chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Throughout the morning ''I'' developed a fever eventually hitting 102 by late afternoon; Shivering; Body aches; Headache; Generally not feeling well; Extremely gassy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 11May2021 at 17:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 07:00, the morning following the second vaccination shot, the patient started with a sore arm. Throughout the morning the patient developed a fever eventually hitting 102 (unspecified units) by late afternoon. Other symptoms included shivering, body aches, headache and generally not feeling well. The patient eventually became extremely gassy, which lasted through the night. The fever was down to 100 (unspecified units) by morning and after sleeping until nearly 14:00, the fever was gone. Some aching remained in the evening, but the patient was able to function nearly normal at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event fever was recovered on 13May2021 at 14:00. The clinical outcome of the events sore arm, shivering, body aches, headache, generally not feeling well and extremely gassy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging
Clinical narrative: Bilateral severe pain in both shoulders, hips, knees primarily.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL-9267) via an unspecified route of administration in the left arm on 17Feb2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure, chronic knee injury on left side, allergic reaction to Fluoroquinolones, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had received other medication within two weeks of vaccination, which were not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced bilateral severe pain in both shoulders, hips, knees primarily. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with medication, physical therapy and the patient had undergone magnetic resonance imaging (MRI) on an unknown date in 2021, the results of which were unknown. The clinical outcome of the event bilateral severe pain in both shoulders, hips, knees primarily was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy menstrual  bleeding / period clots more than usual larger than a quarter; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1075) via an unspecified route of administration in the right arm on 04Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 13May2021 at 12:00, the patient experienced heavy menstrual bleeding / period clots more than usual larger than a quarter. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy menstrual bleeding / period clots more than usual larger than a quarter was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Significant tinnitus 8 hrs after the 2nd dose.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10May2021 at 16:30 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. On 11May2021 at 01:00, 8 hours after the second dose, the patient experienced significant tinnitus. The patient had first dose 3 weeks prior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant tinnitus 8 hours after the 2nd dose was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Intense chills for 24 solid hours; Fever; Muscle and joint pain; Joint pain; Extreme fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 02:00, the patient experienced intense chills for 24 solid hours, fever, muscle and joint pain, extreme fatigue, brain fog continuing for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event Intense chills for 24 solid hours was resolved with lasting effects on 01Apr2021 at 02:00. The clinical outcome of fever, muscle and joint pain, extreme fatigue was resolved with lasting effects on an unknown date in 2021, whereas brain fog was resolved with lasting effects on 05Apr2021 for about 5 days. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Intense chills for 24 solid hours; Fever; Muscle and joint pain; Joint pain; Extreme fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 31Mar2021 at 02:00, the patient experienced intense chills for 24 solid hours, fever, muscle and joint pain, extreme fatigue, brain fog continuing for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event Intense chills for 24 solid hours was resolved with lasting effects on 01Apr2021 at 02:00. The clinical outcome of fever, muscle and joint pain, extreme fatigue was resolved with lasting effects on an unknown date in 2021, whereas brain fog was resolved with lasting effects on 05Apr2021 for about 5 days. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: Severe arm, leg, neck pain all on right side of body.; Severe arm, leg, neck pain all on right side of body.; Severe headache; Chills; Overall body pain; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12May2021 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 13May2021, the patient experienced severe arm, leg, neck pain all on right side of body, severe headache, chills and overall body pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe arm, leg, neck pain all on right side of body, severe headache, chills and overall body pain were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Headache, Myalgia
Clinical narrative: Chills; Bone and muscle pain; Bone and muscle pain; Headache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13May2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously 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 22Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 14May2021 at 02:00, the patient experienced chills, bone and muscle pain, headache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent bioiq test via nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, bone and muscle pain, headache and stomach ache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills; Bone and muscle pain; Bone and muscle pain; Headache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13May2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously 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 22Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 14May2021 at 02:00, the patient experienced chills, bone and muscle pain, headache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent bioiq test via nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, bone and muscle pain, headache and stomach ache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, X-ray
Clinical narrative: slight headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number not reported) via an unspecified route of administration, administered in left arm on 05Feb2021 10:30 AM (at the age of 71 years) as dose 2, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EK5730) via an unspecified route of administration on 15Jan2021 10:47 (at the age of 71 years) as dose 1, single dose for covid-19 immunization and experienced pain on left side to left breast, breathing was a little compromised and oxygen saturation was down and no treatment received, and patient was fine now and also reported that pain in the left arm to leg and breast area, thinking it was pneumonia, but lungs clear. On unspecified date in Feb2021, the patient experienced slight headache. It was reported that no physician office and emergency office visit. The patient underwent lab tests and procedures which included chest x-ray results normal on 20Jan2021. Therapeutic measures were taken as a result of slight headache (headache) includes iced her arm and took Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Tiredness; Headache; Hot flashes; Chills; Joint pain; Nausea; Injection site pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies that she was aware of. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (PRILOSEC) and ethinylestradiol/norethisterone acetate (LOESTRIN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 16May2021 at 23:00, the patient experienced tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Tiredness; Headache; Hot flashes; Chills; Joint pain; Nausea; Injection site pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies that she was aware of. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (PRILOSEC) and ethinylestradiol/norethisterone acetate (LOESTRIN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 16May2021 at 23:00, the patient experienced tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Muscular weakness, Vertigo
