chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5 ml, intramuscular; third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011907, 1407USA011908, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster disseminated, Rash
Clinical narrative: Pt with a diagnosis of chronic lymphocytic leukemia was administered ZOSTAVAX on 10/7/13 (contraindicated) Patient presented on 10/28/13 with a rash on legs, and again on 10/29/13 with a different rash to face. Patient instructed by primary care to hydrate, use cortisone cream and BENADRYL cream. Patient called heme/onc 10/30/2013 requesting meds for chicken pox and was prescribed acyclovir 800mg five times daily for 5 days. Patient reported to ER on 11/1/2013 with worsening rash. Was admitted with disseminated zoster and started on acyclovir 800mg IV QSH. He was discharged 11/4/2013.
Sex: M
Vaccine: ANTH, TYP
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2014. A male subject with a history of receiving ACAM2000 in May 2008 had received on 19 June 2014 the following concomitant vaccines: Typhoid vaccine and Anthrax vaccines (manufacturer, lot numbers, routes and sites of administration not reported) and 25 days later experienced a positive rapid troponin I. The subject had a normal lab troponin and an ECG that "appears normal". The subject was asymptomatic and recovered on the same day 14 July 2014 without treatment. The subject was in the control group and did not receive the study vaccine during the study period. According to the investigator, no information was expected to become available. The investigator considered the event of positive rapid Troponin I to be mild in severity, remotely related and an other important medical event. Documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin Rash. Diphenhydramine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5 ml, intramuscular; third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011905, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site of injection.
Sex: M
Vaccine: ANTH, TYP
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 18 July 2014. A male subject (date of birth unspecified) had a history of receiving the following vaccination on an unspecified date in January 2003: ACAM2000 (lot number, route and site not reported). On 19 June 2014, the subject also received Typhoid (Manufacturer Unknown, lot number, route and site not reported), and Anthrax (Other Manufacturer, lot number, route and site not reported). Twenty-five days later on 14 July 2014, the subject was found to have a positive rapid Troponin level I. Lab work from 14 July 2014, the troponin level was <=0.10 ng/ml. An ECG appeared normal and the subject was asymptomatic on an unreported date. The subject did not have any medical history relevant to the event and did not take any medications to treat the event. The subject recovered on 14 July 2014. The subject was in the control group and did not receive the study vaccine during the study period. According to the investigator, no information was expected to become available. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Injection site rash, Irritability, Rash generalised
Clinical narrative: Approximately 11 days (10-11 days) after patient received 1yr vaccines (MMR, Varicella, Hib, Hep A), she became fussy with decreased appetite. Today (7-24-14), she developed a rash which started on her back, then spread to her stomach, diaper area, arms, then face and behind her ears and behind her knees. See attached office visit note.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. Pharmacist reported that sometime in 2007 and 2008, an unspecified number of patients received improperly stored doses of GARDASIL (dose, route and lot number not reported). However, he stated that more dates were involved (unspecified what the other dates were) and multiple patients were involved (unspecified number). He did not have patient information. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Redness, soreness, swelling, mild lump, warmth around the site of injection down to her elbow. Left shoulder and neck has a tingly feeling.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Paraesthesia
Clinical narrative: Redness, soreness, swelling, mild lump, warmth around the site of injection down to her elbow. Left shoulder and neck has a tingly feeling.
