chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: sore spot at the injection site; Initial information received on 04-Nov-2021 regarding an unsolicited valid Media non-serious case received from a consumer/non-health care professional.   This case involves adult patient (unknown age and gender) who had sore spot at the injection site (vaccination site pain) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore spot at the injection site (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine Tuesday. Painless and no side effects other than a sore spot at the injection site".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a female patient (unknown age) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My wife is always wary about the flu shot because she swears it has given her the flu at least twice. I have to remind her that it cannot possibly cause the flu and that she usually gets the shot at the height of the flu season."  It is unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information received on 08-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Digital Media.  This case involves adult patient (unknown demographic) who had sick (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported " I have only took the flu shot twice in my lifetime, and both times I got sick and people think after that, im going to take the covid, vaccine."  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: 4 month old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration/ no AE; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a other health care professional via non-healthcare professional/consumer via Medical Information  (Reference number- 00832566).  This case involves a four-month-old female patient who inadvertently received only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (Product preparation issue).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Pneumococcal Vaccine 13V (Pneumococcal 13 Valent Vaccine) for Immunisation; and Rotavirus Vaccine for prophylactic vaccination.  On 27-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ531AA and expiry date: 22-Jul-2022) (Frequency: series of four) via an intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (latency on same day).  It was reported "four-month-old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration".  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: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Medication leaked out onto patient's skin; Fluzone Quadrivalent prefilled syringe was administered to a patient estimated that only half the dose was given; Initial information regarding an unsolicited non-valid non serious case was received from other health professional via Regulatory Authority (RA) (Reference number: 00832584) and transmitted on 28-Oct-2021.  This case involves a 24-month-old female patient receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered to a patient estimated that only half the dose was given (underdose) who experienced medication leaked out onto patients skin (exposure via skin contact).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Sodium (not applicable).  On 20-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ767AA, expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination.  On 20-Oct-2021 the patient developed a non-serious event, medication leaked out onto patients skin (exposure via skin contact) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 20-Oct-2021, INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered to a patient, estimated that only half the dose was given (underdose) same day latency, non serious event.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.
Age: 78.0
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient had received Flublok instead of Fluzone High Dose instead/ no AE; Initial information was received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a Patient via Information (under reference- 00833066) and transmitted to Sanofi on 28-Oct-2021.  This case involves a 78-year-old male patient who had received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a (total) dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number not reported and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination and a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE via unknown route in unknown administration site for prophylactic vaccination.  It was reported "He received the 18yr + Flu vaccine FLUBLOK and he is wondering if he should have gotten the 65+ FLUZONE HIGH DOSE instead and can he still get it? He states that he believes there was a miscommunication between himself and the person administering the vaccine".   It was a case of actual medication error due Wrong vaccine administered (latency was on the same day).  At the time of reporting, patient had no 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 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 batch number for this case.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Body temperature, Chills, Cough, Dysgeusia, Headache
Clinical narrative: I got sick with flu like systems; metalic taste in his mouth; body aches; chills; 101.4 degrees Farad fever; cough; runny nose; sore throat; headache; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional via Medical Information (MI) (Reference number- 00833649) and transmitted on 29-Oct-2021. This case involves a 68-year-old male patient who experienced I got sick with flu like systems (influenza like illness), metalic taste in his mouth (dysgeusia), body aches (pain), chills, 101.4 degrees Farad fever  (pyrexia), cough, runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and headache, after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and COVID-19 VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 01-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced  (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious I got sick with flu like systems (influenza like illness), metalic taste in his mouth (dysgeusia), body aches (pain), chills, 101.4 degrees Farad fever (pyrexia), cough, runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and COVID-19 VACCINE.  Other relevant laboratory test not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "I got sick with flu like systems, (chills, body aches, 101.4 degrees, sore throat, headache), metalic taste in his mouth, a cough and runny nose three weeks after getting the shot on October 1st, 2021, less than 36 hours after giving my Covid-19 booster (Moderna)."  