chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia, Somnolence
Clinical narrative: the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; the migraine continued along with fatigue,slept, joint aches, fever, sweats andrestless sleep.; I got really hot after thefirst 15 minutes which followed by amigraine headache; I got really hot after thefirst 15 minutes which followed by amigraine headache; This is a spontaneous report from a contactable consumer, the patient. A 51-years-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 27Mar2021 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Patient had previously had sulfur (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), nuts and pineapples and experienced allergy to sulfur (MANUFACTURER UNKNOWN), azithromycin (ZITHROMAX), nuts and pineapples. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: en6205), via an unspecified route of administration in the right arm on 06Mar2021 at 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and had no side effects.. 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 was not tested for COVID-19. On 27Mar2021 at 14:45, 15 minutes after vaccination, the patient experienced feeling hot and migraine headache. After the second dose she got really hot after first 15 minutes which was followed by a migraine headache. The next day, on 28Mar2021, migraine continued along with fatigue, slept, joint aches, fever, sweats and restless sleep. 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. The patient did not receive treatment for the events. The clinical outcomes of feeling hot, migraine headache, fatigue, slept, joint aches, fever, sweats and restless sleep were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: no appetite; not feeling good; stomach upset; No energy; My lymph nodes were swollen; chills; I was tired; shivering; headache; My arm was sore.; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955); via an unspecified route of administration in the left arm on 25Mar2021 (at the age 67-years) at 09:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient had received other unspecified medications in two weeks of vaccination. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198); via unspecified route of administration in the left arm on 04Mar2021 (at the age 67-year-old) at 14:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 22:00, the patient experienced sore arm and swollen lymph nodes. The patient was tired and had headache, had chills so bad was shivering. The patient had no appetite and was not feeling good. The patient also experienced stomach upset, had no energy and was not hungry. The adverse 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 events. The clinical outcome of sore arm, swollen lymph nodes, stomach upset, chills, shivering, headache, tired, no appetite, not feeling good and no energy was recovered on an unknown date at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: no appetite; not feeling good; stomach upset; No energy; My lymph nodes were swollen; chills; I was tired; shivering; headache; My arm was sore.; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955); via an unspecified route of administration in the left arm on 25Mar2021 (at the age 67-years) at 09:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient had received other unspecified medications in two weeks of vaccination. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198); via unspecified route of administration in the left arm on 04Mar2021 (at the age 67-year-old) at 14:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 22:00, the patient experienced sore arm and swollen lymph nodes. The patient was tired and had headache, had chills so bad was shivering. The patient had no appetite and was not feeling good. The patient also experienced stomach upset, had no energy and was not hungry. The adverse 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 events. The clinical outcome of sore arm, swollen lymph nodes, stomach upset, chills, shivering, headache, tired, no appetite, not feeling good and no energy was recovered on an unknown date at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had no known allergies. The concomitant medications included ibuprofen (MANUFUCTURER UNKNOWN), levothyroxine (MANUFUCTURER UNKNOWN), amlodipine (MANUFUCTURER UNKNOWN) and lisinopril (MANUFUCTURER UNKNOWN) taken for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6202), via an unspecified route of administration in the left arm on 03Mar2021 at 10:00. 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. Since the vaccination, the patient was not been tested for COVID-19. The patient underwent lab test and procedure which included body temperature and result was shown as 101-degree Fahrenheit. On 26Mar2021, at 18:00 the patient experienced headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness. No therapeutic measures were taken for these 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 headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had no known allergies. The concomitant medications included ibuprofen (MANUFUCTURER UNKNOWN), levothyroxine (MANUFUCTURER UNKNOWN), amlodipine (MANUFUCTURER UNKNOWN) and lisinopril (MANUFUCTURER UNKNOWN) taken for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6202), via an unspecified route of administration in the left arm on 03Mar2021 at 10:00. 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. Since the vaccination, the patient was not been tested for COVID-19. The patient underwent lab test and procedure which included body temperature and result was shown as 101-degree Fahrenheit. On 26Mar2021, at 18:00 the patient experienced headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness. No therapeutic measures were taken for these 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 headache, muscle pain, joint pain, chills, fever, feeling unwell and tiredness was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears; This is a spontaneous report from a contactable consumer, the patient. A 65-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 05Mar2021 at 20:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included Cholesterol medications. The patient had no known allergies to medications, food, or other products. 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 tested for COVID-19. On 15Mar2021 at 12:00, the patient experienced ringing in ears. 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. The clinical outcome of the ringing in ears was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Malaise, Pain
