chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Amnesia
Clinical narrative: memory lost; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient of an unknown demographics who had memory lost last year (amnesia), after the patient received INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, Concomitant medications 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 date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in the last year, the patient developed non-serious memory lost (amnesia) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: reporter believe that flu vaccine killed reporter's father; After internal review on 02-Nov-2020, the report upgraded from non-valid to valid: [suspect updated to INFLUENZA VACCINE].  Initial and live follow-up information regarding this unsolicited non-valid serious case from a consumer via social media on 07-Oct-2020.   This case involved a male patient of unknown age who died (death), after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history of the patient 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 in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was reported that the INFLUENZA VACCINE killed reporter's father.  Relevant tests were not reported.  It was not reported if the patient received a corrective treatment before he died.  It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.  Follow up information received on 02-Nov-2020 regarding an unsolicited valid serious social media case received from a consumer.  Case upgraded to valid case, suspect updated to INFLUENZA VACCINE, lot number requested and narrative updated accordingly.; Sender's Comments: Sanofi company comment dated 02-Nov-2020: Follow up information received changes the previous assessment of this case as follows. This poorly documented social media case concerns a male patient of unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: reporter believe that flu vaccine killed reporter's father
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (patient's spouse) via public post on social media.   This case involves male patient (unknown age) who got flu (influenza), after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) on an unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment.  The outcome of event influenza was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick after; Initial information was received on 28-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves an unknown demographic patient who was got sick after (illness), while the patient received vaccines INFLUENZA VACCINE.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick after (illness) (unknown latency) following the administration of INFLUENZA VACCINE PNEUMOCOCCAL VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Ill-defined disorder
Clinical narrative: I took the fly from it due to egg allergy and almost died; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient (unknown demography) who almost died (unevaluable event), while he/she received vaccine INFLUENZA VACCINE.  At the time of the event, the patient had ongoing Food allergy. The patient's medical history, 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious almost died (unevaluable event), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.
Age: 70.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient received regular strength Fluzone Quadrivalent instead of Fluzone High Dose Quadrivalent, no adverse event; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a 70 years old male patient received a 0.5 mL dose INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on an unknown date (reportedly 2 weeks ago) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No concomitant vaccines was not given to the patient.  It was a case of actual medication error due to wrong vaccine administered. (Latency: same day of vaccination).  The reporter requested to revaccinate the patient.  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 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: FLUX
Symptoms: Condition aggravated, Eye disorder, Gingival erythema, Lichen planus
Clinical narrative: lichen planus has blossomed all over with involvement of her fingernails, gums, and legs.; She also has an eye problem; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a patient  .   This case involves patient (gender unspecified) who had little redness on her gums (gingival erythema) and lichen planus has blossomed all over with involvement of her fingernails, gums, and legs (Lichen planus), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history included lichen planus for many years and eye problem and is unable to take steroids due to the eye problem.  The patient's past vaccination(s) included flu shots in the past.    The patient's medical treatment(s) family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious eye problem (eye disorder) and lichen planus has blossomed all over with involvement of her fingernails, gums, and legs (Lichen planus), after the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of the report, the both events were unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pentacel has been administered to a 5 years old boy in place of Dtap Ipv combination, no AE; Pentacel has been administered to a 5 years old boy, no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 5-years-old male patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (dose, batch number, epiry date, route and site were unknown for both vaccines) in place of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV [DTAP IPV] combination (wrong product administered and product administered to patient of inappropriate age), as prophylactic vaccination.  Medical history, concomitant therapy, medical treatments, vaccinations and family history were not provided.  This was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired Fluzone High Dose vaccine/ No AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical Assistant).  This case is linked to case 2020SA275945 (81 years old patient).  This case involves a 75 years old male patient who received 0.5 mL first dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ306AA, expiry date: 24-JUN-2020) via un unknown route on Deltoid of unknown arm on 30-Sep-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy given.  It was an actual medication error due to the expired vaccine used (latency same day).  No symptoms occurred to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: FLUZONE HIGH DOSE vaccine coming back out of the patient's arm at injection site/ No AE; a patient was given partial dose of Fluzone High Dose/ No AE; the pharmacist misjudged patient weight and used a 1 inch needle/No AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who was given partial dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and the pharmacist misjudged patient weight and used a 1-inch needle and vaccine coming back out of the patient's arm at injection site (lot number and expiration date was not reported) via an unknown route in the arm for prophylactic vaccination on 05-Oct-2020 (wrong technique in product usage process).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.   