chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse reports received from a healthcare professional on 22 April 2014. A patient (no information regarding patient was reported) had received a dose of YF VAX (batch number, dose in series, route and site of administration was not reported) on an unspecified date. The patient had received a dose of YF VAX reconstituted with some other diluent. No adverse event was reported. List of documents held by sender: none
Age: 19.0
Sex: F
Vaccine: RAB, YF
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 13 May 2014. A '19-year-old' female patient, whose medical history and concomitant medication was not reported, had received the first dose of pre exposure series of IMOVAX (IPV (VERO)) (lot number J1391-1, expiration date, and route of vaccination was not reported) in to the left deltoid, and a dose of YF-VAX (Lot number UH675AA, expiration date, and route of vaccination was not reported) in to the right deltoid on 06 May 2014, and patient had experienced achiness, itchy around injection site, tiredness, large red oblong area about 2 in. long x 1.5 in, wide, slightly raised around injection site on 07 May 2014. It was reported that the patient's symptoms was ongoing at the time of report. The detail of laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered at the time of report. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 December 2014. A patient of unknown age and gender received YELLOW FEVER VACCINE (batch number, expiry date 06 February 2014, route, dose and anatomical site of administration not reported) on 18 February 2014. The patient received an expired vaccine. No adverse event was reported. The list of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 20 March 2014 at GPV. A dose of YF VAX was inadvertently reconstituted with sterile water and administered (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 October 2013. The cases were received on 21 March 2014 at the agency. A patient had received an expired dose of YF-VAX on an unspecified date. No adverse events were reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ, YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 21 OCT 2013. The case was received on 21 March 2014 at GPV. This is an invalid case as individual patient identifiers are not reported. The patient received expired dose of MENACTRA vaccine and a dose of YF-VAX vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV, YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 21 March 2014 at GPV. A patient had received a dose of YF Vax and a dose of ACT-HIB on an unspecified date. It was reported that gave both ACT-HIB and IF Vax with incorrect diluent. No adverse events were reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 February 2014. The cases were received on 21 March 2014 at GPV. A patient had received an expired dose of YF Vax on an unspecified date. No adverse events were reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a non-healthcare professional on 24 January 2014. The case was receive on 21 March 2014 at GPV. The two patients had received yellow fever vaccine reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a non-healthcare professional on 23 January 2014. The case was received on 21 March 2014 at agency. A patient had received YF VAX intramuscularly instead of subcutaneously. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 JAN 2014. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The patient inadvertently received a dose of YF VAX intramuscularly on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: DT, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 08 August 2013. A 10-year-old male patient had received first dose of DT (For Pediatric Use) (batch number: C4161AA, expiry date: 27 October 2014) intramuscularly in the left deltoid and first dose of BOOSTRIX vaccine (other manufacturer product, batch number: 739Y2, expiry date: 19 April 2015) intramuscularly in left deltoid on 06 August 2013. The patient had no illness at the time of vaccination. The patient was allergic to eggs and peanuts and his concomitant medications were not reported. The patient received DT and BOOSTRIX vaccine on the same day instead of MENACTRA. On 07 August 2013, 1 day after vaccination, the patient developed redness, swelling, warmth and discomfort at the injection site. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. Follow-up information received from a healthcare professional on 23 September 2013. On 08 September 2013, the patient had recovered from events. Documents held by sender: none.
Sex: U
Vaccine: DT
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 11 September 2013. A patient whose gender, age at the time of event, medical history and concomitant medications were not reported, had received a dose of DIPHTHERIA AND TETANUS TOXOIDS vaccine (unknown manufacturer, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient developed a bad reaction (unspecified). Lab details and corrective treatment details were not provided. At the time of this report, the outcome was not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none. Follow up information received from a healthcare professional on 21 October 2013 stating no further information available.
