chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125072, 2019SA125094, 2019SA125008, 2019SA125047, 2019SA125041, 2019SA125033, 2019SA125054, 2019SA125066 and 2019SA125066 (same reporter).  This case involves a four years old male patient (also reported as 5 years) who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 12-Mar-2019 which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received ActHIB that was diluted with diluent which had expired; Initial information received on 03-May-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.  This case involves a 5 months old male patient who was vaccinate d with 0.5 ml expired second dose of HIB (PRP/T) VACCINE [ActHIB] (Batch number: UI860AAA and expiry date: 09-Jan-2019) via unknown route in the left thigh on 12-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to expired vaccine used because patient received ActHIB that was diluted with diluent which had expired.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Loss of consciousness, Syncope
Clinical narrative: Lost of consciousness and syncope; headache; Initial information received on 02-May-2019 regarding an unsolicited valid serious case received from a Nurse.  This case involves a 16 years old male patient who experienced lost of consciousness and syncope, and headache, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BUXSERO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided.  On 29-Apr-2019, the patient received a 2nd dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6204AA and expiry date: 08-May-2020 via intramuscular route in the right deltoid and a dose of Buxsero (details not reported).  On an unknown date, within 8 hours of the vaccination the patient experienced loss of consciousness and syncope and headache. Syncope was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was syncope, loss of consciousness and headache.  It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as recovered on an unknown date.  List of documents held by sender: none.; Sender's Comments: This case involves a 16 years old male patient who presented with syncope with loss of consciousness and headache 8 hours after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient got her 1st Menactra on 30Apr2019 and then came in today (03-May-2019) and got another one; Initial information received on 03-May-2019 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 32 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Myasthenia gravis.  On 30-Apr-2019, the patient received a 0.5 mL 1st dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA, expiry date: 29-Mar-2020, via intramuscular route in left arm.  On 03-May-2019, the patient received another 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA, expiry date: 29-Mar-2020, via intramuscular route in right arm.  It was a case of actual medication error due to extra dose administered. It was reported that it was not realized till after the fact that she had gotten the same vaccine 4 days ago. Her neurologist wanted her to get the Meningococcal vaccines. She had a pre existing diagnosis of Myasthenia gravis and therefore the doctor wanted her to have this vaccine. She is supposed to get a series of Meningococcal vaccine and the 1st on would have been the one she got on 30Apr2019.  It was not reported if the patient experienced any adverse event following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Act-Hib vaccine was administered to a patient, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA125940 (case for female patient).  This case involves a 15 months old (16 months as reported) male patient received expired 0.5ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI735AA, expiration date: 07-Nov-2017 via unknown route in unknown administration site on 08-Nov-2017.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included was MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and INFLUENZA VACCINE (FLUVACCINE) on same visit.  It was an actual medication error due to expired vaccine used. Expired Act-Hib vaccine was administered to a patient.  No Adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Aphasia
Clinical narrative: prior to receiving the vaccine the child could talk,and after administration the child "could no longer talk"; Initial information received on 03-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient (age not reported) for whom it was reported that prior to receiving the vaccine the child could talk,and after administration the child "could no longer talk", while he received vaccine  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a a dose of suspect  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.(lot number not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious prior to receiving the vaccine the child could talk, and after administration the child "could no longer talk" (aphasia) (Unknown latency) following the administration of  DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  No relevant tests were reported.  Final diagnosis was prior to receiving the vaccine the child could talk,and after administration the child "could no longer talk".    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for prior to receiving the vaccine the child could talk,and after administration the child "could no longer talk" on an unknown date.  There will be no information available on the batch number for this case (reporter refused to provide).  Documents held by the sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: 32 year old male received expired Adacel; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA126028 (same reporter).  This case involves a 32 years old male patient who received an expired vaccine (first dose) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5656AA or U6565AA) via intramuscular route in the left arm, on 05-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication reported as none.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: mistakenly administered the patient Infanrix instead of Adacel; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old patient (gender unknown) who received vaccine INFANRIX instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFANRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was an actual medication error due to wrong vaccine administered.  It was reported that the provider had ordered TDaP (Adacel) but nurse mistakenly administered the patient DTaP (Infanrix).  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: the third dose of Menactra was given in error, no adverse effects; 17 year old male had Menactra doses on 15Feb2016, 15Oct2018, and 26Dec2018, no adverse effects; patient had to recieve Gardasil HPV got Menactra instead, no adverse effects; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 17 years old male patient who received vaccines three doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 15-Feb-2016, 15-Oct-2018 and 26-Dec-2018 respectively.