chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Death, Loss of consciousness
Clinical narrative: passes out and dies after practice; passes out and dies after practice; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 17 years old male patient who passes out and dies after practice while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, lot number not reported via unknown route in unknown administration site.  On an unknown date the patient passes out and dies after practice (death) (Loss of consciousness) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) passes out and dies after practice.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (passes out and dies after practice).  At time of reporting, the outcome was Fatal for the event death, unknown for Loss of consciousness.  It is unknown if an autopsy was done. The cause of death was reported as Unknown cause of death.; Sender's Comments: Sanofi Company Comment date 03-Feb-2022: This case involves a 17 years old male patient who passes out and dies after practice while receiving vaccine INFLUENZA VACCINE. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event, latency to onset, concomitant medications, medical history, family history for unexplained death, autopsy details if available, interventional therapy (if received), cause of death, pre-existing risk factors would aid in a complete case assessment.; Reported Cause(s) of Death: passes out and dies after practice
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Death, Syncope
Clinical narrative: collapses and Died; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 16 years old male patient who collapses and died while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient collapses and died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) collapses and died.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses and Died).  At time of reporting, the outcome was Fatal for the event collapses and died. No autopsy was done. The cause of death was reported as Unknown cause of death.; Reported Cause(s) of Death: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Circulatory collapse, Death, Syncope
Clinical narrative: collapsed and dies during conditioning practice; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 15 years old and unknown gender patient who collapsed and dies during conditioning practice while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event "collapsed and dies during conditioning practice" (circulatory collapse) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment for the event (collapsed and dies during conditioning practice).  Event outcome : At time of reporting, the outcome was fatal for the event collapsed and dies during conditioning practice. It is unknown if an autopsy was done. The cause of death was reported as Circulatory collapse.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) collapsed and dies during conditioning practice.; Sender's Comments: Sanofi company comment dated 02-Feb-2022: This case involves a 15 years old and unknown gender patient who collapsed and dies during conditioning practice while receiving vaccine Influenza Vaccine. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event, latency to onset, concomitant medications, medical history, family history for unexplained death, autopsy details if available, interventional therapy (if received), established cause of death, pre-existing risk factors would aid in a complete case assessment. ; Reported Cause(s) of Death: collapsed and dies during conditioning practice
Age: 15.0
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Dead; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves a 15 years old and unknown gender patient who was reported dead after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient was reported to be dead (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) dead.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Dead).  At time of reporting, the outcome was Fatal for the event dead. No autopsy was done. The cause of death was reported as Unknown cause of death.; Reported Cause(s) of Death: Not Provided
Sex: U
Vaccine: FLUX
Symptoms: Resuscitation, Syncope
Clinical narrative: collapses on the field and has to be resuscitated; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 29 years old  patient with unknown demographics who collapses on the field and has to be resuscitated while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.   On an unknown date the patient collapsed on the field and has to be resuscitated (syncope) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening.  Final diagnosis was (life-threatening) collapses on the field and has to be resuscitated.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the field and has to be resuscitated).  At time of reporting, the outcome was Unknown for the event collapses on the field and has to be resuscitated.; Sender's Comments: Sanofi Company Comment dated 03-Feb-2022: This case involves a 29 years old  patient with unknown demographics who collapses on the field and has to be resuscitated while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded.  Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: mistakenly an extra dose of ACTHIB with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2-year-old male patient who had mistakenly an extra dose of ACT-HIB with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Immunisation.  On 17-Jan-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ525AA, expiration: 16-Jul-2022, via intramuscular route in the right thigh as Immunisation.  On 17-JAN-2022 the patient developed a non-serious event "mistakenly an extra dose of ACT-HIB with no reported adverse event" (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  It was reported" Caller states that a 2 yo was mistakenly an extra dose of ACTHIB and would like to know if it is safe? Caller would like to know how to proceed? Additional Description of event Adverse events: A 2year old patient received an extra dose of ACTHIB. Caller states that the patient had already had 3 doses of ACTHIB and was seen on 17Jan2022 where she received the 4th dose of HIB via VAXELIS. Caller states that after the patient received VAXELIS she was also given a dose of ACTHIB by mistake on the same day."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (mistakenly an extra dose of ACTHIB with no reported adverse event).  At time of reporting, the outcome was Unknown for the event mistakenly an extra dose of ACT-HIB with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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 preparation issue
Clinical narrative: one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  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 lot UJ575AAA expiration date 07-Oct-2022 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event, "one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event" (product preparation error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  It was reported, "Caller stated that during inventory she noticed that there was an extra diluent in the box of ACTHIB. Caller stated that someone must have reconstituted a dose of ACTHIB with the incorrect diluent. Caller unsure of which patient would have received incorrect diluent. Caller asking what recommendations are and if they should revaccinate all potential patients who received this vaccine."  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (one of three patients received an ACTHIB vaccine that was not diluted with the 0.4% Sodium Chloride with no reported adverse event).  At time of reporting, the outcome was Unknown for the event one of three patients received an acthib vaccine that was not diluted with the 0.4% sodium chloride with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 61.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 61year old was inadvertently given Fluzone HD with no reported adverse event; Initial information received on 20-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 61 years old of unknown gender patient who was inadvertently given fluzone hd with no reported adverse event ,while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE( lot number not reported) at a unknown dose via unknown route in unknown administration site a prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " 61year old was inadvertently given fluzone hd with no reported adverse event" (off label use) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported" We had a 61 year old patient who was inadvertently given the Fluzone HD (65+ years old) product. I am wondering if there is any information from on the safety of this, or any precautions or steps we should take/offer to the patient. Let me know if you have any resources to assist us."  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (61year old was inadvertently given Fluzone HD with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 61year old was inadvertently given fluzone hd with no reported adverse event.
