chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
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 19-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J000141 and expiry date: 04-JUL-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), 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 PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. It was reported that, the patient received ADACEL vaccine on 03 September 2013 which was expired on 02 September 2013. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 02 December 2013. A 68-year-old female patient had received an intramuscular dose of ADACEL (batch number: C4432AB, dose number was not reported) in the right deltoid and had received an intramuscular dose of PCV23 (manufacturer other, batch number: J005068, dose in series was not reported) in the right deltoid on 30 September 2013. The patient had a history of anxiety. The patient had no illness at the time of vaccination and had no known drug allergy. On 30 September 2013, same day of vaccination, the patient developed an erythema just below the injection site on the right deltoid. It covered the half of the upper arm, area and was raised. No other symptoms reported. No laboratory tests were performed and corrective treatments were not reported. At the time of this report, the patient was not recovered. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
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 27-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04-Nov-2013. Several patients administered ADACEL. They stored product at 30F, It was determined as unstable for use. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 10 OCT 2013. A 36-year-old male patient was given ADACEL intramuscularly on left deltoid on 27 SEP 2013. Patient had left deltoid pain that radiates down the arm and numbness and tingling in the left hand on 27 SEP 2013. The events were not recovered. List of documents held by sender: none
Sex: U
Vaccine: VARCEL
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 01-JUL-2013, the patient was vaccinated with VARIVX (Merck) (dos strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 09-Sep-2013. The 4-year-old patient had received two ADACEL, multiple doses. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
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 30-JUL-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 13-Sep-2013. A 4 months old patient was administered with ADACEL instead of DAPTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
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 22-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) 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.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Injection site pain, Irritability, Malaise, Poor quality sleep
Clinical narrative: Initial report received from a consumer's mother 08 DECEMBER 2013. Corrective treatment included TYLENOL. A 1.5 month neonate old female patient was vaccinated on an unknown date of DTAP for an unknown indication. Patient's mother stated that after first couple of days after the shot, including the day of the shot, until about 2 days after she had a fever that was up 102 degrees. She had a bad appetite, really fussy. Just seemed to be very sick, legs were tender. She was not sleeping well. The patient was recovered. No further relevant information was reported.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer's mother 08 DECEMBER 2013. Corrective treatment included TYLENOL. A 1.5 month neonate old female patient was vaccinated on an unknown date of DTAP for an unknown indication. Patient's mother stated that after first couple of days after the shot, including the day of the shot, until about 2 days after she had a fever that was up 102 degrees. She had a bad appetite, really fussy. Just seemed to be very sick, legs were tender. She was not sleeping well. The patient was recovered. No further relevant information was reported.
Sex: U
Vaccine: VARCEL
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 14-JUL-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 16 December 2013. 3 patients, whose gender, age, medical history and concomitant medications were not reported, had received a dose of ADACEL (Lot number U4612AA, site of vaccination was not reported) intramuscularly, on an unspecified date in December 2013. Patients reported the injection site became warm to touch, reddened, itchy, and a knot formed. Corrective treatment was not reported. At the time of this report the outcome of adverse event was unknown. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Initial report received from consumer on 13 DECEMBER 2013. A male patient whose age, medical history and concomitant medications were not reported, received TDAP (lot number, expiration date, route and site of administration were unknown) on an unknown date. ON an unknown date, patient developed hives after receiving vaccine when he was 12 or 13 years of age. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none
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 gender. The patient pertinent medical history was not reported. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot# K000456 and expiry date: 15-DEC-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: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received on 02 December 2013 from office person Med Asst. A 19-months-old child patients whose gender, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received ADACEL instead of DTaP for the 4th dose in the DTaP series. Patient did not have any adverse event. List of documents held by sender: none.
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 22-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-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.
