chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia
Clinical narrative: low grade fever with temperatures going up to 99.F (his usual temperature is 98.F); Chest pain; This is a spontaneous report from a contactable nurse reporting for her husband. A male patient of an unspecified age (age: 77, unit: unspecified) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included heart disorder (reported as long heart history). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced low-grade fever with temperatures going up to 99 degrees Fahrenheit that lasted for about 24 hours, his usual temperature was 98 degrees Fahrenheit. The next day, he went to the ER because of chest pain, but they attribute it to his long heart history. The outcome of the event low-grade fever was recovered on an unspecified date in 2021 and unknown for chest pain.   Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test/COVID 19 Pneumonia; This is a spontaneous report from a contactable physician. A 79-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), the first dose via intramuscular on 14Jan2021 (Lot Number: EV1685, at age of 79 years old, no pregnant) at a single dose and the second dose via intramuscular on 04Feb2021 (Lot Number: EL8982, at age of 79 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 05Mar2021, patient was hospitalized with severe COVID 19 Pneumonia requiring 100% BiPAP. Antibody to SARS-COV2 not detected. AE resulted in: Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization: 8 days. Treatment received: Steroids. The patient did not have COVID prior vaccination. Covid test post vaccination on 06Mar2021: covid test type post vaccination: Nasal Swab. Covid test result=Positive. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, causality between events vaccination failure / covid-19 pneumonia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,) cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested for Covid Wednesday 10Mar2021, first dose 27dec2020, 2nd dose 14jan2021,Severe headache, fatigue, cough and congestion  on 09mar2021; tested for Covid Wednesday 10Mar2021, first dose 27dec2020, 2nd dose 14jan2021,Severe headache, fatigue, cough and congestion  on 09mar2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (unknown if pregnant) received first dose (lot number: EK9231) on 27Dec2020, second dose (lot number: EL1283) of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration, single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient experienced Severe headache, fatigue, cough and congestion began on Tuesday 09Mar2021, tested for Covid Wednesday 10Mar2021, positive results received Thursday 11Mar2021 and reporter notified Friday 12Mar2021. The outcome of the events was unknown. Unknown if treatment were given for the adverse events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Nasopharyngitis, SARS-CoV-1 test, Vaccination failure
Clinical narrative: diagnosed with CoVID positive; diagnosed with CoVID positive; mild symptoms of cold and congestion; mild symptoms of cold and congestion; This is a spontaneous report from a contactable Other HCP (patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EH9899), Expiration date: Unknown) via intramuscular route of administration in the left arm on 20Jan2021 at 15:45 (at the age of 36-year-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies. Concomitant medication includes Levothyroxine 5 mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2021 patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an intramuscular route of administration in the right arm on 30Dec2020 at 15:00. On 10Mar2021 at 12:300 patient was diagnosed with Covid positive. Patient have mild symptoms of cold and congestion. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported 'COVID 19' cannot be completely excluded.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects with breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng206), via an unspecified route of administration, administered in arm left on 08Mar2021 15:45 as a single dose (at the age of 37-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On 08Mar2021 17:00 (as reported) about an hour after receiving the first does, she felt her tongue swell and throat close. Resulted in multiple epi shots, hospitalization and still have lingering side effects with breathing. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for 2 days. The patient received epi shot in urgent care, another at hospital. The outcome of still lingering side effects with breathing was not recovered, while recovered on an unspecified date for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Oropharyngeal discomfort, Swollen tongue, Throat tightness
Clinical narrative: tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects with breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng206), via an unspecified route of administration, administered in arm left on 08Mar2021 15:45 as a single dose (at the age of 37-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On 08Mar2021 17:00 (as reported) about an hour after receiving the first does, she felt her tongue swell and throat close. Resulted in multiple epi shots, hospitalization and still have lingering side effects with breathing. