chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE NP they received on Friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA295385, US-SA-2024SA295436, US-SA-2024SA295520, US-SA-2024SA295994, US-SA-2024SA295596, US-SA-2024SA295446, US-SA-2024SA295462, US-SA-2024SA296042, US-SA-2024SA295848, US-SA-2024SA296324 and US-SA-2024SA295434  This case involves a 7 year and 2 months old male patient  the reporter reported fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Sep-2024, the patient received a dose 1, 0.5 ml 1x (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection lot UT8506A expiyr-30-Jun-2025,via intramuscular route in the right arm for influenza (Influenza immunisation) (strength unknown) fluzone np they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, Clinical supervisor stated they received a notification from Vaccine clinic for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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-2024SA295385:02243780 US-SA-2024SA295446: US-SA-2024SA295434: US-SA-2024SA295436: US-SA-2024SA295462: US-SA-2024SA295848: US-SA-2024SA295994: US-SA-2024SA296371: US-SA-2024SA296042: US-SA-2024SA295324: US-SA-2024SA295324:
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE NP they received on Friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA295385, US-SA-2024SA295436, US-SA-2024SA295520, US-SA-2024SA295994, US-SA-2024SA295596, US-SA-2024SA295446, US-SA-2024SA295462, US-SA-2024SA296042 and US-SA-2024SA295434  This case involves a 10 years and 7 months old female patient, the reporter reported fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Sep-2024, the patient received a dose 1, 0.5 ml 1x (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection lot UT8506A expiyr-30-Jun-2025,via intramuscular route in the left arm for influenza (Influenza immunisation) (strength unknown) fluzone np they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event (poor quality product administered) (latency same day).   Reportedly, Clinical supervisor stated they received a notification from Shoppe for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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-2024SA295385: US-SA-2024SA295436: US-SA-2024SA295994: US-SA-2024SA295462: US-SA-2024SA296042: US-SA-2024SA296371:
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines arrived cold and was given to patients on the same day (with no reported adverse event); Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA295462.  This case involves a 8 years old female patient and is reported influenza USP trival A-B subvirion no preservative vaccine [Fluzone] vaccine arrived cold and was given to patients on the same day (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Sep-2024, the patient received a 0.5 ml  dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (strength: standard, frequency: once) of lot UT8506A and expiry date: 30-Jun-2025 via intramuscular route in the left arm for Influenza (Influenza immunization) which arrived cold (with no reported adverse event) (poor quality product administered) (latency: on 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.; Sender's Comments:  US-SA-2024SA295385:02243804
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: an inappropriate use due to administering fluzone np vaccines that are no longer suitable to patients with no reported adverse event; vaccines that are no longer suitable to patients with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA295385 (Master case).   This case involves a 2 years old male patient and the reporter reported an inappropriate use due to administering influenza USP trival A-B subvirion vaccine [Fluzone] vaccines that are no longer suitable to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2024, the patient received 0.5 ml of dose 1 of influenza USP trival A-B subvirion vaccine Suspension for injection with standard strength (lot UT8506A and expiry date- 30-Jun-2025) once via intramuscular route in the right thigh for Influenza (Influenza immunization) that are no longer suitable to patients with no reported adverse event (product storage error) (poor quality product administered) (latency- same day).  Reportedly, Clinical supervisor stated they received a notification from Vaccine clinic for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24-Sep-2024 and due to the delay in shipment, it arrived on 27-Sep-2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30-Sep-2024.  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-2024SA296371: US-SA-2024SA295385:Master case US-SA-2024SA295848: US-SA-2024SA295462:02243824
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine arrived cold and was given to patients on the same day (with no reported adverse event).; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2024SA295462.  This case involves a 15 months old female patient and is reported influenza USP trival A-B subvirion no preservative vaccine [Fluzone] vaccine arrived cold and was given to patients on the same day (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) and Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation.   On 30-Sep-2024, the patient received a 0.5 ml  dose (dose 1) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (strength: standard, frequency:once) of lot UT8506A and expiry date: 30-Jun-2025 via unknown route in unknown administration site for immunization which arrived cold (with no reported adverse event) (poor quality product administered) (latency: on 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.; Sender's Comments:  US-SA-2024SA295462:02243829 US-SA-2024SA295385:02243829
