chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: 12 year old patient administered expired dose of MENACTRA vaccine with no reported AE; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Physician.  This case involves a 12 year old and unknown gender patient who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 28-May-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6575AB and expiry date: 08-May-2021) (Frequency: once) via an intramuscular route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was also reported Caller stated that a dose of MENACTRA was given on 5/28/2021 but it had expired on 5/8/2021. If baby was delivered: delivery date and if baby experienced an adverse event. Inform that they will be receiving a follow up questionnaire. If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA requirement. Product used: Used  At the time of reporting, 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 the 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea, achy, chills, fever, headache, tiredness  All lasted approximately 24 hours
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea, achy, chills, fever, headache, tiredness  All lasted approximately 24 hours
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: administering Pentacel today that was not reconstituted (only liquid was administered, not powder)v with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00672844) and transmitted to Sanofi on 07-Jul-2021 in United States.  This case involved a 6 month old male patient who administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL].  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  On 07-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: once) (lot U694DBA) via unknown route in the right thigh for prophylactic vaccination.   On 07-JUL-2021 the patient developed a non-serious when administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE.  This was an actual medication error case due to inappropriate reconstitution technique (latency was same day).  Additionally it was reported that the caller wanted to know how long they need to wait before starting the series over for this patient. The call became disconnected while the caller was holding and an outbound call was made and the MIA (manufacturing / importers authorisation) continued the call. The call was transferred from MIA. PENTACEL was administered incorrectly.  At the time of reporting, 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 the 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: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Product preparation issue
Clinical narrative: diluent portion of Pentacel has been administered without being mixed with the powder (HIB) / no AE; Initial information received on 08-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Global Medical Information (reference number- 00674315).  This case involves a patient of (unknown demographics) who inadvertently received dtap ipv from Pentacel without reconstituting with HIB (product preparation issue) when received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  ''It was reported that while doing his inventory, he noticed that a diluent was missing. They are in the process of verifying which patient was immunized last week with only the DTAP-IPV portion.''  At the time of reporting, 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received an expired dose of Act-Hib vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00674336) and transmitted to Sanofi on 08-Jul-2021.  This case involves a patient with unknown demographics who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).    Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ327AA, expiry date: 28-Jun-2021, diluent expiration date: 30-Sep-2021, other dosing details were not reported] for prophylactic vaccination. (expired product administered) (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  It was reported that, reporter did not have any additional information, she was handed a box and requested to make call regarding validity of vaccine. (reporter wanted to know if this vaccine is considered viable or not)  At the time of report, 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 the 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: expired dose of PENTACEL was administered with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00674627) and transmitted to Sanofi on 08-Jul-2021.   This case involves a 2-month-old male patient who administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] vaccine.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ336AAA and expiry date: 05-Jul-2021] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  No adverse effects have been reported.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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 the 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.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event
Clinical narrative: expired pentacel was administered to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) and physician via global medical information (GMI) (Reference number- 00674667) and transmitted to Sanofi on 08-Jul-2021.  This case involves a 19-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS A VACCINE.  On 07-Jul-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB [Pentacel] VACCINE (total, lot UJ336AAA and Expiry date- 05-Jul-2021) via an unknown route at the right vastus lateralus site for prophylactic vaccination (expired product administered) (latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  At the time of report, reporter was asked for any adverse event to watch for and what should they do.   At the time of report, 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 the 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: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: A patient received ACT-HIB VACCINE which was not mixed with the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00674736) and transmitted to Sanofi on 08-Jul-2021.  This case involves a patient (unknown demographics) who received HIB (PRP/T) VACCINE [ACT-HIB] which was not mixed with the diluent (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which was not mixed with the diluent (product preparation issue).  It was reported that "The caller wanted to know what to do from here. Pharmacist reported ActHIB was administered with diluent other than what was provided with vaccine''.  It was a case of actual medication error due to Inappropriate reconstitution technique (latency same day).  At time of reporting, no adverse events were 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 the 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.  There will be no information available on the batch number for this case.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, Wrong product administered