Clinical narrative: fever; chills; Gastrointestinal discomfort; malaise; body ache; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and hay fever; all from unknown dates. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have 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. On 05Mar2021, second day after the second shot, the patient experienced fever, chills, gastrointestinal discomfort, malaise, body ache and joint ache. The fever, chills, gastrointestinal discomfort, malaise had begun to subside on 4-5th day after the shot. The body ache remained, but joint pain had been noticeable and had remained . 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 fever, chills, gastrointestinal discomfort, malaise and body ache. The patient received treatment for joint pain that included ibuprofen. The clinical outcome of fever, chills, gastrointestinal discomfort, malaise, body ache and joint pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; Gastrointestinal discomfort; malaise; body ache; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and hay fever; all from unknown dates. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have 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. On 05Mar2021, second day after the second shot, the patient experienced fever, chills, gastrointestinal discomfort, malaise, body ache and joint ache. The fever, chills, gastrointestinal discomfort, malaise had begun to subside on 4-5th day after the shot. The body ache remained, but joint pain had been noticeable and had remained . 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 fever, chills, gastrointestinal discomfort, malaise and body ache. The patient received treatment for joint pain that included ibuprofen. The clinical outcome of fever, chills, gastrointestinal discomfort, malaise, body ache and joint pain was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Gait disturbance, Pain
Clinical narrative: lost of taste; Legs. An not support walking; aching; weakness; Severe chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the right arm on 24Mar2021 15:45 (at the age of 73-years-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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 27Mar2021, the patient experienced severe chills, weakness, aching, lost of taste and "legs. An not support walking" (as reported). The patient did not receive any treatment for the events chills, weakness, ache, loss of taste and difficulty in walking. The clinical outcomes of the events chills, weakness, ache, loss of taste and difficulty in walking were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: very dizzy/light headed; heart palpitations; felt like a knot in throat and could not take deep breaths; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er 8727), via an unspecified route of administration in the right arm on 24Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ibuprofen (ADVIL) for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en 6205) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and buckwheat on unknown date and experienced anaphylaxis. The patient did not receive any other vaccines within four 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 25Mar2021 at 18:30, after receiving second dose of vaccine 24 hours later, the patient experienced heart palpitations, got very dizzy and light headed, and felt like a knot in throat and could not take deep breaths. Since then, patient was feeling lightheaded and dizzy and it wont go away. The events resulted in doctor or other healthcare professional office/clinic visit twice and its been 5 days and events did not subside. The clinical outcome of event dizzy, heart palpitation and difficulty breathing was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: painful menstrualcramping; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in right arm on 29Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos thyroiditis and hypothyroidism. The patient was allergic to dairy, tramadol and gluten. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID) and liothyronine sodium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 08Mar2021 at 10:00(at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00, the patient experienced increased painful menstrual cramping which was abnormal and patient usually had menstrual cramping on second day in past, but instead it got extreme after 8 hours of the shot. Unspecified NSAIDs only took the edge off. 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 event painful menstrual cramping were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: given all 6 doses of a undiluted vial; Overdose; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 10:00, the patient was given all six doses of an undiluted vial also asked whether he should still go for the second shot. The patient did not receive treatment for the reported events. The 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 event given all six doses of an undiluted vial was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in left arm on 17Mar2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis (EOE) and the patient was allergic to sulfa and penicillin. Concomitant medications included multivitamin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6202) via an unspecified route of administration in left arm on 24Feb2021 at 14:30 (at the age of 33-years-old). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 24Mar2021, the patient underwent COVID-19 nasal swab test and the result was negative. On 28Mar2021 at 10:00, 10 days after the second dose of vaccination, the patient experienced shingles. The adverse event resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient received treatment with antiviral and lidocaine patches for the reported event. The clinical outcome of the event shingles was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy on same side of shot; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 17:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination was reported as not applicable (N/A). 