chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Headache, Pain, Rash
Clinical narrative: Temperature over101 Body aches Severe headache Projectile vomiting Dizziness/vertigo Rash on arm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Temperature over101 Body aches Severe headache Projectile vomiting Dizziness/vertigo Rash on arm
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anion gap decreased, Aortic valve incompetence, Atrial fibrillation, Atrial flutter
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Base excess increased, Blood bicarbonate decreased, Blood calcium decreased, Blood chloride normal, Blood creatinine increased
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pH increased, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Cardiomegaly, Chest X-ray abnormal, Defect conduction intraventricular, Dyspnoea
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Echocardiogram, Ejection fraction decreased, Electrocardiogram abnormal, Fatigue
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Haematocrit normal, Haemoglobin normal, Hepatic steatosis, Left ventricular dilatation
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Left ventricular dysfunction, Mean cell volume normal, Mitral valve incompetence, N-terminal prohormone brain natriuretic peptide increased, PCO2 decreased
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: PO2 increased, Platelet count normal, Pleural effusion, Pulmonary congestion, Pulmonary oedema
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Right ventricular systolic pressure increased, SARS-CoV-2 test negative, Scan with contrast abnormal, Tachycardia, Tracheomalacia
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence, Troponin decreased, Ventricular dyskinesia, Ventricular hypokinesia, White blood cell count normal
Clinical narrative: Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Nausea, Tremor
Clinical narrative: 3 days of severe nausea/ vomitting, temp of 104, chills, shaking, hacking cough
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 3 days of severe nausea/ vomitting, temp of 104, chills, shaking, hacking cough
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Tinnitus, Tongue disorder
Clinical narrative: ringing in ears,; fat lips, fat throat, fat tongue,  Benadryl at 1540;  symptom resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: light headed/dizzy constantly; tingling in face; This is a spontaneous report from a contactable non pregnant female consumer reported for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3249, Expiration date was not reported), via an unspecified route of administration, in arm right on 23Jan2021 03:15 as single dose for covid-19 immunisation. Medical history included heart burn. Patient did not have allergies to medications, food, or other products. Concomitant medications included oxybutynin, omeprazole and famotidine all are taken for an unspecified indication, start and stop date were not reported. The patient experienced lightheaded/dizzy and tingling in face on 27Jan2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cancer surgery, Diabetes mellitus, Hypertension
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: One week after injection, red swollen area on left upper arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Individual states that she was interested in getting the Moderna vaccine after she had been been administered the Janssen vaccine.  Reports that she had researched the Moderna vaccine and become comfortable with receiving that particular vaccine instead of the Janssen.  There have been no reactions to this point.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Bad headache, chills, fever, upset stomach, fatigue, sore injection site
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Bad headache, chills, fever, upset stomach, fatigue, sore injection site
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus, increasing in severity after second inoculation
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given at age of 17, unknown age to healthcare provider
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea, Chills, Vomiting for 6 days
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein normal, Fatigue, Full blood count, Metabolic function test
Clinical narrative: 1 month of body aches, severe fatigue, night sweats
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Red blood cell sedimentation rate normal
Clinical narrative: 1 month of body aches, severe fatigue, night sweats
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Dyspnoea, Ultrasound scan
Clinical narrative: Patient states she received first COVID vaccination approximately one week ago (not a great historian); she tells me about 4 days later she became shorth of breath that progressively worsened - especially with exertion.  She went to ER and was sent home on steroids and antibiotics.  Shortness of breath became worsened so she presented back to ER and CTA was performed.  There is no evidence of PE but patient has what looks to be a chronic DVT of left subclavian vein extending up to IJ junction.  I do not believe this is for sure vaccine related but felt it was important to report it anyway.  She cannot tell me why she takes warfarin at home but I do assume it is for this known chronic DVT.  Unsure of Vaccine brand name.  Most vaccines in this area have been Moderna.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysuria, Gastrointestinal disorder, Injection site pain, Injection site swelling