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE NP they received on Friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA295385, US-SA-2024SA295436, US-SA-2024SA295520, US-SA-2024SA295994, US-SA-2024SA295596, US-SA-2024SA295446, US-SA-2024SA295462, US-SA-2024SA296042, US-SA-2024SA295848 and US-SA-2024SA295434  This case involves a 3 years 6 months old female patient  the reporter reported fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Sep-2024, the patient received a dose 1, 0.5 ml 1x (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection lot UT8506A expiyr-30-Jun-2025,via intramuscular route in the left arm for influenza (Influenza immunisation) (strength unknown) fluzone np they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, Clinical supervisor stated they received a notification from Shop for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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-2024SA295385:02243836 US-SA-2024SA295434: US-SA-2024SA295462: US-SA-2024SA295848: US-SA-2024SA295520: US-SA-2024SA295436: US-SA-2024SA295446: US-SA-2024SA296042: US-SA-2024SA295994: US-SA-2024SA295596:
Age: 1.25
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: an inappropriate use due to administering fluzone np vaccines that are no longer suitable to patients with no reported adverse event; vaccines that are no longer suitable to patients with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA295385 (Master case).   This case involves a 15 months old male patient and the reporter reported an inappropriate use due to administering influenza USP trival A-B subvirion vaccine [Fluzone] vaccines that are no longer suitable to patients 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, HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Pentacel); and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) both for Immunisation.  On 27-Sep-2024, the patient received 0.5 ml of dose 1 of influenza USP trival A-B subvirion vaccine Suspension for injection with standard strength (lot UT8506A and expiry date- 30-Jun-2025) once via intramuscular route in the right thigh for Influenza (Influenza immunization) that are no longer suitable to patients with no reported adverse event (product storage error) (poor quality product administered) (latency- same day).  Reportedly, Clinical supervisor stated they received a notification from Vaccine clinic for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24-Sep-2024 and due to the delay in shipment, it arrived on 27-Sep-2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30-Sep-2024.  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-2024SA295385:Patient 1 (02243659) US-SA-2024SA296371: US-SA-2024SA295462:02243780 US-SA-2024SA295462:02243875 US-SA-2024SA295462:02243836 US-SA-2024SA295462:02243842 US-SA-2024SA295462:02243867 US-SA-2024SA295848: US-SA-2024SA295462:02243791
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE NP they received on Friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases- US-SA-2024SA295385, US-SA-2024SA295436, US-SA-2024SA295520, US-SA-2024SA295994, US-SA-2024SA295596, US-SA-2024SA295446, US-SA-2024SA295462, US-SA-2024SA296042, US-SA-2024SA295848 and US-SA-2024SA295434.  This case involves a 2 years old male patient the reporter reported fluzone np (INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]) they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Sep-2024, the patient received 0.5 ml 1x (once) dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (strength- standard) Suspension for injection lot UT8506A expiyr-30-Jun-2025,via intramuscular route in the left arm for influenza (Influenza immunisation) and fluzone np they received on friday that are no longer good, the vaccines arrived cold and was given to patient with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, Clinical supervisor stated they received a notification from  Shop for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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-2024SA296371:
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administering fluzone np vaccines that are no longer suitable to patients with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA295436, US-SA-2024SA295520, US-SA-2024SA295994, US-SA-2024SA295596, US-SA-2024SA295436.  This case involves a 14 years old female patient who had inappropriate use due to administering Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] vaccines that are no longer suitable to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 27-Sep-2024, the patient received a dose 1 of 0.5 ml of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) (Frequency : Once, lot UT8506A, Expiry date: 30-Jun-2025, strength was unknown) via intramuscular route in the right arm for Prophylactic vaccination (Immunization) and inappropriate use due to administering fluzone np vaccines that are no longer suitable to patients with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering FLUZONE NP vaccines that are no longer suitable to patients. Clinical supervisor stated they received a notification from Shop for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor has reached out to some patient already but she's checking to see the company's recommendations for the patients that would typically need two doses of the vaccine. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024."   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-2024SA295436:02243780 US-SA-2024SA295436:02243791 US-SA-2024SA295520:02243804 US-SA-2024SA295994:02243824 US-SA-2024SA295596:02243829 US-SA-2024SA295436:02243836 US-SA-2024SA295436:02243842 US-SA-2024SA295446:02243852 US-SA-2024SA295436:02243867 US-SA-2024SA295436:02243875