It was a case of an actual medication error due incorrect needle gauge used and it was also a case of vaccine underdose and exposure via skin contact (Latency: 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.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 65 years old male inadvertently received Fluzone quadrivalent instead of Fluzone high-dose quadrivalent with no adverse event; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old male patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe (Lot number- UJ491AA, expiration date- 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 05-Oct-2020 instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered (latency same day).  Adverse event symptoms: None 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: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: patient was prescribed Bexsaro but was inadvertently given Menactra, no AE; second dose of Menactra given too soon after first dose of Menactra, no AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from the nurse.  This case involve a 17 years old female patient who was vaccinated with the first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 25-Feb-2016 and second dose on 13-Aug-2018 (batch number and other dosing details were not reported), also received the 0.5 ml third dose of the same vaccine on 01-Oct-2020 (lot ABXA60BA and expiration date 30-Sep-2021) via an intramuscular route in the left deltoid instead of BEXSERO vaccine (not produced by Sanofi Pasteur) for prophylactic vaccination.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  This was an actual medication error case due to wrong vaccine administered (wrong product administered) and drug dose administration interval too short (inappropriate schedule of product administration), latency was same day.   Nurse stated that the second dose was given too soon hence that dose was not valid.  Also, the physician wants to know if it was ok for the patient to have the third dose.  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 the batch number for this case.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 51 year old patient was administered Fluzone High Dose with no adverse event; 51 year old patient was administered Fluzone High Dose with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist via regulatory authority.  This case involves a 51-year-old female patient who received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and Overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. .   On 07-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Lot number- UJ499AB, expiration date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  This is a case of actual medication error due to Inappropriate age at vaccine administration and Overdose (latency same day).  At the time of reporting, patient had no adverse event. Reporter wanted to know adverse reactions (if any) related to it.  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: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 9 patients received an expired dose of Fluzone Quadrivalent vaccine with no adverse event; Initial information received on 07-Oct-2020 regarding this unsolicited valid non-serious case from a consumer/non-healthcare professional (Practice manager)   This case involves 9 patients of an unknown demographic who received a dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UT6695KA, Expiration date- 30-Jun-2020) via an unknown route in unknown administration site (expired product administered) for prophylactic vaccination on an unknown date.  The patients medical history, medical treatments, vaccinations, concomitant drug and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (Latency: Same day).  At the time of reporting, patient had no adverse event.  Reporter wanted to know if the patient should revaccinated.  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: 74.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 74 year old patient was given Fluzone quadrivalent in error instead of Fluzone high-dose with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist on 08-Oct-2020 via Global Medical Information (GMI) (Reference number- 00307175).  This case involved a 74 years old female patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  On 07-Oct-2020, the patient received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE (Lot number- UT7007KA, Expiration date- 30-Jun-2021) pre-filled syringe via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE for prophylactic vaccination.  It was a case of actual medication error due to Wrong vaccine administered (Latency: same day).  At the time of reporting, patient had no adverse event.  Reporter queried about how soon can it be re-administered with the FLUZONE HIGH DOSE QUADRIVALENT immediately after.  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: 1.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Wrong product administered
Clinical narrative: a 12-months old patient was given Menactra on accident instead Pneumococcal vaccine, No AE; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12-months-old male patient who was given dose of 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number- U6586BA, expiry date- 20-Apr-2020) via intramuscular route in the left thigh on accident instead PNEUMOCOCCAL VACCINE for prophylactic vaccination on 08-Oct-2020 (wrong product administered).   Medical history, medical treatments and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE, HIB VACCINE and INFLUENZA VACCINE for prophylactic vaccination.  This was a case of an actual medication error due to wrong vaccine administered (latency 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient has significant injection site reaction which was red and swollen; patient has significant injection site reaction which was red; patient has significant injection site reaction which was swollen; bruised appear on injection site; patient has significant injection site reaction which was itchy; Based on the information received on 13-Oct-2020 the case became valid from non-valid as the reactions were specified for the patient.  Initial information regarding an unsolicited valid non-serious non-valid case was received from an other healthcare professional via global medical information (GMI) (reference number- 00307600) and transmitted to Sanofi on 08-OCT-2020.  This case was considered as non valid case since no clear adverse event was reported.  This case involves female patient (age unspecified) who experienced significant injection site reaction which was red and swollen, itchy and appeared bruised (Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received 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 developed a non-serious severe reaction which was red and swollen, itchy and appeared bruised (Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome for reported events was unknown.  There will be no information available on the batch number for this case.  Additional information was received on 13-Oct-2020 Events were added (added events: Vaccination site inflammation, Vaccination site erythema, Vaccination site swelling, Vaccination site bruising, Vaccination site inflammation pruritus) ).
