chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from registered nurse refers to her 21 years old son with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route and lot number not reported) on an unknown date and on 29-JUN-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that her sone on unknown date, had experienced slight tenderness and swelling at the injection site after his first dose of GARDASIL. Nurse also reported that on an approximated 29-JUN-2012, her son developed 3 red, raised, itchy areas, softball size on his right arm, after receiving his second dose of GARDASIL. Nurse stated that he developed slight redness and swelling at the injection site that day (on 29-JUN-2012). It was also reported that by 11-JUl-2012, the redness, swelling, and itching had become worse and included 2 additional areas of softball size redness, swelling and itching, one just above his right elbow and the other on his right wrist. No lab studies were performed. Treatment for the patient's event that occurred after second dose of GARDASIL included BENADRYL, IVYSTAT, hydrocortisone cream (manufacturer unknown) and prednisone (manufacturer unknown). At the time of report, the patient's outcome regarding to slight tenderness and swelling at the injection site after his first dose of GARDASIL was unknown and outcomes regarding to all other patient's events that occurred after the second dose were not recovered. The relatedness for GARDASIL was not reported. Reporting nurse considered severe itching to be disabling (interfering with school). Follow-up information has been received from registered nurse refers to her 22 years old son who indicated that there was only slight reaction (as indicated in circular) after the 1st dose of GARDASIL (date not reported). Registered nurse also reported that with 2nd dose of GARDASIL, the reaction was disabling. Lot numbers were not reported. It was reported that a present (25-JUL-2012), the patient was not symptomatic but did still had three raised areas ranging in size from three to five centimeters. The patient did not seek medical attention, but did receive prednisone from health care professional contact of the mother. The relatedness for GARDASIL was not reported. Reporting nurse considered reaction with 2nd dose (previously reported as "3 red, raised, itchy areas, softball size on his right arm") to be disabling. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from registered nurse refers to her 21 years old son with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route and lot number not reported) on an unknown date and on 29-JUN-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that her sone on unknown date, had experienced slight tenderness and swelling at the injection site after his first dose of GARDASIL. Nurse also reported that on an approximated 29-JUN-2012, her son developed 3 red, raised, itchy areas, softball size on his right arm, after receiving his second dose of GARDASIL. Nurse stated that he developed slight redness and swelling at the injection site that day (on 29-JUN-2012). It was also reported that by 11-JUl-2012, the redness, swelling, and itching had become worse and included 2 additional areas of softball size redness, swelling and itching, one just above his right elbow and the other on his right wrist. No lab studies were performed. Treatment for the patient's event that occurred after second dose of GARDASIL included BENADRYL, IVYSTAT, hydrocortisone cream (manufacturer unknown) and prednisone (manufacturer unknown). At the time of report, the patient's outcome regarding to slight tenderness and swelling at the injection site after his first dose of GARDASIL was unknown and outcomes regarding to all other patient's events that occurred after the second dose were not recovered. The relatedness for GARDASIL was not reported. Reporting nurse considered severe itching to be disabling (interfering with school). Follow-up information has been received from registered nurse refers to her 22 years old son who indicated that there was only slight reaction (as indicated in circular) after the 1st dose of GARDASIL (date not reported). Registered nurse also reported that with 2nd dose of GARDASIL, the reaction was disabling. Lot numbers were not reported. It was reported that a present (25-JUL-2012), the patient was not symptomatic but did still had three raised areas ranging in size from three to five centimeters. The patient did not seek medical attention, but did receive prednisone from health care professional contact of the mother. The relatedness for GARDASIL was not reported. Reporting nurse considered reaction with 2nd dose (previously reported as "3 red, raised, itchy areas, softball size on his right arm") to be disabling. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR, TD
