chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 20 year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: mild to moderate covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200131953 same reporter, drug event and different patient.;US-PFIZER INC-202200203970 same reporter, drug event and different patient.;US-PFIZER INC-202200204043 same reporter, drug event and different patient.;US-PFIZER INC-202200204041 same reporter, drug event and different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed mild to moderate COVID; developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 -old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid prior to vaccination" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza, Vaccine positive rechallenge
Clinical narrative: Every single time my sons get the flu shot they come down with the flu; They don't always work; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient's mother) via social media.  This case involves an Adult male patient who every single time got the flu shot came down with 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "every single time my sons get the flu shot they come down with the flu (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious "they don't always work with no adverse event (drug ineffective)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Every single time my sons get the flu shot they come down with the flu one son was so bad he was on a nebulizer and a z-pack they thought it might have been covid but it wasn't bad bad case of the flu so don't tell me shots work they don't always work."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  Nebulizer and a z-pack was received as a corrective treatment for the event (Every single time my sons get the flu shot they come down with the flu).  At time of reporting, the outcome was Unknown for the event every single time my sons get the flu shot they come down with the flu.; Sender's Comments:  SanofiPVPortal20220124000809:
Sex: M
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: make me sick; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Social Media.  This case involves a male patient who noted INFLUENZA VACCINE made him sick.  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. There will be no information available on the batch number for this case.  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 "Author/Reporter Comment: Oh hell no! They make me sick! If I don't get the shot I'm fine! Author/Reporter Comment: smart, I never get a shot and I don't get sick. I was talked into it ONCE and got sick! So I stay away from that crap! My God given immunity works great, also take lots of vitamins!"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was 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: Influenza
Clinical narrative: flu; Initial information received on 18-Jan-2022 regarding an unsolicited valid  non-serious social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu 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 "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got the flu shot and 2 months later catched the flu , don't get it, it's a scam ! Totally useless".  Action taken with INFLUENZA VACCINE (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 flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via interactive digital media.  This case involves an unknown age and unknown gender patient who got 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information available on the batch number for this case  On an unknown date the patient developed a non-serious "got sick (illness)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Author/Reporter Comment: No thank you! Last time I got one I got sick for 2 weeks."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult of an unknown gender patient who experienced sick ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  In 2021,the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I hot the flu shot last October and got sick a few days later."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: took it twice years gone by got the flu three days after; Initial information received on 22-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who took it twice years gone by got the flu three days after   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, route, lot number and expiry date was unknown) for 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 "took it twice years gone by got the flu three days after" (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 (took it twice years gone by got the flu three days after  ).  At time of reporting, the outcome was Unknown for the event took it twice years gone by got the flu three days after  .
Sex: U
Vaccine: FLUX
Symptoms: Anticoagulant therapy, COVID-19, Thrombosis
Clinical narrative: blood clots; covid 19; Initial information received on 20-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via social media.  This case involves an adult patient of an unknown gender who experienced blood clots and covid 19 ,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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient  reported  they had their shots then got 2 blood clots 4 months later(thrombosis)(latency:4 months) then 2 months after that covid-19 (latency: 6 months) then a month later another clot. Now the patient is on warfarin for life. The patient was healthy before then. The patient had 3 hospital stays totaling 7 days. Doctor said no booster for the patient.   Action taken: not applicable for both events   corrective treatment: warfarin for thrombosis.  At time of reporting, the outcome was Unknown for the event blood clots and was Unknown for the event covid 19.  Seriousness criteria: medically significant and hospitalization for thrombosis and hospitalization for covid -19; Sender's Comments: Sanofi company comment dated 30-Jan-2022: This case concerns an adult patient of unknown gender who had thrombosis and hospitalization , after vaccination Influenza vaccine (manufacturer unknown). The time to onset is compatible with the role of the vaccine. However the lack of information regarding past drugs, relevant medical history, concurrent conditions, psychiatric history, personal history, therapy details, latency and concomitant medications preclude a comprehensive assessment of this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise, Sinusitis
Clinical narrative: got a a little bit sick every time; sinus infections; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had got a a little bit sick every time and sinus infections 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  got a a little bit sick every time (illness)and sinus infections (sinusitis) (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 (got a a little bit sick every time, sinus infections).  At time of reporting, the outcome was Unknown for the event got a a little bit sick every time and was Unknown for the event sinus infections.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: My worst flu was right after the flu shot.; Initial information received on 22-Jan-2022 regarding an unsolicited valid social media non-serious case was received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient, whose worst flu was right after the flu shot, 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was reported.   On an unknown date, the patient developed a non-serious event 'my worst flu was right after the flu shot' (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My worst flu was right after the flu shot. It is 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 (My worst flu was right after the flu shot.).  At time of reporting, the outcome was Unknown for the event 'my worst flu was right after the flu shot'.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I'll never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow; Initial information received on 22-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional via digital media.  This case involves patient of unknown demographics who reported  sickness ("I will never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow") after 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, formulation, frequency, route, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i'll never get one again, first flu shot i had, got so sick i actually laid on the bathroom floor for 2 days with my pillow" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (I'll never get one again, first flu shot I had, got so sick I actually laid on the bathroom floor for 2 days with my pillow).  At time of reporting, the outcome was Unknown for the event i'll never get one again, first flu shot i had, got so sick i actually laid on the bathroom floor for 2 days with my pillow.
