chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTP
Symptoms: Crying
Clinical narrative: persistent inconsolable crying/uncontrollable crying; Initial information was received on 21-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 4 months old female patient who experienced persistent inconsolable crying/uncontrollable crying while receiving vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE.  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 DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious persistent inconsolable crying/uncontrollable crying (crying) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (persistent inconsolable crying/uncontrollable crying).  At time of reporting, the outcome was Unknown for the event persistent inconsolable crying/uncontrollable crying.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: I've been sick for 2 weeks; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who reported i've been sick for 2 weeks after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, expiry date, formulation, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient reported i've been sick for 2 weeks (illness) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  It was reported, : I got my flu shot and I've been sick for 2 weeks.  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 events
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu was when got flu shots; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced had the flu was when got flu shots (Influenza Vaccine).  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 Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient had the flu was when got flu shots (influenza) (unknown latency). Reporter Commented: No flu shots only time I had the flu was when I got flu shots.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu was when got flu shots).  At time of reporting, the outcome was Unknown for the event had the flu was when got flu shots.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: only get the flu when I get the flu shot; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional) via Social Media.  This case involves an unknown age and unknown gender patient who only get the flu when patient got the influenza vaccine.  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 vaccine produced by unknown manufacturer (strength, dosage, expiry date, formulation, lot number- not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).Information on the batch number was requested.  On an unknown date the patient only get the flu when patient got the flu shot (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information was received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced got sick while receiving vaccine INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer (dose, lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious got sick (illness) (unknown latency)  Reportedly:- Unfortunately, we got sick before we could get the new Corona booster and my shingles shot  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.; Sender's Comments:  US-SA-2023SA327196:
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: still feeling a bit down from the shot on wednesday; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown age and gender who experienced still feeling a bit down from the shot on wednesday after receiving Influenza vaccine.  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 unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On 19-Oct-2023 the patient developed feeling a bit down from the shot on wednesday (malaise) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: it makes me sick; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported it makes me sick for  influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient reported it makes me sick (illness) (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: quit taking the flu shot, it started making me sick; Initial information received on 19-Oct-2023 regarding an unsolicited valid social media non-serious case received from patient.  This case involves an unknown age and gender patient who quit taking the Influenza Vaccine shot, as it started making patient sick.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had quit taking the flu shot, it started making sick (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (quit taking the flu shot, it started making me sick).  At time of reporting, the outcome was Unknown for the event quit taking the flu shot, it started making me sick.
Sex: U
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: flu shot they really help even though some of the side effects hit me though I don't like but good get a flu shot; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who had influenza vaccine and reported that flu shot they really help even though some of the side effects hit me though i don't like but good get a flu shot.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that flu shot they really help even though some of the side effects hit me though i don't like but good get a flu shot (immunisation reaction) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: usually get sick from it shortly after; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who usually get sick from it shortly after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient usually get sick from it shortly after (illness) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported, This is a social media case found on social media. I get my flu shot every year. I usually get sick from it shortly after, or so it seems then I am good to go all winter I probably should go get that done this week thanks for reminding me sir.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: arm hurts as normal; Initial information was received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced arm hurts as normal while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient received a  dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (dose,lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for Covid-19 immunization.  On an unknown date the patient developed a non-serious arm hurts as normal (pain in extremity) (unknown latency).  Action taken: not applicable for both suspects.  It was not reported if the patient received a corrective treatment for the event (arm hurts as normal).  At time of reporting, the outcome was Unknown for the event arm hurts as normal.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced sore arm after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on the batch number was requested.  On an unknown date the patient developed sore arm for 2 days (pain in extremity) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event pain in extremity.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: took flu shot once and got very I'll! Never took it again; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age/gender patient who experienced took flu shot once and got very i'll! never took it again while receiving vaccine INFLUENZA VACCINE.  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 VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious took flu shot once and got very i'll! never took it again (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (took flu shot once and got very I'll! Never took it again).  At time of reporting, the outcome was Unknown for the event took flu shot once and got very i'll! never took it again.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: ongoing arm pain post administration; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 0180811(CLUSTER), 01808146 (CLUSTER) and 01808177(CLUSTER).  This case involves a 28 years old female patient who experienced ongoing arm pain post administration after receiving Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  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 of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number:UT8076NA) (Expiry date: 30-Jun-2024) (with an unknown strength) via intramuscular route in the left deltoid for immunization.  