chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: FLUZONE HIGH-DOSE dose was administered from the frozen shipment no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00814956) and transmitted to Sanofi on 29-Sep-2021.  This case is linked to cases 2021SA344085, 2021SA344225, 2021SA344344, 2021SA344823, 2021SA345076, 2021SA345205, 2021SA345236, 2021SA345293, 2021SA345361, 2021SA345367, 2021SA345483 and 2021SA345780 (same reporter).  This case involves an 81-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 21-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ716AA, expiry: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low (latency same day).  It was reported "Can you please contact this customer re the stability of Influenza vaccines. Customer received their Influenza vaccines and a portion of the doses were frozen. They have administered some of the doses that they claim were not frozen. To Whom it May Concern, I am requesting information on how to return the flu vaccines that we received this year. We have 9 boxes of high-dose flu vaccines and 4 boxes of regular flu vaccines. They came to our office frozen, and therefore are no longer viable. We need to return these vaccines and get a refund. An Office manager reporting that doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident after a shipment of FLUZONE HIGH-DOSE and FLUZONE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  No other adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of IPOL vaccine was administered with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from an other health professional via Media information (under the reference 00814960).  This case involved a 5-year- old female patient who received an expired dose of POLIOMYELITIS VACCINE (INACTIVATED)[IPOL] (expired product used).  Concomitant medication was included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP]   Medical history, medical treatment, vaccination and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) [lot R1F801M, expiry date: 28-Sep-2021] via intramuscular route at a right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported " Caller states that a patient received an IPOL vaccine in her clinic on 14-Oct-2021 that had expired on 28-Sep-2021. Caller states that the multidose vial (MDV) was unopened prior to this administration and that only 1 patient received the expired IPOL. Caller states that this was an open clinic for patients without doctors and did not provide a doctor's name."  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HIGH-DOSE QUADRIVALENT arrived frozen. The caller reported that the doses were accidently used before realizing the shipment was frozen with no ae; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Regulatory authority number: 00814971.  This case is linked to case 2021SA345065(CLUSTER).  This case involves a 66 years old male patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On 24-Sep-2021, the patient received a 0.7 ml of dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 81.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via Medical Information (MI) number: 00814993 '.  This case was linked to case 2021SA345065 (CLUSTER).  This case involves an 81-year-old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] were administered on accident from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 27-Sep-2021 01:59, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv Vaccine, Strength : high-dose, frequency: once, Dose :0.70 mL , lot UJ716AA, expiry: 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  On unknown date, dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low (latency same day).  It was reported " The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for the FLUZONE QUADRIVALENT.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Medical Information number: 00815008.  This case is linked to case 2021SA345065(CLUSTER).  This case involves a 74 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 27-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Agency under reference number - 00815014).  This case is linked to case 2021SA345065(CLUSTER).  This case involves 87-years-old male patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 27-Sep-2021, the patient received a 0.7ml {total} once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 81.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: possibly frozen product was administered on accident with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Global Medical information (GMI under reference number - 00815021).  This case is linked to case 2021SA345065(CLUSTER).  This case involves 81-years-old female patient who was accidently vaccinated with possibly frozen suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 27-Sep-2021, the patient received a 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ716AA expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported "the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  At the time of report, no adverse event was reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: FLU4
Symptoms: Product storage error
Clinical narrative: FLUZONE HIGH-DOSE doses were administered from the frozen shipment with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Agency (under the reference 00815032).  This case is linked to case 2021SA345065 (same reporter).  This case involves a 71 years old male patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 29-Sep-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.7 ml, total, lot UJ716AA and expiration date: 30-Jun-2021) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product storage error temperature too low (latency same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  At time of reporting, the outcome was unknown for the reported 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: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: an expired dose of PENTACEL was given to a patient with no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and consumer/non-healthcare professional via call center via the Regulatory Authority (Reference number- 00815089). This case involves a (unknown demographic)  patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ411AA, UJ385AA and expiry date: 12-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Caller wanted to know if the patient needs another dose."  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: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired Fluzone Quad vaccination with no reported adverse event; Initial information regarding this unsolicited valid non-serious case from via Agency (Reference number- 00816412) was received from a via other health professional via consumer/non-hcp and transmitted to Sanofi on 18-Oct-2021.  