chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mononucleosis heterophile test positive, Nausea, Nuclear magnetic resonance imaging normal, Peripheral coldness, Sinusitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11 year old female patient (daughter). The patients medical history included temporomandibular joint(June 2013). The patient, was administered her first dose of GARDASIL on 04-SEP-2013. On an unknown date in early October 2013, the patient developed a persistent headache. The patient was seen at a local urgent care facility on 27-Oct-2013 and was prescribed CEFDINIR for probable sinusitis. An unspecified physician added prednisone(manufacturer unknown) to therapy on 31-OCT-2013. The symptoms did not improve. In November 2013, a Computerised tomography scan of the head revealed swollen lymph nodes (disability). A mono test was positive. The patient has been on bed rest, unable to attend school, since November 2013. The patient was experiencing ear pain and extreme sensitivity to sound, intermittent nausea, and cold hands and feet. The outcome of swollen lymph nodes, cold hands and feet, intermittent nausea, extreme sensitivity to sound, ear pain and persistent headache was reported as not recovered. The causality for the events was not reported. Follow up information has been received from the pharmacist which stated that there has been no change to his daughter's condition. She was still bedridden, no energy and continued with the same symptoms for the last 4.5 months. The mononucleosis had been found following vaccination. The patient also had fatigue. The patient was having lab work done the day of the report. Results from MRI and CT scans (dates unspecified) were unremarkable. All reported events were considered as disability. It has been determined that case # 1402USA008807 is a duplicate of case # 1402USA004484. Therefore, case # 1402USA008807 is being deleted from our files and the cases consolidated into case # 1402USA004484. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Eye inflammation, Laboratory test, Nuclear magnetic resonance imaging, Papilloedema
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Tumour marker test, Visual impairment, Vitreous floaters
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Visual impairment, Vitreous floaters
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness, Blood test, Computerised tomogram head, Lumbar puncture normal, Nuclear magnetic resonance imaging brain
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Papilloedema, Visual impairment, Vitreous floaters
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, B-lymphocyte count, Blindness, Blood albumin normal, Blood bilirubin increased
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase MB, CSF cell count normal, CSF glucose normal, CSF oligoclonal band, CSF protein normal
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: CSF test, Chest X-ray, Computerised tomogram, Electrocardiogram normal, Eye pain
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hypertension, Inflammation, International normalised ratio normal, Iritis
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test, Lymphocyte percentage decreased, Maculopathy, Mean cell haemoglobin increased, Monocyte percentage
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neutrophil count normal, Neutrophil percentage increased, Nuclear magnetic resonance imaging normal, Optic neuritis, Papilloedema
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Photophobia, Protein total normal, Prothrombin time, Pterygium, Retinopathy
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Tumour marker test, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: This consumer report (initial receipt 12-Feb-2013) concerns a 63 year old female patient who had a medical history of penicillin allergy. Concomitant medications included cetirizine. On the 15-Oct-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On the 01-Nov-2013, the patient received ZOSTAVAX (batch number not provided) as the directed dosage via the subQ (subcutaneous) route. On the 14-Nov-2013, about two weeks after having the vaccine, the patient developed a lot of floaters in her eye. Within less than one month she developed papilledema with inflammation. The patient was tested for tumours and in early Feb-2014 she had exidant (sic) present on her retinas. The patient developed vision problems in both of her eyes. The patient was hospitalised on 20-Dec-2013 until 21-Dec-2013 and was treated in the hospital. Treatment included prednisolone and acyclovir. Diagnostic tests included MRI (magnetic resonance imaging), CAT scan (computed tomography) and other unspecified testing. Outcome was reported as not recovered.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed thigh swelling and redness 10-15min prior to mommy pager call. No treatments to date as mother on way home from MGM's house and father just arrived home from work. He had only seen a photo sent to his phone. Recommended Tylenol and cold compresses and evaluating leg to see if good color to leg, ensure he is moving it and monitor for changes in redness or swelling. If erythema spreads upward, worsening pain or swelling, increased fussiness or any other concerns, recommended bringing him into the ED to have a provider look at his leg. Father indicated his understanding.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: Patient had 2 day h/o substernal chestpain. Patient seen in the Emergency Department on 21 FEB 2014. Patient admitted for 1 day for Pericarditis and discharged on 21 FEB 2014.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericarditis, Troponin I normal
Clinical narrative: Patient had 2 day h/o substernal chestpain. Patient seen in the Emergency Department on 21 FEB 2014. Patient admitted for 1 day for Pericarditis and discharged on 21 FEB 2014.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Antibody test positive, Bacterial test positive, Blood immunoglobulin E increased, Bordetella test positive, Clostridium test positive
