chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, International normalised ratio normal, Lymphocyte count increased, Lymphocyte percentage increased
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Macule, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume decreased
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Monocyte count increased, Monocyte percentage increased, Neutrophil count decreased, Neutrophil percentage decreased, Oral disorder
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Papule, Platelet count decreased, Platelet count increased, Prothrombin time prolonged
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate increased, Red cell distribution width increased, Skin lesion, Viral rash
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: 10 mins after vaccine given, pt complained of blurred vision, dizziness and increased sweating. Called pt's PCP and she said to check pt's bp and see if the pt wanted to go to a walk in clinic.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old, non-pregnant, female patient. On 04-JUN-2014 the patient was vaccinated with VARIVAX (Merck) (lot number reported as K001364) (dose and route were not reported). Concomitant medications were not reported. On 04-JUN-2014, the patient became white as a sheet and fainted for about 20 seconds, after receiving VARIVAX (Merck)." The pharmacist observed the patient for 25 minutes after she came to and the patient left the pharmacy on her own. Patient did not seek medical attention. The outcome of became white like a sheet was not reported. The outcome of fainted for about 20 seconds was recovered/resolved. The relationship between VARIVAX (Merck) and the events was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Loss of consciousness, Malaise, Pallor, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old, non-pregnant, female patient. On 04-JUN-2014 the patient was vaccinated with VARIVAX (Merck) (lot number reported as K001364) (dose and route were not reported). Concomitant medications were not reported. On 04-JUN-2014, the patient became white as a sheet and fainted for about 20 seconds, after receiving VARIVAX (Merck)." The pharmacist observed the patient for 25 minutes after she came to and the patient left the pharmacy on her own. Patient did not seek medical attention. The outcome of became white like a sheet was not reported. The outcome of fainted for about 20 seconds was recovered/resolved. The relationship between VARIVAX (Merck) and the events was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old male patient with no pertinent medical history. The patient's drug reaction/allergies were not reported. On 06-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot number J014809 expiration date 20-FEB-2015 (dose and route not reported). Concomitant therapies were hydrochlorothiazide, cyclobenzaprine hydrochloride, PERCOCET, ELIDEL cream and desonide cream. Approximately on 07-MAY-2014, reported as a day or two after receiving the vaccine, the patient experienced a rash around the injection site that was about the size of the palm of the hand. The patient contacted the pharmacist for medical attention and was treated with BENADRYL. At the time of the report the patient was not recovered from rash at the injection site. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Eye movement disorder, Hyperhidrosis, Presyncope
Clinical narrative: Vaccine injection was administered at 10:15am 6/18/14. 10:17am 6/18/14 patient had a reaction, eyes rolling, patient sweaty patient was near syncope. Patient was stable in 5 seconds. Vital signs temperature 99.4 BP 100/60 mmHg, pulse 82 b/m, Resp. 16. Patient ate popsicle and waiting 30 mins. Was fine and stable. Patient left with mom. No further intervention needed.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Dry mouth, Glossitis, Swollen tongue
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 27 year old male patient. On 03-JUN-2014 the patient was vaccinated with VARIVAX (Merck), subcutaneous, (dose and dosage schedule were not reported). The patient had allergies to penicillin and amoxicillin. There was not concomitant medication, medical history and laboratories performed. On 04-JUN-2014, the patient experienced swollen tongue, patient experienced raw tongue of the side of his tongue and dry mouth. Patient sought medical attention and was treated with BENADRYL and an unspecified salt water wash. Patient was being directed to visit the occupational health for treatment. The reporter mentioned that this patient had similar symptoms in the past when he received unspecified penicillin and unspecified amoxicillin. The outcome of the events mentioned above was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration 9 cm at injection site of VARIVAX 48 hours after administration.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient developed hives 24 hours after being given GARDASIL HPV and HepA vaccines. Hives are on her arm and legs not at the injection site. Gone after rx with hydrocortisone, cetirizine and BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The registered nurse reported that an unspecified number of patients were administered an unspecified number of doses on unspecified dates of GARDASIL (lot#, expiration date, dose, strength and route not reported) that were improperly stored. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Angioedema, Interchange of vaccine products, Rubber sensitivity