This case involved a 70 years old male patient reported about administered expired fluzone quad vaccination with no reported adverse event (expired product administered) while receiving vaccine Influenza Quadrival A-B Intradermal Vaccine [Fluzone].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 15-Oct-2021, the patient received a dose  dose of suspect Influenza Quadrival A-B Intradermal Vaccine lot UJ567AB via intramuscular indication prophylactic vaccination(with unknon formulation, strength, dosage).  On 15-OCT-2021 the patient developed a non-serious event administered expired fluzone quad vaccination with no reported adverse event (expired product administered) following the administration of Influenza Quadrival A-B Intradermal Vaccine.  Action taken with Quadrivalent Influenza Vaccine (Fluzone) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired Fluzone Quad vaccination with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further information was reported.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Medication error, Wrong product administered
Clinical narrative: that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no adverse event reported.; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00816965) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 54-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM.  On 17-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AB, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to wrong product administered (latency: same day).  It was reported that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT.  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol was administered to patient with no adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from nurse and consumer/ non health care professional via Media Information (under reference 00817126). This case involves a 10 years old female patient who received an expired IPV (VERO) [IPOL] (expired product administered).  Patient did not receive any concomitant medication.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL third dose of suspect IPV (VERO) (Total, lot R1F80 and expiration date: 12-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received expired doses with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via Global Media Information (under the reference 00817263).  This case is linked to case 2021SA348292 (case for wife).  This case involves a 74 years old male patient who received expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 27-Sep-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.7 ml, total, once, lot UJ540AA and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  I was an actual medication error due to expired product administered (same day latency).  No adverse event reported.  At time of reporting, the outcome was unknown for the reported event.  It was reported "Clinical supervisor states they gave FLUZONE HD QUAD to a patient in September and it was expired. Do they give another dose or what does she do? The caller reported that a husband and wife received expired doses on the same day."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was received an expired dose of vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00817294) and transmitted to Sanofi on 18-Oct-2021.  This case is linked to case 2021SA347320 (same reporter).  This case involves a 72-year-old female patient who was received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 27-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ540AA, expiry: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Clinical supervisor states they gave FLUZONE high dose (HD) QUADRIVALENT to a patient in September and it was expired. Do they give another dose or what does she do? The caller reported that a husband and wife received expired doses on the same day."  No other 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 by the regulatory authority. 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: FLUX
Symptoms: Periorbital swelling
Clinical narrative: Eyes "puffed up"; This spontaneous case was received on 02-Oct-2021 from other non-health professional via Med Communications (reference number: SEQW21-03183) and concerned a male patient, of an unreported age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient's eyes 'puffed up'.  The outcome of the event was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.   The case is linked to case 202103301 (the same reporter).  Company comment: A male patient, of an unreported age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient the patient's eyes puffed up, as reported. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.; Sender's Comments: A male patient, of an unreported age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient the patient's eyes puffed up, as reported. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Dyspnoea exertional, Illness, Malaise
Clinical narrative: Oxygen level goes below 90; Wheezing; Difficulty breathing / Shortness of breath on exertion; Congested cough; Got very sick; This spontaneous case was received on 12-Oct-2021 from other non-health professional (consumer) via Regulatory authority (reference number: SEQW21-03777) and concerned a 65-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On an unknown date in 2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date in 2020, exactly two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced difficulty breathing, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90.   On an unknown date, the patient recovered from the events of 'oxygen saturation decreased', wheezing, 'dyspnoea' and 'sickness', as all her symptoms cleared up.   On an unknown date, ten months after the onset, the patient recovered from the event of 'productive cough'.  The reporter did not provide causality assessment.  The case is linked to case 202103714 (the same patient).  The reporter assessed all events as serious.  Company comment: A 65-year-old patient was vaccinated with influenza virus vaccine polyvalent. Two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced dyspnoea, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90. Due lack of information regarding diagnostic findings, causality is unassessable.; Sender's Comments: A 65-year-old patient was vaccinated with influenza virus vaccine polyvalent. Two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced dyspnoea, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90. Due lack of information regarding diagnostic findings, causality is unassessable.
