chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Circulatory collapse, Death
Clinical narrative: collapses and dies; 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 27 years old male patient who collapses and dies 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 collapses and dies (circulatory collapse) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event collapses and dies is unknown if an autopsy was done. The cause of death was reported as Collapse circulatory.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) collapses and dies.; Sender's Comments: Sanofi company comment dated 03-Feb-2022. This case involves a 27 years old male patient who collapses and dies 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 are needed to fully assess this case. Further information regarding the latency to onset, family history for unexplained death, previous history/risk factors, therapy details, corrective treatment (interventional therapy), autopsy details would aid in a comprehensive case assessment.; Reported Cause(s) of Death: collapses
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Made sick for 2 weeks; Initial information received on 30-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 reported made sick for 2 weeks 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 non-serious event "made sick for 2 weeks" (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were 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 (Made sick for 2 weeks).  At time of reporting, the outcome was Unknown for the event made sick for 2 weeks.
Sex: M
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: suffers stroke during game; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via social media.  This case involves a 23 year old male patient who suffered stroke during game 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, dose, frequency, 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 baseball player and on an unknown date, the patient suffered stroke during game (cerebrovascular accident) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant. The reporter commented that the list went on and on and it was happening every where. It is unknown if the patient experienced any additional symptoms/events.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (suffers stroke during game).  At time of reporting, the outcome was Unknown for the event suffers stroke during game.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns a 23 year old male patient who suffered stroke during game, after vaccination with Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed to rule out any alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: DIES; 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 dies 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 dies (death) (unknown latency) following the administration of Influenza Vaccine.   It was reported that it's happening everywhere, and is not normal. 13 year old dies during practice  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : At time of reporting, the outcome was Fatal for the event dies. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) dies..; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 13 years old and unknown gender patient who dies 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: DIES
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves patient with unknown demographics 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 heart attack (myocardial infarction) (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 (heart attack).  At time of reporting, the outcome was Unknown for the event heart attack.; Sender's Comments: Sanofi Company Comment dated 03-Jan-2022:This case involves patient with unknown demographics had heart attack while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any any concurrent conditions precludes comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: 30 year old dead; 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 30 years old and unknown gender patient who experienced 30 year old dead 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 30 year old dead (death) (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. 30 year old dead.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event 30 year old dead. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) 30 year old  dead.; Sender's Comments: Sanofi company comment dated 03-Feb-2022. This case involves a 30 years old and unknown gender patient who experienced 30 year dead 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
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: mysteriously 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 and unknown gender patient who mysteriously 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 mysteriously 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) mysteriously died.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (mysteriously died).  At time of reporting, the outcome was Fatal for the event mysteriously died. 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 dated 03-Jan-2022: This case involves a 16 years old patient who mysteriously died while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be assessed. Further information of condition at the time of vaccination, latency to onset, past and concomitant medications, therapy details,  medical history, autopsy reports are essential for a comprehensive case assessment.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: pro dancer suffers heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 33 year old and unknown gender pro dancer who suffered heart attack 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, dose, frequency, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  It was reported that the patient was a pro dancer and suffered heart attack (myocardial infarction) (latency: 5 days) following the administration of influenza vaccine. This event was assessed as medically significant. The reporter commented that the list went on and on, and on and it was happening everywhere, and was not normal. It was unknown if the patient experienced any additional symptoms/events.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (pro dancer suffers heart attack).  At time of reporting, the outcome was Unknown for the event pro dancer suffers heart attack.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns a 33 year old and unknown gender pro dancer who suffered heart attack, 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, would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: 20 years old young rider suffers a heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves a male patient of 20 years old young rider suffers a 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 suspect Influenza Vaccine (strength, formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. Information on Batch number will not be available for this case  On an unknown date the patient developed a serious 20 years old young rider suffers a heart attack (myocardial infarction) (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 (20 years old young rider suffers a heart attack).  At time of reporting, the outcome was Unknown for the event 20 years old young rider suffers a heart attack.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns an 20 years old male patient young rider suffers a heart attack 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. Furthermore, additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors, medical history, corrective treatment/medical management, family history for cardiac diseases (at young age) 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.