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for 2 days. The patient received epi shot in urgent care, another at hospital. The outcome of still lingering side effects with breathing was not recovered, while recovered on an unspecified date for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: tongue swell and throat close.; tongue swell and throat close.; still have lingering side effects with breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng206), via an unspecified route of administration, administered in arm left on 08Mar2021 15:45 as a single dose (at the age of 37-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. On 08Mar2021 17:00 (as reported) about an hour after receiving the first does, she felt her tongue swell and throat close. Resulted in multiple epi shots, hospitalization and still have lingering side effects with breathing. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for 2 days. The patient received epi shot in urgent care, another at hospital. The outcome of still lingering side effects with breathing was not recovered, while recovered on an unspecified date for the other events.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: About an hour after the shot I felt my tongue swell slightly. Drinking water helped at first but about 20 mins after that I felt my throat get tight in the back. Went and received an epi shot. Paramedics took me to ER at the Hospital. In ER I received a a second epi shot about an hour after admission as tightness as starting again. Benadryl, prednisone and Pepcid was also given. I was admitted for observation for close to 28 hrs. Following morning I was given more prednisone and Benadryl. It?s been 3 weeks and I still have side effects with throat and tongue discomfort at night and when laying down. Awaiting results from follow up testing.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Oropharyngeal discomfort, Swollen tongue, Throat tightness
Clinical narrative: About an hour after the shot I felt my tongue swell slightly. Drinking water helped at first but about 20 mins after that I felt my throat get tight in the back. Went and received an epi shot. Paramedics took me to ER at the Hospital. In ER I received a a second epi shot about an hour after admission as tightness as starting again. Benadryl, prednisone and Pepcid was also given. I was admitted for observation for close to 28 hrs. Following morning I was given more prednisone and Benadryl. It?s been 3 weeks and I still have side effects with throat and tongue discomfort at night and when laying down. Awaiting results from follow up testing.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: About an hour after the shot I felt my tongue swell slightly. Drinking water helped at first but about 20 mins after that I felt my throat get tight in the back. Went and received an epi shot. Paramedics took me to ER at the Hospital. In ER I received a a second epi shot about an hour after admission as tightness as starting again. Benadryl, prednisone and Pepcid was also given. I was admitted for observation for close to 28 hrs. Following morning I was given more prednisone and Benadryl. It?s been 3 weeks and I still have side effects with throat and tongue discomfort at night and when laying down. Awaiting results from follow up testing.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: I went to emergency room due to abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 19:00 (lot number: PAA156051) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient went to emergency room due to abdominal pain on an unspecified date. No treatment was given for the event. Prior to vaccination, the patient had no COVID and patient was not tested for COVID post-vaccination. The patient was not pregnant at the time of report. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after receiving first dose of vaccine; tested positive after receiving first dose of vaccine; This is a spontaneous report from a Pfizer. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Caller's mom tested positive after receiving first dose of vaccine. Caller wanted to know if his mom should receive second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They fell sick and tested positive for Covid 19; They fell sick and tested positive for Covid 19; This is a spontaneous report from a contactable pharmacist. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date in Feb2021, as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Relevant medical history and concomitant medication were not provided. On an unspecified date in Feb2021 after receiving the first dose, the patient fell sick and tested positive for Covid 19 and missed the second dose. They came into the pharmacy to get the second dose of the vaccine. The outcome of the event fell sick and tested positive for Covid 19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) at the age of 44, intramuscularly, administered in the left arm on 15Feb2021 at 15:30 as a single dose for covid-19 immunization. Medical history included covid-19 (If covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Patient has no known allergies.  Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); and ibuprofen (ADVIL [IBUPROFEN]) all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 at the age of 44, given intramuscularly in the left arm on 25Jan2021 at 03:30 PM for Covid-19 immunisation. On 22Feb2021, 6 days after receiving the 2nd dose, patient experienced sudden hearing loss and tinnitus in right ear and severe vertigo 8 days after (24Feb2021). Patient was prescribed high dose steroids from doctor. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient was still suffering from hearing loss and tinnitus 3 weeks later. The patient underwent lab tests and procedures which included multiple hearing tests and Magnetic resonance imaging (MRI) both on unknown date with unknown result. The outcome of the event was recovering at the time of the report.; Sender's Comments: Based on known drug profile it  is unlikely that the reported sudden hearing loss, tinnitus and severe vertigo were causally related to bnt162b2.  