chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia
Clinical narrative: Metallic taste in mouth after injection; Left side of face was tingling; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 left arm on 21Mar2021 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to kiwi. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient had experienced a metallic taste in mouth after injection and left side of face was tingling. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events metallic taste in mouth after injection and left side of face was tingling was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity
Clinical narrative: Aching; Muscle Cramps in Left Arm; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via unspecified route of administration in left arm on 19Feb2021 at 23:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation and also received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via unspecified route of administration in left arm on 14Mar2021 at 12:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient medical history included ascending aortic aneurism, high blood pressure and high cholesterol. The concomitant medications included metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) for an unknown indication. The patient had no known allergies. 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 had not been tested for COVID-19. On 21Feb2021, the patient experienced soreness, aching, muscle cramps in left arm. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events soreness, aching, muscle Cramps in left arm were not recovered at the time of the report.    No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain
Clinical narrative: Redness around neck, arms and  chest; body ache; muscle soreness; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unspecified dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 43-years-old) as dose number unknown, single for COVID-19 immunisation. The patient did not have any medical history. Concomitant medication included meloxicam for an unknown indication from an unspecified date and unknown if ongoing. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 16:00, the patient experienced redness around neck, arms and chest, body ache, muscle soreness. It was unknown whether the patient received any treatment for the reported 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 the redness around neck, arms and chest, body ache, muscle soreness was recovering at the time of the report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment 30Jun2021: This follow-up report is being submitted to amend previously reported information: Patient state updated as two-digit, Dose Description updated as dose number unknown, single, Narrative sentence patient received second dose of BNT162b2 updated as patient received unspecified dose number of BNT162b2, Narrative updated. Narrative sentence The patient had not tested positive for COVID-19 since the vaccination was replaced with The patient had not tested for COVID-19 since the vaccination. And the sentence The patient did not received treatment for the reported events was replaced with It was unknown whether the patient received any treatment for the reported events.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Swelling of eyelid
Clinical narrative: Right eyelid swelling; Eye can still open but painful; This is a spontaneous report from a contactable consumer, the patient. A 23-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 left arm on 23Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history includes immune thrombocytopenic purpura (reported as ITP) and lupus. The patient had no known allergies to medications, food, or other products. 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 COVID vaccine. Concomitant medications received within two weeks of vaccination include multivitamins for unspecified indication from an unknown date. On 23Mar2021 at 12:00, the patient experienced right eyelid swelling and eye can still open but it was painful. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of eight eyelid swelling and pain eye was not resolved at the time of this report. No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient.   A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 09:30 (at the age of 51 years) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies. 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 vaccination. On 19Mar2021, at 15:00 hours, the patient experienced events sore arm, headache and tiredness. 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 events sore arm, headache and tiredness were recovering at the time of reporting.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Age and age at vaccination updated from 52 years to 51 years per DOB and event onset time. Final sentence updated as no follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pain
Clinical narrative: Lethargy; Body aches; Nausea; Severe chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 9:15 as single dose (at the age of 67 years) for COVID-19 immunisation. Medical history was not reported. No concomitant medication were reported. Patient had no known allergies to medications, food, or other products. The patient received first dose of BNT162b2; (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via unspecified route of administration administered in left arm on 25Feb2021 at 11.00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, (after receiving first dose of Covid-19 vaccination), the patient experienced first episode of severe chills, body aches nausea, lethargy and headache and lasted for 2 days. On 18Mar2021 at 22:45, (after receiving second dose of Covid-19 vaccination), the patient experienced second episode of severe chills, body aches nausea, lethargy and headache. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient never had a reaction other than a sore arm from any other vaccine she had. It was reported that she will definitely use a different brand for future. No therapeutic measures were taken for the event. The clinical outcome of the second episode severe chills, body aches nausea, lethargy and headache were reported as resolving.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report was being submitted to amend previously reported information patient initial captured in first name field of the patient tab, removed name fromand last name field and country US added for patient in patient tab.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: fever 101.5; fatigue; Headache; Chills; left arm pain from my shoulder to fingers; Nausea; Body aches; hazy feeling; This is a spontaneous report from a contactable other health care professional, the patient. A 48-year-old non- pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypertension, Inflammatory bowel syndrome (IBS) and migraines. The patient did not have allergies to medications, food, or other products. Unspecified concomitant medications were taken by the patient. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route in the left arm on 03Mar20221 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID 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. On 23Mar2021 at 14:00, the patient experienced fever 101.5 (units unspecified), fatigue, headache, hazy feeling (hazy vision), chills, left arm pain from her shoulder to fingers, nausea, body aches. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of fever 101.5, fatigue, headache, hazy feeling, chills, left arm pain from her shoulder to fingers, nausea and body aches were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: fever 101.5; fatigue; Headache; Chills; left arm pain from my shoulder to fingers; Nausea; Body aches; hazy feeling; This is a spontaneous report from a contactable other health care professional, the patient. A 48-year-old non- pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypertension, Inflammatory bowel syndrome (IBS) and migraines. The patient did not have allergies to medications, food, or other products. Unspecified concomitant medications were taken by the patient. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route in the left arm on 03Mar20221 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID 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. On 23Mar2021 at 14:00, the patient experienced fever 101.5 (units unspecified), fatigue, headache, hazy feeling (hazy vision), chills, left arm pain from her shoulder to fingers, nausea, body aches. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of fever 101.5, fatigue, headache, hazy feeling, chills, left arm pain from her shoulder to fingers, nausea and body aches were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Within 24 hours of receiving the 1st vaccine shot my menstrual cycle started 17 days after my last period.  This is 10 days early and is not normal for me.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included paraguard (intra uterine device) IUD (no hormones). Concomitant medications included multivitamins (MANUFACTURER UNKNOWN) and fish oil vitamin (MANUFACTURER UNKNOWN). Prior to 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 23Mar2021, the patient had nasal swab test (Roche Rapid Antigen Test) and resulted negative. On 23Mar2021 at 16:30, the patient experienced abnormal menstruation within 24 hours of the first dose of vaccine. It was reported that, menstruation was 10 days early and this was not normal for the patient. Her menstrual cycle started 17 days after my last period. From the last 7 years the patient tracked the cycle and it was always 4 weeks apart. The patient had not experienced any recent weight loss or gain. The patient stress level was not any higher than it was over the last year. The patients mother did not go through menopause until her mid 50's. The patient was a healthy active adult. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment received for the event. The clinical outcome of event abnormal menstruation was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Persistent tip of the tongue numbness.; This is a spontaneous report from a contactable nurse, the patient. A 42-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 06Dec2020 at 12:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not take any concomitant medications. 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 06Dec2020 at 12:00, the patient experienced persistent tip of the tongue numbness. The event 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 persistent tip of the tongue numbness. The clinical outcome of the event persistent tip of the tongue numbness was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; Mild headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration on 11Mar2021 (age at vaccination 41-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to macrobid. Patient's concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021, the patient experienced sore arm, mild headache, nausea and fatigue. No therapeutic measures were taken as a result of sore arm, mild headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of sore arm, mild headache, nausea and fatigue was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name's format updated, Vaccination Facility Country captured. Reaction of Past Drug Event updated as known allergies: Macrobid. Narrative updated from This is a spontaneous report from a contactable consumer to This is a spontaneous report from a non-contactable consumer.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Extreme fever; chills; vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on 19Mar2021 at arm left (at the age of 36-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. In Mar-2021 the patient experienced Extreme fever, chills, vomiting, diarrhoea. The clinical outcome of Extreme fever, chills, vomiting, diarrhea was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patients Initials updated in First Name field only. Patients Age/Units captured as 36 years per vaccination date=19Mar2021, event's onset and DoB. For all events: Onset captured as Mar2021 per vaccination date=19Mar2021 and PRD=21Mar2021. Please review if need remove It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine from consolidated narrative since not mention this in source. And also for Case id: 24753, it not reported in source. Initial information need review: Covid vaccine details updated
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain
Clinical narrative: soreness; loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration in right arm on 23Mar2021 (at the age of 29-years-old) as single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies to medications, food or other products. There were no concomitant medications.The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unknown date patient experienced fatigue, soreness and loss of appetite. The patient did not received treatment due to the events. The outcome of events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headache; LOW FEVER; FATIGUE; This is a spontaneous report received from a contactable consumer (Patient). A 37-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown), via unspecified route of administration in left arm on 23Mar2021 at 10:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient medical history was none and had no allergies to medications, food, or other products. The patient neither received any concomitant medications in two weeks nor any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had not tested for COVID-19 since having the vaccine. On 23Mar2021 at 12:00, the patient experienced headache, low fever and fatigue. 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 events. The clinical outcome of events headache, fever and fatigue was recovering at the time of this report.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth ulcers; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on an unspecified date (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 18Mar2021, the patient experienced mouth ulcers. The patient did not receive any treatment for the adverse event. The clinical outcome of mouth ulcers was not resolved at the time of the report.