chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report recei9ved from a health care professional on 20 June 2013. A 26-year-old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: U4612AA, site of administration was not reported) on 20 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 08 November 2012. The estimated date of delivery was 15 August 2013. The patient's health during pregnancy, risk factors, concomitant medications, treatment for infertility and medical history were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 25 June 2013. A female patient (age was not reported) had received an intramuscular first dose of ADACEL vaccine (lot number: C4424AA, expiry date-10/03/2015, site of administration was not reported) on 25 June 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was not reported and estimated date of delivery was on an unspecified date in July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. Medical history and concomitant medications were not reported. At the time of this report. the patient had not experienced any adverse event. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 26 June 2013. A 36-year-old female patient, whose medical history and concomitant medication were not reported, had received an intramuscular first dose of ADACEL vaccine (lot number: U4612AA, site of administration was not reported) on 26 June 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was 02 December 2012 and estimated date of delivery was 30 August 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received on 25 June 2013 and follow-up information received on 26 June 2013 from a healthcare professional. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine lot number: U4612AA in right deltoid on 25 June 2013. The patient was not sick at the time of vaccination. The patient had Penicillin and Sulfa drugs allergy. The patient had no serious reaction after receiving a vaccination in past. The patient had no history of cancer, leukemia, AIDS or any other immune system problem and did not receive any Cortisone, Prednisone, other steroids or anticancer drugs or had any X-ray treatment. The patient had not received a transfusion of blood or blood products or any immune (gamma) globulin in past 1 year. The patient did not receive any vaccination in the past 4 weeks. The patient's treatment for infertility, health during pregnancy and risk factors was reported as N/A. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 13 November 2012 and the estimated date of delivery was 20 August 2013. As of 25 June 2013, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 28 June 2013. A 37-year-old female patient, whose medical history and concomitant medication were not reported, had received an intramuscular first dose of ADACEL (lot number: U4612AA, Expiry date: 20-Sep-2015, site of administration was not reported) on 28 June 2013. The patient was pregnant at the time of vaccination. Date of last menstrual period (LMP) was 14 November 2012 and estimated date of delivery (EDD) was reported as 21 August 2013. At the time of the report, the patient had experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility was not reported. Concomitant medications were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 July 2013. A 39-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular first dose of ADACEL vaccine (batch number: U4612AA, site of vaccination was not reported) on 01 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as "22 January 1974" and the estimated date of delivery was 03 October 2013. The patient's health during pregnancy, risk factors and treatment for infertility were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 July 2013. A 29-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose 1 of ADACEL (Lot number: U4612AA, site of vaccination not reported) on 01 July 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was 24 October 2012 and the estimated date of delivery was 07 August 2013. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs), treatment for infertility and concomitant medications were not reported. As of 01 July 2013, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 July 2013. A 34-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: C4385AA and site of administration was not reported) on 27 June 2013. The patient was pregnant. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was not reported. At the time of the report, the patient had not experienced any adverse events. Patient health was good at the time of vaccination and risk factors were not reported. Concomitant medications and past medical history was not reported. Treatment for infertility was reported as unknown. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein abnormal, Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 02 July 2013. A 24-year-old female patient may be inadvertently received an intramuscular dose 2 of ADACEL vaccine (batch number: U4586AA, site of administration was not reported) on 02 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 December 2012 and estimated date of delivery was 11 September 2013. The patient had received dose 1 of ADACEL vaccine (lot number, route and site of administration was not reported) on 14 June 2013 during current pregnancy as well. Thus the patient received an extra dose of ADACEL. The patient had no risk factors. Medical history, concomitant medications and treatment for infertility were not reported. At the time of the report, the patient had not experienced any adverse events. Follow up information received from a healthcare professional on 15 August 2013: The patient had no family history of congenital abnormality. The patient had not received any treatment for infertility. The patient had one previous pregnancy with a live birth with no congenital abnormality. The patient had no pre-term births, no elective abortions and no spontaneous abortions or fetal deaths (>20 weeks gestation). The patient had not received any drug during or prior pregnancy that could remain present at the time of fertilization. The patient did not have any pregnancy complications. On an unspecified date, Quad AFP test was done which was positive for increased risk for Down syndrome. On an unspecified date, the patient gave birth to a single male baby vaginally at 40 weeks of gestation. The weight of the baby was reported as "6.5" oz. The baby had no congenital abnormality. The baby's APGAR score was not reported. List of documents held by the reported: None. Follow-up information received from a healthcare professional on 10 October 2013. The patient had no history of congenital abnormality. The patient had anemia. The estimated date of delivery was 30 August 2013. Number of previous pregnancies was 2 (live birth of male baby vaginally at 40 weeks of gestation and weighed 6.5 kg and live birth to a female baby at 38 weeks of gestation). Prenatal testing for alpha foetoprotein was done which was positive for Down's syndrome.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 02 July 2013. A 32-year-old female patient had received intramuscularly first dose of ADACEL vaccine (Lot number: L44617AA and site of administration was not reported) on 02 July 2013. The patient had no significant medical history, no known allergy and had no serious reaction to previous vaccination. The patient had not received any vaccinations in last four weeks and has no history of taking Prednisone, cortisone, steroids nor any anticancer drugs. The patient had not received transfusions of any blood or blood products. The patient received vaccine during pregnancy. The patient's last menstrual period date was 24 November 2012 and estimated date of delivery was reported as "26 February 2013". The patient did not experience any serious adverse event. The patient's outcome was unknown. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 10 July 2013. A female patient whose age, date of birth, medical history and concomitant medications were not reported, had received an intramuscular first dose of ADACEL vaccine (batch number: U4612AA and site of administration was not reported) on 09 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 02 December 2012 and the estimated date of delivery is 08 September 2013. Laboratory investigations were not reported. As of 10 July 2013, the patient had not experienced any adverse events. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Pregnancy
Clinical narrative: Initial pregnancy report received from a healthcare professional on 11 July 2013. A female patient whose age and date of birth was not reported, had received an intramuscular dose of ADACEL vaccine (Lot number: U4617AA, dose number and site of vaccination was not reported) on an unspecified date. The patient's health during pregnancy, concomitant medications and medical history were not reported. The patient had no risk factors at the time of vaccination. The patient was pregnant. The patient's last menstrual period date was on 29 October 2012 and the estimated date of delivery was 06 August 2013. As of 11 July 2013, the patient had no experienced any adverse events. Laboratory investigations were not reported. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 11 July 2013. A 24-year-old female patient, whose medical history, risk factors, health during pregnancy and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine, batch number: U4617AA in left deltoid on 11 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reproted and the estimated date of delivery was 18 August 2013. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 11 July 2013. A female patient, had received a dose of ADACEL vaccine, batch number: U4667AA (route and anatomical site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period data was 1 December 2012 and the estimated date of delivery was 07 September 2013. The patient's medical history and concomitant medications were not reported. Patient had no risk factors. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Age: 31.0
Sex: U