Sex: U
Vaccine: FLUX
Symptoms: Muscle injury, Nerve injury, Pain
Clinical narrative: Significant injury to the deltoid muscle and nerves.; still in pain; Significant injury to the deltoid muscle and nerves.; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp found on a public social media platform.  This case involves an unknown age and unknown gender patient who experienced significant injury to the deltoid muscle and nerves and was still in pain while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (lot number, frequency and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "significant injury to the deltoid muscle and nerves" (muscle injury) (Nerve injury) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  On an unknown date the patient developed a non-serious "still in pain" (pain) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  It was reported " It can cause significant injury to the deltoid muscle and nerves. I know. 7 weeks later and still in pain!"  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Significant injury to the deltoid muscle and nerves., still in pain).  At time of reporting, the outcome was Unknown for the event significant injury to the deltoid muscle and nerves and was Unknown for the event still in pain.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: I get sick every time I get the flu vaccine; Initial information received on 20-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced i get sick every time i get the flu vaccine while receiving vaccine INFLUENZA VACCINE (MONOVALENT).   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 (MONOVALENT) produced by (unknown manufacturer lot number, strength and expiry date)  via unknown route in unknown administration site.In the context of COVID19 crisis, the batch number and expiration date were requested.  On an unknown date the patient developed a non-serious event "i get sick every time i get the flu vaccine "(illness) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).  Action taken with INFLUENZA VACCINE MONOVALENT (INFLUENZA VACCINE (MONOVALENT)) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I get sick every time I get the flu vaccine).  At time of reporting, the outcome was Unknown for the event i get sick every time i get the flu vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had 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 had 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 (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: Covid; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via global digital media.  This case involves an unknown age and gender patient who experienced covid, 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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date ,the patient developed a non-serious covid (covid-19) ( latency: 2 days) following the administration of INFLUENZA VACCINE.  It was reported"yea two days later i had covid"  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Covid).  At time of reporting, the outcome was Unknown for the event covid.
Sex: U
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: abnormal lymph glands under arm; Initial information received on 24-Jan-2022 regarding an unsolicited valid non-serious case was received from the patient.  This case involves an unknown age and unknown gender patient who had abnormal lymph glands under arm, while receiving vaccine INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP].  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 a dose of suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED (strength, formulation, dosage regimen, 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 a non-serious event 'abnormal lymph glands under arm' (lymphadenopathy) 3 days following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  It was reported "They just don't know. I have abnormal lymph glands under my arm found 3 days after flu shot. Have to go in for another scan. Radiologist said they see this a lot w/Covid vaccinations."  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE UNSP) was not applicable.  It was not reported if the patient received a corrective treatment for the event (abnormal lymph glands under arm).  At time of reporting, the outcome was Unknown for the event 'abnormal lymph glands under arm'.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 23-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 experienced 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 an unknown dose of suspect INFLUENZA VACCINE (formulation, strength, route: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "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 (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sicker; Initial information received on 26-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 was sicker 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 developed a non-serious event "sicker" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported" Never ever getting this poison. Had to when working in hospital got sicker and sicker."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sicker).  At time of reporting, the outcome was Unknown for the event sicker.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu twice my whole life; Initial information received on 21-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age and unknown gender patient who experienced had the flu twice my whole life 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, route and lot/batch number: unknown) produced by unknown manufacture in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had the flu twice my whole life (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported that "I've had 2 flu shots my whole life. I've had the flu twice my whole life. Stop getting the flu when I stopped getting the shot".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu twice my whole life).  Outcome: unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via digital media.  This case involves Adult of an unknown gender patient who experienced 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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Nothing like getting the hypochondriacs riled up again. I had the flu shot twice in my life. Had the worst case of flu both times. The rest of the time, I haven't had the flu. Imagine that. Decided by using critical thinking that I don't need a flu shot ."  Action taken with INFLUENZA VACCINE (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 flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient with unknown demographics who had 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 had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: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 flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu that put me down for a week; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp. This case involves a patient with unknown demographics who had got the flu that put him down for a week 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 who got the flu that put him down for a week (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 the flu that put me down for a week). At time of reporting, the outcome was Unknown for the event got the flu that put me down for a week.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves  patient of unknown demographics  who had flu 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "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 (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder, Blindness, Gait inability, Pain
Clinical narrative: leg. bl. in both eyes; constant pain; can barely walk; autoim dis; Initial information received on 25-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves adult and unknown gender patient who experienced leg. bl. in both eyes, autoim dis, constant pain and can barely walk 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 in 2009, the patient received a dose of 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 (Immunization).  On an unknown date in 2009, the patient reported that immediately (next day) it started affecting, and the patient developed an autoim dis but didn't know what was going on at the time. (autoimmune disorder) following the administration of influenza vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a serious leg. bl. in both eyes (blindness) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious constant pain (pain) (unknown latency) following the administration of influenza vaccine. On an unknown date the patient developed a non-serious can barely walk (gait inability) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown; Sender's Comments: Sanofi company comment dated 02-Feb-2022: This case involves an adult patient of unknown age and gender who experienced leg. bl. in both eyes (Blindness), autoim dis (Autoimmune disorder), while receiving Influenza Vaccine. The causal role of the suspect vaccine cannot be assessed based on the temporal relevance for legal blindness. 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: Illness, Influenza, Malaise
Clinical narrative: worst flu; Very sick; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced worst flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   In 2020(two years ago), the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form 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 a non-serious event "worst flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious event "very sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Two years ago I got flu shot, caught the worst Flu. Very sick. But they saved me so many years. Will never miss one."  It is unknown if there were lab data/results available.  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 flu, Very sick).  At time of reporting, the outcome was Unknown for the event worst flu.