Age: 53.0
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: heart attack while training; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 53 years old and unknown gender patient who had heart attack while training 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 had a heart attack while training (myocardial infarction) (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 (heart attack while training).  At time of reporting, the outcome was Unknown for the event heart attack while training.; Sender's Comments: Sanofi Company Comment dated 03-Jan-2022: This case involves a 53 years old and unknown gender patient who had heart attack while training while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of date of vaccination, event onset date, outcome, corrective treatment, past and concomitant medication, any concurrent conditions precludes comprehensive case assessment.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: make me sick; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced make me sick while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose and route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination (Flu vaccination).  On an unknown date the patient developed a non-serious "make me sick (illness)" (unknown latency) following the administration of Influenza Vaccine.  It was reported that "They make me sick I'll have to pass thx".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (make me sick).  At time of reporting, the outcome was Unknown for the event make me sick.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: never had the flue for years until I got sick from the flu shot twice; 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 a patient of unknown demographics who reported "never had the flue for years until i got sick from the flu shot twice", 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 (strength, formulation, dose: unknown) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date, the patient reported to never had the flue for years until i got sick from the flu shot twice (illness) (unknown latency) following the administration of INFLUENZA 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  At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; worst reaction; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult and unknown gender patient who was sick and worst reaction while receiving 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "worst reaction" (adverse reaction) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Last flu shot I got gave me the worst reaction I ever had, sick for 5 days, never had one since and never had the flu again."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (worst reaction, Sick).  At time of reporting, the outcome was Unknown for the event worst reaction and was Unknown for the event sick.
Age: 19.0
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: dies at campus after the game; 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 19 year old patient of unknown gender who died at campus after the game 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 it was reported that the patient died at campus after the game (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)   Action taken was not applicable.  At time of reporting, the outcome was Fatal   It is unknown if an autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022: This case involves a 19 years old and unknown gender patient who died at campus after the game after receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any concurrent conditions, medical history precludes comprehensive case assessment.; Reported Cause(s) of Death: dies at campus after the game
Sex: U
Vaccine: FLUX
Symptoms: Circulatory collapse, Syncope
Clinical narrative: collapses on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves an adult and unknown gender patient who had collapses on the field 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 experienced a serious event "player collapses on the field and has to be revived" (circulatory collapse) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It is unknown if the patient experienced any additional symptoms/events  Action taken was not applicable.  It was not reported what specific method of 'revive' the patient received as corrective treatment for the event (collapses on the field).  At time of reporting, the outcome was Unknown for the event collapses on the field.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case involves a adult and unknown gender patient who had collapses on the field while receiving vaccine INFLUENZA VACCINE. The causal role of the 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
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a patient (age, gender: unknown) who got the flu 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: 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 non-serious event " got the flu (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "This case is received from Social media. The following potential adverse event has been found on a public post for social media page. Since this is a public post on the flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. I got a flu shot , got the flu a week later, Next year I tried it again a year later, Yep a week later I got the flu. NEVER AGAIN!!! I refuse the covid vaccine. I tested positive for the cooties. I got my test, I got the test on a Tue, they said 3-5 days to get results. I had it back (positive) the next day. It is unknown if the patient experienced any additional symptoms/events".   Relevant laboratory test results included: Laboratory test - On an unknown date: positive [tested positive for the cooties]  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu.
Age: 49.0
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case  was received from a consumer/non-healthcare professional.  This case involves a 49 years old patient  of unknown gender, who had heart attack, while receiving 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. Information on batch number was requested.   On an unknown date, the patient had heart attack (myocardial infarction) in locker room (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 (heart attack).  At time of reporting, the outcome was Unknown for the event (heart attack).; Sender's Comments: Sanofi Company Comment dated 07-Feb-2022: This case involves a 49 years old patient  of unknown gender, who had heart attack, while receiving influenza vaccine. Further information regarding medical history, 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 suspect vaccine cannot be assessed.
Age: 54.0
Sex: U
Vaccine: FLUX
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack; 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 54 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as Immunisation. Information on lot number was requested.  On an unknown date the patient had heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  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 54 years old and unknown gender patient who had heart attack while receiving vaccine INFLUENZA VACCINE.. Based upon the reported information, the role of a vaccine cannot be assessed  Further information regarding time to onset, 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: heart attack
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: 2 times i took flu shots, i caught the flu; Initial information received on 31-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 2 times took flu shots and 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 for immunization.  On an unknown date the patient developed a non-serious event "2 times i took flu shots, i caught the flu" (influenza) (unknown latency) following the administration of INFLUENZA 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 (2 times i took flu shots, i caught the flu).  At time of reporting, the outcome was Unknown for the event 2 times i took flu shots, i caught the flu.
