chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: CD8 lymphocytes increased, Chest tube insertion, Clostridium test, Clostridium test positive, Corynebacterium test
Clinical narrative: This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Corynebacterium test positive, Cytogenetic analysis normal, Enterovirus test positive, HIV antibody negative, HIV test negative
Clinical narrative: This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Immunoglobulins normal, Intensive care, No therapeutic response, Pleural effusion, Pneumonia
Clinical narrative: This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Polymerase chain reaction, Respiratory failure, Stool trypsin, T-lymphocyte count, Therapeutic procedure
Clinical narrative: This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received ZOSTAVAX on 2-17-14 broke out with rash over right temple on 2-20-14, reported event to pharmacy on 2-22-14 pt said it is improving.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity, Pruritus
Clinical narrative: Arm was itchy and sore after immunization, soreness moved down the arm into the forearm and elbow area, pt could not pick up or support weight with arm that shot was administered in. Pt has not seen MD about ruling out other diagnosis.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling at inj. site (L deltoid) immediately following vaccination.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Irritability
Clinical narrative: Severe malaise, chills, severe headache, flu-like symptoms, severe (L) arm tenderness, (L) arm redness from shoulder to elbow, subjective fever, irritability, malaise, Symptoms lasted 8 days,
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Malaise, Pyrexia, Tenderness
Clinical narrative: Severe malaise, chills, severe headache, flu-like symptoms, severe (L) arm tenderness, (L) arm redness from shoulder to elbow, subjective fever, irritability, malaise, Symptoms lasted 8 days,
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Severe malaise, chills, severe headache, flu-like symptoms, severe (L) arm tenderness, (L) arm redness from shoulder to elbow, subjective fever, irritability, malaise, Symptoms lasted 8 days,
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia
Clinical narrative: Severe malaise, chills, severe headache, flu-like symptoms, severe (L) arm tenderness, (L) arm redness from shoulder to elbow, subjective fever, irritability, malaise, Symptoms lasted 8 days,
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients (sex and age unknown). The reporter saw on the CDC website that there was a publication MMWR from 30-NOV-2001. It reference a study in children. On an unknown date, the children had received VARIVAX (Merck) (dose, strength, frequency and route of administration unknown) and MMR II concomitantly. No concomitant medication was reported. On an unknown date unspecified number of children had developed chickenpox. Outcome of the event was unknown. The causality of the event with VARIVAX (Merck) and MMR II was unknown. The case is linked with MARRS # 1402USA006201 and MARRS # 1402USA006288 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Insomnia
Clinical narrative: This spontaneous report as received from licensed practical nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (strength, dose, unit, route, lot# and expiry date unknown). On an unknown date within 24 hours of the administration, the patient experienced insomnia and severe headache. Patient called to office to report the events. The outcome of insomnia and severe headache was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. On 18-FEB-2014 the patient was inadvertently vaccinated with ZOSTAVAX (strength, dose unit and route unknown) single dose with lot # H013945 that had expired on 25-OCT-2013, subcutaneously. No adverse effects reported. The outcomes of inadvertently administered ZOSTAVAX that had expired and no adverse effect reported was unknown. No further information provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician for GARDASIL a Pregnancy Registry product, concerning a 16 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with lot # (670050/1229AA) dose1, 0.5 ml of GARDASIL IM on 08-JUN-2012. There were no concomitant medications. Subsequently, the patient became pregnant. On 06-JUL-2012, a serum pregnancy test was performed with a positive result. The patient's LMP was on 08-MAY-2012 and an her EDD would be on 12-FEB-2013. Initial exposure to GARDASIL was at 4 weeks. The patient was exposed to GARDASIL during trimester 1. No problems were reported. Additional information has been requested. Follow up information received, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. This case was lost to follow up. The pregnancy outcome was lost to follow up. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a consumer refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. On May 2012, the patient was vaccinated with dose 2 GARDASIL. Concomitant medications included JOLESSA, sumatriptan and trazodone hydrochloride. On 24-AUG-2012, the patient found out she was pregnant after getting the second dose of GARDASIL. No treatment was given. Blood test was performed (results not available). The outcome of the event was unknown. The event was not related to GARDASIL. Additional information had been requested. Follow up information received, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. This case was lost follow up. The pregnancy outcome was lost to follow up. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. The healthcare worker reported that a patient received a dose of PROQUAD, 0.5 milliliter (ml) subcutaneously and a dose of VARIVAX (Merck) (dosage unspecified) reportedly today, 12-FEB-2014. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 28 years old patient of unknown gender. On an unkonwn date a few years ago, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot number and expiry date unknown) subcutaneously. No adverse effects were reported. The outcome of 28 year old patient was administered a dose of ZOSTAVAX, and no adverse effects was unkonwn. No further information provided. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 17 month old male patient with none allergies or past medical history. On 27-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J006695). None concurrent medication was reported. On 02-FEB-2014, 38 days after onset of therapy the patient experienced rash papulovesicular, approximately 5 lesions, linear on right lower leg. None other systemic symptoms was observed. On 05-FEB-2014 vesicle/lesion VZVIP sample obtained. The outcome of rash papulovesicular was reported as recovered/resolved (date not reported). Relatedness between therapy and adverse event was not reported. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 17 month old male patient with none allergies or past medical history. On 27-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J006695). None concurrent medication was reported. On 02-FEB-2014, 38 days after onset of therapy the patient experienced rash papulovesicular, approximately 5 lesions, linear on right lower leg. None other systemic symptoms was observed. On 05-FEB-2014 vesicle/lesion VZVIP sample obtained. The outcome of rash papulovesicular was reported as recovered/resolved (date not reported). Relatedness between therapy and adverse event was not reported. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Full blood count normal, HIV test negative, Injection site induration, Injection site plaque, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 17 month old male patient with none allergies or past medical history. On 27-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J006695). None concurrent medication was reported. On 02-FEB-2014, 38 days after onset of therapy the patient experienced rash papulovesicular, approximately 5 lesions, linear on right lower leg. None other systemic symptoms was observed. On 05-FEB-2014 vesicle/lesion VZVIP sample obtained. The outcome of rash papulovesicular was reported as recovered/resolved (date not reported). Relatedness between therapy and adverse event was not reported. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: DTAP, MMR, VARCEL, VARCEL, VARCEL
Symptoms: Polymerase chain reaction, Rash papular, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 17 month old male patient with none allergies or past medical history. On 27-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J006695). None concurrent medication was reported. On 02-FEB-2014, 38 days after onset of therapy the patient experienced rash papulovesicular, approximately 5 lesions, linear on right lower leg. None other systemic symptoms was observed. On 05-FEB-2014 vesicle/lesion VZVIP sample obtained. The outcome of rash papulovesicular was reported as recovered/resolved (date not reported). Relatedness between therapy and adverse event was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLUX, HIBV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Food allergy, Skin test
Clinical narrative: Severe peanut allergy and egg allergy that cause anaphylaxis, mild allergy to coconuts, almonds, walnuts; needed a shot of epinephrine at the time of peanut ingestion; needed an skin prick test; we now carry an Epi-pen with us everywhere. I'm looking for any information about what is in vaccines and if there are any studies that show or disprove a link between anaphylactic allergies and vaccines.
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: WELTS ON ARM, NECK, SHOULDER.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Influenza like illness, Local swelling, Myalgia, Oropharyngeal pain
Clinical narrative: Patient reports her arm swelled and felt hot. Swelling went down after a day. Reported 9 days later she felt like she was coming down with the flu (aching muscles, sore throat and runny nose). Told patient to get in contact with her primary physician.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea
Clinical narrative: Patient reports her arm swelled and felt hot. Swelling went down after a day. Reported 9 days later she felt like she was coming down with the flu (aching muscles, sore throat and runny nose). Told patient to get in contact with her primary physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Gingival bleeding, Oral mucosal blistering, Pemphigoid, Pemphigus
Clinical narrative: Bleeding gums and onset of oral blisters pemphigoid/ pemphigus autoimmune disease onset.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain, Rash erythematous, Skin warm, Somnolence
Clinical narrative: Patient stated: "her left armpit area hurts & it hurts to bring the arm up, she has a rash of 1.5 to 2 inches in circumference and another circle circling that , the rash are is red and warm, and she feels really sleepy"  -- I counseled to take pain reliever, anti-itch medication & perhaps a applying cold compress over clothing covered rash area. I also urged if still not better by mon 2/24/14 to give her PCP a call for a consult.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Vaccinated arm began to hurt and caused immobility at attempt to move it.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Vaccinated arm began to hurt and caused immobility.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Vaccinated arm began to hurt and caused immobility.