Age: 1.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: child moved around quite a bit and the needle came out of her skin during administration and it was unknown how much of the vaccine was received/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 09-Oct-2020 from a Health Care Professional via The Agency (Reference number- 00309435) and transmitted to Sanofi on 09-Oct-2020.  This case involves a 17 month-old female patient was vaccinated with (less than 0.5 mL, once) dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe) (batch number UT7065LA and expiry date 30-Jun-2021) via an intramuscular route at the left arm on 06-Oct-2020 for prophylactic vaccination (under dose).  Patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.    It was a case of actual medication error due to vaccine under dose (latency was on same day).  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.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, Product storage error
Clinical narrative: Act-Hib exposed to 34.5 degrees Fahrenheit for 40 minutes was given to a patient with no AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographics patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ144AAA, expiry date: 22-Mar-2021), via an unknown route and site, on an unknown date for prophylactic vaccination (product storage error).  The patient's medical history, medical treatments, concomitant medication, vaccinations and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low. It was reported that the Act-Hib exposed to 34.5 degrees Fahrenheit for 40 minutes which was given to a patient.  Reason for excursion was the temperature monitoring probe inside the fridge was displaced and they had to move it behind the fridge so that it can regulate temperature.  At the time of reporting, the 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.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse administered expired vaccine to patient with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist was received on 12-Oct-2020.  This case involved an unknown age patient received a 0.5 ml once dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot number- UJ292AB, Expiration date- 30-Jun-2020) via unknown route in unknown administration site for prophylactic vaccination on an unknown date. (Expired product administered)   The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications was not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: 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.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient got two Fluzone High Dose in a couple of days, no AE; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a 69-years-old male patient who was vaccinated with 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ501AB and expiration date was 30-Jun-2021) on 12-Oct-2020 via an unknown route at an unknown administration site and received another dose on 13-Oct-2020 via an intramuscular route in the right arm for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not reported.   This was an actual medication error case due to extra dose administered (latency was same day).  At the time of reporting, patient had 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.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered to someone under 65/no AE; accidentally administered to someone under 65/no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves less than 65 years old female patient for whom it was reported that quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) was accidentally administered to someone under 65/no AE (adverse event) (inappropriate age at vaccine administration and overdose).  The patient's past medical history and family history were not provided.  The patient did not receive any other vaccinations or medications   On 19-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) (batch number: UJ491A and expiration date: 30-Jun-2021) the left deltoid by staff person for prophylactic vaccination.   On 19-Oct-2020, same day after initiation of quadrivalent influenza vaccine, accidentally administration of quadrivalent influenza vaccine to someone under 65 with no adverse event (AE) was reported.   Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  No other relevant information was reported.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue
Clinical narrative: Shipment had been in transit to long with no AE; Initial information regarding an unsolicited valid Non-serious case was received from a pharmacist via The Agency (Reference number- 00325402) and transmitted to Sanofi on 21-Oct-2020.   It was reported that a 77-year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT (lot number: UJ546AA, expiry date: 06/30/2021, Route: Via intramuscular in the right arm) which received delay shipment (Product distribution issue) on 19-oct-2020 and vaccine will administrated as soon as they received for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to product shipment delay.  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: F
Vaccine: FLUR4
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Based on information received on 28-Oct-2020, the report previously considered as non-valid became valid: [unevaluable event updated to allergic reaction].  Initial information received on 28-Oct-2020 regarding an unsolicited non-valid non-serious case received from a pharmacist.  This case involves female patient (age not reported) who experienced allergic reaction (hypersensitivity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past  vaccination included FLUBLOK for prophylactic vaccination in 2019.  The patient's medical history, concomitant therapy, medical treatment and family history were not provided.   On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed non-serious allergic reaction (hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.  Follow up information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  Event updated
