chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Injection site reaction- raised; Painful at injection site apparent 24H post dose.; Red area surrounding at injection site apparent 24H post dose.; Full body aches; This is a spontaneous report from a contactable pharmacist, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 23Feb2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Feb2021, the patient experienced injection site reaction which was raised, painful and red area surrounding injection site was apparent 24 hours post dose and also experienced full body aches. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site reaction which was raised, painful, red area surrounding injection site and full body aches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain
Clinical narrative: Chills; Sore throat; Fatigue; This is a spontaneous report from a contactable physician. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Feb2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On On 13Feb2021, the patient experienced sore throat, fatigue and chills which was persisting for more than 10 days after the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, fatigue and chills was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Threw up; Flu like symptoms; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date taken for an unknown indication and unknown if ongoing. On 27Feb2021, the patient had threw up once about 24 hours after vaccine and from that point began feeling flu like symptoms. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events threw up and flu like symptoms was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain/soreness at injection site starting at injection and lasting until the next day so far; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified gender and of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 14:15, the patient experienced pain/soreness at injection site starting at injection and lasting until the next day till the time of report. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain/soreness at injection site starting at injection and lasting until the next day till the time of report was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful swollen lymph nodes in underarm and around collarbone; Swollen lymph nodes in underarm and around collarbone.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer, hypertension, obesity and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), desvenlafaxine succinate monohydrate (PRISTIQ), spironolactone (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 07Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 16:00, the patient experienced painful swollen lymph nodes in underarm and around collarbone. Nodes ranged between 0.5-3 cm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events painful swollen lymph nodes in underarm and around collarbone was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in left arm pit slightly swollen; Lymph nodes in left arm pit slightly swollen and sore; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 28Feb2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021, the patient experienced that the lymph nodes in left arm pit were slightly swollen and sore. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes in left arm pit slightly swollen and sore was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: Vertigo; Nausea; Room spinning when bending over or try to roll over in bed; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 27Feb2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypertension and intermediate to severe depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and levomilnacipran hydrochloride (FETZIMA); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received ondansetron hydrochloride (ZOFRAN) and experienced drug allergy. On 01Mar2021 at 11:00, the patient experienced vertigo, nausea and room spinning when bending over or trying to roll over in bed. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with meclozine (MECLIZINE) 25 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, nausea and room spinning when bending over or trying to roll over in bed were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021(at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medication, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control from an unknown date for unspecified indication and unknown if ongoing. On 02Mar2021 at 05:00, the patient experienced nasal congestion. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nasal congestion was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm.; This is a spontaneous report from a non-contactable pharmacist. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event sore arm was resolved on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Chills; Headache; Sore arm pain; This is a spontaneous report from a contactable pharmacist. An adult non-pregnant female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Feb2021, the patient experienced chills, headache and sore arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, headache and sore arm pain were recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at injection site; Mild pain at injection site; Was remarked lethargic; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 11Feb2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis, Automatic Implantable Cardioverter-Defibrillator (AICD) pacemaker, Chronic Obstructive Pulmonary Disease (COPD), heart disease, obesity, oxygen therapy and sleep apnea. The patient had allergies to penicillin, milk, wool and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol sulfate (ALBUTEROL), atorvastatin (MANUFACTURER UNKNOWN), digoxin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and furosemide (FUROSEM); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Feb2021 at 10:00, the patient experienced flu like symptoms, she had no fever, no chills and stayed in bed; also experienced swelling and mild pain at injection site and her adult son remarked that she was lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, swelling and mild pain at injection site and lethargic was recovered on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Skin warm
Clinical narrative: Enlarged lymph node in same arm as vaccine, under armpit,; Enlarged lymph node in same arm as vaccine, under armpit, very sore; Enlarged lymph node in same arm as vaccine, under armpit, very sore and warm feeling; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, the patient experienced enlarged lymph node in same arm as vaccine, under armpit, very sore and warm feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event enlarged lymph node in same arm as vaccine, under armpit, very sore and warm feeling was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; 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: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, allergies, blood cholesterol abnormal (factor v cholesterol) and blood pressure abnormal. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), carbamazepine (TEGRETOL), bupropion hydrochloride (WELLBUTRIN) and montelukast sodium (SINGULA) and  had received within 2 weeks of vaccination for an unknown indication. On 20Feb2021, the patient experienced nausea. The event did not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event nausea was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Severe stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 15:00, the patient experienced severe stomach cramps within 4 hours of injection and diarrhoea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe stomach cramps and diarrhoea was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Pain
