chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Pruritus, Rash
Clinical narrative: Rash with swelling and heat; Mildly sore arm; Tennis ball sized itchy rash on left arm at injection site; Tennis ball sized itchy rash on left arm at injection site; This is a spontaneous report received from a contactable consumer, the patient. A, non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number- EN6200); via an unspecified route of administration in left arm on 17Feb2021 at 11:00 AM as a single dose for Covid-19 immunisation and second dose via an unspecified route of administration in the left arm 10Mar2021 at 10:00 AM (Lot Number- EN6206) as a single dose. Medical history includes allergy to Sulfa, Penicillin, Latex, Lactose and other food sensitives. Concomitant medication includes Rosuvastatin (MANUFACTURER UNKNOWN), D3 (MANUFACTURER UNKNOWN), RepHresh Pro-B (MANUFACTURER UNKNOWN), 7 others for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test.                  On 10Mar2021 the patient experienced tennis ball sized itchy rash on left arm at injection site and mildly sore arm. On 16Mar2021 at 12:30 AM, the patient experienced rash with some swelling and heat to it. No treatment was received for tennis ball sized itchy rash on left arm at injection site, mildly sore arm, rash. The clinical outcome of swelling had subsided but redness and itching were not recovered. The clinical outcome of tennis ball sized itchy rash on left arm at injection site, mildly sore arm was unknown.                  No follow-up attempts are needed and no further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation anxiety related reaction, Palpitations
Clinical narrative: Immunisation anxiety related reaction; the patient began to experience heart racing.; This is a spontaneous report from a non-contactable healthcare professional. A 35-years old female adult patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: unknown), via unspecified route of administration in the unspecified anatomical site (at the age of 35-year-old at vaccination) on 12 March2021 as a single dose, for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, foods or other products The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On 12 March 2021, the patient experienced During her 15-minute waiting period after the injection, the patient began to experience heart racing. The patient diagnosed as (Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health). The patient was received treatment for the event with water to reduce anxiety. The Clinical outcome of the event heart racing was recovered. The Patient is Stable to go home and follow up with PCP. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Nausea, Throat tightness, Vomiting
Clinical narrative: throat felt tight; ears started burning,; began vomiting; became nauseous; This is a spontaneous report from a contactable non-health care professional. A 50-year-old, non-pregnant female patient received BNT162B2 (BNT162B2), Lot Number: em9809, via unspecified route of administration on left arm on 21Feb2021 at 11:30, (at the age of 50-years-old), as first dose, single for COVID-19 immunisation. 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. Medical history was not reported. The patient had no allergy to food or other products but was allergic to penicillin and sulfa drugs. Concomitant medications included fluoxetine 40 mg, letrozole 2.5 mg and eliquis 5 mg. On 23Feb2021, the patient experienced nausea and vomiting. The patient told that she had eaten eggs her entire life several times a week. On 23Feb2021, two days after the patient had the vaccine, she ate an egg for breakfast and within two hours the patient became nauseous and then began vomiting. A week and a half later the patient had an egg for breakfast, and the exact same thing happened. The patient waited one more week, ate nothing other than an egg for breakfast, and immediately her ears started burning, throat felt tight, and within 20 minutes she began to vomit. The patient did not receive any treatment for the events. The outcome of the events was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; High fever 101; Mussel aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200], as first dose via an unspecified route of administration, in left arm on 14Mar2021 at 01:00 AM (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, ulcerative colitis and non alcoholic steatohepatitis (NASH) also the patient was allergic to Morifine. The patient was diagnosed with COVID-19 prior to vaccination. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced high fever 101, muscle aches (reported as mussel aches) and nausea. The patient did not receive any treatment for the reported events. The clinical outcome of the events high fever 101, muscle aches and nausea were resolved with sequelae. No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Influenza like illness, Lymphadenopathy, Pyrexia
