chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Metrorrhagia, Migraine
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) refers to a 15 year old female patient. Patient's medical history and concurrent conditions was not reported. On 08-AUG-2013 the patient was vaccinated with GARDASIL (reported as GARDASIL INJ 120 Y) Strength 120MCG, dose 1. Concomitant therapies included ALLEGRA. On an unknown date in November 2012 the patient experienced migraine headaches. On an unknown date the patient experienced chronic fatigue, is missing a lot of school due to her not feeling well (disability), is having difficulty in school and her grades are dropping, can't focus, is sensitive to light and noise, nauseous, feels dizzy, has her period every 2 weeks, low blood pressure, fainted, vision problems (double vision), and neck pain. The reporter stated that her daughter's migraine headaches started on an unspecified date in November 2013 and lasted for 4 days. The patient had a second migraine headache in February 2014. The reporter also stated that the patient was a swimmer and used to swim 4 hours per day and was in good health prior to receiving GARDASIL. The reporter stated that the patient had fainted and had an irregular EKG after fainting. The patient's second EKG was normal. It was reported that in November 2013 the CT of Brain done by the neurologist was normal. The patient was treated for the adverse events with cyproheptadine and Ondansetron. The outcome of the events was unknown. The reporter's causality assessment was not provided. The patient developed severe stomach problems, hyperthyroidism and early menopause after taking VIOXX (MARRS ID 1404USA014704). Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
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 ages and genders. On an unkonwn date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. ROTATEQ was administered a 5 month old patient. ROTATEQ lot number J008725. This is case 3 of 4 patients. This case was linked to cases: 1403USA007267, 1404USA014641, 1404USA014643. Additinoal information has been requested, all scheduled correspondence was scheudled.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with dose 3 of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with dose 2 of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a 58 year old female consumer with no pertinent medical history or drug reactions/allergies, refers to herself. Ten days ago, on 12-APR-2014, the patient was vaccinated with ZOSTAVAX VIAL, left arm injection (dose, lot number and route not provided). No co-suspect therapies were reported. There were no concomitant medications. On 22-APR-2014, in the morning, the patient noticed red, non-painful, non-pustule, sporadic red spots all over her face, and in the evening, the patient noticed the same bumps on her left arm but the bumps on her arm were slightly itchy. At the time of the report, the outcome for the events was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient sought medical attention by a telephone call placed on 22-APR-2014. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Convulsion, Laboratory test normal, Lumbar puncture normal
Clinical narrative: 3 seizures 2 days after administration MMR, VARIVAX and Hep A. Had full septic work up including LP - all negative.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash to arms and legs 4-20-2014. Went to ER 4-22-2014 12.5mg BENADRYL given PO.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: C/O constant dizziness started 2 hours after vaccines were given. Observed after shots, no fever, no headache.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: C/O constant dizziness since 2 hours after shot given, HA, no fever. TYLENOL with relief of HA.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 77 year old female patient with none pertinent medical history. On an unspecified date in 2009, the patient was vaccinated with a dose of ZOSTAVAX, single shot, subcutaneous for prevention of shingles (lot# and expiry not reported). On an unknown date, this patient developed a "light case of shingles" (also reported as "post vaccination shingles") that according to the representative "came and went". For this patient there was no need for hospitalization and treated in a "normal fashion by the physician". The outcome of the event was now recovered on an unspecified date. The patient sought medical attention. Therapy with ZOSTATAX was also reported as continued. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 31-MAR-2014, the patient was vaccinated with an expired second dose of ROTATEQ (lot # H016259, expiration date 26-MAR-2014), strength: 2 ml (dose and route not reported). The healthcare worker mentioned the ROTATEQ in question did not have any previous temperature excursions. No adverse symptoms reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Hepatitis B antibody negative
Clinical narrative: This spontaneous retrospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with two doses of RECOMBIVAX HB (dose, route, lot# and expiration date not provided). It was reported that the patient did not receive a third dose of RECOMBIVAX HB, because on unknown date she had become pregnant. Her last menstrual period (LMP) date and delivery date were not provided. The pregnancy outcome was unknown. The reporter stated that on an unknown date the patient experienced negative titers for Hepatitis B. The outcome of negative titers for hepatitis B was unknown. The relatedness between the events and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to the case 1404USA014432 and 1404USA014696 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored GARDASIL (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to case 1404USA014432 and 1404USA014697 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength: 2ml) (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product. Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to the case 1404USA014696 and 1404USA014697 (same reporter link). Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Blister, Irritability, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Mother brought child in for fussiness x24h on 4/21/14. Patient developed "rash" on trunk and low grade fever. My exam revealed both and typical varicella (vesicles) mild rash approximately 20 vesicles on front and back.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Malaise, Nausea