Clinical narrative: Lymph node tenderness under left armpit; Body aches; Fatigue; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heartbeat, occasional high blood pressure, low thyroid and recurring shingles. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX), betablockers and vitamins (unspecified); all from unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also received pethidine hydrochloride (DEMEROL) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 14:30, 24 hours after injection, the patient experienced body aches, fatigue and headache and all subsided by the following morning. On 27Feb2021 at 14:30, 48 hours after injection, the patient experienced same symptoms reoccurred, along with lymph node tenderness under left armpit. Symptoms subsided by the following morning and did not recur. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fatigue, headache and lymph nodes tenderness was resolved on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth for ~ 30 minutes after shot; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 15:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hodgkin's lymphoma (in remission). The patient had no known allergies. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and rosuvastatin calcium (CRESTOR); all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 15:15, the patient experienced metallic taste in mouth for approximately 30 minutes after shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in mouth for approximately 30 minutes after shot was resolved on 26Feb2021 at 15:45.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Moderate arm pain occasionally zinging down into fingers; Significant fatigue; This is a spontaneous report from a non-contactable nurse, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient previously received celecoxib (CELEBREX) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the patient experienced moderate arm pain occasionally zinging down into fingers and significant fatigue which started the following day and lasted approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant fatigue was resolved on 07Feb2021; while that of the event moderate arm pain occasionally zinging down into fingers was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: arm ache in the arm the vaccine was injected into; shivers for 2 hours about 13 hours after getting injection; This is a spontaneous report from a contactable consumer. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration on 27Feb2021(at the age of 23-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 28Feb2021 at 01:30, about 13 hours after getting injection, the patient experienced arm ache in the arm the vaccine was injected into and shivers for 2 hours. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm ache in the arm the vaccine was injected into and shivers was recovered on 28Feb2021 at 15:30.    No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm near the injection site, the morning after the 1st dose; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 01Mar2021 at 02:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the morning after the first dose, the patient experienced sore arm near the injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm near the injection site was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that; Very sore arm; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 07:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received benzoin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Mar2021 at 12:00, the patient had very sore arm. On 01Mar2021 at 21:00, the patient experienced intense myalgia for 8 hours starting about 14 hours after the shot and mild myalgia after that. No therapeutic measures were taken as a result of the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm and intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: headache; some dizziness; chills; joint and muscle pain; joint and muscle pain; feeling unwell; tiredness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that:  A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6198) via an unspecified route of administration in left arm on 26Feb2021 10:00 (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history were none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks prior vaccination. Other medications in two weeks were dietary supplements. The patient had no COVID prior vaccination, no COVID tested post vaccination. On 27Feb2021, the patient experienced tiredness, headache, some dizziness, chills, joint and muscle pain and generally feeling unwell. No treatment was given for the events. The outcome of the events was not recovered at the time of last observation. It was reported that, the patient stated that she got her first shot on 10Mar2021, and she was supposed to get the second dose on 26Mar2021. Her doctor changed the schedule to 31Mar2021 because 26Mar 2021 was less than 21 days. However, she received a phone call yesterday that the schedule for her second dose has changed on 01Apr2021 (more than 21 days). The unaddressed medical questions was referred to Medical Information.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: headache; some dizziness; chills; joint and muscle pain; joint and muscle pain; feeling unwell; tiredness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that:  A 71-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6198) via an unspecified route of administration in left arm on 26Feb2021 10:00 (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history were none. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks prior vaccination. Other medications in two weeks were dietary supplements. The patient had no COVID prior vaccination, no COVID tested post vaccination. On 27Feb2021, the patient experienced tiredness, headache, some dizziness, chills, joint and muscle pain and generally feeling unwell. No treatment was given for the events. The outcome of the events was not recovered at the time of last observation. It was reported that, the patient stated that she got her first shot on 10Mar2021, and she was supposed to get the second dose on 26Mar2021. Her doctor changed the schedule to 31Mar2021 because 26Mar 2021 was less than 21 days. However, she received a phone call yesterday that the schedule for her second dose has changed on 01Apr2021 (more than 21 days). The unaddressed medical questions was referred to Medical Information.  No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Flatulence
Clinical narrative: light headed; dizzy; passing gas; upset stomach; loose stool; This is a spontaneous report from a contactable consumer (patient himself). An 89-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration in left arm on 08Mar2021 (age at vaccination: 89-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Last night or yesterday he had an upset stomach and a loose stool on 10Mar2021. He took some Pepto Bismol and it went away. But today on 11Mar2021 he was light headed, had an upset stomach and another loose stool. He's passing gas. He took Tylenol about 3 hours ago. Hes dizzy, light headed, had a loose stool, passing more gas than he usually does in a day. He goes back on 29Mar2021 for the second shot. The outcome of events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, Fatigue, Full blood count, Gait disturbance