Clinical narrative: Armpit pain; Lymph node swelling in left arm pit; Extremely Chills and shivering; Flu like symptoms; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6200), via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 32-years-old), as a second single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not had any allergies to medications, food and  other products. Prior to 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 vaccine. The patient received other medications (Unknown) within 2 weeks of vaccination. On 13Mar2021 at 06:00, the patient experienced flu like symptoms, arm pit pain, lymph node swelling in left arm pit, fever, extreme chills and shivering. Therapeutic measures were taken for the events with Advil and iced lymph node. At the time of report, the clinical outcome of the events flu like symptoms, arm pit pain, lymph node swelling in left arm pit, fever, extreme chills and shivering was recovering. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Slight Headache; Full body joint aches; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 12Mar2021 at 2:30 pm (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. Concomitant medications included myfortic (MANUFACTURER UNKNOWN), tacrilomus (MANUFACTURER UNKNOWN), effexor (MANUFACTURER UNKNOWN), calcitrol MANUFACTURER UNKNOWN), contrave (MANUFACTURER UNKNOWN) all for an unspecified indication. 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 02Mar2021, the patient received Tetanus vaccine prior to the COVID-19 vaccination. On 13Mar2021, the patient experienced slight headache that lasted 24-36 hours and full body joint aches. The patient did not receive any treatment for the events. The clinical outcome of the slight headache and full body joint aches was recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Left arm soreness up through left side of neck three weeks after injection,; headache from injection through this report (3 weeks post-injection); Left arm soreness up through left side of neck; This is a spontaneous report from a contactable patient. A 58-year-old adult non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH, Batch number was EL3247) via an unspecified route of administration on the left arm on 23Feb2021 at 11:00 AM (at the age of 58-years-old) for COVID-19 immunisation. Her medical history included allergic to penicillin, erythromycin, metronidazole (FLAGYL). Concomitant medications given within 2 weeks of vaccination included (levothyroxine) SYNTHROID, liothyronine (CYTOMEL), escitalopram (LEXAPRO), all administered for an unspecified indication however no any other vaccines were provided within 4 weeks prior to the COVID vaccine. Furthermore, prior to vaccination, she was diagnosed with COVID-19 and since the vaccination, she has not tested positive for COVID-19. On an unknown date in Mar2021 (3 weeks post vaccination), she experienced left arm soreness which then radiated to left side of neck three weeks after injection, headache from injection reported. Sumatriptan (IMITREX) was taken by the patient to treat these events and she visited doctor office due to these events as well. At the time of report, the clinical outcome of left arm soreness up through left side of neck and headache was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Low Grade Fever; Headache; Chills; Body aches; Sore arm at injection area; This is a spontaneous report from a contactable Consumer, Patient. A 48-Year(s)-old Male patient received COVID-19 mRNA VACCINE BIONTECH, Batch No: Lot EL3247 administered in Left arm through Intra muscular on 12-MAR-2021 11:45 AM for covid-19 Immunization. Medical history included High Blood Pressure & Cholesterol. Concomitant medication(s) included Lipitor, Amlodipine, Valsartan, Omeprazole. The patient has taken medications within 2 weeks of vaccination. The patient experienced Body aches, Chills, Headache, Low Grade Fever, Sore arm at injection area. The patient experienced Sore arm at injection area on 12-MAR-2021 and Body aches, Chills, Headache, Low Grade Fever on 16-MAR-2021, 03:00AM. The patient had not done Covid-19 test during vaccination. He was not diagnosed for covid-19 infection. The patient has no allergies to medications, food, or other products. No therapeutic measures were taken. The patient was recovered on 16-MAR-2021 by 11:00 AM. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the unspecified anatomical site on 15Mar2021 at 13:45 (at an unspecified age), as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not provided. On an unknown date, the patient had fatigue and low-grade fever. The clinical outcome of fatigue and low-grade fever was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: chills; general feeling of unwellness; joint pain; tired; felt nausea; muscle pain; site of injection was sore; mild headache; This is a spontaneous report from a contactable consumer. A 63-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 26Feb2021 at 18:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included pernicious anaemia, osteoarthritis, breast cancer history, osteoporosis, recovering from fall, operation from rib surgery removal of ribs & hard wiring of sternum, fibromyalgia, migraines. The patient had IVP Dye allergy. 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 Bupaenorphine trans patch (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), triplex (MANUFACTURER UNKNOWN) for unknown indications received on unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb202, the first day patient experienced vaccination site pain. On second day felt nausea, mild headache, tired & general feeling of un-wellness, had chills, muscle, joint pain plus all morning symptoms much worse. headache to point where she considered a migraine. The patient stated that, she would definitely get her second shot even if she experienced these symptoms again because she was handicapped and believe in this vaccine. Therapeutic measures taken for the adverse events unknown. The clinical outcome of the events headache, muscle soreness, muscle pain, joint pain, nausea, tiredness, joint pain, feeling unwell, chills was resolved. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: chills; general feeling of unwellness; joint pain; tired; felt nausea; muscle pain; site of injection was sore; mild headache; This is a spontaneous report from a contactable consumer. A 63-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 26Feb2021 at 18:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included pernicious anaemia, osteoarthritis, breast cancer history, osteoporosis, recovering from fall, operation from rib surgery removal of ribs & hard wiring of sternum, fibromyalgia, migraines. The patient had IVP Dye allergy. 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 Bupaenorphine trans patch (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), triplex (MANUFACTURER UNKNOWN) for unknown indications received on unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb202, the first day patient experienced vaccination site pain. On second day felt nausea, mild headache, tired & general feeling of un-wellness, had chills, muscle, joint pain plus all morning symptoms much worse. headache to point where she considered a migraine. The patient stated that, she would definitely get her second shot even if she experienced these symptoms again because she was handicapped and believe in this vaccine. Therapeutic measures taken for the adverse events unknown. The clinical outcome of the events headache, muscle soreness, muscle pain, joint pain, nausea, tiredness, joint pain, feeling unwell, chills was resolved. Information about lot/batch number cannot be obtained. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node on left side of neck swollen; Lymph node on left side of neck sore to touch; This is a spontaneous report received from a contactable consumer, the patient. An elderly no pregnant female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) unknown dose, via an unspecified route of administration in the left arm on 10Mar2021 (Lot/batch no: cW6206) expiration date not provided as a single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, hypertension and high cholesterol. Concomitant medications were not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 am, the patient experienced lymph node on left side of neck swollen and sore to touch. No therapeutic measures were taken for the events. The clinical outcome of the events lymph node on left side of neck sore to touch and lymph node on left side of neck swollen were not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on Face; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in an unspecified anatomical site on 12Mar2021 (at an unspecified age), as a first single dose for COVID-19 vaccination. The patient's medical history was not reported. 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 tested for COVID-19. Concomitant medications were not reported. On 12Mar2021, the patient experienced rash on face. The patient did not receive any treatment for the adverse events. The clinical outcome of rash on face was recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: hives on my arms, forhead and chest; fatigue; chills; headache; dizziness; nausea; This is a spontaneous report received from a consumer, the patient. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: not known) via unspecified route of administration in Left arm on 13Mar2021 at 12:45 (at the age of 41-years-old at vaccination) for COVID-19 immunisation. The patient's medical history included asthma, obesity and mitral valve prolapse w/ regurgitation. Concomitant medications included lorazepam (MANUFACTURE UNKNOWN), sertraline(MANUFACTURE UNKNOWN), lamictil (MANUFACTURE UNKNOWN), benedryl (MANUFACTURE UNKNOWN) and Motrin (MANUFACTURE UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient didn't not receive any vaccines within four weeks prior to the vaccination. The patient had no history of allergies. The patient experienced headache, nausea, chills, fatigue and dizziness within 24 hours of the vaccination. The patient broken out in hives on her arms, forehead and chest after 48 hours of vaccination.  Today is day 3 (72 hours) however, she still experiencing mild nausea. The patient received the treatment for the adverse events telehealth, benedryl for rash and nausea medications. At the time of report, the outcome of the events was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on my arms, forhead and chest; fatigue; chills; headache; dizziness; nausea; This is a spontaneous report received from a consumer, the patient. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: not known) via unspecified route of administration in Left arm on 13Mar2021 at 12:45 (at the age of 41-years-old at vaccination) for COVID-19 immunisation. The patient's medical history included asthma, obesity and mitral valve prolapse w/ regurgitation. Concomitant medications included lorazepam (MANUFACTURE UNKNOWN), sertraline(MANUFACTURE UNKNOWN), lamictil (MANUFACTURE UNKNOWN), benedryl (MANUFACTURE UNKNOWN) and Motrin (MANUFACTURE UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient didn't not receive any vaccines within four weeks prior to the vaccination. The patient had no history of allergies. The patient experienced headache, nausea, chills, fatigue and dizziness within 24 hours of the vaccination. The patient broken out in hives on her arms, forehead and chest after 48 hours of vaccination.  