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.   On an unknown date, the patient was recovered from the event chills, pain, pyrexia, dysgeusia, cough and rhinorrhea.  At time of reporting, the outcome was unknown for the events influenza like illness, oropharyngeal pain, headache.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Influenza like illness, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: I got sick with flu like systems; metalic taste in his mouth; body aches; chills; 101.4 degrees Farad fever; cough; runny nose; sore throat; headache; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional via Medical Information (MI) (Reference number- 00833649) and transmitted on 29-Oct-2021. This case involves a 68-year-old male patient who experienced I got sick with flu like systems (influenza like illness), metalic taste in his mouth (dysgeusia), body aches (pain), chills, 101.4 degrees Farad fever  (pyrexia), cough, runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and headache, after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and COVID-19 VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 01-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced  (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious I got sick with flu like systems (influenza like illness), metalic taste in his mouth (dysgeusia), body aches (pain), chills, 101.4 degrees Farad fever (pyrexia), cough, runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and COVID-19 VACCINE.  Other relevant laboratory test not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "I got sick with flu like systems, (chills, body aches, 101.4 degrees, sore throat, headache), metalic taste in his mouth, a cough and runny nose three weeks after getting the shot on October 1st, 2021, less than 36 hours after giving my Covid-19 booster (Moderna)."  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.   On an unknown date, the patient was recovered from the event chills, pain, pyrexia, dysgeusia, cough and rhinorrhea.  At time of reporting, the outcome was unknown for the events influenza like illness, oropharyngeal pain, headache.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given two doses of Fluzone HD with no reported adverse event; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer.  This case involved an unknown age gender patient for whom it was stated that patient was given two doses of fluzone high dose (HD) (product dispensing error) with no reported adverse event, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at dose of 2 dosage form (lot number and expiry date) via unknown route in unknown administration site.  On 29-Oct-2021, it was reported "patient was given two doses of fluzone high dose (HD)" (product dispensing error) with no reported adverse event (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory data was not reported.  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  It was not reported, if the patient received a 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.  The reporter did not report causality of events with suspects.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Lymphadenopathy, Pain in extremity, Tinnitus
Clinical narrative: Ringing in her ears; swollen lymph nodes; achy joints, especially her fingers; headache; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from non-healthcare professional via Regulatory Authority (RA) (Reference number- 00835123).  This case involves a female patient of unknown age who experienced swollen lymph node (lymphadenopathy), headache, ringing in her ears (tinnitus), achy joints especially fingers (arthralgia) when received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Patient gets a flu (INFLUENZA VACCINE) shot every year, and usually experiences a headache and achy joints, which resolve quickly.  The patient's medical history, concomitant medication and family history were not provided.   On 05-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325LA and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 05-OCT-2021 the patient developed a non-serious swollen lymph node (lymphadenopathy), headache, ringing in her ears (tinnitus) persisted for over three weeks, achy joints especially fingers (arthralgia) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  When the event (tinnitus) persisted for a couple of days, she contacted her healthcare professional.  It was reported "Caller states that she experienced adverse effects from FLUZONE QUADRIVALENT and she is asking for information on how to treat those symptoms. She declined to provide demographics."  Laboratory details were not reported.  The patient was treated with ADVIL [IBUPROFEN] for lymphadenopathy, headache, tinnitus and arthralgia.  The Advil caused resolution of events, except the tinnitus.  On an unknown date, the patient recovered from the events (lymphadenopathy, headache, arthralgia).  At the time of this report, outcome of the events (tinnitus) was not resolved.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error
Clinical narrative: Accidentally administering Fluzone high dose quadrivalent to patient who received Fluzone high dose quadrivalent vaccine 10 days earlier with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non health care professional via Information (under reference 00838776).  This case involves a 65 years old female patient who accidentally received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and she already received same vaccine 10 days earlier (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) [lot number and expiration date were not reported] via unknown route in an unknown administration for Prophylactic vaccination.  On 01-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ741AA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Caller would like safety information."  At time of reporting, no reported 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: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling abnormal, Lymphadenopathy
