chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a nurse and described the occurrence of therapy non-responder in a 23-year-old female patient who received ENGERIX B. Co-suspect products included ENGERIX B adult and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B adult (unknown) and the 2nd dose of ENGERIX B adult (unknown). In 2014, the patient received the 3rd dose of ENGERIX B adult (unknown). On an unknown date, an unknown time after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult, the patient experienced therapy non-responder. Rechallenge with ENGERIX B adult was positive. Re challenge with ENGERIX B adult was positive. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information received on 13 November 2014: The patient completed the 3 doses schedule of ENGERIX B (on 0,1, 6 month schedule). Then, on 07 November 2014, 1-2 months after the series completion, she had titers drawn at clinic and was found to be non-responder (less than 10).
Age: 42.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a pharmacist and described the occurrence of inappropriate age of administration in a 42-month-old unk patient who received KINRIX. On an unknown date, the patient received the 1st dose of KINRIX. On an unknown date, on unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received on 13 November 2014: The 3.5 years old patient was inadvertently given a dose of KINRIX. The reporter was unaware of whether it was given as primary series dose of as the 4th DTaP. No adverse event was reported.
Sex: U
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of extra dose administered in a male patient who received ROTARIX (batch number A41CB426A, expiry date 7th September 2015). Previously administered products included ROTARIX (dose 1) and ROTARIX (dose 2). On an unknown date, the patient received the 3rd dose of ROTARIX 1 ml. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Nurse reported that a third dose of ROTARIX was given to a patient by mistake today. It was just the third dose given today. Other two doses were given to the patient in the past. No symptoms reported.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a nurse and described the occurrence of therapy non-responder in a 48-year-old male patient who received ENGERIX B (batch number L5MN2, expiry date September 2016). On 29th August 2014, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 14th November 2014, 77 days after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional information received: Non responder after completion of 3 doses of Hepatitis B (only certain that last dose was ENGERIX B). Titer drawn on 14 November 2014.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Acoustic stimulation tests abnormal, Hypoaesthesia, Tinnitus, Tympanometry normal
Clinical narrative: Numbness feeling inner right ear and tinnitus began 14 hours after HPV #3 - began w/ numbness - then tinnitus 1 hr later - persists to now - later in day - no other sx or illness.
Age: 1.26
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received BOOSTRIX (batch number 472S7, expiry date 13th April 2016). The patient's past medical history included no adverse. Concomitant products included Hib vaccine. On 17th November 2014, the patient received BOOSTRIX. On an unknown date, an unknown time after BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine to be related BOOSTRIX. Additional information received: A 15 months old male patient received an injection of BOOSTRIX. No other events noted or reported.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a female patient who received ENGERIX B. Previously administered products included TWINRIX (dose 1) and TWINRIX (dose 3). On 8th July 2013, the patient received the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced wrong vaccine administered and inappropriate schedule of vaccination administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administration were unknown. Additional information received.
Age: 1.26
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received BOOSTRIX (batch number 472S7, expiry date 3rd April 2016). On 17 November 2014, the patient received BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: LPN reports that 15 month-old male inadvertently received BOOSTRIX instead of INFANRIX for 4th DTaP dose. Maladministration was human error of new employee to peds. Maladministration AE. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Medical history was not reported. Patient was administered a dose of ZOSTAVAX, subcutaneous injection (dose, lot number and expiry date not provided) on an unspecified date in 2008 at a pharmacy. On 31-OCT-2014 the patient was inadvertently administered with a second dose of ZOSTAVAX subcutaneous injection (dose, lot number and expiry date not provided). No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received KINRIX (batch number 95237, expiry date October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. Additional information received: KINRIX given as dose 1 of a Dtap series.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling of (L) deltoid about 10 hours after injection; went to urgent care 2 days later and was put on cephalexin 500 mg 1 cap TID x 10 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist via agency concerning unspecified patients of unknown age and gender. The pharmacist heard about the new Advisory Committee On Immunization Practices (ACIP) recommendation and indicated that it might be possible that the unspecified patients were not given PREVNAR 13 (lot#, dose, route not reported) first or not given the PNEUMOVAX 23 (lot#, dose, route not reported) after 12+ months of PREVNAR 13 vaccination, which was considered to be inappropriate schedule of vaccine administered per new Advisory Committee On Immunization Practices (ACIP) recommendation. Additional information is not expected as the reporter was not willing to be contacted.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 31 July 2013. A 25-year old female patient, whose medical history and concomitant medications were not reported, had received first intramuscular dose of ADACEL vaccine (batch number: U4586AA, and site of administration was not reported) on 30 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 15 April 2013. The estimated date of delivery was reported as 26 September 2013. Patient's health during pregnancy and risk factors were reported as "N/A". At the time of the report, the patient had not experienced any adverse events. 