chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant drugs was provided. On an unknown date in 2014 the patient was intramuscularly vaccinated with GARDASIL, dose, route, site of injection, lot# and expiration date not reported. It was reported that on an unspecified date in 2014 (reported as "within the last month"), prior to vaccination of the patient, the GARDASIL was improperly stored at 34F for 70 minutes. There were no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 48 patients of unknown age and gender. On an unknown date, an unknown number of doses of PROQUAD were inadvertently administered between January 2014 and June 2014 that had been improperly stored (-14C to -10C for about 5 months) was administered. No adverse effect reported. The reporter was unable to clarify how many of the 48 patients were administered PROQUAD and how many were administered VARIVAX (1406USA010167). At the time of the report the action taken was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 48 patients of unknown age and gender. On an unknown date, and unknown number of doses of VARIVAX were inadvertently administered between January 2014 and June 2014 that had been improperly stored (-14C to -10C for about 5 months) was administered. No adverse effect reported. The reported was unable to clarify how many of the 48 patients were administered VARIVAX and how many were administered PROQUAD (1406USA012539). At the time of the report the action taken was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Local swelling
Clinical narrative: This spontaneous report as received from approximately 63 year old female consumer regarding herself. The patient had none pertinent medical history and drug reactions/allergies to SULFUR, epinephrine and unspecified steroids reported. On 16-JUN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous 1 single shot for the prevention of shingles. Concomitant therapies included CORGARD. The consumer reported that on 17-JUN-2014, one day after receiving ZOSTAVAX her arm swelled to the size of a grapefruit, it was red and she developed elbow pain. No laboratory diagnostic studies performed. The patient sought medical attention and was treated with oxycodone and PHENERGAN. The events were recovering at the time of the report. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old male patient with elevated blood pressure and hyperlipidemia and no drug reactions or allergies. On 20-MAY-2014 the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (dose was not reported, lot #K004207, expiration date 13-MAR-2015). Concomitant therapies included atorvastatin and aspirin. On 21-MAY-2014 the patient experienced pain at the site of PNEUMOVAX 23 injection. This pain spread down the arm from the site of PNEUMOVAX 23 injection on unspecified date, in 2014 and thus the patient had difficulty moving that arm. There were no lab diagnostic studies performed. The patient took either ibuprofen or ALEVE for the pain on unspecified dates, in 2014. The patient sought medical attention by calling the physician (date unspecified, in 2014). On 10-JUN-2014 the patient recovered. No PQC (product quality complaint) was involved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from a nurse, an 85 year old female, regarding herself. On 31-APR-2012 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included fluocinonide ointment, 0.05% (manufacturer unspecified). On 18-MAY-2014, 749 days after onset of therapy, the patient experienced shingles outbreak, which she described as "feeling a tingling sensation followed by blisters at the center of her back and towards her breast." The nurse stated that the blisters were "now in the healing stages." Approximately four days later, treatment with an unspecified antiviral medication (manufacturer unspecified). The nurse also reported that, on an unspecified date, she developed "nerve pain from the shingles outbreak". Treatment for the nerve pain included TYLENOL #3 and LAVE (manufacturer unspecified), however the pain did not resolve. The outcome of shingles outbreak was reported as recovering/resolving. The outcome of nerve pain was reported as not recovered/not resolved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a 3 month old male patient. On 25-FEB-2005, the patient was vaccinated with MMR II (therapy type HSA), subcutaneously when the patient was 11 months old. The patient also received first dose of VARIVAX at the age of 11 months. A second dose of MMR II was administered to the patient on 29-MAY-2009. The patient also received a dose of PROQUAD on 23-JUN-2004 due to the first dose of MMR II not being valid. No adverse effect was reported. Outcome of the medication errors was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 23-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 25-JUL-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Flushing
Clinical narrative: Flushing face and neck. "Feels like it was on fire. Is better now."