Clinical narrative: described as feeling crummy; the lymph nodes swelled; being hard to breathe; Initial information regarding an unsolicited valid non serious case was received from physician via Medical Information (Reference number: 00840271) and transmitted to Sanofi on 03-Nov-2021.  This case involves a 38-year-old female patient who experienced described as feeling crummy (feeling abnormal), the lymph nodes swelled (lymphadenopathy) and being hard to breathe (dyspnoea) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious described as feeling crummy (feeling abnormal), the lymph nodes swelled (lymphadenopathy), being hard to breathe (dyspnoea) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient was treated with PREDNISONE.  It was reported "A Physician reporting on behalf of a female receiving Fluzone Quadrivalent 2019/2020 experiencing a delayed reaction, after getting the vaccine, described as feeling crummy, the lymph nodes swelled and being hard to breathe. The Physician reported that the consumer went to urgent care; that she underwent a 6-day prednisone course."  It was unknown if the patient experienced any additional symptoms/events.  At time of reporting, the outcome was unknown for the reported event.  On an unknown date, patient recovered for the feeling abnormal, lymphadenopathy, dyspnoea.  There will be no information available on the batch number for this case.
Age: 95.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event; 20-staff members and 7-Residents received expired doses, with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional, physician and non health care professional via Agency number: 00842649.  This case is linked to cases 2021SA371630, 2021SA369738, US-SA-2021SA370183, US-SA-2021SA371632, US-SA-2021SA369738, US-SA-2021SA370183, US-SA-2021SA371632, 2021SA370209 and 2021SA369789 (CLUSTER).  This case involves a 95 years old female patient who experienced in their shipment of 2021-2022 product they received vials of 2020-2021, with no reported adverse event administered an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number: UJ507AC and expiry date: 30-JUN-2021via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  It was reported 'The Nurse reported that the doses came shipped to their central supply; that then the vaccines were distributed and placed in the vaccine refrigerators through the facility; that she is not the person that receives the vaccines from shipping and that she does not have the packaging slips or boxes due to it is handled with central supply; that when their staff is administering a vaccine the expiration date is not noted prior to administration; that the expiration date is not documented but just the LOT number; that the staff is not looking at the expiration date when administering; and that a nurse, yesterday, saw the expiration date to be expired after vaccinating residents."  At time of reporting, the outcome of the event was reported as unknown  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.; Sender's Comments:  US-SA-2021SA369738:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally gave a 2 month old baby PENTACEL resulting in an extra does of HIB with no adverse event.;Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00843694).  This case involves a 2 months old male patient who was accidentally given a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] resulting in an extra dose of HIB with no adverse event (extra dose administered).   The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: uJ424AAA and expiry date: 21-May-2022) via intramuscular route in the left thigh (left vastus lateralis) for prophylactic vaccination.   It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Caller states that she gave a two-month-old a pentacel injection and a pediarix which resulted in the patient receiving two doses of dtap and ipol. Caller states that she reported the incident to the physician, but she just wanted to check with the manufacturer."  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: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Physician states the 4 month old received Quadracel and Hib today instead of the Pentacel he ordered with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid  non-serious case received from a physician via Medical Information (MI) number: 00843731.  This case involves a four months old female patient was received HAEMOPHILUS INFLUENZA TYPE B VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE,  PNEUMOCOCCAL VACCINE CONJ, DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID for Immunisation.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number: C5763AA and expiry date: 28-8-2022 via unknown route in unknown administration site and a dose of suspect HAEMOPHILUS INFLUENZA TYPE B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to wrong product administered (latency: same day).  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: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine was inadvertently administered to a patient who was under the recommended age with no reported adverse event; Initial information received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old patient (unknown gender) whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] was inadvertently administered under the recommended age (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (once, total, 0.5 ml, lot QFAA2152 and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration.  No adverse event reported.  It was reported "Pharmacist reporting that FLUBLOK vaccine was inadvertently administered to a patient who was under the recommended age, she is concerned about possible side effects and also re- administration."  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: 6.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received the adult version instead of the children's with no reported adverse event; received the adult version instead of the children's with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via Information (Reference number: 00845148) and transmitted to Sanofi on 05-Nov-2021.  This case involves a six-year-old male patient receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] incorrectly and they received the adult version instead of the children (product administered to patient of inappropriate age and Wrong vaccine administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On 04-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency: once, Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, Frequency: once, lot number and expiry date not reported] via unknown route in the left arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency: same day).  It was reported "Caller stated that his son and daughter ages 11 and 6 received FLUBLOK was administered incorrectly and they received the adult version instead of the children and asking if we have any information regarding children receiving adult vaccine and what they should be concerned about."   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 available on the batch number for this case.