Age: 1.3
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 03-SEP-2013.  A 15 months old patient was administered with ADACEL. (No information was provided regarding the patient). 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 on 03 DECEMBER 2013 from nurse. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Patient administered Td vaccine last week but was suppose to have been administered a TDap. Patient did not have any adverse events. List of documents held by sender: none
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 13-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-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 ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 December 2013. The patient had received unstable ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Initial report received from healthcare professional on 26 NOVEMBER 2013. A female patient whose age, medical history and concomitant medications were not reported, received ADACEL (lot number, expiration date unknown) intramuscularly at the left deltoid on  25-NOV-2013. On 26-NOV-2013, patients reported large swollen lymph node under the left armpit. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 07 February 2014. A 66-year-old male patient, whose medical history included HTN, cholesterol, gout, sleep apnea and Colon CA in 2013 had received an intramuscular dose of ADACEL (batch number: C4506BA, expiry date: 04 April 2016, dose number was not reported) in the left deltoid and an intramuscular dose of PNEUMOVAX (batch number: J009827) in the right deltoid on 06 February 2014. Patient's concomitant medications were not reported. On 07 February 2014, the patient developed redness, swelling and induration measuring 4x4 cm on his left deltoid. Corrective treatments were not reported. No laboratory investigations were done. At the time of this report, the patient had not recovered from the event. Documents held by sender none. Follow up information was received on 04 April 2014: It was reported that the patient had received concomitant medications of Simvastatin 40 mg, and VIAGRA 50 mg. and corrective treatment of ice to warm. It was updated that the patient was recovered from the event in a few days on an unspecified date.
Sex: U
Vaccine: MMRV
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 17-MAR-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J014235 and expiry date; 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), 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 PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 09-SEP-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 29-APR-2014, the patient was vaccinated with PROQUAD (dose strength and route was not reported) (lot # J002306 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, 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 PROQUAD. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 06-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), 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 PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # and expiry date were unknown) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 07-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 31-JAN-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), 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 VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 10-NOV-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K007797 and expiry date: 29-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 20-NOV-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), 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 PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: TD
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 09-SEP-2013. A patient was given ADACEL inadvertently by subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 08 OCTOBER 2013. A 4-year-old female patient had received ADACEL instead of KINRIX last week. 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 04 NOVEMBER 2013. The 04 year old patient had received ADACEL (lot # and expiration date unknown) ad the 5th DAPTACEL. The nurse reported that if Tdap was inadvertently administered as the fourth or fifth dose in the tetanus-diphtheria-pertussis vaccination series to a child less than 7 years of age, the Tdap dose should be counted as valid and does not need to be repeated. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Joint swelling, Peripheral swelling
Clinical narrative: Initial case was received from a consumer on 12 MAY 2013. This 43-year-old female patient whose medical history included allergic to Zithromax and seasonal allergies. Concomitant medication was not reported. The patient had received an intramuscular dose of ADACEL (batch number, dose not reported) on right deltoid on 12 MARCH 2013. On 12 MARCH 2013, by the evening of vaccination, patient noticed swelling in her ankles and legs. Her swelling reduced to the some extent but was still present at the time of the report. She also reported soreness at the right deltoid. The laboratory details were not reported. Corrective treatment was not reported.  The outcome of the event was not reported. The 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 07 FEBRUARY 2017. A patient (date of birth and gender was not reported) had received a dose of ADACEL (expired on 18 JANUARY 2014) on an unspecified date. No adverse event was reported. Documents held by sender: none
