chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 78 years old female with depression, migraines, Gastrooesophageal reflux disease (GERD), and allergy to small pox vaccine and gluten. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (Lot# and dose not reported) "about 4 years ago" in September 2008. Concomitant medications included PROZAC, magnesium chloride, PRILOSEC, vitamins including calcium (unspecified) and cyanocobalamin, and minerals (unspecified), CENTRUM SILVER. In September 2010, "about 2 years" after the patient received ZOSTAVAX she was diagnosed with celiac disease. She broke out with "pimples" on her back, legs, and scalp as well as her face. They were painful and she continued to break out to date, just not as bad. She also fainted this week in September 2012. The patient sought for unspecified medical attention. Biopsies were performed 2 years ago, also blood work (results not reported). The patient was given aloe vera cream for treatment and avoided perfumed products and took gluten free diet. The patient's status was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patients received an expired dose of PNEUMOVAX 23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX. The pharmacist mentioned that on an unknown date, during administration of ZOSTAVAX some of the product leaked out of the syringe on the patient's arm. No adverse symptoms reported. The outcome of the events was unknown. The event was not related to ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old male patient. On 19-SEP-2012, the patient was vaccinated with ZOSTAVAX (Lot# H011333; exp. date: 08-SEP-2013) subcutaneously. The pharmacist noted that on 20-SEP-2012, the patient experienced itching on his hands, legs, and feet and that on 21-SEP-2012, he had a rash. The pharmacist noted she did not know the extent of the rash but did not there was no injection site reaction. No treatment was given. The patient's outcome for the event was not recovered. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-SEP-2012 the patient was vaccinated subcutaneously with an expired dose of M-M-R II (Lot# reported as 1057Z, expired date 11-AUG-2012, dose not reported). This was the second dose of M-M-R II for the patient. It was not known when the first dose of M-M-R II was administered. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to three different patients. In September 2012 the three patients were vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Lot# reported as H011333). In September 2012 the three patients all experienced injection site reaction after being vaccinated with ZOSTAVAX. It was not known if the patients sought for medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer concerning her daughter of unknown age. The reporter mentioned the patient had the first dose of GARDASIL (lot # was unknown) when her and her doctor chose for prophylaxis. The second dose was provided 4 months after the first dose and the third dose was provided 6 months after the first dose. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified child of unknown age. The nurse reported that the child was administered with a dose of MMR II (Lot # not reported) 0.5 ml by subcutaneous injection with a 25 gauge 5/8 inch needle in the thigh and a dose of VARIVAX (Merck) (Lot # not reported) 0.5 ml by subcutaneous injection with a 25 gauge 5/8 inch needle in the thigh on the same day (17-SEP-2012). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported that on 24-AUG-2012, a patient was administered "the entire contents of a multidose vial of PNEUMOVAX 23". No adverse experiences were reported. No further information was provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 71 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 11-SEP-2012. No other co-suspects were reported. There were not concomitant medications. It was reported that 4 days ago on 24-SEP-2012, the patient developed nausea and rash after receiving ZOSTAVAX. The patient sought medical attention by contacting the pharmacist and no lab diagnostic tests were performed. No treatment information was reported. The outcome of nausea and rash was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Live birth, Maternal exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from an 18 year old female patient with no pertinent medical history and no drug reactions or allergies, for GARDASIL, a Pregnancy Registry product, reporting on herself who on 17-OCT-2011 was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot # not reported). The patient performed pregnancy test and had discovered that she was 9 weeks pregnant now. There were no adverse events to report. The patient did not seek medical attention. Her LMP was approximately on 23-AUG-2012 and EDD is on 29-MAY-2012. Follow-up information was received from the physician regarding a female patient with attention deficit disorder, seasonal allergies, GERD. Concomitant medications included SINGULAIR, ATROVENT and ZANTAC. On 28-MAY-2012, the patient gave birth to a male (8 lbs., 2 oz.; 20" in length). 40 weeks from LMP. The infant was reported as being normal with no reported congenital anomalies or any other complications. The patient had a shortened cervix during pregnancy and required bed rest during the pregnancy. There were no complications reported during labor or delivery. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Shortened cervix