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure spiked to 160/110 from 120/70 day after shot and stayed elevated; This is a spontaneous report form a contactable consumer. A 54-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, at the age of 54-year-old), via an unspecified route of administration, administered in arm left on 21Mar2021 13:30 as dose number unknown, single for covid-19 immunisation in pharmacy or drug Store. Medical history included hypertension, high cholesterol, thyroid and depression. Concomitant medication included levothyroxine sodium (SYNTHROID), ramipril (RAMIPRIL), rosuvastatin calcium (CRESTOR), lamotrigine (LAMICTAL) and desvenlafaxine succinate (PRISTIQ) for unknown indication were received within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced blood pressure spiked to 160/110 from 120/70 day after vaccine shot and stayed elevated on 22Mar2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient lab test included blood pressure was spiked from 120/70 to 160/110 after vaccine shot and stayed elevated. No treatment medication was received for the event. Since the vaccination, the patient had not tested for COVID-19. The outcome of the event was not resolved.  Follow up attempts are needed. Further information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sinusitis
Clinical narrative: Mild to sever headache; Sinus infection like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in right arm on 10Mar2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On 11Mar2021, patient had experienced mild to severe headache and sinus infection like symptoms. It was unknown if therapeutic measures were taken for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and sinus infection was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Soreness of arm injection site; Headache; Tired; Feeling sick; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old, non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in left arm on 23Mar2021 at 08:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient had no medical history. It was reported that the patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00, the patient experienced soreness of arm on injection site, headache, tiredness and feeling sick. The patient did not receive treatment for the reported 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 the event soreness of arm on vaccination site, headache, tiredness and feeling sick were recovering at the time of this report.    No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Dizziness, Dysgeusia, Fatigue
Clinical narrative: Bad nausea; Abdominal upset; Lightheaded; Tired; Joint hurt; Strong metallic taste; Arm hurt; This is a spontaneous report from a contactable consumer, the patient. A 52-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 left arm on 23Mar2021 (at the age of 52-years-old) at 10:30, as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis), Reynauds and bone cancer. The patient has known allergies to inapsine and guaifenesin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Started with in minutes on 23Mar2021, patient experienced strong metallic taste in mouth. It got worse as the day went on and was still current. Her arm hurt during the night and current.  On 24Mar2021 at 10:30 (It was 24 hours in and she had bad nausea and abdominal upset, was somewhat lightheaded, tired and had joint hurt). she experienced bad nausea, abdominal upset, lightheaded, tired and joint hurt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for nausea. The clinical outcome of metallic taste in mouth, arm hurt was not recovered and outcome of the events bad nausea, abdominal upset, lightheaded, tired, joint hurt was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Bad nausea; Abdominal upset; Lightheaded; Tired; Joint hurt; Strong metallic taste; Arm hurt; This is a spontaneous report from a contactable consumer, the patient. A 52-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 left arm on 23Mar2021 (at the age of 52-years-old) at 10:30, as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis), Reynauds and bone cancer. The patient has known allergies to inapsine and guaifenesin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Started with in minutes on 23Mar2021, patient experienced strong metallic taste in mouth. It got worse as the day went on and was still current. Her arm hurt during the night and current.  On 24Mar2021 at 10:30 (It was 24 hours in and she had bad nausea and abdominal upset, was somewhat lightheaded, tired and had joint hurt). she experienced bad nausea, abdominal upset, lightheaded, tired and joint hurt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for nausea. The clinical outcome of metallic taste in mouth, arm hurt was not recovered and outcome of the events bad nausea, abdominal upset, lightheaded, tired, joint hurt was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; chills; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) in the left arm at 23Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included ulcerative colitis (reported UC). The patient's concomitant medications taken in two weeks included vitamin B12 (MANUFACTURER UNKNOWN) and mesalamine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) at 10:00 (at the age of 51-years-old) in the left arm on 01Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced low grade fever, chills, nausea, fatigue and sore arm. Therapeutic measures were not given as a result of fever, chills, nausea, fatigue and sore arm. 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 the events fever, chills, nausea, fatigue and sore arm was resolved on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: some dizziness; Headache; Slight fever (100); muscle/joint ache; muscle/joint ache; slight nausea; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 24-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown), via an unspecified route of administration in the left arm on 20Mar2021(at the age of 24-years-old) at 22:00 as a single dose for COVID-19 immunisation. Medical history and 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 in the left arm on 28Feb2021(at the age of 24-years-old) at 06:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four week prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient experienced headache, fever (100- units unspecified), muscle ache, joint ache, dizziness, nausea, fatigue on 21Mar2021 16:00. The patient underwent lab tests and procedures which included body temperature: 100 on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of events headache, fever, muscle ache, joint ache, dizziness, nausea, fatigue was recovering.    Amendment: This follow-up report is being submitted to amend previously reported information: For "Historical Vaccine": "Age/Unit" captured as "24 years" per vaccination date 28Feb2021 and DOB. For Lab Data "Body temperature": Test date captured as "21Mar2021". Final sentence "Information about lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Initial information need review.