Today is day 3 (72 hours) however, she still experiencing mild nausea. The patient received the treatment for the adverse events telehealth, benedryl for rash and nausea medications. At the time of report, the outcome of the events was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargy; low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 15March2021 at 14:15 hours (at the age of 58-years-old) for COVID-19 immunisation. Medical history included high cholesterol. Patient was administered first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 22Feb2021 at 14:15 hours. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and 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 vaccine. On 16Mar2021 at 10:00 AM, the patient experienced lethargy and low-grade fever, Therapeutic measures were not taken for events experienced. The clinical outcome of the events of lethargy and low grade fever was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Strawberry sized swelling two inches from injection site; Rash along both sides of neck; This is a spontaneous report received from a contactable patient. A 54-year-old non-pregnant female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number was En6204) via an unspecified route of administration on the left arm on 12Mar2021 at 12:00PM (at the age of 54-year-old) for Covid-19 immunisation. Medical history included epilepsy and chronic migraine, she was allergic to Penicillin, sulfa, nonsteroidal anti-inflammatory drugs (NSAIDs) and minocycline. Concomitant medications (taken within 2 weeks of vaccination) included erenumab (AIMOVIG), spironolactone, pregabalin (LYRICA), lorazepam and phentermine (PHEN), used administered for unreported indication. It was further reported that prior to vaccination, she was not diagnosed with COVID-19 and has not been tested positive for COVID-19 since having the vaccine. On 12Mar2021, she experienced strawberry sized swelling two inches from injection site and rash along both sides of neck. No therapeutic measures were taken for the events. The clinical outcome of the vaccination site swelling and neck rash was recovering. No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6202, Dose number: 1) via an unspecified route of administration on the left arm on 25Feb2021 at 17:30 as single dose for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Medical history included asthma. The patient was not allergic to any medication, food, or other products. Concomitant medications were not reported. On 26Feb2021, a day after receiving vaccine, the patient experienced full body rash. Upon consultation with the doctor regarding the event, the patient was prescribed Prednisone pack and a steroid shot was administered. The patient stated that, the steroid shot effect reduced within one day and rash went away with prednisone pack. But after completing Prednisone pack, rash returned a couple of days later. Treatment with second prednisone pack was started which was not working as well as first pack. The clinical outcome of the event rash all over was not resolved. No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Face is numb and tingly; Face is numb and tingly; This is a spontaneous report from a contactable non-health care professional, the patient. A 53-years old non-pregnant female patient received BNT162B2 (BNT162B2) (Lot/batch no: EP7534), via an unspecified route of administration on the left arm, as second dose, single on 16Mar2021 at 09:00 (at age of 53 years old) for COVID-19 immunization. Medical history included hypothyroidism. Past drug included BNT162B2 (BNT162B2) (Lot/batch no: EL9267), via an unspecified route of administration on the left arm, as first dose, single on 23Feb2021 at 10:00 for COVID-19 immunization. Concomitant medications included levothyroxine. Allergies included allergy to sulfa drugs. Prior to vaccination, patient had not been diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 09:15, the patient experienced numbness and tingling on her face. The patient did not receive any treatment for the events. The patient was not recovered from the events. No follow-up attempts are needed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hyperhidrosis, Malaise, Pain
Clinical narrative: Sweating; slight fever; Body aches; began to feel unwell; Chills; I developed a cough for 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6205) via unspecified route in the left arm, as a single dose on 09Mar2021 at 11:45 for COVID-19 immunization (at the age of 40-years). The most recent COVID-19 vaccine was administered in the public health clinic/veterans administration facility. The patient's medical history included allergic to sulfa and hydrocodone. Concomitant therapy included levothyroxine (MANUFACTURER UNKNOWN), multivitamins, vitamin D3 (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and fluticasone (FLONASE) taken within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 09Mar2021 at 01:30 PM, the patient developed cough for 3 days. On 13Mar2021 (reported as "4 days after the vaccination"), the patient felt unwell with body aches, chills, sweating and slight fever for 2 days. No treatment was provided for these events. On 16Mar2021, the patient underwent nasal swab test whose result was pending. The clinical outcome of the events cough, felt unwell with body aches, chills, sweating and slight fever was reported as recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Viral test