Sex: F
Vaccine: FLUX
Symptoms: Oxygen saturation decreased, Productive cough, Wheezing
Clinical narrative: Oxygen level goes below 90; Wheezing; Difficulty breathing / Shortness of breath on exertion; Congested cough; Got very sick; This spontaneous case was received on 12-Oct-2021 from other non-health professional (consumer) via Regulatory authority (reference number: SEQW21-03777) and concerned a 65-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On an unknown date in 2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date in 2020, exactly two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced difficulty breathing, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90.   On an unknown date, the patient recovered from the events of 'oxygen saturation decreased', wheezing, 'dyspnoea' and 'sickness', as all her symptoms cleared up.   On an unknown date, ten months after the onset, the patient recovered from the event of 'productive cough'.  The reporter did not provide causality assessment.  The case is linked to case 202103714 (the same patient).  The reporter assessed all events as serious.  Company comment: A 65-year-old patient was vaccinated with influenza virus vaccine polyvalent. Two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced dyspnoea, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90. Due lack of information regarding diagnostic findings, causality is unassessable.; Sender's Comments: A 65-year-old patient was vaccinated with influenza virus vaccine polyvalent. Two and half weeks after receiving influenza virus vaccine polyvalent, the patient got very sick and experienced dyspnoea, shortness of breath on exertion, wheezing, congested cough and her oxygen level went below 90. Due lack of information regarding diagnostic findings, causality is unassessable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Eye swelling, Eyelids pruritus, Laboratory test, Periorbital oedema
Clinical narrative: Periorbital edema, hives throughout body,  eventually feeling of throat swelling. Started at 3am with one eyelid itching , swelling and throughout the day second eye began itching and swelling. Hives appeared in multiple places all over and by 8pm throat began to feel as if it was swelling-couldn?t swallow well and at that time went to the ER. Was treated with Epi. Benadryl. Pepcid and solu medrol, monitored and eventually discharged home with 5 days of prednisone and epi pen for any further reaction.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: Periorbital edema, hives throughout body,  eventually feeling of throat swelling. Started at 3am with one eyelid itching , swelling and throughout the day second eye began itching and swelling. Hives appeared in multiple places all over and by 8pm throat began to feel as if it was swelling-couldn?t swallow well and at that time went to the ER. Was treated with Epi. Benadryl. Pepcid and solu medrol, monitored and eventually discharged home with 5 days of prednisone and epi pen for any further reaction.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Listless, Pain, Pyrexia
Clinical narrative: Intense and persistent headaches, intense and persistent body aches, regularly recurring low grade fevers, generalized and persistent fatigue and listlessness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: About 12 hours after the injection I experienced explosive diarrhea that continued off and on for  about 5 hours until my stool ran clear. Also gut cramping.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Urinary tract infection
Clinical narrative: I got my period three hours after the vaccine and have not had it in over a year.  It lasted for five days where typically it would last one, no more than two.  The following day I got a urinary tract infection.  The doctor prescribed sulfamethoxazole-trime 800-160 tabs (six tabs).  After completing medicine, I can still feel the urinary infection symptoms and am going to call doctor for next step
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: I actually had the shot on Monday October 11 but my VaX card says 10-10-21.  On Thursday I started to notice swelling around my eyes and nose.  By  Friday morning my eyes were EXTREMELY a swollen and the bridge of my nose was twice it?s normal size.  Went to dr and they told me to take benedryl and prescribed prednisone.  Today is Saturday and this morning I woke up and I?m so swollen I could barely get my contacts in.  I have no other redness, itching, etc.  literally just massive swollen eyes and nose.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint range of motion decreased, Limb injury, Muscle spasms
Clinical narrative: Right Shoulder Injury, consisting of soreness, cramping, and limited range of motion associated with pain
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, X-ray limb
Clinical narrative: Right Shoulder Injury, consisting of soreness, cramping, and limited range of motion associated with pain
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Chest discomfort, Dyspnoea, Erythema
Clinical narrative: Shortly after the vaccination, I felt a sharp, burning pain in my left arm. I also experienced a tightening in my chest, as well as shortness of breath and elevated blood pressure. I left arm felt like it was "on fire" for three days straight. It's been eleven days since the vaccination and my arm has been swollen, red, hot on touch  and very painful. I've been taking 800mg of Ibuprofen twice a day for the pain but it has been offering little relief.  My blood pressure runs high  I have chest tightness on and off , shortness of breath  and increased tiredness.  The pain in my arm in constant and feels like my upper arm is inflamed. I can very concerned about taking a second dose of Moderna COVID-19 vaccine and having worst reaction.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Shortly after the vaccination, I felt a sharp, burning pain in my left arm. I also experienced a tightening in my chest, as well as shortness of breath and elevated blood pressure. I left arm felt like it was "on fire" for three days straight. It's been eleven days since the vaccination and my arm has been swollen, red, hot on touch  and very painful. I've been taking 800mg of Ibuprofen twice a day for the pain but it has been offering little relief.  My blood pressure runs high  I have chest tightness on and off , shortness of breath  and increased tiredness.  The pain in my arm in constant and feels like my upper arm is inflamed. I can very concerned about taking a second dose of Moderna COVID-19 vaccine and having worst reaction.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Lethargy, Pain
Clinical narrative: Vomiting, lethargy, headache, body aches, hives, chills, fever, shortness of breath
