chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: It was reported that, the patient got the new omicron booster and have had all regular and all boosters Mostly had chills fever But with the bivalent the patient had a little sore arm Maybe tired.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "chills", "fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Patient got the new omicron booster. Patient had a little sore arm with bivalent.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased
Clinical narrative: my hemoglobin dropped from 11.4 to 8.1.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I am on dialysis" (ongoing), notes: I am on dialysis and severe asthma; "severe asthma" (unspecified if ongoing), notes: I am on dialysis and severe asthma; "insulin dependent diabetic" (ongoing), notes: as well as being insulin dependent, diabetic. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "my hemoglobin dropped from 11.4 to 8.1.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient was on dialysis and severe asthma, as well as being insulin dependent diabetic. The week after my COVID mixed variant booster #3, my hemoglobin dropped from 11.4 to 8.1. Patient was struggling.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Diarrhoea, Headache, Somnolence, Vomiting
Clinical narrative: Vomiting; Diarrhea; Headache; Sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ6742) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepiness". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Feeling abnormal, Lymphadenopathy, Pruritus, Rash
Clinical narrative: The lymph node under my arm has a lump and is swollen; Have a rash, on my elbow; Swelling and pain at the injection site; Swelling and pain at the injection site; Itching on my hand where I did not get the shot; Breasts hurt; Feel awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The lymph node under my arm has a lump and is swollen"; RASH (non-serious), outcome "unknown", described as "Have a rash, on my elbow"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Swelling and pain at the injection site"; PRURITUS (non-serious), outcome "unknown", described as "Itching on my hand where I did not get the shot"; BREAST PAIN (non-serious), outcome "unknown", described as "Breasts hurt"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel awful".  Additional information: Patient was forced to take the bivalent COVID vaccination in order to get a job and now the lymph node under arm had a lump and was swollen. Patient had a rash, on elbow, swelling and pain at the injection site, itching on hand where patient did not get the shot. Patient breasts hurt patient was feeling fine until patient took the booster. The first series patient was fine got it at (Withheld) this time got the booster at (Withheld) and feel awful. I hope you add this to your data statistics. Patient would never do this again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: The lymph node under my arm has a lump and is swollen; Have a rash, on my elbow; Swelling and pain at the injection site; Swelling and pain at the injection site; Itching on my hand where I did not get the shot; Breasts hurt; Feel awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "The lymph node under my arm has a lump and is swollen"; RASH (non-serious), outcome "unknown", described as "Have a rash, on my elbow"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Swelling and pain at the injection site"; PRURITUS (non-serious), outcome "unknown", described as "Itching on my hand where I did not get the shot"; BREAST PAIN (non-serious), outcome "unknown", described as "Breasts hurt"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel awful".  Additional information: Patient was forced to take the bivalent COVID vaccination in order to get a job and now the lymph node under arm had a lump and was swollen. Patient had a rash, on elbow, swelling and pain at the injection site, itching on hand where patient did not get the shot. Patient breasts hurt patient was feeling fine until patient took the booster. The first series patient was fine got it at (Withheld) this time got the booster at (Withheld) and feel awful. I hope you add this to your data statistics. Patient would never do this again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: eceived a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA392579(CLUSTER) and 2022SA400367(CLUSTER).  This case involves Elderly of an unknown gender patient who was given expired  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiration date: date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date, the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  Action taken: not applicable.  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.
