chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: reported that a 12-year-old patient was inadvertently given a dose of Daptacel instead of Adacel with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (practice manager).  This case involves a 12 years old female patient who was inadvertently given a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead 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 Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Prophylactic vaccination.  On an unknown date, the patient was inadvertently given a dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], suspension for injection, strength: unknown (lot number: C5980AB, Expiry date: 26-apr-2024) intramuscular route in the left arm for immunization, instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel], suspension for injection (strength, lot number, expiry date: not reported, via unknown route in unknown administration site for immunization, with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested for adacel.  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.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Fluzone QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA321113(CLUSTER), 2023SA319649(CLUSTER), 2023SA321127(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 11 months old female patient who was administered influenza quadrival A-B vaccine [Fluzone QIV] and was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (lot: U8192BA; expiry date: Jun-2024; strength: standard) via intramuscular route in the left thigh for Immunization.  On 16-Oct-2023 the influenza quadrival A-B vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was 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 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: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Vasculitis
Clinical narrative: all over body rash; vasculitis; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 75 years old male patient who experienced all over body rash and vasculitis, after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (form, strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed all over body rash (rash) and vasculitis (unknown latency) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: 2 doses of ADACEL was administered to a patient 6 weeks apart with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 6 weeks apart with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received Dose 1 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot number: U766GAA) (Expiry date: 08-Mar-2025) (with an unknown strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 29-Sep-2023 he/she also received  Dose 2 of the same vaccine (lot number: U766GAA) (Expiry date: 08-Mar-2025) via unknown route in unknown administration site.  On 29-Sep-2023, the patient was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 6 weeks apart with no adverse event (extra dose administered) (latency: 1 month 14 days).  It was reported, Pharmacy director asks for safety data and recommendations following the administration of 2 doses of ADACEL to a patient 6 weeks apart, first dose was given on 15Aug2023, the second one was given on 29Sep2023. This situation is reported as a medication error due to 2 doses of ADACEL was administered to a patient 6 weeks apart.  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: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Limb discomfort, Pain
Clinical narrative: arm discomfort, difficulty lifting her arm because of the pain; redness around the injection site; prolonged arm pain at injection site post administration; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old female patient who experienced arm discomfort, difficulty lifting her arm because of the pain, redness around the injection site and prolonged arm pain at injection site post administration after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received 0.5 ml dose (frequency: once; strength: standard) of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT8076NA and expiry: Jun-2024 via intramuscular route in the right deltoid for immunization.  On an unknown date, the patient developed arm discomfort, difficulty lifting her arm because of the pain (limb discomfort), redness around the injection site (vaccination site erythema) and prolonged arm pain at injection site post administration (vaccination site pain) (unknown latency) following the administration of Influenza Quadrival A-B vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA323666(CLUSTER), 2023SA323508(CLUSTER) and 2023SA323592(CLUSTER).  This case involves a 77 years old female patient to whom clinic already had given 4 doses of the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] that were out of the stability range with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a 0.7 ml, total, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8162BA, expiry date: 30-Jun-2024 , strength: High dose) via intramuscular route in the left deltoid for Immunization and the time the clinic already had given 4 doses of the vaccine out of stability with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date, vaccines were out of the stability range with no reported adverse event (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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 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: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received a shipment of fluzone high dose quadrivalent on 16oct2023 that was shipped out on 12oct2023 and vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 66 years old female patient who was administered the Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent] which were out of stability due to reporter received a shipment on 16Oct2023 that was shipped out on 12Oct2023 and vaccines were out of the stability range with no reported adverse event no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Oct-2023, the patient received 0.7 ml dose (frequency: once; strength: high dose) of suspect Influenza Quadrival A-B High Dose HV vaccine of lot number: U8162BA and expiry: 30-Jun-2024 (formulation: not reported) via intramuscular route in the left deltoid for immunization.  On an unknown date, it was reported that a shipment of Influenza Quadrival A-B High Dose HV vaccine was received on 16Oct2023 that was shipped out on 12Oct2023 and vaccines were out of the stability range with no reported adverse event (product storage error) (unknown latency).  On 16-Oct-2023, the patient was already administered Influenza Quadrival A-B High Dose HV vaccine out of stability with no reported adverse event (poor quality product administered) (latency: same day).  No lab data 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: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA323966, 2023SA323508 and 2023SA323592.  