Sex: U
Vaccine: TDAP
Symptoms: Accidental exposure to product, Expired product administered
Clinical narrative: inadvertently received a Adacel vaccine; few days ago that expired in Dec2021; Initial information received on 21-Jan-2022 regarding an unsolicited non-valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had inadvertently received a adacel vaccine and few days ago that expired in dec2021 while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had inadvertently received a adacel vaccine (accidental exposure to product) and few days ago that expired in dec2021 (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the events (inadvertently received a Adacel vaccine, few days ago that expired in Dec2021).  At time of reporting, the outcome was Unknown for the event inadvertently received a adacel vaccine and was Unknown for the event few days ago that expired in dec2021.  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: YF
Symptoms: Expired product administered
Clinical narrative: an expired Sanofi yellow fever vaccine was administered with no reported adverse event; Initial information received on 22-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient who received an expired sanofi yellow fever vaccine was administered with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Jan-2022, the patient received a dose of suspect YELLOW FEVER VACCINE (formulation, strength: unknown) (lot number: not reported, expiry date: Sep 2020) (expired product administered) via an unknown route in unknown administration site for prophylactic vaccination.  It was reported that "After hours call received at 8:01pm on 21jan2022. Caller states that a patient received and expired dose of the yellow fever vaccine at a travel clinic today. "What do we do now? Do we need to take the patient to the ER(emergency room)?" After hours call returned at 8:21pm on 21jan2022. Caller states that he is the husband of the patient and he received an expired dose of the Yellow Fever vaccine. He was told that the protocol was for them to contact the manufacturer for guidance."  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    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Temperature excursion was 68F; total time of excursion was 8 hours with no reported adverse event; Initial information received on 24-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion of  68f; total time of excursion was 8 hours with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  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 IPV (VERO) lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had temperature excursion was 68f; total time of excursion was 8 hours with no reported adverse event (intercepted product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Temperature excursion was 68F; total time of excursion was 8 hours with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion was 68f; total time of excursion was 8 hours with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient inadvertently received ADACEL instead of DTAP with no ae; Initial information received on 24-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced a patient inadvertently received adacel instead of dtap with no adverse event  while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 07-Dec-2021, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6830AA via (unknown route, strength) (expiry date:17-Sep-2022)  in unknown administration site for prophylactic vaccination.  On 07-DEC-2021 the patient developed a non-serious event "a patient inadvertently received adacel instead of dtap with no adverse event " (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"the nurse who administered the vaccine was unsure of which patient received the ADACEL instead of DTAP, it was one of the reported two patients. Caller reporting the nurse was falsifying records, she had a pocket full of vials at the end of the day and had to sort out who received what vaccination. See related case on second patient #00946669".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (a patient inadvertently received ADACEL instead of DTAP with no ae).  At time of reporting, the outcome was Unknown for the event a patient inadvertently received adacel instead of dtap with no ae.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Wrong product administered
Clinical narrative: a patient inadvertently received ADACEL instead of DTAP with no reported adverse event; Initial information received on 24-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who inadvertently received Adacel instead of DTAP 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 INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Immunization; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunization.  On 07-Dec-2021, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot U6830AA via intramuscular route in the left thigh as Immunisation.  On 07-DEC-2021 the patient developed a non-serious event "a patient inadvertently received Adacel instead of DTAP with no reported adverse event" (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE..  It was reported" Caller reporting the nurse who administered the vaccine was unsure of which patient received the ADACEL, it was between two patients. Caller reporting the nurse was falsifying records, she had a pocket full of vials at the end of the day and had to sort out who received what vaccination."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (a patient inadvertently received ADACEL instead of DTAP with no reported adverse event).  At time of reporting, the outcome was Unknown for the event a patient inadvertently received Adacel instead of DTAP with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event