Age: 11.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 FEBRUARY 2014. An 11-year-old patient had received a dose of MENACTRA and a dose of ADACEL, both on 14 JANUARY 2014. The patient had received a dose of MENACTRA and a dose of ADACEL, both on 13 AUGUST 2013. No adverse event was reported. List of documents held by sender: none
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received on 07-NOVEMBER-2013 from a pharmacist. A 12-year-old female patient whose medical history and concomitant medications were not reported, received a dose of ADACEL via intramuscular route (site of administration not reported) on 17-SEPTEMBER 2007. On 18-SEPTEMBER 2007, after vaccination the patient experienced redness, swelling and tenderness at the injection site. Corrective treatment was not reported. At the time of this report the outcome of the event was resolved. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Mobility decreased, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 07 NOVEMBER 2013. A female patient, whose age, medical history and concomitant medications were not reported, received ADACEL (lot number and expiration date unknown) intramuscularly and in left deltoid on 02 NOVEMBER 2013. On 07 NOVEMBER 2013, the patient had swollen, very sore arm, nausea, and lightheadedness. Stated can barely move arm since it is so painful. Laboratory investigation and corrective treatment were not reported. As of this report, outcome of the event was unknown. Documents held by sender: none
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Malaise
Clinical narrative: Initial information received on 05 FEBRUARY 2013 from a consumer who is the patient's parent.  A male child, age at time of event not reported received DTAP on an unknown date, (manufacturer, route, dose and site of administration were not reported). Six months after vaccination, the parent was notified from the hospital that the patient had received an "extra shot of DTAP", details not reported. Around the time of the child's vaccinations, the patient "got real sick for a few days". The parent reported that she thinks he had an allergic reaction to the shot. The patient's concomitant medications and medical history were not reported. The patient outcome was not reported. No further details were available at the tine of this report.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional (Pharmacist) on 06 FEBRUARY 2014. A patient  (age and gender not reported) whose medical history and concomitant medication were not reported,  had received TDAP (batch number, dose, route and anatomical site of administration were not reported) instead of TB test. 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 health care professional on 10 February 2014. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of Tdap vaccine (manufacturer unknown, lot number, dose number route and site of vaccination was not reported) on 07 February 2014 and 10 February 2014 respectively. It was reported that the patient received a dose on Friday 2014, and another dose again on 10 February 2014 thus, an extra dose was administered. At the time of this report, the patient did not experienced any adverse events. List od documents held by sender: none.
Age: 2.0
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 05 FEBRUARY 2014. A 2-year-old patient (gender was not reported) had received fifth dose of ADACEL on an unspecified date. No adverse event was reported. 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 03 February 2014. A patient had received a dose of ADACEL rather than a Tdap by mistake on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional on 16 January 2014. A 66-year-old female patient had received a dose of ADACEL intramuscularly in left deltoid on 13 January 2014. The patient had no illness at the time of vaccination and had allergic to latex, erythromycin, sulfa, iodine. Concomitant medication was not reported. On 13 January 2014, same days after vaccination the patient's left deltoid became swollen, bruised, and hard like a rock. On 15 January 2014, the patient developed a red, raised from the injection site down the arm almost to the elbow; the area is also warm to touch. The rash is not itchy. The patient was extremely tired since the vaccination. Corrective treatment were not reported and a laboratory investigation was not performed. At the time of this report, the patient was not reported. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Initial report received from a non-healthcare professional on 16 January 2014. A 66-year-old female patient had received a dose of ADACEL intramuscularly in left deltoid on 13 January 2014. The patient had no illness at the time of vaccination and had allergic to latex, erythromycin, sulfa, iodine. Concomitant medication was not reported. On 13 January 2014, same days after vaccination the patient's left deltoid became swollen, bruised, and hard like a rock. On 15 January 2014, the patient developed a red, raised from the injection site down the arm almost to the elbow; the area is also warm to touch. The rash is not itchy. The patient was extremely tired since the vaccination. Corrective treatment were not reported and a laboratory investigation was not performed. At the time of this report, the patient was not reported. Documents held by sender: none.
