chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Renal failure, Respiratory failure, SARS-CoV-2 test
Clinical narrative: died of complications with Covid including kidney and lung failure; died of complications with Covid including kidney and lung failure; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A 55 year-old male patient received sirolimus (RAPAMUNE) (ongoing) (Lot number: 2000012386, Expiration Date: Sep2022) at 1 mg for prophylaxis against transplant rejection; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot # unknown), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot # unknown), administration date: May2021, for Covid-19 immunization. The following information was reported: RENAL FAILURE (death, medically significant), RESPIRATORY FAILURE (death, medically significant) all with onset 12Jan2022, outcome "fatal" and all described as "died of complications with Covid including kidney and lung failure"; DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant) all with onset 12Jan2022, outcome "fatal" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2021) positive. The action taken for sirolimus was dosage not changed. Therapeutic measures were taken as a result of covid-19. The patient date of death was 05Feb2022. The reported cause of death was renal failure, respiratory failure, covid-19. No autopsy was performed. Additional information: Caller states the patient had both Covid vaccinations and the booster (in Sep or Oct2021), confirms these were the Pfizer vaccines. The patient was diagnosed with Covid on 12Jan2021, and was given the monoclonal treatment, No one told patient to stop taking the antirejection medication sirolimus, which he had been taking for about a year. The patient got Covid in Jan2022, and died on 05Feb2022 of complications with Covid including kidney and lung failure.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died of complications with Covid including kidney and lung failure; died of complications with Covid including kidney and lung failure; COVID-19
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Hyperhidrosis, Muscle atrophy, Muscle tightness
Clinical narrative: 2 days after started falling to the ground again; more sweating; fatigue; Muscle collapsing down; muscle tightening; weakening of muscles/paralyzing effects of their muscles/muscle collapsing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 (Lot number: 30135BA) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), note: resulted from an exposure to chemicals. Concomitant medication included: THYROXINE taken for autoimmune disorder, start date: 19May2018. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EM6203, Anatomical location: right arm.), administration date: 19Mar2021, for covid-19 immunisation, reaction: "Muscle weakness", "aching arm", "paralyzing effects of their muscles"; Bnt162b2 (Dose:02, Lot number: ER8727, Anatomical location: right arm.), administration date: 09Apr2021, for COVID-19 Immunization, reaction: "Muscle weakness", "paralyzing effects of their muscles", "aching arm". The following information was reported: PARALYSIS (medically significant) with onset Oct2021, outcome "unknown", described as "weakening of muscles/paralyzing effects of their muscles/muscle collapsing"; FALL (non-serious) with onset 23Oct2021, outcome "unknown", described as "2 days after started falling to the ground again"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "more sweating"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "fatigue"; MUSCLE ATROPHY (non-serious) with onset Oct2021, outcome "unknown", described as "Muscle collapsing down"; MUSCLE TIGHTNESS (non-serious) with onset Oct2021, outcome "unknown", described as "muscle tightening". Therapeutic measures were taken as a result of paralysis, muscle tightness. Clinical course: the patient had the vaccination in the end of Oct2021, 2 days after started falling to the ground again then she started to experience more sweating, fatigue and collapsing down again. At the end of Oct2021, 2 days after, it looks like she started feeling sweating and muscle tightening. The patient clarified that she does science research.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: 2 days after started falling to the ground again; more sweating; fatigue; Muscle collapsing down; muscle tightening; weakening of muscles/paralyzing effects of their muscles/muscle collapsing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 (Lot number: 30135BA) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), note: resulted from an exposure to chemicals. Concomitant medication included: THYROXINE taken for autoimmune disorder, start date: 19May2018. Vaccination history included: Bnt162b2 (Dose:01, Lot number: EM6203, Anatomical location: right arm.), administration date: 19Mar2021, for covid-19 immunisation, reaction: "Muscle weakness", "aching arm", "paralyzing effects of their muscles"; Bnt162b2 (Dose:02, Lot number: ER8727, Anatomical location: right arm.), administration date: 09Apr2021, for COVID-19 Immunization, reaction: "Muscle weakness", "paralyzing effects of their muscles", "aching arm". The following information was reported: PARALYSIS (medically significant) with onset Oct2021, outcome "unknown", described as "weakening of muscles/paralyzing effects of their muscles/muscle collapsing"; FALL (non-serious) with onset 23Oct2021, outcome "unknown", described as "2 days after started falling to the ground again"; HYPERHIDROSIS (non-serious) with onset Oct2021, outcome "unknown", described as "more sweating"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "fatigue"; MUSCLE ATROPHY (non-serious) with onset Oct2021, outcome "unknown", described as "Muscle collapsing down"; MUSCLE TIGHTNESS (non-serious) with onset Oct2021, outcome "unknown", described as "muscle tightening". Therapeutic measures were taken as a result of paralysis, muscle tightness. Clinical course: the patient had the vaccination in the end of Oct2021, 2 days after started falling to the ground again then she started to experience more sweating, fatigue and collapsing down again. At the end of Oct2021, 2 days after, it looks like she started feeling sweating and muscle tightening. The patient clarified that she does science research.