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 16 July 2013.  A 31-year old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: UA567AA) in the right deltoid on 16 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was unspecified date of September 2013. At the time of the report, the patient had not experienced any adverse events. It was reported that patient didn't indicate anything specific for health during pregnancy and risk factors. Concomitant medications and past medical history was not reported. As per reporter treatment for infertility was reported as no indicated. Follow-up information received from a healthcare professional on 09 September 2013. The patient had one previous pregnancy-spontaneous abortion prior to 20 weeks gestation. The patient's last menstrual period date was on 30 December 2012 and estimated delivery date was reported as 06 October 2013. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 17 July 2013. A 33-year-old female patient had received an intramuscular dose of ADACEL vaccine; lot number U4667AA (anatomical site of administration was not reported) on 17 July 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was 30 November 2012. The estimated date of delivery was reported as 06 September 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs), medical history, concomitant medications and treatment for infertility were not reported. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from healthcare professional on 30 April 2013.  A 26-year-old female patient had received an intramuscular dose of Tdap vaccine (Mfr unknown) (batch number-64612AA, anatomical site of administration was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period was on 20 September 2013. The patient's estimated date of delivery was 06 July 2013. The patent's health during pregnancy, risk factors, medical history and concomitant medication was not reported. Laboratory investigations were not reported. As of 30 April 2013, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse event, Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 17 July 2013. A female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (Lot number: U4667AA, anatomical site of administration not reported) on an unspecified date. The last menstrual period was reported as 03 December 2012. The patient's estimated date of delivery was reported as 09 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. The patient's had experienced adverse events on an unspecified date. Concomitant medications and past medical history were not reported. Treatment for infertility was not reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 10 April 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL vaccine (lot number: U4612AA, site of administration was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 10 August 2012 and the expected date of delivery is 15 May 2013. At the time of this report, the patient did not experienced any adverse event. List of documents held by the sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 11 April 2013. A 29-year-old female patient, with no medical history, had received an intramuscular dose of ADACEL vaccine (Lot number: C4152AA, site of vaccination was not reported) on 20 September 2012. The patient was pregnant at the time of vaccination. No other information was provided. The last menstrual period date was unknown. The patient's estimated date of delivery was reproted as May 2013. As per the reporter, the patient had not experienced any adverse event. Document held by sender: None.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 12 April 2013. A 27-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (batch number: C4366AA, expiry date: 06/27/2015, site of administration was not reported) on 10 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history, health during pregnancy, specific risk factors and concomitant medications were not reported. The patient's last menstrual period date was 16 August 2012 and estimated delivery date was 23 May 2013. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none. Follow-up information received from health care professional on 05 July 2013. The date of birth of the patient was updated. The date of vaccination of ADACEL was updated as 30 April 2013 previously reported as 10 April 2013 and the vaccine was given in left deltoid. The patient had no family history of congenital abnormality and not received any treatments for infertility. The patient had one previous live birth and a congenital abnormality was not reported, no pre-term births, no elective abortions, no fetal deaths (20 weeks gestation) and no complication for delivery. The patient had received Prenatal vitamins during pregnancy on unspecified dates. The patient had gestational diabetes on an unspecified date, during pregnancy which was controlled by diet. The pregnancy outcome details were as follows: The patient gave birth to a female single baby weighing 23.75 (unit not reported) without any congenital abnormality, APGAR score after 1 min was 8 and after 5 min was 9. Mode of delivery was vaginal. List of documents held by the reported: None.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Laboratory test normal, No adverse event, Prenatal screening test
Clinical narrative: Initial pregnancy report received from a healthcare professional on 15 April 2013. A 41-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL vaccine batch number C4366AA (anatomical site of vaccination was not reported) on 15 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown and the estimated date of delivery (EDD) was reported as 18 June 2013. The patient did not experience any adverse event. Documents held by sender none. Follow-up information received from a healthcare professional on 19 August 2013: The patient and her husband had no ongoing illness. The patient did not receive any treatment for infertility. The patient had no previous pregnancies. The patient had not received any drug during pregnancy or prior fertilization that could remain at the time of fertilization. The patient's risk factors included advanced maternal age at pregnancy. The patients prenatal testing done on an unspecified date was normal. The patient's LMP date was unknown. The patient had received ADACEL in the left deltoid. At 39 weeks of gestation, the patient delivered a female child weighting 3.22 kg without any complications by C-section. The height of the baby was 51 cm and APGAR score at 1 minute and 5 minute was 9. The baby had no any congenital anomaly.