chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Biopsy, Breast swelling, Investigation, Neuroendocrine carcinoma
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 50 year-old female patient received bnt162b2 (BNT162B2) (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: "Hasimoto's thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROENDOCRINE CARCINOMA (death, hospitalization, medically significant), outcome "fatal", described as "She was diagnosed with neuroendocrine cancer"; AUTOIMMUNE THYROIDITIS (death, hospitalization, medically significant), outcome "fatal", described as "She did have Hasimoto's thyroid disease"; PERIPHERAL SWELLING (non-serious), BREAST SWELLING (non-serious), outcome "unknown" and all described as "right arm and breast swelled". The patient underwent the following laboratory tests and procedures: biopsy: negative, notes: 2 biopsies were neg; investigation: neuroendocrine cancer. The patient date of death was unknown. The reported cause of death was neuroendocrine carcinoma, autoimmune thyroiditis. It was not reported if an autopsy was performed. It was reported that patient received both doses and two weeks after the second dose her right arm and breast swelled. She was diagnosed with neuroendocrine cancer, spent close to 60 days in the ICU (17 days on a ventilator) and died 4 months and 1 day after her first symptoms. Reporter reported this to Pfizer before she was diagnosed with cancer. She did have Hasimoto's thyroid disease. 2 biopsies were negative. The lot number for bnt162b2 was not provided and will be requested during follow up. Reported Cause(s) of Death: he was diagnosed with neuroendocrine cancer. She did have Hasimoto's thyroid disease.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 50 year-old female patient received bnt162b2 (BNT162B2) (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: "Hasimoto's thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROENDOCRINE CARCINOMA (death, hospitalization, medically significant), outcome "fatal", described as "She was diagnosed with neuroendocrine cancer"; AUTOIMMUNE THYROIDITIS (death, hospitalization, medically significant), outcome "fatal", described as "She did have Hasimoto's thyroid disease"; PERIPHERAL SWELLING (non-serious), BREAST SWELLING (non-serious), outcome "unknown" and all described as "right arm and breast swelled". The patient underwent the following laboratory tests and procedures: biopsy: negative, notes: 2 biopsies were neg; investigation: neuroendocrine cancer. The patient date of death was unknown. The reported cause of death was neuroendocrine carcinoma, autoimmune thyroiditis. It was not reported if an autopsy was performed. It was reported that patient received both doses and two weeks after the second dose her right arm and breast swelled. She was diagnosed with neuroendocrine cancer, spent close to 60 days in the ICU (17 days on a ventilator) and died 4 months and 1 day after her first symptoms. Reporter reported this to Pfizer before she was diagnosed with cancer. She did have Hasimoto's thyroid disease. 2 biopsies were negative. The lot number for bnt162b2 was not provided and will be requested during follow up. Reported Cause(s) of Death: he was diagnosed with neuroendocrine cancer. She did have Hasimoto's thyroid disease.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me; Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Palpitations
Clinical narrative: feeling pain/pressure in my chest; feeling pain/pressure in my chest; my heart was racing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN , Dose number unknown), for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious), CHEST DISCOMFORT (non-serious) all with onset 08Jan2022, outcome "recovered" (Feb2022) and all described as "feeling pain/pressure in my chest"; PALPITATIONS (non-serious) with onset 08Jan2022, outcome "recovered" (Feb2022), described as "my heart was racing". The events "feeling pain/pressure in my chest", "feeling pain/pressure in my chest" and "my heart was racing" were evaluated at the emergency room visit.  Additional information: Patient reports that she and her husband (31 years old, female) received their booster shot on 06Jan2022. She reports that 2 days later she "started feeling pain/pressure in chest, her heart was racing. After 1 month she went to emergency room, the doctors said everything was fine, but last Friday my husband starts to feel the same thing, he went to the hospital today everything looks good. this is heart pain. They wanted to know because the doctors say everything is okay. They never had this before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neuralgia, SARS-CoV-2 test
Clinical narrative: neurological pain shooting up her body; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "she had a positive covid diagnosis", start date: 16Aug2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious), outcome "unknown", described as "neurological pain shooting up her body"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: After the 1st dose, she experienced neurological pain shooting up her body. She was in pain both sitting or standing. She also experienced extreme fatigue. Twenty eight hours post her 2nd dose, she collapsed, had a seizure, and then vomited. She also experienced the neurological pain again. She has also experienced an elevated resting heart rate (around 123) and ongoing fatigue ever since.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (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: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Feb2022, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 08Feb2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Walking disability