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician refers to a 35 years old female patient with cervical dysplasia and amoxicillin allergy. The history of previous pregnancies and live births of the patient was not known. The patient was vaccinated SC with a 0.5 ml dose of M-M-R II on 23-JUL-2012. No other co-suspects were reported. Concomitant medications included diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and metronidazole. Physician stated patient called the office on 30-JUL-2012 stating she was pregnant. Patient was seen in the office and urine pregnancy tet taken and result was positive. Gestation 4 weeks and 3 days. Estimated due date was 17-APR-2012. Physician stated patient was not experiencing any adverse effects. Follow up information was received. The lot number 1119AA for M-M-R II  was verified as a valid lot number. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Blood test normal, Exposure during pregnancy, Ultrasound antenatal screen normal, Urine ketone body absent, Vomiting
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, for GARDASIL, a Pregnancy Registry product, refers to an approximately 16-year-old female patient with no drug reactions/allergies. This is patient's first pregnancy. On 04-OCT-2012 the patient was vaccinated with dose 2 GARDASIL (lot # not reported) dose and route not reported. No other co-suspects were reported. Concomitant vaccines included meningococcal vaccine (unspecified) (manufacturer unknown) and FLUMIST given on the same date. Approximately on 10-OCT-2012 the patient found out that she was pregnant. Her Last Menstrual Period (LMP) was on 23-AUG-2012 with an estimated delivery date (EDD) of 30-MAY-2013. Patient was scheduled for an ultrasound on 13-NOV-2012. The patient received 1st and 2nd doses of GARDASIL at physician's office. There was an unspecified physician for that facility. The patient had an appointment with an unspecified specialist but then she moved to another state and was being seen at this office. No treatment was given. Patient sought medical attention. Follow-up information was received on 14-FEB-2013 from the registered nurse. The GARDASIL was not continued. During pregnant, the patient also took pyridoxine (P. N vitamin) (oral, one dose a day for pregnant, start date unknown). On 10-OCT-2012, gestational age was 7 weeks 2 days, patient weight was 139, blood pressure was 127/75, leukocyte was negative, blood test was negative, and ketones was negative. Denied contractions (CTX), vaginal birth (VB), or range of motion (ROM). Vomiting but able to keep some liquid and solids down. Discussed maternal fetal medicine (MFM) for vaccination with live viruses in early pregnancy. Ultrasound on 13-NOV-2012 (week 11) was normal. Ultrasound on 08-JAN-2013 (week 19) was normal. Pregnancy was ongoing. Estimated delivery date (EDD) was on 30-MAY-2013 (also reported as 27-MAY-2013). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: White blood cell count normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, for GARDASIL, a Pregnancy Registry product, refers to an approximately 16-year-old female patient with no drug reactions/allergies. This is patient's first pregnancy. On 04-OCT-2012 the patient was vaccinated with dose 2 GARDASIL (lot # not reported) dose and route not reported. No other co-suspects were reported. Concomitant vaccines included meningococcal vaccine (unspecified) (manufacturer unknown) and FLUMIST given on the same date. Approximately on 10-OCT-2012 the patient found out that she was pregnant. Her Last Menstrual Period (LMP) was on 23-AUG-2012 with an estimated delivery date (EDD) of 30-MAY-2013. Patient was scheduled for an ultrasound on 13-NOV-2012. The patient received 1st and 2nd doses of GARDASIL at physician's office. There was an unspecified physician for that facility. The patient had an appointment with an unspecified specialist but then she moved to another state and was being seen at this office. No treatment was given. Patient sought medical attention. Follow-up information was received on 14-FEB-2013 from the registered nurse. The GARDASIL was not continued. During pregnant, the patient also took pyridoxine (P. N vitamin) (oral, one dose a day for pregnant, start date unknown). On 10-OCT-2012, gestational age was 7 weeks 2 days, patient weight was 139, blood pressure was 127/75, leukocyte was negative, blood test was negative, and ketones was negative. Denied contractions (CTX), vaginal birth (VB), or range of motion (ROM). Vomiting but able to keep some liquid and solids down. Discussed maternal fetal medicine (MFM) for vaccination with live viruses in early pregnancy. Ultrasound on 13-NOV-2012 (week 11) was normal. Ultrasound on 08-JAN-2013 (week 19) was normal. Pregnancy was ongoing. Estimated delivery date (EDD) was on 30-MAY-2013 (also reported as 27-MAY-2013). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot # not reported) in JAN-2012 and a second dose of PNEUMOVAX23 (dose, route, lot # not reported) on 19-OCT-2012. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Chlamydia test negative, Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a midwife nurse for GARDASIL, a Pregnancy Registry product, concerning a 19 years old female patient with a history of mood disorder. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with the first dose GARDASIL (lot number reported as 0624AE; expired date 16-DEC-2014) (0.5 ml, intramuscular, left deltoid) on 21-AUG-2012. No other co-suspects were reported. The reporter stated that there was no concomitant medication. Subsequently, the patient became pregnant with an LMP of 03-AUG-2012 and an EDD of 10-MAY-2013. The patient had taken a home pregnancy test and it was positive then came in for office visit on 06-SEP-2012 and blood labs were performed for gonorrhea and chlamydia with negative results. Reporter stated prenatal blood work labs were recently drawn and awaiting the results. There were no adverse effects reported. The patient had came to the office to seek medical attention. Follow up information was received which stated that 672676/0069AE has been verified as a valid lot number for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a Medical Assistant refers to a 12 years old female patient with no drug reactions/allergies. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with her first dose of GARDASIL (lot # 671006/1291AA, expiration date 12-APR-2014) on 23-APR-2012, the second dose (lot # 671994/1537AA, expiration date 21-JUN-2014) on 06-JUL-2012 and third dose (lot # H010123, expiration date 14-JAN-2013) (route of vaccination was not reported). Concomitant medications included prenatal vitamin. The patient was pregnant when she received her third dose of vaccination. The LMP and EDD were not known. The patient had sought medical attention via office visit. No treatment was given. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a female patient who was also a pharmacist. On an unknown date approximately in August 2012, about 2 weeks ago, the patient inadvertently touched a drop of reconstituted ZOSTAVAX with her finger. Sh immediately washed her finger and no adverse event was reported. No concomitant medications were reported. This follow up spontaneous prospective pregnancy information as received from a pharmacist for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The patient's history of previous pregnancies and live births was not known. The pharmacist reported while mixing ZOSTAVAX to administer to a patient, she injected the diluent into the ZOSTAVAX vial and withdraw it, she noticed there was a little ZOSTAVAX left in the vial so she re-injected to diluent to get full dose. She administered the vaccine with no issue but when she picked up the used vial to discard she noticed it was wet. She feared touches the vaccine might be dangerous because she was pregnant and called manufacturer to be sure it was ok and it was. The pharmacist touched it with a naked hand, but her skin was intact. There was no issue with vaccination patient. The pharmacist reported that on 19-SEP-2012 15:00, she was administered into the left arm, with the first dose of FLUZONE. Thiel pharmacy was pregnancy before getting the vaccine. Her gestation age at initial exposure to ZOSTAVAX was unknown. The LMP and EDD were not known. The pharmacist's trimester of exposure was unknown. Additional information has been requested. 20DEC2012 This is an amended report. An event of accidental exposure was added to the case.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful reaction at site of SQ injection. Red circle approx 3" in diameter very pink and fevered.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Painful reaction at site of SQ injection. Red circle approx 3" in diameter very pink and fevered.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: Information has been received from a 58 year old female consumer with drug reactions/allergies of sulfa who on 03-OCT-2011 was vaccinated with a dose of ZOSTAVAX (lot #, dose and frequency were not provided). Concomitant medication included "Anti-depressant and sleeping pill". The consumer reported that she experienced "unusual side effect" after receiving ZOSTAVAX. She reported that on 11-OCT-2011, she experienced post herpetic neuralgia (PHN) coming back and stated that "Neuralgia came back to the exact same location where she had it, on the right side of crown of her head to the hair line". She had a recent episode of shingles in June 2011 (also reported as no pertinent medical history) but she stated she had gotten over shingles completely with no PHN at the time of the ZOSTAVAX administration. She reported that the PHN was not as severe as before and she had been managing it with over the counter (OTC) medications (unspecified). The patient had sought medical attention by calling health department where she received ZOSTAVAX. No lab diagnostics study was performed. Her physician stated