Clinical narrative: patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine, with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (GMI Inquiry number: 00675660).  This case involves 18-year-old male patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the left deltoid in error, instead of the intended meningococcal b vaccine (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  On an unknown date, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U6690AA, expiry date: 23-Aug-2021] via an unknown route at left deltoid for prophylactic vaccination.  At the time of report, no adverse event reported.  Description: Yesterday, 08Jul2021, a patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine. o Treatment NA o Dose # if series Yesterday's dose was an accidental, extra third dose of Menactra. The patient's two prior doses of MCV4 vaccine were in 2014 and Jun2020.  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.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: 18 year old female patient was given an expired dose of Menactra with no reported adverse event; Initial information received on 09-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via physician in.  This case involves a 18 year old female patient who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Jul-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6594AA and expiry date: 21-May-2021) (Frequency: once) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that "Patient Information Patient age greater than 1 year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test- 0.5 ML Strength -standard except for Fluzone HD-STANDARD Pregnancy- no pregnancy, Last menstrual period-not applicable, Due date- not applicable. If baby was delivered: delivery date and if baby experienced an adverse event- not applicable Inform that they will be receiving a follow up questionnaire- not applicable If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an Drug Administration requirement.- not applicable. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes Still using product: No".  At the time of reporting, 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 the guidelines. 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: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: expired PENTACEL was accidentally administered to a patient with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist in the United States (GMI Inquiry number: 00676148).  This case involves a patient (age and gender not reported) who was administered with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was accidentally administered (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due expired vaccine used.  At the time of reporting, 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 the 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.  There will be no information on batch number for this case.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: provider in the office gave a 5 year old child a dose of ADACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00676275) and transmitted to Sanofi on 09-Jul-2021.  This case involves a 5-year old male patient for whom it was reported that provider in the office gave dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 06-Jul-2021, the patient received 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6817BA and expiration date: 18-Sep-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported that " Caller is requesting to know what she should do and if the child needs to have another vaccination to replace it. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age".  At the time of report, 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.
Age: 0.33
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Doses of Menactra and Adacel were administered to patient post temperature excursion of 32-degrees Fahrenheit temperatures with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00676408) and transmitted to Sanofi on 09-Jul-2021.  This case is linked to cases 2021SA229197 and 2021SA230017. (Same reporter)  This case involves a 4 month old male patient who was received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] post temperature excursion of 32-degrees Fahrenheit temperatures (product storage error).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [total, once, lot U6927AA, expiry date: 28-Jan-2023] via an intramuscular route at the left arm and a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6921AB, expiry date: 17-Apr-2022] via an intramuscular route at the right arm for prophylactic vaccination.  It was a case of actual medication error due to product storage error temperature too low. (Latency: on the same day of vaccination)  At the time of report, 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 the 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.
Age: 67.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 67 years old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered). The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) and POLIO VACCINE (POLIO) (lot number and expiration date not reported) via unknown route and unknown site of administration for  prophylactic vaccination. On 12-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (total, lot UJ359AA and expiry date: 11-Jul-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration (product administered to patient of inappropriate age and expired product administered, latency: same day). The reporter was with the question that what does she do. At the time of reporting, it was unknown whether the patient experienced any adverse event. 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 the 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.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: patient has received expired dose of vaccine/ NO AE; Initial information received on 12-Jul-2021 regarding an unsolicited valid non-serious case received from other health professional via Medical information (MI) number 00678839.  This case involves 11 years old male patient who administered an expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  On 06-Jul-2021, the patient received a dose first 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) Suspension for injection (strength: standard, Frequency: once, lot number U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was reported that ''the caller would like to know whether the dose should be repeated''.   