chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Facial asymmetry, Fatigue
Clinical narrative: distorted her face/ one eye was sometimes smaller than the other; got a little cold; chills; very dizzy/ lightheaded; very weak; spotty eye sight; her bottom legs tightened up like they would not work right; got tired; the COVID vaccine led to neurology problem; felt so lousy; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 04Mar2021 12:45 (Lot number: EN6205) at the age of 69 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "chills"; DIZZINESS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "very dizzy/ lightheaded"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "very weak"; VISUAL IMPAIRMENT (non-serious) with onset 04Mar2021, outcome "unknown", described as "spotty eye sight"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "her bottom legs tightened up like they would not work right"; FACIAL ASYMMETRY (non-serious) with onset 06Mar2021, outcome "unknown", described as "distorted her face/ one eye was sometimes smaller than the other"; FEELING COLD (non-serious) with onset 04Mar2021, outcome "unknown", described as "got a little cold"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "got tired"; NERVOUS SYSTEM DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "the COVID vaccine led to neurology problem"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "felt so lousy ". The events "very dizzy/ lightheaded", "very weak", "spotty eye sight", "distorted her face/ one eye was sometimes smaller than the other", "got a little cold", "got tired" and "the COVID vaccine led to neurology problem" were evaluated at the physician office visit and emergency room visit.  Additional information: She went to the emergency room on Sunday, 21Mar2021, because she just could not take it anymore with the side effects she was having. The emergency room also thought it was a neurology problem. She went to see her primary care doctor on 26Mar2021, who said it was a neurology problem. Even the doctor saw the distortion on her face as well. The patient stated that she was not going to be getting her 2nd COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Musculoskeletal stiffness, Nervous system disorder, Visual impairment
Clinical narrative: distorted her face/ one eye was sometimes smaller than the other; got a little cold; chills; very dizzy/ lightheaded; very weak; spotty eye sight; her bottom legs tightened up like they would not work right; got tired; the COVID vaccine led to neurology problem; felt so lousy; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 04Mar2021 12:45 (Lot number: EN6205) at the age of 69 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "chills"; DIZZINESS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "very dizzy/ lightheaded"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "very weak"; VISUAL IMPAIRMENT (non-serious) with onset 04Mar2021, outcome "unknown", described as "spotty eye sight"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "her bottom legs tightened up like they would not work right"; FACIAL ASYMMETRY (non-serious) with onset 06Mar2021, outcome "unknown", described as "distorted her face/ one eye was sometimes smaller than the other"; FEELING COLD (non-serious) with onset 04Mar2021, outcome "unknown", described as "got a little cold"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "got tired"; NERVOUS SYSTEM DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "the COVID vaccine led to neurology problem"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "felt so lousy ". The events "very dizzy/ lightheaded", "very weak", "spotty eye sight", "distorted her face/ one eye was sometimes smaller than the other", "got a little cold", "got tired" and "the COVID vaccine led to neurology problem" were evaluated at the physician office visit and emergency room visit.  Additional information: She went to the emergency room on Sunday, 21Mar2021, because she just could not take it anymore with the side effects she was having. The emergency room also thought it was a neurology problem. She went to see her primary care doctor on 26Mar2021, who said it was a neurology problem. Even the doctor saw the distortion on her face as well. The patient stated that she was not going to be getting her 2nd COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Fever; Chills; nausea; fatigue; fainted; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 09:00 (Lot number: ER2613, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2020 (ongoing), notes: Pertinent details: Metoprolol 125mg; "contracted COVID-19", start date: 11Dec2020 (unspecified if ongoing), notes: I contracted COVID-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "stayed sick two weeks" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "with fatigue lingering 2 months" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits. Concomitant medication(s) included: METOPROLOL taken for hypertension. Vaccination history included: Bnt162b2 (Pfizer/BioNTech COVID-19 vaccine details, Dose: 1st, Date/time, date: 18Mar2021, Time: 09:00AM, Site and route of injection, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: ER2613), administration date: 18Mar2021, for COVID-19 immunization, reaction(s): "fever", "chills", "extreme nausea", "fatigue", "aches", "headache". The following information was reported: PYREXIA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Fever"; CHILLS (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Chills"; NAUSEA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "nausea"; FATIGUE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fatigue"; SYNCOPE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fainted"; PAIN (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Apr2021) unknown result. Therapeutic measures were taken as a result of pyrexia, chills, nausea, fatigue, syncope, pain.  Clinical course: The patient had no prior vaccinations within 4 weeks.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain
Clinical narrative: Fever; Chills; nausea; fatigue; fainted; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 09:00 (Lot number: ER2613, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2020 (ongoing), notes: Pertinent details: Metoprolol 125mg; "contracted COVID-19", start date: 11Dec2020 (unspecified if ongoing), notes: I contracted COVID-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "stayed sick two weeks" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "with fatigue lingering 2 months" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits. Concomitant medication(s) included: METOPROLOL taken for hypertension. Vaccination history included: Bnt162b2 (Pfizer/BioNTech COVID-19 vaccine details, Dose: 1st, Date/time, date: 18Mar2021, Time: 09:00AM, Site and route of injection, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: ER2613), administration date: 18Mar2021, for COVID-19 immunization, reaction(s): "fever", "chills", "extreme nausea", "fatigue", "aches", "headache". The following information was reported: PYREXIA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Fever"; CHILLS (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Chills"; NAUSEA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "nausea"; FATIGUE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fatigue"; SYNCOPE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fainted"; PAIN (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Apr2021) unknown result. Therapeutic measures were taken as a result of pyrexia, chills, nausea, fatigue, syncope, pain.  Clinical course: The patient had no prior vaccinations within 4 weeks.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Fever; Chills; nausea; fatigue; fainted; Aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 09:00 (Lot number: ER2613, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2020 (ongoing), notes: Pertinent details: Metoprolol 125mg; "contracted COVID-19", start date: 11Dec2020 (unspecified if ongoing), notes: I contracted COVID-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "stayed sick two weeks" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits.; "with fatigue lingering 2 months" (unspecified if ongoing), notes: I contracted Covid-19 11Dec2020, and stayed sick two weeks, with fatigue lingering 2 months. No hospitalization or ER visits. Concomitant medication(s) included: METOPROLOL taken for hypertension. Vaccination history included: Bnt162b2 (Pfizer/BioNTech COVID-19 vaccine details, Dose: 1st, Date/time, date: 18Mar2021, Time: 09:00AM, Site and route of injection, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: ER2613), administration date: 18Mar2021, for COVID-19 immunization, reaction(s): "fever", "chills", "extreme nausea", "fatigue", "aches", "headache". The following information was reported: PYREXIA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Fever"; CHILLS (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Chills"; NAUSEA (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "nausea"; FATIGUE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fatigue"; SYNCOPE (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "fainted"; PAIN (disability, medically significant) with onset 15Apr2021 09:05, outcome "recovered" (Apr2021), described as "Aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Apr2021) unknown result. Therapeutic measures were taken as a result of pyrexia, chills, nausea, fatigue, syncope, pain.  Clinical course: The patient had no prior vaccinations within 4 weeks.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Chest pain, Fatigue, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Panic attack, Respiratory tract congestion
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Electrocardiogram normal, Palpitations
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Inappropriate schedule of product administration, Limb discomfort, Malaise
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nasopharyngeal swab, Skin burning sensation
Clinical narrative: I had anxiety spells for several days, and what felt like a racing heart when being active.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Immunisation, Joint effusion, Joint swelling, Nephrolithiasis
Clinical narrative: had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) 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), for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.". The patient underwent the following laboratory tests and procedures: investigation: haven't found out anything. Clinical course: Caller states she is calling regarding the Pfizer Covid vaccine booster. While caller was reporting on her experience after getting the booster, she mentioned that she does have customers that have had similar reactions to this. She had one lady who had to have 3 units of blood afterward. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) 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), for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.". The patient underwent the following laboratory tests and procedures: investigation: haven't found out anything. Clinical course: Caller states she is calling regarding the Pfizer Covid vaccine booster. While caller was reporting on her experience after getting the booster, she mentioned that she does have customers that have had similar reactions to this. She had one lady who had to have 3 units of blood afterward. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Investigation