Age: 1.74
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a non healthcare professional on 31 October 2013. A 21-month-old male patient who received second dose of DT pediatric vaccine DECAVAC (batch number: C4161AA, intramuscularly in the right deltoid) on 08 August 2013. The patient's medical history was not reported and had no illness at the time of vaccination. On 08 August 2013, the injection site became red. 3 days later, patient's arm was more red and swollen from top of arm to his elbow. On an unspecified date, the patient recovered. Lab investigations and treatment medications were not reported. The company causality of this case was unclassified. List of document held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 29-DEC-2014 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (lot # H020587, expiry date: 13-NOV-2014, dose, route of administration was unknown). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Computerised tomogram head normal, Erythema, Flatulence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 year old male patient. Patient's concurrent conditions included hypertension, high cholesterol and degenerative joint disease of neck and back. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot number: J007210 with expiry date of 20-SEP-2014) (dose, route and frequency unspecified). Concomitant therapies included ZETIA, simvastatin (manufacturer unknown) and losartan potassium (manufacturer unknown). On an unknown date in November 2013 (three weeks after vaccination with ZOSTAVAX), the patient experienced gas like odd smell. The event progressed to total loss of smell. The patient also experienced burning sensation in the throat, tongue and lips along with loss of taste since three weeks after vaccination with ZOSTAVAX. On an unknown date the patient also experienced intermittent rash on face with welts and redness. The patient was treated with prednisone (manufacturer unknown) but was not effective. The patient sought medical attention. The patient was seen by ENT physician with no significant findings. The patient has undergone computerized tomography of brain which was normal. The patient was seen by Neurologist. The Neurologist documented in his report that symptoms were not related to ZOSTAVAX. The patient was referred to Dermatologist and was ordered additional blood work to rule out rheumatoid arthritis. The outcome of events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was considered to be not related by the Neurologist. This case is linked to # 1412USA010669 via same patient link. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Glossodynia, Oral discomfort, Rash, Throat irritation, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 year old male patient. Patient's concurrent conditions included hypertension, high cholesterol and degenerative joint disease of neck and back. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot number: J007210 with expiry date of 20-SEP-2014) (dose, route and frequency unspecified). Concomitant therapies included ZETIA, simvastatin (manufacturer unknown) and losartan potassium (manufacturer unknown). On an unknown date in November 2013 (three weeks after vaccination with ZOSTAVAX), the patient experienced gas like odd smell. The event progressed to total loss of smell. The patient also experienced burning sensation in the throat, tongue and lips along with loss of taste since three weeks after vaccination with ZOSTAVAX. On an unknown date the patient also experienced intermittent rash on face with welts and redness. The patient was treated with prednisone (manufacturer unknown) but was not effective. The patient sought medical attention. The patient was seen by ENT physician with no significant findings. The patient has undergone computerized tomography of brain which was normal. The patient was seen by Neurologist. The Neurologist documented in his report that symptoms were not related to ZOSTAVAX. The patient was referred to Dermatologist and was ordered additional blood work to rule out rheumatoid arthritis. The outcome of events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was considered to be not related by the Neurologist. This case is linked to # 1412USA010669 via same patient link. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Fall, Injection site pain
Clinical narrative: This spontaneous report was received from a 57 year old female patient, regarding herself. Patient was reported as allergic to indocine and SEPTRA DS. On 18-DEC-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, subcutaneous. It was reported that the patient received PNEUMOVAX23 approximately 4 weeks after receiving the flu shot. Concomitant therapies included NORVASC, LIVALO, SINGULAIR and ADVAIR. On 18-DEC-2014, patient reported having an upset stomach for about a week along with having injection site pain, vomiting (8 hours after receiving the shot), diarrhea which lasted 24 hours, and towards the end of her night she felt dizzy and fell. This all occurred after receiving PNEUMOVAX23. Patient also explained having an itchy rash on her chest and post nasal dripping. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash pruritic, Upper-airway cough syndrome, Vomiting