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After receiving vaccines, patient got dizzy and lightheaded. Patient sat down and waited 5 minutes and began to feel better.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Autopsy, Chemotherapy, Death, Metastases to heart, Metastases to lung
Clinical narrative: Initial report received from the literature article on 18 June 2014. A 2-year-old patient (gender not reported) had received fourth dose of TDAP vaccine (dose, lot number, route and site of vaccination not reported) on an unspecified date. The patient had received all previous three doses on unspecified dates. The patient had a reported medical history of rhabdomyosarcoma and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO course including necrotizing pneumonia and tumor progression. After fourth vaccination of TDAP, the patient underwent chemotherapy. On an unspecified date, the patient developed pertussis. The patient died on an unspecified date. Time to death from illness onset was 78 days. The autopsy results were evident for pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no trace of ongoing infection found. Documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis, Pulmonary fibrosis, Pulmonary hypertension, White blood cell count decreased, White blood cell count increased
Clinical narrative: Initial report received from the literature article on 18 June 2014. A 2-year-old patient (gender not reported) had received fourth dose of TDAP vaccine (dose, lot number, route and site of vaccination not reported) on an unspecified date. The patient had received all previous three doses on unspecified dates. The patient had a reported medical history of rhabdomyosarcoma and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO course including necrotizing pneumonia and tumor progression. After fourth vaccination of TDAP, the patient underwent chemotherapy. On an unspecified date, the patient developed pertussis. The patient died on an unspecified date. Time to death from illness onset was 78 days. The autopsy results were evident for pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no trace of ongoing infection found. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The VARIVAX (Merck) had been stored at -10 C (Celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a field employee refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-JUN-2014, the patient was vaccinated with RECOMBIVAX HB lot # 0387AE, expiration date 31-MAY-2014. Dose and route were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that the patient received an expired dose of RECOMBIVAX HB. No adverse effects reported. 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 an unspecified number of unspecified patients. On unknown dates the patients were vaccinated with doses of GARDASIL (lot #, expiration date, dose and route unspecified) that were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 29-AUG-2012 and 02-OCT-2012 ZOSTAVAX (lot #, expiration date unspecified) (0.65ml, subcutaneously) was administered both times inadvertently instead of VARIVAX (Merck). No adverse effects reported either time. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored VARIVAX (Merck) 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10C (Celsius) (above recommended temperature range in product information) since July 2013. No adverse effect reported. Follow up information has been received form a healthcare worker concerning a patient of unspecified age and gender. On 30-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # H018786, exp date: 15-OCT-2014) that had been stored at -10 C (Celsius) (above recommended temperature range in product information) since July 2013. 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 28-OCT-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # reported as J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous (strength ans indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Headache, Hyperhidrosis, Muscle twitching, Nausea, Syncope
Clinical narrative: Patient fainted andtwitched in chair in lobby after receiving vaccinations. Patient vomited 4 times over the next hour and 40 minutes, with c/o nausea, sweating, and headache.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Patient fainted andtwitched in chair in lobby after receiving vaccinations. Patient vomited 4 times over the next hour and 40 minutes, with c/o nausea, sweating, and headache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Localized hives approximately 2 hours post vaccination. OTC hydrocortisone used to treat symptoms. Reaction subsided by next day.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Death
Clinical narrative: Unknown. Patient was at work. Taken to hospital and died. Details unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 22-JUL-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15 OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored via (Oka/Merck) VARIVAX 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effect reported. Follow up information has been received from a healthcare worker concerning a patient of unspecified age and gender. On 30-JUL-2013, the patient was vaccinated with a dose (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014) that had been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects 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: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown gender and age. The nurse reported that on an unknown date the multiple unspecified patient's were vaccinated with (Oka/Merck) VARIVAX (dose, frequency, lot number, expiry date not reported) that were improperly stored and no adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The nurse reported that unspecified number of improperly stored (Oka/Merck) VARIVAX 0.5 milliliter (ml) doses have been administered subcutaneously to unspecified number of patients on unspecified dates. The vaccine have been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. Follow up information has been received from a healthcare worker concerning a patient of unspecified age and gender. On 26-AUG-2013, the patient was vaccinated with a dose of (Oka/Merck) (VARIVAX) (lot # H018786, exp date: 15-OCT-2014) that had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one source of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received form a nurse practitioner regarding multiple unspecified number of patients of unknown gender and age. The nurse reported that on an unknown date the multiple unspecified patients were vaccinated with PROQUAD (dose, frequency, lot number, expiry date not reported) that were improperly stored and no adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Extreme swelling, redness, pain, fever to 100.5, muscle pains.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abasia, Dysstasia, Joint contracture, Weight bearing difficulty
