chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Myocarditis
Clinical narrative: myocarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-health care professional via social media.  This case involves a 29 years old and unknown gender patient who had myocarditis afterreceiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, 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 (frequency, formulation, route, strength, lot number and expiry date was unknown) via unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date after vaccination patient had myocarditis (latency: unknown). This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (myocarditis).  At time of reporting, the outcome was Unknown for the event myocarditis.; Sender's Comments: Sanofi company dated: 27-Jan-2022: This case involves 29 year old male patient who had myocarditis with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, 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: U
Vaccine: FLUX
Symptoms: Myocarditis
Clinical narrative: myocarditis; 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 24 years old and unknown gender patient who reported myocarditis 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 developed a serious myocarditis (unknown latency) following the administration of Influenza Vaccine.   Action taken :  not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : Unknown for the event.  Seriousness criteria : This event(myocarditis) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 24 years old and unknown gender patient who reported myocarditis while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
Age: 25.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional  This case involves a 25 years old and unknown gender patient who had cardiac arrest after receiving  INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  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 had cardiac arrest (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi company comment dated 8-Feb-2022 : This case involves a 25 years old and unknown gender patient who had cardiac arrest after receiving  INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, 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: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; 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 and unknown gender patient who suffers cardiac arrest 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient suffers cardiac arrest (cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 04-Feb-2022.This case involves a 16 years old and unknown gender patient who suffers cardiac arrest after receiving INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors, family history for cardiac disease(s), corrective treatment and clinical course details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: suffers cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp via social media.  This case involves a 16 year old and unknown gender patient who suffered cardiac arrest while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a football player and on an unknown date the patient suffered cardiac arrest (cardiac arrest) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffers cardiac arrest).  At time of reporting, the outcome was Unknown for the event suffers cardiac arrest.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 16 year old patient of unknown gender who suffered cardiac arrest after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got mine, but still caught the flu; Initial information received on 28-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with who still caught the flu 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 still caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got mine, but still caught the flu).  At time of reporting, the outcome was Unknown for the event got mine, but still caught the flu.
Sex: U
Vaccine: FLUX
Symptoms: Death, Myocardial infarction, Seizure
Clinical narrative: dead of heart attack during the game; 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 49 years old and unknown gender patient who dead of heart attack during the game 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 dead of heart attack during the game (myocardial infarction) (unknown latency) following the administration of Influenza Vaccine.   It was reported that It goes on and on, and on. it's happening everywhere, and is not normal. 49 years old player dead of heart attack during the game.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the events.  Event outcome : At time of reporting, the outcome was Fatal for the event dead of heart attack during the game. It is unknown if an autopsy was done. The cause of death was reported as Heart attack.  Seriousness criteria : This event(seizure) was assessed as medically significant and was leading to death. Final diagnosis was (fatal) dead of heart attack during the game.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 49 years old and unknown gender patient who dead of heart attack during the game while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: dead of heart attack during the game
Age: 13.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest, Syncope
Clinical narrative: collapses on the field with cardiac arrest; 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 13 years old and unknown gender patient who was collapsed on the field with cardiac arrest while receiving vaccine influenza vaccine.  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 vaccine produced by unknown manufacturer at an unknown dose, (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event of collapses on the field with cardiac arrest (cardiac arrest) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the field with cardiac arrest).  At time of reporting, the outcome was Unknown for the event collapses on the field with cardiac arrest.; Sender's Comments: Sanofi comment dated 07-Feb-2022: This case involves a 13 years old and unknown gender patient who collapses on the field with cardiac arrest while receiving vaccine influenza vaccine. The time to onset was unknown for cardiac arrest. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction, Syncope
Clinical narrative: collapses on the golf course after a heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via public post.  This case involves a patient of unknown demographics who collapsed on the golf course after a heart attack while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, frequency, lot number, route, administration site) for prophylactic vaccination. Information on the batch number was requested.  On an unknown onset and unspecified latency, the patient "collapsed on the golf course after a heart attack" (myocardial infarction) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the golf course after a heart attack).  At time of reporting, the outcome was Unknown for the event collapses on the golf course after a heart attack.; Sender's Comments: Sanofi Company Comment dated 08-Feb-2022: This case involves a patient of unknown demographics who collapsed on the golf course after a heart attack while receiving vaccine INFLUENZA VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case  received from a consumer/non-hcp via public post.  This case involves patient of unknown demographics who experienced cardiac arrest 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 at (unknown: formulation, strength, dosage, route, frequency, lot number, administration site) for prophylactic vaccination. Information on the batch number was requested.  On an unknown onset and unspecified latency, the patient developed a serious cardiac arrest following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (Cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 27-Jan-2022: This case involves patient who experienced cardiac arrest while receiving vaccine Influenza Vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 22.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest, Circulatory collapse, Syncope