Clinical narrative: had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) 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), for COVID-19 immunization. The following information was reported: HAEMORRHAGE (medically significant), outcome "unknown", described as "had to have 3 units of blood. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.". The patient underwent the following laboratory tests and procedures: investigation: haven't found out anything. Clinical course: Caller states she is calling regarding the Pfizer Covid vaccine booster. While caller was reporting on her experience after getting the booster, she mentioned that she does have customers that have had similar reactions to this. She had one lady who had to have 3 units of blood afterward. All they could find after all kinds of tests were that it might be bleeding but, haven't found out anything.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Cardiac arrest
Clinical narrative: Sudden Cardiac Arrest/My heart stopped beating for 20 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Oct2021 15:30 (Lot number: Fh8020) 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 (Primary Immunization series completed, dose number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: CARDIAC ARREST (hospitalization, medically significant) with onset 25Oct2021 17:00, outcome "unknown", described as "Sudden Cardiac Arrest/My heart stopped beating for 20 minutes". The patient was hospitalized for cardiac arrest (start date: 25Oct2021, discharge date: 05Nov2021, hospitalization duration: 11 day(s)). Therapeutic measures were taken as a result of cardiac arrest (an ICD (Implantable defibrillator) was implanted in my upper-left chest). No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: excruciating neck pain; left side was tingling and numb until my entire side is completely numb; left side was tingling and numb until my entire side is completely numb; thought I had experienced a stroke; adverse reaction to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2588, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Sep2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NECK PAIN (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "excruciating neck pain"; PARAESTHESIA (hospitalization), HYPOAESTHESIA (hospitalization) all with onset 13Jan2022 04:00, outcome "not recovered" and all described as "left side was tingling and numb until my entire side is completely numb"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "thought I had experienced a stroke"; ADVERSE REACTION (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "adverse reaction to the vaccine". The patient was hospitalized for neck pain, paraesthesia, hypoaesthesia, adverse reaction (start date: 17Jan2022, hospitalization duration: 3 day(s)); the patient was hospitalized for cerebrovascular accident (start date: 17Jan2022, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neck pain, paraesthesia, hypoaesthesia, cerebrovascular accident, adverse reaction. About 3 months after getting my second dose I started experiencing excruciating neck pain and my left side was tingling and numb until my entire side is completely numb I went to (with held) hospital on17Jan2022 and was admitted because they thought I had experienced a stroke to later find out that I was having an adverse reaction to the vaccine. Patient did not take any other medications in two weeks and no other vaccine in four weeks. No covid prior vaccination and patient was tested for covid post vaccination, No known allergies were reported.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Neurological symptom, Pain, Vaccination complication
Clinical narrative: excruciating neck pain; left side was tingling and numb until my entire side is completely numb; left side was tingling and numb until my entire side is completely numb; thought I had experienced a stroke; adverse reaction to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2588, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Sep2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NECK PAIN (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "excruciating neck pain"; PARAESTHESIA (hospitalization), HYPOAESTHESIA (hospitalization) all with onset 13Jan2022 04:00, outcome "not recovered" and all described as "left side was tingling and numb until my entire side is completely numb"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "thought I had experienced a stroke"; ADVERSE REACTION (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "adverse reaction to the vaccine". The patient was hospitalized for neck pain, paraesthesia, hypoaesthesia, adverse reaction (start date: 17Jan2022, hospitalization duration: 3 day(s)); the patient was hospitalized for cerebrovascular accident (start date: 17Jan2022, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neck pain, paraesthesia, hypoaesthesia, cerebrovascular accident, adverse reaction. About 3 months after getting my second dose I started experiencing excruciating neck pain and my left side was tingling and numb until my entire side is completely numb I went to (with held) hospital on17Jan2022 and was admitted because they thought I had experienced a stroke to later find out that I was having an adverse reaction to the vaccine. Patient did not take any other medications in two weeks and no other vaccine in four weeks. No covid prior vaccination and patient was tested for covid post vaccination, No known allergies were reported.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Cerebrovascular accident, Hypoaesthesia, Neck pain, Paraesthesia