Clinical narrative: Hep B #1 vaccine 1 ml given 4-29-14 about 3:30 pm. Presently at work (4-30-14 at 11:20 am) called with complaints of nausea, decreased appetite, not feeling well. No fever.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with second dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with first dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vomiting
Clinical narrative: Client felt dizzy and vomited.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Headache, Injection site swelling, Malaise, Pruritus
Clinical narrative: Swelling at the site of injection, headache, brusing, itching, feeling ill.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: This spontaneous report was received from a Nurse refers to a 12 month old male patient. On 17-NOV-2009, the patient was vaccinated with first dose of VARIVAX (Merck) (Expiry: 11-JUL-2010) (0.5 ml once) subcutaneous. On 17-NOV-2009 (also reported as within 24 hours) the patient experienced fever and chicken pox-like rash. On 24-APR-2014, the patient visited the physician office and reported the events. The outcome of fever and chicken pox-like rash was reported as recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP
Symptoms: Gun shot wound, Impaired work ability, Surgery
Clinical narrative: Initial report received on 18 April 2014 from an investigator participating in a trial. A male subject (age not reported), with no relevant medical history reported, had received an injection of ACAM2000 concomitantly with an injection of Typhoid Vaccine, Anthrax vaccine and PNEUMOVAX vaccine on 01 April 2014 (lot number, route and site of administration were not reported for the 4 vaccines). On 02 April 2014, the subject experienced a severe gun shot wound to the chest. He was hospitalized immediately after. He was treated with surgery and pain medication: NORCO tab per os every 4 to 6 hours. The subject was discharged from the hospital on 04 April 2014. He continued to take NORCO until 10 April 2014. The subject went to the doctor for a follow-up visit on 11 April 2014. He was prescribed and started taking PERCOCET tab every 4 to 6 hours, cyclobenzaprine tab per os TID and naproxen per os BID on 11 April 2014. At the time of the report, the subject was still being treated with these medications, and did not returned to work. He had residual effects still present. The subject's outcome is not recovered. According to the investigator, the event was not related to the study vaccine, and no action was taken. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Autopsy, Death, Influenza, Influenza virus test, Polymerase chain reaction
Clinical narrative: Initial report received from literature on 11 April 2014. A 6 adult patients of age below 65 years, whose concomitant medications were not reported, had received 2013-14 seasonal Influenza Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The department of public health conducts surveillance on severe influenza like illness aged less than 65 years. This case includes the influenza with symptom onset on or after 29 September 2013 of 2013-14 influenza seasons. There were only 6 out of 28 patients whose vaccination status were known had received 2013-14 influenza seasonal vaccine greater than or equal to 2 weeks before symptoms onset. DPH sought the data from autopsy and medical records for fatal cases and reviewed available data for all severe cases for 2013-14 season vaccine. Data review includes patient's demographics, clinical courses and treatment underlying medical conditions, influenza vaccination status and underlying medical conditions. There were 3 fatal influenza cases includes children aged less than 18 years and one fatal case includes a patient less than 5 years old. Of six patients with no known comorbid conditions predisposing them to complications from influenza, as defined by ACIP three were obese with body mass indices of 30-39. The data from 2013-14 influenza vaccination season indicates that the patients aged 41-64 years are at the higher risk of influenza. The antiviral treatment was underutilized by these patients and overreliance on rapid diagnostic test with poor sensitivity. The patient's died on unspecified date. Documents held by sender: none.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 06-MAR-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin negative, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous pregnancy report as received from a other health professional refers to a female patient of unknown age with vaccination. On 13-MAR-2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. No relevant medical history was reported. Concomitant therapies included Tdap. After a negative urine HCG test, but has been subsequently determined to be pregnant by serum HCG test. The consumer became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. Initial exposure to M-M-R II was at 3 week(s). On an unknown date the patient experienced pregnant. No treatment information was reported. The outcome of pregnant is unknown. The reporter considered pregnant to be not related to M-M-R II. No further information is available.