Clinical narrative: collapses with cardiac arrest; collapses with cardiac arrest; 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 22 years old of unknown gender patient who reported event "collapses with cardiac arrest", 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 unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  It was reported that on an unknown date, the patient collapses with cardiac arrest during a two-tier game (circulatory collapse, cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapses with cardiac arrest, collapses with cardiac arrest).  At time of reporting, the outcome was Unknown for the event collapses with cardiac arrest and was Unknown for the event collapses with cardiac arrest.; Sender's Comments: Sanofi Company Comment dated 27-Jan-2022: This case involves a 22 years old of unknown gender patient who reported event "collapses with cardiac arrest", after receiving vaccine INFLUENZA VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the company suspect vaccine cannot be excluded in occurrence of the events and role of the vaccine cannot be assessed
Age: 18.0
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: double heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves an 18 year old adult patient (gender: unknown) who experienced double heart attack while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (strength, formulation, frequency: unknown) produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.Information on the batch number was requested.  On an unknown date the patient developed a serious event, double heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It goes on and on, and on.. it's happening everywhere and is NOT normal!! Event: 18 years old has double heart attack and is fighting for his life. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (life-threatening) double heart attack.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (double heart attack).  At time of reporting, the outcome was Unknown for the event double heart attack.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns 18 years old adult patient who experienced double heart attack, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest, Fall, Syncope
Clinical narrative: cardiac arrest; collapsed; 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 patient of unknown demographics who had cardiac arrest and collapsed 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 an unknown dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as Prophylactic vaccination.  On an unknown date the patient had cardiac arrest (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  On an unknown date the patient collapsed (fall) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed, cardiac arrest).  At time of reporting, the outcome was Unknown for all.; Sender's Comments: Company Comment dated 07-Feb-2022. This case involves a patient of unknown demographics who had cardiac arrest and collapsed while receiving vaccine Influenza Vaccine. Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case.
Sex: U
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: dies suddenly and unexpectedly; 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 37 years old adult and unknown gender patient who died suddenly and unexpectedly 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 (strength, dose, frequency and formulation: unknown) produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  The consumer commented that the list went on and on, and on and it was happening everywhere and was not normal. On an unknown date the patient died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant and was leading to death. It is unknown if an autopsy was done. The cause of death was reported as Sudden death NOS.  Final diagnosis was (fatal) dies suddenly and unexpectedly.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (dies suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event dies suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 37 years old adult and unknown gender patient who died suddenly and unexpectedly, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, autopsy findings would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: suddenly and unexpectedly
Age: 40.0
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: a heart attack after warming up; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 40-year-old patient (unknown gender) who experienced a heart attack after warming up while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation: unknown) (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event of, heart attack after warming up (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (a heart attack after warming up).  At time of reporting, the outcome was Unknown for the event a heart attack after warming up.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 40-year-old adult patient who experienced a heart attack after warming up, after vaccination with Influenza Vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 16.0
Sex: U
Vaccine: FLUX
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 16 years old and unknown gender patient who had heart attack 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 had serious heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) heart attack.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart attack).  At time of reporting, the outcome was Fatal for the event heart attack. It is unknown if an autopsy was done. The cause of death was reported as Heart attack.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case involves a 16 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: NOT PROVIDED
Sex: U
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: dead suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp via social media.  This case involves a 42 year old and unknown gender patient who died suddenly and unexpectedly 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and was leading to death. The cause of death was unknown. It is unknown if an autopsy was done. Final diagnosis was (fatal) dead suddenly and unexpectedly.  Action taken with influenza vaccine was not applicable.  At time of reporting, the outcome was Fatal for the event dead suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 42 year old patient of unknown gender who died suddenly and unexpectedly after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants and autopsy report would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: dead suddenly and unexpected
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest, Physical fitness training, Syncope
Clinical narrative: collapses while training with cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves a 17 years old adolescent and unknown gender patient who collapsed while training with cardiac arrest 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 (strength, dose, route, formulation and frequency: unknown) produced by unknown manufacturer (lot number and expiry date: not reported) in unknown administration site as prophylactic vaccination (Flu).  The consumer commented that the list went on and on, and on and it was happening everywhere and was not normal. On an unknown date the patient collapsed while training with cardiac arrest (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac arrest).  At time of reporting, the outcome was Unknown for the event cardiac arrest.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 17 years old adolescent and unknown gender patient who collapsed while training with cardiac arrest, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history and concomitant medication would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 29-Jan-2022 regarding an unsolicited valid social media non-serious case was received from the patient.  This case involves an adult patient of unknown demographics, who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine. Reportedly, had the flu once in his life the year patient got the flu shot.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event of flu.