Clinical narrative: PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Corynebacterium test positive, Dizziness, Eosinophil count normal, Erysipelas, Fatigue
Clinical narrative: PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Granulocyte count increased, Headache, Immunoglobulins normal, Injection site erythema, Injection site induration
Clinical narrative: PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Leukocytosis, Nausea, Pyrexia, Streptococcus test positive, Type III immune complex mediated reaction
Clinical narrative: PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: White blood cell count increased
Clinical narrative: PNEUMOVAX23 was indicated for prevention of pneumococcal disease by the 23 serotypes contained in the vaccine. Despite its extensive use, relatively few cases of severe hypersensitivity reactions have been reported. This literature marketed report as received from a health care professional refers to a 24 year old female patient with a history of persistent asthma, allergic rhinitis. It was assumed that patient had been vaccinated with PREVENAR previously. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, dose number, lot no and route of administration unknown). Concomitant therapies included Tdap. The patient had been vaccinated with both vaccines for school enrollment. One day after the immunizations she developed a 10 cm induration and erythema at the PNEUMOVAX injection site and a fever of 104.3 F, fatigue, dizziness, headache and nausea. She was admitted to the hospital for presumed erysipelas versus a vaccine allergic reaction. Relevant laboratory values on admission were leukocytosis (19,100/uL) with 86% granulocytes. There was no eosinophilia. She was treated with intravenous antibiotics for two days with improvement and was discharged on antibiotics. Two months later, an allergy clinic follow up visit revealed very high titers against Streptococcus pneumoniae (serotype 14- 223.0 mcg/ml; serotype 5 > 100 mcg/ml; and elevated but normal range protective titers for all other serotypes). Anti Tdap antigen titers were only moderately elevated (tetanus toxoid-5.34 IU/ml; diphtheria-2.67 IU/ml; and pertussis-12 IU/ml). Total serum IgE was elevated (317.6 IU/ml), but quantitative serum immunoglobulin levels were normal. She had a history of gelatin intolerance which caused nausea. None of the two vaccines she received contained gelatin but porcine gelatin-specific serum IgE levels were minimally elevated. It was concluded that the severe delayed systemic reaction associated with very high anti-pneumococcal antibody levels, suggested a type 3 (immune complex mediated) hypersensitivity (hospitalization). Highest antibody titers after the PNEUMOVAX were against two serotypes (5 and 14) that were contained in the 13 serotype PREVENAR. The outcome of Type 3 immune complex mediated reaction was reported as recovering. The event Type 3 immune complex mediated reaction was reported to be related to the suspect product. This case suggested that caution should be used when immunizing younger individuals with PNEUMOVAX, especially if they have previously been immunized with PREVENAR. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report as received from a registered nurse at prison refers to a patient of unknown age (an inmate). In 2005, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot/batch number not reported). The reporter didn't know if the patient had received PNEUMOVAX23 and then was diagnosed with multiple sclerosis or had been diagnosed with multiple sclerosis and then received PNEUMOVAX23. The reporter was too busy to answer questions for the report. The outcome of event was not reported. The relatedness between PNEUMOVAX23 and event was not reported. Upon internal review, the event of multiple sclerosis was considered as medically significant. The reporter also mentioned that an unknown number of HIV (Human Immunodeficiency Virus) patients were revaccinated with PNEUMOVAX23 one time in 5 years. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Skin papilloma, Wart excision
Clinical narrative: This spontaneous report was received from a nurse (who is also the mother) via company representative refers to a female patient (who is the daughter) of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (2 dose). No other vaccines were given on the same day as GARDASIL. No concomitant medication was reported. On an unknown date, after the second dose the patient developed warts in the ear, unspecified if one ear or two. Patient was taken to ear, nose and throat physician who surgically removed the warts. The outcome of the events were reported as recovered. The reporter considered warts in the ear to be related to GARDASIL. It was reported that physician was now serotyping the warts to determine the origin. Events of warts in the ear was considered serious because surgical excision was required. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bacterial test negative, Impetigo, Otitis externa, Skin papilloma, Wart excision
Clinical narrative: This spontaneous report was received from a nurse (who is also the mother) via company representative refers to a female patient (who is the daughter) of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (2 dose). No other vaccines were given on the same day as GARDASIL. No concomitant medication was reported. On an unknown date, after the second dose the patient developed warts in the ear, unspecified if one ear or two. Patient was taken to ear, nose and throat physician who surgically removed the warts. The outcome of the events were reported as recovered. The reporter considered warts in the ear to be related to GARDASIL. It was reported that physician was now serotyping the warts to determine the origin. Events of warts in the ear was considered serious because surgical excision was required. Additional information has been requested.