Sex: F
Vaccine: RAB, UNK
Symptoms: Headache, Peripheral swelling, Pyrexia
Clinical narrative: low grade headache; fever; arm got swollen; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who experienced low grade headache, fever and arm got swollen while receiving vaccines RABAVERT and IPV (VERO) [IMOVAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), anti allergy medicine, nasal spray and corticosteroids.  on 22-aug-2022, patient received first dose and On an unknown date, the patient received a  dose 2, 3 and 4 of suspect IPV (VERO) Suspension for injection (strength, dose, route, lot number not reported)  in unknown administration site for immunization and RABAVERT not produced by Sanofi Pasteur (strength, dose, route, lot number not reported)   On an unknown date the patient developed a non-serious low grade headache (headache), fever (pyrexia), arm got swollen (peripheral swelling) (unknown latency) following the administration of IPV (VERO) and (unknown latency) following the administration of RABAVERT.  It was reported with the 1st and 2nd dose the patient had no any side effects.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (headache, pyrexia, peripheral swelling).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the event.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Fluzone High Dose given to patient over 65 years with no adverse event.; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA392579, 2022SA400131, 2022SA400976, 2022SA400367, 2022SA400987, 2022SA400371, 2022SA401056 2022SA400981 and 2022SA401104(CLUSTER).  This case involves unknown gender (over 65 years) elderly patient who was given expired influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a expired dose of suspect influenza quadrival A-B high dose HV vaccine (lot UJ772AA; expiry date: 30-Jun-2022) to patient over 65 years with no adverse event. (expired product administered) (unknown latency).  Action taken : not applicable.  Outcome : 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.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of QUADRACEL, with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who received an expired dose of quadracel, with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation and strength not reported; lot C5763AA and expiry date: 26-Aug-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 22-Sep-2022, (latency: same day) the patient received an expired dose of quadracel, with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  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 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: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Hepatic enzyme abnormal, Hepatic enzyme increased, Myalgia
Clinical narrative: a bilateral rash on her trunk; chest discomfort with chest tightness; sore throat; myalgia; fever of 103.5; chest pain; elevated cardiac enzymes; abnormal liver enzymes; Initial information received on 23-Sep-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 62 years old female patient who experienced sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, elevated cardiac enzymes and abnormal liver enzymes  and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Sep-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (lot UT7682LA; 30-06-2022) via unknown route in unknown administration site for immunization.  On an unknown date after 12 hours, the patient developed a serious events sore throat (oropharyngeal pain),  bilateral rash on her trunk (rash), myalgia, fever of 103.5 (pyrexia), chest discomfort with chest tightness (chest discomfort) and chest pain  (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for these events and discharged on 19-Sep-2022.On an unknown date the patient developed a serious events elevated cardiac enzymes (myocardial necrosis marker increased) and abnormal liver enzymes (hepatic enzyme abnormal) These events were assessed as medically significant.  Relevant laboratory test results included: Hepatic enzyme increased - On an unknown date:  [not available] Myocardial necrosis marker increased - On an unknown date:  [not applicable] Pyrexia - On an unknown date: 103.5 UNK  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, chest pain, hepatic enzyme abnormal, myocardial necrosis marker increased ).  At time of reporting, the outcome was unknown for hepatic enzyme abnormal and Not Recovered / Not Resolved for rest of the events.; Sender's Comments: Sanofi Company Comment dated: 29-Sep-2022: This case involves a 62 years old female patient who experienced sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, elevated cardiac enzymes, abnormal liver enzymes  and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Myocardial necrosis marker increased, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: a bilateral rash on her trunk; chest discomfort with chest tightness; sore throat; myalgia; fever of 103.5; chest pain; elevated cardiac enzymes; abnormal liver enzymes; Initial information received on 23-Sep-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 62 years old female patient who experienced sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, elevated cardiac enzymes and abnormal liver enzymes  and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Sep-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (lot UT7682LA; 30-06-2022) via unknown route in unknown administration site for immunization.  On an unknown date after 12 hours, the patient developed a serious events sore throat (oropharyngeal pain),  bilateral rash on her trunk (rash), myalgia, fever of 103.5 (pyrexia), chest discomfort with chest tightness (chest discomfort) and chest pain  (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for these events and discharged on 19-Sep-2022.On an unknown date the patient developed a serious events elevated cardiac enzymes (myocardial necrosis marker increased) and abnormal liver enzymes (hepatic enzyme abnormal) These events were assessed as medically significant.  Relevant laboratory test results included: Hepatic enzyme increased - On an unknown date:  [not available] Myocardial necrosis marker increased - On an unknown date:  [not applicable] Pyrexia - On an unknown date: 103.5 UNK  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, chest pain, hepatic enzyme abnormal, myocardial necrosis marker increased ).  At time of reporting, the outcome was unknown for hepatic enzyme abnormal and Not Recovered / Not Resolved for rest of the events.; Sender's Comments: Sanofi Company Comment dated: 29-Sep-2022: This case involves a 62 years old female patient who experienced sore throat, a bilateral rash on her trunk, myalgia, fever of 103.5, chest discomfort with chest tightness, elevated cardiac enzymes, abnormal liver enzymes  and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Syringe issue, Underdose
Clinical narrative: did not fully attach the needle to the FLUZONE HIGH DOSE QUADRIVALENT syringe/ during injection, about half of the vaccine squirted out/ did not receive the full dose with no reported adverse event; Initial information received  on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and reported  immunizer did not fully attach the needle to the fluzone high dose quadrivalent syringe/ during injection, about half of the vaccine squirted out/ did not receive the full dose with no reported adverse event , and it involved vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot number and expiry date: not reported) via unknown route in unknown administration site for immunization.  It was reported that there was an administration issue when they administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  to a patient. The reporter stated that the immunizer did not fully attach the needle to the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE syringe, and during injection, about half of the vaccine squirted out between the needle and the syringe/the patient did not receive the full dose with no reported adverse event (accidental exposure to product) (latency: unknown)  Action taken : not applicable.  Outcome: 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.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose was administered to a patient with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from Other Health Care Professional.  This case involves a 44 years old female patient and expired dose was administered to a patient with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s) and family history were not provided.   On 26-Sep-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml (strength, formulation: not provided; lot number: QFAA2125 and expiry date : 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 26-Sep-2022 the patient had expired dose was administered to a patient with no reported adverse event (expired product administered) same day following the administration of influenza quadrivalent recombinant vaccine,  Action taken was not applicable.  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.
