chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Tremor
Clinical narrative: severe chills; shaking; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity, heart disease (unspecified), dental implantation, blood pressure high and COVID-19 (which was diagnosed prior to the vaccination). On 25Jun2020, the patient underwent SARS-Cov-2-IgG (Blood test) and the result was positive. The patient received unspecified medications within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the result was unknown. On 25Mar2021 at about 15:00, the patient experienced severe chills and shaking, needed third blanket to sleep. The condition abated by morning. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills and shaking was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tremor
Clinical narrative: severe chills; shaking; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity, heart disease (unspecified), dental implantation, blood pressure high and COVID-19 (which was diagnosed prior to the vaccination). On 25Jun2020, the patient underwent SARS-Cov-2-IgG (Blood test) and the result was positive. The patient received unspecified medications within two weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for an unspecified indication and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the result was unknown. On 25Mar2021 at about 15:00, the patient experienced severe chills and shaking, needed third blanket to sleep. The condition abated by morning. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills and shaking was recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Loss of personal independence in daily activities
Clinical narrative: body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Musculoskeletal stiffness, Nausea, Night sweats, Pain
Clinical narrative: body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Somnolence, Vision blurred
Clinical narrative: body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pain
Clinical narrative: body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: body aches (back, head, shoulders, neck, stiff neck, etc); chills; high fever 103; fatigue/wiped out; no strength; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6207) via an unspecified route of administration in the left arm on 25Mar2021 at 18:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, 10 years prior in 2011. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG6201) via an unspecified route of administration in the left arm on 04Mar2021 at 20:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26March2021, day after shot, the patient experienced chills, high fever 103, fatigue, no strength, and wiped out. On 27Mar2021, the patient experienced body aches (back, head, shoulders, neck, stiff neck, etc), and fatigue. On 26Mar2021, the body temperature was reported as 103. Therapeutic measures were taken as a result of the event fever and included treatment with TYLENOL, fever broke approximately at 18:00 after taking TYLENOL a few hours earlier on 27Mar2021. The clinical outcome of the events chills, high fever, fatigue, no strength, wiped out, and body aches (back, head, shoulders, neck, stiff neck, etc) was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Pain in extremity, Tinnitus
Clinical narrative: Metallic taste in mouth; Tinnitus; Sore armpit; Sore arm; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 08Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 19:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included functional natural killer cell deficiency, ulcerative colitis, lichen sclerosus, asthma, eczema, blepharitis. The patient had a history of allergies to sulfa and cephalosporins. Concomitant medications included mesalazine (LIALDA), famciclovir (FAMVIR), docusate sodium (COLACE), vitamin d not otherwise specified (NOS) (MANUFRATURER UNKNOWN), zinc (MANUFRATURER UNKNOWN), unknown active substance (COQ10) and "mi" all since an unknown date for an unknown indication. The patient previously took levofloxacin (LEVAQUIN) on an unknown date for unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 15:00, the patient experienced tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The patient did not receive any treatment for the events. The clinical outcome of the events tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Dysgeusia, Fatigue, Herpes zoster, Pain in extremity
Clinical narrative: Metallic taste in mouth; Tinnitus; Sore armpit; Sore arm; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 08Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 19:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included functional natural killer cell deficiency, ulcerative colitis, lichen sclerosus, asthma, eczema, blepharitis. The patient had a history of allergies to sulfa and cephalosporins. Concomitant medications included mesalazine (LIALDA), famciclovir (FAMVIR), docusate sodium (COLACE), vitamin d not otherwise specified (NOS) (MANUFRATURER UNKNOWN), zinc (MANUFRATURER UNKNOWN), unknown active substance (COQ10) and "mi" all since an unknown date for an unknown indication. The patient previously took levofloxacin (LEVAQUIN) on an unknown date for unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 15:00, the patient experienced tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The patient did not receive any treatment for the events. The clinical outcome of the events tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Metallic taste in mouth; Tinnitus; Sore armpit; Sore arm; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 08Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 19:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included functional natural killer cell deficiency, ulcerative colitis, lichen sclerosus, asthma, eczema, blepharitis. The patient had a history of allergies to sulfa and cephalosporins. Concomitant medications included mesalazine (LIALDA), famciclovir (FAMVIR), docusate sodium (COLACE), vitamin d not otherwise specified (NOS) (MANUFRATURER UNKNOWN), zinc (MANUFRATURER UNKNOWN), unknown active substance (COQ10) and "mi" all since an unknown date for an unknown indication. The patient previously took levofloxacin (LEVAQUIN) on an unknown date for unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 15:00, the patient experienced tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The patient did not receive any treatment for the events. The clinical outcome of the events tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Dysgeusia, Fatigue, Headache, Pain in extremity
