chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blastic plasmacytoid dendritric cell neoplasia, Cell marker, 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: Gene mutation identification test negative, Hyperchromasia, Immunohistochemistry, Light chain analysis normal, Lymphocytic infiltration
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: Skin exfoliation, Vaccination site erythema, Vaccination site induration, Vaccination site plaque, 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.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blastic plasmacytoid dendritic cell neoplasia, Epstein-Barr virus test negative, Immunohistochemistry
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 erythema, Injection site hypersensitivity, Injection site induration, Injection site plaque, Injection 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.
Age: 71.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX, FLUX
Symptoms: Laboratory test normal, Light chain analysis normal, Skin exfoliation, 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: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: Family report of fussiness for 24 hours after vaccine with low grade fever. Three days after vaccine, the family felt that baby's left foot was curved downward and stiff. Mother noticed body shaking for a few seconds.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Palmar-plantar erythrodysaesthesia syndrome, Paraesthesia, Peripheral swelling
Clinical narrative: Woke up with alarm. Palms of hands were red, tingling, slightly swollen. After being awake for a half hour, I realized the soles of my feet had similar symptoms but not as pronounced.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dyskinesia, Eyelid function disorder, Mastication disorder, VIIth nerve paralysis
Clinical narrative: Right sided Bell's Palsy (Can't close right eye, mouth pulls up to left when smiling, can't chew on right side.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. On 04-JUN-2015, the patient who was indicated for ZOSTAVAX was vaccinated with a dose of VARIVAX (Merck) (dose, strength and route were unknown, lot # L002870, expiry date: 27-JAN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist revers to a 60 year old adult non pregnant female patient. No information about medical history, concurrent conditions was reported for the patient. Approximately on 18-MAY-2015 (reported as 3 weeks ago) the patient was vaccinated with ZOSTAVAX dose 0.65 ml, subcutaneously, lot # K024031, expiration date 20-FEB-2016 for shingles prevention. No concomitant therapy was reported. The reporter stated that approximately on 25-MAY-2015 (reported as 1 week later from the date of vaccination) the patient experienced shingles-like rash, two on her left leg, one on her neck and one on her lip post vaccination with ZOSTAVAX. The patient also complained of pain associated with the rash. The patient was not treated for the events reported. The outcome of events was reported as not recovered/not resolved. The patient had not sought medical attention. No product quality complaint was involved. Pharmacist declined Varicella Zoster Virus Identification (VZVIP). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from registered nurse refers to a male patient of unknown age. No concurrent condition or medical history reported. On an unknown date in 2014 (reported as year ago), the patient was vaccinated with 2 doses of (Oka/Merck) VARIVAX. On an unknown date in 2015 (reported as recently), the patient was determined to have negative antibody titers to varicella. No treatment was given for the event. The patient sought medical attention and had an office visit. Action taken with (Oka/Merck) VARIVAX was not applicable. The outcome of the event was unknown. The causality was not provided. No product quality complaint reported. Additional information is not expected as the reporter did not wish further contact.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 69 year old female patient concerning herself. Pertinent medical history was: none. Drug reactions/allergies: tetracycline. On 12-JUN-2015 the patient was vaccinated with ZOSTAVAX, subcutaneous, one single shot (dose and lot # was unspecified). Concomitant therapies included unspecified blood pressure medications, daily vitamins (unspecified), ALLEGRA and fluid pill. On 13-JUN-2015, the morning after receiving her dose of ZOSTAVAX, she indicated the area of the injection was red, raised, itchy, and saw one circle. There were no blisters or bumps. She called the pharmacy where the injection was given and was advised to apply ice and CORTIZONE 10 cream to the site each day. No lab tests were done. Her condition of injection site mass, injection site erythema and injection site pruritus was improving daily (resolving). Causality assessment was not reported. Additional information has been requested.