Clinical narrative: In less than a week, patient began taking large exaggerated steps and began to have a bend in his legs.  He had been walking fine before the vaccine. By August he could no longer walk, stand or bear any weight on his legs and his legs became severely contracted.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This report refers to unspecified patients enrolled in a not blinded other studies on line at clinicaltrials.gov in which patients under the age of 50 years old received ZOSTAVAX. She reported that the study was started in July 2011 and completed in April 2012 and was sponsored by University. No adverse effect reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose decreased, Foetal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a pharmacist and described the occurrence of low blood sugar in a neonate male subject whose mother was vaccinated with BOOSTRIX (GlaxoSmithKline). On 29 January 2014, the 29-year-old subject's mother received an unspecified dose of BOOSTRIX (transplacentary, administration site unknown). The subject's mother last menstrual period was on 3 June 2013 and estimated date of delivery was on 6 March 2014. The neonate was exposed to the vaccine during the third trimester. At 39 weeks gestation, the neonate was delivered by normal vaginal and weighed 7 lb. At an unspecified time after birth, the neonate experienced low blood sugar. Therefore, he was hospitalised for 3 days. At the time of reporting, the outcome of the events was unspecified. Please see report A1059531A for details regarding the mother case.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. The patients medical histories were not reported. On an unknown date the unspecified number of patients were vaccinated with GARDASIL which were improperly stored. Concomitant medications were not reported. No symptoms reported. The outcome of improperly stored vaccine administered was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 05-FEB-2014 the patient was vaccinated with the first dose of GARDASIL (lot number reported as J008423, expiry date 21-JAN-2016, intramuscularly, 0.5 ml). On 24-JUN-2014, patient was confirmed to be pregnant by urine test. Her last menstrual period was 23-MAR-2014 and estimated date of delivery is 28-DEC-2014. The pregnancy outcome was pending. No treatment was provided. Patient sought medical attention. There was no significant disability, the experienced was not life threatening and there was no hospitalization. A product quality complaint was also not involved. Outcome of the vaccine exposure during pregnancy was unknown. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 2 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 25-JUN-2014, the patient was inadvertently administered a dose of VAQTA (dose, route and lot number not provided), instead of a dose of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 08-JUN-2014, the patient was administered MMR II INJ, 0.5 mL, subcutaneously (lot number not provided). The nurse reported that the MMR II expired on 17-MAY-2014. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age and gender. The healthcare worker reported that on 05-JUN-2014 a patient received an expired ROTATEQ (lot# H017721, expiration date 01-APR-2014, 2ml oral). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test positive, Parotitis
Clinical narrative: This literature market report was received from an author. Abstract Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccines intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Council of Stated and Territorial Epidemiologists (CSTE). A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without other apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstration of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without laboratory confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to the 2 case-patients with documented 1 doses of Measles, Mumps, and Rubella Virus Vaccine, Live (manufacturer unknown) vaccine, 2 (12%) were found to be mumps IgM antibody positive and on an unknown date the patients developed parotitis. The outcome of event was unknown. The reporter considered events to be related to Measles, Mumps, and Rubella Virus Vaccine, (manufacturer unknown). This is one of the several reports with literature linked. Additional information has been compatible.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test positive, Parotitis
Clinical narrative: This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Epidemiologists. A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstration of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without laboratory confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to the 27 case-patients with documented 2 doses of MMR (manufacturer unknown) vaccine, 27 (15%) were found to be mumps IgM antibody positive and on an unknown date the patients developed parotitis. The outcome of event was unknown. The reporter considered events to be related to MMR (manufacturer unknown). This is one of the several reports with literature linked. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and unknown age. On 20-JUN-2014, the patient was vaccinated with an expired dose of ZOSTAVAX lot # H021459, expiration date 30-APR-2014 (dose, route and indication not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test positive, Parotitis
Clinical narrative: This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Epidemiologists. A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstration of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without laboratory confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to the 156 case-patients with documented 2 doses of MMR (manufacturer unknown) vaccine, 27 (15%) and who on an unknown date the patients developed parotitis. The outcome of event was unknown. The reporter considered events to be related to MMR (manufacturer unknown). This is one of the several reports with literature linked. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Epidemiologists. A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstration of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without laboratory confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to the 15 case-patients with documented 1 doses of MMR (manufacturer unknown) vaccine, 27 (15%) and on an unknown date the patients developed parotitis. The outcome of event was unknown. The reporter considered events to be related to MMR (manufacturer unknown). This is one of the several reports with literature linked. Additional information has been requested.
Age: 1.07
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Convulsion
Clinical narrative: Apparent first time seizure - parent brought child to ER but left without being seen last night. Seen in office today in follow up. Denies fever at time of seizure.