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered, inappropriate schedule of vaccine administered and wrong vaccine administered. The patient supposed to recieve GARDASIL HPV but got MENACTRA instead, (lot number and Exp. Date 26-AUG-2019) lot U5986AA via intramuscular route in the right deltoid, on 26-Dec-2018.  The patient did not had any signs of any adverse effect.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for second and third dose of MENACTRA.  Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menactra was inadvertently administered to a patient; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old female patient who received expired 0.5 ml booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5839AA and Exp. Date 05-Mar-2019) via intramuscular route in the left deltoid, on 03-May-2019.  The patient's past vaccination(s) included Menactra in Jun-2011.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received Daptacel vaccine that was expired, no adverse event; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 months old male patient received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C51718AA and Exp. Date 23-Mar-2019) via unknown route in unknown administration site, on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: accidentally administered Ipol instead of a TB shot/no AE; Ipol vaccination that was delivered Interdermally/no AE; she only drew up 0.1mL/no AE; she thought she was administering a TB shot/no AE; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who accidently received vaccine IPV (VERO) [IPOL] instead of TUBERCULIN TEST [TUBERCULIN PPD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were received.  On 06-May-2019, the patient received a 0.1 ml dose of suspect IPV (VERO) lot N1F931M via intradermal route.  It was of actual medication error case due to Wrong product selected, Vaccine underdose, Inappropriate route of vaccination and Wrong vaccine administered. Nurse manager states that one of her nurses accidentally administered Ipol instead of a TB shot. Because she thought she was administering a TB shot, she only drew up 0.1mL and injected it intradermally.  The patient had not reported nor shown any signs of any potential adverse effects since the time of the injection.  Information on the batch number was requested for TUBERCULIN PPD.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Tubersol and Tenivac vaccines was given to a patient which was stored at lowest temperature of minus16.4 degrees Celsius/No AE; Initial and additional information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 years old female patient who received a dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot number and expiration date not reported via unknown route in unknown administration site on an unknown date and 0.1 ml dose of TUBERSOL (lot - C55698A, expiration date: 08-Apr-2021) for on 07-May-2019 tuberculin test.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage. Tubersol and Tenivac vaccines was given to a patient which was stored at lowest temperature of minus 16.4 degrees Celsius.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient/no adverse event; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 18 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on unknown date.  On 07-May-2019, the patient received a 0.5 ml single fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5169AA (expiry date: 16-Mar-2019) via intramuscular route in the left thigh.  It was of actual medication error case due to  expired vaccine used.  No adverse event was experienced by patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: gave previously frozen Tenivac to a patient; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date by the nurse.  This case was linked with 2019SA126878 (For patient recieved Tubersol)  This case involves a patient who received frozen vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (0.5 ml, lot number: U6021AA) on 07-May-2019.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to product storage error.  It was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TD, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: rash and itching; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 50 years old female patient who experienced rash and itching, while she received vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Nurse states patient was unsure of which Tdap she received that caused the reaction).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  On an unknown date, The patient developed a non-serious rash and itching (rash pruritic) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  No lab test reported.  Final diagnosis was rash and itching.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported.  Information on the batch number was requested
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: deep tissue redness and about a 3x3cm abscess/lump underneath the skin at the injection site/ very painful to touch/ Redness, swelling, tenderness, and lump/abscess under skin at the injection site; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional via phone and additional information was received on 07-May-2019.  This case involves a 44 years old female patient who experienced deep tissue redness and about a 3x3cm abscess/lump underneath the skin at the injection site/ very painful to touch/ redness, swelling, tenderness, and lump/abscess under skin at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past vaccination(s) included ADACEL and developed local reaction.  The patient's past medical history, medical treatment(s), family history and concomitant medications were not provided.   On 16-Apr-2019, the patient received a booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6217AA and expiry date not reported) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious deep tissue redness and about a 3x3cm abscess/lump underneath the skin at the injection site/ very painful to touch/ redness, swelling, tenderness, and lump/abscess under skin at the injection site (vaccination site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was deep tissue redness and about a 3x3cm abscess/lump underneath the skin at the injection site/ very painful to touch/ redness, swelling, tenderness, and lump/abscess under skin at the injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for deep tissue redness and about a 3x3cm abscess/lump underneath the skin at the injection site/ very painful to touch/ redness, swelling, tenderness, and lump/abscess under skin at the injection site.  Documents held by the sender: none.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission
Clinical narrative: A patient was given Day 1,3,and 7 but not day 14 of rabies vaccine; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who missed the day 14 dose of RABIES (HDC) VACCINE [IMOVAX RABIES].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to missed dose.   It was reported that patient was given Rabies vaccine Day 1,3,and 7 but not day 14. It was reported that patient asked if this was sufficient or if the full rounds need to be repeated.   It was not reported if the patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: mistook Ipol vial for Tubersol vial and administered 0.1ml Ipol ID rather than the prescribed Tubersol 0.1ml, no symptoms reported; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old male patient who was vaccinated with a 0.1 ml dose of IPV (VERO) [IPOL] (lot N1K931M and Exp. Date 18-Nov-2019) via intradermal route in the right arm on 08-May-2019 instead of TUBERCULIN TEST [TUBERSOL].   The patient's medical history not reported and concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunization.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: a 10 years old patient was given expired vaccine; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 years old male patient received a expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] lot N1B901M and expiration date: 18-Mar-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  Adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a Ipol vaccine after an excursion, no adverse event; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA129834 (same reporter).  This case involves a 17 years old male patient who received a IPV (VERO) [IPOL] vaccine (vial lot P1A17, Box Lot # P1A171M, and Exp. Date 24-Apr-2020) via intramuscular route in the left arm after an excursion, on 03-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to incorrect product storage.   It was reported that MA wanted to gather stability information on ActHIB, IPOL(open), Penatcel and Tdap vaccines exposed to a temp of 46.6 degrees F for 30 mins. This Happened on 03 Apr 2019.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally gave the patient a third dose of Menactra on 08May2019, no adverse effects; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who accidentally given a third 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6204AA and Exp. Date 08-May-2020) via intramuscular route in the right deltoid on 08-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that Menactra was given in Aug-2013, the second Menactra dose was in Mar-2018, and the nurse practitioner accidentally gave the patient a third dose of Menactra on 08-May-2019.   It was an actual medication error case due extra dose administered.  No adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for first and second dose.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: excursion which the Ipol needed to be discarded; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA129403 (same reporter).  This case involves a 13 years old male patient who received a IPV (VERO) [IPOL] vaccine (vial lot P1A17, Box Lot # P1A171M, and Exp. Date 24-Apr-2020) via intramuscular route in the left arm after an excursion, on 03-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to incorrect product storage.   It was reported that MA wanted to gather stability information on ActHIB, IPOL(open), Penatcel and Tdap vaccines exposed to a temp of 46.6 degrees F for 30 mins. This Happened on 03 Apr 2019.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV, UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored at temperature outside the recommended range; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 year old male patient who received vaccines IPV (VERO) [IPOL] lot NIK931M, expiry date: 18-Nov-2019 via subcutaneous route in the left thigh on 09-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. A temperature excursion IPOl (open), Typhoid. MIA advised not to use the IPOL. Stated that they did administer the IPOL that was out of range yesterday, but they did not know that and now wants to know what do.  It was unknown if any adverse event was occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: vaccinated with Pentacel on 23 Aug 2017, 14 Nov 2017, and 08 May 2019, rather that receiving the component vaccines; Initial information received on 09-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced vaccinated with pentacel on 23 aug 2017, 14 nov 2017, and 08 may 2019, rather that receiving the component vaccines, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was an actual medication error case due to Single component of a two-component product administered..   No adverse event was reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Syringe issue
Clinical narrative: swelling, soreness at the injection site; lump at the injection site; syringe issue; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA130001 and 2019SA129987 (same reporter).  This case involves Adult female patient who experienced swelling, soreness at the injection site, lump at the injection site and syringe issue, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB.  On an unknown date, The patient developed a non-serious swelling, soreness at the injection site (vaccination site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, The patient developed a non-serious lump at the injection site (vaccination site mass)  following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of syringe issue. . Final diagnosis was syringe issue, lump at the injection site and swelling, soreness at the injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for swelling, soreness at the injection site, as Unknown for lump at the injection site and as Not Applicable for syringe issue.
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Ipol vial that was exposed to a temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130412 and 2019SA130410.  This case involves a 2 months old male patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and ROTATEQ for Immunisation.  It was of actual medication error due to incorrect product storage. It was reported vaccine underwent the following elevated temperature excursion on 23 Apr 2019 at 1:05 pm the temperature was 46.4 degrees Fahrenheit, at 2:05 pm the temperature 46.7 degrees Fahrenheit , and by 2:35 pm it had returned to within range at 45.8 degrees Fahrenheit.  It was unknown whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: opened Ipol was at 1.0 C for about 1 hour 15 minutes/there may be one child that received a dose; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received vaccine IPV (VERO) [IPOL] (lot number not reported via unknown route in unknown administration site) that was opened at 1 degree C for about 1 hour 15 minutes.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error case due to incorrect product storage. Nurse stated they had an issue with the refrigerator during restocking and the refrigerator was cycling to keep up and got too cold.  It was unknown whether adverse event was experienced..  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.