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. This reporter is patient's sister.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Clinical details: patient's alive but reporter didn't know if heart attack was from the shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid  test  result=Positive; covid  test  result=Positive; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jul2021 16:00 (Lot number: EW0196) at the age of 38 years as dose 2, single and administered in arm left, administration date 22Jun2021 10:00 (Lot number: EW0181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromicen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Aug2021, outcome "recovered" (24Aug2021) and all described as "covid  test  result=Positive". The event "covid  test  result=positive" and "covid  test  result=positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Aug2021) positive, notes: Nasal swab; (24Aug2021) negative, notes: Nasal swab; (26Aug2021) negative, notes: Nasal swab; (07Sep2021) negative, notes: Nasal swab. Clinical course: No other vaccine in four weeks. The patient had not covid prior to vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101466860 same patient, different dose, different events
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: was bed ridden for 2 days afterwards; Initial information received on 14-Feb-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age female patient who was bed ridden for 2 days afterwards, after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection with lot UT7347LA at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient was bedridden (unknown latency) for 2 day afterwards (bedridden ), so she was concerned, she may had received high dose. This event was leading to disability.  Action taken was not applicable for the event  It was not reported if the patient received a corrective treatment for the event (Bedridden).  At time of reporting, the outcome was Unknown for the event bedridden.; Sender's Comments: Sanofi company comment date 21-Feb-2022:This case concerns a female patient of unknown age who was bedridden for 2 days afterwards, after vaccination with Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent]. 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 product cannot be excluded in occurrence of the event.  Further information regarding patient age, 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 suspected influenza vaccine cannot be excluded in occurrence of the events and role of the individual suspect vaccine cannot be assessed.
Age: 7.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was used for 7 year old child with no adverse event; Flublok was used for 7 year old child with no adverse event; Initial information received on 17-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old child of unknown gender for whom it was reported that flubok is used for 7 year old child with no adverse event while receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  First time vaccine used was reported as no.  On an unknown date, the patient received a  dose of suspect Flublok Qiv vaccine (form, strength, administration site, route,  lot number not reported) for immunization. Information on batch number was requested.  On an unknown date it was reported Flublok was used for 7 year old child with no adverse event (Product administered to patient of inappropriate age) (unknown latency) and Flublok was used for 7 year old child with no adverse event (product prescribing issue) (unknown latency) following the administration of Flublok Qiv.  Action taken was not applicable.  Outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  00971589:related
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Contraindicated product administered, Malaise, Pyrexia
Clinical narrative: mother stated he had the flu vaccine and dupixent injection close together; fever; got a little sick; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who reported fever, got a little sick and mother stated he had the flu vaccine and dupixent injection close together while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via prefilled syringe.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  In August 2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW(every other week) via subcutaneous route,strength-300 mg/2mL (with an unknown batch number,indication).  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 01-NOV-2021 the patient developed a non-serious event "fever" (pyrexia) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  On 11-FEB-2021 the patient developed a non-serious event "got a little sick" (malaise) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "mother stated he had the flu vaccine and dupixent injection close together" (contraindicated product administered) (unknown latency) following the first dose intake of DUPILUMAB and  INFLUENZA VACCINE.  It was reported "Fever after flu shot for 24 hours while on Dupixent".  DUPILUMAB (DUPIXENT) was continued and Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (fever, got a little sick).  At time of reporting, the outcome was Unknown for the event fever, was Unknown for the event got a little sick and was Unknown for the event mother stated he had the flu vaccine and dupixent injection close together.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Additional information was received on 11-Feb-2022 from consumer/non-Health care professional : frequency added for dupilumab, causality and action taken added for influenza vaccine and narrative amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: still got COVID; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult female patient who got 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 (strength, formulation, dose, route, batch number and expiry date) at an unknown administration site for immunization. information on batch number was requested.  On an unknown date the patient reported a non-serious event still got covid (covid-19) (unknown latency) following the administration of Influenza Vaccine  Action was not applicable.  It was not reported if the patient received a corrective treatment for the event covid-19.  Outcome was Unknown for the event covid-19.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 12-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a adult patient (age and gender: unknown) who experienced flu 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 (strength, dose, route and formulation: unknown) (lot and expiry date: not reported) in unknown administration site for prophylactic vaccination.   On 11-FEB-2022, the patient developed a non-serious event flu (influenza) (latency: unknown) 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, Malaise