Sex: U
Vaccine: FLUX
Symptoms: Blood mercury abnormal
Clinical narrative: excess mercury in my body; Initial information received on 21-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 excess mercury in my body 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 "excess mercury in my body" (blood mercury abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Flu Shot Fridays I took flu shots for over 11 years, a requirement to volunteer for hospice. Today I have excess mercury in my body. Never again will I volunteer for anything that requires any shot or 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 (excess mercury in my body).  At time of reporting, the outcome was Unknown for the event excess mercury in my body.
Sex: U
Vaccine: FLUX
Symptoms: Biopsy lymph gland abnormal, Lymphadenopathy
Clinical narrative: Abnormal lymph glands under my arm; Initial information received on 25-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported abnormal lymph glands under my arm 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 "abnormal lymph glands under my arm" (biopsy lymph gland abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have abnormal lymph glands under my armfound 3 days after flu shot. Have to go in for another scan. Radiologist said they see this a lot with Covid vaccinations. As it is, I hope the lymph gland condition is temporary".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Abnormal lymph glands under my arm).  At time of reporting, the outcome was Unknown for the event abnormal lymph glands under my arm.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Last time I got the flu shot I got the Flu; Initial information received on 25-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who last time  got the flu shot and got 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 got the flu shot and got 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 (Last time I got the flu shot I got the Flu).  At time of reporting, the outcome was Unknown for the event last time i got the flu shot i got the flu.
Sex: F
Vaccine: FLUX
Symptoms: Circulatory collapse, Coma
Clinical narrative: coma; 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 14 years old female patient who was in coma 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 was in coma (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening. The patient was hospitalized for this event.  On an unknown date the patient collapsed (circulatory collapse) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported" 14-year-old collapsed on pitch, is fighting for her life in an artificial coma."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (collapsed, coma).  At time of reporting, the outcome was Unknown for all.; Sender's Comments: Sanofi Company Comment dated 02-Feb-2022. This case involves a 14 years old female patient who was in coma 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, cause of collapse, medical history, past drugs, 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: Death, Loss of consciousness, Syncope
Clinical narrative: collapsed in his home and died on the way to hospital; 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 23 years old and unknown gender patient who collapsed in his home and died on the way to hospital while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event collapsed in his home and died on the way to hospital (Loss of consciousness) (unknown latency) following the administration of Influenza Vaccine.  It was reported that e Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. 23 year old collapsed in his home and died on the way to hospital.  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 collapsed in his home and died on the way to hospital. No autopsy was done. The cause of death was reported as Loss of consciousness.  Seriousness criteria : This event was assessed as medically significant and was leading to Loss of consciousness Final diagnosis was (fatal) collapsed in his home and died on the way to hospital.; Sender's Comments: Sanofi company comment dated 03-Feb-2022:This case involves a 23 years old and unknown gender patient who collapsed in his home and died on the way to hospital 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 and autopsy findings . The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: collapsed in his home and died on the way to hospital
Sex: U
Vaccine: FLUX
Symptoms: Death, Myocardial infarction
Clinical narrative: dies of a double heart attack during a 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 17 years old and unknown gender patient who dies of a double heart attack during a 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 suspect influenza vaccine (strength, formulation, dose and frequency: 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 developed a serious dies of a double heart attack during a game (myocardial infarction) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant and was leading to death. No autopsy was done. The cause of death was reported as Heart attack.  Final diagnosis was (fatal) dies of a double heart attack during a game.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (dies of a double heart attack during a game).  At time of reporting, the outcome was Fatal for the event dies of a double heart attack during a game.; Sender's Comments: Sanofi company comment dated 02-Feb-2022: This case concerns a 17 years old adolescent patient of unknown gender who died due to heart attack during the 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, 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: Double heart attack