Clinical narrative: Information has been received from an 18 year old female patient with no pertinent medical history and no drug reactions or allergies, for GARDASIL, a Pregnancy Registry product, reporting on herself who on 17-OCT-2011 was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot # not reported). The patient performed pregnancy test and had discovered that she was 9 weeks pregnant now. There were no adverse events to report. The patient did not seek medical attention. Her LMP was approximately on 23-AUG-2012 and EDD is on 29-MAY-2012. Follow-up information was received from the physician regarding a female patient with attention deficit disorder, seasonal allergies, GERD. Concomitant medications included SINGULAIR, ATROVENT and ZANTAC. On 28-MAY-2012, the patient gave birth to a male (8 lbs., 2 oz.; 20" in length). 40 weeks from LMP. The infant was reported as being normal with no reported congenital anomalies or any other complications. The patient had a shortened cervix during pregnancy and required bed rest during the pregnancy. There were no complications reported during labor or delivery. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a other health professional refers to a 14 years old female patient who in 2012, during the spring was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The health care professional reported that on an unknown date in 2012, the patient became faint immediately after the GARDASIL dose. No treatment information was reported. At the time of the report, the patient had recovered with sequelae. It was unspecified if the patient sought medical attention. The relatedness for became faint immediately after dose was unknown for GARDASIL. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX23 during the time period of 14-SEP-2012 thought 18-SEP-2012. The PNEUMOVAX23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested. Follow up information was provided during a phone call on 26-SEP-2012 stating the health care professional could not supply patient names, date of birth, dates of vaccination or dates of events. Follow up was received on 26-SEP-2012 reported that the 39 year old female patient received an expired dose of PNEUMOVAX23 (lot # 669382/1490Z) on 13-SEP-2012. The source case 1209USA008402 was split into three cases. This case is also linked to case 1210USA000521.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was supposed to receive ZOSTAVAX received VARIVAX (Merck) (Lot #, dose, route unspecified) instead of September 2011, "1 year ago". The patient was not experiencing any known symptoms. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 63 years old patient. The patient was subcutaneously vaccinated with 0.5 ml VARIVAX (Merck) (Lot# unspecified) on 21-SEP-2012 instead of ZOSTAVAX. The patient was not experiencing any known symptoms. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (Bachelor of Science of Nursing)refers to a 31 year old female patient. The postpartum patient was vaccinated with a dose of expired VARIVAX (merck) (lot number reported as 0282Z, expiration date 12-FEB-2012) (dose, route not reported) on 14-SEP-2012. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Respiratory tract infection
Clinical narrative: Information has been received from a registered pharmacist concerning a 70 year old male patient with asthma and type 2 diabetes mellitus and no drug reactions/allergies who on 20-APR-2012 was vaccinated SQ with a dose of ZOSTAVAX (dose and lot # not provided). The pharmacist reported that the patient who was administered ZOSTAVAX at the pharmacy developed itchy, red dots on both arms and hands on 01-MAY-2012. No treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The patient sought medical attention, called the pharmacy. Follow-up information has been received from the registered pharmacist provided a new information about the patient, who was vaccinated SQ in the right arm in deltoid region with a dose of ZOSTAVAX (Merck) (lot# reported as G007869) (dose not provided). The pharmacist reported that patient 1-2 weeks after receiving vaccine, developed itchy on both arms and hands, red dots on both arms and hands (approximately on 01-MAY-2012). Patient had also just started taking "ZPak" for respiratory infection (approximately in 2012). No treatment required for rash. None relevant diagnostics test were performed. The patient recovered "after 2-3weeks" (approximately on 22-MAY-2012). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 23 years old female patient with gastrooesophageal reflux disease. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 12-NOV-2007, 21-JAN-2011 and 05-SEP-2012. No other co-suspects were reported. Concomitant medications included: ZANTAC. The patient became pregnant with an LMP of 01-AUG-2012 and an EDD of 09-MAY-13 before receiving the third dose of vaccine. The pregnancy was discovered via home pregnancy test on 08-SEP-2012. The patient was exposed to GARDASIL during trimester 1. The patient is still pregnant. The patient had sought medical attention via seeing the nurse practitioner. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 18 year old female patient with no pertinent medical history, drug reactions or allergies. The patient's history of previous pregnancies and live births was not reported. The patient was vaccinated with dose 1 and dose 2 of GARDASIL (lot #, dose and route not reported) one year ago (approximately in 2011). No other co-suspects were reported. There were no concomitant medications. Subsequently, the patient became pregnant with an approximate LMP of April 2011. It was reported that the patient delivered a healthy infant without complications in January 2012. On 24-aug-2012, patient was in the office to receive the third dose of vaccine. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's medical history included Multiple Sclerosis. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot # unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles within one month after they received ZOSTAVAX. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously (lot number was not reported). No concomitant medications were reported. On an unknown date, the patient received ZOSTAVAX and got a rash at injection site that was itchy and a red patch, no treatment was given. The patient sought medical attention. On an unknown date, the patient recovered from the events. This case is linked to 1209USA011205(same reporter link). Additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot # unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed shingles within one month after they received ZOSTAVAX. At the report time the outcome of event was unknown. It was unknown 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: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # and route were not reported). No other co-suspects were reported. Concomitant medications included: LIPITOR. The pharmacist stated the patient reported "having tingling nerve sensations in her cheek and lips after receiving ZOSTAVAX. "The patient mentioned that it felt like her lips were getting bigger". The patient sought medical attention by contacting pharmacist. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Antibody test negative, Blood culture positive, Complement factor decreased, Death, Meningococcal sepsis
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Neisseria test positive
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Activated partial thromboplastin time prolonged, Blood creatinine increased, Blood culture positive, Blood pH decreased, Blood product transfusion
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Blood thromboplastin increased, Chills, Complement factor C3, Complement factor C4 decreased, Complement factor decreased
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Death, Disseminated intravascular coagulation, Endotracheal intubation, Haemodialysis, Haemorrhage intracranial
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Headache, Meningococcal sepsis, Myalgia, Nausea, Neisseria test positive
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Photophobia, Platelet count decreased, Prothrombin time prolonged, Pyrexia, Rash macular
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Respiratory distress, Viral infection, Vomiting, White blood cell count normal
Clinical narrative: Case number PHHY2012US086034 is an initial literature report received on 01 Oct 2012. The intent of the article was to present the case of a patient who developed fatal meningococcal sepsis despite having received immunization with MENVEO. This report refers to a 20-years-old male patient whose medical history included meningococcal meningitis 10 years ago. His concomitant medications were not reported. He was vaccinated with MENVEO (manufacturer and batch number not reported, hence conservatively taken as MENVEO) on an unknown date. Fifteen months later, he was presented with muscle aches, chills, fever, headache and sensitivity to light. He was diagnosed with a virus and ibuprofen was prescribed. Approximately eight hours later, he developed nausea, vomiting and a purplish macular rash. He was taken to the emergency room in respiratory distress and was intubated upon arrival. Laboratory investigations were performed and the results were reported as follows. His WBC count was 5.2 x 10^3/mm^3, platelet count was 23 x 10^3/mm^3, activated partial thromboplastin time was 131.9 seconds, prothrombin time was 31.6 seconds, arterial PH was 7.20 and creatinine was 2.42 mg/dL respectively (normal values of the laboratory tests were not reported). Despite treatment with ceftriaxone, dexamethasone, fresh frozen plasma (plasma protein fraction (human)), pressors and haemodialysis, he died on day 6 in hospital due to disseminated intravascular coagulation and intracranial haemorrhage. Blood cultures at 24 hours were positive for Neisseria meningitides serogroup Y. The author concluded the article stating that some individuals with terminal complement component deficiency (TCCD) demonstrate an impaired or short lives response to vaccination with meningococcal capsular polysaccharide.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician concerning to a female patient of unknown age who on an unspecified date was vaccinated with the first dose of GARDASIL (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient was administered with the first dose in the GARDASIL series and developed hives. The patient was prescribed BENADRYL and she recovered from the event. The patient sought medical attention, she was under care of the physician. The relatedness for developed hives was unknown for GARDASIL. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Culture cervix, Injection site anaesthesia, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 02-AUG-2012 was vaccinated with the third dose of GARDASIL (Lot#0624AE, expiration date not provided) into the left deltoid. On 08-AUG-2012, the patient came into the office with complaints of numbness in left arm. No further information was provided. Outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 02-AUG-2012 was vaccinated with the third dose of GARDASIL (Lot#0624AE, expiration date not provided) into the left deltoid. On 08-AUG-2012, the patient came into the office with complaints of numbness in left arm. No further information was provided. Outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on 02-AUG-2012 was vaccinated with the third dose of GARDASIL (Lot#0624AE, expiration date not provided) into the left deltoid. On 08-AUG-2012, the patient came into the office with complaints of numbness in left arm. No further information was provided. Outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Pain, Skin reaction, Skin warm, Urticaria