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event, Syringe issue
Clinical narrative: leaking occurred when she was administering the vaccine/the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 72 years old female patient and it was reported leaking occurred when she was administering the vaccine/the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event , while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  dose of 0.7 ml , once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot: UJ875AD ; expiry date: not reported) via intramuscular route in the left arm for immunization. No concomitant vaccination taken  The reporter stated that on 26-Sep-2022 the leaking occurred when she was administering the vaccine and the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event (accidental exposure to product) (latency: same day). There was no crack or visible problem with the prefilled vaccine. The caller stated that she tightened the needle but possibly not enough. Some leaked out where the needle attaches to the syringe. Some of the vaccine was administered to the patient, but some leaked out.  The vaccine started to leak after the pharmacist began to administer the vaccine to the patient. Part of the vaccine went into the patient's arm and part of the vaccine leaked out  Action taken : not applicable.  Outcome: 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.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: mistakenly giving a patient the FLUZONE HD QUADRIVALENT vaccine who was not supposed to get it due to patient being under the age of 65  with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 44 years old female patient who had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a 0.75 ml dose of suspect (once) influenza quadrival A-B high dose HD vaccine (lot number: UJ918AAE) (Strength: high-dose) (form was unknown) (expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization.  On 26-SEP-2022 the patient had been mistakenly given the influenza quadrival A-B high dose HD vaccine [fluzone high-dose quadrivalent] which was not supposed to get it due to patient being under the age of 65 with no reported adverse event (product use issue) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: 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.
Age: 5.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK administered to pediatric patients with no reported adverse event; Initial information received  on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER) and 2022SA402443(CLUSTER).  This case involves a 5 years pediatric male patient who administered vaccine Influenza Quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular 5-Component, Polio vaccine Inact 3V (MRC 5), tetanus vaccine toxoid (Quadracel).  On 12-Sep-2022, the patient received a 0.5 ml dose of suspect Influenza Quadrivalent recombinant vaccine (Frequency: once) (Strength: standard) (form was unknown) (lot number: UJ887AA) (expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 12-SEP-2022 the pediatric male patient administered vaccine Influenza Quadrivalent recombinant vaccine [Flublok] with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  It was reported Caller reported FLUBLOK administered to 15 pediatric patients and is requesting validity information.   Action: not applicable.  It was not reported if the patient received a corrective treatment  outcome : 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.
Age: 5.0
Sex: M
Vaccine: FLUR3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402505(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402530(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER), 2022SA402530(CLUSTER) and 2022SA402436(CLUSTER).  This case involves a 5 years old male patient who was administered Influenza Quadrivalent Recombinant Vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccinations included: Diphtheria vaccine toxoid, HIB vaccine CONJ (TET TOX), Pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), Tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination; Measles vaccine live (ENDERS-Edmonston), Mumps vaccine live (JERYL LYNN), Rubella vaccine live (WISTAR RA 27/3) (MMRVAXPRO) for Prophylactic vaccination; and Varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 13-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, expiration date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization at 5 years of age with no reported adverse event (product administered to patient of inappropriate age).  Action taken: Not applicable.  Outcome: 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.
