chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: gas; gas that resulted in throwing up bile (was on a empty stomach); all day fatigue; muscle aches; slight lethargy; sight injection pain; nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-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 an unknown date in Mar2021 at 17:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, lupus, narcolepsy and sinus/allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included antianxiety medication, antidepressant medication, sinus allergy medication, vit (vitamins) and medication for HBP, all from unknown dates. On an unknown date in Mar2021 at 20:30, the patient experienced mild symptoms that include sight injection pain within four hours that was not as painful as the next day. The next day after about one hour after being awake she had nausea and gas that resulted in throwing up bile (was on an empty stomach), remained nauseous for about two more hours, all day fatigue, muscle aches, and slight lethargy. Therapeutic measures were taken for the events gas that resulted in throwing up bile included Gas-X pill. 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 sight injection pain, nausea, gas that resulted in throwing up bile, fatigue, muscle aches and slight lethargy was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Anxiety, Arthralgia, Chills, Cough
Clinical narrative: Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-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 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. 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 tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hot flush, Palpitations
Clinical narrative: Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-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 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. 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 tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pulmonary pain, Rhinitis, Rhinorrhoea, Tinnitus
Clinical narrative: Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-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 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. 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 tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo, Vision blurred
Clinical narrative: Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-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 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. 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 tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Joint swelling, Muscle swelling, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male 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 18Mar2021 at 12:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, coronary heart disease and osteoarthritis. The patient did not have 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 for COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), roflumilast (DALIRESP), olmesartan-HCTZ (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), salbutamol sulfate (VENTOLIN HFA), budesonide;fomoterol (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), vitamin b complex (B-COMPLEX), probiotic (MANUFACTURER UNKNOWN), ascorbic; acid;retinol;tocopherol (OCUVITE), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), astaxanthin (BIOASTIN), turmeric (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), ascorbic acid;pyridoxine hydrochloride;biotin;folic acid;thiamine;nicotinic acid;pantothenic acid; riboflavin; beta-carotene; magnesium; molybdenum; manganese; potassium; chromium; copper; vanadium; zinc; calcium; iodine; phosphorus; selenium; vitamin d nos; vitamin k nos; vitamin e nos; vitamin b12 nos; chloride; xantofyl; lycopene; nickel; silicone (CENTRUM SILVER MEN 50 plus), magnesium (MANUFACTURER UNKNOWN) and calcium citrate;colecalciferol (CITRICAL CALCIUM D3), all for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 08:00, the patient experienced pain and swelling in muscle and joint in left shoulder to fingertip. The left arm especially elbow area was warm to the touch. It was started with low level pain which was increasing and became intolerable. On Day 3, the patient was still in pain. The patient had a healthcare professional visit, with no reference to COVID vaccine. The patient was instructed to take paracetamol (TYLENOL) or ibuprofen (MANUFACTURER UNKNOWN) for pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events muscle swelling, joint swelling and feeling of warmth. The clinical outcomes of the events muscle swelling, joint swelling, feeling of warmth, muscle pain and joint pain were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; chills fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old adult 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 12Mar2021 at 10:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), guanfacine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), NAC (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, at 19:00 (around day 8 after injection), the patient experienced fatigue, headache, chills fever, still persisting by the day of report. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fatigue, headache, chills fever was not resolved. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site turned red and swollenand hot; Injection site turned red and swollenand hot; Injection site turned red and swollenand hot also itches.; Injection site turned red and swollenand hot; This is a spontaneous report from a contactable consumer, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN 6203) via an unspecified route of administration in left arm on 15Mar2021 at 08:30 (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin from unknown date. Concomitant medication within 2 weeks of vaccination included montelucast (MANUFACTURER UNKNOWN) 10 milligrams (mg) for unknown indication and since from unknown date. 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 was not tested for COVID-19. The patient experienced injection site turned red, swollen, hot and also itches on 23Mar2021 reportedly on the 9 day. No treatment was received for the adverse 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 vaccination site erythema, vaccination site swelling, vaccination site warmth and also vaccination site itching was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Mydriasis
Clinical narrative: Eyes dilated for about 3 hours; metallic taste in mouth for 1 day; Headache for 3 days; Felt tired; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 10:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patients medical history included CMT disease (Charcot-Marie-Tooth disease). The patient was allergic to Sulfa. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and duloxetine hydrochloride (CYMBALTA), all started on an unknown date for an unknown indication. The patient did not receive any other vaccine in four 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 04Mar2021 at 10:45, the patients eyes dilated for about 3 hours, experienced a metallic taste in the mouth for a day, experienced headache for 3 days and felt tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event dilated pupils recovered on 04Mar2021. The clinical outcome of the event metallic taste in mouth recovered on 05Mar2021. The clinical outcome of the event headache recovered on 07Mar2021. The clinical outcome of the event felt tired recovered on an unknown date in Mar2021.  No follow-up attempts are possible; information about the lot number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left upper leg. Looks like shingles but has no shingle symptoms (pain, fever, chill ect).; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 29-years-old), as a single dose, for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine 4 weeks, prior to COVID vaccine. The patient did not receive any medications 2 weeks, prior to COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 14Mar2021, the patient experienced rash on left upper leg which looked like shingles but had no shingle symptoms (pain, fever, chill etc). The clinical outcome of the rash  was recovering at the time of reporting.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Hypoaesthesia, Skin discolouration