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUL-2014, the patient received VARIVAX (lot# J003223, expiration date: 15-MAR-2015) 0.5 ml, subcutaneous, which was stored improperly. The patient received Diphtheria toxoid, Pertussis acellular vaccine (unspecified), Tetanus toxoid (reported as Pediatric TDaP booster) and MENACTRA. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's demographics were unknown. There was no information on pertinent medical history and drug reaction or allergies. On 23-JUL-2014, the patient was inadvertently vaccinated with PNEUMOVAX23 (dose, frequency, product#, expiration date, not reported), intramuscularly which expired on 25-JAN-2014. This was supported. No adverse effects were reported. There was no product quality complaints involved. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 47 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with expired PNEUMOVAX23 (lot# H017759, expiration date: 04-JUL-2014). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23.  Additional information is not expected because the reporter does not want to be contacted regarding the report.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 08-JUL-2014, the patient was vaccinated with an improperly stored does of (Oka/Merck) PROQUAD injection (dose, route of administration, indication, lot #, expiry date unspecified). No concomitant medications were reported. No symptoms were reported. Additional information is not expected because the reporter refused follow-up.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 35 year old female consumer refers to herself. On 04-JUN-2014 the patient was vaccinated with M-M-R II (lot# H017433, exp. 20-SEP-2014) 0.5 ml, subcutaneous. The consumer reported that she became pregnant within 3 weeks of receiving M-M-R II. The patient became pregnant with date of last menstrual period (LMP) of 09-MAY-2014 based on by subtracting the gestational age from 27-JUN-2014 and estimated delivery date (EDD) of 13-FEB-2015. Date of conception based on first day of the last menstrual period was 23-MAY-2014. On 23-JUN-2014 pregnancy test was performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.06 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405USA012894, 1406USA000955, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as from 20-MAR-2014-MAY 2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibratiion to the health department.    Follow-up info has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on unknown dates 25 patients received doses of PNEUMOVAX (lot # J014399, exp date 20-NOV-2014), where were stored improperly (highest temperature: 9.5C and number of hours prior to administration: 7 hours; 2 patients, highest temperature: 9.5C and number of hours prior to administration: 41  hours: 2 patients, highest temperature: 9.5C and number of hours prior to administration: 78 hours: 3 patients, highest temperature: 10C and number of hours prior to administration: 4, 1 patient, highest temperature: 10C and number 0f hours prior to administration: 3 hours: 4 patients, highest temperature: 10C and number of hours prior to administration: 8 hours, 1 patient, highest temperature: 10C and number of hours prior to administration: 9 hours, 12 patients) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter. Additional information is not expected, as correspondence was returned by post office.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.06 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405usa012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J009723 and exp date 30-JAN-2015 (also reported as 31-JAN-2015) which was stored improperly (highest temperature: 9C, number of hours prior to administration: 18 hours) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5ml once, subcutaneously (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 50  hours) through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS#1406USA000955, 1406USA000956, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow up information was received from the registered nurse. I was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as from 20-MAR-2014 to 07-MAY-2014). The reporter stated they were replacing the refrigerator, freezer, and the data logger and were sending the data logger for calibration to the health department.   Follow up information has been received from the registered nurse. She called back to specify that 7 patients were vaccinated with doses of M-M-R II, lot J002934 expiry date: 14-MAR-2015, which was stored improperly for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). One patient received dose that was stored at highest temperature 9.5C for 269 hours. Four patients were given doses that were stored at highest temperature 10C for 274 hours. Two patients were vaccinated with doses that were stored at highest temperature 10C for 278 hours. This is one of several reports from the same reporter. Additional information is not expected as the correspondence was returned by the post office.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405USA012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J009723 and exp date 30-JAN-2015 which were stored improperly (highest temperature: 9C, number of hours prior to administration: 7 hours: 4 patients; highest temperature: 9.5C and number of hours prior to administration: 13 hours: 1 patient) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 5 year old female patient. The patients drug allergies and pertinent medical history was not reported. On 03-JUL-2013 the patient was vaccinated with M-M-R II (dose: 0.5ml) (lot # and expiry date was not reported, therapy status was not reported) subcutaneously in the left thigh. Concomitant medications were not reported. On 03-JUL-2013, the patient was vaccinated with extra dose, third dose of M-M-R II. No adverse effects were reported. The healthcare worker reported that this error occurred when they were converting their paper charts to electronic records. No product quality complaint (PQC) was reported for M-M-R II. The case is linked to case # 1407USA011741 (same reporter link. Additional information is not expected as the reporter do not want to be contacted about the report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash erythematous, Swelling