her on LYRICA 50 mg twice daily for 4 weeks. At the time of report, the outcome of the adverse event was unknown. Follow up information has been received from the consumer. On 17-SEP-2012 the patient developed a red rash in the area around her right eye. On 18-SEP-2013 she had a scratchy feeling in the right eye. On 19-SEP-2013 she was diagnosed with shingles and started taking acyclovir tablets. The outcome of shingles was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a child patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (Lot#, dose and route were not provided). The child experienced a high fever after being vaccinated with M-M-R II. The outcome of the event is unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient's relevant medical history was unknown. On 05-SEP-2013, the patient was vaccinated with ZOSTAVAX in an unknown arm (route, indication, dose and lot number were not provided). No concomitant medications were reported. On 07-SEP-2013, 3 days after onset of therapy the patient went into the pharmacy with an approximate 3 inch by 6 inch area at the injection site that was red, itching, and warm to the touch (started on approximately 05-SEP-2013). No laboratory data was provided. The outcome of an approximate 3 inch by 6 inch area at the injection site that was red, itching and warm to the touch was reported as not recovered. The causality between the events and the suspect product was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Upper extremity mass
Clinical narrative: This spontaneous report as received from a female consumer refers a 69 year old regarding herself with cancer in ankle and Penicillin allergy. The patient's medical history included left leg amputated from cancer in ankle. About 2 years ago, approximately in 2012, the patient was vaccinated with ZOSTAVAX injection (dose, concentration, indication, route and expiration date were not reported). None concomitant therapy were reported. In 2011, the patient experienced redness at the injection site few days after receiving the ZOSTAVAX. On unknown date the redness evolved into what resembled a bubble that has hardened. On an unknown date the patient experienced resemble a lump in the right arm. None Lab diagnostics were reported. The patient did not received treatments for the events. On unknown date, the patient asked her relative, who is a nurse, to looked at what has evolved on her arm over the last 2 years. The nurse, told her "it is not a lymph node" but not other information was given to her. The outcome of redness at the injection site, a bubble that has hardened and resemble a lump in the right arm was reported as not recovered/not resolved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient, regarding GARDASIL, the Pregnancy Registry Product. On 08-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection)0.5 mL once (lot # not reported). The patient was pregnant at vaccination (LMP: 27-NOV-2012; EDD: 03-SEP-2013). No adverse effects reported. The patient sought medical attention, it was an office visit. Follow-up information was received from the physician concerning the patient with no concurrent medical conditions and a history of obesity. On 08-JAN-2013, the patient was vaccinated with a first dose of GARDASIL (lot # H016960, expiration date 02-DEC-2013). Concomitant medication included vitamins (unspecified) ("prenatal vitamins") and coal tar (NEUTROGENA T/GEL). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to numerous patients. Nurse reported that she observed an unspecified physician's office, storing ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) which improperly, at room temperature, approximately 3 years ago on an unspecified date. She stated that numerous patients might have been administered improperly stored vaccines. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from an unspecified healthcare worker, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient. On 07-NOV-2012 at 12:15 PM, the patient was vaccinated with a third dose of GARDASIL IM (dose not reported) (lot number reported as 1397). There was no illness at the time of vaccination. It was reported that the patient was pregnant at the time of vaccination (adverse event onset was reported as 23-JAN-2013). The LMP and EDD was not known. There were no lab diagnostic studies performed. The outcome of the pregnancy was unknown. Lot # 1397 is an invalid lot number for GARDASIL. Follow up information has been received from a registered nurse which reported that lot# 668261/1397AA, expiration date: 09-APR-2013. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from Registered Nurse refers to a 23 year old female patient with HIV and with none drug reactions or allergies. The patient's history of previous pregnancies and live birth is unknown. The registered nurse reported that the patient was vaccinated on 15-FEB-2013 with GARDASIL injection, (lot# 1570Z and exp date 06-APR-2013) first dose, (dose and anatomical site of injection were not specified). Concomitant therapies included COMPLERA. The registered nurse reported that the patient about 20 weeks pregnant (second trimester) was administered the first dose of GARDASIL on 15-FEB-2013. The last menstrual period (LMP) was estimated on 28-SEP-2012 and Estimated Date of Delivery (EDD) on 05-JUL-2013. At the time of the report no adverse events were reported. There was no treatment given by the reporter. Laboratory tests were not performed. At the time of the report the pregnancy outcome was pending. Follow-up information received. The lot number 1570Z has been verified as valid with lot number 668260/1570Z for GARDASIL. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Rhesus antibodies positive
Clinical narrative: This spontaneous prospective pregnancy report received from a medical assistant concerning to 22 years old female patient. On 16-JAN-2013, the patient was vaccinated with a dose of GARDASIL lot # H014645; Exp date. 27-MAR-2015; (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient was now pregnant. The pregnancy was normal to date. The approximately last menstrual period (LMP) was on 18-DEC-2012 and an estimate delivery date (EDD) of 24-SEP-2013. The patient was exposed to GARDASIL during trimester 1. A blood screen for anti D bodies was performed and was positive. The outcome of the event was unknown. The reporter considered that the event to be not related to GARDASIL. Follow up information was received. Date of birth and ethnicity of the patient were updated. There were no known drug allergies. On an unknown date in April 2010, the patient had delivered a baby weighing 3.2 kilograms (Anti D Rh negative). Since 05-DEC-2012 to 14-DEC-2012, the patient had taken acyclovir (orally, daily). The patient smokes 5-10 cigarettes per day and drinks ethanol occasionally. Last menstrual period (LMP) was on 19-DEC-2012 (previously reported as 18-DEC-2012). Pregnancy was ongoing at the time of reporting. On 16-JAN-2013, the patient was vaccinated with 0.5 milliliter (ml) of GARDASIL and it was discontinued on the same day. The patient was continuing the care with the physician. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from an approximately 26-year-old female patient with no drug reactions/allergies regarding herself. Current conditions included high risk for labor. On an unknown date in 2012 the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route not reported). No concomitant medications were reported. Subsequently, the patient became pregnant with a Last Menstrual Period (LMP) on an unknown date in April 2012. The trimester of exposure was first and second. The patient stated she was vaccinated with GARDASIL before she had the knowledge of knowing that she was 5 months pregnant. She found out that she was 5 months pregnant on an unknown date in September 2012. Treatment was given for the event, she was prescribed some unspecified pills. No laboratory diagnostic tests were performed. Patient sought medical attention, she went to Emergency Room. Follow up information was received from the physician. The physician details were updated. The physician stated that he is a radiologist and the patient who reported the adverse event was not affiliated with his practice. He requested no further contact regarding the adverse event. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a doctor of pharmacy refers to a 27-year-old female patient. Current conditions included asthma and allergic reactions to penicillin, diphenhydramine and ketorolac. On 12-DEC-2012 the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date and route not reported). Concomitant medications included albuterol, COMBIVENT, loratadine, SINGLULAIR, ondansetron and vitamins (unspecified) (reported as pre-natal vitamins). Patient's last menstrual period (LMP) was 12-SEP-2012 and an estimated date of deliver (EDD) of 19-JUN-13. Initial exposure to PNEUMOVAX23 was at 13 week(s). The patient was exposed to PNEUMOVAX23 during trimester 1. No adverse symptoms reports. Reporter mentioned that the patient was using an illicit drug "meth" on 03-OCT-2012. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 21 years old female patient. The patient's history of previous pregnancies and lives births was not known. The patient was vaccinated with  dose of M-M-R II (lot number 0497AE, expiration date 07-MAR-2014) subcutaneously on 12-OCT-2012 when she was seven months pregnant. It was not known which dose this was in the M-M-R II. There were no co-suspects and no concomitant medications. The patient became pregnant with an LMP of approximately 12-MAR-2013 and an EDD of approximately 17-DEC-2012. Initial exposure to M-M-R II was at 30 week(s). The patient was exposed to M-M-R II during trimester 3. No treatment was given for adverse event. No laboratory diagnostics studies were performed. The