Sex: U
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: collapses; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via a consumer/non-hcp.  This case involves adult and unknown gender patient who 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 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 (Influenza Vaccine).  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 a player collapsed; the game was canceled (syncope) (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 (collapses).  At time of reporting, the outcome was Unknown for the event collapses.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns an adult and unknown gender patient who collapsed during game, 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: Unevaluable event
Clinical narrative: have to rush your kid to the ER right after; 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 patient of unknown demographics who had to rush to the (emergency room) ER right 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 at (unknown: formulation, strength, dosage, route, frequency, lot number, route, administration site) as flu shot.  On an unknown onset and latency, the patient "have to rush your kid to the er right after" (emergency care) following the administration of INFLUENZA VACCINE.  It was reported that: "Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Oh yeah its great Unless you have to rush your kid to the ER right after. No flu shots since then, no flu in over 11 years, No one needs a flu shot"  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (emergency care).  At time of reporting, the outcome was Unknown for the event emergency care.
Sex: F
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: dies suddenly and mysteriously in her room; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves a 24 years old adult female patient who died suddenly and mysteriously in her room 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 suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for 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 developed a serious dies suddenly and mysteriously in her room (sudden 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) dies suddenly and mysteriously in her room.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (dies suddenly and mysteriously in her room).  At time of reporting, the outcome was Fatal for the event dies suddenly and mysteriously in her room. No autopsy was done. The cause of death was reported as Death NOS.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 24 year old adult female patient who died suddenly and mysteriously in her room, 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: not provided
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder, Circulatory collapse
Clinical narrative: collapses during match with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves a 32 years old and unknown gender patient who experienced collapses during match 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 serious event collapses during match with heart problems (circulatory collapse) (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, 32 year old Tennis player collapses during match with heart problems.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : Unknown for the event.  Seriousness criteria : This event (circulatory collapse) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 07-Feb-2022. This case involves a 32 years old and unknown gender patient who experienced collapses during match with heart problems 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.
Sex: U
Vaccine: FLUX
Symptoms: Circulatory collapse, Death
Clinical narrative: dies after collapsing on the field; 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 18 years old and unknown gender patient who experienced dies after collapsing on the field 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 dies after collapsing on the field (circulatory collapse) (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. 18 year old dies after collapsing on the field.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : At time of reporting, the outcome was Fatal for the event dies after collapsing on the field. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) dies after collapsing on the field.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 18 years old and unknown gender patient who experienced dies after collapsing on the field while receiving 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.; Reported Cause(s) of Death: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: died suddenly and unexpectedly; Initial information received on 27-Jan-2022 from regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics 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, expiry date, frequency, strength unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  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.  Final diagnosis was (fatal) died suddenly and unexpectedly.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (died suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event died suddenly and unexpectedly. No autopsy was done. The cause of death was reported as Sudden death NOS.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022: This case involves a patient with unknown demographics who  died suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past and concomitant medication, any concurrent conditions precludes comprehensive case assessment.; Reported Cause(s) of Death: died suddenly and unexpectedly
Age: 17.0
Sex: U
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: died suddenly and unexpectedly; 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 17-year-old Adolescent patient who died suddenly and unexpectedly 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, route: unknown) (lot number not reported) in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a serious event, 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.  Reportedly, 17-year-old died suddenly and unexpectedly, cause given by media, unclear It is unknown if the patient experienced any additional symptoms/events.   Final diagnosis was (fatal) died suddenly and unexpectedly.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (died suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event died suddenly and unexpectedly. It is unknown if an autopsy was done. The cause of death was reported as Sudden death NOS.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 17 year old adolescent patient who died suddenly and unexpectedly, after vaccination with 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: died suddenly and unexpectedly
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 received from a consumer/non-hcp (non health care professional).  This case involves a 24 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 (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 involves a 24 years old and unknown gender patient who suffers cardiac arrest 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.