These are intercurrent  medical conditions.  Case will be reassessed if additional information is received.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: felt unwell; This is a spontaneous report from a contactable healthcare professional. A 65-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in arm left on 11Feb2021 16:00 as single dose for COVID-19 immunisation. Medical history included in the 1990's, patient was diagnosed with systemic sclerosis (limited) this used to be called CREST scleroderma. She had pretty severe Raynaud's Syndrome and telangiectasia, fatigue and sometimes, joint aches. She was healthy despite this. Patient was not pregnant. Concomitant medications included amlodipine besylate, escitalopram oxalate (LEXAPRO), and clonazepam (KLONOPIN). The patient felt unwell after the first vaccine on an unspecified date but went to work and was fine in 2 days. The patient underwent lab tests and procedures which included Covid test (nasal swab): Negative on 03Mar2021. Outcome of the event was resolved.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hot flush, Thyroid function test, Thyroid function test abnormal
Clinical narrative: Thyroid test spiked; Hot and cold flashes; Hot and cold flashes; Tired; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Mar2021 (Sunday) 18:30 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at 63-year-old) at single dose in arm right for COVID-19 immunization. Medical history included mitral valve and atrial valve leaking from last year (2020), thyroid removed. No additional vaccines administered on same date of BNT162B2, no prior vaccine within 4 weeks, and no family medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration Date: 30Jun2021) on 14Feb2021 18:30 at single dose in the right arm for COVID-19 immunization. She noticed on "Monday" (08Mar2021) she had some hot and cold flashes and she felt tired, which went away the same day. They always checked blood test for thyroid levels randomly because she had her thyroid removed in the past. It has been three months since the last test and the nurse called her "today"/ "this morning" (09Mar2021) to report the result was spiked (thyroid test spiked). She didn't know the actual result, just it was spiked. She usually took 125 mcg levothyroxine sodium (SYNTHROID) once daily by mouth. The events didn't require a visit to physician or ER, and no other relevant test. The outcomes of events tiredness, hot and cold flashes was resolved on 08Mar2021, while of event thyroid function test abnormal was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Thyroiditis: inflammation of thyroid; Pain swallowing; Sweating; Fatigue; Nausea; Elevated creative protein; Elevated ESR Rate; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), (lot number unknown, Unable to locate or read the details), via an unspecified route of administration, administered in Arm Left on 03Feb2021 13:15 as single dose for COVID-19 immunisation. Medical history included known allergies to Sulfa and High blood pressure. The patient was not pregnant. Concomitant medications in two weeks included rosuvastatin calcium (CRESTOR); valsartan; ezetimibe (ZETIA); hydrochlorothiazide (HCTZ); colesevelam hydrochloride (WELCHOL) ; ergocalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 13Jan2021 15:45 as single dose for COVID-19 immunization.  The patient did not receive other vaccine in four weeks. The patient experienced thyroiditis: inflammation of thyroid, pain swallowing, sweating, fatigue, Nausea, elevated creative protein: went from 0.4 to 14 Elevated ESR Rate on 04Feb2021 01:00 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included 400 mg of Motrin every 6-8 hours. The patient did not have covid prior vaccination. The patient had COVID tested post vaccination, test type post vaccination was Nasal Swab on 26Feb2021 with results Negative. Facility type vaccine was Nursing Home/Senior Living Facility. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Odynophagia, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, SARS-CoV-2 test, Thyroiditis
Clinical narrative: Thyroiditis: inflammation of thyroid; Pain swallowing; Sweating; Fatigue; Nausea; Elevated creative protein; Elevated ESR Rate; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), (lot number unknown, Unable to locate or read the details), via an unspecified route of administration, administered in Arm Left on 03Feb2021 13:15 as single dose for COVID-19 immunisation. Medical history included known allergies to Sulfa and High blood pressure. The patient was not pregnant. Concomitant medications in two weeks included rosuvastatin calcium (CRESTOR); valsartan; ezetimibe (ZETIA); hydrochlorothiazide (HCTZ); colesevelam hydrochloride (WELCHOL) ; ergocalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 13Jan2021 15:45 as single dose for COVID-19 immunization.  The patient did not receive other vaccine in four weeks. The patient experienced thyroiditis: inflammation of thyroid, pain swallowing, sweating, fatigue, Nausea, elevated creative protein: went from 0.4 to 14 Elevated ESR Rate on 04Feb2021 01:00 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included 400 mg of Motrin every 6-8 hours. The patient did not have covid prior vaccination. The patient had COVID tested post vaccination, test type post vaccination was Nasal Swab on 26Feb2021 with results Negative. Facility type vaccine was Nursing Home/Senior Living Facility. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Chills, Eye pain
