chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received 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 health professional.   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. This case is linked to cases 2022SA392579, 2022SA400367, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA400976, 2022SA401056, 2022SA400981 and 2022SA401104.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, exp 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: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received 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 case 2022SA392579(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: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received 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 healthcare professional.  This case is linked to case 2022SA392579 (CLUSTER).  This case involves an Elderly patient (gender: unknown), reportedly received a box of expired Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] dose for jun 30, 2022 and gave all 10 doses 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 suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number: UJ772AA and expiry date: unknown) in unknown administration site for prophylactic vaccination (Immunisation), reportedly 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) (unknown latency).  It was reported, office wants either replacement / refund for the box and has only the empty box to return. It is unknown if there were lab data/results. Patient did not experience any additional symptoms/events.  Action taken with Quadrivalent Influenza Vaccine (Fluzone High-Dose Quadrivalent) was 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.; Sender's Comments:  SAD20220921002678:
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
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 case 2022SA392579(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.; Sender's Comments:  SAD20220921002678:
Age: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: product ACTHIB was expired and was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and the product acthib was expired and was administered to a patient 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for Immunisation; and HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation.  On an unknown date, the patient received a fourth series dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation: powder, strength: unknown) (LOT UJ574AA Expiration: 24Sep2022 Diluent-Lot U7114AA Expiration: 20Sep2022 Carton-Lot UJ574AAA Expiration: 20Sep2022) via intramuscular route in left leg as Immunization.  On an unknown date the product acthib was expired and was administered to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product ACTHIB was expired and was administered to a patient 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 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: 0.83
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Pentacel vaccine was given and was not mixed so the patient only got the liquid portion with no reported adverse event; Pentacel vaccine was given and was not mixed so the patient only got the liquid portion with no reported adverse event; Initial information was received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 10 months old male patient who experienced pentacel vaccine was given and was not mixed so the patient only got the liquid portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunization.  On 16-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ673AAA and expiry 30-Apr-23) (formulation and strength: unknown) via intramuscular route in the left thigh for Immunization .  On 16-SEP-2022 the patient developed a non-serious pentacel vaccine was given and was not mixed so the patient only got the liquid portion with no reported adverse event (Product preparation issue) (Single component of a two-component product administered)  (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel vaccine was given and was not mixed so the patient only got the liquid portion with no reported adverse event and was unknown for the event pentacel vaccine was given and was not mixed so the patient only got the liquid portion 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 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: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees fahrenheit with no reported adverse event; Ipol which was accessed was administered to a 7 year old child post excursion 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 7 years old female patient and reported that temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees Fahrenheit and Ipol which was accessed was administered to a 7 year old child post excursion with no reported adverse event , and it involved vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received a  dose of 0.5 ml (first dose) of suspect IPV (VERO), with an unknown formulation, strength (lot: T1E87 ; expiry date: 10-Oct-2022) via intramuscular route in the left vastus lateralis for immunization.  On 31-Aug-2022 there was a temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees Fahrenheit (product storage error) and Ipol which was accessed was administered to a 7 year old child post excursion with no reported adverse event (poor quality product administered) (latency: same day)  Action taken : not applicable.  Outcome: unknown for both the events   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: RAB
Symptoms: Contraindicated product administered
Clinical narrative: IMOVAX in the same site as the globulin with no adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp. Agency number: 01292287.  This case involves an unknown age male patient who experienced Rabies (HDC) Vaccine [Imovax Rabies] in the same site as the globulin with no 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 suspect RABIES (HDC) VACCINE at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. Information regarding batch number requested.  On an unknown date, the patient received imovax in the same site as the globulin with no adverse event (contraindicated product administered) at unknown latency.  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: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Tremor