Age: 11.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patients with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402505(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 11 years old female patient who was administered Influenza quadrivalent recombinant vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2022, the patient had received a dose of 0.5 mL total of suspect Influenza quadrivalent recombinant vaccine standard (lot number UJ887AA, expiry date- 9-Jun-2023) ) (with an unknown formulation) via intramuscular route in the left deltoid for Immunization.  On 16-Sep-2022, (latency same day), the patient had developed a non-serious event flublok being administered to pediatric patients with no reported adverse event (product administered to patient of inappropriate age) following the administration of  Influenza quadrivalent recombinant vaccine  No lab data was reported  Action taken with Influenza quadrivalent recombinant vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event flublok being administered to pediatric patients with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Cough, Headache, Magnetic resonance imaging normal, Motor dysfunction, Muscle twitching
Clinical narrative: motor control loss that comes and goes throughout his whole body; muscle twitching in leg where it shakes uncontrollably; muscle twitching in his left leg where it shakes uncontrollably; sore throat; mild cough; headaches; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves "an approximately" a 28 year old male patient who experienced motor control loss that comes and goes throughout his whole body, sore throat, mild cough, headaches, muscle twitching in leg where it shakes uncontrollably and muscle twitching in his left leg where it shakes uncontrollably while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Dog scratch on 04-Jul-2021. The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date in Jul-2021, the patient received suspect RABIES (HDC) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for post exposure immunisation. On an unknown dates in 2021 he also received 2 other doses of the same vaccine at an unknown dose with an unknown batch number via unknown route in unknown administration site.  In JUL-2021 the patient developed a non-serious sore throat (oropharyngeal pain), mild cough (cough), headaches (headache) (unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date the patient developed a non-serious muscle twitching in his left leg where it shakes uncontrollably (tremor, muscle twitching) and motor control loss that comes and goes throughout his whole body (motor dysfunction) (unknown latency) following the administration of RABIES (HDC) VACCINE. Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: [everything is clean]   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.
Sex: M
Vaccine: RAB
Symptoms: Oropharyngeal pain, Tremor
Clinical narrative: motor control loss that comes and goes throughout his whole body; muscle twitching in leg where it shakes uncontrollably; muscle twitching in his left leg where it shakes uncontrollably; sore throat; mild cough; headaches; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves "an approximately" a 28 year old male patient who experienced motor control loss that comes and goes throughout his whole body, sore throat, mild cough, headaches, muscle twitching in leg where it shakes uncontrollably and muscle twitching in his left leg where it shakes uncontrollably while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Dog scratch on 04-Jul-2021. The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date in Jul-2021, the patient received suspect RABIES (HDC) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for post exposure immunisation. On an unknown dates in 2021 he also received 2 other doses of the same vaccine at an unknown dose with an unknown batch number via unknown route in unknown administration site.  In JUL-2021 the patient developed a non-serious sore throat (oropharyngeal pain), mild cough (cough), headaches (headache) (unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date the patient developed a non-serious muscle twitching in his left leg where it shakes uncontrollably (tremor, muscle twitching) and motor control loss that comes and goes throughout his whole body (motor dysfunction) (unknown latency) following the administration of RABIES (HDC) VACCINE. Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: [everything is clean]   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: blister had developed about an inch and a half from the injection puncture site; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 26 years old female patient who experienced blister had developed about an inch and a half from the injection puncture site after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Sep-2022, the patient received a 0.5 ml  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once ( lot UT7689JA; 30-Jun-2024) via intramuscular route in the right arm for Immunization.  On an unknown date the patient developed a non-serious event blister had developed about an inch and a half from the injection puncture site (Vaccination site vesicles) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Vaccination site vesicles).  At time of reporting, the outcome was Unknown for the event.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product use issue
Clinical narrative: FLUZONE HIGH DOSE was given to a 44 year old in error with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 44 years old female patient who was given FLUZONE HIGH-DOSE in error with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, route, administration site and lot number not reported) for prophylactic vaccination.  On 28-Sep-2022, (latency: same day) the fluzone high dose was given to a 44 year old in error with no reported adverse event (product use issue) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  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: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product use issue
Clinical narrative: administered to a patient 7 years of age with no adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case received via health professional. number: 01298571  This case involves a 7-year-old male patient to whom Diphtheria-15/Tetanus/5 Hybrid AC PERTUSSIS/IPV (MRC5) Vaccine [Quadracel] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 23-Aug-2022, the patient received 3rd dose of suspect Quadracel vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (lot: C5851AA, expiry date: 25-Mar-2023) for Immunization with no adverse event (product use issue).  Action taken: Not applicable.  At time of reporting, the 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 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: 0.25
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: crying; fever; irritability; Initial information received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 3 months old male patient who was crying, had fever and irritability while receiving vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] and FLUARIX.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On an unknown date, the patient received an unknown dose suspect FLUARIX not produced by Sanofi Pasteur (formulation, strength: unknown) lot number not reported in unknown administration site as prophylactic vaccination.  On 28-SEP-2022 the patient was crying (unknown latency) fever (pyrexia) irritability (unknown latency) the administration of suspect vaccines.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (crying, fever, irritability).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.