Age: 0.19
Sex: M
Vaccine: HIBV, PPV
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Within a short time after receiving the vaccine, intense and prolonged vomiting, fever and lethargy, lasting approximately 36 hours.
Age: 1.05
Sex: M
Vaccine: IPV, MMR
Symptoms: Blood test abnormal, Food allergy, Hypersensitivity, Skin test positive
Clinical narrative: Allergic reaction to peanut butter first observed.  Patient had previously eaten peanuts without any problems, but this was the first time eating them after the vaccine.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction raised red bump golf ball site slightly larger over night to orange size, hard in center to touch. Pt used ALEVE.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events. Patient age 16 vaccinated with FLUCELVAX: approved for 18+ y/o.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Nausea
Clinical narrative: Nausea for 3-4 days post vaccination. Rested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Injection site reaction, Neuroendocrine carcinoma of the skin, Pain in extremity, Upper limb fracture
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The pharmacist reporting that his niece's husband, received ZOSTAVAX (dose, frequency, route, lot # unknown) a year ago in 2013 (specified date unknown) and following vaccination (a week) the patient had pain in his vaccinated arm and then fell and broke his arm, during examination an area was identified around the area of vaccination - that was diagnosed as Merkel Cell Cancer. The pharmacist stated that the patient now was in Stage 4 of Merkel Cell cancer. The patient had not started treatment yet for his cancer but he would be receiving chemotherapy, radiation and an unspecified treatment which would stimulate his immune system. One of the facilities he would be getting treatment from was a cancer center. The patient would be undergoing just radiation for treatment (no date specified). The pharmacist stated that the patient had "2 factors" (unknown what factors - but pharmacist believed had to do with immune system) missing and the radiation treatment would "generate" what was missing. The patient sought medical attention via unspecified contact. Stage 4 of Merkel Cell cancer, fell and broke a bone was reported as not recovered. Outcome of pain in his vaccinated arm was unknown. Upon internal review, merkel cell cancer was considered to be medically significant. Merkel cell cancer, fell and broke a bone were considered to be life threatening by reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting for 3-4 days post vaccination. Rested.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Vomiting
Clinical narrative: Patient experienced vomiting for 3-4 days post vaccination. Rested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Several days after getting ZOSTAVAX pt. arm where shot was administered started to swell and feel uncomfortable.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient had no previous pertinent medical history and drug allergic reactions. On 18-FEB-2014 the patient was vaccinated with ZOSTAVAX vial, single dose with lot # J002693 and expiry date 07-JUN-2014, (dose unit unknown) subcutaneously in the left arm for vaccination. No concomitant medications were administered. On 18-FEB-2014, the patient experienced developed redness, pain, itching, swelling, warmth and induration at the injection site. Patient visited pharmacy and no treatment was given for the events. No laboratory tests were performed. The outcome of developed redness, pain, itching, swelling, warmth and induration at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient had no previous pertinent medical history and drug allergic reactions. On 18-FEB-2014 the patient was vaccinated with ZOSTAVAX vial, single dose with lot # J002693 and expiry date 07-JUN-2014, (dose unit unknown) subcutaneously in the left arm for vaccination. No concomitant medications were administered. On 18-FEB-2014, the patient experienced developed redness, pain, itching, swelling, warmth and induration at the injection site. Patient visited pharmacy and no treatment was given for the events. No laboratory tests were performed. The outcome of developed redness, pain, itching, swelling, warmth and induration at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 6 year old male patient. The patient's medical history included chicken pox. The patient was adopted from another country at 22 months of age. On an unknown date at the age of 24 months age, the patient was vaccinated with VARIVAX (merck) (strength, dose unit, lot# and expiry date unknown). On an unknown date at the age of 4 years, patient received additional vaccination with VARIVAX (merck). On an unknown date in 2014 at the age of 6 years, patient experienced shingles rash. On 17-FEB-2014, patient visited the doctor office with shingles rash. It was reported that medical papers that came in with the child from another country stated that the child had chickenpox prior to coming to this country, the papers do not clarify if this statement refers to the patient receiving a previous vaccination against chicken pox or if they are referring to the patient having had the chickenpox condition. The outcome of shingles rash was unknown. No further AE information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC, VARCEL