It was a case of an actual medication error due to expired vaccine used (latency: same day).  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 the 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: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient gave an expired dose of PENTACEL vaccine today with no reported adverse event; Initial information received on 12-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown demographics) who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 12-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ339AAA and expiry date: 05-Jul-2021) via an unknown route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "one of our Medical Assistants gave an expired vaccine today. Does the vaccine need to be re-administered. Pentacel There is no more information for this report due to being a web case".  At the time of reporting, 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 the 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.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction, Vaccination site inflammation
Clinical narrative: This case involves 11-years-old male patient who experienced itching at the injection site (vaccination site pruritus), vaccination site inflammation, redness at the injection site (vaccination site erythema) and mild swelling at the injection site (vaccination site swelling) when received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient's past medical treatment, vaccination and family history were not provided. At the time of the event, the patient had ongoing Meat allergy. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination. On 13-Jul-2021, the patient received a first 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6920AB and expiry date : 15-Apr-2022) via an intramuscular route in the right arm for prophylactic vaccination. On 13-JUL-2021 the patient developed a non-serious itching at the injection site (vaccination site pruritus), vaccination site inflammation, redness at the injection site (vaccination site erythema) and mild swelling at the injection site (vaccination site swelling) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was reported that, "Nurse practitioner reporting a dose of MENACTRA was administered today and the patient experienced a local reaction including redness, itching, and mild swelling at the injection site. Caller reporting she kept patient for observation for 15 minutes, and symptoms were improving. Caller reporting no medications administered. Caller reporting patient does have allergy to pork. Caller with question on whether MENACTRA contains traces of pork. Caller with question on whether it's okay for patient to receive MENACTRA in the future." Laboratory details were not reported. Unknown corrective treatment was received for events as patient kept for observation for 15 minutes (redness at the injection site, itching at the injection site, mild swelling at the injection site, Vaccination site inflammation). The patient was recovering from all the events (redness at the injection site, itching at the injection site, mild swelling at the injection site, Vaccination site inflammation) at the time of reported.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Wrong product administered
Clinical narrative: This case involves adult male patient (age unknown) who was supposed to get DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] but was mistakenly given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant were given to the patient. On an unknown date, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiration date :21-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported). It was a case of an actual medication error due to wrong vaccine administered (same day latency) and they want to know what to do now. Later, states that the physician looked at the comparison and they know patient got more antigen than he needed.  At time of reporting, it was unknown whether the patient experienced any adverse event. 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 the 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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain and swelling; Arm pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021, the patient experienced arm pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events arm pain and swelling was recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Thrombosis
Clinical narrative: Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previous menses only happened 3-4 times a year for four days and was very light.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previous menses only happened 3-4 times a year for four days and was very light.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Systemic: blood on toilet paper after bowel movement-Mild
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt prone to fainting due to vagal-vasal  response. she expected it, her mom was with her. she did faint for about 30-40 seconds and then came to.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt prone to fainting due to vagal-vasal  response. she expected it, her mom was with her. she did faint for about 30-40 seconds and then came to.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Systemic: Tinnitus-Severe
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Light headedness, fever, muscle aches, headache. Began approximately 12 hours after dose was administered.  Prevented returning to work or any strenuous physical activity?have not waned noticeably now 34 hours after vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: Patient stated he had a fear of needles at the start of the interaction. Was fine right after the injection, then after I completed the immunization for the person he came in with, he fainted. Was out for approx. 30 sec, then awoke. I provided a bottle of water, and ice pack. They sat for 20mins, walked around the store for a bit, then left. He was accompanied by a female who he lived with.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Error: Incorrect Reconstitution-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Mild, Additional Details: Following patients first dose of Pfizer, she reported a it swelled up like a "large marble". She reported redness that went all the way down her arm and it took about 1 week for pain and redness to improve. There still is a hard node under her skin at the site where vaccine was administered. Patient came in for second dose and reported these symptoms from 6/22. Instructed patient to follow up with PCP and to monitor.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Mild, Additional Details: Following patients first dose of Pfizer, she reported a it swelled up like a "large marble". She reported redness that went all the way down her arm and it took about 1 week for pain and redness to improve. There still is a hard node under her skin at the site where vaccine was administered. Patient came in for second dose and reported these symptoms from 6/22. Instructed patient to follow up with PCP and to monitor.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heavy menstrual bleeding, Menstruation irregular, Muscle twitching
