chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Fatigue, Pain
Clinical narrative: Blood Pressure is still "bouncing around" while on Lenvima; it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue; it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 20 mg, daily for uterine cancer. Medical History: "Diagnosis/ICD code: C55 Carcinosarcoma of uterus, arthritis prior to Lenvima. Concomitant medication(s) included pembrolizumab (KEYTRUDA) taken for an unspecified indication, start and stop date were not reported. Patient began Lenvima therapy on 15Feb2021, currently taking 20 milligrams daily, along with Keytruda. Patient reported she received her second "COVID vaccine" yesterday (22Feb2021), and reported "it's really knocked me out, it hit me like a ton of bricks, I had aches & pains, & fatigue" that all began last night (22Feb2021). Patient reported "I've been feeling good" while on Lenvima, and stated she thinks the symptoms were all from the vaccine. Cause was not related to Lenvima, but event occurred while on Lenvima. Advised Patient to notify & follow up with Health Care Provider. (Exact Event Onset Date was unknown, & Event end Date unknown) Patient reported her Blood Pressure is still "bouncing around" while on Lenvima. Cause thought to be related to Lenvima. Advised Patient to notify and follow up with Health Care Provider. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Lightheadedness; Nausea; On and off like weakness in the legs, a little bit more tired; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269), dose 1 via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamins. On an unspecified date, the patient experienced lightheadedness, nausea and on and off like weakness in the legs, a little bit more tired. The patient had week long symptom. The patient did not had medical condition. The patient was surprised by the link of the symptoms, so she called. The patient did not received treatment. The outcome of the events were unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pyrexia
Clinical narrative: I have got lump under my left arm and it's rather sore; I ache from head to toe; I have got a temperature of 102; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. The reporter stated that I am experiencing some side effects, I ache from head to toe, I have got lump under my left arm which is where I got the injection (Clarified as Covid-19 Vaccine by Pfizer) in my left arm and it's rather sore and I have got a temperature of 102. The patient not received any treatment for the events. The outcome of the events was reported as unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; fever; muscle aches; This is a spontaneous report from a contactable consumer. A 67-year-old male consumer reported that he received first BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264), via an unspecified route of administration on 05Feb2021 as single dose on right arm for COVID-19 immunisation. The patient's medical history included ongoing enlarged prostate diagnosed 5 years ago (patient was taking a med for this). Patient's concomitant medications were reported as patient taking med for enlarged prostate. It was reported that patient took the first dose of Vaccine on 05Feb2021 and then couple of days later had symptoms of COVID, the COVID was diagnosed on 09Feb2021 and was given monoclonal infusion treatments. It was also reported that patient had positive COVID-19 tests were rapid tests, specific test name unknown, they were done on 09Feb2021, says it was a strong positive, but he had no symptoms, and thought it was from the vaccine since the next day after getting the vaccine he started getting a fever and muscle aches both on 06Feb2021. It was reported that took Aspirin to treat the fever and muscle aches. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021212385 Same reporter/diff patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: had her vaccine three weeks ago and is now on quarantine after testing positive for Covid.; had her vaccine three weeks ago and is now on quarantine after testing positive for Covid.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had her vaccine three weeks ago and is now on quarantine after testing positive for covid on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Vaccination site bruising, Vaccination site pain
Clinical narrative: migraine and chills; chills; Bruising and soreness at injection site; Bruising and soreness at injection site; This is a spontaneous case from a contactable consumer (patient). This 33-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) on 09Feb2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history included eczema, headaches, and benign tumor neck. Concomitant medications were none. Family history included Parkinon's disease and diabetes in the patient's father and diabetes, arthritis, kidney disease, psoriasis, fibromyalgia, glaucoma, and irritable bowel syndrome (IBS) in the patient's mother. The patient previously received dose 1 of BNT162B2 (lot number EL1283) on 19Jan2021 as a single dose in the right arm for COVID-19 immunization and experienced blistered burn and sensation of low grade current flowing through hands and sporadically throughout the limbs. On 10Feb2021, 25 hours after dose 2 of BNT162B2, the patient experienced migraine and chills. On an unspecified date after dose 2 of BNT162B2 the patient experienced bruising and soreness at injection site that lasted approximately 3 days. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of migraine and chills were recovered after approximately 12 hours. The outcomes of bruising and soreness at injection site were recovered after approximately 3 days.   No follow-up attempts are needed. No further information expected.  