Clinical narrative: stroke; can't walk and talk anymore; can't walk and talk anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; WALKING DISABILITY (medically significant), APHASIA (medically significant), outcome "unknown" and all described as "can't walk and talk anymore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Pulmonary thrombosis, Thrombosis
Clinical narrative: blood clotted in her lung and her leg; blood clotted in her lung and her leg; almost died; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 31 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), THROMBOSIS (medically significant), outcome "unknown" and both described as "blood clotted in her lung and her leg"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died." The reporter called the adverse events an experiment, where one might die and other no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Neck pain, Urticaria
Clinical narrative: Hives on chest and arms; Swollen lymph nodes in neck, both still evident one month after last vaccine; Soreness on back of neck and both shoulders making arm movement painful; Soreness on back of neck and both shoulders making arm movement painful; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 09:30 (Lot number: FE3594) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: MULTIVITAMIN, CLARITIN and IBUPROFEN. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6202; Anatomical site: Right arm; Administration time: 10:00), administration date: 26Feb2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ENG207; Anatomical site: Left arm; Administration time: 10:00), administration date: 17Mar2021, when the patient was 62 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 13Jan2022 at 06:15, outcome "not recovered", described as "Hives on chest and arms"; LYMPHADENOPATHY (non-serious) with onset 13Jan2022 at 06:15, outcome "not recovered", described as "Swollen lymph nodes in neck, both still evident one month after last vaccine"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 13Jan2022 at 06:15, outcome "not recovered", and all described as "Soreness on back of neck and both shoulders making arm movement painful". The events "Hives on chest and arms", "Swollen lymph nodes in neck, both still evident one month after last vaccine" and "Soreness on back of neck and both shoulders making arm movement painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria, lymphadenopathy, neck pain and arthralgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac disorder, Circulatory collapse
Clinical narrative: collapses with heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via public post.  This case involves patient with unknown demographics who collapsed with heart problems while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA035806(CLUSTER).   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer at (unknown: formulation, strength, dosage, route, lot number, expiry date, route in unknown administration site) as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a referee of game. On unknown onset and latency, the patient collapsed with heart problems (circulatory collapse) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses with heart problems).  At time of reporting, the outcome was Unknown for the event collapses with heart problems.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case involves patient with unknown demographics who collapsed with heart problems while receiving vaccine Influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got really sick; Initial information received on 21-Jan-2022  and live follow-up received on same day (processed together) regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 75 years old female patient who experienced got really sick while receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] delivered via dupilumab prefilled syringe.  The patient's past medical history included Anaemia, unspecified, anorexia nervosa, unspecified, anxiety disorder, unspecified, difficulty in walking, not elsewhere classified, essential (primary) hypertension, gastro-esophageal reflux disease without esophagitis, Major depressive disorder, single episode, unspecified, Sleep disorder, unspecified, nonrheumatic mitral (valve) insufficiency, Unspecified protein-calorie malnutrition and dvrtclos of intest (intestine), parunsp, w/o perf or abscess w/o bleed (Diverticulosis of intestine, part unspecified, without perforation or abscess without bleeding) The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing unspecified atrial fibrillation and atopic dermatitis, unspecified. Patient had no known drug allergy.  Concomitant medications included LORATADINE (CLARITINE).  On 26-Jan-2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW (every other week) subcutaneously (strength: 300mg/2ml, lot - IL346A and expiry date: 31-May-2024) for atopic Dermatitis, unspecified delivered via dupilumab prefilled syringe.  On 20-Jan-2022, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, lot number and expiry date were unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On 20-JAN-2022 the patient developed a non-serious event "got really sick"(illness)11 months 25 days following the first dose intake of DUPILUMAB.  On 20-JAN-2022 the patient developed a non-serious event "got really sick" (illness) following the administration of INFLUENZA VACCINE  It was reported"pt (patient) had flu shot and got really sick last night. she said after some time had passed today she feels better. to her shot yesterday and she got very night. and after a Few hour or so she okay. She passed pt due dupixent shot tomorrow. She wasnt sure if she should take medication. advised her that if she didn't fell may consider holding off on dose."   Action taken with DUPILUMAB (DUPIXENT) was unknown. 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 really sick).  At time of reporting, the outcome was Recovered / Resolved in January 2022 for the event got really sick.
