chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Fatigue, Headache
Clinical narrative: I am suffering from extreme pain in all of my joints; I am suffering from extreme pain in muscles also; I am suffering from severe exhaustion; I am suffering from headaches; I am suffering from nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration on an unspecified date, at the age of 64 years as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension and gastroesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), hydrocortisone (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN). The patient suffered from extreme pain in all of my joints (joint pain) and muscles (muscle pain). The patient also suffered from severe exhaustion (exhaustion), headaches and nausea on 12Mar2021 at 12:00. The patient cannot do any day to day activities. The patient did not receive any treatment for events. The clinical outcome of events joint pain, muscle pain, exhaustion, headache and nausea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Myalgia, Pain, Pyrexia, Speech disorder
Clinical narrative: I am suffering from extreme pain in all of my joints; I am suffering from extreme pain in muscles also; I am suffering from severe exhaustion; I am suffering from headaches; I am suffering from nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration on an unspecified date, at the age of 64 years as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension and gastroesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), hydrocortisone (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN). The patient suffered from extreme pain in all of my joints (joint pain) and muscles (muscle pain). The patient also suffered from severe exhaustion (exhaustion), headaches and nausea on 12Mar2021 at 12:00. The patient cannot do any day to day activities. The patient did not receive any treatment for events. The clinical outcome of events joint pain, muscle pain, exhaustion, headache and nausea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: I am suffering from extreme pain in all of my joints; I am suffering from extreme pain in muscles also; I am suffering from severe exhaustion; I am suffering from headaches; I am suffering from nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration on an unspecified date, at the age of 64 years as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension and gastroesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), hydrocortisone (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN). The patient suffered from extreme pain in all of my joints (joint pain) and muscles (muscle pain). The patient also suffered from severe exhaustion (exhaustion), headaches and nausea on 12Mar2021 at 12:00. The patient cannot do any day to day activities. The patient did not receive any treatment for events. The clinical outcome of events joint pain, muscle pain, exhaustion, headache and nausea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Throat irritation
Clinical narrative: Dizziness; Nausea; Blurred vision; Elevated blood pressure; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 17Mar2021 at 13 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included gluten and alcohol allergy. Past drug history included allergy to codeine. Concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 13:15 hours the patient experienced dizziness, nausea, blurred vision and elevated blood pressure. The adverse events resulted in emergency room/department or urgent care visit. No therapeutic measures were taken for the events. The clinical outcome of events dizziness, nausea, blurred vision, elevated blood pressure was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Muscle tightness, Nausea, Vision blurred
Clinical narrative: Dizziness; Nausea; Blurred vision; Elevated blood pressure; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 17Mar2021 at 13 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included gluten and alcohol allergy. Past drug history included allergy to codeine. Concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 13:15 hours the patient experienced dizziness, nausea, blurred vision and elevated blood pressure. The adverse events resulted in emergency room/department or urgent care visit. No therapeutic measures were taken for the events. The clinical outcome of events dizziness, nausea, blurred vision, elevated blood pressure was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness; Nausea; Blurred vision; Elevated blood pressure; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on left arm on 17Mar2021 at 13 hours (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included gluten and alcohol allergy. Past drug history included allergy to codeine. Concomitant medications were not reported. The patient had no symptoms associated with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 13:15 hours the patient experienced dizziness, nausea, blurred vision and elevated blood pressure. The adverse events resulted in emergency room/department or urgent care visit. No therapeutic measures were taken for the events. The clinical outcome of events dizziness, nausea, blurred vision, elevated blood pressure was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Dysphagia, Fatigue, Pharyngeal swelling
Clinical narrative: chemical taste in mouth; rash on neck; Rash on face; slight swelling in throat; slight dizziness; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included hypothyroidism. Concomitant medications included NP THYROID 120mcg, multivitamin (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received toradol and experienced allergy. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. 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. On 18Mar2021 at 12:30, the patient experienced chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat were recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: chemical taste in mouth; rash on neck; Rash on face; slight swelling in throat; slight dizziness; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included hypothyroidism. Concomitant medications included NP THYROID 120mcg, multivitamin (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received toradol and experienced allergy. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. 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. On 18Mar2021 at 12:30, the patient experienced chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat were recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Heart rate increased, Pharyngeal swelling, Rash