Age: 0.91
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 22-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 71 year old patient of unknown gender. On 02-JUN-2015, the patient who was indicated for ZOSTAVAX was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, strength and route were unknown, lot # L002870, expiry date: 27-JAN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old patient of unknown gender. On 05-JUN-2015, the patient who was indicated for ZOSTAVAX was vaccinated with a dose of VARIVAX (Merck) (dose, strength and route were unknown, lot # L002870, expiry date: 27-JAN-2017) (wrong vaccine administered). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history or drug allergies were not reported. On unknown dates patients received improperly stored ZOSTAVAX (lot # L006379, expiration date 25-MAY-2016, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient's medical history was not provided. None concomitant medications and drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with dose of MMR II (dose, route of administration, lot # and expiration date were not reported). In 1999, the patient received the second dose of MMR II (dose, route of administration, lot # and expiration date were not reported). It was reported that on 18-JUN-2015, the patient had titers drawn and the titers for measles were low. The outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and the vaccination with MMR II. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age with hypertension, chronic kidney disease, asthma, rhinitis allergic, back pain, drug reactions/allergies to CIPRO, doxycycline and shellfish and with some other unspecified food allergies. The patient was not pregnant at the time of the report. On 05-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, dose: 0.65 ml, subcutaneously in the left upper arm (lot # and expiration date were not reported). Concomitant therapies included hydrochlorothiazide (manufacturer unknown), EFFEXOR XR and ergocalciferol. On 06-JUN-2015, the patient had pink/red colored, lemon sized rash/blisters at the injection site of left arm. On 08-JUN-2015 (reported as "today"), the patient came into the doctor's office. Rash/blisters were examined and the site was warm to the touch. No treatment was given and no lab diagnostic studies were performed. The outcome of adverse events was reported as not recovered at the time of the report. The patient sought medical attention - he came to the office. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care professional refers to a 2 month old patient of unknown gender. On 24-JUN-2015 the patient was inadvertently vaccinated with PNEUNOVAX 23 (dose, route, frequency and lot 3 unspecified) instead of the intended doses of PREVNAR 13. No adverse effect reported. No product confusion reported. The outcome of wrong drug administered was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 36 year old female patient. The concurrent condition and medical history was not reported. On 31-DEC-2014, the patient was vaccinated with RECOMBIVAX HB dose 1 (route unknown). The concomitant medication was not reported. The pharmacist reported that the patient was going to administer to second dose of RECOMBIVAX HB on 25-JUN-2015 (reported as today) which was outside of the recommended schedule. The pharmacist also reported that the patient was waiting to receive the second dose at the time of this call and she would administer it as soon as the call is over. The patient has not experienced any adverse effects. 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 registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB, lot # L004738, expiry date 10-NOV-2017; K019700, expiry date 16-JUL-2017; L006546, expiry date 27-NOV-2017; K025006, expiry date 22-JUL-2017. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. 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 medical assistant refers to an unspecified number of patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored ROTATEQ (lot #, expiration date and dose were not reported), orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On an unknown date in January 2014 (reported as last year), the patient was vaccinated with PNEUMOVAX 23. Approximately on an unknown date in 2014, the patient experienced arm pain at lot after the vaccination. The patient also enquired that would this happened on PREVNAR 13 as well. Action taken with PNEUMOVAX 23 was unknown. The outcome and causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient were vaccinated with unspecified doses of MMR II (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored MMR II, so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status' was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unkonwn date, the patients were inadvertently vaccinated with doses of improperly stored M-M-R II, (dose and route of administration were not reported, lot # K014833 and expiry date 14-SEP-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information about her pertinent medical history was provided. The patient was allergic to penicillin, cephalosporin, adhesive tape, NEXIUM, hydrochlorothiazide (captured in MARRS# 1506USA012939), iodine and oxycodone. She developed a rash and itching to oxycodone in the past (date unspecified). On 22-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L008357, exp. date: 11-JUN-2016 (dose and route of administration not reported). Patient's concomitant medication included PULMICORT inhaler. On 24-JUN-2015, also reported as "today", the patient called the pharmacist and reported that on 23-JUN-2015 she developed an injection site reaction. The patient stated that the injection site was a swollen area approximately 3 inches by 1.5 inches in diameter. The area was red, itchy and warm to the touch with a mild burning sensation. The patient stated that it looked like "one big hive". No treatment was given to the patient. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information about her pertinent medical history was provided. The patient was allergic to penicillin, cephalosporin, adhesive tape, NEXIUM, hydrochlorothiazide (captured in MARRS# 1506USA012939), iodine and oxycodone. She developed a rash and itching to oxycodone in the past (date unspecified). On 22-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L008357, exp. date: 11-JUN-2016 (dose and route of administration not reported). Patient's concomitant medication included PULMICORT inhaler. On 24-JUN-2015, also reported as "today", the patient called the pharmacist and reported that on 23-JUN-2015 she developed an injection site reaction. The patient stated that the injection site was a swollen area approximately 3 inches by 1.5 inches in diameter. The area was red, itchy and warm to the touch with a mild burning sensation. The patient stated that it looked like "one big hive". No treatment was given to the patient. The outcome of the events was reported as not recovered. The relatedness between ZOSTAVAX and the events was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Pt received vaccination. Pt was talking and appear to be fine. Pt was in hallway talking with others and stated I need to sit down. Pt fainted and hit trash can. Pt placed on back with feet elevated. Pt pale, sweating and dizzy. Ice pack and ice water given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck), lot # L0045650, expiry date 11-FEB-2017; K010440, expiry date 22-JUL-2016; K021485 expiry date 03-NOV-2016, (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.89