On an unknown date, the patient developed event of ongoing arm pain post administration (pain in extremity) (unknown latency).  It was reported, Caller reporting 4 of their employees have experienced reactions after receiving FLUZONE QIV PFS, administered at their clinic as part of employee health. Caller reporting 3 patients have complained of ongoing arm discomfort and one patient experienced redness around the injection site. Caller reporting, she is concerned about continuing to use this batch of vaccines, she reports they have given over 70 FLUZONE QIV PFS and 4 have experienced reactions. Caller did not have any information as far as time frame of onset of symptoms. Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 3 Days After Vaccination in Adults 18 Years of Age and Older, including Grade 2 and Grade 3 injection site pain. 3: Injection site adverse reactions: redness/erythema. Caller also with question on whether we have any information we can send as administration guide as a reference for administration.Caller reporting patient is experiencing ongoing arm pain post administration. Caller does not have details on onset of symptoms, caller has not assessed whether patient is having any difficulty lifting her arm  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Not Recovered / Not Resolved for the event; Sender's Comments:  US-SA-2023SA322206: US-SA-2023SA322148:01808146 01808146:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines were also administered to patients post excursion 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 2023SA322724 and 2023SA324260.  This case involves an unknown age and unknown gender patient who reported that influenza quadrival a-b vaccine [Fluzone QUADRIVALENT] vaccines were also administered to patients post excursion 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 unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient reported that vaccines were also administered to patients post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Caller did not have the product and patient information for safety reporting at the time of call, but she gave permission to be contacted by Sanofi if further information is needed. Product/s: Unopened Fluzone QIV, Fluzone HD QIV and Adacel Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours Human error? No Does extended stability data cover the excursion? No, unopened Fluzone QIV, Fluzone HD QIV and Adacel are no longer covered by the extended stability data. If negative advice, was the product administered to a patient? Yes. Batch/lot number requested, not available at the time of call. Follow-up with caller possible. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; ; the vaccines were also administered to patients post excursion."  Action taken with QUADRIVALENT influenza vaccine (Fluzone QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event vaccines were also administered to patients post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours with no adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA322719(CLUSTER) and 2023SA322724(CLUSTER).  This case involves temperature excursion for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection via unknown route in unknown administration site for Immunization (strength, batch, and expiry date: unknown) max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours  with no adverse event (poor quality product administered) (latency same day). Information on the batch number was requested.  It was reported, Nurse asks for the stability data of unopened FLUZONE QIV, FLUZONE HD QIV and ADACEL following a temperature excursion, she would also like to know the recommendations following administration of the involved vaccines to patients post excursion. Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours Human error: No Does extended stability data cover the excursion: No, unopened FLUZONE QIV, FLUZONE HD QIV and ADACEL are no longer covered by the extended stability data. If negative advice, was the product administered to a patient: Yes. Batch/lot number requested, not available at the time of call. Follow-up with caller possible. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data; the vaccines were also administered to patients post excursion.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.5
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Pentacel was accidentally administered (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 6 months old male patient who was accidentally administered expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] (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 HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination.  On 16-Oct-2023, the patient received 0.5 ml (Dose 3) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ791AB) (Expiry date: 10-Oct-2023) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for immunization.  On 16-Oct-2023, the patient was accidentally administered expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] (with no reported adverse event) (expired product administered) (latency: same day).  It was reported, Caller reporting an expired dose of Pentacel was accidentally administered. Caller with question on whether dose needs repeating. Caller also reporting the shipment was received in MAY 2023 and doses are already expired, caller asking to speak with someone regarding the short expiration dates. This is considered a medication error due to administering an expired dose  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: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered a vaccine post expiration with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post expiration 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 was administered a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (expiry date- 08-OCT-2023) (lot number, strength, dosage- not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) post expiration with no reported adverse event (expired product administered) (latency- same day). Information on the batch number was requested.  Reportedly, Caller would like to know the efficacy of the vaccine given to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1.83
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administering ADACEL to a 22-month-old patient instead of DAPTACEL with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 22 months old male patient who was administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] instead of 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 an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of lot U7929AA and expiry: 14-Nov-2025 via unknown route in unknown administration site for Immunization; instead of Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection (strength, lot and expiry: not reported) with no reported adverse event (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 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: 0.75
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: she administered a one-day old expired PENTACEL vaccine to a patient 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 9 months old female patient who was administered a one-day old expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine 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 Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ794AB) (Expiry date: 08-Oct-2023) (with an unknown strength) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered a one-day old expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Medical assistant called stating that she administered a one-day old expired PENTACEL vaccine to a patient. She is calling to inquire if she needs to revaccinate.  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: Incorrect dose administered, No adverse event