Clinical narrative: very ill/sick; fever ran between 101 and 102.5; in bed for two days; Severe headache; Eye pain; Chills; Feeling bad; do not feel strong enough to deal with the side effects; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Oct2020 (very end of Oct). The patient's concomitant medications were not reported. The patient experienced feeling very ill/sick, fever ran between 101 and 102.5, in bed for two days, severe headache, eye pain, chills, feeling bad, and do not feel strong enough to deal with the side effects in Mar2021. The clinical course was reported as follows: the patient ran a 100.5 fever and high fever (between 101 and 102.5) in Mar2021 and was in bed for two days with severe headache, and eye pain. The patient stated it was like having COVID-19 all over again. The clinical outcome of all of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290577 same reporter/drug, different patient, similar events
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Pyrexia
Clinical narrative: very ill/sick; fever ran between 101 and 102.5; in bed for two days; Severe headache; Eye pain; Chills; Feeling bad; do not feel strong enough to deal with the side effects; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Oct2020 (very end of Oct). The patient's concomitant medications were not reported. The patient experienced feeling very ill/sick, fever ran between 101 and 102.5, in bed for two days, severe headache, eye pain, chills, feeling bad, and do not feel strong enough to deal with the side effects in Mar2021. The clinical course was reported as follows: the patient ran a 100.5 fever and high fever (between 101 and 102.5) in Mar2021 and was in bed for two days with severe headache, and eye pain. The patient stated it was like having COVID-19 all over again. The clinical outcome of all of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290577 same reporter/drug, different patient, similar events
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Computerised tomogram, Cough, Dysphonia, Electrocardiogram
Clinical narrative: Froggy throat; Cough; This is a spontaneous report from a contactable consumer, the patient   A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: LV6199)  via an unspecified route of administration, administered in Arm Left on 04Mar2021 (right before 12:00PM)  as SINGLE DOSE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Hospital Medical history included  pulmonary embolism from Aug2020 to an unknown date , Arthritic injured equestrian knees/Has bad knees (gets x-ray guided knee injections) , abdominal pain,  Small hiatal hernia (had a stress test in January and they found a small hiatal hernia) , hearing aid user,  weight decreased (prior to getting the vaccine),  Lost her appetite (walking around with a pulmonary embolism and lost her appetite) , Pulse rate low (hospitalized twice  thought she had heart attack, but it was just the blood pressure medication) and tooth extraction (Root canal and Crown went bad). Concomitant medications  included apixaban (ELIQUIS) taken for pulmonary embolism from Aug2020, losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), omeprazole (OMEPRAZOLE) taken for abdominal pain,  paracetamol (TYLENOL) taken for arthritis. Past drug events include Lisinopril made her feel awful, Amlodipine (put her in the ER), Metoprolol (kept her blood pressure low. No other vaccines were given within 4 weeks.   Historical Vaccine includes bnt162b2 Dose 1, Lot Number: EM9810 in the: left upper arm for Covid-19 Immunization.  Historical vaccine also includes Pneumonia Vaccine, Shingles Vaccine (up to date with vaccines that are appropriate for her age group) and Flu Vaccine (last fall). The consumer (patient) stated she is just reporting what she believes is a side effect. On 09Mar2021,The patient experienced froggy throat and on Mar2021 experienced cough that came on a few days after getting the vaccine.  Patient only called to her physician see if they were tracking it, Not that she needed care. She called her doctors office and they were not concerned unless it did not go away. Froggy Throat  is persisting, but like right now she is talking and drinking it is a little better. The patient underwent lab tests and procedures (all tests were prior to covid-19 vaccine) which included Regular annual physical unknown results on Dec2020; Stress test discovered small hiatal hernia  Every now and then she gets chest twinges in January (year unspecified) and they found a small hiatal hernia) on an unspecified date; CT scan result pulmonary embolism Aug 2020, EKG (After her last annual physical and after the embolism) Unknown Results on an unspecified date, Pulse rate 48 (hospitalized twice and they thought she had heart attack, but it was just the blood pressure medication)  on an unspecified date and X-ray (for guided knee injection) on unspecified date. The clinical outcome of the event foggy throat was recovering while cough was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Laboratory test, X-ray