Clinical narrative: This spontaneous report was received from a 57 year old female patient, regarding herself. Patient was reported as allergic to indocine and SEPTRA DS. On 18-DEC-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, subcutaneous. It was reported that the patient received PNEUMOVAX23 approximately 4 weeks after receiving the flu shot. Concomitant therapies included NORVASC, LIVALO, SINGULAIR and ADVAIR. On 18-DEC-2014, patient reported having an upset stomach for about a week along with having injection site pain, vomiting (8 hours after receiving the shot), diarrhea which lasted 24 hours, and towards the end of her night she felt dizzy and fell. This all occurred after receiving PNEUMOVAX23. Patient also explained having an itchy rash on her chest and post nasal dripping. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a hospital purchaser via company representative refers to a patient of unknown age and gender. The purchaser reported that, on 29-DEC-2014, the nurse inadvertently administered a dose of GARDASIL lot # K008213, expiration date: 17-DEC-2016 (dose and route of administration were not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected as there is no consent to follow up contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 patients of unknown age and gender. In an approximately 2014 (reported as recently, exact date not provided), 2 patients were vaccinated with a dose of improperly stored ZOSTAVAX (lot number, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a currently 42 year old male patient refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration were not reported). On an unknown date, 24 hours after vaccination the patient noticed he had a pink spot and started to become sore and warm on the site of vaccination. The outcome of events was unknown. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information is not expected, because reporter's details were not provided.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 56 year old male pharmacist, reporting on himself. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the upper arm; dosage, dose number and lot number unknown). The pharmacist reported that on an unspecified date in 2013 he and his wife (MARRS case no. 1411USA013480) experienced an injection site reaction that "was mild" when they received ZOSTAVAX. He stated that they received the same lot number of ZOSTAVAX on the same day, but he does not have access to the documentation of the lot number report. He states that he and his wife both experienced a "quarter-sized" injection site redness with no pain or swelling. Neither he nor his wife sought medical attention nor received treatment. The pharmacist indicated that "injection site reactions are common" with ZOSTAVAX, and he observed many injection site reactions (MARRS case no. 1411USA013481). The outcome of the injection site redness was reported as recovered in an unspecified date in 2013 (reported as: within a couple of days). Relatedness between use of ZOSTAVAX and the adverse event was not reported. This is one of three reports from the same source. On 16-DEC-2014, a phone call was placed to the reporting pharmacist. He stated that he had no access to the lot number for the ZOSTAVAX vaccine he and his wife received. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient with no medical history, concurrent condition and no drug allergies. On 15-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX (vial, dose: 0.65 ml, subcutaneous, lot number: K011224, expiration date: 30-NOV-2014). On 17-DEC-2014 the patient experienced an intensely painful, blistered rash on his foot. The patient sought medical attention (saw a physician/podiatrist). There was a treatment given for adverse event. The physician prescribed the patient antiviral medication. The outcome of an intensely painful, blistered rash on his foot was reported as not recovered. The relatedness between ZOSTAVAX and an intensely painful, blistered rash on his foot was not reported. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 January 2014. A 09-month-old patient (whose gender, medical history and concomitant medications were not reported) had received a dose of DAPTACEL and a dose of ACT-HIB on 02 January 2014. The patient had received third dose of DAPTACEL and a dose of ACT-HIB on 19 October 2013, thus inappropriate schedule of vaccination was administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 February 2014. A patient had received a dose of DAPTACEL that was expired 5 days ago, on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, FLU3, HIBV, MNQ, TDAP, DTAP, FLU3, HIBV, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 07 November 2013. The patient had received ACTHIB, MENACTRA, DAPTACEL, FLUZONE and ADACEL. On 31 October 2013, temp went down to 33F. On 01 November 2013, temp went down to 33F. On 04 November 2013, temp went up to 50.7F. On 06 November 2013, the alarm went off at 29F. As of 31 October 2013, all MENACTRA were unstable. As of 06 November 2013, all products expect ACTHIB are unstable for use. (No information was given regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 09 August 2013. A patient (no information was provided regarding the patient) had received an intradermal dose of DAPTACEL instead of TUBERSOL. The patient was then administered TB skin test at another side (administration site- not reported). No adverse event was reported. Documents held by sender: None.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received from a healthcare professional on 01 August 2013. An 11-year-old patient was administered a dose of DAPTACEL. No other information was provided. Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on August 2013. It was reported that whole vaccination the patient (No information was provided regarding the patient) moved and full amount of DAPTACEL vaccine could not be administered. No adverse event was reported. List of documents held by sender: none.