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 02Mar2021 at 09:15 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced lymphadenopathy on the same side of the vaccination. 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 the event. The clinical outcome of lymphadenopathy was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: bottom lip on the left side swelled very large; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included High blood pressure, anxiety/depression, high triglycerides and makeup tattooing on lips (permanent makeup). Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), drospirenone, ethinylestradiol (GIANVI), levothyroxine (MANUFACTURER UNKNOWN), duloxetine hydrochloride (DULOX) used for unknown indication from an unspecified date received within 2 weeks of vaccination. The patient was allergic to sulfa based antibiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 20:00 on 5th day after vaccination, the patient had a swelling on her bottom lip on the left side swelled, was very large. The patient reported that it was not painful but it was just uncomfortable. 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. Therapeutic measures were taken as a result of event which included treatment with prednisone and Benadryl. The clinical outcome of the event swollen lips was recovered after 24 hours on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Pins and needles acute; Warm feeling in arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730), in left arm on 26Mar2021 (at the age of 55-year-old), as single dose for COVID-19 immunisation. Patient had no medical history. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), armour thyroid, multi vitamins received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. The patient had no known allergies to any medications, food or other products were not known. On 26Mar2021 at 1300 the patient experienced acute pins and needles on left side of left arm and also had warm sensation inside the arm near injection site. After 3 days, the patient was still experiencing pins and needle occasionally. No therapeutic measures were taken as a result of 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 pins and needle and warm sensation were resolved with lasting effects.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a headache all night long. It was a numbing chilling kind of headache, almost like brain freeze.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 16Mar2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 20:30, the night of the vaccine, the patient had a headache all night long. It was a numbing chilling kind of headache, almost like brain freeze. It was pretty constant through the night. Now it was two weeks later and she was still getting moments of these headaches coming and going. They did not feel like ordinary headaches. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the headache occurring. The clinical outcome of the event headache occurring was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Malaise, Musculoskeletal stiffness
Clinical narrative: Malaise; body aches; muscle stiffness/ body stiffness; high fever of 102.8; chills; shaking; sweating; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in right arm on 27Mar2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hashimotos hypothyroid, congenital heart malformation, obesity and glaucoma. The patient had allergies to sulfa, TEGRETOL, TRILEPTAL and bee stings. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL), all for unknown indications and received within 2 weeks of vaccination. The patient previously received first dose for BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks of COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 19:30, the patient experienced malaise, body aches, muscle stiffness. It was reported that, progressed to high fever of 102.8, chills, shaking, malaise, sweating, and all over body stiffness and aches for the next 24 hours. It was reported that she had sore and stiff till 29Mar2021 and the fever was gone down. On 27Mar2021, the patient underwent body temperature measurement and the result was 102.8 (unspecified units). The patient did not receive any treatment for the events. The clinical outcome of the events malaise, body aches, muscle stiffness, fever, chills, shaking and sweating was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Malaise; body aches; muscle stiffness/ body stiffness; high fever of 102.8; chills; shaking; sweating; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in right arm on 27Mar2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hashimotos hypothyroid, congenital heart malformation, obesity and glaucoma. The patient had allergies to sulfa, TEGRETOL, TRILEPTAL and bee stings. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL), all for unknown indications and received within 2 weeks of vaccination. The patient previously received first dose for BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 at 16:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks of COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 19:30, the patient experienced malaise, body aches, muscle stiffness. It was reported that, progressed to high fever of 102.8, chills, shaking, malaise, sweating, and all over body stiffness and aches for the next 24 hours. It was reported that she had sore and stiff till 29Mar2021 and the fever was gone down. On 27Mar2021, the patient underwent body temperature measurement and the result was 102.8 (unspecified units). The patient did not receive any treatment for the events. The clinical outcome of the events malaise, body aches, muscle stiffness, fever, chills, shaking and sweating was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lip swelling, Pruritus, Swelling, Urticaria