Clinical narrative: I got the flu shot and I was sick with the flu the next day; Initial information received on 13-Feb-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 got the flu shot and i was sick with the flu the next day 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 (formulation and strength :unknown)produced by unknown manufacturer(lot & batch number and expirydate: unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious i got the flu shot and i was sick with the flu the next day (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 influenza.  At time of reporting, the outcome was Unknown for the event influenza.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Urticaria
Clinical narrative: Hives; Initial information received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 58 years old female patient who experienced hives while receiving vaccine tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included fluconazole (Diflucan) and venlafaxine hydrochloride (Effexor-XR).  On 25-Feb-2008, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer (with an unknown strength, formulation, frequency, lot number and expiry date) via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious hives (urticaria) (unknown latency) following the administration of tetanus toxoid.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (hives).  At time of reporting, the outcome was unknown for the event hives.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore; Initial information received on 15-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who had arm is still sore after being vaccinated with 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, formulation, strength, lot number and expiration date via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious event "arm is still sore" (pain in extremity) (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 (Arm is still sore).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event arm is still sore.
Sex: M
Vaccine: FLUX
Symptoms: Thrombosis
Clinical narrative: had a blood clot; Initial information received on 15-Feb-2022 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves an unknown age male patient who had a blood clot 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 via Unknown route in unknown administration site (with an unknown strength, dosage, formulation batch number and expiry date) for immunization .  On an unknown date the patient developed a serious event of blood clot (thrombosis) (Latency : Unknown) following the administration of influenza vaccine. This event blood clot (thrombosis) was assessed as medically significant.  Action taken : Not Applicable  It was not reported if the patient received a corrective treatment for the event (had a blood clot).  At time of reporting, the outcome was Unknown for the event (had a blood clot).; Sender's Comments: Sanofi company comment dated 23-Feb-2022: This case concerns an unknown age male patient who experienced a blood clot after vaccination while receiving influenza vaccine. The time to onset was unknown. Additional information regarding condition at the time of vaccination, medical history, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 15-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer.  This case involves a adult patient (gender and age: unknown) who experienced flu 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 (formulation, strength, dose, route, lot and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event flu (influenza) (latency: unknown) following the administration of Influenza vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event influenza.  At time of reporting, the outcome was unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 16-Feb-2022 regarding an unsolicited valid  non-serious case received from patient.  This case involves Adult and 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 once four years in row (with an unknown formulation, route, strength, batch number ,administration site and expiry date) produced by unknown manufacturer for immunization.   On an unknown date the patient developed a non-serious event of 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: Influenza
Clinical narrative: flu; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves a patient unknown identifiers who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for immunization. Information on batch number is requested  On an unknown date the patient developed "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: Gait inability, Vaccination complication
Clinical narrative: barely walk; severe side effects; Initial information received on 16-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient (age and gender: unknown) who experienced barely walk and severe side effects 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 (strength, dose, route, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed  a non-serious events barely walk (gait inability) and severe side effects (vaccination complication) (latency: unknown) following the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (gait inability, vaccination complication).  At time of reporting, the outcome was unknown for the events gait inability, vaccination complication.
