chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Headache, Visual impairment
Clinical narrative: left eye was not seeing right; she got a really sharp headache on the left side of her head/light headache on right side, in the back on the side; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-heathcare professional.  This case involves an unknown age female patient who experienced left eye was not seeing right and she got a really sharp headache on the left side of her head/light headache on right side, in the back on the side, after receiving vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  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 Hypertension with high blood but currently not on meds right now. Diagnosed about 10-15 years ago. Concomitant Medications: vitamins   On an unknown date in 2024, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (form, strength: unknown) (lot number, expiry date: not reported) via intramuscular route in the left arm for prophylactic vaccination (immunization).  On an unknown date in 2024, the patient developed left eye was not seeing right (visual impairment) and she got a really sharp headache on the left side of her head/light headache on right side, in the back on the side (headache) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Action taken : not applicable.  The patient was treated with Acetylsalicylic acid (Aspirin).  At time of reporting, the outcome was Unknown for the event visual impairment and Recovering / Resolving for the event headache.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: ipol was involved in a temperature excursion and administered to the patient with no reported adverse event; Initial information received on 21-Oct-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and gender patient where reporter reported IPV (VERO) [IPOL] was involved in a temperature excursion and administered to the patient 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 in 2024, the patient received a dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation and ipol was involved in a temperature excursion and administered to the patient with no reported adverse event (poor quality product administered) (latency- same day).   Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Reportedly, Nurse stated that the IPOL was involved in a temperature excursion on 9/23/2024 and administered to the patient involved at an unknown date and time after the excursion occurred. Nurse confirmed the patient has not reported any medical concerns or symptoms after being administered the improperly stored vaccines.    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: M
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: arm was equally as sore; Initial information received on 02-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a nurse.  This case is linked to US-SA-2024SA302376 and US-SA-2024SA307855.  This case involves male patient of an unknown age whose arm was equally as sore after receiving pfizer biontech COVID-19 vaccine and influenza usp trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2024, the patient received an unknown dose of suspect influenza usp trival A-B high dose subvirion vaccine (formulation; strength; lot number; expiry date not reported) and on the same day, the patient received an unknown dose suspect pfizer biontech COVID-19 vaccine not produced by Sanofi Pasteur (formulation; strength; lot number; expiry date not reported) both via unknown route in the arm NOS (Not Otherwise Specified) for Immunisation.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence will not be available.  On 20-Sep-2024 the patient's arm was equally as sore (pain in extremity) (latency: same day).  Reportedly, during call  caller stated her husband also has both of his but did different arms. His arm was equally as sore but  subsided by next morning. Does not specify names of  product. His was not unusual. That was all he has ever  had was a little bit of soreness.  He was just very sore when she put it in  and tender quite a while. Next morning seemed a lot  better.   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 Recovered/Resolved for the event on 21-Sep-2024; Sender's Comments:  US-SA-2024SA302376: US-SA-2024SA307855:
Age: 80.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Erythema, Injection site rash, Rash erythematous
Clinical narrative: Erythema; Injection Site Rash; Rash Erythematous; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 80 years old male patient who had erythema, injection site rash and rash erythematous after receiving RSV vaccine PROT. subunit PREF3 (Arexvy), COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) and influenza USP trival A-B high dose SUBVIRION vaccine [fluzone high dose].  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.  On 16-Sep-2024, the patient received unknown dose of suspect Arexvy (RSV vaccine prot. subunit PREF3) (unknown strength, expiry date and formulation) not produced by Sanofi Pasteur with lot 2FP37 via intramuscular route in unknown administration site for prophylactic vaccination, unknown dose of COVID-19 vaccine prot. subunit (NVX CoV 2373) (unknown strength, expiry date and formulation) not produced by Sanofi Pasteur with lot 6024MF013 via intramuscular route in unknown administration site for COVID-19 immunization and influenza USP trival A-B high dose SUBVIRION vaccine Suspension for injection in pre-filled syringe (unknown strength and expiry date) with lot U8429CA via intramuscular route in unknown administration site for prophylactic vaccination.  On 17-SEP-2024 the patient developed erythema, injection site rash and rash erythematous (Latency 1 day) following the administration of RSV vaccine prot. subunit PREF3, OVID-19 vaccine prot. subunit (NVX COV 2373) and influenza USP trival A-B high dose SUBVIRION vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: very ill for over 3 weeks with it; Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a Nurse as courtesy case from Pfizer.  This case is linked with US-SA-2024SA306969 and US-SA-2024SA302376.  This case involves a 75 years old female patient who was very ill for over 3 weeks with it after receiving Influenza usp trival A-B HIGH dose subvirion vaccine [Fluzone high dose].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Systemic lupus erythematosus (had Lupus 35-40 years).   On 20-Sep-2024, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence cannot be requested.  On an unknown date in 2024 the patient was very ill for over 3 weeks with it (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.; Sender's Comments:  US-SA-2024SA306969: US-SA-2024SA302376:
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: leg on left was more swollen and tender; leg on left was more swollen and tender; fever; Initial information received on 14-Oct-2024 regarding an unsolicited valid non-serious courtesy case received from a nurse.  This case involves an unknown age male patient (16.45 kg) who experienced leg on left was more swollen and tender and fever after receiving elasomeran [Spikevax] and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 21-Sep-2024, the patient received 1 DF (Dosage Form) of suspect Influenza Vaccine produced by unknown manufacturer (lot: UT8408NA) (formulation; strength; expiry date unknown) via intramuscular route in unknown administration site for Immunisation and on the same day, the patient received a dose of 0.5 ml (dose 4) suspect Spikevax not produced by Sanofi Pasteur (lot: B0005) (formulation; strength; expiry date unknown) via intramuscular route in unknown administration site for COVID-19 prophylaxis.  On 21-Sep-2024 the patient developed leg on left was more swollen and tender (peripheral swelling); leg on left was more swollen and tender (tenderness) and fever (pyrexia) (latency: same day).  Reportedly, Patient received the incorrect formulation of vaccine, he was meant to have received MCV 6mos-11yr formulation but, instead received Spikevax for 12yr and older.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on 22-Sep-2024 for all the events.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, lot UK006AA and expiry date- 28-Feb-2025) (other lot reported: UJ995AA, UK010AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.  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-2024SA269367:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves Infant and unknown gender patient who received HIB (PRP/T) Vaccine  [ACT-HIB] that was involved in a temperature excursion resulting in below 0 temperature exposure was given 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 an unknown date, the patient received a  dose of suspect HIB (PRP/T) Vaccine (unknown strength, dosage, expiry date , batch number and route) in unknown administration site for prophylactic vaccination was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, From 08-2024 to 09-MAY-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.  Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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: No adverse event, Product storage error
Clinical narrative: vaccine administered post excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, lot UK006AA and expiry date- 28-Feb-2025) (other lot reported: UJ995AA, UK010AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.  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-2024SA269367:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered post excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked to 2024SA269367 (master case).  This case involves Infant of unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient was administered with an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, lot UK010AA, UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.  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-2024SA269367:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of vaccines that are no longer viable to use post temperature excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked with US-SA-2024SA269367(master case).  This case involves Hib (Prp/T) Vaccine [Act-Hib] which was inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post temperature 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 in 2024, the patient inappropriately received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation that are no longer viable to use post temperature excursion, with no reported adverse event (poor quality product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Reportedly, From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.  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-2024SA269367:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion resulting in below 0 temperature with no reported adverse event; temperature excursion resulting in below 0 temperature exposure was given to patient with no reported adverse event; Initial information received on 24-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves Infant and unknown gender patient who received HIB (PRP/T) Vaccine [ACT-HIB] who experienced temperature excursion resulting in below 0 temperature with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK010AA) (unknown formulation, expiry date, strength, dosage and route) route in unknown administration site for Prophylactic vaccination had temperature excursion resulting in below 0 temperature with no reported adverse event (product storage error) and (poor quality product administered) (unknown latency).  Reportedly, from 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.   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: No adverse event, Product storage error
Clinical narrative: Vaccine administered post excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient was administered with a  dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK010AA, expiry date- 28-FEB-2025; lot numbers-UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-AUG-2024 to 05-SEP-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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-2024SA269367:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of vaccines that are no longer viable to use post temperature excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to master case US-SA-2024SA269367.  This case involves Hib (Prp/T) Vaccine [Act-Hib] which was inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post temperature 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 suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) which was inappropriately administered, that are no longer viable to use post temperature excursion, with no reported adverse event (poor quality product administered) (lot: UK010AA, Expiry date: 28-Feb-2025 other lot UJ995AA, UK006AA) via unknown route in unknown administration site for immunization.  Reportedly from 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.    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-2024SA309458: US-SA-2024SA269367:Master case
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered post excursion with no reported adverse event.; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case was linked to US-SA-2024SA269367 (master case).  This case involves a 1 years old and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient was administered with a  dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK010AA, expiry date- 28-FEB-2025; lot numbers-UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-AUG-2024 to 05-SEP-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.  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-2024SA269367:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of vaccines that are no longer viable to use post temperature excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked with US-SA-2024SA269367(master case).  This case involves Hib (Prp/T) Vaccine [Act-Hib] which was inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post temperature 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 in 2024, the patient inappropriately received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation that are no longer viable to use post temperature excursion, with no reported adverse event (poor quality product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Reportedly, From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.  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-2024SA269367:Master case US-SA-2024SA309399:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported ae; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 26 Infant (range were one year of age) and unknown gender patients were received Hib (Prp/T) Vaccine [Act-Hib] vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure, 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 in (24-Aug-2024 to 05-Sep-2024), the 26 infant patients received a dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) (lot number, expiry date: not reported) that was involved in a temperature excursion resulting in below 0 temperature exposure, with no reported adverse event (poor quality product administered) (latency: same day) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  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: No adverse event, Product storage error