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 7 year old male patient. On 21-JAN-2008 at 12 months age, the patient was vaccinated with first dose of VARIVAX (merck) (strength, dose and unit unknown) with lot number 1095U. On 25-MAR-2011 at the age of 4 years, patient received second dose of VARIVAX (merck), (strength, dose and unit unknown) with lot number 0962Z. Approximately on an unknown date in February 2014, the patient experienced severe leg pain and visited physician approximately on 09-FEB-2014 (4 days ago) who received 2 doses of VARIVAX (merck). No other symptoms were present at the first visit. On 13-FEB-2014 today, the patient came back to the office and presented with shingles on his thigh and rash. No treatment was given for shingles rash and was not hospitalized. Physician stated that she collected specimen from this patient and specimen was submitted to Merck for analysis. The outcome of severe leg pain, shingle rash and shingles on his thigh was unknown. No additional information provided. This case # 1402USA007533 was linked to case # 1402USA010748 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported that an unspecified number of patients received GARDASIL injection 120 Y and oral ROTATEQ that were exposed to 51F (Fahrenheit) for 22.8 hours, which was an excursion that was found to be unsupported by in-house stability data. No adverse symptoms reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse inquired around dosing regimen for RECOMBIVAX HB. The pediatric-patient (age unspecified) had first dose of RECOMBIVAX HB on 22-AUG-2013, 2nd dose on 08-JAN-2014 (dose regimen unspecified). The nurse asked when we recommend providing 3rd dose. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. The patient's medical history included appendix removed. The patient stated he received the ZOSTAVAX vaccine 2 to 3 years ago (estimated 2011 to 2012) (unspecified month and date) (dose, frequency, route, lot # unknown). The patient said he had several outbreaks of red blistery rash that scabbed over and disappeared. The patient currently had a chickenpox appearance pimple bump on his face that the physician was treating with a cream (brand, dose, and manufacturer unspecified) and the physician stated it was unrelated to the ZOSTAVAX vaccine he received. The patient sought medical attention via office contact. No diagnosis was given by the physician stated "the patient". The patient believed it was related. Patient present status was reported as not recovered. Patient provided little detail as he wanted to contact the physician for further consultation. Physician demographics were not provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report was received from health professional, concerning a pregnant 25 year old, Female subject. She had no significant medical history and was not taking medication for any illnesses. On 02-Oct-2012, the patient received nasal FLUMIST. The patient was pregnant while she received this drug which started on 02-Oct-2012. The date of the patient's last menstruation was 06-Jul-2012. The estimated date of delivery was 13-Apr-2013. The outcome of the pregnancy was reported to be a Healthy baby born on Apr-2013. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune from registered nurse on 24-Oct-2012: last menstruation, expected delivery date, patient contact phone number added. Corrected report: The event of administration to pregnant female has become a KUR term, therefore the case has been updated accordingly. Full narrative edited. Number of previous pregnancies added. Received last season added as unknown. Summary of follow-up information received by AstraZeneca/MedImmune on 03-Jun-2013 from Health Professional: Form completed due date was updated. Corrected report 04-Jun-2013: Manufacturer added. Reporter's type responsible physician was added. Trimester exposed was corrected. Case category was updated. Summary of follow-up information received by AstraZeneca/MedImmune on 22-Nov-2013 from Health Professional: Pregnancy outcome was added. Corrected report 03-Dec-2013: Reporter's details corrected.
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Decreased appetite, Liver function test abnormal, Nausea, Neutropenia, Pyrexia
Clinical narrative: A report has been received from VAERS concerning a 13 years old male. His relevant medical history and concomitant medications were not reported. On 17-Oct-2012 the patient received nasal FLUMIST, intramuscular GARDASIL, and intramuscular HAVRIX. FLUMIST was administered by a private doctor and purchased with public funds. On 03-Nov-2012 he had abnormal liver function test. The patient required emergency room visit and was in hospital for four days. He had fever for five days up to 104. Symptoms also included nausea, decreased appetite, and neutropenia. The outcomes of the events were unknown. The reporter assessed the liver function test abnormal to be serious due to hospitalization.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Muscular weakness, Nausea
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST started on an unknown date. The patient experienced DIZZINESS, NAUSEA, WEAKNESS IN ARMS and WEAKNESS IN LEGS which started on 02-Oct-2013. The outcome of the event of DIZZINESS, NAUSEA, WEAKNESS IN ARMS and WEAKNESS IN LEGS was recovered. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 09-Oct-2013 from health professional: Updated the outcome of all the events from unknown to recover.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 29 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Oct-2013. On 04-Oct-2013 the patient had EXPOSURE TO FLUMIST IN PREGNANCY. The patient was pregnant when RECEIVED FLUMIST QUADRIVALENT . The outcome of the event of EXPOSURE TO FLUMIST IN PREGNANCY and A PATIENT WHO WAS PREGNANT RECEIVED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter. The event of exposure to FLUMIST in pregnancy have been identified by the company physician from the source documents and added as non-serious adverse event.