Clinical narrative: This spontaneous report as received from a other via GSK (MRF#492166-1024460209) refers to a female patient of unknown age. On 21-APR-2014 the patient was vaccinated with dose 1 of RECOMBIVAX HB (lot# was not reported). The patient had a severe latex allergy and angioedema response to the first dose of RECOMBIVAX HB that she received and would therefore be completing her last two parts of the series with ENGERIX-B. She was scheduled to receive her first dose of ENGERIX-B on 22-MAY-2014. The outcome of latex allergy, interchange of vaccines and angioedema was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a sales representative, refers to a male patient of unknown age. On an unknown date the patient received a first dose of GARDASIL, (route, lot # and expiration date was not provided). Co-suspect therapy was not provided. Concomitant therapy included Tdap and meningococcal vaccine (unspecified). It was reported that the patient fainted after received the first dose of GARDASIL on an unknown date. The patient recovered on an unknown date. The relatedness between the event and suspect therapy was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a sales representative, refers to a male patient of unknown age. On an unknown date the patient received a first dose of GARDASIL , (route, lot # and expiration date was not provided). Co-suspect therapy was not provided. Concomitant therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (therapy unspecified) and meningococcal vaccine (unspecified). It was reported that the patient fainted after received the first dose of GARDASIL on an unknown date. The patient recovered on an unknown date. The relatedness between the event and suspect therapy was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The registered nurse reported that an unspecified number of patients were administered an unspecified number of doses on unspecified dates of M-M-R II (lot#, expiration date, dose, strength and route not reported) that were improperly stored. No adverse events were reported. It was unspecified if the patient seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Diarrhoea, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, neck pain, low grade fever, diarrhea (loose stools) x2 days. Pt instructed to go the Emergency Dept.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The registered nurse reported that an unspecified number of patients were administered an unspecified number of doses on unspecified dates of VARIVAX (Merck) (lot# J012377 with expiration date 03-OCT-2015, lot# J009002 with expiration date 19-JUL-2015 and lot# J009728 with expiration date 07-AUG-2015) (dose, strength and route not reported) that were improperly stored. No adverse events were reported. It was unspecified if the patient seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient with currently 73 years old. On unspecified date back in 2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in the patient's arm (dose, lot number and expiration date were not reported). Concomitant medication, medical history and drug reactions and allergies were not reported. On an unknown date the patient experienced painful lump in his arm at the injection site. The outcome of painful lump in the patient's arm at the injection site was reported as not recovered/not resolved. The patient did not receive any treatment for the adverse event and did not seek medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, B-lymphocyte count decreased, Blood immunoglobulin G decreased, CD4 lymphocytes decreased, CD8 lymphocytes decreased
Clinical narrative: This literature marketed report as received from a public article, refers to a 75 year old male patient. The patient initially developed radiographic evidence of a mediastinal mass at the age of 65 years. Further evaluation and biopsy revealed the presence of a thymoma. Three years after the resection of the thymoma, the patient developed recurrent thrush, esophageal candidiasis, and onychomycosis. The patient was hospitalized for pneumonia 4 times per year before treatment. At the age of 73 years, with no prior history of muscle disease, he developed proximal muscle weakness that involved, most prominently, the muscles of his neck and shoulders. Elevated muscle enzyme levels (creatine phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy. A left deltoid muscle biopsy specimen revealed inflammatory myopathy without inclusive bodies. Degeneration and regeneration of muscle fibers were noted accompanied by focal perimysial and endomysia lymphatic infiltrates. Electromyographic analysis suggested myopathic changes. Laboratory evaluation performed at 75 years of age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL. He received the PNEUMOVAX 23 (for antigen stimulation), and both the prevaccine and 30-day postvaccine titers were absent. He was treated with intravenous immunoglobulin, 1 g/kg every 4 weeks, and oral fluconazole every other day. These therapeutic options stabilized his condition for several years. He eventually died of respiratory failure during a pneumonia infection. The association of thymoma with autoimmune and paraneoplastic disorders is well documented. Polymyositis is found in approximately 5% of thymoma cases; however, polymyositis has never been previously documented in a patient with confirmed GS. This case represents the first association of Good Syndrome (GS) (with thymoma and immunodeficiency) and polymyositis. Clarification was received stating that the indication should be changed to "prophylaxis" since the patient was hospitalized 4 times for pneumonia and the event of absent titers should be captured as it synonymously conveys vaccine failure even though not reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Death, Immunoglobulin therapy, Pneumonia, Respiratory failure, T-lymphocyte count decreased