Clinical narrative: Sweating; slight fever; Body aches; began to feel unwell; Chills; I developed a cough for 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: EN6205) via unspecified route in the left arm, as a single dose on 09Mar2021 at 11:45 for COVID-19 immunization (at the age of 40-years). The most recent COVID-19 vaccine was administered in the public health clinic/veterans administration facility. The patient's medical history included allergic to sulfa and hydrocodone. Concomitant therapy included levothyroxine (MANUFACTURER UNKNOWN), multivitamins, vitamin D3 (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and fluticasone (FLONASE) taken within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On 09Mar2021 at 01:30 PM, the patient developed cough for 3 days. On 13Mar2021 (reported as "4 days after the vaccination"), the patient felt unwell with body aches, chills, sweating and slight fever for 2 days. No treatment was provided for these events. On 16Mar2021, the patient underwent nasal swab test whose result was pending. The clinical outcome of the events cough, felt unwell with body aches, chills, sweating and slight fever was reported as recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: feeling unwell; nausea; injection swelling site; fever; joint pain; Chills; muscle pain; headache; tiredness; This is a spontaneous report from a contactable patient. A 72-year-old elderly non-pregnant female patient received second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via unspecified route of administration on her left arm on 12Mar2021 at 13:00 PM (at the age of 72-year-old at vaccination) for COVID-19 immunisation. Medical history of the patient included kidney function abnormality (kidney functioning 30 percent). Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested with COVID-19. Concomitant medications were not reported. Past drug history included she received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19267) via unspecified route of administration on her left arm 18Feb2021 at 13:00PM for COVID 19 immunisation. On 13Mar2021, she experienced headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell. Therapeutic measures were not taken to treat these events. At the time of the report, the events, headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell were recovering. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: feeling unwell; nausea; injection swelling site; fever; joint pain; Chills; muscle pain; headache; tiredness; This is a spontaneous report from a contactable patient. A 72-year-old elderly non-pregnant female patient received second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via unspecified route of administration on her left arm on 12Mar2021 at 13:00 PM (at the age of 72-year-old at vaccination) for COVID-19 immunisation. Medical history of the patient included kidney function abnormality (kidney functioning 30 percent). Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested with COVID-19. Concomitant medications were not reported. Past drug history included she received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19267) via unspecified route of administration on her left arm 18Feb2021 at 13:00PM for COVID 19 immunisation. On 13Mar2021, she experienced headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell. Therapeutic measures were not taken to treat these events. At the time of the report, the events, headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell were recovering. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable consumer or other health professional.   A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 14:30 (at the age of 56-years-old), as a second single dose for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 56-years-old), as a first single dose for COVID-19 immunisation. No relevant medical history and concomitant medications was reported. The patient did not have any known 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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 16Mar2021, the patient experienced pain in right arm, headache, fatigue, and muscle soreness. There was No fever or other symptoms. The patient received Tylenol 500 mg for the adverse events. The clinical outcome of right arm pain, headache, fatigue, and muscle soreness was recovering. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269); via an unspecified route of administration in the left arm on 19Feb2021 at 01:00 PM (at the age of 75-years-old) as a single dose for COVID-19 immunisation. The patient received second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN); via an unspecified route of administration in the left arm on 12Mar2021(Lot Number: EN6202) as a single dose. The patient reported allergies to SULPHA DRUGS (MANUFACTURER UNKNOWN). Concomitant medications included Synthroid (MANUFACTURER UNKNOWN) for an unknown indication and unknown date and Triamterene (MANUFACTURER UNKNOWN) for an unknown indication and unknown date. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 19Feb2021, the patient experienced diarrhea. It was unclear if the patient received any treatment for the event. The clinical outcome of diarrhea was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry mouth, Feeling hot, Malaise
