chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Taste disorder
Clinical narrative: it hurt her arm; it was swollen for a while; Very dry mouth; nauseated; can't taste the food; really bad headache; really exhausted; diarrhea; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs; brain fog (needs to double check everything she does); not feeling well; 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 65 year-old female patient received bnt162b2 (BNT162B2), administration date 2022 (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), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "it hurt her arm"; PERIPHERAL SWELLING (non-serious) with onset 2022, outcome "unknown", described as "it was swollen for a while"; DRY MOUTH (non-serious) with onset 2022, outcome "unknown", described as "Very dry mouth"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "nauseated"; TASTE DISORDER (non-serious) with onset 2022, outcome "unknown", described as "can't taste the food"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "really bad headache"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "really exhausted"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 2022, outcome "unknown" and all described as "everything hurts (neck, back, legs, knees and jaw bones) cramps in her legs"; FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "brain fog (needs to double check everything she does)"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "not feeling well".  Additional Information: Patient reported that she had her Pfizer Covid19 Booster shot at pharmacy 2 weeks ago, and it hurt her arm, it was swollen for a while, and right after the shot she had symptoms. She stated that up until now she was still not feeling well. She never had these problems with the first 2 shots of the Pfizer-BioNTech Covid19 Vaccine. She wanted to know what's wrong with her and when this will go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hyperhidrosis, Hypertension, Palpitations, Pyrexia
Clinical narrative: blood pressure high; high fever; wet; rapid heart/palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 15:30 (Lot number: EL3302) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "blood thinner" (unspecified if ongoing); "colon cancer", start date: 26Mar2018 (ongoing), notes: Pertinent Details: Surgery to remove colon cancer for 2 years chemotherapy to put cancer in remission; "Hypertension", start date: 1980 (ongoing), notes: Pertinent Details: HBP controlled by medications, increased diet; "Mitral valve", start date: 1980 (ongoing), notes: Pertinent Details: controlled by atenolol. Family history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for cardiac disorder (ongoing); AMLODIPINE taken for hypertension (ongoing); BABY ASPIRIN taken for anticoagulant therapy (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date: 05Feb2021, Time: 3:30 PM, Anatomical Site of injection: left upper arm, Route of administration: Intramuscular, Batch/Lot Number: Pfizer EK4176), administration date: 05Feb2021, when the patient was 85 years old, for Covid-19 immunization. The following information was reported: HYPERTENSION (hospitalization), outcome "unknown", described as "blood pressure high"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "rapid heart/palpitations"; HYPERHIDROSIS (non-serious) with onset Mar2021, outcome "unknown", described as "wet"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "high fever". The patient underwent the following laboratory tests and procedures: blood pressure measurement: over 200. Additional Information: I am a heart patient and I am also in remission for colon cancer. Approximately ten days after my second Pfizer shot I woke up very early in the morning with a high fever and my groin was sobby wet. The concierge (illegible) an ambulance + before I went to the hospital, my pressure was over 200 and I began to get rapid heart palpitations a few days later my doctors and I got over that through. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211093 same patient/drug/different event/dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient developed full body hives day after receipt of 3rd booster shot.; This is a spontaneous report from a contactable reporter (physician).   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 11Feb2022 (Lot number: unknown) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hemorrhoids" (unspecified if ongoing). There were no concomitant medications (it was reported that the patient denied). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 12Feb2022, outcome "recovering", described as "Patient developed full body hives day after receipt of 3rd booster shot". Therapeutic measures were taken as a result of urticaria. The event "Patient developed full body hives day after receipt of 3rd booster shot." was evaluated at the physician office visit.   Additional information: The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was reported that the patient denied any other new medications, foods, soaps nor other vaccines. The patient received Prednisone and BENADRYL as treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Migraine
Clinical narrative: Light headedness; Wheezing; Headache; Migraine; Weakness; Fatigue; Fever for 3 days.; This is a spontaneous report from a non-contactable reporter (healthcare professional). The reporter is the patient.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single and bnt162b2 (BNT162B2) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported.   The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; WHEEZING (non-serious), outcome "unknown", described as "Wheezing"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PYREXIA (non-serious), outcome "unknown", described as "Fever for 3 days".   Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Light headedness; Wheezing; Headache; Migraine; Weakness; Fatigue; Fever for 3 days.; This is a spontaneous report from a non-contactable reporter (healthcare professional). The reporter is the patient.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single and bnt162b2 (BNT162B2) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications were not reported.   The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light headedness"; WHEEZING (non-serious), outcome "unknown", described as "Wheezing"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PYREXIA (non-serious), outcome "unknown", described as "Fever for 3 days".   Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pericarditis