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 16 April 2013. A female patient of unspecified age, had received intramuscular dose of ADACEL batch number U4612AA (Anatomical site of vaccination was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. The patient was pregnant. The patient's last menstrual period date was reported as 11 September 2012. The expected date of delivery (EDD) is 18 June 2013. The patient did not experience any adverse event. List of documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 17 April 2013. A 30-year-old female patient had received an intramuscular first dose of ADACEL (batch number: U4612AA, expiry date: 9-20-15, site of administration was not reported) on 17 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history, risk factors and concomitant medications were not reported. The patient's last menstrual period date was 01 August 2012 and expected delivery date was 10 Jun3 2013. At the time of this report, the patient had no adverse event. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: Initial report received from a healthcare professional on 18 April 2013. A 32-year-old female patient had received an intramuscular first dose of ADACEL vaccine (batch number: C4366AA, expiry date: 06/27/2015, site of administration was not reported) on 18 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient's risk factors included obesity. The patient's last menstrual period date was 30 August 2012 and expected date of delivery was 06 June 2013. As of 19 April 2013, the patient didn't present any adverse event. Follow up information received from a healthcare professional on 19 August 2013. Father's age was unknown. The patient had received vaccine in the left deltoid. The patient had no risk factors (e.g.: alcohol, tobacco or recreational drugs), relevant ongoing illness, family history of congenital abnormality and concomitant medications. Father had no relevant ongoing illness. The mother had not received any drug during pregnancy or prior to fertilization that could remain present at the time of fertilization. The patient's prenatal tests were normal. The patient's body weight during pregnancy was 188 pounds and height 5'4'', while body weight at delivery was 239 pounds. The patient had not previous pregnancy. The pregnancy outcome details were as follows: on 11 June 2013, the patient gave birth to a male single baby weighing 3.37 (kg) without congenital abnormality and mode of delivery was C-section. The APGAR score at 1 min was 9 and at 5 min were 9. It was reported that there was no complication of labor/or delivery. The patient had not received any treatment for infertility. At the time of the report, the patient had not experienced any adverse events. List of documents held by the reported: None.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 18 April 2013. A pregnant female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose of ADACEL (Lot number U4612AA, dose number and anatomical site of vaccination were not reported) on unspecified date. The patient was pregnant. The patient's last menstrual period date was 26 July 2012 and the estimated date os delivery (EDD) is 22 may 2013. As per reporter the patient did not experienced any adverse event.  Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Laboratory test normal, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 18 April 2013. A 18-year-old female patient, had received intramuscular first dose ADACEL vaccine batch number U4384AA, in right deltoid on 17 April 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. The patient received vaccine during pregnancy. The patient's last menstrual period date was not reported. The expected date of delivery (EDD) is unspecified date in June 2013. On 17 April 2013, the gestational age was 30 weeks and 6 days IUP. The patient did not experience any adverse event. Follow up information received from a healthcare professional on 26 August 2013: The patient had on pregnancy previously and had delivered one live birth. The patient had taken multi prenatal vitamins tablets daily and had no illness at the time of vaccination. The patient was treated for positive Chlamydia on 27 February 2012. Father's health status was not disclosed. The patient was healthy with no concerns during pregnancy. The patient's last menstrual period date was on 10 September 2012 and the estimate4d date of delivery was reported as 17 June 2013. The laboratory test results were within normal limits. No genetic testing/screening were done or noted in patient's medical record. No treatment for infertility was done. On 18 June 2013, the patient delivered a single male baby (at 39th week of gestation of unknown weight and unknown height) with no congenital abnormality. The mode of delivery was vaginal. The Apgar score was 8 at 1 minute and 9 at 5 minutes. List of documents held by the reported: None.