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 19 July 2013. A 30-year-old female patient whose medical history and concomitant medications were not reported, had received an intramuscular first dose of ADACEL vaccine (batch number: U4667AA, expiry date- 11-Jul-2015, anatomical site of administration was not reported) on 19 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 12 November 2012 and the estimated date of delivery was 19 August 2013. The patient's health during pregnancy, risk factors and treatment for infertility was not reported. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. At the time of this report, the outcome was unknown. List of documents held by the sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 19 July 2013. A 32-year-old female patient, had received first intramuscular dose of ADACEL (Lot number U4612AA, anatomical site of vaccination was not reported) on 18 July 2013. The patient was pregnant at the time of report. The patient's last menstrual period date was 26 December 2012 and the expected date of delivery was reported as 02 October 2013. The patient's health during pregnancy, concomitant medications and risk factors were not reported. At the time of report, the patient had not experienced any adverse event. List of documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 23 July 2013. A 38-year-old female patient, had received first intramuscular dose of ADACEL vaccine (Lot number: U4586AA and site of administration was not reported) on 23 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 14 November 2012. The patient's estimated date of delivery was reported as 21 August 2013. At the time of this report, the patient had not experienced any adverse events. The patient's health during pregnancy, concomitant medications, medical history and specific risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 23 July 2013. A female patient (age not reported) had received dose 1 of ADACEL vaccine (batch number: U4586AA, route and site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 01 November 2012. The estimated date of delivery was 17 August 2013. Patient's health during pregnancy, specific risk factors and concomitant medications were not reported. Treatment for infertility was not reported. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from  healthcare professional on 01 August 2013. A 32-year-old female patient had received first intramuscular dose of ADACEL (lot number: U4646AA, anatomical site of vaccination was not reported) on 01 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period was 14 January 2013 and the expected date of delivery was reported as 07 October 2013. The patient's health during pregnancy and ris factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. At the time of this report, the patient had not experienced 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 pregnancy report received from a healthcare professional on 29 July 2013. A 30-year-old female patient had received first dose of ADACEL vaccine (lot number: U4646AA, expiry date 28 November 2015, anatomical site of administration was not reported) intramuscularly on 29 July 2013. The patient's health during pregnancy, and risk factors (e.g. Alcohol), tobacco or recreational drugs) were reported as "NA". The patient's last menstrual period date was 24 December 2012 and the expected date of delivery was reported as 30 September 2013. At the time of this report, the patient had not experience any adverse event. List of documents held by the 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 29 July 2013. A 33-year-old female patient had received first intramuscular dose of ADACEL (Lot number U4586AA, anatomical site of vaccination was not reported) on 29 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 14 January 2013 and the estimated date of delivery was 21 October 2013. The patient's health during pregnancy, risk factors (e.g.: alcohol, tobacco or recreational drugs), medical history, concomitant medications and laboratory tests 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: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 15 April 2013. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received a post-partum dose of Tdap vaccine (unknown manufacturer) (batch number, dose number and anatomical site of administration were not reported) intramuscularly on 09 April 2013. It was reported that, the patient experienced 3 cm by 3 cm induration, raised, erythema, area at injection site. The corrective treatments and laboratory investigations were not reported. At the time of this report received, the patient was not recovered from the event. Follow up information received from a healthcare professional on 04 June 2013. The patient had received ADACEL vaccine (lot number U4567AA, expiry date 19-June-2015) subcutaneously and not intramuscular in right upper arm not in deltoid as reported previously. Case of misuse as patient received wrong route of vaccination. The patient's concomitant medications included prenatal vitamins. The patient instructed to take BENADRYL and prescribed clindamycin and had to return to clinic in 24-48 hours if no improvement was observed. The patient did not return with further concerns. On an unspecified date, the patient had recovered from the events. Follow up information received from a healthcare professional on 11 July 2013: The patient was post-partum at the time of vaccination. 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 06 August 2013. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received first dose of ADACEL vaccine, batch number: U4646AA (route and anatomical site of administration were not reported) on 05 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 28 December 2012 and the estimated date of delivery was 08 October 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was reported as "N/A". Laboratory investigations and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 August 2013. A female patient had received an intramuscular dose of ADACEL vaccine (lot number: U4646AA, dose in series and site of administration was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 04 January 2013 and the estimated date of delivery was 11 October 2013. Laboratory investigations were not reported. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". Medical history and concomitant medications 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 15 August 2013. A female patient, had received first dose of ADACEL vaccine, batch number: U4612AA (anatomical site of administration was not reported) intramuscularly on an unspecified date. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 06 January 2013 and the estimated date of delivery was 05 October 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA" and concomitant medications were not reproted. 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: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: A 31-year-old female patient, had received intramuscular dose 1 of ADACEL vaccine (lot number: U4612AA and site if administration was not reported) on 15 August 2013. The patient's last menstrual period date was 06 January 2013 and the expected date if delivery was reported as 13 October 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 14 August 2013. A 32-year-old female patient had received intramuscular first dose of ADACEL vaccine. (lot number- C4313AA, expiry date- 22 March 2015) in the right deltoid on 14 August 2013. The patient's last menstrual period date was not reported and the estimated date of delivery was "05 October 2015". The patient's health during pregnancy, risk factors, concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 12 August 2013. A female patient, whose age, medical history and concomitant medication were not reported, had received an intramuscular dose of ADACEL (Lot number: U4612AA, expiry date: 20 September 2015, anatomical site of vaccination was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 06 December 2012 and the estimated date of delivery was 12 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". Treatment for infertility was 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: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 12 August 2013. A 30-year-old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: U4646AA, site of administration was not reported) on 09 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 December 2012. The estimated date of delivery was 11 September 2013. The patient's health during pregnancy and risk factors was reported as 'N/A'. Concomitant medications, medical history and laboratory investigations were not reported. Treatment for infertility was reported as 'N/A'. 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 from a healthcare professional on 12 August 2013. A 30-year-old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: U4313AA and site of administration was not reported) on 12 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 12 January 2013. The estimated date of delivery was 19 October 2013. Patient's health during pregnancy, risk factors, concomitant medications and medical history were not reported. Treatment for infertility was not reported. Laboratory details were not reported. At the time of the report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial case was received from a healthcare professional on 09 August 2013. A 35-year old female patient whose medical history and concomitant medications were not reported had received an intramuscular first dose of ADACEL Vaccine (lot number U4646 AA) in her deltoid of the left arm on 07 August 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 was reported as 25 September 2013. The patient had no healthy problem during pregnancy and had no specific risk factors. No laboratory details were provided. At the time of this report the patient did not experience any adverse event. List of documents held by sender were 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 03 September 2013. A 30-year-old female patient had received intramuscular first dose of ADACEL vaccine (lot number: C4313AA, expiry date: 22 March 2015, anatomical site of administration was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 20 January 2013 and the estimated date of delivery was reported as 27 October 2013. The patient's health during pregnancy, risk factors (e.g.: alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 30 August 2013. A 26-years-old female patient had received an intramuscular  dose 1 of ADACLE vaccine; lot number C4432AB (anatomical site of administration was not reported) on 30 August 2013. The patient was pregnant at the time of vaccination. Date of last menstrual period was 16 January 2013. The estimated date of delivery was on 23 October 201. At the time of the report, the patient had not experienced any adverse events. Patient's health during pregnancy, specify risk factors (e.g.: alcohol, tobacco or recreational drugs) and treatment for infertility, specific risk factors were reported as not applicable. Concomitant medications and past medical history was not reported. At the time of this report, the patient's outcome was unknown. 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 27 August 2013. A 24-year-old female patient had received an intramuscular 0.5 ml dose of ADACEL vaccine (lot number C4313AA, expiry date- 3/22/15, dose number-not reported) in the right deltoid on 27 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 13 January 2013 and the estimated date of delivery was 20 October 2013. The patient's health during pregnancy, risk factors (e.g. alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 22 August 2013. A female patient, had received intramuscular dose 1 of ADACEL vaccine (Lot number: U4586AA, anatomical site of administration was not reported) on an unspecified date. The patient was pregnant. The last menstrual period was on 08 December 2012. The patient's estimated date of delivery was reported on 25 October 2013. Patient's health during pregnancy, risk factors and concomitant medication were not reported. At the time of this report the patient had not experienced any adverse events. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 August 2013. A 37-year-old female patient had received an intramuscular dose of ADACEL vaccine (lot number: LU464AA (dose in series and site of administration were not reported) on 08 August 2013. The patient was pregnant was pregnant at the time of vaccination. Last menstrual period date was unknown and the estimated date of delivery was 24 September 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs), treatment for infertility, medical history and concomitant medications 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: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 August 2013. A female patient (age at the time of event was not reported) had received an intramuscular dose of ADACEL (Lot number: C4313AA, anatomical site of vaccination was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was unknown and estimated date of delivery was 24 October 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs), treatment for infertility, medical history and concomitant medications 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 pregnancy report received from a healthcare professional on 19 August 2013. A 29-year-old female patient, had received a dose of ADACEL vaccine (lot number: C4170AA, expiry date: 11/03/2014, dose number, route and anatomical site of administration were not reported) on 19 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was not reported and the expected date of delivery was reported as 06 September 2013. The patient did not experience any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. List of documents held by the sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 04 September 2013. A female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose of ADACEL, lot number: C4432AB (dose number and anatomical site of administration were not reported) having expiry date October 2015 on an unspecified date. The patient's last menstrual period was reported as 17 January 2013 and the expected date of delivery is 24 October 2013. As per reporter, the patient had not experienced any adverse event. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 04 September 2013. A 27-year-old female patient had received intramuscular first dose of ADACEL (lot number: U4618AA and expiry date: 23 October 2015) in the right deltoid on 30 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown and the expected date of delivery was reported as an unspecified date in October 2013. The patient had no significant medical history or risk factors (e.g. : alcohol, tobacco or recreational drugs) and her concomitant medications were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 04 September 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACE (lot number, dose in series and site of administration were not reported) on 04 September 2013. The patient's last menstrual period date was unknown and the expected date of delivery was reported as 20 October 2013. The patient was healthy at the time of vaccination. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 April 2013. A 4-year-old patient had received ADACEL vaccine as a fifth dose in of DTaP series. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 06 February 2014. A patient had received a dose of ADACEL intramuscularly in deltoid when she was supposed to get TST on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 April 2013. ADACEL was administered to a 3-year-old patient. No adverse event was reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 13 May 2013. A 66-year-old female patient, had received a dose of ADACEL vaccine (lot number: U4567AA, route of administration was not reported) in right deltoid on 06 May 2013. The patient had no relevant medical history or illness at time of vaccination. The patient had not received Tetanus vaccine since 1950. Concomitant medications were not reported. On 08 May 2013 i.e. 2 day after administration, the patient had developed swelling, redness, minimal itching to injection site that covered her upper arm above the elbow to shoulder and slight fever. The patient laboratory tests were not reported and the patient had received ibuprofen, BENADRYL and ice packs as corrective treatment. At the time of this report, the patient had not recovered. Documents held by sender were none. Follow-up information received from healthcare professional on 24 June 2013. The patient received vaccine intramuscularly in right arm. It was reported that, on 20 May 2013, the patient's arm was back to normal.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 16 May 2013. An 11-year-old female patient, had received an intramuscular dose of ADACEL vaccine (lot number: C4332BA) in left deltoid and an intramuscular first dose of MENACTRA (lot number: U4593AB) in right deltoid, both on 14 May 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. Concomitant medications were not reported. The patient had received last DTaP dose in 2006. On 15 May 2013, one day after vaccination, the patient developed redness, warmth and swelling at both right and left deltoid. The redness on right deltoid was 6 cm and the left deltoid was 9 cm. No laboratory tests were done. On 16 May 2013, the patient was evaluated by the physician and prescribed BENADRYL and cool compresses as corrective treatments. At the time of this report, the outcome of events was unknown. Documents held by sender were none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 April 2013. A dose of ADACEL administered to patient, that had expired on 9/2/2012 was on 09 April 2013 (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test, Cough
Clinical narrative: Initial report received from a healthcare professional on 21 May 2013. A 41-year-old female patient had received a booster dose of ADACEL vaccine (lot number: unknown, route and site of administration unknown) on 21 March 2013. The patient illness at time of vaccination was reported as unknown. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were unknown. It was reported that few weeks after vaccination patient experienced cough on an unspecified date. On 10 May 2013, Laboratory investigations from "Bordetella pertussis labs" included: IGA was 41, igGA was elevated at 41, PTI iGA was at 41, fHigG was 88 and pTigG was at 87. Corrective treatment was not reported. At the time of this report, the outcome of the event was unknown. List of document held by sender: None.
Age: 0.5
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a non healthcare professional on 16 April 2013. A 6-month-old patient had received ADACEL vaccine instead of DAPTACEL vaccine as of three doses in the series. No adverse event was reported. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 April 2013. ADACEL was given to a patient 65 years old patient. No adverse event was reported. List of documents held by sender: none.