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered, Product distribution issue
Clinical narrative: vaccines that were no longer suitable was administered to the patient with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a months old female patient and reporter stated that influenza USP trival A-B subvirion NO preservative vaccine [fluzone] that were no longer suitable was administered to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 27-Sep-2024, the patient received standard dose of 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection once with lot UT8506A and expiry date 30-Jun-2025 via intramuscular route in unknown administration site for immunization.  On 27-SEP-2024 influenza USP trival A-B subvirion NO preservative vaccine [fluzone] that were no longer suitable was administered to the patient with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly, Clinical supervisor stated they received a notification from Vaccine clinic for the FLUZONE NP they received on Friday that are no longer good. She said that by the time they received the notification, the vaccines were already given to 12 patients. Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24Sep2024 and due to the delay in shipment, it arrived on 27Sep2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30Sep2024.  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-2024SA295385:02243867 US-SA-2024SA295848: US-SA-2024SA296371:
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: fluzone np they received on friday that are no longer good. she said that by the time they received the notification, the vaccines were already given to 12 patients with no reported ae; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA295385 (master case).  This case involves a 30 months old female patient who received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] on friday that was no longer good, she said that by the time they received the notification, the vaccines were already given to 12 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 vaccine (COVID-19 vaccine) for Prophylactic vaccination.  On 30-Sep-2024, the patient received a dose of suspect 0.5ml (dose 1) (once) standard Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8506A, expiry date: 30-Jun-2025) (unknown strength and route) via intramuscular route in the left thigh for Prophylactic vaccination was received on friday that are no longer good, she said that by the time they received the notification, the vaccines were already given to 12 patients with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, Clinical supervisor mentioned that it was not a planned shipment; it was shipped on the midnight of 24-Sep-2024 and due to the delay in shipment, it arrived on 27-Sep-2024. The vaccines arrived cold and was given to patients on the same day, while some patients received it on 30-Sep-2024.   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-2024SA295385:master case US-SA-2024SA296371:
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Flublok that were transit for too long/ was administered to patient, with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked with 2024SA294961 (Cluster case).  This case involves a 37 years old male patient who had received influenza trivalent recombinant vaccine [Flublok TIV] that were transit for too long and was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2024, the patient received 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (Frequency: once, strength: standard, expiry date: 30-Jun-2025 and lot TFAA2431) via unknown route in unknown administration site as Immunization that were transit for too with no reported adverse event (poor quality 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: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product preparation issue
Clinical narrative: gave MENQUADFI to a patient last week and it was mixed with a sterile diluent with no reported AE; gave MENQUADFI to a patient last week and it was mixed with a sterile diluent with no reported AE; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from  a pharmacist.  This case involves a 16-year-old female patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] to a patient last week and it was mixed with a sterile diluent with no reported adverse event and incomplete dose administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitants: no other vaccines.  On 25-Sep-2024, the patient received a dose 0.5ml Standard (once) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (once) (lot-U7852AB, expiry date: 31-Oct-2025) (unknown dosage and strength) via intramuscular route in right arm for prophylactic vaccination.  On 25-Sep-2024 the patient developed gave Meningococcal A-C-Y-W135 (T CONJ) Vaccine to a patient last week and it was mixed with a sterile diluent with no reported adverse event (product preparation error) and (incomplete dose administered) (latency-same day).  