Sex: U
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen for days; Initial information received on 24-Jan-2022 regarding an unsolicited valid Social Media non-serious case was received from a patient via social media.  This case involves Adult and unknown gender patient who experienced arm was swollen for days 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, dose, frequency, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient developed a non-serious "arm was swollen for days (peripheral swelling)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I hate getting that flu shot. The last time I got it my arm was swollen for days."  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 was swollen for days).  At time of reporting, the outcome was Unknown for the event arm was swollen for days.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sick with the flu; Initial information received on 20-Jan-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid social media serious case received from a consumer/non-hcp (non health care professional).  This case involves Adult male patient who was sick with the 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, frequency, formulation, route, lot number and expiry date were unknown) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  It was reported that patient get the flu shot seems like 2 years in a row and he was in the hospital right after for 10 days each time (influenza, latency: unknown). The patient was hospitalized for this event.  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 with the flu).  At time of reporting, the outcome was Unknown for the event sick with the flu.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves adult male patient who was sick with the flu (influenza) and was hospitalized with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: can't get a side effect from no longer taking a flu shot; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves adult patient (unknown age, gender) who can't get a side effect from no longer taking a flu shot while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency: unknown) (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. Information on the batch number was requested.  On an unknown date the patient developed a non-serious event "can't get a side effect from no longer taking a flu shot (unevaluable event)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. I can't get a side effect from no longer taking a 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 (can't get a side effect from no longer taking a flu shot).  At time of reporting, the outcome was Unknown for the event can't get a side effect from no longer taking a flu shot.
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: hives; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult and unknown gender patient who experienced hives while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious "hives (urticaria)" (unknown latency) following the administration of influenza vaccine.  It was reported that "I've never had a flu shot in my life. I take vitamin C, Zinc, & D3 to build my immunity. I've heard from some people the flu shot makes you sick. It also made one of my friends break out in hives".  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: Influenza, Malaise
Clinical narrative: flu; 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 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) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, route and frequency: not reported) produced by unknown manufacturer lot number not reported in unknown administration site for prophylactic vaccination. Information on Batch number will not be available for this case  On an unknown date the patient developed a non-serious "flu (influenza)" (unknown latency) following the administration of influenza vaccine.  It was reported that "Only time I ever took a flu shot I was sick for a week with the flu never again that was 35 years ago".   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, Multiple organ dysfunction syndrome
Clinical narrative: multiple organ failure; Flu; Initial information received on 26-Jan-2022 regarding an unsolicited valid social media serious case received from a non-healthcare professional.  This case involves an adult patient of unknown gender and age, who experienced multiple organ failure and flu while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor and laboratory data/results .  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation: unknown) (lot number not reported) (route, frequency: unknown) in unknown administration site for Influenza, Immunisation. There will be no information available on the batch number for this case.  It was reported that, got a flu shot once in his/her life 12 years ago. Got the flu (influenza) anyway (onset date, latency: unknown). 6 weeks in the hospital. Multiple organ failure (multiple organ dysfunction syndrome) (onset date, latency: unknown) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. Died 3 times and brought back. Never again. 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 events (multiple organ failure, Flu).  At time of reporting, the outcome was Unknown for the event multiple organ failure and was Unknown for the event flu.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case involves an adult patient who experienced multiple organ failure and flu while receiving vaccine INFLUENZA VACCINE. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and vaccination history, concurrent illnesses, laboratory investigations for the reported events and therapy details.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: nurse had given a pregnant women a fluzone HD shot by accident with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP] in context of nurse had given a pregnant women a fluzone hd shot by accident with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported nurse had given a pregnant women a fluzone HD shot by accident with no reported adverse event occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "nurse had given a pregnant women a fluzone hd shot by accident with no reported adverse event" (maternal exposure during pregnancy) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  It was reported " I just spoke with a customer that stated her nurse had given a pregnant women a fluzone HD shot by accident. Patient is doing well and I told the clinic manager that you would follow up with her".  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE UNSP) was not applicable.  At time of reporting, the outcome was Unknown for the event nurse had given a pregnant women a fluzone hd shot by accident with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: Covid; flu; Initial information received on 27-Jan-2022 with live follow up 27-Jan-2022 (processed together) 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 covid and flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "covid" (covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  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 events (Covid, flu).  At time of reporting, the outcome was Unknown for the event covid and was Unknown for the event flu.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the worst flu of my life; 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 an unknown age female patient who experienced got the worst flu of my 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 a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious got the worst flu of my life (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 (got the worst flu of my life).  At time of reporting, the outcome was Unknown for the event got the worst flu of my life.