Age: 0.11
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 week old male patient with vaccination. On 21-FEB-2014 the patient was vaccinated with VAQTA (lot # J005081, Expiry date 22-OCT-2015) 0.5 ml in the right anterior thigh instead of hepatitis B vaccine. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia
Clinical narrative: This spontaneous report was received from a consumer refers to himself as a 65 year old male patient. The patient pertinent medical history included high blood pressure. On 17-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and frequency were not reported) 1 time vaccine. On an unknown date in January 2014 (also reported as end of January 2014) the patient experienced hoarse. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Concurrent condition included CIPRO allergy, KEFLEX allergy, LEVAQUIN allergy, penicillin allergy and sulfonamide (unknown reaction). Concomitant medication was not provided. On 10-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J007858, 1 DF, subcutaneous. Frequency was not provided. In February 2014, after the administration, the patient developed a large, hard, red spot at the injection site. The area of the reaction was enlarging. The patient did not receive any treatment. The outcome of the developed a large, hard, red spot at the injection site was reported as not recovered/not resolved. The reporter causality was unknown. Additional information has been reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. On 24-FEB-2014 the patient was vaccinated with PROQUAD (strength, dose number, dose unit, lot # route unknown) that expired on 21-FEB-2014. No adverse symptoms reported. The outcome of received an expired dose of PROQUAD and no adverse symptoms was unknown. No further information provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: This spontaneous report was received from a registered nurse refers to an approximately 13 year old female patient. Pertinent medical history and drug reactions or allergies was reported as none. On 10-FEB-2014 at 11:30 AM the patient was vaccinated with GARDASIL lot # H015555 expiry 13-APR-2015 dose number 2 in series, dose: 0.5 ml (milliliters), intramuscular in the right deltoid for vaccination. Concomitant therapy was reported as none. On 11-FEB-2014, the patient presented to doctor office with face that was red, swollen and pruritic. There was no wheezing or throat problems. The patient reported that face swelling occurred at around 7 AM on 11-FEB-2014. The patient was treated with PREDNISONE and ZYRTEC. It was reported that injection site of right deltoid was not red, not swollen and looked fine. Nurse states that she does not know if the reaction was caused by GARDASIL, but thought she would report it. Lab tests were not performed. Product quality complaint was not involved. The outcome of face that was red, swollen, pruritic was reported as not recovered. The causality of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unspecified demographics. On 24-FEB-2014, the patient was vaccinated with an expired dose of ROTATEQ, Oral liquid (dose and frequency unspecified) (lot number unspecified, expiry date 07-FEB-2014). Concomitant medication was unspecified. No adverse symptoms reported. No product quality complaint involved. No further information provided. Additional information has been requested.