Clinical narrative: Bottom of both feet were very blue/purple, bottom of my feet became very red and eventually returned to the normal color; Numbness in my hands and feet; Became very cold; This is a spontaneous report received 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: ER2613) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 60 years) at 11:00 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included CRESTOR for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021 at 19:00, the patient became very cold whereas the temperature remained 97.3 (unspecified units) and bottom of the feet turned blue/purple. The patient took a warm bath after which the bottom of the feet became red and eventually turned normal. The hands and feet had numbness. No treatment was received for the adverse events. The clinical outcome for the events feeling cold, feet turned blue/purple and numbness of hands and feet were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal cyst
Clinical narrative: The cyst has doubled in size, has come to a head at my skin, and is pretty painful.; This is a spontaneous report from a contactable consumer, the patient. A 35-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 9Mar2021 at 13:15 (at the age of 35-years-old) as single dose for COVID-19 immunisation. Medical history included depression, Attention deficit disorder and anxiety. Concomitant medications included trazadone (MANUFACTURER UNKNOWN), Adderall (MANUFACTURER UNKNOWN) and wellbutrin(MANUFACTURER UNKNOWN),all for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, the patient experienced skin cyst. 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 event. The clinical outcome for the skin cyst was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: left side of face and neck felt full numb and tingling; left side of face and neck felt full numb and tingling; Tingling; This is a spontaneous report from a non-contactable nurse. A 25-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via intramuscular route in the left arm on 22Mar2021 at 10:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient medical history included penicillins and sulfa allergy. The patient was allergic to azithromycin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN). Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 10:30, the patient experienced face numbness, neck numbness and tingling, 30 minutes after receiving the vaccine, the left side of her face and neck felt full numb and was tingling. There was no facial droop, but when the face was poked, the left was duller than right. The patient did not receive any treatment for the reported events. The adverse events resulted in the doctor or other healthcare professional office/clinic visit. The clinical outcome of face numbness, neck numbness, tingling was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful arm from injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6198) via an unspecified route of administration in the right arm on 03Mar2021 at 13:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to codeine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced painful arm from injection. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with Advil for the event painful arm from injection. The clinical outcome of the event painful arm from injection was resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; Soreness at the injection site; Chills; Fatigue; Low grade fever (up to 100.6 F); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 19Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and the patient had known penicillin allergy. 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 02Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient received the first dose on 02Mar2021 and second dose on 19Mar2021 (inappropriate schedule of vaccine administration). 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 4 weeks prior to the COVID vaccine. Concomitant medications included acetaminophen (TYLENOL), ibuprofen (ADVIL), melatonin (MANUFACTURER UNKNOWN), all taken for unknown indication and from unspecified dates. On 19Mar2021 at 21:00, the patient experienced soreness at the injection site, fatigue and low-grade fever (up to 100.6 F) beginning at the night of vaccine and continued for about 48 hours. It was reported that the patient did not receive any treatment for the adverse 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 of soreness at the injection site, fatigue, chills and low-grade fever was resolved on 21Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; Soreness at the injection site; Chills; Fatigue; Low grade fever (up to 100.6 F); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 19Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and the patient had known penicillin allergy. 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 02Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient received the first dose on 02Mar2021 and second dose on 19Mar2021 (inappropriate schedule of vaccine administration). 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 4 weeks prior to the COVID vaccine. Concomitant medications included acetaminophen (TYLENOL), ibuprofen (ADVIL), melatonin (MANUFACTURER UNKNOWN), all taken for unknown indication and from unspecified dates. On 19Mar2021 at 21:00, the patient experienced soreness at the injection site, fatigue and low-grade fever (up to 100.6 F) beginning at the night of vaccine and continued for about 48 hours. It was reported that the patient did not receive any treatment for the adverse 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 of soreness at the injection site, fatigue, chills and low-grade fever was resolved on 21Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Back pain, Chest discomfort, Chills, Dyspnoea
Clinical narrative: Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had 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 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Insomnia, SARS-CoV-2 test