Follow-Up (05APR2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: nauseous; Sick; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 05Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient experienced nauseous and sick, after receiving the vaccine. The clinical outcome of the events nauseous and sick was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: This is a spontaneous report received from a Pfizer-sponsored program. A other healthcare professional reported that a 62-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: unknown), via an unspecified route of administration on 25 Feb 2021 (received at the age of 62-years-old) at a single dose for COVID-19 immunization; and started to receive tofacitinib citrate (XELJANZ XR, 11 mg prolonged-release tablet), orally, from Oct2020 to an unspecified date at 11 mg, 1x/day for rheumatoid arthritis. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient reported being off medication (tofacitinib citrate) for about 8 days, as instructed by MD (doctor). When she got her covid vaccine (BNT162B2) on 25Feb2021, she was supposed to be off her medication for almost 2 more weeks. She reported that while being off tofacitinib citrate she saw an improvement in symptoms. Her normal symptom with rheumatoid arthritis affected her left elbow and arm. Since being off of tofacitinib citrate she has less stiffness and pain to the left elbow. It wasn't until one day after getting the vaccine, she started having increased pain and swelling in the elbow again; she was unsure if it is from the vaccine or her rheumatoid arthritis. The action taken in response to the events for tofacitinib citrate was post-therapy. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: abdominal cramps turned to diarrhea; abdominal cramps turned to diarrhea; This is a spontaneous report via a Pfizer sponsored program Covax US Support from a contactable consumer, the patient.   A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162b2 first dose on 05Mar2021 and experienced side effects, abdominal cramps turned to diarrhea from yesterday and today (in Mar2021). She is not dehydrated. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Loss of consciousness, Magnetic resonance imaging, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: passed out; i may have had a TIA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 11:15 (at the age of 59-year-old) at single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies. Concomitant medication included losartan. No other vaccine in four weeks. No COVID prior vaccination. On 19Mar2021 11:15 AM, the patient immediately passed out and was taken by ambulance to hospital. They said that he may have had a TIA (even though the CT scan and MRI were clean). The patient will not get the 2nd vaccine because of his reaction. The adverse events resulted in Emergency room/department or urgent care, Hospitalization. He was hospitalized on 19Mar2021. The patient had nasal swab test on 19Mar2021 with negative result. The patient received treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Dysstasia, Feeling abnormal, Gait inability
Clinical narrative: I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I couldn't walk, sit, or lay on that side; I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed; I'm unable to work at my physical part-time job, and have extreme difficulty sitting for 8 hours for my banking job; It hurts to stand too long; I'm miserable; This is a spontaneous report from a contactable consumer, the patient.   A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at11:15 (at the age of 70 years old);  (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included stroke, high blood pressure, overweight. The patient has no known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)), ; lisinopril (LISINOPRIL); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); atorvastatin (ATORVASTATIN). Facility in which the vaccine was a Public Health Clinic. No other vaccines were given. Since the vaccination the patient had not been tested for COVID-19.  On 06Mar2021 at 18:00 The patient experienced Bursitis, Pain in hip, Unable to walk, Pain, Impaired work ability, Difficulty in standing and Feeling miserable. The events were reported as a disability. The clinical course is as follows The day before, the patient was totally healthy. Day after, I have excruciating hip pain in which the patient's doctor diagnosed as bursitis of the left hip. I couldn't walk, sit, or lay on that side. I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed. Oxycod/Acetamin only barely takes the edge off. The patient was unable to work at his physical part-time job, and have extreme difficulty sitting for 8 hours for his job. It hurts to stand too long. In short, I'm miserable and need help. The adverse events resulted in Physician Office Visit . Treatment given for the events include alternate hot/cold packs, oxycodin/acetamin. The clinical outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pain