Clinical narrative: excruciating neck pain; left side was tingling and numb until my entire side is completely numb; left side was tingling and numb until my entire side is completely numb; thought I had experienced a stroke; adverse reaction to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2588, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Sep2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NECK PAIN (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "excruciating neck pain"; PARAESTHESIA (hospitalization), HYPOAESTHESIA (hospitalization) all with onset 13Jan2022 04:00, outcome "not recovered" and all described as "left side was tingling and numb until my entire side is completely numb"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "thought I had experienced a stroke"; ADVERSE REACTION (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "adverse reaction to the vaccine". The patient was hospitalized for neck pain, paraesthesia, hypoaesthesia, adverse reaction (start date: 17Jan2022, hospitalization duration: 3 day(s)); the patient was hospitalized for cerebrovascular accident (start date: 17Jan2022, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neck pain, paraesthesia, hypoaesthesia, cerebrovascular accident, adverse reaction. About 3 months after getting my second dose I started experiencing excruciating neck pain and my left side was tingling and numb until my entire side is completely numb I went to (with held) hospital on17Jan2022 and was admitted because they thought I had experienced a stroke to later find out that I was having an adverse reaction to the vaccine. Patient did not take any other medications in two weeks and no other vaccine in four weeks. No covid prior vaccination and patient was tested for covid post vaccination, No known allergies were reported.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: excruciating neck pain; left side was tingling and numb until my entire side is completely numb; left side was tingling and numb until my entire side is completely numb; thought I had experienced a stroke; adverse reaction to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 15:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ff2588, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Sep2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: NECK PAIN (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "excruciating neck pain"; PARAESTHESIA (hospitalization), HYPOAESTHESIA (hospitalization) all with onset 13Jan2022 04:00, outcome "not recovered" and all described as "left side was tingling and numb until my entire side is completely numb"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "thought I had experienced a stroke"; ADVERSE REACTION (hospitalization) with onset 13Jan2022 04:00, outcome "not recovered", described as "adverse reaction to the vaccine". The patient was hospitalized for neck pain, paraesthesia, hypoaesthesia, adverse reaction (start date: 17Jan2022, hospitalization duration: 3 day(s)); the patient was hospitalized for cerebrovascular accident (start date: 17Jan2022, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neck pain, paraesthesia, hypoaesthesia, cerebrovascular accident, adverse reaction. About 3 months after getting my second dose I started experiencing excruciating neck pain and my left side was tingling and numb until my entire side is completely numb I went to (with held) hospital on17Jan2022 and was admitted because they thought I had experienced a stroke to later find out that I was having an adverse reaction to the vaccine. Patient did not take any other medications in two weeks and no other vaccine in four weeks. No covid prior vaccination and patient was tested for covid post vaccination, No known allergies were reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: chronic urticaria; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200091932 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Oct2021 (Lot number: 30125BA) at the age of 70 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2017 (unspecified if ongoing); "Borderline high blood pressure", start date: Jan2021 (unspecified if ongoing), notes: Verbatim: Borderline high blood pressure; "Breast cancer", start date: Feb2021 (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "adenocarcinoma", start date: Jan2019 (unspecified if ongoing), notes: The nodules were removed on following dates:  Jan2019, Jul2019, Dec2020.; "Allergies to dust" (unspecified if ongoing), notes: Allergies to dust. There were no concomitant medications. Past drug history included: Vitamin c, reaction(s): "Allergies: Vitamin C", notes: Allergies to dust and vitamin C, diagnosed a long time ago. Vaccination history included: Bnt162b2 (1st dose  , Lot EL9262 , expires May2021, Injected in unknown arm.), administration date: 22Jan2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "tested positive for covid", "tested positive for covid", "chronic urticaria"; Bnt162b2 (2nd dose , Lot EL9266, expires May2021, Injected in unknown arm.), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "chronic urticaria", "tested positive for covid", "tested positive for covid". The following information was reported: IMMUNISATION (non-serious) with onset 16Oct2021, outcome "unknown", described as "3rd dose"; URTICARIA CHRONIC (non-serious) with onset Nov2021, outcome "recovering", described as "chronic urticaria". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria chronic. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, SARS-CoV-2 test, Urticaria chronic
Clinical narrative: chronic urticaria; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200091932 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Oct2021 (Lot number: 30125BA) at the age of 70 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2017 (unspecified if ongoing); "Borderline high blood pressure", start date: Jan2021 (unspecified if ongoing), notes: Verbatim: Borderline high blood pressure; "Breast cancer", start date: Feb2021 (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "adenocarcinoma", start date: Jan2019 (unspecified if ongoing), notes: The nodules were removed on following dates:  Jan2019, Jul2019, Dec2020.; "Allergies to dust" (unspecified if ongoing), notes: Allergies to dust. There were no concomitant medications. Past drug history included: Vitamin c, reaction(s): "Allergies: Vitamin C", notes: Allergies to dust and vitamin C, diagnosed a long time ago. Vaccination history included: Bnt162b2 (1st dose  , Lot EL9262 , expires May2021, Injected in unknown arm.), administration date: 22Jan2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "tested positive for covid", "tested positive for covid", "chronic urticaria"; Bnt162b2 (2nd dose , Lot EL9266, expires May2021, Injected in unknown arm.), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "chronic urticaria", "tested positive for covid", "tested positive for covid". The following information was reported: IMMUNISATION (non-serious) with onset 16Oct2021, outcome "unknown", described as "3rd dose"; URTICARIA CHRONIC (non-serious) with onset Nov2021, outcome "recovering", described as "chronic urticaria". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria chronic. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: at rest heart rate up to 101-102; O2 saturations at 94%; maybe it was anxiety; shortness of breath; shortness of breath/progressively getting worse/states she has been short of breath with talking and walking; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 16:00 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation at Pharmacy. Relevant medical history included: "Sarcoidosis", start date: 2012 (ongoing), notes: where the majority of the lymph nodes are effected; "autoimmune disease" (unspecified if ongoing), notes: have effects lymph nodes in center of chest; "so many allergies" (unspecified if ongoing). There were no concomitant medications. Family Medical History Relevant to AE(s): None. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines administered on Same Date of the Pfizer Suspect: None. Prior Vaccinations (within 4 weeks): None. The following information was reported: DYSPNOEA (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath"; CONDITION AGGRAVATED (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath/progressively getting worse/states she has been short of breath with talking and walking"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "at rest heart rate up to 101-102"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "O2 saturations at 94%"; ANXIETY (non-serious), outcome "unknown", described as "maybe it was anxiety". After the vaccine it was just really hard to take a deep breath. AE(s) require a visit to: Emergency Room: No and Physician Office: No. The patient underwent the following laboratory tests and procedures: heart rate: elevated to 101-102; oxygen saturation: 94 %, notes: her O2 saturations has been fine around 94% but for her that is a little low. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: at rest heart rate up to 101-102; O2 saturations at 94%; maybe it was anxiety; shortness of breath; shortness of breath/progressively getting worse/states she has been short of breath with talking and walking; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 16:00 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation at Pharmacy. Relevant medical history included: "Sarcoidosis", start date: 2012 (ongoing), notes: where the majority of the lymph nodes are effected; "autoimmune disease" (unspecified if ongoing), notes: have effects lymph nodes in center of chest; "so many allergies" (unspecified if ongoing). There were no concomitant medications. Family Medical History Relevant to AE(s): None. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines administered on Same Date of the Pfizer Suspect: None. Prior Vaccinations (within 4 weeks): None. The following information was reported: DYSPNOEA (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath"; CONDITION AGGRAVATED (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath/progressively getting worse/states she has been short of breath with talking and walking"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "at rest heart rate up to 101-102"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "O2 saturations at 94%"; ANXIETY (non-serious), outcome "unknown", described as "maybe it was anxiety". After the vaccine it was just really hard to take a deep breath. AE(s) require a visit to: Emergency Room: No and Physician Office: No. The patient underwent the following laboratory tests and procedures: heart rate: elevated to 101-102; oxygen saturation: 94 %, notes: her O2 saturations has been fine around 94% but for her that is a little low. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: at rest heart rate up to 101-102; O2 saturations at 94%; maybe it was anxiety; shortness of breath; shortness of breath/progressively getting worse/states she has been short of breath with talking and walking; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2022 16:00 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation at Pharmacy. Relevant medical history included: "Sarcoidosis", start date: 2012 (ongoing), notes: where the majority of the lymph nodes are effected; "autoimmune disease" (unspecified if ongoing), notes: have effects lymph nodes in center of chest; "so many allergies" (unspecified if ongoing). There were no concomitant medications. Family Medical History Relevant to AE(s): None. History of all previous immunization with the Pfizer vaccine considered as suspect: none. Additional Vaccines administered on Same Date of the Pfizer Suspect: None. Prior Vaccinations (within 4 weeks): None. The following information was reported: DYSPNOEA (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath"; CONDITION AGGRAVATED (medically significant) with onset 22Jan2022, outcome "not recovered", described as "shortness of breath/progressively getting worse/states she has been short of breath with talking and walking"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "at rest heart rate up to 101-102"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "O2 saturations at 94%"; ANXIETY (non-serious), outcome "unknown", described as "maybe it was anxiety". After the vaccine it was just really hard to take a deep breath. AE(s) require a visit to: Emergency Room: No and Physician Office: No. The patient underwent the following laboratory tests and procedures: heart rate: elevated to 101-102; oxygen saturation: 94 %, notes: her O2 saturations has been fine around 94% but for her that is a little low. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.