Clinical narrative: Middle of the night last  8ghr stabbing pains in area of stomach and abdomen. Also intense nausea.  Pain so bad I could nearly  death...couldnt move.  Tried to take long breathes and slow things done but it was far too intense.  I have major GI issues and have had an ERCP.  Monday the day before I had a four hour gastric emptying test with nuclear aspects that was in some of the egg whites I ate.  They said there would not be any side effects...i do thing that related to the vaccine side effects and created the perfect storm for an over 3 hour stomach attach.  Couldn't have bowel movement although I felt like it was needed.  Couldn't throw up yet I was extremely naseaus.  Very sore and swollen arm today where vaccine was given...very very thirsty today.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Middle of the night last  8ghr stabbing pains in area of stomach and abdomen. Also intense nausea.  Pain so bad I could nearly  death...couldnt move.  Tried to take long breathes and slow things done but it was far too intense.  I have major GI issues and have had an ERCP.  Monday the day before I had a four hour gastric emptying test with nuclear aspects that was in some of the egg whites I ate.  They said there would not be any side effects...i do thing that related to the vaccine side effects and created the perfect storm for an over 3 hour stomach attach.  Couldn't have bowel movement although I felt like it was needed.  Couldn't throw up yet I was extremely naseaus.  Very sore and swollen arm today where vaccine was given...very very thirsty today.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Syncope
Clinical narrative: had dose two in the morning - felt fine all day - went to sleep that night - woke up with headache, got up, took Advil, which promptly made me nauseous - went into bathroom, fainted, collapsed on floor - my husband came in and took care of me, then diarrhea, then back to sleep and I was pretty much fine the next day, although I rested all day
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vertigo, Vomiting
Clinical narrative: Extreme vertigo, included nausea, vomiting, dizziness and heavy sweating.  Lasted a few hours, another incidence on March 30.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She missed her second dose due to the advisement of her doctor
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: body aches and nausea
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache, fever, chills. Arm very sore
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: Fever; body aches; fatigue; redness at injection site; muscle stiffness at injection site; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, Expiration date: Unknown) via intramuscular route of administration in the left arm on 25Jan2021 10:00 at SINGLE DOSE for COVID-19 Immunization.  The patient had no medical history and had no known allergies. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient was not having COVID-19 prior vaccination. On 25Jan2021 at 21:00 the patient experienced Fever, body aches, fatigue, redness at injection site, muscle stiffness at injection site. On 28Jan2021 post vaccination, the patient had nasal swab for COVID-19 test which was negative. The patient was not given treatment. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Fever; body aches; fatigue; redness at injection site; muscle stiffness at injection site; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, Expiration date: Unknown) via intramuscular route of administration in the left arm on 25Jan2021 10:00 at SINGLE DOSE for COVID-19 Immunization.  The patient had no medical history and had no known allergies. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient was not having COVID-19 prior vaccination. On 25Jan2021 at 21:00 the patient experienced Fever, body aches, fatigue, redness at injection site, muscle stiffness at injection site. On 28Jan2021 post vaccination, the patient had nasal swab for COVID-19 test which was negative. The patient was not given treatment. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Superficial injury of eye, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy hands, legs, head, top of head and his face is itchy; achy and hurts where got the vaccine; he also has itching also on arm where vaccine given; scratching eyes; This is a spontaneous report from a contactable Consumer. An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9Z6Z) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 83-year-old) as a single dose for COVID-19 immunisation. The patient medical history included parkinson's (ongoing) diagnosed 3-4 years ago, 2 stents placed in heart on an unknown date in2009, high cholesterol and high blood pressure diagnosed about 20 years ago (ongoing), right total knee replacement on 08Dec2020, prostate enlargement surgery on an unknown date in 2019 (2 years ago). The family medical history was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine and did not had history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer vaccination. The concomitant medication included 15 to 20 different tablets a day (not specified). It was reported that patient experienced itching on an unknown date in 2021. The reporter thought that itching was caused due to detergent and washed everything without detergent thinking maybe he was allergic. The patient had itchy hands, legs, head, top of head and his face was itchy on an unknown date in 2021. It was reported that patient was scratching his eyes, hands and head using nails like an animal. Patient added that he also has itching also on arm where vaccine given, still achy and hurts where got the vaccine on an unknown date in 2021. The patient visited a primary doctor since he was due for a visit (right knee replaced 2 months ago). The patient complained about itching to doctor and doctor said it might be due to dryness. The patient had made appointment for 2nd vaccine. The patient states he has done nothing special or specific besides washing hands every time. The patient did not receive any treatment for the events. The outcome of the events Itchy hands, legs, head, top of head and his face is itchy, achy and hurts where got the vaccine and scratching eyes was not recovered while for other event was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Sinus congestion, Stomatitis
Clinical narrative: temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Sinus congestion