Age: 30.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a other health professional refers to a female patient of unknown age with vaccination. On 13-MAR-2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. No relevant medical history was reported. Concomitant therapies included Tdap. After a negative urine HCG test, but has been subsequently determined to be pregnant by serum HCG test. The consumer became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. Initial exposure to M-M-R II was at 3 week(s). On an unknown date the patient experienced pregnant. No treatment information was reported. The outcome of pregnant is unknown. The reporter considered pregnant to be not related to M-M-R II. No further information is available.
Sex: U
Vaccine: MMR, MMR, TDAP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin negative, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous pregnancy report as received from a other health professional refers to a female patient of unknown age with vaccination. On 13-MAR-2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. No relevant medical history was reported. Concomitant therapies included Tdap. After a negative urine HCG test, but has been subsequently determined to be pregnant by serum HCG test. The consumer became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. Initial exposure to M-M-R II was at 3 week(s). On an unknown date the patient experienced pregnant. No treatment information was reported. The outcome of pregnant is unknown. The reporter considered pregnant to be not related to M-M-R II. No further information is available. This baby case was created from maternal case 1404USA003125 patient was exposed to M-M-R II, Tdap. Patient information is unknown. Adverse event vaccine exposure before pregnancy. This is first trimester of exposure. No further information is available.
Sex: U
Vaccine: MMR, MMR, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a other health professional refers to a female patient of unknown age with vaccination. On 13-MAR-2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. No relevant medical history was reported. Concomitant therapies included Tdap. After a negative urine HCG test, but has been subsequently determined to be pregnant by serum HCG test. The consumer became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. Initial exposure to M-M-R II was at 3 week(s). On an unknown date the patient experienced pregnant. No treatment information was reported. The outcome of pregnant is unknown. The reporter considered pregnant to be not related to M-M-R II. No further information is available. This baby case was created from maternal case 1404USA003125 patient was exposed to M-M-R II, Tdap. Patient information is unknown. Adverse event vaccine exposure before pregnancy. This is first trimester of exposure. No further information is available.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014, the patient was vaccinated with the second dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Decreased activity, Headache, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a Nurse refers to a 10 year old patient. The patient was allergic to penicillin (manufacturer unknown). On 21-APR-2014, the patient was vaccinated with VARIVAX (0.5 ml once) subcutaneous in left deltoid region. Other suspect therapies included DTAP (manufacturer unknown) (dose and frequency were not reported) and meningococcal  vaccine (unspecified) (manufacturer unknown) (vaccinated in the left deltoid) (dose and frequency were not reported). On 21-APR-2014 (also reported as within 24 hours of receiving VARIVAX the patient experienced high fevers, headaches, injection site swelling, just lying around and sleeping and spreading of swelling under the arm. It was reported that the patient temperature was 101.8F. The patient sough medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case of 1404USA014725 AND 1404USA014726 (same reporter link). Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Somnolence
Clinical narrative: This spontaneous report was received from a Nurse refers to a 10 year old patient. The patient was allergic to penicillin (manufacturer unknown). On 21-APR-2014, the patient was vaccinated with VARIVAX (0.5 ml once) subcutaneous in left deltoid region. Other suspect therapies included DTAP (manufacturer unknown) (dose and frequency were not reported) and meningococcal  vaccine (unspecified) (manufacturer unknown) (vaccinated in the left deltoid) (dose and frequency were not reported). On 21-APR-2014 (also reported as within 24 hours of receiving VARIVAX the patient experienced high fevers, headaches, injection site swelling, just lying around and sleeping and spreading of swelling under the arm. It was reported that the patient temperature was 101.8F. The patient sough medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case of 1404USA014725 AND 1404USA014726 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a Nurse refers to 2 or 3 school aged patients of unknown demography. On an unknown date, the patients were vaccinated with VARIVAX (Merck) lot # J003705 (dose, route and frequency were not reported). On an unknown date, the patients experienced high fevers and swelling at injection site. The outcome of high fevers and swelling at injection site was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA014484 and 1404USA014725 (same reporter link). Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a physician (internal medicine specialist), via a company representative, refers to an 85 year old female patient. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unspecified date in April 2010 the patient was vaccinated with ZOSTAVAX, single 0.65 ml shot, subcutaneously. On an unknown date in April 2010 after receiving a dose of ZOSTAVAX the patient developed pain on one side and a rash. On 07-APR-2014 the patient was diagnosed with shingles. The patient sought medical attention via visiting a physician and received not further specified "antiviral antibiotic" (dosage, frequency, manufacturer unknown) as a treatment. The outcome of the reported adverse events was assessed as recovering/resolving by the reporter. Relatedness between vaccination with ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: MEN, TDAP, VARCEL
Symptoms: Decreased activity, Headache, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: This spontaneous report was received from a Nurse refers to a 10 year old patient. On 21-APR-2014, the patient was vaccinated with VARIVAX (0.5 ml once) subcutaneous in left deltoid region. Other suspect therapies included DTAP (manufacturer unknown) (dose and frequency were not reported) and meningococcal vaccine (unspecified) (manufacturer unknown)  (vaccinated in the left deltoid) (dose and frequency were not reported). On 21-APR-2014 (also reported as within 24 hours of receiving VARIVAX (Merck)) the patient experienced high fevers, headaches, injection site swelling and just lying around and sleeping. The patient sought medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was not reported as recovering. The reporter did not provide the causality between the event an the suspect drug. This case is linked to the case 1404USA014484 and 1404USA014726 (same reporter link). 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 an immunization coordinator refers to an unknown number of patients of unknown age and gender. The immunization coordinator mentioned VARIVAX was improperly stored and might have been given to an unknown number of patients. VARIVAX was exposed to temperatures of 11F (Fahrenheit) for 853 hours then 15F for 297 hours (according to assessment data, these products should be used within 1 month). No adverse effects reported. This is one of several reports received from the same reporter (MARRS # 1404USA012060, 1404USA012061, 1404USA012063 and 1402USA007570). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: HEPAB, MEN, PPV, TDAP, TYP, YF
Symptoms: Fatigue, Headache, Nausea, Neck pain, Oral mucosal blistering
Clinical narrative: Fever 102F, chills, fever blisters in mouth and throat, severe headache, neck pain radiating to foot, nausea, vomiting, fatigue.
Age: 67.0
Sex: F
Vaccine: HEPAB, MEN, PPV, TDAP, TYP, YF
Symptoms: Platelet count decreased, Pyrexia, Vomiting
Clinical narrative: Fever 102F, chills, fever blisters in mouth and throat, severe headache, neck pain radiating to foot, nausea, vomiting, fatigue.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Red softball sized rash on left upper arm where vaccine was administered. Onset several hours after being discharged/vaccine administered.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Blood potassium decreased, Bone pain, Ecchymosis, Hypokalaemia
Clinical narrative: Ecchymosis, femur pain, stomach pain, nausea, platelet reduction, hypokalemia.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Platelet count decreased
Clinical narrative: Ecchymosis, femur pain, stomach pain, nausea, platelet reduction, hypokalemia.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: The patient had a syncopal episode 15 minutes after immunization when she stood.  She continued to be nauseated and have vomiting for approximately 75 minutes after her syncope.  She talked very little and did not want to answer questions.  Her vital signs- HR, BP, RR were normal.  She was more interactive when she left the office.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain
Clinical narrative: Shingles pain under my left arm.  Then had a second bout with shingles on 3/11/2012, and a third bout on 6/28/2013.  Now I have chronic nerve pain on the bottoms of both feet and down my left leg.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain
Clinical narrative: Headache, neck ache.