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; Initial information received on 28-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult male patient who experienced runny nose 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 dose of 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. Information on batch number was requested.  On an unknown date the patient developed a non-serious event "runny nose"(rhinorrhoea) (unknown latency) following the administration of influenza vaccine.  It was reported "my husband had the flu shot 5 years ago, he's had runny nose issues ever since".  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (runny nose).  At time of reporting, the outcome was Unknown for the event runny nose.
Sex: U
Vaccine: FLUX
Symptoms: Syncope
Clinical narrative: faints on the field; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves a 18 years old and unknown gender patient who faints on the field while receiving vaccine INFLUENZA VACCINE.  The patient's past , medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received 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. Information on lot number was requested.  On an unknown date the patient faints on the field (syncope) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  There were no lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (faints on the field).  At time of reporting, the outcome was Unknown for the event faints on the field.; Sender's Comments: Sanofi Company Comment dated 03-Feb-2022. This case involves a 18 years old and unknown gender patient who experienced faints on the field 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 faint,  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: Influenza
Clinical narrative: I got the flu after my last flu shot. Not sure how it happened; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got the flu after the patient's last flu shot, not sure how it happened after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation 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 "i got the flu after my last flu shot. not sure how it happened" (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 (I got the flu after my last flu shot. Not sure how it happened).  At time of reporting, the outcome was Unknown for the event i got the flu after my last flu shot. not sure how it happened.
Age: 19.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: It goes on and on, and on.. it's happening everywhere, and is NOT normal Influenza; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves a 19 years old and unknown gender patient who mentioned that it goes on and on, and on.. it's happening everywhere, and is not normal influenza while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed mentioned it goes on and on, and on.. it's happening everywhere, and is not normal influenza (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 (It goes on and on, and on.. it's happening everywhere, and is NOT normal Influenza).  At time of reporting, the outcome was Unknown for the event it goes on and on, and on.. it's happening everywhere, and is not normal influenza.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: nearly killed me; Initial information received from on 28-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported nearly killed me 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 influenza immunisation. Information on batch number was requested.  On an unknown date the patient developed serious event nearly killed me (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Reporter stated anyone with egg allergies was to be asked first. It nearly killed me cause I didn't.  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (nearly killed me).  At time of reporting, the outcome was Unknown for the event nearly killed me.; Sender's Comments: Sanofi comment dated 07-Feb-2022: This case involves an unknown age and unknown gender patient who reported nearly killed me while receiving vaccine influenza vaccine. The time to onset was unknown for near death experience. Additional information regarding condition at the time of vaccination, concomitant disease or risk factor and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: revived during game; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 17 year old and unknown gender patient who revived during game while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a soccer player and on an unknown date the patient revived during game (loss of consciousness) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (revived during game).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event revived during game.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 17 year old patient of unknown gender who had revived during game after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 28-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who 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 (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).  At time of reporting, the outcome was Unknown for the event got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Made me sick for 2 weeks; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who after treatment with influenza vaccine reported it made me sick for 2 weeks.     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, lot number not reported) via an unknown route in an unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported it made me sick for 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event made me sick for 2 weeks.
Sex: M
Vaccine: FLUX
Symptoms: Myocardial infarction, Syncope
Clinical narrative: collapses during game from heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp via social media.  This case involves a 28 years old male patient who had collapses during game from heart attack 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, frequency, formulation, lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient had collapses during game from heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses during game from heart attack).  At time of reporting, the outcome was Unknown for the event collapses during game from heart attack.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves 28 years old male had myocardial infarction with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors and clinical course details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Cardiac disorder, Impaired work ability
Clinical narrative: forced to end his career after due to heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 22 years old male patient who was forced to end his career after due to heart problems while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient was forced to end his career after due to heart problems (cardiac disorder) (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 (forced to end his career after due to heart problems).  At time of reporting, the outcome was Unknown for the event forced to end his career after due to heart problems.