Clinical narrative: Metallic taste in mouth; Tinnitus; Sore armpit; Sore arm; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 08Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the right arm on 29Mar2021 at 19:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included functional natural killer cell deficiency, ulcerative colitis, lichen sclerosus, asthma, eczema, blepharitis. The patient had a history of allergies to sulfa and cephalosporins. Concomitant medications included mesalazine (LIALDA), famciclovir (FAMVIR), docusate sodium (COLACE), vitamin d not otherwise specified (NOS) (MANUFRATURER UNKNOWN), zinc (MANUFRATURER UNKNOWN), unknown active substance (COQ10) and "mi" all since an unknown date for an unknown indication. The patient previously took levofloxacin (LEVAQUIN) on an unknown date for unknown indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 15:00, the patient experienced tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The patient did not receive any treatment for the events. The clinical outcome of the events tinnitus, sore arm, sore armpit, metallic taste in mouth, fatigue and headache were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 10:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic cough. The patient has pineapple allergy. The concomitant medications not included. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021 at 10:30, almost immediately after vaccine was administered the patient experienced metallic taste in the mouth. The patient did not receive any treatment for the event. The clinical outcome of the event metallic taste was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Rash both sides of neck; itching; flushing of area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), osteoarthritis, generalized anxiety, histoplasmosis, right orbital Arteriovenous malformations (AVM), trigeminal neuralgia, recurrent pneumonia and acid reflux. The patient was allergic to penicillin (PCN) and sulfa meds. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and had drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 22:30, the patient experienced rash on both sides of neck, itching and flushing of area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events rash both sides of neck, itching and flushing was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: Rash both sides of neck; itching; flushing of area; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), osteoarthritis, generalized anxiety, histoplasmosis, right orbital Arteriovenous malformations (AVM), trigeminal neuralgia, recurrent pneumonia and acid reflux. The patient was allergic to penicillin (PCN) and sulfa meds. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and had drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 22:30, the patient experienced rash on both sides of neck, itching and flushing of area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events rash both sides of neck, itching and flushing was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Parosmia, Rhinorrhoea, Sinusitis
Clinical narrative: congestion; cough; eyes hurt; nasal drip; aches and pains all over; fever; chills; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 31Mar2021 at 10:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included acute frontal sinusitis, thyroid disorder (underactive thyroid), type 2 diabetes mellitus without complication, mixed hyperlipidemia, blood pressure high, COVID-19, seafood allergy, fish allergy, and drug allergy (all statins drug allergy). Patient received other medications in two weeks which included ipratropium (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication received within 2 weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the arm left on 10Mar2021 at 12:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 19:00 the patient experienced fever, chills, cough, fatigue, congestion, headache, eyes hurt, nasal drip, aches and pains all over. Patient received treatment for the events which included cephalexin antibiotic for sinuses, tylen. The reported events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of fever, chills, cough, fatigue, nasal congestion, headache, pain in eyes, post nasal drip, general body pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Eye pain, Fatigue, Headache
Clinical narrative: congestion; cough; eyes hurt; nasal drip; aches and pains all over; fever; chills; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 31Mar2021 at 10:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included acute frontal sinusitis, thyroid disorder (underactive thyroid), type 2 diabetes mellitus without complication, mixed hyperlipidemia, blood pressure high, COVID-19, seafood allergy, fish allergy, and drug allergy (all statins drug allergy). Patient received other medications in two weeks which included ipratropium (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication received within 2 weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the arm left on 10Mar2021 at 12:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 19:00 the patient experienced fever, chills, cough, fatigue, congestion, headache, eyes hurt, nasal drip, aches and pains all over. Patient received treatment for the events which included cephalexin antibiotic for sinuses, tylen. The reported events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of fever, chills, cough, fatigue, nasal congestion, headache, pain in eyes, post nasal drip, general body pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, Upper-airway cough syndrome