Clinical narrative: mild pericarditis; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Family history included: "heart problems" (unspecified if ongoing), notes: he also stated that her wife's family has had heart problems through the years. The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "mild pericarditis"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Clinical course: The reporter called on behalf her wife that was administered with the Pfizer-BioNTech COVID 19 Vaccine a few months ago and now she was having some heart palpitations and racing hearts. He was wondering if that mild pericarditis that started with the vaccine could be triggered by the anxiety she was suffering right now. He also stated that her wife's family has had heart problems through the years.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Since my 2nd shot, I have been having hives on my chest, neck and face.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Jan2021 at 10:00 (Lot number: EL9265) at the age of 54 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Wheat, Yeast. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL1283; Route of administration: unspecified; Anatomical location: left arm, Administration time: 09:30), administration date: 09Jan2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 22Feb2021, outcome "not recovered", described as "Since my 2nd shot, I have been having hives on my chest, neck and face". The event "Since my 2nd shot, I have been having hives on my chest, neck and face." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 29Oct2021 at 08:00 (Lot number: FF2590) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller reported two high schoolers dropped dead from the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  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: DEATH (death), outcome "fatal", described as "Caller reported two high schoolers dropped dead from the vaccine". The patient date of death was unknown. The reported cause of death was "Caller reported two high schoolers dropped dead from the vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200280341 same reporter/product/event, different patient; Reported Cause(s) of Death: Caller reported two high schoolers dropped dead from the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, SINGLE , Lot no#: EL1283), administration date: 12Jan2021, for COVID-19 Immunization, reaction(s): "Tired"; and "Little soreness". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "Tired". Clinical course: After the 2nd shot went home and slept. Have been tired ever since  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021139683 Same patient, different vaccine dose
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Was sick". Additional information:  pharmacist has a patient there who is to get the second vax but is at 45 days mark, She is asking if this is ok or redo the series. She stated the patient was sick and her HCP told her to wait 2 weeks before getting the second vax The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021447906 same patient same drug different dose and event
Sex: U
Vaccine: COVID19
Symptoms: Chills, Vaccination site induration
Clinical narrative: bumps on the deltoid and they were experiencing side effects, such as chills; bumps on the deltoid and they were experiencing side effects, such as chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: CHILLS (non-serious), VACCINATION SITE INDURATION (non-serious), outcome "unknown" and all described as "bumps on the deltoid and they were experiencing side effects, such as chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Muscle mass
Clinical narrative: chills; bumps on the deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: CHILLS (non-serious), outcome "unknown", described as "chills"; MUSCLE MASS (non-serious), outcome "unknown", described as "bumps on the deltoid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374450 same reporter/drug/ AE, different patient
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Myalgia, Paraesthesia
Clinical narrative: muscle pains and muscle tinglings in the left arm bicep and both feet area; muscle pains and muscle tinglings in the left arm bicep and both feet area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication included: LEVOTHYROXINE. The following information was reported: PARAESTHESIA (disability), MYALGIA (disability) all with onset 12Mar2021, outcome "not recovered" and all described as "muscle pains and muscle tinglings in the left arm bicep and both feet area". The event "muscle pains and muscle tinglings in the left arm bicep and both feet area" and "muscle pains and muscle tinglings in the left arm bicep and both feet area" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: did not show anything; electrocardiogram: did not show anything. Therapeutic measures were taken as a result of paraesthesia, myalgia which included Oral treatment. Clinical course: My body started changing after the COVID vaccine in early March. I stated some muscle pains and muscle tinglings in the left arm bicep and both feet area which I didn't have earlier. EKG and blood tests did not show anything. Later, I started observing several changes in my body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder
Clinical narrative: severe pain in chest; heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: ANGINA PECTORIS (medically significant), outcome "unknown", described as "severe pain in chest"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart issues".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder
Clinical narrative: severe pain in chest; Heart issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: ANGINA PECTORIS (medically significant), outcome "unknown", described as "severe pain in chest"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "Heart issues".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Sick; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves Adult patient of unknown demographics who was sick 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 (formulation, route, frequency, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" I stopped getting sick when I stopped getting the flu shot. You clowns peddle your dope to someone else."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: one flu shot made me sick as a dog; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (health care professional)  This case involves Adult and unknown gender patient who experienced one flu shot made me sick as a dog while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength 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 "one flu shot made me sick as a dog "(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 (one flu shot made me sick as a dog).  At time of reporting, the outcome was Unknown for the event one flu shot made me sick as a dog.