Age: 0.45
Sex: M
Vaccine: RV5
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 ages and genders. On an unknown date, the patients were vaccinated with ROTATEQ (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. ROTATEQ was administered to a 6 month old patient. ROTATEQ lot number J008725 with expiration 04-MAR-2015. This is cases 4 of 4 patients. This case was linked to cases: 1403USA007267, 1404USA014641, 1404USA014642. Additional information has been requested, all scheduled correspondence was scheduled.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient of unknown age. On 10-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX, refrigerated vial 19400PFU, injection (lot# and route not reported). The physician reports that the patient received ZOSTAVAX at the wrong place on his arm. The patient received the ZOSTAVAX underneath his arm and close to his armpit. The ZOSTAVAX was not administered at the physician's office, it was administered at a pharmacy (location unspecified). On 10-APR-2014, the patient experienced a red welt and itching at the injection site. No product quality complaint (PQC) was reported. The patient was recovering and the welt was much smaller now. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Rash on various parts of body starting with neck and forearm.  Not at site of injection.  Using Benadryl po and steroid cream.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pain, Rhinorrhoea
Clinical narrative: Injection site pain, chills, fatigue, body aches and runny nose.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mom reported arm pain and swelling to right arm 4 days after receiving varicella # 2 vaccine, started as bump- increased after 2 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Localised infection
Clinical narrative: Swelling, redness, itching at and around the injection site. Swelling and redness continued to increase 48 hours after injection. Pt was seen by a physician 48 hours after injection and determined to have a localized infection.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Decreased appetite, Pyelonephritis, Pyrexia, Vomiting
Clinical narrative: Baby developed fever of 101.8 after vaccinations, stopped eating and drinking formula began vomiting. Fever spiked to 104.5 and was taken to the ER where she was diagnosed with pyelonephritis.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Culture negative, Debridement, Injection site warmth, Necrotising fasciitis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain, fever at site, achy.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pain, fever at site, achy.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Acute psychosis
Clinical narrative: Acute psychotic episode. Admitted to psychiatric hospital.
Age: 0.23
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 months old patient of unknown gender. The nurse reported that on 17-MAR-2014, the patient was vaccinated with the first dose of ROTATEQ, (lot #J008507; expiration date: 13-MAR-2015. Route and dose were not reported. No other co-suspect or concomitant medications were reported. The nurse reported that the vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with an unspecified reaction to a tuberculosis (TB) test years ago. On 23-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011337, exp. 13-DEC-2014, single dose, subcutaneous) in the left arm. Concomitant therapy was not reported. On 24-APR-2014, the patient experienced inflamed rash at the injection site. The patient called the pharmacy and was advised to take BENADRYL. Laboratory diagnostic studies were not performed. The patient's outcome was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received by an office manager and a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 26-JUL-2012, the patient received the first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On 25-APR-2014, was administered a second dose of GARDASIL (dose, route, lot and expiration date were not provided). The office manager reported a pre-filled GARDASIL syringe (lot # J012438, expiration date 05-OCT-2015) which leaked out from around the base during attempted administration after the syringe needle had already been injected into the patient's skin. The GARDASIL was being administered as "one shot intramuscularly" for the patients second dose in the GARDASIL series the medical assistant confirmed that none of the product contacted her skin or the patient's skin when the leaking occurred. The patient was able to receive a GARDASIL dose from another pre-filled syringe during the same clinic visit. No adverse effect were reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 47 year old female patient. In November 2013, the patient was vaccinated with a 0.5 ml dose of PROQUAD (Merck) (Lot # reported as J006868, expiration date 14-DEC-2014) subcutaneously. No adverse effects were reported. Additional information has been requested.