Clinical narrative: This literature marketed report as received from a public article, refers to a 75 year old male patient. The patient initially developed radiographic evidence of a mediastinal mass at the age of 65 years. Further evaluation and biopsy revealed the presence of a thymoma. Three years after the resection of the thymoma, the patient developed recurrent thrush, esophageal candidiasis, and onychomycosis. The patient was hospitalized for pneumonia 4 times per year before treatment. At the age of 73 years, with no prior history of muscle disease, he developed proximal muscle weakness that involved, most prominently, the muscles of his neck and shoulders. Elevated muscle enzyme levels (creatine phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy. A left deltoid muscle biopsy specimen revealed inflammatory myopathy without inclusive bodies. Degeneration and regeneration of muscle fibers were noted accompanied by focal perimysial and endomysia lymphatic infiltrates. Electromyographic analysis suggested myopathic changes. Laboratory evaluation performed at 75 years of age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL. He received the PNEUMOVAX 23 (for antigen stimulation), and both the prevaccine and 30-day postvaccine titers were absent. He was treated with intravenous immunoglobulin, 1 g/kg every 4 weeks, and oral fluconazole every other day. These therapeutic options stabilized his condition for several years. He eventually died of respiratory failure during a pneumonia infection. The association of thymoma with autoimmune and paraneoplastic disorders is well documented. Polymyositis is found in approximately 5% of thymoma cases; however, polymyositis has never been previously documented in a patient with confirmed GS. This case represents the first association of Good Syndrome (GS) (with thymoma and immunodeficiency) and polymyositis. Clarification was received stating that the indication should be changed to "prophylaxis" since the patient was hospitalized 4 times for pneumonia and the event of absent titers should be captured as it synonymously conveys vaccine failure even though not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Lump and pain where shot administered, swelling increased for more than two months, looks like a carbuncle but hasn't erupted yet.  Went to surgeon two weeks ago who said. It to worry about it, but it has continued to swell and gotten worse.  No fever accompanies it, but site is hot to touch.  Using warm compress presently.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Back pain, Ear pain, Fatigue, Headache
Clinical narrative: Right arm pain at site of injection on 6/6/14- 6/9/14.  Discovered swollen right supraclavicular lymph node and swollen right axillary lymph node on 6/9/2014.  Right side of back near shoulder blade started hurting 6/14/14.  Icepick headaches on top right side of head here and there for 2 weeks.  On and off ear ache.  Rear right neck pain.  Tired ever since the day of the injection.  Random body aches.  Lots of anxiety because now we have to screen for cancer.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Right arm pain at site of injection on 6/6/14- 6/9/14.  Discovered swollen right supraclavicular lymph node and swollen right axillary lymph node on 6/9/2014.  Right side of back near shoulder blade started hurting 6/14/14.  Icepick headaches on top right side of head here and there for 2 weeks.  On and off ear ache.  Rear right neck pain.  Tired ever since the day of the injection.  Random body aches.  Lots of anxiety because now we have to screen for cancer.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Increasing pain to left arm requiring pain meds, steroids, physicial therapy, consult by Neurology.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Increasing pain Left arm radiating to Left shoulder with weakness and tingling. Requiring steroids, pain meds, physical therapy, MRI and Neurology consult.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Irritability, Musculoskeletal stiffness
Clinical narrative: Stiffness and soreness around injection site. Irritability. Tried icing the injection site, administered recommended dosage of childrens Advil.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Itching swelling and every day after bump got larger and hot to touch.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Anal fissure, Crying, Haematochezia, Injection site erythema, Injection site swelling
Clinical narrative: Inconsolable loud shrieking cries, every time awake for a period of 24 hours following the vaccination. A cry atypical of my daughter, nothing I did could calm her, she is a very calm baby normally. I did administer Tylenol and considered that the crying was a result of her red and swollen legs at the site of injection. I have done further research and concluded that her crying was above and beyond the scope of normal.