Clinical narrative: Upper right arm pain, low grade temp that evening 3" high and 5" wide. Irregular shaped red rash appeared in a.m. with temps average 100 degrees during day. Temp within normal range but rash seems to be spreading. Client taking Nuprin 300 mg every 3-4 hours for pain. Client stated she wasn't informed of side effects of vaccines.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Body temperature increased, Injection site pain, Rash erythematous
Clinical narrative: Upper right arm pain, low grade temp that evening 3" high and 5" wide. Irregular shaped red rash appeared in a.m. with temps average 100 degrees during day. Temp within normal range but rash seems to be spreading. Client taking Nuprin 300 mg every 3-4 hours for pain. Client stated she wasn't informed of side effects of vaccines.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle twitching, Palpitations
Clinical narrative: Abnormal Heart flutter
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cardiac flutter
Clinical narrative: Abnormal Heart flutter
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: C-reactive protein increased, Erythema, Leukocytosis, Mobility decreased, Oedema peripheral
Clinical narrative: Redness and swelling at the site of injection, fever to 104.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Redness and swelling at the site of injection, fever to 104.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: C-reactive protein increased, Full blood count, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at the site of injection, fever to 104.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersomnia, Irritability, Pyrexia
Clinical narrative: My Son has a rectal fever of 103.5 that won't stay down he is extremely fussy and has slept most of the day.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Asthenia, Burning sensation, Dizziness, Injected limb mobility decreased
Clinical narrative: Fever of 100-102 that won't break with Motrin, can't lift arm where I received the shot, injection site really hot, resting pulse between 110-120, dizzy, no energy, increased respiratory rate, joint aches, burning sensation in chest wall.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pyrexia, Respiratory rate increased
Clinical narrative: Fever of 100-102 that won't break with Motrin, can't lift arm where I received the shot, injection site really hot, resting pulse between 110-120, dizzy, no energy, increased respiratory rate, joint aches, burning sensation in chest wall.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Paraesthesia
Clinical narrative: Generalized rash, urticaria, lip and facial swelling/tingling/numbness, shortness of breath, pruritus.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus, Rash generalised, Swelling face, Urticaria
Clinical narrative: Generalized rash, urticaria, lip and facial swelling/tingling/numbness, shortness of breath, pruritus.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen normal, Vomiting projectile
Clinical narrative: Baby started forceful projectile vomiting with every feeding. There was no change in feeding according to mom.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pruritus, Rash macular
Clinical narrative: Minimal blotching upper arms, torso (anter) pruritus. ALLEGRA OTC with f/u appt 10/5/12 expect full recovery with returned to full day 10/5.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Employee developed rash after receiving vaccine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Employee developed rash after receiving vaccine.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Client receive Tdap; MCV4; influenza; varicella; HAV. After GARDASIL given client passed out in chair. Mother reports she had not eaten since 12PM. Client recovered within 1/2 hour, Sprite & crackers given. Client left 1/2 hour later.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Full body rash occurring 2 to 4 days after injection. Patient did no treat & clearing on its own.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Swelling