Reportedly, reporter said that she was alerted that one of the pharmacist in the pharmacy gave MENQUADFI to a patient last week and it was mixed with a sterile diluent, half a dose of the vaccine was given. They need to know if they need to revaccinate with the full dose or if they need to try to give another half dose. No treatment received.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only administered the diluent (ipol portion part) with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  The case is linked to US-SA-2024SA254317.  This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] had only administered the diluent (ipol portion part) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and only administered the diluent (ipol portion part) with no reported adverse event (single component of a two-component product administered) (unknown latency).  Reportedly "Caller stated that a nurse had previously called in and reported the issue. Caller stated that the product was not reconstituted. Two patients received the vaccine this way. They only administered the diluent (ipol portion part) The issue."   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-2024SA254317:02199043
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered to a 63-year old patient with no adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 63 years old and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and fluzone hd was administered to a 63-year old patient with no adverse event (product administered to patient of inappropriate age) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to FLUZONE HD was administered to a 63-year old patient. Pharmacist reports that one of their clinics administered FLUZONE HD to a 63-year old issue; he asks if Sanofi has any paper or information to say that it would not be harmful to the patient? Pharmacist initially states that the patient was administered FLUZONE HD QIV; MIS advised the pharmacist that the 2024-2025 FLUZONE HD are trivalent formulations. He states he was just repeating what the clinic told him, and states that they probably just said FLUZONE HD QIV on accident. He confirms that it was the FLUZONE HD for the 2024-2025 season."   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: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2nd dose of fluzone hd on 30-Sep- 2024 with no reported adverse event; Initial information received on 30-Sep-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 67 years old male patient who receive 2nd dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 30-sep- 2024 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2024, the patient received a dose 1, 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8527CA and expiry 30-JUN-2025 ) (strength: unknown) via intramuscular route in the left arm and patient received dose 2 on 30-Sep-2024 with no adverse event (extra dose administered) (latency same day) for immunization.  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: 8.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low Temperature 10.1 degree Celsius upto 39 minutes :and it was administered post excursion with no adverse event; Open Ipol exposed to 10.1 C upto 39 minutes due to human error with no reported adverse event; Initial information received on 01-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an 8 years old female patient who received open IPV (VERO) [IPOL] exposed to 10.1 (degree Celsius) upto 39 minutes due to human error with no reported adverse event and Max/low temperature 10.1 degree Celsius upto 39 minutes and it 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. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, TETANUS Vaccine Toxoid (Tdap) and Varicella Vaccine (Live) for prophylactic vaccination.   On 04-Sep-2024, IPV (VERO) [IPOL] was exposed to 10.1 (degree Celsius) upto 39 minutes due to human error with no reported adverse event (product storage error).  On 23-Sep-2024, the patient received 0.5ml (dose 1) and (dose 2) of suspect IPV (VERO) Suspension for injection (lot-W1C741M) (unknown expiry date, strength, dosage and route) via subcutaneous route in the left arm for prophylactic vaccination reporter reported Max/low Temperature 10.1 degree Celsius upto 39 minutes :and it was administered post excursion with no adverse event (poor quality vaccine administered) (latency-same day).  Reportedly, 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. 2 doses of IPOL vaccine were administered but none of the ADACEL. Occurred due to human error.  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-2024SA295970:02245279
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone reached 31.3 degrees for 2 hours, it was administered post excursion with no reported adverse event; Initial information received on 01-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 86 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] reached 31.3 degrees for 2 hours, it was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 30-Sep-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (lot U8499DA, Expiry date: 30-Jun-2025, strength was unknown) via intramuscular route in the left deltoid for Immunization and fluzone reached 31.3 degrees for 2 hours, it was administered post excursion with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "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."   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: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Atrial flutter, Cardiac monitoring abnormal, Chest X-ray abnormal, Electrocardiogram abnormal