Age: 76.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first and second dose of  FLUZONE HIGH-DOSE QUADRIVALENT vaccines was received in in same month with no reported adverse event; Initial information received on 05-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional.  This case involves a 76 years old male patient who received first and second dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within same month (inappropriate schedule of product administration).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 14-Oct-2021, the patient received a 0.7 mL first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 28-Oct-2021 he also received a 0.7 mL second dose of the same vaccine (strength: high-dose, lot UJ747AA, expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (at a different facility).  It was an actual medication error case drug dose administration interval too short (latency: same day).   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.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired flu vaccine was administered, with no reported adverse event; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consume/ non-healthcare professional via Regulatory Authority (Global Medical Information- 00845345).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number UJ477AA and expiry date 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported an office administer, stated an expired FLU VACCINE was administered and she would like to know what should be done. AE reported. Caller stated she DOES NOT KNOW THE NAME OF THE VACCINE; she will call back with the name of the flu vaccine.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Proquad and the medicine was not checked before administering; Initial information received on 08-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional via Medical Information number: 00847738.  This case involves a five years old female patient was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations, medications and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 08-Nov-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U6937AA and expiry date not reported via unknown route in unknown administration site.  It was case of an actual medication error due to wrong vaccine administered (latency: same day).  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.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 38 year old patient received fluzone high dose quadrivalent vaccine instead of flublok quadrivalent with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; Initial information was received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-health care professional via Agency (under reference number - 00847903).  This case involves a 38-years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the flublok quadrivalent with no adverse event (Wrong product administered,  Product administered to patient of inappropriate age and Overdose).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 06-Nov-2021, the patient received 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ759AD and expiry date 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Overdose (latency was on same day).  There were no laboratory data/results available.  At the time of report, no adverse event reported.  Event outcome was unknown.  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: 73.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: A dose of expired TYPHIM VI was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00849879) and transmitted to Sanofi on 09-Nov-2021.  This case involves a 73 year old male patient who was received an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Prophylactic vaccination.  On 06-Nov-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A871M, expiry: 11-Oct-2021, formulation: Solution) via intramuscular route in the right deltoid for Prophylactic vaccination.  It was reported "Pharmacist reported that a dose of expired TYPHIM VI was administered to a patient. The caller would like information on the use of expired products and what steps need to be taken."  No other 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: 60.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Patient administered with expired vacciine, no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid  non-serious case from a consumer/non-healthcare professionals via Medical Information (under reference number 00849947).  This case involves a 60 years old female patient who was administered with expired IPV (VERO) [IPOL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HEPATITIS A VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  No other vaccines was given to patient.  On 09-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (once in total, lot number RIF917 and expiry date- 03-Oct-2021) via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported that "Caller stated that medical assistant administered poliovirus vaccine inactivated (IPOL) to patient and it expired on 03-Oct-2021. Caller asking if there is going to be a reaction, do they need to revaccinate? Caller asking what they should do. Caller declined to provide email. Agent transferred caller to management. Call transferred without email address."  At 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.