Sex: M
Vaccine: HIBV
Symptoms: Antibody test negative, Chemotherapy, Neoplasm malignant
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. No medical history or concurrent conditions were reported. On an unspecified date, the patient was vaccinated with PEDVAXHIB (dose, route, strength and lot number not provided). No co-suspect or concomitant therapies were provided. On an unspecified date, the patient received chemotherapy for cancer and now had no antibodies for any of the (unspecified) vaccines he received during childhood. Physician stated that the patient now needs to receive a haemophilus b conjugate vaccine (unspecified). Physician did not state if the patient received PEDVAXHIB in the past or if PEDVAXHIB caused cancer in the patient. Patient sought medical attention. At the time of the report, the outcome of the events was unknown. The causal relationship between the events and PEDVAXHIB was unknown. Upon internal review the event cancer was considered as another important medical event. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: RED BUMPS ON HIS LEGS BACK.
Age: 1.82
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site, lasted for about 4 days.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Convulsion
Clinical narrative: On 6/18 brief episode seizure x once.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pink swollen area - local to where vaccines were given.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: Vaccine administered 6-13-14, pt's arm turned bright red (size of circular coffee cup), next day. 2nd day out he got progressively redder and seems to be getting bigger - moving toward elbow.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine administered 6-13-14, pt's arm turned bright red (size of circular coffee cup), next day. 2nd day out he got progressively redder and seems to be getting bigger - moving toward elbow.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: Raised red area to injection site down to elbow was given N/O to take ZYRTEC BID and cimetidine BID if no improvement within 48 hours to call office.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised red area to injection site down to elbow was given N/O to take ZYRTEC BID and cimetidine BID if no improvement within 48 hours to call office.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 25 years old female patient. On 06-DEC-2012 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#/batch# unknown) intramuscular at left deltoid. The patient was late in getting 0.5ml the second dose of GARDASIL (lot#/batch# unknown) intramuscular at left deltoid on 17-JUN-2014. No adverse event reported. Nurse also stated that due to the alternate dosing client would be scheduled to receive her third dose of GARDASIL after the age of 26 years. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pyrexia, Rash, Skin warm, Tenderness
Clinical narrative: Skin erythematous, hot, tender following vaccination. Day after vaccination rash extended to 9.5 cm x 7 cm area and fever to 102.1. 48 hr after vaccination area extended to 11.5 cm x 9 cm. Oral antibiotics started at that time.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a female patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that the patient received her third dose of GARDASIL 9 weeks after the second dose of GARDASIL. There were no adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11 year old male patient. On 10-JAN-2014 the patient was vaccinated with GARDASIL lot # H017698, .5 ml, intramuscular. Other suspect therapies also administered on 10-JAN-2014 included DTAP (manufacturer unknown) and MENVEO. About a week after onset of therapy the patient experienced rash all over his body. No treatment was given and the outcome of rash all over was reported as recovered/recovered on an unspecified date. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Abdominal pain upper, Pain, Vomiting
Clinical narrative: Rec'd call from aunt 4:50 pm; aunt reports: "aches", "pain in stomach", "vomit x1" reported by aunt. Instructed for patient to call MD for concerns r/t symptoms. 6/4/14 5:04PM: Message left on machine for patient. 6/9/14 0920 MLOM for pt.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to 3 patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with ZOSTAVAX vial, dose/frequency reported as "as directed" (route and lot number not provided). No co-suspect or concomitant therapies were reported. The physician reported that he had like 3 patients who developed shingles about a year or two after getting the ZOSTAVAX, but they seemed pretty mild (dates not specified). The physician reported that he "thought antivirals" as treatment for these events. The patients sought medical attention by talking with the physician. At the time of the report, the outcome for the patients was reported as recovered/resolved (dates unspecified). Additional information is not expected.