Age: 70.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 August 2013. A 70-year-old patient was administered a dose of DAPTACEL vaccine. No more information was provided. No adverse event was reported. Documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 August 2013. It was reported that DAPTACEL was administered to a 12-year-old patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 August 2013. An 11-year-old patient was administered DAPTACEL vaccine. No more information was provided. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 August 2013. It was reported that DAPTACEL was administered to an 11 year old patient. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Injection site swelling
Clinical narrative: This case is linked to the case# 2013-08055 (sister's case received from same reporter and same product). Initial information received from a healthcare professional on 09 September 2013. A male patient had received a dose of DAPTACEL (0.5 ml, batch number C42111AA, dose number- 5) intramuscularly in the right lateral thigh, on 18 October 2011. The patient had severe food allergies in past. The patient's other medical history and concomitant medications were not reported. It was reported that the component of Dtap Stainer-Scholte liquid medium, source was under investigation as children are highly allergic to nuts, eggs, cow's milk, gluten and other foods. On an unspecified date, after vaccination, the patient experienced swelling in the injected leg and the patient also had symptomology of eczema. Laboratory investigations and corrective treatment was not reported. At the time of this report, the outcome of the adverse event was not reported. Documents held by sender: none. The follow up information received from a healthcare professional on 25 October 2013: The patient received IPV (dose unknown, batch number- G108321, dose number- 3) intramuscularly in the left lateral thigh, on 18 October 2013. The patient did not receive any other medications. The patient had no illness at the time of vaccination. Events eczema and vaccination site swelling were recovered at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This case is a part of 2 cluster cases and is linked to case number 2013-09703) (same vaccine lot number and same reporter). Initial report received from a healthcare professional on 11 September 2013. A 05-year-old male patient had received an intramuscular fifth dose of DAPTACEL vaccine (batch number: C4431AA and expiry date: 10/16/2015) in the left deltoid on 21 August 2013. The patient had no illness at the time of vaccination, had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 23 August 2013, the patient developed vaccination site redness, warmth, hardness and swelling. No laboratory investigations were done and the patient had received MOTRIN and cold compresses to the site so corrective treatment. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site swelling
Clinical narrative: This case is a part of 2 cluster cases and is linked to case number 2013-09702 (same vaccine lot number and same reporter). Initial report received from a healthcare professional on 11 September 2013. A 05-year-old male patient, had received an intramuscular fifth dose of DAPTACEL vaccine (batch number: C4431AA and expiry date: 10/16/2015) in the left deltoid on 21 August 2013. The patient had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 23 August 2013, the patient developed vaccination site blister, redness and swelling. No laboratory investigations were done and the patient had received MOTRIN and cold compresses with ice to the site as corrective treatment. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial medication error report received on 04-September-2013 from a health care professional. A 4 year old child patient, medical history and concomitant medications were not reported, received a 5th dose of ADACEL (lot number, route and site of vaccination was not reported) instead of DAPTACEL on an unspecified date. As of 04-September-2013. Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Initial misuse report received on 09 September 2013 from a health care professional. A 2 day old 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) in error. As of 04 October 2013, the patient did not have any adverse events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial medication error report received from a healthcare professional on 03 October 2013. The 10 year patient had received DAPTACEL vaccine. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial report received from a healthcare professional on 09-Oct-2013. Adults were administered given DAPTACEL instead of TDAP. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 29 April 2013. A child received partial dose of DAPTACEL since part of vaccine leaked from around needle and plastic syringe durign administration. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial misuse report received on 22 April 2013 from a health care professional.