Clinical narrative: I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I couldn't walk, sit, or lay on that side; I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed; I'm unable to work at my physical part-time job, and have extreme difficulty sitting for 8 hours for my banking job; It hurts to stand too long; I'm miserable; This is a spontaneous report from a contactable consumer, the patient.   A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at11:15 (at the age of 70 years old);  (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included stroke, high blood pressure, overweight. The patient has no known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)), ; lisinopril (LISINOPRIL); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); atorvastatin (ATORVASTATIN). Facility in which the vaccine was a Public Health Clinic. No other vaccines were given. Since the vaccination the patient had not been tested for COVID-19.  On 06Mar2021 at 18:00 The patient experienced Bursitis, Pain in hip, Unable to walk, Pain, Impaired work ability, Difficulty in standing and Feeling miserable. The events were reported as a disability. The clinical course is as follows The day before, the patient was totally healthy. Day after, I have excruciating hip pain in which the patient's doctor diagnosed as bursitis of the left hip. I couldn't walk, sit, or lay on that side. I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed. Oxycod/Acetamin only barely takes the edge off. The patient was unable to work at his physical part-time job, and have extreme difficulty sitting for 8 hours for his job. It hurts to stand too long. In short, I'm miserable and need help. The adverse events resulted in Physician Office Visit . Treatment given for the events include alternate hot/cold packs, oxycodin/acetamin. The clinical outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; aches; confusion; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the right arm on 12Mar2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) but had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine was administered in a public health clinic/veterans administration facility. On 14Mar2021, the patient had fever, aches and confusion. These events resulted in an emergency room/department or urgent care and hospitalization for 4 days (Mar2021). It was unknown if the patient received treatment. The patient has been tested for COVID-19 since vaccination, a nasal swab with the result of negative on 17Mar2021. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out approximately 6 hours after receive COVID-19 injection; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:30 (lot number: ENU204) at the age of 77 years old, as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. No other vaccines received four weeks prior to COVID vaccination. The patient took other unspecified medications two weeks prior to COVID vaccination. The patient passed out approximately 6 hours after receipt of COVID-19 injection on 18Mar2021 16:00. There was no warning, dizziness nor weakness of the knees, prior to passing out. The patient landed on his forehead (out less than a minute). There was no reoccurrence. His wife had shot same time, no effects. No treatment was received for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event on an unspecified date.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Pain assessment, Ultrasound scan
Clinical narrative: severe upper abdominal pain after eating; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) as single dose for covid-19 immunisation in the student health clinic. Medical history included MS and transverse myelitis, and peanuts allergy. The patient was not pregnant. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medications included lamotrigine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and ocrelizumab (OCREVUS); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the dose 1 BNT162B2 administered in right arm on 01Mar2021 16:00 (Lot Number: EN6202) (at age 52 years old) for covid-19 immunisation. No other vaccine was given in four weeks. The patient stated that she is not sure if this is related to the vaccine, but it's the only thing she has done differently. The day after her vaccine, on 20Mar2021, she had severe upper abdominal pain after eating. Then on day 2 (21Mar2021), she had another bout of unbearably severe pain (10/10) after eating. She went to ER and had a CT scan & ultrasound. The patient was given IV fluids, pain meds, and antacid. Outcome of the event was recovered with lasting effects.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head normal, Intensive care, Magnetic resonance imaging head abnormal
Clinical narrative: developed a clot which led to a left frontal cerebral vascular accident (CVA)/stroke; developed a clot which led to a left frontal cerebral vascular accident (CVA)/stroke; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 15Mar2021 11:00 (lot number: EN6207) at single dose for COVID-19 immunisation. The patient's medical history included ongoing slightly elevated blood pressure (diagnosis about 5 years ago). The patient's concomitant medication included metoprolol taken for slightly elevated blood pressure from 2017 and ongoing. The patient previously took second dose of influenza vaccine on Sep2019 and experienced flu like symptoms for 24hours. The vaccine facility type was clinic. Prior vaccinations (within 4 weeks) was none. On 22Mar2021, the patient developed a clot which led to left frontal cerebral vascular accident (CVA)/stroke on 22Mar2021 that resulted to an Emergency Room visit. The patient was hospitalized for from 22Mar2021 to 25Mar2021 (3 days) due to the events. The patient does not have any left or right arm deficits. Her speech has came back. She was cognizant right now. She had no other factors that would have contributed to this. She has no other pre-existing conditions or co-morbidities. The patient underwent lab tests and procedures which included blood pressure: within normal limits prior to the events on an unspecified date, head CT: unknown result, and MRI: left frontal lobe infarct, both on 23Mar2021. The outcome of the events were recovered on an unspecified date. The reporter was inquiring about correlation between vaccine and clot formation, cerebrovascular accidents, strokes. Seriousness criteria of the events were hospitalization, life-threatening.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Cerebrovascular accident and Clot blood cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Computerised tomogram head, Magnetic resonance imaging, Thrombosis