This case involves a 86 years old female patient to whom clinic already had given 4 doses of the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] that were out of the stability range with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a 0.7 ml, total, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8162BA, expiry date: 30-Jun-2024 , strength: High dose) via intramuscular route in the right deltoid for Immunization and the time the clinic already had given 4 doses of the vaccine out of stability with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date, vaccines were out of the stability range with no reported adverse event (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for 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 Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involving Opened IPOL, Reason: unknown, Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error: unknown with no reported adverse event; vaccines were used after the temperature excursion with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who was administered opened IPV (VERO) [IPOL] after temperature excursion, reason: unknown, max temperature reached: 47.1°F duration out of labelled range: 15 minutes, human error: unknown 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 0.5 ml dose (dose 2; frequency: once; strength: standard) of suspect IPV (VERO) Suspension for injection of lot W1A101M (expiry: not reported) via intramuscular route in the left deltoid for immunization.  On an unknown date, it was reported, temperature excursion involving opened IPV (VERO), reason: unknown, max temperature reached: 47.1°F duration out of labelled range: 15 minutes human error: unknown with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient was administered IPV (VERO) vaccine after the temperature excursion with no reported adverse event (poor quality product administered) (latency: Same day).  No lab data 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.; Sender's Comments:  US-SA-2023SA322119:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired hib vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who experienced received an expired HIB (PRP/T) vaccine [ACT-HIB] 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, Tetanus and Acellular pertussis vaccine (Daptacel) for Immunisation; and Pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 17-Oct-2023, the patient received an expired 0.5 ml dose of suspect HIB (PRP/T) vaccine (frequency: once; Strength: standard) Powder and solvent for solution for injection of lot UJ73AA and expiry: 07-Oct-2023 via intramuscular route in the left vastus lateralis for immunization, with no reported adverse event (expired product administered) (latency: same day).  No lab data 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.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently given the regular Fluzone vaccine instead of the Fluzone high dose with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Elderly and unknown gender patient who was inadvertently given the regular quadrivalent influenza vaccine [Fluzone] instead of the 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 an unknown dose of suspect quadrivalent influenza vaccine (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and inadvertently given the regular fluzone vaccine to a senior citizen instead of the fluzone high dose with no reported adverse event (wrong product administered) (Latency: same day). The information on the batch number was requested.  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.
Age: 1.08
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: due to not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old female patient and stated that the product was not properly reconstituting the lyophilized component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] using the liquid vaccine component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, it was reported that only the lyophilized component of PENTACEL was administered to a patient and was not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event (product preparation error) (Suspension for injection) (latency: same day) (lot UJ805AA) (Frequency = once) (Strength = standard) via unknown route in unknown administration site for immunization.  It was reported that "Medical assistant stated that the lyophilized component was mixed with a sterile diluent the clinic uses to dilute MMR vaccine. There was no mention of the specific sterile diluent that was used. No further information provided. Sales representative mentioned that the clinic wanted to know what to do next with the situation."  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: 80.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: tentivac was expired for 16 days and was accidentally given to a patient with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an 80 years old female patient where diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was expired for 16 days and was accidentally given 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 16-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7189AA and expiration date- 30-Sep-2023) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (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.
Age: 6.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Patient was not supposed to receive a dose of Menquadfi with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 6 years old male patient who was not supposed to receive a dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Oct-2023, the patient received 0.5 ml dose (frequency: once) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7675DB via route : (abbreviation not known; requested) in unknown administration site for immunization; however, patient was not supposed to receive a dose of menquadfi (wrong product administered) (latency: same day).  No lab data was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: received 2 doses of polio (IPV) virus vaccine today with no reported adverse event; Initial information was received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old female patient who received 2 doses of IPV (VERO) [Ipol] today 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, hepatitis b vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (pediarix) and pneumococcal vaccine conj (pneumococcal conjugate vaccine) for Prophylactic vaccination.  On 18-Oct-2023, the patient received a 0.5 ml (dose 3), once of suspect IPV (VERO) (Suspension for injection) (lot V1A022M,  expiry date: 17-Feb-2024, strength: standard) via intramuscular route in Right thigh for Immunization and received 2 doses of polio (ipv) virus vaccine today with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: gets the injection, there is light redness, almost pink, at the injection site; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient for whom there is light redness, almost pink, at the injection site after receiving Influenza Vaccine.  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) for Immunisation.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient had light redness, almost pink, at the injection site (vaccination site erythema) (unknown latency) following the administration of influenza vaccine.  Reportedly, the caller mentioned that she was preparing to get the Flu Vaccine for people aged 65 and older, and she usually received the injection. She had noticed that each time she got the injection, there was light redness, almost pink, at the injection site. Additionally, each year the redness appeared to be larger than the previous year. Two years ago, it was the size of a 50-cent coin, and the year after it was a bit larger than that. She also observed a similar effect with a different vaccine called Shingrix. She would like to know if it is safe for her to proceed with the Fluzone Vaccine shot and whether this is a normal effect.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gets the injection, there is light redness, almost pink, at the injection site).  At time of reporting, the outcome was Unknown for the event gets the injection, there is light redness, almost pink, at the injection site.