Clinical narrative: congestion; cough; eyes hurt; nasal drip; aches and pains all over; fever; chills; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 31Mar2021 at 10:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included acute frontal sinusitis, thyroid disorder (underactive thyroid), type 2 diabetes mellitus without complication, mixed hyperlipidemia, blood pressure high, COVID-19, seafood allergy, fish allergy, and drug allergy (all statins drug allergy). Patient received other medications in two weeks which included ipratropium (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication received within 2 weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the arm left on 10Mar2021 at 12:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 19:00 the patient experienced fever, chills, cough, fatigue, congestion, headache, eyes hurt, nasal drip, aches and pains all over. Patient received treatment for the events which included cephalexin antibiotic for sinuses, tylen. The reported events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of fever, chills, cough, fatigue, nasal congestion, headache, pain in eyes, post nasal drip, general body pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears. Tinnitus.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included immunization. Concomitant medications were not reported. The patient previously received vaccine flu shot (MANUFACTURER UNKNOWN) in the left arm on 18Feb2021 for immunisation. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced ringing in ears, tinnitus which did not stop or go away. Therapeutic measures were taken as a result of reported event was unknown. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ringing in ears, tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood culture, Chest X-ray, Chest pain, Culture urine, Cytomegalovirus test
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Echocardiogram, Electrocardiogram, Fatigue, Feeding disorder
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Malaise, Nausea, Pyrexia, Respiratory viral panel
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler, Ultrasound kidney, Ventilation/perfusion scan
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Blood parathyroid hormone, Blood urea increased, Chest pain, Decreased appetite
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dehydration, Glomerular filtration rate increased, Haematocrit decreased, Haemoglobin decreased, Malaise
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Renal impairment
Clinical narrative: Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days  Treatment: IV fluids  observation
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site vesicles, Rash
Clinical narrative: After shot blisters stop popping up on upper and lower arm which spread to his thighs and back filled with clear fluid, start popping up again on hands and arms
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: After shot blisters stop popping up on upper and lower arm which spread to his thighs and back filled with clear fluid, start popping up again on hands and arms
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Allergy test, Dyspepsia, Eructation
Clinical narrative: Tachycardia/POTS; Gastritis; Constant dull ache in stomach and severe burning pain; severe burning pain in stomach after eating anything; Eating anything; major bloating, gas, burping.; Eating anything; major bloating, gas, burping.; major bloating, gas, burping.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8737), intramuscular, in the left arm on 07Apr2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. Medical history included bradycardia, covid-19 from 24Dec2020 to 06Jan2021 with very minor symptoms, allergy to amoxicillin and azithromycin. There were no concomitant medications. The patient was vaccinated at urgent care center and was not pregnant. No other vaccine was given in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6207), intramuscular, in the left arm on 13Mar2021 13:00 as dose 1, single for COVID-19 immunization. The patient experienced constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping in Apr2021. The debilitating stomach issues started 1 week after second vaccination. The patient had gastritis on 11Apr2021 and Tachycardia on 14Jun2021. The patient reported that the events gastritis and tachycardia/POTS were serious and caused persistent/significant disability/incapacity. The events resulted in physician office visit. The events constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping was treated with PPIs and acupuncture. Therapeutic measure for event gastritis included PPI and time off weekly endoscopy. Therapeutic measure for the event tachycardia/ POTS included Holter monitor for 15 days. The patient also had ongoing work with cardiologist. The patient underwent lab tests and procedures which included Covid nasal swab test: positive on 31Dec2020, negative on 06Jan2021 and negative in May2021. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flatulence, Helicobacter test negative
