chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: very cold; fatigue; body aches; Severe tremors and shaking lasting one and a half hour.; Chills; fever of 102.1; This is a spontaneous report received from a contactable consumer, the patient. A 74-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6200, via unspecified route of administration in the right arm on an 19Feb2021 at 18:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patients past medical history was not provided. The concomitant medications included amlodipine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN). The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EP7534), via unspecified route of administration in right arm on an 14Mar2021 at 11:30 as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since having the vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 12:30, the patient experienced severe tremors and shaking which lasted for one and a half hour. After that, chills and fever of 102.1. On 16Mar2021, the following day, the patient felt very cold, experienced fatigue and some body aches. No treatment was received for these events and the events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tremors, chills, fever, cold, fatigue and body aches were recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Ocular hypertension
Clinical narrative: The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; The next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114).; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Mar2021 at 10:00 AM (age at vaccination: 61 Years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included high bp, diabetes 2, high cholesterol, low thyroid, and drug allergy to meloxicam, Norvasc. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 17Mar2021 at 07:00 AM, the next morning after vaccine, I woke up with horrible headache, intense pressure behind my eyes, and extremely high bp (198/114). The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment which included doubled blood pressure Rx until dr follow up. There was not a product complaint to report. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue
Clinical narrative: Sudden fatigue; Chills (97.9F temp); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 65-years-old), as single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. The concomitant medication included tylenol (MANUFACTURER UNKNWON) at a dose of 500 milligram (mg) 2 times a day from 18Mar2021 at 23:00 for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced sudden fatigue and chills on 19Mar2021 at 19:30. The patient underwent lab tests and procedures which included body temperature on 19Mar2021 at 19:30 and it was 97.9 degree Fahrenheit. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue and chills were resolving at the time of this report. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Injection site pain.; Tiredness; Chills; Joint pain; Feeling unwell; Muscle pain; This is a spontaneous report received from a consumer, the patient. A 18-years-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 the right arm on 15Mar2021 at 1230 (at the age of 18-years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was allergic to bactrim. The patient concomitant medications was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 1600 the patient experienced injection site pain (vaccination site pain), tiredness, muscle pain, chills, joint pain and myalgia. The patient did not receive any treatment for the 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 the events vaccination site pain, tiredness, muscle pain, chills, joint pain and myalgia was recovering at the time of this report.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain.; Tiredness; Chills; Joint pain; Feeling unwell; Muscle pain; This is a spontaneous report received from a consumer, the patient. A 18-years-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 the right arm on 15Mar2021 at 1230 (at the age of 18-years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was allergic to bactrim. The patient concomitant medications was not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, at 1600 the patient experienced injection site pain (vaccination site pain), tiredness, muscle pain, chills, joint pain and myalgia. The patient did not receive any treatment for the 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 the events vaccination site pain, tiredness, muscle pain, chills, joint pain and myalgia was recovering at the time of this report.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oropharyngeal pain, Pain in extremity
Clinical narrative: scratchy throat; blisters on the roof of mouth; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration on 15Mar2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy, environmental allergy and exercise induced anaphylaxis. Concomitant medications were not reported. 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 18Mar2021 at 16:00, the patient experienced scratchy throat, not a big deal but also got blisters on the roof of the mouth, the kind of burn in the mouth from a hot beverage, and sore arm until day 3. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore throat, pain in arm and blisters was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes in neck.; Painful Lump; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis. The patient was allergic to green onions. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications within the two weeks of vaccination included FLONASE SENSIMIST, BENADRYL and TYLENOL for unknown indications received from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, the patient experienced painful lump/ swollen lymph nodes in neck. It was reported that, looking straight forward/ holding head straight, particularly when driving, for longer than a few minutes causes the swollen area to throb and this was not normal to her. 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 adverse events. The clinical outcome of the events swollen lymph node and lymph node pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Allergic reaction; extreme itchy; hives; swollen hands; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via unspecified route of administration on the left arm on 19Mar2021 at 03.45 pm (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant past medical history. The patient did not have any 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 the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient developed allergic reaction which was extreme itchy, hives and swollen hands and feet. Therapeutic measure included the use of BENADRYL for the treatment of the adverse events. The clinical outcome of the event allergic reaction involving events itchy hives, swollen hands and feet was recovering at the time of report.  No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Fast heartbeat; Hard time breathing; This is spontaneous report from contactable consumer, the patient. A 55-years-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 17Mar2021 at 12:00, (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, asthma and allergy to penicillin. The patient received unspecified medication within 2 weeks of vaccination. 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 17Mar2021, the patient experienced fast heartbeat and had hard time for breathing. The patient received BENADRYAL as treatment for the reported events. The clinical outcome of fast heartbeat and hard time breathing was unknown at the time of report.   Information about lot number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mouth ulceration, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Soreness at vaccine site; Fever; Myalgias; Mouth ulcers; This is a spontaneous report received from a contactable consumer, the patient. A 20-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on18Mar2021, at 08:30 AM as a single dose for COVID-19 immunisation. Medical history included ADD and genetic inflammatory fever syndrome. It was reported that no allergies to medications, food or other products. Concomitant medications included FOCALIN and LEXAPRO. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:00 the patient experienced mouth ulcers, headache, myalgia, fever and soreness at vaccination site. Therapeutic measures were taken as a result of mouth ulcers, headache, myalgia, fever and soreness at vaccination with mortin (MANUFACTURER UNKNOWN). The clinical outcome of the events mouth ulcers, headache, myalgia, fever and soreness at vaccination site was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded/dizzy; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown] via an unspecified route of administration in left arm on 27Feb2021 at 09:45 (age at vaccination is 64-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient was unaware of any known allergies. The concomitant medications included gemfibrozil (MANUFACTURER UNKNOWN), metamucil (MANUFACTURER UNKNOWN), losartan HCTZ (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 07Mar2021 at 10:00, the patient experienced the event lightheaded/dizzy which started 8 days after first dose and slowly decreased for a week and reported that most part went away till 19Mar2021 and it was much worse. The patient did not receive any treatment for event. 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 the event lightheaded/dizzy was not recovered at the time of this report.  Information about lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea
Clinical narrative: Diarrhea that began as annoying but progressed and became a problem 13 days after first dose.; Diarrhea; This is a spontaneous report received from a contactable patient. A 48-year-old non pregnant female patient 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 06Mar2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included supravalvular aortic stenosis, familial hypercholesterolemia, coronary artery disease, three heart surgeries including one bypass and ascending aorta graft with aortic valve repair on unspecified date. Concomitant medication received within 2 weeks of vaccination included lipitor ( ATORVASTATIN) and REPATHA from an unspecified date for unknown indication. The patient was allergic to penicillin. 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 was not tested for COVID-19. On 07Mar2021, the patient experienced diarrhea, that began as annoying but progressed (condition aggravated)and became a problem on 19Mar2021 (13 days after the vaccination). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken in response to the event. The clinical outcome of diarrhea and condition aggravated was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bone cyst
Clinical narrative: Squishy cyst on left collarbone; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via unspecified route in left arm on 13Mar2021 at 13:15 PM (at the age of 60-year-old) for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was reported that the patient has not had any allergies to 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 positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient had developed a squishy cyst on left collarbone. The patient never had a problem like this before. No treatment was received for the event. The clinical outcome of squishy cyst on left collarbone was not resolved at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular, Urticaria
Clinical narrative: Area on back of right thigh, two places on right ankle - raised rash with hive-like symptoms.  Very itchy.; Area on back of right thigh, two placeson right ankle - raised rash with hivelikesymptoms. Very itchy.; Area on back of right thigh, two placeson right ankle - raised rash with hivelikesymptoms. Very itchy.; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration on the right arm on 11Mar2021 at 00:00 hours (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and estrogen (MANUFACTURER UNKNOWN) all for unknown indication. The patient had allergies to codeine, sulfa and naproxin. 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 was not tested positive for COVID-19. On 15Mar2021 at 12:00 hours, the patient experienced area on the back of the right thigh, two places on the right ankle had raised rash with hive-like symptoms and were very itchy. No therapeutic measures were taken for the events. The clinical outcome of the events raised rash, urticarial symptoms and itchy was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling, Vaccination site pain
Clinical narrative: My left kneecap had an unusual golfball size swelling 8 hrs after shot; Joint pain; Headache; Fatigue; Ache at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021, at 12:45, (at the age of 68-years) as a single dose, for COVID-19 immunisation. The patient did not have any other medical history. The patient had history of allergy to contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included linseed 290mg (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN), vitamin B12 (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), flax oil (MANUFACTURER UNKNOWN) and turmeric (MANUFACTURER UNKNOWN) for an unknown indication. The patient experienced unusual golf ball size swelling in her left kneecap 8 hours after shot followed by joint pain, headache, fatigue, ache at injection site on 18Mar2021 at 21:15. 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 my left kneecap had an unusual golf ball size swelling 8 hrs after shot, joint pain, headache, fatigue and ache at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Location site pain; Chills; Mild head ache; Low grade fever; Stomach cramping; Diarrhea; This is a spontaneous report from a contactable health care professional, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in her left arm, on 18Mar2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included asthma and patient had allergies to sulfer medications and others are mild reactions. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for asthma within 2 weeks of vaccination. On 18Mar2021 at 17:45 hours, the patient experienced location site pain (vaccination site pain), chills, mild head ache, low grade fever, and stomach cramping with diarrhoea. Patient did not receive any treatment for the adverse events. 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 clinical outcome of the events vaccination site pain, chills, headache, fever, stomach cramping and diarrhoea were resolving at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Location site pain; Chills; Mild head ache; Low grade fever; Stomach cramping; Diarrhea; This is a spontaneous report from a contactable health care professional, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in her left arm, on 18Mar2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included asthma and patient had allergies to sulfer medications and others are mild reactions. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for asthma within 2 weeks of vaccination. On 18Mar2021 at 17:45 hours, the patient experienced location site pain (vaccination site pain), chills, mild head ache, low grade fever, and stomach cramping with diarrhoea. Patient did not receive any treatment for the adverse events. 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 clinical outcome of the events vaccination site pain, chills, headache, fever, stomach cramping and diarrhoea were resolving at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinitus (ear ringing) on the same side as the injection (left ear); This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included albuterol (MANUFACTURER UNKNOWN) and ADVAIR for an unknown indication from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced tinnitus (ear ringing) on the same side as the injection (left ear) on 19Mar2021. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the tinnitus (ear ringing) on the same side as the injection (left ear) was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient.  A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  Past drug history also included DEMEROL for which patient developed allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node.  No therapeutic measures were taken in response to the events.  The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient.  A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  Past drug history also included DEMEROL for which patient developed allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node.  