Clinical narrative: developed a clot which led to a left frontal cerebral vascular accident (CVA)/stroke; developed a clot which led to a left frontal cerebral vascular accident (CVA)/stroke; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 15Mar2021 11:00 (lot number: EN6207) at single dose for COVID-19 immunisation. The patient's medical history included ongoing slightly elevated blood pressure (diagnosis about 5 years ago). The patient's concomitant medication included metoprolol taken for slightly elevated blood pressure from 2017 and ongoing. The patient previously took second dose of influenza vaccine on Sep2019 and experienced flu like symptoms for 24hours. The vaccine facility type was clinic. Prior vaccinations (within 4 weeks) was none. On 22Mar2021, the patient developed a clot which led to left frontal cerebral vascular accident (CVA)/stroke on 22Mar2021 that resulted to an Emergency Room visit. The patient was hospitalized for from 22Mar2021 to 25Mar2021 (3 days) due to the events. The patient does not have any left or right arm deficits. Her speech has came back. She was cognizant right now. She had no other factors that would have contributed to this. She has no other pre-existing conditions or co-morbidities. The patient underwent lab tests and procedures which included blood pressure: within normal limits prior to the events on an unspecified date, head CT: unknown result, and MRI: left frontal lobe infarct, both on 23Mar2021. The outcome of the events were recovered on an unspecified date. The reporter was inquiring about correlation between vaccine and clot formation, cerebrovascular accidents, strokes. Seriousness criteria of the events were hospitalization, life-threatening.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Cerebrovascular accident and Clot blood cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; X-rays on his chest was bad, almost pneumonia; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 52; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer Covid vaccine on 15Mar2021. He went to the emergency room today (unspecified date/Mar2021) and tested positive for Covid. The X-rays on his chest was bad, almost pneumonia. No treatment was given but he was sent home with an oxygen and pulse meter. The patient's 2nd dose was scheduled on 05Apr2021. The reporter wanted to know whether the patient should get a second Covid test before receiving his 2nd dose of the Covid vaccine. The outcome of events was unknown.  Information about the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Deafness unilateral
Clinical narrative: Lost hearing in my right ear; lost most of vision in right eye; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at the age of 58-years-old on 03Mar2021 12:00 (Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included failed back surgery, heart disease, and known allergies. Concomitant medications included losartan potassium (LOSARTIN), carvedilol, levothyroxine sodium, atorvastatin calcium (ATORVASTIN), and "subu"; all taken for an unspecified indication, start and stop date were not reported. The patient reported, "Lost hearing in my right ear and lost most of vision in right eye" on 07Mar2021 06:30. Therapeutic measures were taken as a result of the events, which included Steroid shot through ear drum and oral steroids. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Facility type Vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, on an unspecified date in left arm at a single dose for COVID-19 immunization.  Information on lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling abnormal, Headache
Clinical narrative: the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Migraine, Pain, Pallor
Clinical narrative: the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tension headache, Tunnel vision, Vomiting
Clinical narrative: the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropathy, Cardiac flutter, Cardiac monitoring, Electrocardiogram
Clinical narrative: weakness in the knees; developed fluttering in the chest; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients (herself and husband). This is the first of two reports.   A female patient of an unspecified age (reported as 63,  no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, aterial stenosis, chronic kidney disease, and diabetes. The patient's concomitant medications were not reported. On 11Mar2021, during the initial 15 minutes she had no side effect or sore arm, but on the drive home which was approximately 30 miles, both she and her husband developed fluttering in the chest and then it went away. She felt okay that Friday, Saturday, and Sunday. Then Tuesday (16Mar2021) she developed fluttering in the chest and weakness in the knees. She called her PCP, and they did an EKG and that came back good. Then she went to the ER Saturday night (20Mar2021), received a drip, heart monitor and the doctor said everything looked okay. She was scheduled to see a heart doctor this upcoming Wednesday. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021314633 same report/drug, similar event, different patient.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropathy, Blood cholesterol, Blood pressure measurement, Cardiac flutter, Echocardiogram
Clinical narrative: weakness in the knees; developed fluttering in the chest; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients (herself and husband). This is the first of two reports.   A female patient of an unspecified age (reported as 63,  no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, aterial stenosis, chronic kidney disease, and diabetes. The patient's concomitant medications were not reported. On 11Mar2021, during the initial 15 minutes she had no side effect or sore arm, but on the drive home which was approximately 30 miles, both she and her husband developed fluttering in the chest and then it went away. She felt okay that Friday, Saturday, and Sunday. Then Tuesday (16Mar2021) she developed fluttering in the chest and weakness in the knees. She called her PCP, and they did an EKG and that came back good. Then she went to the ER Saturday night (20Mar2021), received a drip, heart monitor and the doctor said everything looked okay. She was scheduled to see a heart doctor this upcoming Wednesday. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021314633 same report/drug, similar event, different patient.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram
Clinical narrative: weakness in the knees; developed fluttering in the chest; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients (herself and husband). This is the first of two reports.   A female patient of an unspecified age (reported as 63,  no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, aterial stenosis, chronic kidney disease, and diabetes. The patient's concomitant medications were not reported. On 11Mar2021, during the initial 15 minutes she had no side effect or sore arm, but on the drive home which was approximately 30 miles, both she and her husband developed fluttering in the chest and then it went away. She felt okay that Friday, Saturday, and Sunday. Then Tuesday (16Mar2021) she developed fluttering in the chest and weakness in the knees. She called her PCP, and they did an EKG and that came back good. Then she went to the ER Saturday night (20Mar2021), received a drip, heart monitor and the doctor said everything looked okay. She was scheduled to see a heart doctor this upcoming Wednesday. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021314633 same report/drug, similar event, different patient.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aortic stenosis, Cardiac function test, Chronic kidney disease, Heart valve incompetence
Clinical narrative: weakness in the knees; developed fluttering in the chest; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients (herself and husband). This is the first of two reports.   A female patient of an unspecified age (reported as 63,  no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, aterial stenosis, chronic kidney disease, and diabetes. The patient's concomitant medications were not reported. On 11Mar2021, during the initial 15 minutes she had no side effect or sore arm, but on the drive home which was approximately 30 miles, both she and her husband developed fluttering in the chest and then it went away. She felt okay that Friday, Saturday, and Sunday. Then Tuesday (16Mar2021) she developed fluttering in the chest and weakness in the knees. She called her PCP, and they did an EKG and that came back good. Then she went to the ER Saturday night (20Mar2021), received a drip, heart monitor and the doctor said everything looked okay. She was scheduled to see a heart doctor this upcoming Wednesday. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021314633 same report/drug, similar event, different patient.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropathy, Cardiac flutter, Cardiac monitoring, Electrocardiogram
Clinical narrative: weak in her knees; fluttering in chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included blood pressure high, diabetes, CKD 3, high cholesterol and aortic stenosis. The patient's concomitant medications were not reported. On 11Mar2021, the patient took the vaccine and she waited the 15 minutes and was fine but on her ride home, she and her husband both got the shots, she got a fluttering in chest, it is a 30 minute drive home. It went away. Monday the patient kind of felt it again, she got it so bad she got weak in her knees (occurred on an unspecified date) but it cleared up so she didn't got to the emergency room. They did an EKG on her at her primary care provider and it was normal. Saturday night the fluttering in the patient's chest happened again but was worse. At about 4:45pm the patient's husband carried her into the emergency room and they gave her an IV drip, put her on the machine and they didn't see anything. The patient is scheduled for her second dose on 01Apr2021. The patient underwent lab tests and procedures which included cholesterol: high, blood pressure: high, echo: aortic stenosis and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of fluttering in chest included IVdrip. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropathy, Blood cholesterol, Blood pressure measurement, Cardiac flutter, Echocardiogram
Clinical narrative: weak in her knees; fluttering in chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included blood pressure high, diabetes, CKD 3, high cholesterol and aortic stenosis. The patient's concomitant medications were not reported. On 11Mar2021, the patient took the vaccine and she waited the 15 minutes and was fine but on her ride home, she and her husband both got the shots, she got a fluttering in chest, it is a 30 minute drive home. It went away. Monday the patient kind of felt it again, she got it so bad she got weak in her knees (occurred on an unspecified date) but it cleared up so she didn't got to the emergency room. They did an EKG on her at her primary care provider and it was normal. Saturday night the fluttering in the patient's chest happened again but was worse. At about 4:45pm the patient's husband carried her into the emergency room and they gave her an IV drip, put her on the machine and they didn't see anything. The patient is scheduled for her second dose on 01Apr2021. The patient underwent lab tests and procedures which included cholesterol: high, blood pressure: high, echo: aortic stenosis and EKG: normal on an unspecified date. Therapeutic measures were taken as a result of fluttering in chest included IVdrip. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.