Sex: U
Vaccine: FLUX
Symptoms: Death, Syncope
Clinical narrative: died in the hospital; collapsed during 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 patient of unknown demographics who died in the hospital and collapsed during 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength, route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for flu.  On an unknown date the patient collapsed during practice (syncope) and died in the hospital (death) (unknown latency) following the administration of INFLUENZA VACCINE.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed during practice, died in the hospital).  At time of reporting, the outcome was Unknown for the event collapsed during practice and was Fatal for the event died in the hospital. It is unknown if an autopsy was done. The cause of death was reported as unknown. Seriousness criteria- Medically significant for all ( hospitalization , life threatening, fatal for death); Sender's Comments: Sanofi company comment for dated 04-Feb-2022: This case involves a patient of unknown demographics who died in the hospital and collapsed during practice while receiving vaccine INFLUENZA VACCINE..Based upon the reported information, the role of a vaccine cannot be assessed Further information regarding time to onset, cause of death, death date, autopsy results, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case; Reported Cause(s) of Death: unknown cause of death
Age: 26.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder, Syncope
Clinical narrative: collapsed with severe heart problems; Initial information receiveds on 27-Jan-2022 regarding an unsolicited valid serious social media case received from a consumer/non-healthcare Professional (hcp).  This case involves a 26-year-old patient (gender: unknown) who was collapsed with severe heart problems while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, collapsed with severe heart problems (cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as life-threatening.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 26 years old collapsed with severe heart problems. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (life-threatening) collapsed with severe heart problems.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapsed with severe heart problems).  At time of reporting, the outcome was Unknown for the event collapsed with severe heart problems.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 26-year-old adult patient who was collapsed with severe heart problems, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder
Clinical narrative: heart problems; 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 33 years old and unknown gender patient who experienced heart problems 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, strength, formulation and expiry date was unknown) via unknown route in unknown administration site.  On an unknown date the patient developed a serious event "heart problems "(cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported" 33-year-old had to be replaced in a game due to heart problems Separate case has been created for each patient It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart problems).  At time of reporting, the outcome was Unknown for the event heart problems.; Sender's Comments: Sanofi company comment dated 08-Feb-2022: This case involves a 33 years old and unknown gender patient who experienced heart problems while receiving vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Age: 41.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac arrest, Death, Syncope
Clinical narrative: collapsed on the field and died due to cardiac arrest; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non- healthcare professional (hcp).  This case involves a 41-year-old patient (gender: unknown) who was collapsed on the field and died due to cardiac arrest while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, collapsed on the field and died due to cardiac arrest (cardiac arrest) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Reportedly, this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 41 years old collapsed on the field and died due to cardiac arrest. It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (fatal) collapsed on the field and died due to cardiac arrest.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapsed on the field and died due to cardiac arrest).  At time of reporting, the outcome was Fatal for the event collapsed on the field and died due to cardiac arrest. It is unknown if an autopsy was done. The cause of death was reported as Cardiac arrest.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 41 year old adult patient who was collapsed on the field and died due to cardiac arrest, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: collapsed on the field and died due to cardiac arrest
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder
Clinical narrative: breaks on the field with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced breaks on the field with heart problems 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 non-serious event "breaks on the field with heart problems" (cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "It goes on and on, and on.. it's happening everywhere, and is not normal. Breaks on the field with heart problems".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (breaks on the field with heart problems).  At time of reporting, the outcome was Unknown for the event breaks on the field with heart problems.
Age: 33.0
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder, Syncope
Clinical narrative: collapses with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media non-serious case from was received from a consumer/non-healthcare professional.  This case involves a 33 years old patient of unknown gender, who collapsed with heart problems, while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for flu. Information on batch number was requested.   On an unknown date, the patient collapsed with heart problems (cardiac disorder) (unknown latency) following the administration of influenza vaccine. There were no lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (cardiac disorder).  At time of reporting, the outcome was Unknown for the event of cardiac disorder.
Sex: U
Vaccine: FLUX
Symptoms: Arrhythmia, Cardiac operation
Clinical narrative: arrhythmia; 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 25 years old and unknown gender patient who experienced arrhythmia 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 arrhythmia (unknown latency) following the administration of Influenza Vaccine.  It was reported that ? It goes on and on, and on. It's happening everywhere, and is not normal. 25 years old, operation on the heart after an arrhythmia.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event(arrhythmia) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 07-Feb-2022. This case involves a 25 years old and unknown gender patient who experienced arrhythmia while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.