Age: 0.4
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 April 2013. A second dose of ADACEL was administered to a 4 month old patient. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 16 April 2013. A 4-year-old patient had received ADACEL vaccine instead of PENTACEL vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 April 2013. A patient received ADACEL on 11 April 2013 and inadvertently received another ADACEL vaccine on 12th April 2013. (No information was provided regarding the patients). No adverse event was reported. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 02 May 2013. A 42-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: C4008AA, dose number not reported) on right deltoid on 26 April 2013. The patient had no drug allergies and no illness at time of vaccination. The patient had food sensitivities to tomatoes, peppers and mangos. The patient's concomitant medications were not reported. On 27 April 2013 (i.e. one day after vaccination), the patient experienced chills, sweating, fever and headache. Laboratory data and corrective treatments were not reported. It was reported that the patient had continued headache over the weekend till 02 May 2013. At the time of this report, the patient had not recovered from the events. Follow up information received from health care professional on 03 June 2013. The patient date of birth updated. The patient received 0.5 ml dose of ADACEL vaccine. The patient had not received any vaccine in past ten years. No illness at time of vaccination. It was reported that patient not received any specific treatment. On 07 May 2013 patient had recovered from the events of chills, sweating, fever and headache. It was reported that the event of injection site reaction was down 'to size of a dime' (recovering).
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 April 2013. A patient (No information was provided regarding the patient) had received first dose of ADACEL in May 2012 and then inadvertently received second dose in March 2013. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 10 April 2013. A patient (No information was provided regarding the patient), who had previously received a dose of ADACEL one year ago, received another dose of ADACEL on 10 April 2013. No adverse event was reported. List of documents held by sender: none.
Age: 1.7
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 April 2013. ADACEL vaccine was administered to 21-month-old patient as fourth dose of DTaP. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 April 2013. ADACEL was administered to an infant (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Initial report received from a consumer who is also patient's parent on 17 April 2013. A 12 year-old female patient, had received a dose of ADACEL vaccine (lot number, dose number, route of vaccination were not reported) in left deltoid on 15 April 2013. The patient had "allergies acting" at the time of vaccination and her medical history and concomitant medications was not reported. On 15 April 2013 in the evening, the patient had fever of 102 (Unit not reported). The patient was treated with Ibuprofen. On 16 April 2013, the patient went to school but had shivering and the fever went to "04.2". At the time of this report, the fever had declined to 101 (Unit not reported). Laboratory investigations were not done and corrective treatments included Ibuprofen. The patient's outcome was not recovered. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received from a healthcare professional on 17 April 2013. A 68-years-old female patient, had received a dose of ADACEL vaccine (Lot no: U4586AA, route and site of administration were not reported) on 15 April 2013. Patient had no medical history and her concomitant medications were not reported. She had allergies to PCN (Penicillin) and Sulfa (Sulfonamide). Patient had received tetanus containing vaccine 5 years ago. On 17 April 2013, the patient had experienced swollen, hard, red, warm to touch area around injection site which had "streaks" or red lines extending from down arm. Corrective treatments and complementary investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site swelling, Pain in jaw, Pyrexia
Clinical narrative: Information received from healthcare professional on 30 April 2013. This is an invalid case as individual patient identifiers were missing. Cluster of 3 patients (demographics not reported) whose medical history and concomitant medications were not reported; received ADACEL vaccine lot number C4365AA (dose number, route and site of vaccination was not reported) on 15 April 2013, 16 April 2013 and 20 April 2013. On an unspecified date, the patient had experienced swelling at injection site, jaw pain and fever. Corrective treatment and laboratory details were not reported. The patient's outcome was unknown. Documents held by sender: None. Follow up information received from a healthcare professional on 03 June 2013. The patients had recovered from the events on unspecified date.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 April 2013. A dose of ADACEL that had expired on 02 September 2012 was administered to a patient (No information was provided regarding the patient) on 09 April 2013. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 April 2013. An expired dose of ADACEL was administered to a patient (No information was provided regarding the patient). No adverse event was reported. List of documents held by 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 03 September 2013. A 28-year-old female patient had received intramuscular first dose of ADACEL (lot number: C4432AB, expiry date: 18 October 2016, site of administration was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 01 February 2013 and the estimated date of delivery was 08 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient did had experienced 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 03 September 2013. A 28-year-old female patient had received intramuscular first dose of ADACEL (Lot number C4432AB, anatomical site of vaccination was not reported) on 03 September 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 12 February 2013 and the expected date of delivery is 12 November 2013. The patient's health during pregnancy and risk factors (e.g. : alcohol, tobacco or recreational drugs) were not reported. Treatment for infertility was not reported. The patient did not experience any adverse event ill the time of this report. List of documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 06 September 2013.A 33-year-old female patient had received an intramuscular first dose of ADACEL (lot number: C4432AB, expiry date: 18 October 2015) in the right deltoid on 04 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was  03 February 2013 and the estimated date of delivery was reported as 10 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), and concomitant medications were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.