Age: 10.0
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 06 January 2014. A 10-year-old patient of unspecified gender had received ADACEL on an unspecified date in July. The patient did not experience any adverse event. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 January 2014. This is invalid case as the individual patient identifiers missing. On 13 January 2014 the patient received ADACEL vaccine intravenous. It's an incorrect route of vaccine administered. 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 January 2014. A female patient  (no other information provided) had received a dose of ADACEL instead of Hepatitis B vaccine on an unspecified date. No adverse event was reported. 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 02 January 2014. A 17-month-old patient had forth dose of had ADACEL instead of DAPTACEL. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a non-healthcare professional (other) on 31 May 2013. This is an invalid case as individual patient identifiers are missing. A cluster of 4-5 patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of ADACEL vaccine (lot number-unknown, dose in series, route and anatomical site of vaccination were not reported) on an unspecified date. On an unspecified date after few days of vaccination, 4 to 5 patients had swollen, red, warm to touch reactions at the injection site. After 2 weeks of vaccination, 1 patient had persistent redness. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Feeling abnormal
Clinical narrative: Initial report received from a non healthcare professional social media on 16 December 2013. A patient of unknown age and gender had received TDAP (lot number: unknown) on unknown date. On 16 December 2013, the patient reported that vaccine made patient feel like crap. Laboratory investigations and corrective medications were not reported. At the time of this report the outcome was unknown. Documents held by sender: None. Follow-up information received on 23 December 2013. Additional MIS number: 13-0952 was added.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Initial report received from a healthcare professional on 31 MAY 2013. A 17-year-old female patient, who had no illness at the time of vaccination and whose concomitant medications were not reported, had received an intradermal dose of ADACEL (lot number: U3956AA with expiry date 16 NOVEMBER 2013, anatomical site of vaccination was not reported) on 31 MAY 2013. The patient was allergic to Augmentin. It was reported that ADACEL prefilled syringe was inadvertently administered intradermal "as in administering a TB test" on 31 MAY 2013 and immediately following the vaccination, the patient developed "local site reaction" of redness and swelling. Laboratory investigations and corrective medications were not reported. Till the time of this report, the patient had not recovered from the events. Follow-up information received from healthcare professional on 11 JULY 2013. Date of vaccination was updated from 31 MAY 2013 to 28 MAY 2013.  The patient address was reported and was updated in patient address screen. Documents held by sender: none
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Joint swelling, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 04 June 2013. A 23-year-old female patient, had received an intradermal 0.1ml dose of ADACEL vaccine (lot number-C4313AA) instead of Tubersol PPD (anatomical site of administration were not reported) on 03 June 2013. On 03 June 2013 i.e. same day post vaccination; the patient experienced mild redness at injection site and her ankles are swelling mildly both ankles. The patient had wrong vaccine administered as patient received ADACEL instead of Tubersol. The patient had no illness at the time of vaccination and concomitant medications were not reported. The patient had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient received intramuscular ADACEL vaccine (batch number: C4313AA) on 29 May 2013. No laboratory investigations were performed. Corrective treatment were not reported. The patient's outcome was not reported. Follow-up information received from a healthcare professional on 16 September 2013. On 29 May 2013, the patient had received ADACEL vaccine intramuscularly in the left deltoid. On 03 June 2013, the patient had received 0.1 cc dose of ADACEL vaccine intradermally in the left forearm. The patient was monitored and follow-up was scheduled in 2 days but she never received the call. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial information received from a healthcare professional on 02 January 2014. A patient, whose demographics, medical history and concomitant medications were unknown, had received a dose of TDAP (batch number, dose number, route and anatomical site of administration unknown) on an unspecified date of April 2013. It was reported that on an unspecified date, the injection site had become swollen, sore and tender. Laboratory data and corrective medications were unknown. The patient outcome was unknown. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Oral pain, Pyrexia, Stomatitis
Clinical narrative: Initial report received from healthcare professional on 18 February 2014. A 52-year-old female patient, who has no medical history with no illness at the time of vaccination and concomitant medications were not reported, had received intramuscular dose of ADACEL (batch number and dose number were not reported) in left deltoid on 14 February 2014. It was reported that on 14 February 2014, by the evening after receiving ADACEL, the patient experienced rash on left shoulder that was red, raised but not itchy. The next morning, the patient had sores in her mouth that were painful and had low grade temperature. The corrective treatment was not reported and laboratory investigations were not performed. At the time of this report, the outcome was not recovered. Documents held by sender: none