Clinical narrative: increased in fatigue; muscle weakness; pain in thighs; joint pain in knees and hip; It's difficult for her to walk upstairs, she has to drag her leg up the stairs; This is a spontaneous report from a contactable Nurse (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 16Feb2021, (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included autoimmune disorder, ongoing migraine and hypothyroidism. Concomitant medication(s) included thyroid (NATURE THROID); citalopram (CITALOPRAM) and Rimegepant sulfate (NURTEC ODT) taken for migraine, start and stop date were not reported. Patient reported that she has an autoimmune and other health issues which are under control. On 19Feb2021, patient noticed increase in fatigue, muscle weakness, pain in her thigh and joint pain in knees, and also her hip, so joint pain and hip. It's difficult for her to walk upstairs, she has to drag her leg up the stairs and it is still ongoing, it is not getting better. She was supposed to get the second dose but she decided to postpone it, so now she is schedule on 25Mar2021, she postponed because she still having this fatigue, her doctor suggested that she speak with the neurologist but her next appointment is in April, so she wanted to know, her question was, how well she is protected and what are the recommendations on getting the second dose if she should take it or not, and finally she mentioned is she spoke with a some healthcare providers and she mentioned people took the Moderna shot and they require a root canal. Patient just little concerned that it has gone on for 4 weeks, so that is why she had originally called she was trying to figure out the timing of the second, she has been putting off the second vaccination for fear of feeling worse than she do now so. Causality: Nurse stated That's the best conclusion I can draw, I certainly don't have total certainty but I, yeah. On 12Mar2021, the patient underwent lab tests and procedures which included c-reactive protein: normal, full blood count: normal and metabolic function test: normal. No therapeutic measures were taken as a result of the events. The outcome of the events increased in fatigue, it's difficult for her to walk upstairs, she has to drag her leg up the stairs, joint pain in knees and hip was not recovered. The outcome of the events muscle weakness and pain in thighs was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Muscular weakness, Pain in extremity
Clinical narrative: increased in fatigue; muscle weakness; pain in thighs; joint pain in knees and hip; It's difficult for her to walk upstairs, she has to drag her leg up the stairs; This is a spontaneous report from a contactable Nurse (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration on 16Feb2021, (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included autoimmune disorder, ongoing migraine and hypothyroidism. Concomitant medication(s) included thyroid (NATURE THROID); citalopram (CITALOPRAM) and Rimegepant sulfate (NURTEC ODT) taken for migraine, start and stop date were not reported. Patient reported that she has an autoimmune and other health issues which are under control. On 19Feb2021, patient noticed increase in fatigue, muscle weakness, pain in her thigh and joint pain in knees, and also her hip, so joint pain and hip. It's difficult for her to walk upstairs, she has to drag her leg up the stairs and it is still ongoing, it is not getting better. She was supposed to get the second dose but she decided to postpone it, so now she is schedule on 25Mar2021, she postponed because she still having this fatigue, her doctor suggested that she speak with the neurologist but her next appointment is in April, so she wanted to know, her question was, how well she is protected and what are the recommendations on getting the second dose if she should take it or not, and finally she mentioned is she spoke with a some healthcare providers and she mentioned people took the Moderna shot and they require a root canal. Patient just little concerned that it has gone on for 4 weeks, so that is why she had originally called she was trying to figure out the timing of the second, she has been putting off the second vaccination for fear of feeling worse than she do now so. Causality: Nurse stated That's the best conclusion I can draw, I certainly don't have total certainty but I, yeah. On 12Mar2021, the patient underwent lab tests and procedures which included c-reactive protein: normal, full blood count: normal and metabolic function test: normal. No therapeutic measures were taken as a result of the events. The outcome of the events increased in fatigue, it's difficult for her to walk upstairs, she has to drag her leg up the stairs, joint pain in knees and hip was not recovered. The outcome of the events muscle weakness and pain in thighs was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: number, expiry date: unknown) via unspecified route of administration, in left arm on 08Mar2021 12:30 (age at vaccination: 79-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route on 15Feb2021 11:00 AM (Age at vaccination: 79-years) as dose 1, single for covid-19 immunisation. Patients medical history included cholesterol, gout and thyroid from an unspecified date and unknown if ongoing (Caller says she takes a medication for this, no details provided about this medication). Concomitant medications were not reported. She said after she got her vaccine it she was fine with no problems, no soreness or nothing, then the 11th she come down with diarrhea that she has had since then. She said the diarrhea was not severe or anything, but it doesn't seem to want to go away, and she would like to know is that a side effect of the shot. She said that the diarrhea started 11Mar2021, and had been staying the same, it doesn't seem to want to go away. As treatment for AE patient said she just start yesterday taking Kaopectate, which had not really done anything yet. She said she took it yesterday two times for her first dose and today she didn't take it at all, though she will probably take it in a little while. She said she doesn't know if it is going to help or not. She said she took one cap full of the liquid that you put in the plastic cap that comes on top of bottle, you drink that. The outcome of event was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Rash
Clinical narrative: Rash; Swollen lips; Tingle lips; This is a spontaneous report from a contactable consumer reported for herself. A 60-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in arm right on 04Mar2021 at 08:00 (age at vaccination was 60 years) as single dose for COVID-19 immunization. The patient's medical history included drug hypersensitivity to penicillin and NASIDS from an unknown date. The patient have any known allergies. Concomitant medication included biotin and multi vitamin taken for an unspecified indication, start and stop date were not reported in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 at 17:00, after the first dose the patient experienced rash, swollen lips and tingle lips. No treatment was received for the adverse events. On 17Mar2021 at 08:30 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right and experienced Severe aches, pain, chills, fatigue and full body rash. The outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.