat with IM epinephrine 0.5 mg.  I also discussed the case with the liver team and plan for Decadron today and tomorrow, Zyrtec, Zantac. 8:40 PM Patient has remained clinically stable throughout his ED course.  Family feels comfortable with discharge home.  I discussed at length with them the risk of biphasic reaction, need for prompt follow-up if it recurs.  They demonstrated good understanding.  Safe for d/c home with PCP f/u.  All questions answered, family demonstrated good understanding of discharge instructions.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, PNC13, TDAP
Symptoms: Throat tightness
Clinical narrative: Patient is a 15 Y male presenting with concern for allergic reaction.  The patient has a history of Neonatal hemochromatosis status post liver transplant ×2, eosinophilic gastroenteritis.  He was seen in the transplant clinic today and given for immunizations around 4:30 PM.  Less than 30 minutes later, he developed swelling of his bilateral eyes, lips, coughing, sneezing, and throat tightness.  The mother gave the patient 50 mg of Benadryl and 2 puffs of albuterol.  She called the transplant clinic who recommended that the patient return to the emergency department for further evaluation.  No nausea, vomiting, abdominal pain, dizziness/presyncope, or other complaints.  Patient states that he is feeling much better at this time, although he still has some mild throat tightness still.  He has multiple allergens, but denies any exposures to them. 15-year-old male with complex past medical history presenting with symptoms concerning for anaphylaxis given involvement of multiple organ systems, normal exam here.  However given anaphylaxis diagnosis, we'll treat with IM epinephrine 0.5 mg.  I also discussed the case with the liver team and plan for Decadron today and tomorrow, Zyrtec, Zantac. 8:40 PM Patient has remained clinically stable throughout his ED course.  Family feels comfortable with discharge home.  I discussed at length with them the risk of biphasic reaction, need for prompt follow-up if it recurs.  They demonstrated good understanding.  Safe for d/c home with PCP f/u.  All questions answered, family demonstrated good understanding of discharge instructions.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blastic plasmacytoid dendritric cell neoplasia, Epstein-Barr virus infection, Epstein-Barr virus test negative
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Fluorescent in situ hybridisation negative, Gene mutation identification test negative, Immunohistochemistry, Injection site erythema, Injection site hypersensitivity
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site induration, Injection site plaque, Light chain analysis normal, Lymphocytic infiltration, Neoplasm skin
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Protein total normal
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blastic plasmacytoid dendritric cell neoplasia, Epstein-Barr virus test negative, Gene mutation identification test negative
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Immunohistochemistry, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site plaque
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site reaction, Light chain analysis normal, Skin lesion
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blastic plasmacytoid dendritric cell neoplasia, Epstein-Barr virus test negative, Gene mutation identification test positive
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Laboratory test abnormal, Light chain analysis normal, Skin lesion, Vaccination site reaction
Clinical narrative: This medically confirmed literature report (initial receipt 23-Jun-2015) concerns a 71 year-old male patient who had no significant medical history. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided) on the left arm. On an unspecified date, 7 days following the influenza vaccination, the patient developed a 5.0 cm non-tender, 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. The initial clinical suspicion was that of an injection site hypersensitivity reaction. A punch biopsy was performed, and a topical high-potency steroid, diflorasone diacetate 0.05%, was prescribed. The 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. Immunohistochemical profiling found the lesion to be diffusely CD4 and CD56. Most of the lesional cells were also CD123 and TdT. Repeat CD123 staining found more intense and diffuse positivity. Admixed were rare CD79 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 TCL1 and CD117 and muramidase negative. After histologic and immunoprofiling of CD4, CD56, TCL1, and CD123, a diagnosis of blastic plasmacytoid dendritic neoplasm (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 centre. At the 2-week follow up, the patient reported that the entire lesion had resolved with topical steroid treatment. Despite the lack of clinical evidence of disease, radiation therapy was delivered at the site. At the time of this report, bone marrow and blood involvement were not found and leukemia was excluded, but watchful follow-up was necessary. The outcome was recovered. Reporter's comments: The reporter stated that this was an unusual case of BPDN occurring at an influenza vaccination site. The atypical presentation and behaviour raises the question if the lesion was indeed a distinct presentation of BPDN that carries a good prognosis or was a BPDN-like reaction to the vaccination.