Clinical narrative: Tachycardia/POTS; Gastritis; Constant dull ache in stomach and severe burning pain; severe burning pain in stomach after eating anything; Eating anything; major bloating, gas, burping.; Eating anything; major bloating, gas, burping.; major bloating, gas, burping.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8737), intramuscular, in the left arm on 07Apr2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. Medical history included bradycardia, covid-19 from 24Dec2020 to 06Jan2021 with very minor symptoms, allergy to amoxicillin and azithromycin. There were no concomitant medications. The patient was vaccinated at urgent care center and was not pregnant. No other vaccine was given in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6207), intramuscular, in the left arm on 13Mar2021 13:00 as dose 1, single for COVID-19 immunization. The patient experienced constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping in Apr2021. The debilitating stomach issues started 1 week after second vaccination. The patient had gastritis on 11Apr2021 and Tachycardia on 14Jun2021. The patient reported that the events gastritis and tachycardia/POTS were serious and caused persistent/significant disability/incapacity. The events resulted in physician office visit. The events constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping was treated with PPIs and acupuncture. Therapeutic measure for event gastritis included PPI and time off weekly endoscopy. Therapeutic measure for the event tachycardia/ POTS included Holter monitor for 15 days. The patient also had ongoing work with cardiologist. The patient underwent lab tests and procedures which included Covid nasal swab test: positive on 31Dec2020, negative on 06Jan2021 and negative in May2021. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Dyspepsia, Electrocardiogram ambulatory, Eructation
Clinical narrative: Tachycardia/POTS; Gastritis; Constant dull ache in stomach and severe burning pain; severe burning pain in stomach after eating anything; Eating anything; major bloating, gas, burping.; Eating anything; major bloating, gas, burping.; major bloating, gas, burping.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8737), intramuscular, in the left arm on 07Apr2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. Medical history included bradycardia, covid-19 from 24Dec2020 to 06Jan2021 with very minor symptoms, allergy to amoxicillin and azithromycin. There were no concomitant medications. The patient was vaccinated at urgent care center and was not pregnant. No other vaccine was given in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6207), intramuscular, in the left arm on 13Mar2021 13:00 as dose 1, single for COVID-19 immunization. The patient experienced constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping in Apr2021. The debilitating stomach issues started 1 week after second vaccination. The patient had gastritis on 11Apr2021 and Tachycardia on 14Jun2021. The patient reported that the events gastritis and tachycardia/POTS were serious and caused persistent/significant disability/incapacity. The events resulted in physician office visit. The events constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping was treated with PPIs and acupuncture. Therapeutic measure for event gastritis included PPI and time off weekly endoscopy. Therapeutic measure for the event tachycardia/ POTS included Holter monitor for 15 days. The patient also had ongoing work with cardiologist. The patient underwent lab tests and procedures which included Covid nasal swab test: positive on 31Dec2020, negative on 06Jan2021 and negative in May2021. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flatulence, Gastritis, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: Tachycardia/POTS; Gastritis; Constant dull ache in stomach and severe burning pain; severe burning pain in stomach after eating anything; Eating anything; major bloating, gas, burping.; Eating anything; major bloating, gas, burping.; major bloating, gas, burping.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number ER8737), intramuscular, in the left arm on 07Apr2021 18:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. Medical history included bradycardia, covid-19 from 24Dec2020 to 06Jan2021 with very minor symptoms, allergy to amoxicillin and azithromycin. There were no concomitant medications. The patient was vaccinated at urgent care center and was not pregnant. No other vaccine was given in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6207), intramuscular, in the left arm on 13Mar2021 13:00 as dose 1, single for COVID-19 immunization. The patient experienced constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping in Apr2021. The debilitating stomach issues started 1 week after second vaccination. The patient had gastritis on 11Apr2021 and Tachycardia on 14Jun2021. The patient reported that the events gastritis and tachycardia/POTS were serious and caused persistent/significant disability/incapacity. The events resulted in physician office visit. The events constant dull ache in stomach and severe burning pain, severe burning pain in stomach after eating anything, major bloating, gas and burping was treated with PPIs and acupuncture. Therapeutic measure for event gastritis included PPI and time off weekly endoscopy. Therapeutic measure for the event tachycardia/ POTS included Holter monitor for 15 days. The patient also had ongoing work with cardiologist. The patient underwent lab tests and procedures which included Covid nasal swab test: positive on 31Dec2020, negative on 06Jan2021 and negative in May2021. The outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Enterovirus test positive, Human rhinovirus test positive, Pericarditis
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for Other acute myocarditis within 6 weeks of receiving COVID vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Respiratory tract congestion, Troponin increased
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for Other acute myocarditis within 6 weeks of receiving COVID vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Chest pain, Intensive care, Myocarditis, Pericarditis
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for Other acute myocarditis within 6 weeks of receiving COVID vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Myocarditis
Clinical narrative: Patient presented to the ED and was subsequently hospitalized for Other acute myocarditis within 6 weeks of receiving COVID vaccination.