Clinical narrative: Large red rash at site and around it. Larger swelling around that area extending to back of arm/2in. long 1in. wide. Second area 5in. long by 2 in. wide. Swollen, itchy. Benadryl and calamine lotion prescribed by Dr.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405USA012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J005067 and exp date 17-JAN-2015 which was stored improperly (highest temperature: 9C, number of hours prior to administration: 36 hours) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405usa012894, 1406USA000955, 1406USA000957, and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department.   Follow-up information has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on an unknown date one patient received PNEUMOVAX lot # J004387 and exp date 04-JAN-2015 (also reported as 31-JAN-2015) which was stored improperly (highest temperature: 8.5C, number of hours prior to administration: 15 minutes (min)) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter.  Additional information is not expected, as correspondence was returned by post office.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unkown age and gender. On 01-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (strength, dosage, route and lot# not reported). Other doses of GARDASIL were administered on 05-OCT-2012 (second dose) and 21-DEC-2012 (third dose). The nurse reported the patient received dose 3 of GARDASIL early. No symptoms reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to 72 year old female patient. On 15-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot # was reported as K000329, expiration date: 06-MAR-2015, dose: 0.65 ml, subcutaneously).  The pharmacist reported that the patient returned to the pharmacy on the next day (16-JUL-2014) with a red, raised, tender area at the injection site which happened on 15-JUL-2014. No treatment was given. At the time of reporting, the patient did not recover from the event "red, raised, tender area at the injection site". Causality between the event and the ZOSTAVAX was not provided.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of M-M-R II, 0.5 ml once, subcutaneously (lot/batch number not available) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also GARDASIL, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS#1406USA000955, 1406USA000956, 1406USA00957 and 1406USA000958 respectively). No adverse effects were reported.   Follow up information was received from the registered nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as 20-MAR-2014 to 07-MAY-2014). The reporter stated they were replacing the refrigerator, freezer and the data logger and were sending the data logger for calibration to the health department.  Follow up information has been received from the registered nurse. She called back to specify that 4 patients were vaccinated with doses of M-M-R II lot J003005 expiry date: 14-MAR-2015, which was stored improperly for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). Two patients were given doses that were stored at highest temperature 10C for 242 and 246 hours, respectively. Two patients were vaccinated with doses that were stored at highest temperature 10C for 248 hours.  This is one of several reports from the same reporter. Additional information is not expected as the correspondence was returned by the post office.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 5 year old female patient. The patients drug allergies and pertinent medical history was not reported. On 03-MAY-2012 the patient was vaccinated with M-M-R II (dose 0.5 ml) (lot # and expiry date was not reported, therapy status was not reported) subcutaneously in an unspecified location. Concomitant medications were not reported. On 03-MAY-2012, the patient was vaccinated with third dose of M-M-R II. No adverse effects were reported. The healthcare worker reported that this error occurred when they were converting their paper records to electronic records. No product quality complaint (PQC) was reported for M-M-R II. This case is linked to case # 1407USA011556 (same reporter link). Additional information is not expected as the reporter do not want to be contacted about the report.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date in 2005 (reported as 9 years ago) the patient was vaccinated with first dose of GARDASIL, intramuscular (dose not reported). No other concomitant therapies reported. On 23-JUL-2014 the patient visited the pharmacy to receive the second dose of GARDASIL. No adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: This spontaneous report as received from a 58 year old female via field representative refers to herself. On 25-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dosage, route unknown) . Concomitant therapies included CORTISONE. On 25-JUN-2014, for two days the patient had a rash underneath the injection site. The patient also had to use cortisone cream to relieve the itching on the third day. The patient mentioned the injection site was still red. The outcome of adverse events was reported as recovered. The causality between the events and ZOSTAVAX was unknown. The patient sought medical attention. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt. reports developed rash on 7/20/14 still present 7/23/14 when seen in clinic. (+) itchiness, no fever no h/a. Rash presents mainly on chest/abdomen few spots on back. No present extremities or lower body. Given MEDROL dose pack and instructed to get hydrocortisone 1% cream OTC to help with itchiness. Spoke with pt. on 7/24/14 after treatment. Reports rash has improved.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Mass, Neck pain, Pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to the 43 year old White male patient with (felt two weeks ago), neck painful and movement painful, Hodgkin's lymphoma, hypothyroid, tobacco use, GERD, vitamin d deficiency and no known allergies. The patient's medical history included sarcoidosis and leukopenia. It was reported that on 20-MAR-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 09-JUN-2014 at 16:00, was vaccinated with the second dose of RECOMBIVAX HB in his left arm (lot number J008505) (dose and route not reported). No adverse events were reported. This is one of several reports from the same patient (MARS# 1406USA006320). Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a medical assistant regarding a 19 year old female patient with penicillin allergy. Patient's pertinent medical history was unspecified. On 09-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot # J010668, expiration date 29-APR-2016). The patient was diagnosed as pregnant after her first dose of GARDASIL. At time of call, on 24-JUL-2014, patient was seven weeks and 4 days pregnant. No adverse effects were noted. The last menstrual period (LMP) was approximately of 01-JUN-2014 and estimated delivery date (EDD) of approximately 08-MAR-2015. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site reaction, Pruritus, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to approximately 58 year old female patient. No pertinent medical history and concurrent conditions reported. On 11-SEP-2013 the patient ws vaccinated with ZOSTAVAX. vial 19400 PFU, subcutaneous (dose not reported). No other concomitant therapies reported. On 11-SEP-2013, the patient experienced immediate reaction at the injection site following the administration of ZOSTAVAX. The reporter also stated that the patient developed round circle about the size of a 50 cent piece that was red, swollen and itchy. It was reported that this area decreased in size after about 15 minutes and the patient was recovered within a few days. No treatment was required for the adverse event. The patient sought medical attention. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. No hospitalization required.The event was not life threatening. The outcome of the events was reported as recovered/resolved. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent medical conditions and medical history was not reported. On 02-JUL-2014, the patient was vaccinated with VARIVAX (merck) (dose and lot #: unknown, subcutaneously) which were given to the patient in error. No adverse effects were known a the time of the report. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5 ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported.  This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011905, 1407USA011906, 1407USA011907, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Contusion, Pain in extremity, Tuberculin test positive
Clinical narrative: Client received 3 immunizations and a TST on Friday, 7/18/14 and returned on Monday for TST read.  Mentioned at that time that she had a bruise and pain on the back of her left arm.  Bruise evident.  It was recommended to her that she take ibuprofen or acetaminophen for pain as needed.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Persistent severe pain left shoulder with limited ROM secondary to pain, more than 7 weeks after the vaccination.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, itchy, tender and warm on the arm administered.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Headache, Migraine, Nausea
Clinical narrative: Feeling weak, nausea, headache. After taking a nap woke up and had a migraine. Stated s/s developed 07/19/2014 and has not reported until 07/24/2014.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Pentacel combination immunization was ordered which included the DTaP,IPV and Haemophilus b Conjugate, This involves mixing the DTaP and IPV with the Haemophilus b Conjugate. I only gave the Hib component. This was noticed immediately and mother was notified, she was still in the office with the child. NP was notified and vaccine was re administered correctly as per protocol. Mother was informed of any potiential risk or harm and the mother and child left the office without any signs of distress or harm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: 2 days of dizziness, nausea, blurred vision. Treatment was rest and fluids with electrolytes and sugar
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Anti-thyroid antibody, Asthenia, Basedow's disease, Blood thyroid stimulating hormone decreased, Myxoedema
Clinical narrative: Acute onset of profound weakness, myxedema and Graves disease.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Thyroxine increased
Clinical narrative: Acute onset of profound weakness, myxedema and Graves disease.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011908, 1407USA011909, 1407USA11910, 1407USA011911). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA11910, 1407USA011911). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011907, 1407USA011908, 1407USA11909, 1407USA011911). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5ml, intramuscular, third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011906, 1407USA011908, 1407USA011909, 1407USA11910). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Her arm was swollen, red, purple red and unable to lift. Pt went to ER. She has a steroid shot and 4-5 days of steroid pills.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt was given Tdap and MCV on 7-22-14. Seen in office on 7-24-14 due to erythema, warmth and mild pain to both injection sites. From Tdap site, erythema is extending down arm to elbow, not hard, weeping or pus seen. Pt has been applying warm compresses. Told to continue this practice.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local site reaction: red, swollen, warm to touch
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eosinophil percentage increased, Erythema, Excoriation, Haematocrit normal, Haemoglobin normal
Clinical narrative: She was given the shot on Tuesday and then Wednesday she took a shower and removed the Band-Aid and started to feel warmth and swelling at the injection site. She used a poison ivy topical spray and started taking oral BENADRYL. Thursday she reported some papules described as hard spots on her back but denies having pustules. Her palms were red as well as having more of the small bumps on her chest and legs. She has been taking ADVIL every 4 hours which is sedating. Yesterday she stop the BENADRYL and had what sounds like a withdrawal headache. She did have some single excoriated papules on her back and upper chest but I did not see any pustules. The right arm injection site has resolved. Diphenhydramine, Hydroxyzine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Injection site warmth, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: She was given the shot on Tuesday and then Wednesday she took a shower and removed the Band-Aid and started to feel warmth and swelling at the injection site. She used a poison ivy topical spray and started taking oral BENADRYL. Thursday she reported some papules described as hard spots on her back but denies having pustules. Her palms were red as well as having more of the small bumps on her chest and legs. She has been taking ADVIL every 4 hours which is sedating. Yesterday she stop the BENADRYL and had what sounds like a withdrawal headache. She did have some