Clinical narrative: Fluzone quadrivalent dose was given a patient after not being viable/it was not supported by extended stability information post excursion and vaccine was given to patient with no adverse event; not supported by the extended stability information post excursion with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown age and gender and nurse reported that the Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] dose was given a patient after not being viable/it was not supported by extended stability information post excursion with no reported adverse event.  On an unknown date, the patient received a unknown (dose 1) dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization and dose was given a patient after not being viable/it was not supported by extended stability information post excursion with no adverse event (poor quality product administered) (same day latency); (product storage error) (unknown latency). Information on the batch number was requested.  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: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered act-Hib with a different diluent with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received via nurse.  This case involves a 4-year-old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] with a different diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and administered act-hib with a different diluent with no reported adverse event (product preparation error) (latency: same day).  Reportedly, Nurse called to report that they administered act-Hib with a different diluent. They did not use the diluent provided on the act-Hib. She said that she has read on a reliable database that dose should be repeated as soon as possible using the diluent provided in act-hib. She wanted to confirm if the data she has read is true and that if they need to report it.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received via consumer.  This case involves a 1-year-old male patient and an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 18-Oct-2023, the patient received an 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ804AA, expiry date: 07-Oct-2023) via intramuscular route in left thigh for immunization and an expired pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out 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: DTAPIPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: QUADRACEL was administered to a patient who was supposed to be given a high dose influenza vaccine with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 69 years old female patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] was administered to a patient who was supposed to be given a high dose influenza vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2023, the patient received 0.5 ml dose (frequency: once; strength: standard) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection of lot U7526AA and expiry: 07-Sep-2024 via intramuscular route in the left deltoid for immunization; who was supposed to be given a high dose influenza vaccine with no reported adverse event (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 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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist called to report about a 15-year-old patient who received Flublok with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15-year-old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 14-Oct-2023, the patient received 0.5 ml total dose of suspect influenza quadrivalent recombinant vaccine (strength, form: unknown) (lot: QFAA2326, expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for immunization and pharmacist called to report about a 15-year-old patient who received flublok with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out 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: 9.0
Sex: M
Vaccine: TYP, YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA326768(CLUSTER) and 2023SA326767(CLUSTER).  This case involves a 9 years old male patient who  came in for a typhoid fever vaccine but was given yellow fever vaccine - [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the  patient came in for a typhoid fever vaccine but received 0.5 ml (dose 1) of suspect yellow fever vaccine, Solution for injection, (lot UJ819AA; Expiration Date : 18-APR-2024: strength not reported) via intramuscular route in the arm nos (unknown if left or right) instead of subcutaneously with no reported adverse event (incorrect route of product administration) (wrong product administered) (latency on 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.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: experiencing shortness of breath; Initial information received on 20-Oct-2023 and live follow up received on same date both were processed together regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who experienced experiencing shortness of breath while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetic.   On 05-Oct-2023, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 19-OCT-2023 the patient developed a non-serious experiencing shortness of breath (dyspnoea) (latency 14 days). Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (experiencing shortness of breath).  At time of reporting, the outcome was Unknown for the event experiencing shortness of breath.
Age: 5.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The red area was warmer to the touch then other areas of the skin; Large red areas around the injection site / Redness covered about 1/2 of their upper arm, from shoulder to 1/2 way to elbow; The red area were somewhat swollen; This spontaneous case was received on 16-Oct-2023 from other non healthcare professional (reference number SEQW23-03428) and concerned a 5-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 14-Oct-2023 , the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm, dose and route of administration: not reported) for influenza immunization.The batch number was not reported.  On 15-Oct-2023, one day after receiving Flucelvax  Quadrivalent the patient experienced a large red area around the injection site, redness covered about 1/2 of their upper arm, from shoulder to 1/2 way to elbow, it was warmer to the touch then other areas of the skin and somewhat swollen.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: One day after receiving Flucelvax Quadrivalent the patient experienced vaccination site swelling, vaccination site erythema, and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for the events, based on chronological and anatomical plausibility.; Sender's Comments: One day after receiving Flucelvax Quadrivalent the patient experienced vaccination site swelling, vaccination site erythema, and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for the events, based on chronological and anatomical plausibility.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Condition aggravated, Heavy menstrual bleeding, Injected limb mobility decreased
Clinical narrative: I had a normal period already at the beginning of the month that lasted for 7 days and was the same as always. Very regular cycle and very easy and predictable typically. But after the shot , in the next 24 I began to bleed again like a full cycle of menstration for another full 7 days but this time very heavy. I am still bleeding abnormally and so heavy I am losing mass amounts of blood and looking into a hysterectomy or ablation surgery to stop the bleeding. I am anemic , lethargic and sore often  now. My arm still hurts at injection site and the pain and lack of movement and swelling affects me daily.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Intermenstrual bleeding, Joint swelling, Lethargy, Menstrual disorder
Clinical narrative: I had a normal period already at the beginning of the month that lasted for 7 days and was the same as always. Very regular cycle and very easy and predictable typically. But after the shot , in the next 24 I began to bleed again like a full cycle of menstration for another full 7 days but this time very heavy. I am still bleeding abnormally and so heavy I am losing mass amounts of blood and looking into a hysterectomy or ablation surgery to stop the bleeding. I am anemic , lethargic and sore often  now. My arm still hurts at injection site and the pain and lack of movement and swelling affects me daily.