Sex: U
Vaccine: FLUX
Symptoms: Disease recurrence, Influenza, Malaise
Clinical narrative: who stopped getting it years ago when working every time would get sick, started again getting them and same thing happen (reoccurrence); Initial information received on 15-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves a patient of unknown demographics who stopped getting it years ago when working every time would get sick, started again getting them and same thing happen (reoccurrence) with the flu 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, patient started taking Influenza Vaccine (dose, form, route, strength, frequency, lot and batch number: unknown) in an unknown administration site for immunization.   On an unknown date 8 years ago, the patient received a  dose of suspect Influenza Vaccine (dose, form, route, strength, frequency, lot and batch number: unknown) in unknown administration site for immunization. Patient took the last dose on an unknown date 4 years ago.  On an unknown date the patient stopped getting it years ago when working every time would get sick, started again getting them and same thing happen (reoccurrence) (illness) (unknown latency) following the administration of Influenza vaccine.  Reportedly, the patient had stopped taking the flu vaccine, was getting it years ago when working every time, would get sick with the flu. Further said that about 8 years ago, patient had started again getting them & same thing happen (reoccurrence) (flu) (onset and latency: unknown). Further said that had stopped again last one was 4 years ago. It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event illness.   At time of reporting, the outcome was Unknown for the event illness.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got deathly sick; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves a 76 years old and unknown gender patient who experienced got deathly sick while receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In1967, on an unknown date the patient received a  dose of suspect Influenza Vaccine.produced by unknown manufacturer (formulation, strength, dose, route, expiry date and batch number: unknown) in unknown administration site for prophylactic vaccination. Information on batch number is requested.  On an unknown date, the patient reported got deathly sick (illness) (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 sickness.  At time of reporting, the outcome was Unknown for the event sickness.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Illness
Clinical narrative: flu shot at young age in her 50's and was so sick; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 50 years old and unknown gender patient who experienced flu shot at young age in her 50's and was so sick while receiving vaccine Influenza USP Trival A-B Subvirion no preservative Vaccine [Fluzone].  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 USP Trival A-B Subvirion no preservative Vaccine  suspension for injection (strength: unknown)at unknown dosage (lot number & expiry date: unknown)in unknown administration site for immunization. Information on batch number is requested.  On an unknown date the patient developed a non-serious flu shot at young age in her 50's and was so sick (illness) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion no preservative Vaccine.    Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event illness.  At time of reporting, the outcome was Unknown for the event illness.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise, Unevaluable event
Clinical narrative: got sick; Hard pass; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Digital Media.  This case involves an adult patient of unknown who experienced got sick and hard pass while receiving vaccine influenza vaccine.  The patient's past medical history included Influenza. The patient's past 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 (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed non-serious events got sick (illness) and hard pass (unevaluable event) (unknown latency) following the administration of influenza vaccine.   It was reported that the patient had to get one for a Clinical site a few years ago.  He/she got sick for almost two years. He/she is fine with his/her TaiChi, Qigong, lots of fresh air and sunshine. He/she had the flu 3 times in his/her life. Was fine in a few days.  Action taken: Not applicable".  It was not reported if the patient received a corrective treatment for the events (got sick, Hard pass).  At time of reporting, the outcome was Unknown for the events got sick and hard pass.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: each time i got flu shot, i got real sick; Initial information received on 18-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer// non-health care professional.  This case involves a patient of unknown age and gender who experienced each time I got flu shot, I got real sick while receiving vaccine influenza vaccine.   The patient's past medical history included Influenza. The patient's past 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 (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event each time I got flu shot, I got real sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported that he/she have had the flu shot 3 times in his/her life and each time he/she got it, he/she got real sick. He/she have also had the flu 3 times without the shot. He/she is better off without it. Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (illness).  At time of reporting, the outcome was Unknown for the event illness.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: each time I got sick; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who reported each time i 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 (form, strength, frequency, route, administration site, batch number and expiry date: unknown) produced by unknown manufacturer for immunization.  On an unknown date the patient developed a non-serious event of each time i got sick (malaise) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  Corrective treatment: not reported   Outcome was Unknown.