Clinical narrative: body tremors; weakness and could not get out of bed without assistance; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves a 70 years old male patient who had body tremors and weakness and could not get out of bed without assistance 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 an unknown date in 2021, the patient received a  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 prophylactic vaccination (immunization). Information regarding batch number has been requested  On an unknown date in 2021, the patient developed a non-serious events of  body tremors (tremor) and weakness and could not get out of bed without assistance from his spouse assistance (asthenia) (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken : not applicable.  Corrective treatment: not reported for both the events  Outcome: unknown for both the events
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired dose of ADACEL 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 51 years old female patient who had administering an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 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 VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for Immunisation.  On an unknown date, the patient received 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation was unknown, lot C5770AA and expiry date: 11-Sep-2022) via intramuscular route in unknown administration site for Immunization.  On 23-Sep-2022 the patient developed a non-serious event of administering an expired dose of adacel with no reported adverse event. (expired product administered) (latency: unknown) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: broke out into hives after receiving the FLUBLOK 3 years in a row; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Healthcare professional).  This case involves a 62 years old female patient who experienced hives after receiving vaccine  Influenza quadrivalent recombinant vaccine  [Flublok ].  The patient's past vaccination(s) included Flublok in 2019 and FLUBLOK in 2020. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy to Sulfa (Drug allergy).  In October 2021, the patient received a dose of suspect Influenza quadrivalent recombinant vaccine lot number not reported via unknown route in the arm and developed a non-serious broke out into hives (urticaria) (latency: 1 day). She broke out in hives in lower extremity above ankle and below knee and hives on upper arms between elbows and shoulders lasted 1 week.  She is concerned with receiving Flublok this year and she wanting to know if there was another flu product that she could get instead of the Flublok.  Caller states she also received the Flublok between the months of September and October in 2019 and 2020 and had the same reaction all 3 years   Action taken: not applicable.  The patient was treated with Benadryl [Diphenhydramine hydrochloride]) for Urticaria.  At time of reporting, the outcome was Recovered / Resolved in 2021 after week for the event.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: administered FLUZONE HIGH DOSE QUADRIVALENT to a 47-year-old patient 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 47 years old female patient who stated that administered influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] 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 at a dose of 0.7 ml once (lot UJ875AB, expiry date- 30-Jun-2023) (formulation and strength was unknown) via intramuscular route in the left deltoid, indication: Immunization.  On an unknown date the 47 years old patient had administered fluzone high dose quadrivalent with no reported adverse event (product use issue) (unknown latency) following the administration of 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: 16.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant inadvertently gave a 16 year old patient the FLUBLOK vaccine thinking the patient was 18 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 16 years old female patient who was inadvertently administered the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] vaccine by medical assistant thinking the patient was 18 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 an unknown dose once of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot: UJ888AA; expiry date 06-Sep-2023; strength: standard; formulation: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 26-Sep-2022, the medical assistant inadvertently gave a 16 year old patient the flublok vaccine thinking the patient was 18 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired fluzone was accidentally administered to a patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 19 years old female patient and reporter reported expired fluzone was accidentally administered to the patient with no reported adverse event while 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 24-Sep-2022, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 mL (milliliter) 1X TOTAL (lot U7328BA, 30-Jun-2022) via unknown route on left arm (strength was unknown) for Immunization   On 24-Sep-2022, the patient was accidentally administered expired fluzone with no reported adverse event (expired product administered) 1 day following the administration of vaccine.  No lab data was reported  Action taken was not applicable.  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: 12.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to 12 year old 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 case 2022SA402510(CLUSTER).  