Age: 6.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient received BOOSTRIX (TDAP) instead of the intended/prescribed product DAPTACEL with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old female patient who received boostrix (tdap) instead of the intended/prescribed product Diphtheria/15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2023, the patient received a dose of suspect Boostrix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site as prophylactic vaccination instead of the intended/prescribed product Diphtheria/15/Tetanus/5 AC Pertussis Vaccine with no reported adverse event (wrong product administered) (latency: same day).  It was reported "Nurse reported that a patient received BOOSTRIX (TDAP) instead of the intended/prescribed product DAPTACEL. Since the vaccines are similar, would this affect the patient's DTAP schedule? The DAPTACEL was ordered but BOOSTRIX was given instead."  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: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertently vaccinated with an expired dose of ACT-HIB with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender 9 patients who were inadvertently vaccinated with an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2017, the 9 patients were inadvertently vaccinated with an expired dose of dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ289AA, expiry date- 05-SEP-2016) (with an unknown dosage and strength) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Caller requested guidance on how to proceed.   Caller declined to provide an e-mail address and would not give any further patient information.   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: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received two fluzone hd qiv, the second dose was within an hour of the first with no reported adverse event; Initial information was received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 79 years old female patient who received two influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] the second dose was within an hour of the first with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2023, the patient received a 0.7 ml,once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot UT8157AA, expiry date: Jun-2024, strength: unknown) via intramuscular route in the left deltoid for Immunization and received two fluzone hd qiv, the second dose was within an hour of the first with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, The caller believed that the patient thought she was getting another COVID vaccine. They have their clinics set up where patients can get both flu vaccines and COVID vaccines. They believe the patient became confused and received two FLUZONE HD QIV  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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test positive, Allergy to plants, Blood test normal, Depression, Discomfort
Clinical narrative: After one month on my second shot vaccine started itching and bumps appearing in arms and back body. After 10-15 mins it will disappear.  This happens 4 to 5 times a day. This causes mentally depressed and discomfort.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Food allergy, Hypersensitivity, Laboratory test normal, Pruritus
Clinical narrative: After one month on my second shot vaccine started itching and bumps appearing in arms and back body. After 10-15 mins it will disappear.  This happens 4 to 5 times a day. This causes mentally depressed and discomfort.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After one month on my second shot vaccine started itching and bumps appearing in arms and back body. After 10-15 mins it will disappear.  This happens 4 to 5 times a day. This causes mentally depressed and discomfort.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: The patient had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (The patient had a sore arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050o22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, BUDESONIDE and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient had a sore arm). At the time of the report, PAIN IN EXTREMITY (The patient had a sore arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.  The patient does not remember which arm she received the vaccine.   This case was linked to MOD-2023-747030, MOD-2023-746962 (Patient Link).