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 22 April 2013. A 24-year-old female patient, had received first dose of ADACEL (batch number: C4365AA, expiry date: 06/25/2015) intramuscularly on the left deltoid on 20 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient's health during pregnancy and risk factors were unknown. The patient's last menstrual period was not reported and the expected delivery date was reported as 08 June 2013. At the time of this report the patient had not experienced any adverse event. List of documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 22 April 2013. A 35-year-old female patient, whose medical history, risk factors and concomitant medication were not reported, had received first dose of 0.5 ml ADACEL vaccine (lot number: U4612AA, expiry date: 09/20/15) intramuscularly on the right deltoid on 22 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) date was on 20 August 2012 and estimated delivery date (EDD) was reported as 02 June 2013. At the time of report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 22 April 2013.  A 33-year-old female patient had received first intramuscular dose of ADACEL (lot number U4612AA) in right deltoid on an unspecified date. The patient was pregnant. The last menstrual period date was 31 July 2012 and the expected date of delivery is 07 May 2013. The patient's health during pregnancy and risk factors were not reported. As per reporter, the patient had not experienced any adverse event. List of documents held by the sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 26 April 2013. A 29-year-old female patient had received an intramuscular first dose of ADACEL (Lot number:  U4612AA, site of administration was not reported) on 26 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 22 September 2012 and estimated date of delivery was 29 June 2013. As of 26 April 2013, the patient had not experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 25 April 2013. A 33-year-old female patient had received an intramuscular first dose of ADACEL (Lot number: U4612AA, site of administration was not reported) on 25 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 24 September 2012 and estimated date of delivery was 01 July 2013. As of 25 April 2013, the patient had not experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Dysphonia, Dyspnoea, Eye discharge
Clinical narrative: Case number PHHY2013US116518 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480253) website on 15 Oct 2013. This report refers to a 37-year-old female patient. Her medical history included allergic to tiger balm. Her concomitant medication included VYVANSE. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 02 Jan 2013. On the same day, after vaccination, she experienced loss of appetite, fatigue, continuous cough, wheezing, felt like throat was closing up with hoarseness, soreness, red itchy eyes, and eyes were discharging (almost looked like egg which discharge which was very thick) and also had hard time breathing. It was reported that she still had coughing and headache, but symptoms seemed to clear for the most part within 24 hours. Outcome of the events was reported as not recovered as of 04 Jan 2013. No seriousness and causality was reported for the events.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Fatigue, Headache, Ocular hyperaemia, Pain
Clinical narrative: Case number PHHY2013US116518 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480253) website on 15 Oct 2013. This report refers to a 37-year-old female patient. Her medical history included allergic to tiger balm. Her concomitant medication included VYVANSE. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 02 Jan 2013. On the same day, after vaccination, she experienced loss of appetite, fatigue, continuous cough, wheezing, felt like throat was closing up with hoarseness, soreness, red itchy eyes, and eyes were discharging (almost looked like egg which discharge which was very thick) and also had hard time breathing. It was reported that she still had coughing and headache, but symptoms seemed to clear for the most part within 24 hours. Outcome of the events was reported as not recovered as of 04 Jan 2013. No seriousness and causality was reported for the events.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Wheezing
Clinical narrative: Case number PHHY2013US116518 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480253) website on 15 Oct 2013. This report refers to a 37-year-old female patient. Her medical history included allergic to tiger balm. Her concomitant medication included VYVANSE. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 02 Jan 2013. On the same day, after vaccination, she experienced loss of appetite, fatigue, continuous cough, wheezing, felt like throat was closing up with hoarseness, soreness, red itchy eyes, and eyes were discharging (almost looked like egg which discharge which was very thick) and also had hard time breathing. It was reported that she still had coughing and headache, but symptoms seemed to clear for the most part within 24 hours. Outcome of the events was reported as not recovered as of 04 Jan 2013. No seriousness and causality was reported for the events.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2013US116803 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 480269) web site on 15 Oct 2013. This report refers to a 64-years-old male patient. His medical history included gout and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 08 Nov 2012. On 03 Jan 2013, he had influenza. The outcome of the event was reported as complete recovery.