Clinical narrative: Froggy throat; Cough; This is a spontaneous report from a contactable consumer, the patient   A 69-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: LV6199)  via an unspecified route of administration, administered in Arm Left on 04Mar2021 (right before 12:00PM)  as SINGLE DOSE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was a Hospital Medical history included  pulmonary embolism from Aug2020 to an unknown date , Arthritic injured equestrian knees/Has bad knees (gets x-ray guided knee injections) , abdominal pain,  Small hiatal hernia (had a stress test in January and they found a small hiatal hernia) , hearing aid user,  weight decreased (prior to getting the vaccine),  Lost her appetite (walking around with a pulmonary embolism and lost her appetite) , Pulse rate low (hospitalized twice  thought she had heart attack, but it was just the blood pressure medication) and tooth extraction (Root canal and Crown went bad). Concomitant medications  included apixaban (ELIQUIS) taken for pulmonary embolism from Aug2020, losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), omeprazole (OMEPRAZOLE) taken for abdominal pain,  paracetamol (TYLENOL) taken for arthritis. Past drug events include Lisinopril made her feel awful, Amlodipine (put her in the ER), Metoprolol (kept her blood pressure low. No other vaccines were given within 4 weeks.   Historical Vaccine includes bnt162b2 Dose 1, Lot Number: EM9810 in the: left upper arm for Covid-19 Immunization.  Historical vaccine also includes Pneumonia Vaccine, Shingles Vaccine (up to date with vaccines that are appropriate for her age group) and Flu Vaccine (last fall). The consumer (patient) stated she is just reporting what she believes is a side effect. On 09Mar2021,The patient experienced froggy throat and on Mar2021 experienced cough that came on a few days after getting the vaccine.  Patient only called to her physician see if they were tracking it, Not that she needed care. She called her doctors office and they were not concerned unless it did not go away. Froggy Throat  is persisting, but like right now she is talking and drinking it is a little better. The patient underwent lab tests and procedures (all tests were prior to covid-19 vaccine) which included Regular annual physical unknown results on Dec2020; Stress test discovered small hiatal hernia  Every now and then she gets chest twinges in January (year unspecified) and they found a small hiatal hernia) on an unspecified date; CT scan result pulmonary embolism Aug 2020, EKG (After her last annual physical and after the embolism) Unknown Results on an unspecified date, Pulse rate 48 (hospitalized twice and they thought she had heart attack, but it was just the blood pressure medication)  on an unspecified date and X-ray (for guided knee injection) on unspecified date. The clinical outcome of the event foggy throat was recovering while cough was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dosage of vaccine on 25Feb2021 and was supposed to receive the second dose somewhere between the 18Mar2021 and 21Mar2021, but the patient got Covid on an unspecified date. The patient was supposed to go back and get it another week to take the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277020 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: fever 103; chills; muscle soreness; Joint pain; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old male patient received second dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (Covid 19; Batch/Lot number: EJ1685 on Interdermal Rightt deltoid, Expiry date: 28Jun2021) on 19Dec2020 at 14:30 for Covid-19 immunization and had Fever 100.2, Chills, Headache, Swollen lymph neck, Muscle and joint ache, Tiredness, Injection site pain. Family history included ongoing High Blood pressure, History of antibodies without confirmed covid 19 +(positive) on Mar2020. Patient previously took Erythromycin and had allergy. On an unspecified date, 6-12 hours post 2nd injection, patient had Fever 103, Chills, muscle soreness/Joint pain. Outcome of events Fever and Chills were recovered on an unspecified date, while with other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Nausea
Clinical narrative: felt pretty sick on his stomach; felt dizzy; Back pain; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient got the second dose 24 hours ago, he felt pretty sick on his stomach and felt dizzy. He took medication as well (Hydrocodone-Acetaminophen) for his back pain. Outcome of all events was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Can not stand up with out feeling like I'm gonna pass out.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 66 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs and bladder infection. The patient's concomitant medications included medications for her bladder infection. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose on 16Feb2021 11:00 AM in the left arm (at 66 years of age) for Covid-19 immunization. The patient was not pregnant. The patient had no other vaccine in four weeks prior to covid vaccine. She had not had Covid-19 prior vaccination and she had not been tested for Covid post vaccination. It was reported that the patient cannot stand up without feeling like she's gonna pass out on 10Mar2021 at 12:00 AM. The outcome of the event was recovering and no treatment received for the event.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flatulence
Clinical narrative: gas on her stomach; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported for herself. A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 05Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient was experiencing like she had a gas on her stomach.  Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: diarrhea that lasted until 06Mar2021 and ended with bleeding.; This is a spontaneous report received from a Pfizer sponsor program via Medical information team. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that on 28Feb2021 she experienced diarrhea that lasted until 06Mar2021 and ended with bleeding on an unspecified date in 2021. Patient was asking if this can be related to the vaccine. Patient received first Covid vaccine on 25Feb2021 Second dose is Scheduled four weeks later on 25Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Diarrhoea, Haemorrhage