Clinical narrative: medication error with no adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who had medication error with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7184AA via intramuscular route in unknown administration site.  On 03-JAN-2022 the patient had medication error with no adverse event (medication error) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error with no adverse event).  At time of reporting, the outcome was Unknown for the event medication error with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature reached 55 F and the total excursion lasted 188.5 hours for ADACEL and was administered to a patient post excursion, with no reported adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid non-serious case was received from the healthcare professional.  This case is linked to case 2022SA029938.  This case involves a 40 years old male patient who had product temperature excursion issue as the temperature reached 55 f and the total excursion lasted 188.5 hours for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and was administered to a patient post excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 03-Jan-2022, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml total (strength, form: not provided; lot number: C5863AA and expiry date: 13-Apr-2023) via intramuscular route in unknown administration site for immunization.  On 03-JAN-2022, the patient developed a non-serious event 'temperature reached 55 f and the total excursion lasted 188.5 hours for adacel and was administered to a patient post excursion, with no reported adverse event' (product temperature excursion issue) (latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "Caller reported a temperature excursion earlier today. The highest temperature reached 55 F and the total excursion lasted 188.5 hours. The ADACEL was administered to a patient post excursion. However, the caller did not have patient specific information available when they reported the excursion earlier. They called back to provide the patient information. Caller requested clarification on the Stability and Storage information, as well as the Administration Post Excursion information. The caller requested that the Stability and Storage information be emailed and faxed again. The caller was not aware of any treatment required post administration. "  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event (temperature reached 55 f and the total excursion lasted 188.5 hours for adacel and was administered to a patient post excursion, with no reported adverse event).  No further information was provided by the reporter.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was administered to a 15 year old with no reported adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 years old and unknown gender patient for whom flublok was administered to a 15 year old with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at an unknown dose (lot number, expiry date, strength, form, frequency: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event "Flublok was administered to a 15 year old with no reported adverse event" (product use issue) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flublok was administered to a 15 year old with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flublok was administered to a 15 year old with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: TD
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PA reporting a dose of TENIVAC was inadvertently administered to a 4 month old, with no Adverse Event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from health professional.  This case involves a physician assistant (pa) reporting a dose of tenivac was inadvertently administered to a 4 month old, with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT  with Standard strength (unknown: formulation) at dose 0.5mL once via intramuscular route in the left thigh (lot U6831AA, expiry date: 25-Jan-2022) for Immunization.  On 25-JAN-2022 (latency same day), the patient developed a non-serious pa reporting a dose of tenivac was inadvertently administered to a 4 month old, with no ae (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown for the event pa reporting a dose of tenivac was inadvertently administered to a 4 month old, with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature excursion due to leaving the refrigerator door ajar with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown gender who had temperature excursion due to leaving the refrigerator door ajar with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7117BA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U7207AA via unknown route in unknown administration site.  On an unknown date the patient had temperature excursion due to leaving the refrigerator door ajar with no reported adverse event (intercepted medication error) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to leaving the refrigerator door ajar with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion due to leaving the refrigerator door ajar with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL was given with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient to whom expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]was given with no reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 25-Jan-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, lot number was unknown and expiry date: 23-May-2021) via intramuscular route in the right thigh for Prophylactic vaccination.   On 25-JAN-2022 the patient developed a non-serious event " expired daptacel was given with no reported adverse event"(expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported"18 month old patient who received an expired DAPTACEL. NP (Nurse practioner) is requesting to know what the recommendation is regarding repeating the vaccine or what other options they have. EXP: 05/23/2021."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired DAPTACEL was given with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired daptacel was given with no reported adverse event.; Sender's Comments:  00950423:
Age: 1.42
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: product was given to 17 month old; three doses of DTaP and this was their fourth dose with no reported adverse event; Initial information received on 28-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old unknown gender patient who was given three doses of dtap and this was their fourth dose with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE dose, frequency,strength, lot number expiry date unknown)with unknown indication.  On an unknown date the patient  was given three doses of dtap and this was their fourth dose with no reported adverse event (off label use) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (product was given to 17 month old; three doses of DTaP and this was their fourth dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event product was given to 17 month old; three doses of dtap and this was their fourth dose with no reported adverse event.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Device connection issue, Exposure via eye contact, Syringe issue, Underdose