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2013US032456 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480610) website on 04 Apr 2013. This report refers to 21-year-old male patient. His medical history and concomitant medication were not reported. The patient denied of any known allergies. He was vaccinated with MENVEO (batch number: M12003) into left arm on 04 Dec 2012 (in the afternoon). He received no other vaccines at that time. On 07 Dec 2012, he woke up with a rash on his face, upper arms, chest and his upper back. He denied of fever or pain since the immunization. He did have a pinkish red raised rash on his forehead, under the eyes (both), cheeks, chest, upper back and both arms above the elbows up to the shoulders. He denied pain but stated the rash was extremely itchy. He denied eating any different foods, or taking any other medications since the immunization. The pharmacist advised him to take BENADRYL and to consult the physician. When pharmacist called back, he was not at home. His mother stated that he was doing much better, he was at work and he had been taking the BENADRYL but he did not go to the physician. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Cyanosis, Loss of consciousness, Oropharyngeal pain, Syncope
Clinical narrative: Case number PHHY2013US116528 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480657) website on 15 Oct 2013. This report refers to a 04-year-old male patient. His medical history and concomitant medication were not reported. His past history included prolonged fainting spell after administration of varicella vaccine (manufacturer and batch number unknown) on an unspecified date. On 07 Jan 2013, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into right leg. On the same day, after vaccination, he experienced chest pain, throat pain, fainting with eyes open, blue lips, unconscious for 10 minutes with a total of 20 minutes span for being able to sit up and support body weight. Outcome of the events was reported as recovered. Seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2013US116598 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 480861) website on 15 Oct 2013. This case refers to a female patient of an unknown age. Her medical history included chronic inflammatory demyelinating polyneuropathy and allergy to flu vaccine. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unknown date. On an unspecified date, after the vaccination, she became ill and was hospitalized for this. The outcome of event was reported as recovery. The causality of event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Nasal congestion, Rash generalised
Clinical narrative: Case number PHHY2013US116615 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 480872) on 15 Oct 2013: This report refers to a female patient of unknown age. Her medical history and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. After administration of the flu vaccine, the patient developed a 'head to toe rash' as well as nose and lip swelling. The patient was seen immediately by her physician and 'given a shot'. The patient fully recovered. No further information about seriousness and causality was reported.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2013US116616 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 480877) website on 15 Oct 2013. This report refers to a 75-year-old male patient. His medical history and concomitant medications were not reported. He was previously vaccinated with flu vaccine (manufacturer and batch number unknown) and experienced Guillain-Barre Syndrome (GBS) and paralysis (see case PHHY2013US117520). Seven years later he was again vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. On an undetermined date, he again developed Guillain-Barre Syndrome. He had a milder case (when compared to the first episode). He recovered from GBS on an unspecified date. No seriousness and causality was reported for the events.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Ocular hyperaemia
Clinical narrative: Case number PHHY2013US116569 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 481010) website on 15 Oct 2013. This report refers to a 45-year-old female patient. Her medical history included allergy to sulfa, LARIAM, salicylates, NSAIDS, diazolidinyl urea, GERMALL 115, and p-tert-Butylphenol formaldehyde resin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 10 Jan 2013. On the same day, after vaccination, she had difficulty in breathing, pain with inspiration, chest tightness, acute congestion and cough, sore throat, bright red eyes, acute periorbital edema and headache. Outcome of the events was reported as not recovered as of 11 Jan 2013. No seriousness and causality was reported for the events.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Painful respiration, Periorbital oedema, Respiratory tract congestion