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an approximately 19 year old female patient. The concurrent condition and medical history was reported as none. On 28-NOV-1995, the patient was vaccinated with RECOMBIVAX HB dose 1, 0.5 ml, intramuscular. The second and third dose of RECOMBIVAX HB were administered on 26-DEC1995 and 16-OCT-1996 respectively. There were no concomitant therapies. On an unknown date in 2015 (reported as recently), patient was determined to have negative hepatitis B antibody titers. The patient sought medical attention by visiting the office and no treatment was rendered. The outcome of hepatitis b surface antibody negative was unknown (present status was reported as negative antibody titers). 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 health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with unspecified doses of VARIVAX (Merck) (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored VARIVAX (Merck), so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored PROQUAD, lot # L004005, expiry date 05-AUG-2016; L006388, expiry date 25-AUG-2016; K003817 expiry date 14-SEP-2015 (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored M-M-R II, lot # L002242, expiry date 21-JAN-2017; K014833, expiry date 14-SEP-2016 (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. 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 was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, lot # K014191, expiry date 10-MAY-2017; K009202, 17-DEC-2016 expiry date (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. 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 was received from a health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with unspecified doses of PROQUAD (Merck) (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored PROQUAD (Merck), so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status' was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 11 months old (not yet 12 months) patient of unknown gender. On 29-JUN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expired date, dose and route unknown), a dose of M-M-R II (lot number, expired date, dose and route unknown), and a dose of VAQTA (lot number, expired date, dose and route unknown). The vaccines were given 4 days too early which was considered as inappropriate schedule of vaccine administration. No adverse effects were reported. 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 health care professional refers to an unspecified number of patients of unknown age and gender. On 27-APR-2015 and 16-JUN-2015, unspecified number of patients were vaccinated with an improperly stored doses of RECOMBIVAX HB and, oral, ROTATEQ lot # J005078 and expiration date 20-SEP-2015, (dose and route 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the unspecified number of patients were vaccinated with unspecified doses of ROTATEQ lot # K013868 and expiration date on 27-MAY-2016 (doses and route 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored RECOMBIVAX HB (lot #, expiration date, route and dose were not reported). No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 3 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K004541, expiration date: 04-DEC-2016 (dose, strength and route of administration were not reported), which had a temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were 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 health care professional refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored post temperature excursion doses of GARDASIL lot # K006960 and expiration date on 19-FEB-2017 (doses and route were not provided) on the following dates: 03-APR-2015, 25-APR-2015, 07-MAY-2015, 28-MAY-2015, 04-JUN-2015 and 16-JUN-2015. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Cold sweat, Gastroenteritis viral, Headache, Tremor
Clinical narrative: This spontaneous report was received from a 64 years old female patient with high blood pressure and drug allergy to amoxicillin reporting on herself. On 15-MAY-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown) (dose, route of administration and lot # were not reported), reported that had to be vaccinated for a job requirement. Concomitant therapies included losartan (manufacturer unknown). On 16-MAY-2015 at approximately 3:00 AM or 4:00 AM, the patient woke up in a cold sweat and was shaking. At approximately 5:30 AM, she had a headache on the top part of her head. She was very weak and she threw up. She couldn't get out of bed because she was weak. She called the physician's office and the nurse thought she had a "stomach bug". Consumer did not have an office visit for her symptoms. No treatment was given for the events. No lab diagnostic tests have been performed. The patient had recovered by 4:30 PM on 16-MAY-2015. The patient would not receive any further doses of RECOMBIVAX HB (manufacturer unknown) because of this adverse events. Relatedness between the events and vaccination with RECOMBIVAX HB (manufacturer unknown) was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a 64 years old female patient with high blood pressure and drug allergy to amoxicillin reporting on herself. On 15-MAY-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown) (dose, route of administration and lot # were not reported), reported that had to be vaccinated for a job requirement. Concomitant therapies included losartan (manufacturer unknown). On 16-MAY-2015 at approximately 3:00 AM or 4:00 AM, the patient woke up in a cold sweat and was shaking. At approximately 5:30 AM, she had a headache on the top part of her head. She was very weak and she threw up. She couldn't get out of bed because she was weak. She called the physician's office and the nurse thought she had a "stomach bug". Consumer did not have an office visit for her symptoms. No treatment was given for the events. No lab diagnostic tests have been performed. The patient had recovered by 4:30 PM on 16-MAY-2015. The patient would not receive any further doses of RECOMBIVAX HB (manufacturer unknown) because of this adverse events. Relatedness between the events and vaccination with RECOMBIVAX HB (manufacturer unknown) was not reported. Additional information has been requested.