Clinical narrative: Annoying headache; sinus congestion; cough; fatigue; This is a spontaneous report from a contactable 69-year-old non pregnant female Other Health Professional reported for herself that:A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN,) via an unspecified route of administration on 03Feb2021 12:30 as SINGLE DOSE for covid-19 immunisation .Medical history included  from an unknown date and unknown if ongoing. On 03-FEB-2021 15:00 patient experienced  the Annoying headache and sinus congestion and cough and fatigue and outcome of the event was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dry mouth, Fatigue, Headache
Clinical narrative: Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/severe headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Feb2021, at 14:00 (at the age of 54-year-old) as a single dose for Covid-19 immunization. The patient medical history included allergies to Penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within 2 weeks of vaccination. On 04Feb2021, the patient had mild headache, Injection site pain. On 05Feb2021 at 11:00 the patient had severe headache, body aches, Chills, Fever of 101, Nausea, dry mouth, extreme fatigue, rapid heartbeat. It was reported that the headache subsided on 06feb2021 at 03:00 and the patient was still fatigued. The patient took Tylenol as a treatment for all the events. The seriousness of the events was reported as non- serious. The outcome of the events was reported as recovering.  Information about lot/batch number requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/severe headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Feb2021, at 14:00 (at the age of 54-year-old) as a single dose for Covid-19 immunization. The patient medical history included allergies to Penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within 2 weeks of vaccination. On 04Feb2021, the patient had mild headache, Injection site pain. On 05Feb2021 at 11:00 the patient had severe headache, body aches, Chills, Fever of 101, Nausea, dry mouth, extreme fatigue, rapid heartbeat. It was reported that the headache subsided on 06feb2021 at 03:00 and the patient was still fatigued. The patient took Tylenol as a treatment for all the events. The seriousness of the events was reported as non- serious. The outcome of the events was reported as recovering.  Information about lot/batch number requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: Headache; dizziness; sore arm; body aches; chills; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the second of bnt162b2 (formulation: solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 14:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL3302), in left arm on 12Jan2021 at 14:00 as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 14:00, the patient experienced headache, dizziness, sore arm, body aches and chills. The patient did not received treatment for the events. The outcome of the events was recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Wrist and Hand on arm of injection was swollen for 3 days after the injection; Wrist and Hand on arm of injection was swollen for 3 days after the injection; This is a spontaneous report from a contactable consumer (reported for herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265 and expiry date was not provided), via an unspecified route of administration, in arm right, on 31Jan2021 08:00, as a single dose for Covid-19 immunization, at hospital. Patient's medical history included Parkinsons and allergies to penicillin. Concomitant medications included carbidopa, levodopa and diltiazem (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 01Feb2021 03:00 AM, the patient had wrist and Hand on arm of injection was swollen for 3 days after the injection Patient was received no treatment for the adverse events. Outcome the event was recovered on an unknown date in Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness
Clinical narrative: fatigue/felt very tired; muscle weakness/legs were weak; This is a spontaneous report from a contactable consumer or other non hcp. An elderly female patient received BNT162B2((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on unspecified site at 11:00 on 04Feb2021 as single dose for COVID-19 immunization. Medical history included hyperthyroidism and hypertension. Concomitant medications included lisinopril, levothyroxine sodium, trazodone. On 04Feb2021, the patient experienced fatigue and muscle weakness. The outcome of event was recovered on unspecified date on 2021.  Follow-up (10Feb2021): New information included that the patient received the Pfizer vaccine approximately 11 am on 04Feb and later in the day (approximately 6 pm)  and she felt very tired and her legs were weak.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 03:45 PM (at the age of 55-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. It was reported that the patient expereinced right arm pain next morning on 04Feb2021. Unable to lift arm above shoulder height without sharp pain on 04Feb2021. No treatment was given to the events. Outcome of the events were recovered on 05Feb2021.  Information about batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in Left arm on 29Jan2021, 09:15 AM (at the age of 68-year-old) as a single dose for COVID-19 immunisation in Public Health Clinic/facility. The patient's medical history included Type 2 Diabetes, High BP (blood pressure), High Cholesterol, Asthma. List of any other medications the patient received within 2 weeks of vaccination: Yes (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. About 48 hours after injection, on 31Jan2021 09:00 am, the patient experienced extreme fatigue, body aches, very sore arm. The reporter assessed the events as non serious. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: feverish and sick (in bed); feverish and sick (in bed); This is a spontaneous report from a contactable consumer. This consumer reported for a 54-years-old-male patient that this patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; unknown), lot unknown reason; not available/provided to reporter at the time of report completion, via an unspecified route of administration from 03Feb2021 to 03Feb2021 at single dose (dose number; 2) for covid-19 immunization. Patient's medical history and concomitant medications were not reported. If covid prior vaccination or covid test post vaccination was reported as unknown. Known allergies and other medical history was reported as not known. If other vaccine in four weeks and other medications in two weeks was reported as unknown. The patient had 2nd vaccination and next day on 04Feb2021 felt feverish and sick (in bed). It was unknown if treatment AE was given. The reporter confirmed the awareness date of this report via query response mail that "I became aware of this report on 05Feb2021 when talking on the phone with a friend of mine, (Name). She first texted me about her husband (which I filled out a separate report on,(Name) and when I called her to get details on her husband's report she told me about her sister's report as well (Name). I became aware of both on 05Feb2021 and filled out the online form later that night." The outcome of events was recovered on an unknown date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Fatigue, Red blood cell count
Clinical narrative: she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/she experienced problems with breathing, loss of energy and looks weird all the time.; tired, her breathing was a bit worse/tired; This is a spontaneous report from a contactable consumer (Patient) from a  sponsored program. A female patient (age:80 units: not provided) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included blood clotting after the miscarriage, blood transfusion, throat surgery, takes baby aspirin, has COPD, infection, breathing problems had pneumonia after the lung surgery, allergy to morphine or Percocet, heart problem . Patient experienced tired, her breathing was a bit worse. Upon follow-up received on 15Feb2021, the medical history included C-section, blood disorder, Lung cancer and Lung surgery (From: 1993 to: Unspecified), Throat cancer and throat surgery (From: 1997 To: Unspecified), blood disorder, the blood not clotting. Again, mentions she had this blood issue in the past, but wondering if she should get the second dose. The patient underwent lab tests included her red corpuscles (does something). Upon follow-up received on 16Feb2021, it was reported that patient experienced problems with breathing, loss of energy and looks weird all the time. The outcome of the events was unknown.  Follow-up (05Feb2021): New information received from spontaneous report received from a contactable consumer (patient) includes: Relevant medical history added, Lab data added.  Follow-up (16Feb2021): New information received from spontaneous report from a sponsored program. A contactable consumer reported: Event added (loss of energy and looks weird all the time).  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Oropharyngeal discomfort
Clinical narrative: Flushed scalp and face; lightheadiness; scratchy throat; This is a spontaneous report received from a contactable consumer (reporting for himself). A 72-year-old male patient received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration in Arm left on 05Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included High blood pressure and asthma. Concomitant medications included bisoprolol; tamsulosin hydrochloride (FLOMAX RELIEF); omeprazole (PROTONIX) and spironolactone. The patient previously took amoxicillin, levofloxacin, clarithromycin, sulfamethoxazole and experienced drug hypersensitivity for all drugs and first dose of BNT162B2 received on 15Jan2021 10:45 for COVID-19 immunization. It was reported that on 05Feb2021 11:00 patient experience Flushed scalp and face, lightheadiness, scratchy throat. As result visited to doctor or other healthcare professional office/clinic visit and treated with Benadryl. The outcome of all events was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for the past 5 days; This is a spontaneous report from a contactable consumer(patient).A 63-years-old male patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration in Arm Left on 29Jan2021 10:00 at single dose for covid-19 immunisation.Medical history included subclavian artery stenosis, heart valve replacement, stents; thyroid cancer; Hodgkin's disease .Concomitant medication included clopidogrel ,atorvastatin, warfarin and amlodipine. On 03Feb2021 12:00 the patient experienced headache for the past 5 days with outcome of unknown. The patient did not received treatment for the event. Patient did not receive other vaccine in four weeks. The patient is not covid tested post vaccination. No known allergies were reported for the patient.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: A fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Left Arm on 06Feb2021 03:45 am as SINGLE DOSE for covid-19 immunisation. facility type vaccine: Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Medical history included 3Rd stage kidney disease. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced a fast heartbeat (non-serious) on 06Feb2021 20:45. If treatment ae: No. The patient underwent lab tests and procedures which included heart rate: fast heart beat   on 06Feb2021. The outcome of event was unknown
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Illness, Nausea, Pain