This case involves a 12 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. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 14-Sep-2022, the patient of 12 year received Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, exp date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age).  Action taken not applicable.  At time of reporting, the outcome was Recovered / Resolved on an unknown date 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: 12.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok administered to 15 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), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402619(CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 12 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 15-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, exp date: 09-Jun-2023) standard strength, via intramuscular route in the left deltoid for immunization at 12 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  On 15-Sep-2022 the patient was administered with flubok with no reported adverse event (product administered to patient of inappropriate age) 1 day following the administration of vaccine.  No lab data was reported  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: 10.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK being administered to pediatric patient, 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 2022SA402443(CLUSTER), 2022SA402619(CLUSTER), 2022SA402396(CLUSTER), 2022SA402662(CLUSTER), 2022SA402500(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402964(CLUSTER), 2022SA402707(CLUSTER) and 2022SA402514(CLUSTER).  This case involves a 10 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), vaccination(s) and family history were not provided.  On 16-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for prophylactic immunization at 10 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken: was 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: 13.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK administered to pediatric patient 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) and 2022SA402436(CLUSTER).  This case involves a 13 years old female patient who was administered FLUBLOK with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation and strength not reported; lot UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 23-Sep-2022, (latency: same day) the patient had flublok administered to pediatric patient with no reported adverse event (product use issue) 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.; Sender's Comments:  01296394: 01296472: 01296480: 01296502: 01296512: 01296528: 01296536: 01296543: 01296554: 01296563: 01296570: 01296578: 01296582: 01296616: 01296621:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: had given an expired acthib vaccine to a patient 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 patient of unknown demographics and it was reported that had given an expired acthib vaccine (HIB (PRP/T) VACCINE) to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received a dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Immunization .  On 13-SEP-2022 an expired acthib vaccine to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had given an expired acthib vaccine to a patient 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 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: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse states that yesterday she gave a flu vaccine that was last years that was expired on date: 30-JUN-2022 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 an unknown age female patient to whom expired Influenza Quadrival A-B Multidose Vaccine [Fluzone] was given 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 0.5 ml once dose of suspect Influenza Quadrival A-B Multidose Vaccine (lot number: UJ694AB, expiry date: 30-jun-2022) (Strength: standard) (formulation unknown) via intramuscular route in the left deltoid for Immunization which was last years expired with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported  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: 69.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: the patient didn't receive very much of the vaccine with no reported adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 69 years old female patient who didn't receive very much 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.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Prophylactic vaccination.  On 28-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation and strength not reported; lot UJ875AE and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 28-Sep-2022, (latency: same day) the patient didn't receive very much of the vaccine with no reported adverse event (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "staff member stating when she went to administer FLUZONE HIGH DOSE QUADRIVAENT on 28SEP2022, "it exploded where it screws on to the needle. It popped off and sprayed everywhere". Stated that she screwed the needle on securely, got the air out and when she administered the vaccine, "the screw part on the medication went faulty and where it was attached popped off but the needle was still in the patient". Wanted to know if the dose needed to be repeated, since she assumed the patient didn't receive very much of the 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: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Ecchymosis, Erythema, Skin warm