Clinical narrative: diarrhea that lasted until 06Mar2021 and ended with bleeding.; This is a spontaneous report received from a Pfizer sponsor program via Medical information team. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient mentioned that on 28Feb2021 she experienced diarrhea that lasted until 06Mar2021 and ended with bleeding on an unspecified date in 2021. Patient was asking if this can be related to the vaccine. Patient received first Covid vaccine on 25Feb2021 Second dose is Scheduled four weeks later on 25Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Feb2021 at 11:00 at a single dose for COVID-19 immunisation. Medical history included anxiety, cholesterol was getting high, blood pressure is a little high, depression, asthma, arthritis and bowel problem. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for depression from 1999 and ongoing; ongoing alprazolam (XANAX) taken for anxiety; ongoing aripiprazole (ABILIFY) taken for anxiety and depression; ongoing mirtazapine; ongoing diclofenac taken for arthritis; ongoing atorvastatin calcium (LIPITOR) taken for Cholesterol was getting high; ongoing enalapril taken since blood pressure is a little high at times; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma. On 28Feb2021, without any changes to her diet; she started having diarrhea and had it for 7 days. Inquiring as to whether it was a possible side effect from vaccine. Stated diarrhea lasted until the morning of 06Mar2021 and ended with bleeding on an unspecified date. Stated she has recovered and was back to normal. She did not have any labs, testing or treatments but was seeing a new Gastroenterologist on 20Apr2021 due to this event. She doesn't know what the bowel problem was; that this happened sometimes but this was the first time ended in bleeding. Had colonoscopy 30Nov2020 and was fine, no polyps. The facility where the vaccine was administered was in a Local (pharmacy name withheld) Pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event diarrhea was recovered on 06Mar2021 and unknown for the other event.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Diarrhoea, Haemorrhage
Clinical narrative: bleeding; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Feb2021 at 11:00 at a single dose for COVID-19 immunisation. Medical history included anxiety, cholesterol was getting high, blood pressure is a little high, depression, asthma, arthritis and bowel problem. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for depression from 1999 and ongoing; ongoing alprazolam (XANAX) taken for anxiety; ongoing aripiprazole (ABILIFY) taken for anxiety and depression; ongoing mirtazapine; ongoing diclofenac taken for arthritis; ongoing atorvastatin calcium (LIPITOR) taken for Cholesterol was getting high; ongoing enalapril taken since blood pressure is a little high at times; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma. On 28Feb2021, without any changes to her diet; she started having diarrhea and had it for 7 days. Inquiring as to whether it was a possible side effect from vaccine. Stated diarrhea lasted until the morning of 06Mar2021 and ended with bleeding on an unspecified date. Stated she has recovered and was back to normal. She did not have any labs, testing or treatments but was seeing a new Gastroenterologist on 20Apr2021 due to this event. She doesn't know what the bowel problem was; that this happened sometimes but this was the first time ended in bleeding. Had colonoscopy 30Nov2020 and was fine, no polyps. The facility where the vaccine was administered was in a Local (pharmacy name withheld) Pharmacy. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office or Emergency Room. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event diarrhea was recovered on 06Mar2021 and unknown for the other event.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Vomiting; sore throat; joint and muscle pain; joint and muscle pain; loss of appetite; cough; extreme fatigue; diarrhea; lost 10 pounds in one week; This is a spontaneous report received from a 69-years-old female consumer (patient) reported that. A 69-years-old female patient received bnt162b2 (BNT162B2;solution for injection; Lot no#EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 04:00 PM as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL) 20 mg once a day. On 03Mar2021, the patient experienced vomiting, sore throat, joint and muscle pain, loss of appetite, cough, extreme fatigue, diarrhea, lost 10 pounds in one week. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021 covid test type post vaccination=Nasal Swab. The patient was not received treatment for the adverse event. Outcome of events were not recovered. Patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, SARS-CoV-2 test, Vomiting, Weight decreased
Clinical narrative: Vomiting; sore throat; joint and muscle pain; joint and muscle pain; loss of appetite; cough; extreme fatigue; diarrhea; lost 10 pounds in one week; This is a spontaneous report received from a 69-years-old female consumer (patient) reported that. A 69-years-old female patient received bnt162b2 (BNT162B2;solution for injection; Lot no#EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 04:00 PM as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL) 20 mg once a day. On 03Mar2021, the patient experienced vomiting, sore throat, joint and muscle pain, loss of appetite, cough, extreme fatigue, diarrhea, lost 10 pounds in one week. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021 covid test type post vaccination=Nasal Swab. The patient was not received treatment for the adverse event. Outcome of events were not recovered. Patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.