pharmacist noted the patient "went to her physician" for see medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information received from a medical assistant who reported that a 20 years old pregnant female patient received her first dose of GARDASIL on 11-SEP-2012. Concomitant medications included prenatal vitamins. The patient's last menstrual period was 13-AUG-2012. No treatment was given. It was reported the patient sought unspecified medical attention. No further information was provided. This is a mended case: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning the 20 years old female patient with no drug reactions/allergies. The patient's history of previous pregnancies and live births were not known. The pregnant patient was vaccinated with her first dose of GARDASIL (lot # 1696AA, exp date: 12-SEP-2014, dose and route unspecified) on 11-SEP-2012. Patient had an LMP of 13-AUG-2012 and an EDD of 20-MAY-2013. Initial exposure to GARDASIL was at 4 weeks. The patient was exposed to GARDASIL during trimester 1. No treatment was given for  AE. The patient sought medical attention by an unknown method. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive, Pregnancy test urine positive
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck) and M-M-R II, a Pregnancy Registry product, concerning a 32 year old female with no drug reactions/allergies who on 14-JUN-2012, was vaccinated with a dose of VARIVAX (Merck) (lot # 1091AA, exp 06-JUL-2013) and on an unknown date, with a dose of M-M-R II (lot # 0512AA, exp 08-APR-2013) while pregnant. There ws no concomitant medication. No adverse effect was reported. The patient's LMP was son 25-APR-2012, EDD; 30-JAn-2013. The patient was exposed to VARIVAX (Merck) and M-M-R II during trimester 1. The patient had a urine and blood pregnancy tests. The patient saw the nurse. At the time of the report, the pregnancy outcome was unknown. No further information is available.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: Lips swelling and tingling, scratchy throat. Treatment: PREDNISONE 40 MG EVERY DAY.
Age: 0.35
Sex: F
Vaccine: DTAPH, IPV, PPV, RVX
Symptoms: Unresponsive to stimuli
Clinical narrative: Found unresponsive in crib at daycare.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chest X-ray, Computerised tomogram, Cough, Dizziness, Increased upper airway secretion
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Laboratory test, Pulmonary function test, Respiration abnormal, Respiratory distress, Retching
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Tinnitus, Vision blurred, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Cough, Dizziness, Dyspnoea, Increased upper airway secretion
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Retching, Vision blurred, Vomiting, Wheezing
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Computerised tomogram normal, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-JAN-2013, one day after vaccination with PNEUMOVAX23 (MARRS case 1308USA014836). On 15-AUG-2013, the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "Pregnazone" (Watson labs brand). At an unspecified dosage and frequency and an unspecified "Z-pack" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a Pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. The health care professional contacted during telephone follow up reported that the physician would be sending the information regarding the patient. Follow up information has been received from the patient and a pulmonary nurse (patient's daughter) indicating that the patient herself was desperately worried because she was following the same course as her sister. The patient reported that she herself felt like her immune system had gone crazy, felt exhausted and had not slept in weeks. The patient still had blurred vision and dizziness as well as difficulty hearing and speaking. The patient had computed axial tomography (CAT) scans on 26-AUG-2013 that "showed nothing" and x-ray (results not provided). Pulmonary nurse stated that hoped her mother would get better and though the problem might be a binder in the vaccine. The nurse suggested the chemist who makes the vaccines should look into it and see what could be harming people. At the time of the report, the patient's outcome for felt like her immune system had gone crazy, felt exhausted and had not slept in weeks was unknown. Upon internal review, difficulty hearing was considered to be medically significant. Additional information was received from the patient which reported that she "was sick after receiving the pneumonia vaccine and was experiencing dizziness, fevers and has quit breathing from (her) diaphragm. The patient stated she "did pulmonary exercises, and was still using prednisone (unspecified dosage/frequency and manufacturer) and hydrocodone (unspecified dosage/frequency and manufacturer) and felt drugged up. Additional information has been requested.