Clinical narrative: Case number PHHY2013US116569 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 481010) website on 15 Oct 2013. This report refers to a 45-year-old female patient. Her medical history included allergy to sulfa, LARIAM, salicylates, NSAIDS, diazolidinyl urea, GERMALL 115, and p-tert-Butylphenol formaldehyde resin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 10 Jan 2013. On the same day, after vaccination, she had difficulty in breathing, pain with inspiration, chest tightness, acute congestion and cough, sore throat, bright red eyes, acute periorbital edema and headache. Outcome of the events was reported as not recovered as of 11 Jan 2013. No seriousness and causality was reported for the events.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Pyrexia, Swelling, Urticaria
Clinical narrative: Case number PHHY2013US116612 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 481125) on 15 Oct 2013: This report refers to female patient of an unspecified age. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced major allergic reaction, fever, hives and swelling. Outcome of the events was reported as not recovered as of 30 Nov 2012. Seriousness and causality was not reported for the events.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Brachial plexopathy, Diarrhoea, Electromyogram abnormal, Impaired work ability, Monoplegia
Clinical narrative: Case number PHHY2013US116618 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 481199) website on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history was not reported. Her concomitant medication included triamterene/hydrochlorothiazide and nifedipine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into left arm on 08 Oct 2012. On the next day, she had a reaction of diarrhea all the day and her arm was swollen and was unable to touch for four days after the flu shot. She was given with ice packs to apply on that area. On 04 Nov 2012, she woke up with excruciating neck, shoulder, and scapula pain. She applied ice, heat and massaged the area all the day but no avail. On 05 Nov 2012 (about 1:00 am), she went to emergency room and she was given two different shots in both arms along with oral medication which did not help. She lost the function of her arm slowly throughout the day. She had not been able to work and was still in pain and also had paralysis of arm. She underwent electromyogram (EMG), nerve conduction tests and nuclear magnetic resonance imaging (MRI) which confirmed Parsonage-Turner Syndrome (brachial plexopathy) as a result of the flu shot. Outcome of diarrhea, swollen arm with unable to touch was not reported. Outcome of other events was reported as not recovered as of 14 Jan 2013. No seriousness and causality of the events were reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Neck pain, Nerve conduction studies abnormal, Neuralgic amyotrophy
Clinical narrative: Case number PHHY2013US116618 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 481199) website on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history was not reported. Her concomitant medication included triamterene/hydrochlorothiazide and nifedipine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into left arm on 08 Oct 2012. On the next day, she had a reaction of diarrhea all the day and her arm was swollen and was unable to touch for four days after the flu shot. She was given with ice packs to apply on that area. On 04 Nov 2012, she woke up with excruciating neck, shoulder, and scapula pain. She applied ice, heat and massaged the area all the day but no avail. On 05 Nov 2012 (about 1:00 am), she went to emergency room and she was given two different shots in both arms along with oral medication which did not help. She lost the function of her arm slowly throughout the day. She had not been able to work and was still in pain and also had paralysis of arm. She underwent electromyogram (EMG), nerve conduction tests and nuclear magnetic resonance imaging (MRI) which confirmed Parsonage-Turner Syndrome (brachial plexopathy) as a result of the flu shot. Outcome of diarrhea, swollen arm with unable to touch was not reported. Outcome of other events was reported as not recovered as of 14 Jan 2013. No seriousness and causality of the events were reported.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Peripheral swelling, Tenderness
Clinical narrative: Case number PHHY2013US116618 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 481199) website on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history was not reported. Her concomitant medication included triamterene/hydrochlorothiazide and nifedipine. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into left arm on 08 Oct 2012. On the next day, she had a reaction of diarrhea all the day and her arm was swollen and was unable to touch for four days after the flu shot. She was given with ice packs to apply on that area. On 04 Nov 2012, she woke up with excruciating neck, shoulder, and scapula pain. She applied ice, heat and massaged the area all the day but no avail. On 05 Nov 2012 (about 1:00 am), she went to emergency room and she was given two different shots in both arms along with oral medication which did not help. She lost the function of her arm slowly throughout the day. She had not been able to work and was still in pain and also had paralysis of arm. She underwent electromyogram (EMG), nerve conduction tests and nuclear magnetic resonance imaging (MRI) which confirmed Parsonage-Turner Syndrome (brachial plexopathy) as a result of the flu shot. Outcome of diarrhea, swollen arm with unable to touch was not reported. Outcome of other events was reported as not recovered as of 14 Jan 2013. No seriousness and causality of the events were reported.