Age: 29.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 29 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 10-Oct-2013. The patient experienced PREGNANT PATIENT INADVERTENTLY RECEIVED FLUMIST which started on 10-Oct-2013. The outcome of the event of PREGNANT PATIENT INADVERTENTLY RECEIVED FLUMIST is unknown. Patient's last menstrual period was on 15-May-2013. Patient's expected date of delivery is 28-Mar-2013. The report was considered to be non-serious. Corrected report 31-Oct-2013: Deleted the event of inadvertently received FLUMIST and updated the narrative accordingly. Summary of follow-up information received by AstraZeneca on 20-Nov-2013: Reporters information was updated. Start date was added for suspect drug. Pregnancy due date was added. Last menstrual period date was added.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient born on 10-DEC-1959, Female subject, who had been receiving Nasal FLUMIST. The patients concurrent disease(s) included rash and throat closing sensation. Concomitant medications included FLUMIST started on an unknown date. It was reported that consumer over 49 received FLUMIST last year. The outcome of the event of Patient over 49 received FLUMIST last year is unknown. The report is considered to be non-serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip pain, Lip swelling, Rash, Rash pruritic, Skin discolouration
Clinical narrative: A report has been received from a Physician concerning a 5 year old, female patient. She had no previous history of allergy to anything and takes no medication. The patient has been receiving nasal FLUMIST quadrivalent started on 19-Oct-2013. The patient's mother reported that her daughter got FLUMIST quadrivalent last Saturday, 19-Oct-2013, and the next morning (20-Oct-2013) she woke up with a few bumps and by 5:00 pm that afternoon she had welts and hives. On Monday, 21-Oct-2013 when she got home from school, her top lip was swelling and hurting. The bottom lip then started to swell and puff up. Some of the welts on the palms of her hands were turning purple. The doctor told us to take her to the emergency, where she received a shot of cortisone. Patient developed itchy rash on 20-Oct-2013. Parent was giving BENADRYL at home on 21-Oct-2013. Parent brought the child to emergency and was diagnosed with urticaria. Discharged with ORAPRED. Action taken with FLUMIST quadrivalent was unknown. The patient recovered from the events of urticaria, lip hurting, patient had few bumps on receiving FLUMIST quadrivalent, welts and hives all over/welts on the palms of her hands were turning purple and swollen lips/bottom lip then started to swell and puff on 24-Oct-2013. The company physician considered the events of urticaria, lip hurting, patient had few bumps on receiving FLUMIST quadrivalent, welts and hives all over/welts on the palms of her hands were turning purple and swollen lips/bottom lip then started to swell and puff to be non serious.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: A report has been received from a Physician concerning a 5 year old, female patient. She had no previous history of allergy to anything and takes no medication. The patient has been receiving nasal FLUMIST quadrivalent started on 19-Oct-2013. The patient's mother reported that her daughter got FLUMIST quadrivalent last Saturday, 19-Oct-2013, and the next morning (20-Oct-2013) she woke up with a few bumps and by 5:00 pm that afternoon she had welts and hives. On Monday, 21-Oct-2013 when she got home from school, her top lip was swelling and hurting. The bottom lip then started to swell and puff up. Some of the welts on the palms of her hands were turning purple. The doctor told us to take her to the emergency, where she received a shot of cortisone. Patient developed itchy rash on 20-Oct-2013. Parent was giving BENADRYL at home on 21-Oct-2013. Parent brought the child to emergency and was diagnosed with urticaria. Discharged with ORAPRED. Action taken with FLUMIST quadrivalent was unknown. The patient recovered from the events of urticaria, lip hurting, patient had few bumps on receiving FLUMIST quadrivalent, welts and hives all over/welts on the palms of her hands were turning purple and swollen lips/bottom lip then started to swell and puff on 24-Oct-2013. The company physician considered the events of urticaria, lip hurting, patient had few bumps on receiving FLUMIST quadrivalent, welts and hives all over/welts on the palms of her hands were turning purple and swollen lips/bottom lip then started to swell and puff to be non serious.