Clinical narrative: Vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no ae; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a non-healthcare professional.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, lot UK006AA and expiry date- 28-Feb-2025) (other lot reported: UJ995AA, UK010AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.  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-2024SA269367:Master case
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported ae; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Infant and unknown gender patient who received Hib (Prp/T) Vaccine [Act-Hib] that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK010AA) (unknown strength, dosage, expiry date and route in unknown administration site for Prophylactic vaccination was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, From 08-2024 to 09-MAY-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. As Per Sanofi guidelines these were inactivated doses and all patients have been informed and offered a no cost revaccination.  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: No adverse event, Product storage error
Clinical narrative: Vaccine administered post excursion with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked to US-SA-2024SA269367 (master case).  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 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 in 2024, the patient was administered with a  dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK010AA, expiry date- 28-FEB-2025; lot numbers-UJ995AA, UK006AA) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation), post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, from 24-AUG-2024 to 05-SEP-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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-2024SA269367:master case
Age: 64.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dysgeusia, Pharyngeal swelling
Clinical narrative: Pharyngeal swelling; Dysgeusia; Initial information received on 23-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 64 year old female patient who had pharyngeal swelling and dysgeusia after receiving novavax COVID-19 VACCINE and influenza quadrival A-B vaccine [fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included atorvastatin and levothyroxine both for Product used for unknown indication.  On 12-Sep-2024, the patient received 0.5 ml of suspect Novavax COVID-19 VACCINE (unknown strength and expiry date) not produced by Sanofi Pasteur with lot 6024MF012 via intramuscular route in unknown administration site for COVID-19 Immunization and unknown dose of influenza quadrival A-B vaccine Suspension for injection (unknown strength and expiry date) with lot U8432AA via unknown route in unknown administration site for prophylactic vaccination.  On 12-Sep-2024 the patient developed pharyngeal swelling and dysgeusia (Latency same day) following the administration of influenza quadrival A-B vaccine and Novavax COVID-19 vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence   Action taken was 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: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Got a little sick from the flu shot; Initial information received on 21-Oct-2024 regarding an unsolicited valid  non-serious case received from Patient.  This case involves a 69 years old male patient (72.73 kg) who got a little sick from the flu shot (Influenza Vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2024, the patient received suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date in 2024 the patient got a little sick from the flu shot (illness) (unknown latency).  Patient stated that he got a little sick from the flu shot and he is feeling better today. He was told to wait a week to take the dupixent.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Got a little sick from the flu shot).  At time of reporting, the outcome was Unknown for the event got a little sick from the flu shot.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event; From 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event; Initial information received on 24-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2024SA269367 (Master case).  This case involves Infant and unknown gender patient from 8/24/24 to 9/5/24 received HIB (PRP/T) Vaccine [ACT-HIB]that was involved in a temperature excursion resulting in below 0 temperature exposure was given 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 an unknown date in 2024, the patient received a unknown dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) lot UK010AA/UJ995AA/UK006AA,strength, expiry date was unknown via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and from 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to patients, with no reported adverse event (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).  Reportedly "All patients involved in this administration range were one year of age. Per Sanofi guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination."   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-2024SA269367:Master case
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Syringe issue
Clinical narrative: attached the needle and pulled it down to  push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported adverse event; attached the needle and pulled it down to  push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported adverse event; Initial information received on 16-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who attached the needle and pulled it down to  push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported adverse event with RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in October 2024, suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection lot X1B611M expiry- 31-JUL-2026 via unknown route in unknown administration site for prophylactic vaccination (Immunisation) attached the needle and pulled it down to  push in the vaccine vial, the diluent seeped out the back of the syringe barrel where the plunger comes in and got onto their hand with no reported adverse event (occupational exposure to product) (exposure via skin contact) (same day latency).  Nurse Manager stated that "nurse wasted a diluent". They never punctured the vial with the IMOVAX RABIES vaccine powder. They wanted to know if they could use a different diluent instead or if they should order a whole new vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error