Age: 1.07
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 month old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 02-JUN-2014 the patient was vaccinated with M-M-R II, dose 0.5ml, route subcutaneous (indication also reported as routine). On 14-JUN-2014, the patient developed measles. The reporter stated that the patient went to the emergency room on 14-JUN-2014 and was sent home from the emergency room with a prescription for an unspecified steroid. The outcome of measles was reported as recovering/resolving. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Ecchymosis, Erythema, Skin warm, Swelling
Clinical narrative: Raised, warm erythematous, small ecchymosis, aprox 6 cm in diameter.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Swelling/redness/itching of left arm x 5 days. Referred pt to PCP.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Viral infection
Clinical narrative: Patient received vaccines, contracted viral illness 5/21/14. Diagnosed w/GBS on 6/11/14.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives from head to toe. Oral antihistamine taken for treatment. Time course of approximately one week.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Syncopal episode.  Pale and diaphoretic.  BP normal.  Recovered completely.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Exremely sore arm. All-day fever, 100.8 f. Weakness. Lethargy.
Age: 7.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events, wrong dose given.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Rash erythematous, Temperature intolerance
Clinical narrative: Slight red bump- No itching or redness transeding. Nausea, fever and cold intolerance.
Age: 1.09
Sex: F
Vaccine: MMR
Symptoms: Bronchitis, Dehydration, Diet refusal, Lymphadenopathy, Pharyngitis streptococcal
Clinical narrative: ON 6/9, CHILD DEVELOPPED RASH, AND HAD A FEVER OF 101.9 F. WAS SEEN AT A CLINIC WAS DIAGNOSED WITH STREP THROAT (NO RECORD OF ANY TESTING DONE). CHILD WAS STARTED ON KEFLEX. ON 6/9, HAD HIGH FEVER 105 THAT WASN'T REDUCED BY TYLENOL ALTERNATING WITH MOTRIN. SHE WAS SEEN AT CLINIC. (FAMILY WAS TRAVELING). AT THE CLINIC, THE CHILD WAS ASSESSED AS HAVING MINOR LYMPHADENOPATHY, CONTINUED RASH, MOUTH SORES. STREP SCREEN WAS NEGATIVE. CHILD WAS TREATED WITH BENADRYL AND MAALOX, AND TO CONTINUE KEFLEX, TYLONOL AND MOTRIN. ON 6/13, CHILD WAS REFUSING TO EAT OR DRINK, WITH LITTLE URINE OUTPUT, SO SHE WAS HOSPITALIZED. DIAGNOSES WERE DEHYDRATION, BRONCHITIS. SHE WAS DISCHARGED ON 6/15.
Age: 1.09
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Stomatitis, Streptococcus test negative, Urine output decreased
Clinical narrative: ON 6/9, CHILD DEVELOPPED RASH, AND HAD A FEVER OF 101.9 F. WAS SEEN AT A CLINIC WAS DIAGNOSED WITH STREP THROAT (NO RECORD OF ANY TESTING DONE). CHILD WAS STARTED ON KEFLEX. ON 6/9, HAD HIGH FEVER 105 THAT WASN'T REDUCED BY TYLENOL ALTERNATING WITH MOTRIN. SHE WAS SEEN AT CLINIC. (FAMILY WAS TRAVELING). AT THE CLINIC, THE CHILD WAS ASSESSED AS HAVING MINOR LYMPHADENOPATHY, CONTINUED RASH, MOUTH SORES. STREP SCREEN WAS NEGATIVE. CHILD WAS TREATED WITH BENADRYL AND MAALOX, AND TO CONTINUE KEFLEX, TYLONOL AND MOTRIN. ON 6/13, CHILD WAS REFUSING TO EAT OR DRINK, WITH LITTLE URINE OUTPUT, SO SHE WAS HOSPITALIZED. DIAGNOSES WERE DEHYDRATION, BRONCHITIS. SHE WAS DISCHARGED ON 6/15.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site about 4 inches in diameter.  The reaction site was also warm to the touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex serology, Rash generalised, Rash vesicular, Viral titre
Clinical narrative: Varicella like rash, started on leg and spread to rest of body. Pt unsure of previous varicella exposure/infection as child--he does not recall any.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Headache, Chills, Fever, Sweating, Shaking, Aches and pain in joints/muscles all over the body. Treatment: Motrin and Tylenol. Patient received telephone consult with RN.  Patient still has the symptoms but they lessening.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Tremor
Clinical narrative: Headache, Chills, Fever, Sweating, Shaking, Aches and pain in joints/muscles all over the body. Treatment: Motrin and Tylenol. Patient received telephone consult with RN.  Patient still has the symptoms but they lessening.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Pyrexia, Swelling
Clinical narrative: Swollen red shoulder with fever and headache.
Age: 44.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: STILL HAVING ALOT OF PAIN THE PAIN IS SO BAD THAT IT INTERFERES TRYING TO GET THINGS DONE AROUND MY HOME. DOCTOR DID GIVE A INFLAMATOR MEDICINE BUT DID NOT HELP.