Clinical narrative: stated that she is as sick as a dog; Fever; Chills; Nauseated; body aches; stated that she cannot get warm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 at 05:00 PM as an unspecified dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that she got Pfizer COVID vaccine yesterday. Stated that she is as sick as a dog. Stated has fever, chills, nauseated and body aches. Stated that she cannot get warm and has blankets all around. on an unspecified date in Jan2021. Wanted to know what to do. Stated that they let her get the vaccine early because she has a bad heart. Stated that she is only 65. Stated that she got it at 5:00PM. The outcome of the events was reported as unknown.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stated that she is as sick as a dog; Fever; Chills; Nauseated; body aches; stated that she cannot get warm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jan2021 at 05:00 PM as an unspecified dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that she got Pfizer COVID vaccine yesterday. Stated that she is as sick as a dog. Stated has fever, chills, nauseated and body aches. Stated that she cannot get warm and has blankets all around. on an unspecified date in Jan2021. Wanted to know what to do. Stated that they let her get the vaccine early because she has a bad heart. Stated that she is only 65. Stated that she got it at 5:00PM. The outcome of the events was reported as unknown.  Information on Lot/Batch has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, SARS-CoV-2 test
Clinical narrative: swelling under both eyes and pain; swelling under both eyes and pain; This is spontaneous report based on the information received by. Reference Number: GL-012221-1879. A contactable Physician reported for a 27-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration from 18Jan2021 to 18Jan2021 at single dose for covid-19 immunization. Patient's medical history included recently testing positive for COVID-19 (date unknown). Past drug included Restylane from Jun2020 to an unspecified date for tear troughs. Concomitant medications were not reported. Patient injected with Restylane to tear troughs in Jun2020. The patient received the first dose of the COVID (Pfizer) Vaccine on 18Jan2021. Reported swelling under both eyes and pain on 20Jan2021. Swelling resolved without treatment by 21Jan2021. The outcome of events was recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Moderate chills; Nausea; Vomiting; This is a spontaneous report from a contactable other HCP. A 24-year-old non-pregnant female other HCP (Patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an Intramuscular route of administration on left arm on 07Feb2021 at 11:15 AM as single dose for COVID-19 Immunization. The patient's medical history and concomitant medication was not reported. The patient received other medications for Birth control in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Feb2021at 01:15 AM patient experienced Moderate chills, Nausea, vomiting, patient had not received any treatment. The outcome for the events was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: painfull to lift left arm; overall mild body aching; head cold; sinuss filling running nose; sneezing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 08:15 (Batch/Lot Number: el9269) as single dose for covid-19 immunisation (age at vaccination was 75 year). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient medical history was not reported. The patient experienced painfull to lift left arm, overall mild body aching, head cold, sinuss filling running nose, sneezing on 04Feb2021. No treatment was received received for the event. The case was reported as non-serious. Prior to vaccination, the patient wasn't diagnosed with COVID-19 and Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Ultrasound scan
Clinical narrative: pain in the neck/pain down her neck on her right side; hard for her to move it from side to side; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246; NDC number: Unknown; Expiry Date: Unknown) from an intramuscular route of administration via left arm on 02Feb2021 as single dose for covid-19 immunisation. Patient's medical history included ear ache in right ear and cold. She explained she did have an ear ache in right ear, she figured she must have had a cold. She was using ear drops and it just sort of went away. She clarified this was prior to the vaccine. It started over a week or 10 days ago, she guesses. She doesn't recall. She believes the ear ache was cleared by Tuesday before receiving the vaccine. The patient was received unknown concomitant medications. No other vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced pain in the neck that makes it hard for her to move it from side to side and pain down her neck on her right side on 04Feb2021. The patient had the first COVID-19 shot last Tuesday evening and everything was fine. Probably on Thursday she started getting pain down her back, clarified as her neck, on her right side. Like, she can't hardly turn her head left or right without turning her whole body. Patient declined to include a healthcare professional for the report. She confirms she started having pain in her neck on the right side. She clarifies she had an ultrasound last Friday because they were concerned with her liver. They called that night and that was fine. However, Friday morning when she went in for that appointment, she really didn't have any pain in her neck. Therefore, it had to have been after. It must have actually started either Friday night or Saturday. Caller explains she paid no attention to the pain until yesterday so she thought she would call today. She was not sure about vaccination time stated had a 7 o'clock appointment, so maybe by 7:30-7:45PM. The outcome of events was reported as not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: I have experienced Headache; chills; felt weak the first day; This is a spontaneous report received from a contactable other health Care Professional (patient herself). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via unspecified route of administration, in right arm on 03Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included Allergies: Penicillin and Allergies: Sulfa. The patient concomitant medications were not reported. Patient previously took first dose BNT162B2 on 13Jan2021 16:00 for COVID-19 immunization. On 04Feb2021 06:00, the patient experienced chills, first day felt weak, the second day felt better and Third- and fourth-days experienced headache. Treatment received was reported as no. The event considered non serious. The outcome of the events was recovering.  Batch/lot number has been requested.