Clinical narrative: Date of injection put in to system was 9/22/22 but vaccine actually given 9/21/22.   She received it at apartment complex.  Records show that she also received covid booster in right arm but she had refused covid booster and only had injection in left arm.  The same evening of injection, her left arm became hot, edematous and very red with an area of ecchymosis extending mid upper arm to elbow.  She went to urgent care and they instructed her to go to ER. She was given Deltasone 60 mg in ER and given a prescription for prednisone 50 mg orally x 5 days.  She was instructed to rest and elevate the arm.  The edema and redness did subside within the 5 days that prednisone was given.  The area of ecchymosis is still fading.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Inflammation, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT CALLED TODAY TO SHARE POTENTIAL VACCINE ADVERSE EVENTS WITH COMPLAIN ABOUT REDNESS, INFLAMMATION, HOT TO TOUCH, AND SWELLING OF THE UPPER HAND. PATIENT'S CONSULT WAS PROVIDED TO APPLY ICE, USE TYLENOL FOR PAIN/DISCOMFORT AND TO BE IN TOUCH WITH DOCTOR/PHARMACY FOR ANY WORSENING SIGNS/SYMPTOMS. PATIENT IS MADE AWARE OF REGULAR FOLLOW UP WITH HER DR'S OFFICE AND TO HERSELF TO SEE HOW THINGS ARE PORGRESSING
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Insomnia, Peripheral swelling, Skin warm
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT CALLED TODAY TO SHARE POTENTIAL VACCINE ADVERSE EVENTS WITH COMPLAIN ABOUT REDNESS, INFLAMMATION, HOT TO TOUCH, AND SWELLING OF THE UPPER HAND. PATIENT'S CONSULT WAS PROVIDED TO APPLY ICE, USE TYLENOL FOR PAIN/DISCOMFORT AND TO BE IN TOUCH WITH DOCTOR/PHARMACY FOR ANY WORSENING SIGNS/SYMPTOMS. PATIENT IS MADE AWARE OF REGULAR FOLLOW UP WITH HER DR'S OFFICE AND TO HERSELF TO SEE HOW THINGS ARE PORGRESSING
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Reported pain and swelling of the left deltoid as well as redness.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chromaturia
Clinical narrative: Systemic: orange urine-Mild, Additional Details: patient reports orange urine 30 minutes after receiving vaccine
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 8 hours after shingles vaccine
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: The patient had a little bleeding, then the area swell a little bit after using a cotton swab to clean it up. the pt was fine and went home, and the swelling was almost gone after 15 minutes.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Symptoms - Severe shivering and chills, severe muscle pain and headache.  The symptoms started about 12 hours after the first shingles shot and lasted 12 to 16 hours.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: On 09/23/2022 at around 1805, the emergency medical button on the wall was pushed and 911 was contacted for an emergency in the clinic.  The patient received her first dose of the Covid-19 vaccination. Immediately after the vaccination, the patient started violently jerking and was unconscious. The patient was diaphoretic also. This is the second episode of the FNP being alone and activating the emergency button and no one coming.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Atrophy, Electromyogram, Hypoaesthesia, Joint range of motion decreased
Clinical narrative: I have been suffering from arm and nerve pain on my dominant arm since May 2022.  I have not had an injury or accident of any kind.  My forearm has gone from normal to numb.  I have significant atrophy in my forearm such that my loss of strength is over 50% compared to my non dominant arm.  I have lost the ability to bend my  first and second fingers.  I was finally diagnosed with Parsonage-Turner Syndrome on 9/30/2022.  I am an otherwise healthy individual, tri-athlete.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Magnetic resonance imaging, Nerve conduction studies, Neuralgia, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: I have been suffering from arm and nerve pain on my dominant arm since May 2022.  I have not had an injury or accident of any kind.  My forearm has gone from normal to numb.  I have significant atrophy in my forearm such that my loss of strength is over 50% compared to my non dominant arm.  I have lost the ability to bend my  first and second fingers.  I was finally diagnosed with Parsonage-Turner Syndrome on 9/30/2022.  I am an otherwise healthy individual, tri-athlete.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ultrasound scan, X-ray
Clinical narrative: I have been suffering from arm and nerve pain on my dominant arm since May 2022.  I have not had an injury or accident of any kind.  My forearm has gone from normal to numb.  I have significant atrophy in my forearm such that my loss of strength is over 50% compared to my non dominant arm.  I have lost the ability to bend my  first and second fingers.  I was finally diagnosed with Parsonage-Turner Syndrome on 9/30/2022.  I am an otherwise healthy individual, tri-athlete.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram pulmonary abnormal, Brain natriuretic peptide increased, Echocardiogram normal, Full blood count normal, Metabolic function test
Clinical narrative: Patient developed acute bilateral pleural effusions within 12-24 hours of vaccine administration requiring hospitalization and treatment with lasix.  CT scan did not show PE or pneumonia, only pleural effusions.  ECHOCARDIOGRAM normal EF-no evidence of myocarditis. She was discharged roughly 24 hours after admission and evaluation.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pleural effusion, Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative
Clinical narrative: Patient developed acute bilateral pleural effusions within 12-24 hours of vaccine administration requiring hospitalization and treatment with lasix.  CT scan did not show PE or pneumonia, only pleural effusions.  ECHOCARDIOGRAM normal EF-no evidence of myocarditis. She was discharged roughly 24 hours after admission and evaluation.
Age: 7.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect product formulation administered
Clinical narrative: Nurse gave pedatric patient Flublok instead of Fluarix. Patient's mother was informed
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MODERNA MONOVALENT COVID 19 VACCINE GIVEN MISTAKENLY AS 2ND BOOSTER.