Sex: U
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Initial report received from a healthcare professional on 02 April 2013. A patient whose age, gender and concomitant medications were not reported, had received a dose of DTaP vaccine (dose number, lot number, route and anatomical site of vaccination - not reported) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, and illness at time of vaccination were as unknown. The patient developed a rash on an unspecified date. The reporter declined to provide information to complete the form, stated that it was a Sanofi Pasteur product and the vaccine were not given by their office. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial report received from a healthcare professional on 13-Sep-2013. A 15-months-old infant was administered with ADACEL instead of DAPTACEL as the 4th dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 03 September 2013. DTaP VACCINE was given to a patient (No information was provided regarding the patient). The vaccine was administered to a 9 year old patient. The vaccine administered at inappropriate age. No adverse event was reported. List of documents held by sender: none.
Age: 6.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 August 2013. A 6-year-old patient received extra dose of DAPTACEL and IPOL vaccines on 8 August (year not specified). The child had received previous dose of DAPTACEL and IPOL on 12 November (year not specified). No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 August 2013. An 11-year-old patient was administered DAPTACEL in error. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case is a part of 2 cluster cases and is linked to AER# 2013-07490 (same reporter, similar event after DAPTACEL (batch number: C4452AA), IPOL (batch number: J1028) and MMR vaccine (Merck Product, Batch number: H013040). Initial report received from a healthcare professional on 28 June 2013. A 04-year-old male patient, whose medical history and concomitant medications were not reported; had received fifth intramuscular dose of DAPTACEL (batch number - C4452AA) in right deltoid, fourth dose of IPOL (batch number - J1028, route of vaccination was not reported) in left deltoid and MMR vaccine (Merck Product, batch number - H013040, route of vaccination was not reported) in left deltoid, all on 26 June 2013. On 28 June 2013, two days after vaccination, the patient experienced red hot swelling at injection site. Patient was to be evaluated and treated by physician on 28 June 2013. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case is a part of 2 cluster cases and is linked to AER# 2013-07489 (same reporter, similar event after DAPTACEL (batch number: C4452AA), IPOL (batch number: J1028). Initial reprot received from a healthcare professional on 28 June 2013. A 05-year-old female patient, whose medical history and concomitant medications were not reported; had received fifth intramuscular dose of DAPTACEL vaccine (batch number - C4452AA) in right deltoid, fourth dose of IPOL vaccine (batch number - J1028, Route of vaccination was not reported) in left deltoid and MMR vaccine (Merck) (batch number - H020854, route of vaccination was not reported) in left deltoid, all on 26 June 2013. On 28 June 2013, two days after vaccination, the patient experienced red hot swelling at injection site right deltoid. Patient was to be evaluated and treated by physician on 28 June 2013. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Initial report received from a healthcare profession on 01 July 2013. A male patient whose medical history and concomitant medications were not reported had received a dose of DAPTACEL vaccine (batch number-C4378AA, expiry date-18 July 2015, dose number and route of administration was not reported) in left thigh on an unspecified date. On an unspecified date, 2 days after vaccination patient went to emergency room then followed up with the provider for a swollen thigh. Majority of the upper thigh was darker in color (almost like a hematoma) and a red rash surrounded the darker area and wrapped around the leg. Laboratory details and corrective treatment details were not reported. Outcome of the events was not reported. Outcome of the events was not reported. Documents held by sender: None.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 June 2013. It was reported that DAPTACEL vaccine administered to an adult patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 July 2013. A patient (in an adult age group, no information was provided regarding the patient), had received DAPTACEL vaccine instead of ADACEL vaccine. Thus the vaccine was administered at an inappropriate age. No adverse event was reported. Documents held by sender: None