Clinical narrative: Severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots; Swollen lips; Itchy; Swollen; Warm injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the right arm on 18Mar2021 at 11:15 (at the age of 37-years-old), as single dose for COVID-19 immunisation. Medical history included chronic idiopathic urticaria. The patient was allergic to amoxicillin. Concomitant medications included cetirizine hydrochloride (Zyrtec), escitalopram oxalate (LEXAPRO), lorazepam (ATIVAN), hydroxyzine (MANUFACTURER UNKNOWN); all taken for unknown indication and from an unknown date. 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 18Mar2021 at 13:30, the patient experienced itchy, swollen and warm injection site (itchiness was continued). On 22Mar2021 (Day 4 after shot), the patient experienced severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots and including swollen lips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included self-treatment with ZYRTEC and ZANTAC. The clinical outcomes of the events itchy, swelling, Injection site warmth, hives and swollen lips was not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; headache; Body aches; tiredness; This is a spontaneous report from non-contactable consumer, the patient. A non-pregnant elderly female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: ER2613), via an unspecified route of administration in the right arm on 25Mar2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included diabetes and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 17:00, the patient had experienced fever, headache, body aches and tiredness. The patient did not receive any treatment for the reported events. Adverse 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, headache, body aches and tiredness was unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: short of breath; Total fatigue; This is a spontaneous report from a contactable consumer. An 89-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to penicillin, codeine, vicodin, sulfur, erythromycin, oxybutalin and oxycodone. Concomitant medications included losartan potassium 50mg (MANUFACTURER UNKNOWN), amlodipine 10mg (MANUFACTURER UNKNOWN), sertraline HCL100mg (MANUFACTURER UNKNOWN), apixaban 2.5mg (ELIQUIS), cetirizine HCL 5mg (MANUFACTURER UNKNOWN), donepezil HCL 10mg (MANUFACTURER UNKNOWN), mirabegron ER 25mg (MYRBETRIG ER), atorvastatin 10 mg (MANUFACTURER UNKNOWN), sodium bicarbonate 650 mg (MANUFACTURER UNKNOWN), paracetamol 650 mg (TYLENOL), riboflavin 100mg (MANUFACTURER UNKNOWN) and cyanocobalamin 5000 mcg (B-12). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. 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 25Mar2021 at 16:00, the patient had experienced short period of short of breath which was about for 03 hours and total fatigue which was started 4 days ago and was continuing at the time of report. 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. No therapeutic measures were taken for the reported events. The clinical outcome of the events short of breath was resolved on 25Mar2021 at 19:00; while that of the total fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information expected
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itchier; This is a spontaneous report from a contactable consumer, the patient. A 20-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 28Mar2021 at 17:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication was not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021at 12:00 (after receiving the first dose of the vaccination), the patient experienced hives and had slowly spread more around the body and had gotten itchier over time, started around elbows on both arms but were the worst around the hips and there were a few patches on the chest, legs, and back as well. 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. It was unknown if the patient receive treatment for the reported events. The clinical outcome of the events hives and itchy were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: metallic taste in my mouth/salty taste; metallic taste in my mouth and itseems like I can almost smell it whenI'm breathing; This is a spontaneous report from a contactable other healthcare professional, the patient. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) four days ago for an unknown indication. The patient was known allergic to nickel. The patient did not receive any other vaccines within four 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 29Mar2021 at 17:00 after taking the vaccination, patient felt metallic taste in mouth (salty taste), almost smell the same when breathing and eating. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events metallic taste and metallic smell were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Injection site pain; Swollen and tender left armpit lymph nodes; 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: PAA165969), via unspecified route of administration in the left arm at 15:30 on 22Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had no known allergies. The concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced injection site pain, swollen and tender left armpit lymph nodes. The patient did not receive treatment for the reported events and 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 injection site pain, swollen and tender left armpit lymph nodes was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Flu-like symptoms; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route administration in left Arm on 27Mar2021 at 1145 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included as mild asthma and overstimulated amygdala. The patient had no known allergies to medications, food, or other products. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in left Arm on 06Mar2021 at 1130 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-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 27Mar2021 at 2100, the patient experienced sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever). The patient did not receive any treatment for the events The patient did not receive 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 sore arm and flu-like symptoms (headache, body aches, weak, fatigue and fever were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; body aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: Not reported) via an unspecified route of administration on 24Mar2021 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: Not reported) as single dose for COVID-19 immunization. On an unspecified date in Mar2021, the patient experienced headache, body aches, chills and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.