Age: 44.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Pain in extremity
Clinical narrative: STILL HAVING ALOT OF PAIN THE PAIN IS SO BAD THAT IT INTERFERES TRYING TO GET THINGS DONE AROUND MY HOME. DOCTOR DID GIVE A INFLAMATOR MEDICINE BUT DID NOT HELP.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pharyngeal oedema
Clinical narrative: Patient stated he went to ER in late evening presenting with swollen throat area. ER stated they gave him IV Solu-Medrol. Wrote prescriptions for prednisone, Benadryl and Ventolin which patient filled on 6/26/14 in the morning.  Patient stated that he felt better this morning but decided to fill his prescriptions to follow MD's orders.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Condition aggravated, Dysarthria, Dysphagia, Immunoglobulin therapy
Clinical narrative: Patient's symptoms have gotten worse, and speech has slurred, swallowing as gotten increasingly worse.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Patient's symptoms have gotten worse, and speech has slurred, swallowing as gotten increasingly worse.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Came for routine physical; gave the provider all papers -except the prescription stating that she had received a HPV Vaccine that same day in morning.  Dr. went over the vacccines to be given and patient expressed understanding.  After the nurse had given seven vaccines patient provided the nurse with a prescripition for HPV and stated she received this shot this am.  Patient got HPV in am and HPV in pm.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Redness and mild swelling first noted in upper arm around injection site. The patients physician was notified and did come in to see pt. No new orders. By the second day it was noted that the redness extended down the arm from the injection site to the wrist. Site was warm to touch. Physician notified again and did come in to see patient. Physician felt patient was experiencing a delayed hypersensitivity-type reaction. Reaction gradually faded.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Redness and mild swelling first noted in upper arm around injection site. The patients physician was notified and did come in to see pt. No new orders. By the second day it was noted that the redness extended down the arm from the injection site to the wrist. Site was warm to touch. Physician notified again and did come in to see patient. Physician felt patient was experiencing a delayed hypersensitivity-type reaction. Reaction gradually faded.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient reported rash at injection site about 2 by 4 inches that was warm and slightly itchy on 6.24. as of 6.26, rash was slightly larger per patient, but less red and itchy per patient report.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: None partial dose administered.   Pt received liquid diluent containing serogroups C, Y, and W135 but did not receive MenA lyophilized conjugate component.   No adverse effects.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Screaming, Weight bearing difficulty
Clinical narrative: Child screaming unconsolably for 1 hour and then would not bear weight but had normal exam.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Needed vaccine compliance; got Tdap in ER. Noticed on 6/24/14 AM redness, pain and itching to site. Treated with TYLENOL and Ibuprofen.
Age: 55.0
Sex: F
Vaccine: HEP, YF
Symptoms: Erythema, Hepatitis B surface antibody positive, Injection site irritation, Local reaction, Oedema peripheral
Clinical narrative: Local reaction. Client came to HD/Imm. clinic for services on 3/13/14. Travel/Immunizations and blood work for HBsAB. 1) Yellow fever and Hep-B #3, 2) blood work for HBsAB. F/U PCP 4/1/14. 1 wk irritation at site of injection, 2nd wk redness and tender, 3 wk 3 lumps (LA) swelling (L) armpit.
Age: 55.0
Sex: F
Vaccine: HEP, YF
Symptoms: Tenderness, Upper extremity mass
Clinical narrative: Local reaction. Client came to HD/Imm. clinic for services on 3/13/14. Travel/Immunizations and blood work for HBsAB. 1) Yellow fever and Hep-B #3, 2) blood work for HBsAB. F/U PCP 4/1/14. 1 wk irritation at site of injection, 2nd wk redness and tender, 3 wk 3 lumps (LA) swelling (L) armpit.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: There is a 1 cm pink area where the vaccine was injected and distal to that a 4-5 cm diameter pink warm area. Larger new reaction that is not.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash
Clinical narrative: 6-25-14 Symptoms of fatigue, rash (started 3 days ago). Diagnosis: Herpes zoster. Treatment: VALTREX 1gm - 1 tab two times daily #14, 7 days, ZOVIRAX 5% cream - 1 app three times daily, 60 grams.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pt began to feel pain 2 days after administration of shot. Pt states that area of pain is growing around sight of injection. No bruising. No rash. No skin irritation.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: There was 9 x 8 inch area of induration, erythema and warmth extending from (R) shoulder to just above elbow. Tx with BENADRYL and KEFLEX.