Age: 1.6
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Local reaction
Clinical narrative: This case is part of a cluster of 3 cases and is linked with AER# 2013-04277, 2013-04530, (adverse events after DAPTACEL lot number C4310BA reported by the same HCP). Initial report received from a healthcare professional on 22 March 2013 and follow-up information received on 01 April 2013. A 12-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (lot number: C4310BA, route of administration was not reported) in right thigh and PREVNAR 13 (lot number: F45137, route of administration was not reported) in left leg on 01 February 2013. On same day i.e on 01 February 2013, the patient experienced a "horrible local reaction" (redness and swelling at injection site) and inflammation in both legs. Laboratory investigations were not reported. Corrective treatments were not prescribed. At the time of this report, the patient outcome was not reported. Documents held by sender: None. Follow up information received from a healthcare professional on 25 April 2013. The patient was 18-month-old. The patient had no illness at time of vaccination. The patient had one brother and both were twins and both had the reactions. The patient mother reported that the localized erythema around shots as well as swelling of legs (worse in one child but present in both) and had no fever, rash and nausea or vomiting. The patient mother did not seek, at time the symptoms resolved within 24 hours and patient was not evaluated of time reaction. The patient was recovered on an unspecified date.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Electroencephalogram normal, Gastrooesophageal reflux disease, Seizure, Staring
Clinical narrative: Initial report received from healthcare professional on 19 December 2013. A 02-month-old male patient, who had no relevant medical history and no illness at the time of vaccination and whose concomitant medications were not reported, had received intramuscular first dose of DAPTACEL vaccine, batch number: C4457AA having expiry date 11 December 2015 in left thigh on 20 November 2013. It was reported that on 23 November 2013, 3 days after receiving DAPTACEL vaccine, the patient experienced staring episodes. The patient experienced 1-2 episodes per day, lasting 5-15 seconds each. Episodes increased to 30 events in one day and patient was admitted on 01 December 2013 and was discharged on 02 December 2013. 24 hour EEG was carried out but there was no change on EEG. Neurologist did not make a diagnosis. Treated child for reflux but treatment not specified. Child now 3 months old. Seizure went away for the most part, a week ago. The patient recovered on an unspecified date. Documents held by sender: none.
Age: 1.6
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: This case is part of a cluster of 3 cases and is linked with AER# 2013-04277, 2013-04363, (adverse events after DAPTACEL lot number C4310BA reported by the same HCP). Initial report received from a healthcare professional on 01 April 2013. A 19-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (lot number: C4310BA, route of administration was not reported) in right thigh on 01 February 2013. The patient also received PREVNAR 13 (lot number: F45137, route of administration was not reported) in left leg on 01 February 2013. On 01 February 2013, the patient experienced "legs swollen" both legs and had trouble walking after vaccination. Laboratory investigations were not reported. No treatments were not prescribed. The patient outcome was not reported. Follow-up information received from a healthcare professional on 08 May 2013. The patient had recovered from the events on an unspecified date. Documents held by sender: None.
Age: 1.3
Sex: U
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 March 2013. A 15-Month-old patient had received 2 DAPTACEL vaccines at 2 different sites in the right leg on 20 march 2013. The patient was also due for MMR, Hepatitis A and Varicella vaccines on 20 March 2013. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 March 2013. An 11-year-old patient had received DAPTACEL vaccine in error. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Overdose, Wrong drug administered
Clinical narrative: Initial overdose report received from a healthcare professional on 21 March 2013. An 11-year-old patient was administered DAPTACEL vaccine instead of Tdap vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 10.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 28 March 2013. DAPTACEL vaccine was administered to a 10-year-old patient. No adverse event was reported. List of documents held by sender: none.