Sex: U
Vaccine: FLU3
Symptoms: Illness, Influenza, Malaise
Clinical narrative: flu; get sick with the flu; Initial information received on 05-Feb-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 and get sick with the flu while receiving vaccine influenza usp trival a-b vaccine - unspecified [Fluzone Unsp].  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 VACCINE - UNSPECIFIED dose and lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious "flu (influenza)" (unknown latency) following the administration of influenza usp trival a-b vaccine - unspecified. On an unknown date the patient developed a non-serious "get sick with the flu (illness)" (unknown latency) following the administration of influenza usp trival a-b vaccine - unspecified.  It was reported that "Every time I get a flu shot I get sick with the flu. I ask my doctor why. He said there's over 200 variants and I happen to get the wrong one. Now I been healthy and well since I haven't gotten the shot. It's like playing roulette with over 200 chances".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (flu, get sick with the flu).  At time of reporting, the outcome was Unknown for the event flu and was Unknown for the event get sick with the flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: terribly sick for nearly a month right after; Initial information received on 07-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves 3 adult patients of unknown demographics who experienced terribly sick for nearly a month right after 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, patients have started taking suspect INFLUENZA VACCINE (dose, route, strength, frequency, lot details are unknown) in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date the patients have developed a non-serious event of terribly sick for nearly a month right after (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, posted a comment on Flu Shot Social Medical page where Three friends in this town all got the flu shot the same week. All three were terribly sick for nearly a month right after. So much for safety and effectiveness.  Action taken was unknown.  It was not reported if the patients have received a corrective treatment for the event (terribly sick for nearly a month right after).  At time of reporting, the outcome was Unknown for the event terribly sick for nearly a month right after.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased
Clinical narrative: If I get the flu shot I will be in bed for 3 days. I haven't had one since I was forced to the swine flu shot. I have not neen sick since; Initial information received on 07-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 if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine (strength, dose and formulation: 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 if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since (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 (If I get the flu shot I will be in bed for 3 days. I haven't had one since I was forced to the swine flu shot. I have not neen sick since).  At time of reporting, the outcome was Unknown for the event if i get the flu shot i will be in bed for 3 days. i haven't had one since i was forced to the swine flu shot. i have not neen sick since.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported i 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 of suspect INFLUENZA  VACCINE (dose, frequency, form, strength, lot number not reported)  via unknown route in unknown administration site for immunization. Information on batch number will not be available.  On an unknown date the patient developed a non-serious event of "i got the flu" (flu) (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 (I got the flu).  At time of reporting, the outcome was Unknown for the event i got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: had one flu shot 10 years ago and got sickest ever in life; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown demographics patient who had one flu shot 10 years ago, got sickest ever in 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 in 2012 (10 years ago), the patient received a suspect influenza vaccine at an unknown dose via unknown route produced by unknown manufacturer (strength, frequency, batch/lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient developed an event had one flu shot 10 years ago, got sickest ever in life (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)  Outcome: unknown for illness
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: flu shot dont help I took the shot about month later i took the flu got real sick; Initial information received on 11-Feb-2022 regarding an unsolicited valid social media non-serious case was received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics, who reported that flu shot didn't help the patient took the shot about month later took the flu, got real sick, while being vaccinated with influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage regimen, lot number, route, administration site not reported) for prophylactic vaccination.  The patient reported that on an unknown date, the flu shot did not help, he/she took the shot about month later, got real sick (illness) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: used to get sore after the shot , did not feels; Initial information received on 12-Feb-2022 regarding an unsolicited valid Social Media non-serious case received  from  consumer/non-hcp via social media.  This case involves an unknown age and  gender patient who reported used to get sore after the shot , did not feels ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported that she/he was wondering if it was a flu shot or water, she/he used to get sore after the shot , does not feels (pain) (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 (used to get sore after the shot , did not feels).  At time of reporting, the outcome was Unknown for the event used to get sore after the shot , did not feels.