Sex: U
Vaccine: MMRV
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. The patients medical history was not reported. On an unknown date the patients were vaccinated with PROQUAD (Merck) that was improperly stored. Concomitant medications were not reported. The nurse stated that PROQUAD (Merck) was exposed to a temperature as high as 14 Fahrenheit (F) for an unspecified amount of hours. No adverse effects were reported. The outcome of improperly stored PROQUAD (Merck) have been administered and no adverse effect was unknown. This case is linked to 1406USA009396, 1406USA009397, 1406USA009398 and 1406USA009282. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 5 year old patient. In August 2008 the patient was vaccinated with first dose of MMR II (strength, route, indication, lot number and expiration date not reported) and (Oka/Merck) VARIVAX (strength, route, indication, lot number expiration date not reported). In September 2013 the patient was vaccinated with second dose of (Oka-Merck) PROQUAD (strength, route, indication, lot number and expiration date not reported). In May 2014 (reported as just last week) the patient was vaccinated with third dose of (Oka-Merck) PROQUAD 0.5 ml, subcutaneous (indication, lot number and expiration date not reported). No adverse effects had been reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 6 doses of ROTATEQ (dose, route of administration, LOT# and expiration dates were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS # 1406USA008283, 1406USA008284, 1406USA008285). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with ROTATEQ that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored ROTATEQ most likely had been administered. The ROTATEQ reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for the ROTATEQ was 35 F to 46 F because she reports that they have always been considered in range at 35F at her office. No adverse effects were reported. The outcome of improperly stored ROTATEQ have been administered and no adverse effect was unknown. This case is linked to 1406USA009396, 1406USA009397, 1406USA009399 and 1406USA009282. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Cough, Ear infection, Ear pain, Neck pain, Oropharyngeal pain
Clinical narrative: Acute onset of cough, rhinorrhea, congestion, sore throat, sore neck, and ear pain. Patient had pharyngitis with early right sided ear infection. Treated with Zithromax antibiotic.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Pharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Acute onset of cough, rhinorrhea, congestion, sore throat, sore neck, and ear pain. Patient had pharyngitis with early right sided ear infection. Treated with Zithromax antibiotic.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored LIQUID PEDVAXHIB most likely had been administered. The LIQUID PEDVAXHIB reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for the LIQUID PEDVAXHIB was 35 F to 46 F because she reports that they have always been considered in range at 35F at her office. No adverse effects were reported. The outcome of improperly stored LIQUID PEDVAXHIB have been administered and no adverse effect was unknown. This case is linked to 1406USA009397, 1406USA009398, 1406USA009399 and 1406USA009282. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored GARDASIL most likely had been administered. The GARDASIL reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for the GARDASIL was 35 F to 46 F because she reports that they have always been considered in range at 35F at her office. No adverse effects were reported. The outcome of improperly stored GARDASIL have been administered and no adverse effect was unknown. This case is linked to 1406USA009396, 1406USA009398, 1406USA009399 and 1406USA009282. Additional information has been requested.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Chills, Injection site movement impairment, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Mother of patient called on 6-18-14 stating that chills had ran fever and had pain and stiffness to leg since vaccine administration. Mother states child was taken to hospital for tests. Mother called 6-19-14 stating that child required MRI of leg due to inability to move leg.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Mother of patient called on 6-18-14 stating that chills had ran fever and had pain and stiffness to leg since vaccine administration. Mother states child was taken to hospital for tests. Mother called 6-19-14 stating that child required MRI of leg due to inability to move leg.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema
Clinical narrative: Received 2mo vaccines 6/17. Parent reported in eve 2hrs inconsolably crying. (L) thigh noticed to be red. Afebrile. Seen in our office 6/18 improved looks well.
Age: 1.27
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Cough, Decreased appetite, Irritability, Pyrexia
Clinical narrative: High fever (to 103.6), cough, fussiness, decreased appetite.  Symptomatic treatment.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling to left thigh. ATARAX and hydrocortisone 1% cream.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Patient given MENVEO. Rash appeared on trunk, arms and legs within 30 minutes. No shortness of breath or angioedema. Given 50 mg BENADRYL and taken to urgent. Physician stated no further treatment. Advised to consult with allergist ASAP.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site reaction, Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 56 year old female patient. It was reported that on an unspecified date the patient had experienced a prior case of shingles, before the vaccination. On 13-JUN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous injection, (frequency reported as 1 single shot) for the prevention of shingles (strength, dose and lot number were not reported). No concomitant medications were reported. It was reported that on an unspecified date after receiving ZOSTAVAX, approximately on an unknown date in June 2014, the patient experienced swelling of arm and red pimpled marks on the injection site. The patient had sought medical attention. There was no product quality complaint (PQC) involved. The outcome of swelling of the ram and red pimpled marks on the injection site was reported as recovering. Causality of the event was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old female patient. In approximately December 2012 (18 months ago), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose, and route not reported) for prevention of "shingles". The physician stated that a few weeks after receiving ZOSTAVAX vaccination the patient developed "Shingles". The patient had had (7) different outbreaks of "Shingles" since the initial ZOSTAVAX Vaccine, the patient sought medical attention through office visit. The adverse event was treated with acyclovir for 12 weeks. The outcome of the adverse event was reported as not recovered. Additional information has been requested.