Clinical narrative: Diagnosed with atrial flutter at ER
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Palpitations
Clinical narrative: I took the Covid vac (Comirnaty 2024-25 SYR 12+) on 10/03/2024 and started severe benign palpitations on early on 10/6/2024. They were continuous throughout the day leading to the emergecy department at 6:00pm that night at the recommendation of the trauma nurse at the cardiologist office. The palpitations returned again on 10/09/2024 lasting about 12 hrs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Describe Event, Problem, or Product Use Error: Patient experienced diaphoresis, erythema of torso and extremities, and feeling faint after administration of her Fluad-65 vaccine. Initial Symptoms resolved, but patient later experienced nausea and vomited 1 time.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted the morning after the high dose flu shot Flu shot on 10/11/2024
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Loss of consciousness
Clinical narrative: About 30 hours after I had been given the Moderna Covid-19 injection, I started feeling weak, had to sit down and passed out with my head in my lap. I came to shortly thereafter and staggered over to another, padded chair, went prostrate and broke out in a cold sweat all over and felt like I was going to faint again. I had someone bring me a cold, wet washcloth for my forehead, sat there for about 30 minutes till I started feeling stronger, then was able to get up, still feeling weak. I feel like, when I passed out, I was going into or was in shock. This side effect happened to me after the first Covid-19 shot I had in 2021, also. At that time, I ended up on my bathroom floor, sprawled out, because it was cold and I was burning up, even though it was a cold sweat, and passed out. Since this has happened to me twice, I thought I should report it, as it was serious at the time, even though I don't appear to have any lasting side effects that I know of. This was Moderna, Lot# 8080797 injection given at pharmacy, on 10/12/2024. It says NDC# 80777-0110-96, by syringe.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: **She informed that she had very sore arms on the day following her flu and Covid vaccines** On Monday morning, her flu vaccine was given in right deltoid by aseptic technique and best practice (Covid vaccine was administered in the same manner in the left deltoid). She also waited in the store 15- 30mins as advised by the Rph. The following day (Tuesday), she said both arms were more sore than she has experienced with previous vaccines and she also experienced loose stools. By Wednesday morning, she said that the soreness and BM has resolved, but was concerned about the vaccine administration because both arms had the same pain. She did not seek medical attention at the but said she may talk to her PCP about the experience at the next appt.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: My husband, my 17-year-old daughter and I received the Moderna vaccine. I will mention that both my husband and I are physicians. We have each had 5 or more prior vaccinations, including at least one Moderna in 2023. This time, we all had profoundly more side effects than on any prior shot. My daughter: Felt sick within 2 hours of shot. 11 hrs after shot spiked a very high fever and vomited. Fever and rigors continued through the night. Fever continued on additional 48 hrs. Now, almost 72 hours out, the fever is gone, but she feels fatigued. My husbnad: Felt poorly 6 hours out. Severe headache by 16 hours with significant paresthesias with every shot, typically starting 6 -12 hrs later. With this shot, they began at 2 hrs. Fevers, chills, nausea, brain fog starting at 12 hours and continuing for 48 hrs. Profound diffuse itching (no rash) and mild wheezing starting 24 hours in and continuing into 72 hrs. We have had mild to moderate side effect with prior shots. We have experienced nothing of this magnitude. I am a huge advocate for vaccines. I have zero concerns about the mRNA. I do have concerns about potential contamination of the shot with something hghly allergenic.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain, Abdominal pain upper, Decreased appetite, Feeling of body temperature change, Influenza like illness
Clinical narrative: On Friday, October 11, 2024, I kept my appointment at my local grocery store pharmacy to get a new updated Pfizer COVID shot and the annual flu shot. I have not had this combo before, I don't think, but felt like maybe I had once in the past. So I felt it was OK to combine them. I normally go to clinic, my medical facility, but they did not have the COVID updated booster yet. But pharmacy did. Anyway, it turns out it was two shots, two enormous needles, and very different than at clinic. I was told I may feel ill the next day. At 2 AM that night, I began to get nauseated and tossed and turned all night. At 6:55 AM, I began violently vomiting, and vomited six times that day, finally stopping around 5 PM. I was hot and cold, completely sick as a dog, unable to eat. Sunday was all the same side effects of flu-like illness but not vomiting. And no eating. It's now Monday, October 14, and I am still really sick. I am not really able to move around much, I feel nauseated and my belly and stomach are tight and in pain. I am completely overwhelmed with what has happened to me.