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: some dizziness; Headache; Slight fever (100); muscle/joint ache; muscle/joint ache; slight nausea; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 24-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown), via an unspecified route of administration in the left arm on 20Mar2021(at the age of 24-years-old) at 22:00 as a single dose for COVID-19 immunisation. Medical history and 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 in the left arm on 28Feb2021(at the age of 24-years-old) at 06:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four week prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient experienced headache, fever (100- units unspecified), muscle ache, joint ache, dizziness, nausea, fatigue on 21Mar2021 16:00. The patient underwent lab tests and procedures which included body temperature: 100 on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of events headache, fever, muscle ache, joint ache, dizziness, nausea, fatigue was recovering.    Amendment: This follow-up report is being submitted to amend previously reported information: For "Historical Vaccine": "Age/Unit" captured as "24 years" per vaccination date 28Feb2021 and DOB. For Lab Data "Body temperature": Test date captured as "21Mar2021". Final sentence "Information about lot number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Initial information need review.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Wheezing
Clinical narrative: wheezy; sob along with diaphoresis; shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: ER8727) via unspecified route of administration on 24Mar2021 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history included asthma. Concomitant medications were not reported. During the 15 minutes waiting period after the injection the patient did fine. However, patient noted to be sitting on side after pushing his sister in wheelchair to take a "break." On 24Mar2021, the patient experienced wheezy, sob along with diaphoresis and shortness of breath. Patient had history of asthma and had forgot to bring inhalers. Patient does not walk much and was a long walk today and was offered a wheelchair and was brought to the bay for inhaler treatment. Patient denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of wheeziness, diaphoresis and shortness of breath which include treatment with albuterol. The clinical outcome of wheeziness, diaphoresis and shortness of breath were unknown.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's last name updated. 2. Country added in patient tab.  3. leading sentence updated to a non-contactable other healthcare professional. Reported Event: During his 15 minute waiting period after the injection he did fine. However, pt noted to be sitting on side after pushing his sister in wheelchair to take a "break." He was noted to be wheezy and sob along with diaphoresis. Pt states he has hx of asthma and forgot to bring his inhalers. He normally doesn't walk much anyway and today was a long walk. He was offered a wheelchair and brought to the bay for inhaler treatment. He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of shortness of breath and wheezing Treatment included: albuterol
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever that went away the next day; This is a spontaneous report from a non-contactable non-healthcare professional or consumer. An adult non pregnant female patient of an unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN, formulation Solution for injection) on an unknown date in Mar 2021 as a dose 2, single for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation (Dose number: DOSE 1, SINGLELot number: UNKNOWNStart date: UNKNOWN). It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in Mar2021, the patient experienced fever that went away the next day. Therapeutic measures taken for fever was unknown. The outcome of the event fever was resolved the next day on an unknown date at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (05Jul2021) Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide#1 and stop Date/Time populated as Mar2021
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 20Mar2021 at 12:30 (at the age of 58 years) as a single dose for COVID-19 immunisation. Medical history included diabetes, asthma and COVID-19 on an unknown date, mushrooms allergy and citrus fruit allergy). Concomitant medication included Networking, Serialize, Venturing Inhaler from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since, the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, patients body temperature was measured and it was found to be 100 (unspecified units) and 103.8 (unspecified units). On 21Mar2021 at 08:00 the patient experienced general body pain, headache, chills, fever (First 12 hours after injection were typical. Woke up day 2 with low grade fever 100. As the day progressed, the body aches, headache, chills, fever became intense. Fever progressed to 103.8. Fever went up and down for 72 hours. Body aches and headache also). The patient did not received 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 the events fever, body aches, headache and chills were resolving. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain
Clinical narrative: Diarrhea; Fatigue; ache; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: GNG204) via an unspecified route of administration in left arm on 18Mar2021 at 14:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid, prostate cancer, cholesterol and blood pressure. The patient had allergies to sulfur. 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 received medications (unknown) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG198) via an unspecified route of administration in left arm on 25Feb2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021, the patient experienced diarrhoea, fatigue and ache. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diarrhoea, fatigue and ache was not resolved at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: Neck Pain; Arm Pain; Shoulder Pain; Swelling of Arm and Underarm; Lump at vaccine site; Headache; Nausea; Feeling Cold; Exhaustion; Cough; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8730) via an unspecified route of administration in the left arm on 22Mar2021 at 19.00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included Osteoporosis. Concomitant medications were not provided. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 17.00 as a single dose for COVID-19 immunisation. The patient was not allergic to any medications, food, or other products. 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 had not received any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other medications within 2 weeks prior to vaccination. On 23Mar2021, the patient experienced severe neck pain, severe arm pain, severe shoulder pain, moderate swelling of arm and underarm, moderate lump at vaccine site, severe headache, moderate nausea, severe cold feeling, severe exhaustion and moderate cough. Therapeutic measures were taken as a result of neck pain, pain in arm, shoulder pain, swelling arm, vaccination site lump, headache, nausea, feeling cold, exhaustion and cough and included ibuprofen.  The clinical outcome of neck pain, pain in arm, shoulder pain, swelling arm, vaccination site lump, headache, nausea, feeling cold, exhaustion and cough was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.