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 20 February 2014. A 51-year-old female patient had received an intramuscular first dose of ADACEL, (batch number U4837AA) in left deltoid on 19 February 2014 at 11:30 hours. The patient had received previously first dose of MENOMUNE, (batch number, route and site of vaccination not reported) on 07 August 2002 and had experienced adverse event (unspecified). The patient had no illness at the time of vaccination and no pre-existing allergies or medical conditions. On 20 February 2014 at 10:30 hours, the patient felt weak, had chills, muscle aches, feverish and leg felt like "jelly" with dull ache. The patient's other medications include miscardis and nevsium (not legible). No laboratory tests were performed and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 20 February 2014. A 51-year-old female patient had received an intramuscular first dose of ADACEL, (batch number U4837AA) in left deltoid on 19 February 2014 at 11:30 hours. The patient had received previously first dose of MENOMUNE, (batch number, route and site of vaccination not reported) on 07 August 2002 and had experienced adverse event (unspecified). The patient had no illness at the time of vaccination and no pre-existing allergies or medical conditions. On 20 February 2014 at 10:30 hours, the patient felt weak, had chills, muscle aches, feverish and leg felt like "jelly" with dull ache. The patient's other medications include miscardis and nevsium (not legible). No laboratory tests were performed and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Initial report received from a healthcare professional on 24 February 2014. A patient, whose date of birth, age, gender, medical history and concomitant medication were not reported, had received another injection instead of ADACEL on an unspecified date, leading to wrong vaccine administration. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Initial report received from healthcare professional on 03 March 2014. (Reference number: 14-0129). A '11-year-old female patient' whose medical history and concomitant medication were not reported, had received a intramuscular dose of ADACEL (Batch number U4655AA, expiration date was not reported) in to the left deltoid on 24 February 2014, a intramuscular dose of MENACTRA (Batch number U4626AA, expiration date was not reported) in to the right deltoid on 24 February 2014, and a dose of HPV (Batch number J011272, expiration date was not reported) in to the right deltoid on 24 February 2014. It was reported that after vaccination the patient experienced right upper arm redness, hot to touch and swollen, local site reactions from 26 February 2014. The detail of lab investigation was not provided. The patient had received corrective treatment of ZYRTEC antihistamine and warm compress. The outcome of the event was unknown at the time of report. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from non-healthcare professional on 04 March 2014. A female patient (Date of birth and age at time of adverse event not provided), whose medical history and concomitant medications were not reported, had received intramuscular doses of ADACEL (batch number and dose number were not reported), received in deltoid on February 2014. It was reported that on February 2014 after receiving ADACEL vaccine, the patient presented redness and swelling at the injection site. The patient took BENADRYL, as corrective treatment. Laboratory investigations were not reported. On unspecified date, the event had Recovered (Date not provided). Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 05 March 2014. Two patient, who demographics were unknown, had received an intramuscular first dose of ADACEL, (batch number U4825AA, site of vaccination unknown) on 03 March 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On an unspecified date, the patients experienced severe pain at injection site with swelling (1/2 dollar red raised at injection sites). Corrective treatment and laboratory details were not reported. At the time of this report the patient had not recovered. Document held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial report received from a healthcare professional on 22 May 2013. A patient (demographics unknown) had received a dose of ADACEL vaccine (lot number, dose in series, route and site of administration was unknown) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was unknown. Concomitant medications were not reported. On an unspecified date, post vaccination the patient had a reaction to ADACEL. The patient laboratory tests and corrective treatment were not reported. The outcome of event was not reported. Documents held by sender were none.
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Initial report received from a consumer who is also the patient on 24 May 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of ADACEL, lot number C4311AA in right arm (deltoid) on an unknown date. On an unknown date, the patient had a golf size swelling and soreness at the vaccination site. The patient applied cold packs. The swelling flattened into broader area but the soreness remained. Stayed swollen for 6 week. Corrective treatment and laboratory investigations were not reported. The patient's outcome was recovered. Documents held by sender none.