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm for about 3 days; real tired for about a week too; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient who experienced sore arm for about 3 days and real tired for about a week too while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, and family history were not provided.    On an unknown date, the patient received one dosage of suspect influenza vaccine suspension for injection produced by unknown manufacturer (strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested.   On an unknown date the patient developed "sore arm for about 3 days" (pain in extremity) and 'real tired for about a week too' (fatigue)  (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 events (sore arm for about 3 days, real tired for about a week too).  At time of reporting, the outcome was Unknown for the event sore arm for about 3 days and was Unknown for the event real tired for about a week too.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got sick with the flu for 2 weeks; Initial information received on 17-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a Patient.  This case involves an adult patient of unknown demographics who got sick with the flu for 2 weeks while receiving vaccine Influenza vaccine.  The patient's medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing COVID-19.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date the patient got sick with the flu for 2 weeks (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 (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Nope got sick as hell on the last one; Initial information received on 17-Feb-2022 regarding an unsolicited valid Social Media non-serious case on page received from a consumer.  This case involves a adult patient of unknown demographics who reported nope got sick as hell on the last one while receiving Influenza Vaccine.  The patient's has no past medical history,concomitant disease or risk factor.   There were no lab data/results available.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength, route, administration site, batch number not reported) for immunization. Information on Batch number was requested.  On an unknown date the patient reported nope got sick as hell on the last one (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable   Corrective treatment was not reported   Outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information was received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient of unknown demographics 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 (formulation, strength, dose, batch number and expiry date: unknown) via unknown route in an unknown administration site for prophylactic vaccination (flu). Information on batch number was requested  On an unknown date, the patient got sick (illness) (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 (illness).  At time of reporting, the outcome was Unknown for the event (illness).
Sex: U
Vaccine: FLUX
Symptoms: Brief resolved unexplained event
Clinical narrative: last one nearly killed me and I'll never take another or advise anyone too; Initial information received on 17-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional via Digital Media.  This case involves a patient of unknown gender and age who experienced last one nearly killed me and i'll never take another or advise anyone too 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 (dose, route, strength, formulation, batch lot number and expiry date: unknown) via unknown route in unknown administration site for Influenza.   On an unknown date, the patient developed a serious event last one nearly killed me and i'll never take another or advise anyone too (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and life-threatening.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (near death experience).  At time of reporting, the outcome was Unknown for the event near death experience.; Sender's Comments: Sanofi Company Comment dated 23-Feb-2022: This case involves a patient of unknown gender and age who experienced last one nearly killed me and i'll never take another or advise anyone too (near death experience) while receiving vaccine influenza vaccine. Based on the 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, therapy details, any family history of cancer and any relevant medical history of patient, any concurrent conditions and type of cancer and indication of the drug precludes comprehensive case assessment.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Truth it affects people differently I lost a Brother; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult male patient who mentioned it affects people differently i lost a brother 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 with unknown dose not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient mentioned it affects people differently i lost a brother (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) it affects people differently i lost a brother.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (it affects people differently I lost a Brother).  At time of reporting, the outcome was Fatal for the event it affects people differently i lost a brother. It is unknown if an autopsy was done.; Sender's Comments: Sanofi company comment dated 22-Feb-2022: This case involves Adult male patient who mentioned it affects people differently i lost a brother while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19
Clinical narrative: omicron flu; Initial information received on 18-Feb-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 developed omicron flu, after being vaccinated with INFLUENZA VACCINE.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    In April-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number (strength, formulation, dose: unknown) with lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  In DEC-2021 the patient developed omicron flu (covid-19) (latency: about 8 months) following the administration of INFLUENZA VACCINE.  It was reported that "I got my shot last April and then got the omicron flu in December along with everyone else. It was very mild so perhaps there was some benefit from being vaccinated. On the other hand, Israel one of the most vaccinated countries in the world is leading the way in infections, hospitalizations, even death rates. It's very difficult to get reliable information about 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 (omicron flu).  At time of reporting, the outcome was Unknown for the event omicron flu.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered
Clinical narrative: that year I got about six flus different ones; Initial information received on 20-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves an unknown age and unknown gender patient who experienced that year i got about six flus different ones while receiving vaccine influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, and family history were not provided.    On an unknown date, the patient received one dosage of suspect influenza vaccine produced by unknown manufacturer (formulation,strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested.   On an unknown date the patient developed "that year i got about six flus different ones" (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 (that year I got about six flus different ones).  At time of reporting, the outcome was Unknown for the event that year i got about six flus different ones.