Sex: F
Vaccine: UNK
Symptoms: Erythema
Clinical narrative: Had red spots all over both of my arms and my legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs). At the time of the report, RASH ERYTHEMATOUS (Had red spots all over both of my arms and my legs) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   concomitant medication and treatment medication were not reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Flushing
Clinical narrative: Given Moderna Spikevax and developed flushing and chest tightness within 2 minutes. Taken to ED for further evaluation and treatment.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Right arm hives - from finger up to whole arm. Lasted 2 days per patient NO Hives on left arm where pt received Influenza HD. ONLY on right arm where she received Covid.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pfizer comirnaty 12yrs and old Patient is 5yrs old at time of vaccination
Sex: U
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: COPD exacerbation
Age: 69.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient arrived at the pharmacy on 10/23/23 and filled out a consent form for a covid-19 vaccine. After completing the consent form, the pharmacist processed the form incorrectly as Fluad Quad flu vaccine and failed to verify the vaccine with patient. The vaccine was then given to our staff nurse to administer to the patient and again was not verified with the patient. As a result, the patient was given a flu shot and not a covid-19 vaccine as requested. The patient then contacted the pharmacy later after noticing their paperwork talked about the influenza and not covid-19. The pharmacist on duty verified the error after pulling the original consent form and inquired about side effects or other issues. The patient reported no side effects or ill harm, however, was frustrated that the wrong vaccine had been given. After talking with the on-duty pharmacist, the patient  was very understanding of the error and decided to come back to the pharmacy on 10/25/23 to receive his covid-19 vaccine. This vaccine was given without any incident.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: 8 hours post vaccine I experienced weakness and "crumbling" feeling in my knees and legs. I was unable to walk without leaning on  something. I felt like I would drop to the ground. It was Not numbness or tingling. It lasted for about 5-5 1/2 hours.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Seizure, Tremor
Clinical narrative: seizure lasting 5 to 10 minutes, with legs and arms jerking and complete loss of consciousness.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Nervous system disorder, Unresponsive to stimuli
Clinical narrative: PATIENT GOT 2 VACCINES, A FEW MINULTES LATER , SHE WAS UNRESPONSIVE AND CNS SIDE EFFECTS
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: Starting later that day I had fatigue and pain at the injection site.  The next day I had severe body aches, mild nausea, more pain at the injection site and now including redness, swelling, and heat.  Fever/chills, sweating, severe fatigue and increased drowsiness, confusion.  Two days after the injection I had all symptoms except nausea.  Sweating was worse but all other remaining symptoms were milder.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Starting later that day I had fatigue and pain at the injection site.  The next day I had severe body aches, mild nausea, more pain at the injection site and now including redness, swelling, and heat.  Fever/chills, sweating, severe fatigue and increased drowsiness, confusion.  Two days after the injection I had all symptoms except nausea.  Sweating was worse but all other remaining symptoms were milder.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Starting later that day I had fatigue and pain at the injection site.  The next day I had severe body aches, mild nausea, more pain at the injection site and now including redness, swelling, and heat.  Fever/chills, sweating, severe fatigue and increased drowsiness, confusion.  Two days after the injection I had all symptoms except nausea.  Sweating was worse but all other remaining symptoms were milder.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Chills, Nausea, Pain, Tremor
Clinical narrative: Body aches, bad chills, shaking, balance was off, nausea/vomiting. Took two advil during the night. Lasting about 24 hours total
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Body aches, bad chills, shaking, balance was off, nausea/vomiting. Took two advil during the night. Lasting about 24 hours total
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects. Pt received one flu vaccine at her physical exam on 9/22/2023. Parent brought child to a flu clinic on 10/9/2023. Pt received 2 doses of flu within 17 days.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: public health nurse reviewed patients vaccine record in  EHR. looked at immunizations under "profile tab" which indicated that the last covid vaccine given was 2/2023. phn should have looked in database to verify and confirm in EHR through the "patient record" tab which indicated patient received Comirnaty 23/24 on 10/6/2023
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Epigastric discomfort, Nausea, Urticaria, Vaccination site reaction
Clinical narrative: Patient states he woke up at 2 am burning in chest, stomach irritation,nausea.  Arm at vaccination site has a large welp approximately 3 inches in diameter with heat.  Patient states "temperature of 99.2".  He states he didn't take anything but was able to rest after about an hour.  At 9:00 am Friday morning, advised patient to take benadryl to help with the obvious arm reaction and apply ice to comfort the arm.  He did admit to arm swelling after the second vaccine but not like this.   Has received Moderna each time.  If gets any worse advised patient that he should seek medical attention via ER.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Patient states he woke up at 2 am burning in chest, stomach irritation,nausea.  Arm at vaccination site has a large welp approximately 3 inches in diameter with heat.  Patient states "temperature of 99.2".  He states he didn't take anything but was able to rest after about an hour.  At 9:00 am Friday morning, advised patient to take benadryl to help with the obvious arm reaction and apply ice to comfort the arm.  He did admit to arm swelling after the second vaccine but not like this.   Has received Moderna each time.  If gets any worse advised patient that he should seek medical attention via ER.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Gaze palsy, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Received Flu vac on 9/26/23 @0845, site left arm. 9/27/23@ 0600 woke up with redness at injection site 4 inches in diameter, warm to touch, tender, not itchy. Denies any rashes and no respiratory distress. Have headache and body aches. All symptoms are resolved after 24 hours. Applied ice pack to affected site and took Advil dual action Q 4 hours
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Pain in the middle of the back on both sides. Pain increased when attempting to take a deep breath.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The nurse administered a high-dose vaccine to a patient who was not yet 65 years old. The patient was 64 years old at the time of vaccination on 10/17/23 and due to turn 65 in three months. No adverse reaction reported.