Clinical narrative: 10/2/12 Redness & swelling immediately status post giving vaccine - 2 1/2 inch x 3 inch. Ice applied for 10 min without significant reduction in erythema. 10/3/12 F/U: Spoke with pt on the phone. She states "she is much better. There is very little swelling and she feels soreness just from the needle stick." Offered to return to clinic if worsens. 10/4/12 RN's note above. Swelling essentially disappeared. Today, 10/4/12 - no swelling.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: This spontaneous report was received from a health care worker regarding a 44 year old female patient. The patient's medical history included trigeminal neuralgia, dysphagia unspecified. The patient's current condition included multiple sclerosis and weakness. The patient had no known drug allergies. The patient was vaccinated with a dose of ZOSTAVAX approximately on 13-SEP-2012 (reported as one week ago) (lot #, dose and route not reported). Concomitant medications included AMITIZA, acetaminophen, VICODIN prn, TRILEPTAL, EFFEXOR and alprazolam. On an unknown date, the patient experienced exacerbation of multiple sclerosis symptoms (medically significant). The patient had a preexisting condition of Multiple Sclerosis and was vaccinated with ZOSTAVAX and it exacerbated her symptoms of multiple sclerosis, caused a flare up. The patient sought medical attention. The outcome of the event was reported as not recovered at the time of this report. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given FLUMIST. Pt over recommended age.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Immediate post-injection reaction, Musculoskeletal pain, Nausea, Pain in extremity
Clinical narrative: Immediately after shot (vaccine) was administered, shoulder hurt into fingers. Had temperature overnight. Nauseated & vomited once. Better next day & now fine. Did not seek medical attention.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Immediately after shot (vaccine) was administered, shoulder hurt into fingers. Had temperature overnight. Nauseated & vomited once. Better next day & now fine. Did not seek medical attention.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient is developing shingles like symptoms on face and neck on same side of body that vaccine was given.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: FLUMIST administered on 9/24/12, on 9/27/12 fever 105.5.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: 2 morning a red rash appeared and was present for 1 week. It itch and was sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Local reaction, Pain, Skin warm
Clinical narrative: 9/28/12 Phone call from dr - states 12 - 24 hour after immunization pt started localized reaction 4 x 6 cm. Hot, painful, burning. Treating with OTC meds.
Age: 55.0
Sex: F
Vaccine: HEPAB, IPV
Symptoms: Rash
Clinical narrative: Took oral typhoid as directed starting 8-30-12, last pill 9-5-12. On 9-12-12 noted pin point rash on neck, arms and legs. No pain, no itching, lasted almost 5 days with concentration of rash that still slightly noted on legs 3 1/2 wk. after starting typhoid pills.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Approximately 3:30 FLUVIRIN given RD. 3:40 Sweating - prone. 3:50 - Pt. given juice & ice pack & prone with feet up. 4:00 Sitting - (-) sweating. 4:10 - Walked sitting (-) sweat. 4:15 - Left office with father & sister. States "I'm okay." Walked unassisted to car. 3:40 160/110 - P 48. 3:50 122/82 P 54. 4:00 146/90. 4:10 142/72 - P 50.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy. Prednisone & VALTREX.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: After vaccination patient complained of "a tingling sensation in the left side of tongue and like he could taste medication". Monitored for 25 minutes at which point symptoms had resolved.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Pt. says he developed rashes in arm on Friday or Saturday and called physician and was advised BENADRYL. Now here for f/u rashes in abd & back - no DIB, SOB, but have allergies to multiple meds. It's unclear if the rashes is particularly to any of the shot per pt has not had reaction before. I have given him prednisone tapering dose, ZYRTEC and ZANTAC & f/u go to ER if SOB.
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Costochondritis, Cough, Electrocardiogram abnormal, Nerve conduction studies
Clinical narrative: This study case was received from the investigator in the trial on 20 September 2012. A male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later on an unspecified date in December 2011, was found to have a dry cough and chest pain. On 03 December 2011 the subject was diagnosed with costochondritis (also with a reported date of 09 December 2011). On 09 December 2011 the subject was found to have a Troponin I, central laboratory level of <0.10 ng/ml and a rapid Troponin I level that was within normal limits (negative). An ECG was performed on 09 December 2011 and the result was abnormal: NCS (also reported as non-specific findings). Concomitant medications were reported as no. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of chest pain and dry cough were considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator in the trial on 20 September 2012. A male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later on an unspecified date in December 2011, was found to have a dry cough and chest pain. On 03 December 2011 the subject was diagnosed with costochondritis (also with a reported date of 09 December 2011). On 09 December 2011 the subject was found to have a Troponin I, central laboratory level of <0.10 ng/ml and a rapid Troponin I level that was within normal limits (negative). An ECG was performed on 09 December 2011 and the result was abnormal: NCS (also reported as non-specific findings). Concomitant medications were reported as no. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of chest pain and dry cough were considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Oedema peripheral, Pain, Rash, Skin warm
Clinical narrative: Swelling (hard) upper 2/3 of upper arm - local hard, hot, fine bumps. Iced & ADVIL. Soreness - day of.