Clinical narrative: Menstrual cycle stoped for 2 months returning with a massive heavy flow.  My cycles usually run 3 to 3 1/2 day and now I have a full 7 day cycle with extreme heavy flow! I also experience Brain fog  along with muscles in fingers, thumb and arm twich intermittently.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: On the first shot, pt has constant sholder/neck pain from shot and still continued after 3 weeks when recieving the 2nd shot (on opposite arm). She says the left arm pain is getting better, but it still has pain. On the second shot, the pain subsided after 3 days.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: left hand felt numb-Mild, Additional Details: light headed right after vaccine. offered and accepted water. observed her for 20minutes. left arm numb. mother was here. offered to call emergency services. pt said no. mother took her home for further observation. checked on her at 8pm. she was back to normal
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Hives. Red bumps that are itchy.  Recurring daily in the morning, occurring in various areas of body. Sometimes it skips a few days. Rash disappears after 3 hours, I guess. One instance happened after I applied a sunscreen before sun exposure- a hives reaction appeared where i applied the sunscreen product, arms, legs, head, neck, and shoulders.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Exposure during pregnancy, Premature delivery, Urine analysis normal
Clinical narrative: I was pregnant due October 26th 2021. This was my second pregnancy. My first, I went 42+ weeks and ended up having a csection. I ended up delivering my second born on 7/6/2021. He was 24 weeks old and 700 grams.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Body and joint aches Previously taken Acetaminophen, Naproxin, currently taking  MethylPredniSolone dose pack
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Condition aggravated, Vaginal haemorrhage
Clinical narrative: Breast tenderness and vaginal bleeding. Bleeding was light and lasted about two weeks.  I didn?t think much of it until I got my second shot and I started bleeding again the same day. The breast tenderness was worse after the second shot than the first, I will file a separate report for the second shot.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Back pain, Chills, Dizziness, Fatigue
Clinical narrative: Five hour after the shot my right arm was sore .   The next day I woke with a headache and was dizzy.  I took Excedrin and Sudafed.  I was tired all day and spent much of it in bed.  By the middle of the day I experienced nausea and had several bowel movements.  By 3 p.m. I experienced stomach pain, began to feel muscle pain (particularly in the low of my back) and got a headache.  At 4 p.m. I started to have a light feaver (98.6) and serious shivers - I couldn't get warm and was shaking terrible.   I took two Excedrin, drank water and used a heat pad and four blankets to stop this shivers.  I also experiences itching on my lower right arm.   By 7 p.m. the fever broke, and most all symptom disappeared.   I remained tired and when to bed early to wake this morning feeling much better.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Feeling cold, Headache, Nausea, Pain in extremity, Pruritus
Clinical narrative: Five hour after the shot my right arm was sore .   The next day I woke with a headache and was dizzy.  I took Excedrin and Sudafed.  I was tired all day and spent much of it in bed.  By the middle of the day I experienced nausea and had several bowel movements.  By 3 p.m. I experienced stomach pain, began to feel muscle pain (particularly in the low of my back) and got a headache.  At 4 p.m. I started to have a light feaver (98.6) and serious shivers - I couldn't get warm and was shaking terrible.   I took two Excedrin, drank water and used a heat pad and four blankets to stop this shivers.  I also experiences itching on my lower right arm.   By 7 p.m. the fever broke, and most all symptom disappeared.   I remained tired and when to bed early to wake this morning feeling much better.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Tremor
Clinical narrative: Five hour after the shot my right arm was sore .   The next day I woke with a headache and was dizzy.  I took Excedrin and Sudafed.  I was tired all day and spent much of it in bed.  By the middle of the day I experienced nausea and had several bowel movements.  By 3 p.m. I experienced stomach pain, began to feel muscle pain (particularly in the low of my back) and got a headache.  At 4 p.m. I started to have a light feaver (98.6) and serious shivers - I couldn't get warm and was shaking terrible.   I took two Excedrin, drank water and used a heat pad and four blankets to stop this shivers.  I also experiences itching on my lower right arm.   By 7 p.m. the fever broke, and most all symptom disappeared.   I remained tired and when to bed early to wake this morning feeling much better.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test normal, Condition aggravated, Diarrhoea, Headache
Clinical narrative: The positive reaction to the vaccine was that my neuropathy pain subsided. The negative reaction was that I started having a headache. It subsided by the time I left the pharmacy. By the time I got home, I experienced the worst stomach pain. I had diarrhea for 32 days. I could not keep anything in my system, not even water. I feel like there was an attack on my stomach. When I went to the doctor, she did a sonogram of my abdomen and some blood work. All testing came back normal. I was sent to do an MRI with contrast, but it was advised against because I was due to have my second vaccine. After the 32 days, the diarrhea stopped, but my neuropathy pain came back. It's not as bad as it was before the vaccine, but it did come back.