single excoriated papules on her back and upper chest but I did not see any pustules. The right arm injection site has resolved. Diphenhydramine, Hydroxyzine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume increased, Monocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: She was given the shot on Tuesday and then Wednesday she took a shower and removed the Band-Aid and started to feel warmth and swelling at the injection site. She used a poison ivy topical spray and started taking oral BENADRYL. Thursday she reported some papules described as hard spots on her back but denies having pustules. Her palms were red as well as having more of the small bumps on her chest and legs. She has been taking ADVIL every 4 hours which is sedating. Yesterday she stop the BENADRYL and had what sounds like a withdrawal headache. She did have some single excoriated papules on her back and upper chest but I did not see any pustules. The right arm injection site has resolved. Diphenhydramine, Hydroxyzine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Papule, Platelet count normal, Red blood cell count normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: She was given the shot on Tuesday and then Wednesday she took a shower and removed the Band-Aid and started to feel warmth and swelling at the injection site. She used a poison ivy topical spray and started taking oral BENADRYL. Thursday she reported some papules described as hard spots on her back but denies having pustules. Her palms were red as well as having more of the small bumps on her chest and legs. She has been taking ADVIL every 4 hours which is sedating. Yesterday she stop the BENADRYL and had what sounds like a withdrawal headache. She did have some single excoriated papules on her back and upper chest but I did not see any pustules. The right arm injection site has resolved. Diphenhydramine, Hydroxyzine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site 6cm x 7cm (left arm). Being treated with BACTRIM.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Mass, Mobility decreased, Pain
Clinical narrative: Pt had reaction to PNEUMOVAX vaccine given. Contacted office on 7/25/14. Pt states she went out to town the morning following appointment. Noticed pain, lump and redness around 7pm the evening of the vaccine. Next day pt states arm was red down to elbow, hot, swollen and she was unable to raise. Patient was out of town and instructed to go to ER. States she was treated with BENADRYL and given a regimen of Clindamycin. States arm is improving as of 7/25/14. Follow up appointment given for 7/29/14 at 11:45 AM with PCP.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt had reaction to PNEUMOVAX vaccine given. Contacted office on 7/25/14. Pt states she went out to town the morning following appointment. Noticed pain, lump and redness around 7pm the evening of the vaccine. Next day pt states arm was red down to elbow, hot, swollen and she was unable to raise. Patient was out of town and instructed to go to ER. States she was treated with BENADRYL and given a regimen of Clindamycin. States arm is improving as of 7/25/14. Follow up appointment given for 7/29/14 at 11:45 AM with PCP.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient received DTaP vaccine in (L) thigh. Patient developed fever of 102.8 degrees F (daycare reports), erythema and redness at site. Erythema and redness is localized to injection site and measures 3 1/2" x 2 5/8" in size.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Sensation of heaviness
Clinical narrative: Tingling and heaviness in her left arm, tingling in her left foot.
Sex: F
Vaccine: FLUX
Symptoms: Fall, Limb injury, Pneumonia
Clinical narrative: This case was reported by a consumer and described the occurrence of pneumonia in an elderly female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified) and Advair for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. Concurrent medical conditions included osteoporosis. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route and injection site; lot number not provided), unspecified dose of Advair (unknown route, dosage and frequency). At an unspecified time after administration of Advair and after vaccination with Influenza vaccine (unspecified), the subject experienced pneumonia, she fell down and hurt her lung. The subject reported that she had to be hospitalised due to reaction of an unknown flu shot. At the time of reporting the outcome of the events was unspecified.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pts. left arm has 4"x1" erythema, 3"x2.5" swelling warm and painful site. Iced several times and took 25mg of BENADRYL.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: Generalized convulsions which required airway support and self resolved before any additional treatment in about 5 minutes while in ambulance to ER.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Symptoms, began last night (7/15/14): Rt. deltoid swelling, pain, tightness and warmth, per patient's mother. Applying ice pack and giving pain medication.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 19 year old female patient. No pertinent medical history, drug reactions or allergies were reported. On an unknown date the patient was vaccinated with GARDASIL (strength, formulation, dose, dose number, route, lot number and expiration date were unspecified) and afterwards it was determined that the patient was pregnant (unspecified date). Concomitant therapies were not reported. Laboratory diagnostic studies performed were unspecified. The patient sought medical attention (unspecified). The patient became pregnant with last menstrual period of 26-JUN-2014 (reported as 3-4 weeks of gestation) and estimated delivery date of 02-APR-2015. The pregnancy outcome was pending. The outcome of the event was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative, refers to a 16 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot number reported as K006447) (1 single shot, unspecified route and dose), intramuscular. Concomitant medications were not reported. The nurse reported that on an unspecified date after receiving the first dose of GARDASIL the patient (demographics unknown) fainted and was taken to the hospital (duration and demographics unknown) for a possible concussion. The outcome of patient fainted and possible concussion was not reported. The relationship between GARDASIL and the events was not reported. Additional information has been requested.