Age: 0.28
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 month old female patient. On 24-APR-2013 the patient was vaccinated with RECOMBIVAX HB (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On 11-JUN-2013, the patient was administered with the second dose of RECOMBIVAX HB and on 31-JUL-2013 a third dose of RECOMBIVAX HB was administered. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-JAN-2014 the doctor had administered M-M-R II (dose and route of administration were not reported) lot # 0705AA, expiration date: MAY 2013 to the patient. No adverse effects reported. The patient did not seek medical attention. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from healthcare worker via company representative, refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (lot # and dose not reported). On an unknown date the patient experienced "a single episode of fainting" after vaccination. The outcome of fainting and relatedness between fainting and GARDASIL were not reported. This is one of several report received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from the female adult healthcare worker reporting on herself. The health care worker stated that she may have received the last (third) dose of GARDASIL when she was 27 years of age. No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal sensation in eye, Dizziness, Eye pain, Headache, Nausea
Clinical narrative: Dizzy, nausea, vertigo, headache and pain in right eye - reported by pt on 2/1/14. On 2/17/14 pt called clinic, reporting pressure behind right eye on 2/19/14 pt had appointment with PCP and pt reports blurred vision, fever, vertigo vomiting 2 hrs after tdap. 4 hrs post tdap -> pressure behind (R) eye, scotomata. Pt has appointment with ophthalmologist on 2/19, referred to neuroophthalmologist.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Scotoma, Vertigo, Vision blurred, Vomiting
Clinical narrative: Dizzy, nausea, vertigo, headache and pain in right eye - reported by pt on 2/1/14. On 2/17/14 pt called clinic, reporting pressure behind right eye on 2/19/14 pt had appointment with PCP and pt reports blurred vision, fever, vertigo vomiting 2 hrs after tdap. 4 hrs post tdap -> pressure behind (R) eye, scotomata. Pt has appointment with ophthalmologist on 2/19, referred to neuroophthalmologist.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 13-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # H019997. Dose, route and frequency were not provided. On 13-FEB-2014, an expired vaccine was administered. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. on 08-JUL-2013, the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). On 13-SEP-2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency were not reported). The patient reported that she not yet received the third dose of GARDASIL. The patient also stated that it has been months between the second dose of GARDASIL and now. No adverse events were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain, Swelling, Vaccination complication
Clinical narrative: Large area of erythema, pain and swelling. Tx w/sulfamethoxazole 200 mg - trimethoprim 40 mg/5 ml.
Sex: U
Vaccine: RV5
Symptoms: Drug dose omission, No adverse event, Product contamination physical
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a couple of patient of unknown age and gender, who approximately in January 2014, reported as about a month ago, were unable to received doses of ROTATEQ vial due to ROTATEQ with "particular matters" - it was reported that ROTATEQ had particulates inside, no information on lot# number, expiry date. No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTP, MMR, OPV
Symptoms: Measles antibody negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a 22 year old male patient. On an unknown date, the patient received their scheduled doses of M-M-R II (lot#, expiry not reported). On an unknown date, recently the patient had titers drawn and the patient did not seroconvert for measles and rubella. No treatment was received. It was unspecified if the patient sought medical attention. The outcome of patient did not seroconvert for measles and rubella was unknown. The relatedness of the event with M-M-R II was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pt says she cannot move her arm due to shoulder pain since receiving vaccine on 1/27/14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. On 24-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On 24-FEB-2014, the patient experienced headache the same day after she received ZOSTAVAX. No treatment was given. No medical attention was sought. The outcome of headache was reported as not recovered. Did Adverse event appear after reintroduction was reported as not reintroduced. The relatedness of the event to ZOSTAVAX was unknown. Additional information has been requested.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Troponin I increased, Tuberculin test negative
Clinical narrative: This study case was received from the investigator in a trial on 20 February 2014. A male subject (date of birth not reported) had received the following vaccines on 07 February 2014: ACAM2000 (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported) and one day later, on 08 February 2014 experienced chest pain and shortness of breath which resolved without any treatment. ECG appeared normal and PPD was normal. The subject's outcome was recovered on 10 February 2014. According to the investigator, if eRT returns otherwise, a follow-up report will submit. No further information was available at the time of the report. According to the investigator, the event of chest pain and shortness of breath was considered mild, an "other important event" and possibly related to vaccination. Documents held by sender: none.