Clinical narrative: Majority of the vaccine" was not administered to the patient; During the administration the vaccine squirted into the patient's eye instead; The needle connecting to the syringe was detached and the vaccine squirted from the connector joint; The needle connecting to the syringe was detached and the vaccine squirted from the connector joint; This spontaneous case was received on 07-Jan-2022 from other healthcare professional (nurse) via regulatory agency (reference number: SEQW22-00095) with additional information (being processed together) received on 11-Jan-2022 and 18-Jan-2022, and concerned a 64-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 07-Jan-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml; route of administration, anatomical location: not reported) for seasonal influenza prevention. The batch number was reported 308467 and expiry date 30-Jun-2022. It was reported the Luer Lok Syringe component of the combination product Flucelvax Quadrivalent  has been identified with a malfunction (leak).  The nurse stated that while administering the Flucelvax Quadrivalent vaccine, the needle connecting to syringe was detached and the vaccine squirted from the connector joint (explicitly coded as 'Device disconnection issue' and 'Syringe leak'). Furthermore, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). The nurse also reported that 'most of the vaccine' was not administered to the patient (explicitly coded as 'Incomplete dose administered').  At the time of initial reporting on 07-Jan-2022, no adverse events were reported after Flucelvax Quadrivalent administration.  This case has been entered onto manufacturing quality assurance tracking database and allocated.  The case was assessed as non-serious.  Company comment: A 64-year-old female patient was vaccinated with Flucelvax Quadrivalent (explicitly coded as 'Device disconnection issue', 'incomplete dose administered' and 'Syringe leak'). Besides, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). Causality for the reported events is assessed as not related to the vaccine and related to the luer lock syringe.; Sender's Comments: A 64-year-old female patient was vaccinated with Flucelvax Quadrivalent (explicitly coded as 'Device disconnection issue', 'incomplete dose administered' and 'Syringe leak'). Besides, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). Causality for the reported events is assessed as not related to the vaccine and related to the luer lock syringe.
Age: 46.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Bone pain, Condition aggravated, Migraine, Rhinorrhoea
Clinical narrative: Migraine; Bone pain; Runny nose; This spontaneous case was initially received on 25-Jan-2022 from other non-health care professional via Pfizer (reference number: 202200037151) with additional information received on the same day  via Agency (reference number: SEQW22-00399) (being processed together) and concerned a 46-year-old female patient.  The patient's medication included bladder infections and kidney problems. The patient's concurrent conditions included migraines, arthritis and allergy to Lyrica (pregabalin), morphine, ibuprofen and gabapentin. The patient's concomitant medication included duloxetine, Hydrocodone/Acetaminophen (hydrocodone, paracetamol), amlodipine and Salonpas (capsaicin, menthol), all used for unreported indication.  On 07-Dec-2021, the patient started using Xeljanz XR (tofacitinib citrate; dose: 11 mg daily; route of administration: oral; indication: not reported). The batch number was not reported.  On unspecified date in Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date in Dec-2021, the patient was vaccinated with non-company co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date, after receiving Flucelvax Quadrivalent and non-company co-suspects Pneumovax and Xeljanz XR (tofacitinib citrate), the patient experienced bone pain, described as 9/10 pain, and one severe migraine, for which she took Aleve (naproxen sodium). The patient had history of migranes but had not had one in a long time. It was also reported that the patient had constant runny nose and that she had difficulty doing daily activities.  On an unspecified date, the patient had recovered from migraine.  At the time of the initial reporting, the outcome of event 'bone pain' was not recovered.  The outcome of event 'rhinorrhoea' was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old female patient experienced bone pain, rhinorrhea and migraine after receiving Flucelvax Quadrivalent, non-company co-suspects Pneumovax and Xeljanz XR. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.; Sender's Comments: A 46-year-old female patient experienced bone pain, rhinorrhea and migraine after receiving Flucelvax Quadrivalent, non-company co-suspects Pneumovax and Xeljanz XR. Elapsed time between vaccination and the onset of the events is unknown. Due to this lack of information regarding chronology, causality is unassessable.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe headache, fatigue and nausea within 3-4 hours, lasting for 3 days. Fever (up to 100.7) lasting for 2 days. Muscle aches (in legs) lasting for 3 days so far. Very sore arm with pink, puffy splotches for 4 days so far.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular
Clinical narrative: Severe headache, fatigue and nausea within 3-4 hours, lasting for 3 days. Fever (up to 100.7) lasting for 2 days. Muscle aches (in legs) lasting for 3 days so far. Very sore arm with pink, puffy splotches for 4 days so far.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray normal, Echocardiogram, Electrocardiogram ambulatory, Electrocardiogram normal
Clinical narrative: Multiple heart palpitations began on day five post booster.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test normal, Palpitations
Clinical narrative: Multiple heart palpitations began on day five post booster.