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Vomiting, lethargy, headache, body aches, hives, chills, fever, shortness of breath
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Swelling of left arm, armpit, breast, hand, etc.  Bump  that was palm size  around injection site. Redness, and fever of upper arm. Soreness of arm  progressed to frozen shoulder in spite of stretching exercises. The pain has been a  constant  ache and increase to sharp  when moved. Decreased my ability to take care of everyday chores and personal care.  Sought help through my rheumatologist who recommended physical therapy and steroid shot to reduce inflammation. Have been attending therapy sessions for 12 weeks as well as seeing a message therapist  since May.  Finally was able to get in to see an Orthopedic specialist for the injection. He also prescribed a Medrol pack to help reduce the inflammation.  Forgot to mention in a previous section that I had  some shoulder discomfort previous to the injection from lifting weights a couple of years ago. I still don?t have full range of motion but it?s getting better.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Magnetic resonance imaging, Periarthritis, Peripheral swelling
Clinical narrative: Swelling of left arm, armpit, breast, hand, etc.  Bump  that was palm size  around injection site. Redness, and fever of upper arm. Soreness of arm  progressed to frozen shoulder in spite of stretching exercises. The pain has been a  constant  ache and increase to sharp  when moved. Decreased my ability to take care of everyday chores and personal care.  Sought help through my rheumatologist who recommended physical therapy and steroid shot to reduce inflammation. Have been attending therapy sessions for 12 weeks as well as seeing a message therapist  since May.  Finally was able to get in to see an Orthopedic specialist for the injection. He also prescribed a Medrol pack to help reduce the inflammation.  Forgot to mention in a previous section that I had  some shoulder discomfort previous to the injection from lifting weights a couple of years ago. I still don?t have full range of motion but it?s getting better.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PT was administered Moderna vaccine with expiry date 10/15/2021.  She was observed 15 min after injection, tolerated the injection well.  No complications or adverse effects noted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever  muscle soreness headache tiredness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I had severe chest pains  around 24 hours later. I continued to intermittently have chest pains over a week?s time. In total the number of chest pain events were about 4 times.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac discomfort, Diarrhoea, Discomfort, Dizziness
Clinical narrative: After booster, severe stomach pain and diarrhea. Next day, pressure and ?twitching in heart?. Lasting for several days. Pressure on heart. Shortness of breath. Pain/discomfort. Radiates around to upper back. Reporting on behalf of  my 23-year-old son who is a healthy and a new nurse. He has been  suffering and thought he was having a heart attack. Went to a walk in facility one night after work and they told him it was anxiety. Pain and discomfort has persisted - we did not know until we researched this was a side affect. A few days ago, he also had shortness of breath and dizziness.  We thought the vaccine had inflamed his asthma.  His symptoms are starting to improve but will still have him checked by cardio doctor before strenuous exercise.  If there is some hotline where we can call or the doctor can call, please let us know. In this small town, I don?t think these doctors see cases like this - young healthy males having a reaction to the vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: After booster, severe stomach pain and diarrhea. Next day, pressure and ?twitching in heart?. Lasting for several days. Pressure on heart. Shortness of breath. Pain/discomfort. Radiates around to upper back. Reporting on behalf of  my 23-year-old son who is a healthy and a new nurse. He has been  suffering and thought he was having a heart attack. Went to a walk in facility one night after work and they told him it was anxiety. Pain and discomfort has persisted - we did not know until we researched this was a side affect. A few days ago, he also had shortness of breath and dizziness.  We thought the vaccine had inflamed his asthma.  His symptoms are starting to improve but will still have him checked by cardio doctor before strenuous exercise.  If there is some hotline where we can call or the doctor can call, please let us know. In this small town, I don?t think these doctors see cases like this - young healthy males having a reaction to the vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Inflammation, Musculoskeletal stiffness
Clinical narrative: Left knee became sore, stiff, inflammed and lasted for over a week. Issue was enough to not be able to actually walk on the left leg for about 5 days
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: Sever painful and itchy rash on both arms, similar to hives.  Sores/rash on knees, hips, lower back and feet. Rash/sores in feet made it difficult to walk.  Swollen hands and feet. Unable to close right hand for several  days.  Mild shortness of breath.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Skin ulcer, Urine analysis
Clinical narrative: Sever painful and itchy rash on both arms, similar to hives.  Sores/rash on knees, hips, lower back and feet. Rash/sores in feet made it difficult to walk.  Swollen hands and feet. Unable to close right hand for several  days.  Mild shortness of breath.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen lymph nodes, Headache, fatigue
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: recurring headaches mostly in the morning. no previous history of headaches
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PT was administered a Moderna vaccine with expiry date 10/15/2021.  He was observed 15min after injection and no complications or adverse effects were noted. Pt. tolerated vaccine well.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 10/22/2021, child received a COVID-19 vaccine prior to the recommended 21-41 days after the initial COVID-19 vaccine. While transcribing COVID-19 vaccines to UAC, MC noted COVID-19 vaccine had previously been given to the child on 10/13/2021. PCP NP was notified of findings and recommended to notify DCS Medical and UMP medical. As per Regional Director of Nursing, a medication error was to be documented along with an SIR. Child is currently safe and stable.