Age: 15.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 25 July 2013. A 15-year-old patient (no other information was provided regarding the patient) had received DAPTACEL instead of ADACEL. No adverse event was reported. Documents held by sender: None.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 17 July 2013. A 12-year-old patient was administered DAPTACEL instead of ADACEL for TDAP vaccination. No adverse event was reported. List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 March 2013. An 8-year-old patient was administered DAPTACEL vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 19 July 2013. An 11-year-old patient was administered DAPTACEL instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 19 April 2013. A 4-year-old female patient had received an intramuscular dose of DAPTACEL (batch number C4363BA, expiry date: 06/21/2015, dose number was not reported) in the left deltoid and an intramuscular dose of Hepatitis B vaccine (Other manufacturer, batch number: H018091, dose number was not reported) in the right deltoid, both on 18 April 2013. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, no birth defects and no medical conditions. The patient's concomitant medications were not reported. On 18 April 2013, post vaccination, the patient developed redness, swelling, warm to touch and a rash at the left deltoid. The patient also complained of stomach ache. The patient was seen by a physician. Corrective treatment details were not reported. No laboratory tests were performed. At the time of report, rash and stomachache had subsided and the left deltoid had some redness, minor swelling and was warm to touch. The patient had not recovered from the events. Documents held by sender: None.
Sex: U
Vaccine: DTAP
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 29 July 2013. It was reported that, while administering DAPTACEL to a patient much of the vaccine ran down the arm as the needle might not have been on properly. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Frustration, Speech disorder
Clinical narrative: Initial report received from a healthcare professional on 23 July 2013. A 06-month-old female patient had received an intramuscular third dose of DAPTACEL (batch number: C4050AB) in left thigh on 13 July 2012. The patient's medical history included minor food allergies and dry skin patches and had no illness at the time of vaccination. Concomitant medication was not reported. On 16 July 2013, 3 days after vaccination, the patient changed how she was babbling. She was no longer using consonants, only vowels. Otherwise no side effects. It seemed that the patient was frustrated when trying to babble. The patient had reduced amount of babbling. Corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received from a healthcare professional on 10 September 2013: The patient was not taking any concomitant medications. The patient birth weight was reported as 5 lb and 11 oz and the patient had no siblings. It was reported that patient was babbling interactively prior to vaccination; however after vaccination the babbling had stopped and the patient acted frustrated trying to babble. The babbling had resumed on 12 August 2013 and baby had recovered completely and was back to normal and doing well developmentally.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Eczema, Injection site induration, Injection site swelling
Clinical narrative: Initial information received from a healthcare professional on 19 July 2013. A 07-month-old female patient had received a dose of DAPTACEL (batch number, dose number and route of administration were not reported) on the leg on an unspecified date. The patient's old brother had severe food allergies. The patient's medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient presented injection site hard swelling. Complementary investigations and corrective treatments were not reported. The hard swelling took a week to go away and on an unspecified date, the patient had recovered from the event. Documents held by sender: none. Follow-up information received from a health care professional on 09 September 2013. It was reported that the component of Dtap Stainer-Scholte liquid medium source was under investigation as children were highly allergic to nuts, eggs, cow's milk, gluten and other foods. The patient also had symptomatology of eczema as her brother had since an unspecified date. This case is linked to the case 2013-09652 (brother case, received from same reporter).
Age: 13.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 July 2013. It was reported that DAPTACEL was administered to a 13-year-old patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional  on 02 July 2013. An 11-year-old male patient had received DAPTACEL vaccine instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Mobility decreased
Clinical narrative: Initial report received from a healthcare professional on 24 June 2013. A patient whose, age gender, medical history and concomitant medications were not reported, had received an intramuscular dose of DAPTACEL (lot number was not reported) in bicep on an unspecified date. The patient had received DAPTACEL possibly into bicep of deltoid thus the vaccine was administered at an inappropriate site. On an unspecified date, after vaccination, the patient developed diminished arm movement. Relevant laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: None.