No therapeutic measures were taken in response to the events.  The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient.  A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  Past drug history also included DEMEROL for which patient developed allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node.  No therapeutic measures were taken in response to the events.  The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient.  A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 18Mar2021 at 09:45 (at the age of 61 year) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure, asthma and food allergy (some food sensitivities). The patient received unspecified medication within 2 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration on left arm on 25Feb2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  Past drug history also included DEMEROL for which patient developed allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  On 18Mar2021 at 15:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node.  No therapeutic measures were taken in response to the events.  The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell and swollen lymph node were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 0.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unweel; This is a spontaneous report received from a contactable patient. A 62-year-old non-pregnant male patient received second dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in right arm on 18Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included benign prostrate hyperplasia (BPH). The patient received unspecified medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6205), via unspecified route of administration in right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 07:00, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. The patient did not receive any treatment for the adverse events. 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 clinical outcome of events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 0.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unweel; This is a spontaneous report received from a contactable patient. A 62-year-old non-pregnant male patient received second dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in right arm on 18Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included benign prostrate hyperplasia (BPH). The patient received unspecified medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6205), via unspecified route of administration in right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 07:00, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. The patient did not receive any treatment for the adverse events. 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 clinical outcome of events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 0.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unweel; This is a spontaneous report received from a contactable patient. A 62-year-old non-pregnant male patient received second dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in right arm on 18Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included benign prostrate hyperplasia (BPH). The patient received unspecified medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6205), via unspecified route of administration in right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 07:00, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. The patient did not receive any treatment for the adverse events. 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 clinical outcome of events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 0.17
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell; tiredness; headache; muscle pain; chills; joint pain; fever; feeling unweel; This is a spontaneous report received from a contactable patient. A 62-year-old non-pregnant male patient received second dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via unspecified route of administration in right arm on 18Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included benign prostrate hyperplasia (BPH). The patient received unspecified medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6205), via unspecified route of administration in right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 07:00, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. The patient did not receive any treatment for the adverse events. 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 clinical outcome of events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell was resolved.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling of body temperature change, Headache, Pain
Clinical narrative: Diarrhea; Body aches; Body was hot and then cold; Weakness; Severe headache; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second 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 12:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included Sjogren's, high blood pressure (BP), thyroid, acid reflux and chronic obstructive pulmonary disease (COPD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pro tonic (MANUFACTURER UNKNOWN), levothyroxine (SYNTHROID), metoprolol (MANUFACTURER UNKNOWN), atorvastatin (LIPITOR) and hydroyc (MANUFACTURER UNKNOWN) all since an unknown date for unknown indication. 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 right arm on 25Feb2021 at 11:30 (at the age of 67-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. On 19Mar2021 at 05:00, the patient experienced severe headache, body aches, weakness and the body was hot and then cold. On 20Mar2021, the patient experienced diarrhea. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events severe headache, body aches, weakness, body was hot and then cold and diarrhea. The clinical outcomes of the events severe headache, body aches, weakness and body was hot and then cold were recovered in Mar2021 while that of diarrhea was recovered on 20Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Sore at the injection site; Itchy at and around the injection site; Red at the injection site; Slight lump at the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 11Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unsure if the patient had any allergies to food, medications, or other products. The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. 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 positive for COVID-19. On 19Mar2021 at 16:00, after one week of vaccination, the patient experienced redness, soreness, slight lump and also itchy at and around the vaccination site. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient was treated with antihistamines for the reported events. The clinical outcome of the events redness, soreness, slight lump and, itchy at and around the vaccination site was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Urticaria
Clinical narrative: Hives on my inner left wrist; The area is still tender 12 hours after; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and allergy to cats. Concomitant medications were not reported. 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 19Mar2021 at 20:00, around 33 hours after vaccination, the patient developed hives on inner left wrist, dimensions were approximately 10 cm x 5 cm but the area was still tender 12 hours after resolution. 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 hives was recovered on an unknown date in Mar2021 and of the tenderness was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: parosmia/ rotten/fecal smell; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic hay fever and sinusitis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included emtricitabine; tenofovir alafenamide (DISCOVY), bupropion (WELLBUTRIN), levocetirizine (XYZAL) and prednisone (MANUFACTURER UNKNOWN), all for unknown indication from unknown dates. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021, 4 days after receiving vaccine, the patient started to experience parosmia. There was an underlying rotten or fecal smell that persisted, and the patient could smell it everywhere. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the event parosmia. The clinical outcome of the event parosmia was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.