Age: 7.0
Sex: U
Vaccine: FLUN4
Symptoms: Hallucination, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a child, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 18-Nov-2013. The patient experienced hallucinations and fever. The patient recovered from the event of hallucinations and fever on an unspecified date. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: MMRV, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician reported the 4 year old male child with none pre-existing allergies, birth defects and medical conditions. The child had one sibling. On 09-JAN-2014 at 10:00, the patient was vaccinated with a dose of Measles, Mumps and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# not reported, exp. date 06-JAN-2014) injection (dose, route and strength not reported). The staff recognized error after parent/child left clinic. The parent was notified on 10-JAN-2014. There was none illness at time of vaccination. There was none relevant diagnostic test and laboratory data. Following prior vaccination the patient and his sibling had none adverse event. This is one of several reports from same reporter. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV, MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a physician reported the 4 year old male child with none pre-existing allergies, birth defects and medical conditions. The child had one sibling. On 09-JAN-2014 at 10:00, the patient was vaccinated with a dose of Measles, Mumps and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# not reported, exp. date 06-JAN-2014) injection (dose, route and strength not reported). The staff recognized error after parent/child left clinic. The parent was notified on 10-JAN-2014. There was none illness at time of vaccination. There was none relevant diagnostic test and laboratory data. Following prior vaccination the patient and his sibling had none adverse event. This is one of several reports from same reporter. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Eye swelling, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Swollen face and throat, headache, fever and body aches.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Swelling face
Clinical narrative: Swollen face and throat, headache, fever and body aches.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Headache, Pain, Pharyngeal oedema, Pyrexia, Swelling face
Clinical narrative: Swollen face and throat, headache, fever and body aches.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Local swelling, Pain, Pyrexia
Clinical narrative: Pain, redness, and swelling at injection site in medial aspect of right arm. Swelling spread from shoulder to elbow. Diagnosis: Cellulitis. Treatment: clindamycin 150 mg q.i.d.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, and swelling at injection site in medial aspect of right arm. Swelling spread from shoulder to elbow. Diagnosis: Cellulitis. Treatment: clindamycin 150 mg q.i.d.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Dyspnoea, Fatigue, Haemoglobin decreased, Menorrhagia, Oligomenorrhoea
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via company representative refers to an approximately 15 year old female patient. On 23-AUG-2011, the patient was vaccinated with 1st dose of GARDASIL (lot # and expiry date unknown). On 29-SEP-2012, the patient was vaccinated with 2nd dose of GARDASIL (lot # 0629AE and expiry date unknown). On 15-FEB-2014, the patient was vaccinated with 3rd dose of GARDASIL (lot # J008423, expiry date 21-JAN-2016). Concomitant therapies included influenza virus vaccine (unspecified) administered on 15-FEB-2014. The patient was found to be 5 months pregnant on 15-FEB-2014 after the third dose of GARDASIL was administered with LMP of 18-SEP-2013 and EDD of 25-JUN-2014. No adverse event was reported. The patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, Haemoglobin decreased, Vaginal haemorrhage
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via company representative refers to an approximately 15 year old female patient. On 23-AUG-2011, the patient was vaccinated with 1st dose of GARDASIL (lot # and expiry date unknown). On 29-SEP-2012, the patient was vaccinated with 2nd dose of GARDASIL (lot # 0629AE and expiry date unknown). On 15-FEB-2014, the patient was vaccinated with 3rd dose of GARDASIL (lot # J008423, expiry date 21-JAN-2016). Concomitant therapies included influenza virus vaccine (unspecified) administered on 15-FEB-2014. The patient was found to be 5 months pregnant on 15-FEB-2014 after the third dose of GARDASIL was administered with LMP of 18-SEP-2013 and EDD of 25-JUN-2014. No adverse event was reported. The patient sought medical attention. Additional information has been requested.