Clinical narrative: Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had 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 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Severe muscle pain (7:10 pain scale); shortness breath; weak; nausea; restlessness; diarrhea; moderate headache; 100.1 temp; This is a spontaneous report from a contactable consumer, the patient. A 66 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6198) in the left arm on 16Mar2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included high cholesterol and triglycerides, obesity, tachycardia, hypertension and IBS (irritable bowel syndrome). The patient's concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), valsartan 5mg (MANUFACTURER UNKNOWN), amlodipine 320mg (MANUFACTURER UNKNOWN), ser (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The patient was allergic to demerol and had vomiting. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) in the left arm on 23Feb2021 at 09:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 16Mar2021 at 17:00, the patient experienced severe muscle pain (7:10 pain scale), shortness breath, weak, nausea, restlessness, diarrhoea, fever (100.1 temp) and moderate headache. On the same day, (16Mar2021), the patient underwent a pulse oximetry test and the result was 97% and temperature was 100.1. No therapeutic measures were taken as a result of the events. The clinical outcome of the events shortness breath, weak, muscle pain, nausea, restlessness, diarrhoea, fever and moderate headache was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oxygen saturation, Pyrexia, Restlessness
Clinical narrative: Severe muscle pain (7:10 pain scale); shortness breath; weak; nausea; restlessness; diarrhea; moderate headache; 100.1 temp; This is a spontaneous report from a contactable consumer, the patient. A 66 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6198) in the left arm on 16Mar2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included high cholesterol and triglycerides, obesity, tachycardia, hypertension and IBS (irritable bowel syndrome). The patient's concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), valsartan 5mg (MANUFACTURER UNKNOWN), amlodipine 320mg (MANUFACTURER UNKNOWN), ser (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The patient was allergic to demerol and had vomiting. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) in the left arm on 23Feb2021 at 09:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 16Mar2021 at 17:00, the patient experienced severe muscle pain (7:10 pain scale), shortness breath, weak, nausea, restlessness, diarrhoea, fever (100.1 temp) and moderate headache. On the same day, (16Mar2021), the patient underwent a pulse oximetry test and the result was 97% and temperature was 100.1. No therapeutic measures were taken as a result of the events. The clinical outcome of the events shortness breath, weak, muscle pain, nausea, restlessness, diarrhoea, fever and moderate headache was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tingling in the back of my throat; tingling in the back of my throat and tongue; Slight numbness in the effective area; a flushed feeling; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 6955), via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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 for COVID-19. The patient received unspecified medications for an unknown indication since unknown dates within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, approximately 20 minutes after the vaccination, the patient experienced tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The adverse events did not result in a visit to the 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 tingling in the back of her throat and tongue, a flushed feeling and slight numbness in the effective area. The clinical outcomes of the events tingling in the back of her throat, tingling tongue, a flushed feeling and slight numbness in the effective area were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on half my body; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: ER2613), via an unspecified route of administration in the right arm on 20Mar2021 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included cancer. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL9267), via an unspecified route of administration in the left arm on 27Feb2021 at 12:30 (at the age of 59-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 was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 21Mar2021, the patient experienced rash on half body. The patient did not receive any treatment for the event. The 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 rash on half body was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Vaccination site pain
Clinical narrative: Body aches and pain; headache; joint pain; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 11:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, obesity and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN), NEXIUM, LIPITOR, allopurinol (MANUFACTURER UNKNOWN) and MICARDIS. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP3247) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced body aches and pain, headache, joint pain, pain at injection site on 23Mar2021 at 23:45. 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 general body pain, headache, joint pain and vaccination site pain was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Rash, SARS-CoV-2 test
Clinical narrative: Face swelling and redness; Rash on arms, face and chest; Face swelling and redness; Numbness and tingling in face; Numbness and tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on an unknown date in Mar2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Past medical history included COVID-19 infection on an unknown date. The patient was allergic to sulfa. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On an unknown date in Mar2021 at 12:15, the patient experienced face swelling and redness, numbness and tingling in face and rash on arms, face and chest. No therapeutic measures were taken for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events face swelling and redness, numbness and tingling in face and rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face swelling and redness; Rash on arms, face and chest; Face swelling and redness; Numbness and tingling in face; Numbness and tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in left arm on an unknown date in Mar2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Past medical history included COVID-19 infection on an unknown date. The patient was allergic to sulfa. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On an unknown date in Mar2021 at 12:15, the patient experienced face swelling and redness, numbness and tingling in face and rash on arms, face and chest. No therapeutic measures were taken for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events face swelling and redness, numbness and tingling in face and rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: aches all over; Fever; chills; really sore arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year- non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6023) via unspecified route of administration in the left arm on 23Mar2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient previously received sulfates (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medication included spironolactone (MANUFACTURER UNKNOWN) for unknown indication. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in the left arm on 01Mar2021 at 14:45(at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 24Mar2021 at 01:00, the patient experienced fever between 101-102(unspecified units) beginning 10 hours after 2nd vaccine, chills, aches all over, really sore arm. 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 fever (between 101-102) beginning 10 hours after 2nd vaccine, chills, aches all over, really sore arm were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.