Clinical narrative: nausea; lightheadedness; ill-appearing; Hot; vomiting; dry mouth; chills; This is a spontaneous report from a contactable Healthcare professional. A 30-Year-old Male patient received BNT162B2 (BNT162B2) 1 single dose via Unknown route of administration in unspecified anatomical location on 20210315 (Lot number: EN6206) for COVID-19 immunisation. On 15Mar2021, during his 15-minute waiting period after the injection, the patient experienced chills, dry mouth, Hot, ill-appearing, light-headedness, nausea and vomiting. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient had complained of chills and vomiting (scantly, x 3 times) and was ill-appearing. He was not diaphoretic. Zofran. The therapeutic measures taken as a result of the adverse events were not reported and follow up response to treatment had no change. The patient was transported to ED (emergency department) by POV (privately owned vehicle). The patient had not recovered from the events at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; lightheadedness; ill-appearing; Hot; vomiting; dry mouth; chills; This is a spontaneous report from a contactable Healthcare professional. A 30-Year-old Male patient received BNT162B2 (BNT162B2) 1 single dose via Unknown route of administration in unspecified anatomical location on 20210315 (Lot number: EN6206) for COVID-19 immunisation. On 15Mar2021, during his 15-minute waiting period after the injection, the patient experienced chills, dry mouth, Hot, ill-appearing, light-headedness, nausea and vomiting. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient had complained of chills and vomiting (scantly, x 3 times) and was ill-appearing. He was not diaphoretic. Zofran. The therapeutic measures taken as a result of the adverse events were not reported and follow up response to treatment had no change. The patient was transported to ED (emergency department) by POV (privately owned vehicle). The patient had not recovered from the events at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: itching and Rash on back of shoulder and upper chest; injection site pain; This is a spontaneous report from a contactable Non health care professional, the patient. A 61 year old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration at left arm on 10Mar2021, as a single dose for COVID-19 immunisation at the age of 61-year-old. The patient's medical history was not reported. The patient was not Allergic to medications, food, or other products. concomitant medications included Lipitor(MANUFACTURER UNKNOWN) for unknown indication, Fosamax(MANUFACTURER UNKNOWN) for unknown indication, calcium supplement (MANUFACTURER UNKNOWN) for unknown indication. Past medication was not reported. The patient did not underwent COVID-19 test. The patient has not had symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Mar2021 after 8 hours of vaccination by 18:30 the patient felt entire left hurt and at the same time Itching on the back of shoulder began. The patient had a raised rash on back of shoulder and some on upper chest. Patient took Self medication, 5mg Xyzal (levocetrizine) as treatment for the allergy and by the early next morning (11Mar2021) the entire rash was gone. Post injection site pain was gone in 3 days (13Mar2021) and she was fine ever since. The clinical outcome for event itching and Rash on back of shoulder and upper chest was recovered on 11Mar2021, injection site pain was recovered on 13Mar2021. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got the virus; got the first shot for the virus then I got the virus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the first shot for the virus then she got the virus. It was reported that patient was done with all of that, and she already received both doses of the Pfizer-BioNtech Covid-19 vaccine. The outcome of events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Weakness; Fever; Body aches; Cold Chills; This is a spontaneous report received from a contactable health care professional. A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6206) intramuscularly in right arm on 07Mar2021 at 12:45 PM (at the age of 43-years) as a single dose for COVID-19 immunization. Patient received her first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EJ1686) intramuscularly in right arm on 06Jan2021 at 02:30 PM for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical and known allergic history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. Patient did not take any other medications within 2 weeks of vaccination. No concomitant drugs were reported. The patient experienced cold chills, body aches, fever and weakness on 14Mar2021 at 09:00 PM. The patient received fever reducers as a treatment for fever. It was not reported if the patient received any treatment for other events. At the time of this report, the patient was recovering from the event cold chills, body aches, fever and weakness.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling very tired; This is a spontaneous report from a contactable reporter. A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6205) as first dose on 08Mar2021 at 12:00 pm on her left arm for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history reported included hypothyroidism and high blood pressure. Concomitant medications taken include Baby aspirin, Tenormin, Rosuvastatin and Levothyroxine that was taken within two weeks of vaccination for unknown indication. 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. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, patient started feeling very tired.No therapeutic measures were taken for the adverse event. The clinical outcome of the event was tiredness and did not recover from the event at the time of reporting. No follow-up attempts are needed. No further information is expected.