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 64 years old patient received a dose of Fluzone High Dose Quadrivalent/ No AE; a 64 years old patient received a dose of Fluzone High Dose Quadrivalent/ No AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via The Agency (Reference number- 00324247) and transmitted to Sanofi on 29-Oct-2020.  This case involves a 64-years-old patient who received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported that, the patient was 1 year under age when administered with FLUZONE HIGH DOSE QUADRIVALENT and he was requested for information regarding this incident.   It was also a case of an overdose (latency: same day).  Product used: Used  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial paralysis
Clinical narrative: Symptoms of Bell's palsy; This spontaneous case was received on 29-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04492) and concerned a 55-year-old, female patient.  The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication.  On 23-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for flu prophylaxis. The batch number reported was 283847 and expiration date: 30-Jun-2021.  On an unspecified day in Oct-2020, within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy.  On 27-Oct-2020, the patient visited emergency room (ER).   The outcome of 'Bell's palsy' was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  The event of ' Bell's palsy' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 55-year-old, female patient was administered Flucelvax QIV. Within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy. The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication. Causal role of the suspect vaccine is assessed as possibly related for facial paralysis, due to plausible chronology.; Sender's Comments: A 55-year-old, female patient was administered Flucelvax QIV. Within 24 hours after receiving Flucelvax QIV, the patient developed symptoms of Bell's palsy. The patient's concurrent condition included diabetic, hypertension and hyperlipidaemia. The patient's concomitant medications included Ozempic (semaglutide), Singulair (montelukast sodium), metoprolol, lisinopril, metformin, Humalog (insulin lispro), Zetia (ezetimibe) and Jardiance (empagliflozin), all used for an unreported indication. Causal role of the suspect vaccine is assessed as possibly related for facial paralysis, due to plausible chronology.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Intense soreness in arm of injection and soreness has lasted over 2 months. Patient reports that the first month, she was very uncomfortable but pain has subsided over the last 30 days, however patient still reports muscular stiffness and discomfort.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Neck pain, Tenderness
Clinical narrative: Muscle pain, headache, neck ache, very tired, arm that the shot was administered was very tender
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Accident, Arthralgia, Chills, Condition aggravated, Fatigue
Clinical narrative: Around 3:00 AM I woke up shivering. The shivering was severe although I didn't feel all that cold.  It was borderline uncontrollable and it was difficult to walk (and I had an accident on the way to the bathroom).    I have never had a similar reaction to a flu vaccination before, though I have received them yearly for decades.  In addition, the usual level of arthritic pain I have in my shoulders and hips was exacerbated. I fell asleep in perhaps two hours after putting a heating pad on my chest and on one especially sore shoulder, and I was still shivering when I drifted off.   I am fatigued and achey today, but feel much better than I did during the night, and not shivering.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Gait disturbance, No reaction on previous exposure to drug, Pain
Clinical narrative: Around 3:00 AM I woke up shivering. The shivering was severe although I didn't feel all that cold.  It was borderline uncontrollable and it was difficult to walk (and I had an accident on the way to the bathroom).    I have never had a similar reaction to a flu vaccination before, though I have received them yearly for decades.  In addition, the usual level of arthritic pain I have in my shoulders and hips was exacerbated. I fell asleep in perhaps two hours after putting a heating pad on my chest and on one especially sore shoulder, and I was still shivering when I drifted off.   I am fatigued and achey today, but feel much better than I did during the night, and not shivering.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain
Clinical narrative: patient complains of lingering pain 3 weeks later. Keeping patient up at night. She has tried cold and heat and tylenol.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle pain (injection site, neck, back and legs), headache, nausea
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Vaccine given Monday in AM. By PM (10-12 hours) later that day site was red, swelling, and warm to the touch. Low grade fever of 100.4.  Parent gave benadryl which did help some. Was seen in office 3 days later at which time area had significantly improved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: Pt was received only the Shingrix diluent instead of the reconstituted Shingrix vaccine. Pt was contacted and reports no adverse reaction except for a sore arm at the site of injection, no other symptoms was reported.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PROQUAD was administered to a 15 year old instead Of MMR II and VARlVAX; PROQUAD was administered to a 15 year old instead Of MMR II and VARlVAX; This spontaneous report was received from a medical assistant referring to a 15 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (0.5 milliliter, lot # T012418, expiration date 06-OCT-2021; strength, frequency and route of administration were not reported) instead of rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and wrong product administered).