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 10-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 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 (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported that every time the patient had the flu vaccine in the past the patient got bad case of the flu. No more. Stopped getting the flu shot and now the patient did not even get colds.  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: Caught the flu no matter what; Initial information received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media  This case involves an unknown age and gender patient who experienced caught the flu no matter what ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported Like never any more the only time I caught the flu no matter what (influenza) (unknown latency) you think. Four years now without flu shot and 4 years now without flu.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Caught the flu no matter what).  At time of reporting, the outcome was Unknown for the event caught the flu no matter what.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown demographics patient 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 (strength, formulation, dose, batch number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had got the 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 influenza  Outcome: unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Got sick as a dog; Initial information received on 14-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 got sick as a dog 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 "got sick as a dog" (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 (Got sick as a dog).  At time of reporting, the outcome was Unknown for the event got sick as a dog.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; 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 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, dose, strength, batch number, route and expiry date: unknown) in an unknown administration site for prophylactic vaccination (flu).  On an unknown date the patient got sick (illness) (unknown latency) following the administration of Influenza vaccine.  In 2005, patient stoped taking Influenza vaccine.  Action Taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: had the shots and it didn't save him; Initial information received on 13-Feb-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 had the shots and it didn't save him 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.  It was reported by patients friend (reporter) that they lost a dear friend (patient) that had the shots and it didn't save him (death) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event Death. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) for event Death.; Sender's Comments: Sanofi company comment dated 17-Feb-2022. This case involves an unknown age and unknown gender patient, who had the shots and it didn't save him while receiving vaccine Influenza Vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: lost a dear friend that had the shots and it didn't save him
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the shot got the flu twice, Now wasn't that sweet; Initial information received on 13-Feb-2022 regarding an unsolicited valid non-serious social media case received from a Patient.  This case involves an unknown age and unknown gender patient who Got the shot got the flu twice, Now wasn't that sweet 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 a dose of suspect influenza vaccine on unknown administration site.(strength, dosage,route of administration, batch number and expiry date: Unknown) for immunization.   On an unknown date the patient developed a non-serious event "Got the shot got the flu twice, Now wasn't that sweet" (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   At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine go out of the temperature range and the warmest temperature was 14.8C for a total duration of 8 hours and 41 min; Initial information received on 04-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE 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 HIGH DOSE HV VACCINE lot UT7378LA via (unknown route , expiry date) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min" (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccine go out of the temperature range and the warmest temperature was 14.8C for a total duration of 8 hours and 41 min).  At time of reporting, the outcome was Unknown for the event vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: first excursion was due to leaving the vaccine on the counter for 1 hour; Initial information received on 04-Feb-2022  regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient with unknown gender who first excursion was due to leaving the vaccine on the counter for 1 hour while receiving vaccine [FLUZONE HIGH-DOSE 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 HIGH DOSE HV VACCINE lot UJ759AB via (unknown strength, dosage, administration site) for prophylactic vaccination.   On an unknown date the patient had excursion which was due to leaving the vaccine on the counter for 1 hour (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (first excursion was due to leaving the vaccine on the counter for 1 hour).  At time of reporting, the outcome was Unknown for the event first excursion was due to leaving the vaccine on the counter for 1 hour.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion involving unopened ADACEL PFS with no reported adverse event; Initial information received  on 07-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced temperature excursion involving unopened adacel pfs (pre-filled syringe) with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6984AA via (unknown route and strength) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "temperature excursion involving unopened adacel pfs with no reported adverse event "(product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion involving unopened ADACEL PFS with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion involving unopened adacel pfs with no reported adverse event.