Clinical narrative: Severe joint pain; vertigo; instability; muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12May2021 at 11:30, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously took haloperidol (HALDOL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 16May2021, 4 days after vaccination, the patient experienced severe joint pain, vertigo, instability and muscle weakness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe joint pain, vertigo, instability and muscle weakness were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal
Clinical narrative: feel really lousy; Felt a little drained, i'm tired of therapy i've had enough.; I have no freaking energy; This is a spontaneous report from a contactable other healthcare professional (patient) from a Pfizer Sponsored Program. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10May2021 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation; axitinib (INLYTA, Batch/Lot number was not reported; Expiration Date: 31Jul2023), tablet orally from 25Mar2020 and ongoing, at 5 mg, 2x/day for renal cancer. Medical history included dysphonia from an unknown date and unknown if ongoing, constipation from an unknown date and unknown if ongoing, decreased appetite from an unknown date and unknown if ongoing, heart rate increased from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing , pulmonary embolism from an unknown date and unknown if ongoing, neoplasm malignant from an unknown date and unknown if ongoing , abdominal discomfort from an unknown date and unknown if ongoing. No known allergies were reported. List of any medication's patient was using at or around the time of the adverse events and dates of therapy included Inlyta, and Famotidine. Concomitant medication included famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for COVID-19 immunisation, pepcid ac for abdominal discomfort. Patient reported, stated "I have the hoarseness, I am a little constipated, I have the loss of appetite. I am fatigued. I have the rapid heartbeat. anything I do, my heart goes crazy. have high blood pressure - slightly elevated. I have a blood clot on the bottom of my lungs (doctor wants him to start on eliquis)- CT scan shows blood clot is caused by my cancer. I cannot take advil is cause of my cause of my kidney, I take pepcid for upset stomach. sometimes when I eat food my nose runs - all food. I am over my treatment, I am so freaking tired. work sent me home (because of it). I had a reaction to the COVID shot second one. 10may2021. I went to work feeling fine and the next thing feel really lousy went home and rested and was better. felt a little drained, I am tired of therapy I have had enough. I have no freaking energy. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Interchange of vaccine products, Off label use, Overdose
Clinical narrative: unable to communicate; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; was given a Moderna Vaccine yesterday and a Pfizer Vaccine today; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received bnt162b2 (Formulation: Solution for injection; (Batch/Lot number was not reported), dose 1 via an un-specified route of administration on 18May2021 as dose 1, single for covid-19 immunisation (at the age of 74-year-old); covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 17May2021 (Batch/Lot number was not reported) to 17May2021, at dose 2, single for covid-19 immunisation (at the age of 74-year-old). Medical history included ongoing dementia. The patient's concomitant medications were not reported. The patient was given a Moderna Vaccine yesterday and a Pfizer Vaccine today. She advised that a family member took her today and she was given the Pfizer vaccine, unaware that the aunt was given the Moderna Vaccine yesterday, as she is also unable to communicate. I advised her to contact the location that provided her the vaccines and to also contact her aunts doctor and or local hospital for medical advice. The locations were closed, and the local hospital couldn't provide her with advice. She complained about the Medical Vaccination Tracking System that contains the vaccination records for everyone as she stated it was the systems mistake for her aunt being vaccinated twice with two different vaccines. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 31-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 31, via an unspecified route of administration, in left arm, on May 19, 2021, at 14:45, single dose, for COVID-19 immunisation. Medical history not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On May 21, 2021, at 21:15, patient experienced severe nausea and dizziness. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of severe nausea and dizziness: unknown (at the time of report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Nausea; Vomiting; Dizziness; Aches; Extreme back pain; Tiredness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 19May2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 20May2021, the patient experienced nausea, vomiting, dizziness, aches, extreme back pain and tiredness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, dizziness, aches, extreme back pain and tiredness was not resolved at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; Dizziness; Aches; Extreme back pain; Tiredness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 19May2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 20May2021, the patient experienced nausea, vomiting, dizziness, aches, extreme back pain and tiredness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, dizziness, aches, extreme back pain and tiredness was not resolved at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Positive side effects of the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00(at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic depression, anxiety, asthma and morbidly obese. The patient had probably known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (PROGESTIN) from an unknown date taken for birth control as implant.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 29Mar2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation.On 19Apr2021 at 15:00, it was reported that the patient  honestly wanted to report a positive side effect. After the second dose, the patient felt great, like really great. The patient felt as if recieved an injection of six months of healthy diet and exercise that took hold all at once and lasted 36 hours, and felt like being on steroids and stimulants and antidepressants all at once. The patient was morbidly obese, but felt like could run for miles. The patient  was extremely peppy and productive at work. The patient  knows positive side effects probably don't get reported often, but had not known if it's a potentially risky side effect or medication interaction, and would leave that to the professionals. The patient thought that these things should be tracked and reported. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events positive side effects reported for the vaccine was resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash over body.; Rash is red; Rash is red and sometimes contain water and grew bigger.; 'I' felt itchy; Short fever; Several days of tiredness/felt again tired.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took ibuprofen (MOTRIN) for an unknown indication on an unknown date and experienced drug allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD157) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 16:15 the patient experienced rash over body. The rash was red and sometimes contained water and grew bigger and the patient felt itchy. Additionally short fever and a several days of tiredness, even after nearly two weeks after the 2nd dose the patient felt tired again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash over body, felt itchy, short fever and a several days of tiredness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash over body.; Rash is red; Rash is red and sometimes contain water and grew bigger.; 'I' felt itchy; Short fever; Several days of tiredness/felt again tired.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took ibuprofen (MOTRIN) for an unknown indication on an unknown date and experienced drug allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD157) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 16:15 the patient experienced rash over body. The rash was red and sometimes contained water and grew bigger and the patient felt itchy. Additionally short fever and a several days of tiredness, even after nearly two weeks after the 2nd dose the patient felt tired again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash over body, felt itchy, short fever and a several days of tiredness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Rash; Tiredness on first day; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18May2021 at 12:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021, the patient experienced rash and tiredness on first day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash and tiredness on first day were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site bruise.; Injection site swelling; Injection site redness; This is a spontaneous report from a non-contactable consumer, the patient. An 84-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 22Mar2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced injection site swelling and site redness, followed by a bruise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events injection site swelling and site redness, followed by a bruise. The clinical outcome of the events Injection site bruise, injection site swelling and injection site redness were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Depression, Dizziness, Fatigue
Clinical narrative: Dizzy; Ringing in both ears, I cant get relief from this noise in my ears; Fever; Chills; Very tired; No energy; Now trouble sleeping because of the noise, this is depressing; Now trouble sleeping because of the noise, this is depressing; After second shot very very sore arm, could not left my arm until the next day then sore; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 01May2021 at 14:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient had no health issues. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced after the second shot very very sore arm, could not left her arm until the next day then sore. On 03May2021, second day, the patient got fever, chills, very tired and no energy. On 04May2021, third day, the patient felt dizzy then got ringing in both ears and it was then 22May2021 and she could not get relief from that noise in her ears and her doctor could not help. Also, she never had ringing in her ears, tinnitus, before that shot and now (at the time of this report) on an unknown date in May2021, the patient had trouble sleeping because of the noise, that was depressing. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events after the second shot very very sore arm, could not left her arm until the next day then sore, fever, chills, very tired, no energy, dizzy and got ringing in both ears, she could not get relief from that noise in her ears and now trouble sleeping because of the noise and that was depressing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Dizzy; Ringing in both ears, I cant get relief from this noise in my ears; Fever; Chills; Very tired; No energy; Now trouble sleeping because of the noise, this is depressing; Now trouble sleeping because of the noise, this is depressing; After second shot very very sore arm, could not left my arm until the next day then sore; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 01May2021 at 14:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient had no health issues. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced after the second shot very very sore arm, could not left her arm until the next day then sore. On 03May2021, second day, the patient got fever, chills, very tired and no energy. On 04May2021, third day, the patient felt dizzy then got ringing in both ears and it was then 22May2021 and she could not get relief from that noise in her ears and her doctor could not help. Also, she never had ringing in her ears, tinnitus, before that shot and now (at the time of this report) on an unknown date in May2021, the patient had trouble sleeping because of the noise, that was depressing. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events after the second shot very very sore arm, could not left her arm until the next day then sore, fever, chills, very tired, no energy, dizzy and got ringing in both ears, she could not get relief from that noise in her ears and now trouble sleeping because of the noise and that was depressing was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Lip swelling, Pregnancy test
Clinical narrative: the left side of her lip was swollen and became numb; the left side of her lip was swollen and became numb; small allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284; Expiration Date: 30Apr2021) via an unspecified route of administration, administered in Arm Left on 21Jan2021 at 11:00 age at vaccination: 30 years old as dose 1, single for covid-19 immunization at the Clinic. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient Historical vaccine included Flu shot in Jan2021 for immunization. The patient experienced the left side of her lip was swollen and became numb on 21Jan2021 and small allergic reaction on 21Jan2021. Patient stated patient experienced on 21Jan2021 that when she got the first dose, she had a small allergic reaction, the left side of her lip was swollen, and became numb. Patient further stated when she went home, she put ice on it, and it was gone the next day. The patient underwent lab tests and procedures which included pregnancy test negative and bloodwork pregnancy test negative on unknown date. The outcome of events was outcome of recovered on 22Jan2021.  No follow-up attempts are needed. No further information is expected.