Clinical narrative: chemical taste in mouth; rash on neck; Rash on face; slight swelling in throat; slight dizziness; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included hypothyroidism. Concomitant medications included NP THYROID 120mcg, multivitamin (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received toradol and experienced allergy. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. 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. On 18Mar2021 at 12:30, the patient experienced chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat were recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: woke up with itching; sweating; hives on arms, legs, stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 18Mar2021 at 12:30 (at the age 48-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimotos disease. The patient was not allergic to medications, food, or other products Concomitant medication included SYNTHROID, ZYRTEC, fluoxetine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 02:00, 12-14hours after injection, the patient woke up with itching, sweating and hives on arms, legs and stomach. Therapeutic measures included treatment with benadryl. The clinical outcome of itching, sweating and hives on arms, legs and stomach was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: woke up with itching; sweating; hives on arms, legs, stomach.; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 18Mar2021 at 12:30 (at the age 48-years-old) as single dose for COVID-19 immunisation. Medical history included Hashimotos disease. The patient was not allergic to medications, food, or other products Concomitant medication included SYNTHROID, ZYRTEC, fluoxetine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 02:00, 12-14hours after injection, the patient woke up with itching, sweating and hives on arms, legs and stomach. Therapeutic measures included treatment with benadryl. The clinical outcome of itching, sweating and hives on arms, legs and stomach was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Extreme nausea; Mild headache; Arm soreness; This is a spontaneous report received 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: unknown) in the left arm via an unspecified route of administration on 18Mar2021 at 09:15 hours as a single dose (at the age of 32-years-old) for COVID-19 immunisation. The medical history included hypothyroidism and anemic and no known allergies. The concomitant medications included levothyroxin (MANUFACTURER UNKNOWN) and SETLAKIN for birth control. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 06:30 hours, the patient experienced extreme nausea, mild headache and arm soreness. Patient had not received any treatment for the events. The clinical outcome of the events nausea, headache and pain at extremity was not recovered at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nasal congestion
Clinical narrative: Really congested; Feeling dizzy; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER1741) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 70-years-old) as a single dose, for COVID-19 immunisation. The patient's medical history included allergies (unspecified). The patient have allergies (unspecified) to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient's concomitant medication included vitamins (unspecified) (MANUFACTURER UNKNOWN) for an unknown indication since an unspecified date. On 18Mar2021 at 19:00 (a few hours after receiving the shot), the patient became really congested and started feeling dizzy. The patient did not receive any treatment for events. The clinical outcome of events really congested and feeling dizzy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dizziness
Clinical narrative: Really congested; Feeling dizzy; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER1741) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 70-years-old) as a single dose, for COVID-19 immunisation. The patient's medical history included allergies (unspecified). The patient have allergies (unspecified) to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient's concomitant medication included vitamins (unspecified) (MANUFACTURER UNKNOWN) for an unknown indication since an unspecified date. On 18Mar2021 at 19:00 (a few hours after receiving the shot), the patient became really congested and started feeling dizzy. The patient did not receive any treatment for events. The clinical outcome of events really congested and feeling dizzy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 100.4 Degree temperature; Chills; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch number: ER8727) in the left arm on 18Mar2021 at 11:30 hours (at the age 60-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had allergies to pollen in the air. Concomitant medications included vitamin-c (MANUFACTURE UNKNOWN), multi-vitamin (MANUFACTURE UNKNOWN) and ther-biotic complete (MANUFACTURE UNKNOWN). The patient underwent lab tests which included nasal swab test on 05Oct2020 and had tested negative. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, (on an unknown date) the patient had taken a COVID-19 test. On 19Mar2021 at 01:30 hours, the patient experienced 100.4 degree temperature and chills. No treatment was received for the adverse events. The clinical outcome of the reported events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Polymerase chain reaction, Pyrexia
Clinical narrative: 100.4 Degree temperature; Chills; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch number: ER8727) in the left arm on 18Mar2021 at 11:30 hours (at the age 60-year-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had allergies to pollen in the air. Concomitant medications included vitamin-c (MANUFACTURE UNKNOWN), multi-vitamin (MANUFACTURE UNKNOWN) and ther-biotic complete (MANUFACTURE UNKNOWN). The patient underwent lab tests which included nasal swab test on 05Oct2020 and had tested negative. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, (on an unknown date) the patient had taken a COVID-19 test. On 19Mar2021 at 01:30 hours, the patient experienced 100.4 degree temperature and chills. No treatment was received for the adverse events. The clinical outcome of the reported events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: eyes red; itchy eyes; watery eyes; This is a spontaneous report from a contactable consumer. A 36 year old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration in the left arm on 14Mar2021 at 13:30 (at the age of 36 years) as a single first dose for Covid-19 immunisation. The patient's concomitant medications included zzzquil (MANUFACTURER UNKNOWN), junel (MANUFACTURER UNKNOWN), restasis (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN). Allergies to medications, food, or other products was reported as gluten, liquid tylenol. 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. On 15Mar2021 at 06:30AM, the patient experienced events eyes were red and itchy when she woke up the next morning. They were then red, itchy, and watery. The clinical outcome for events red eyes, itchy eyes and watery eyes were not recovered at the time of reporting. The patient underwent nasal swab, PCR test for COVID 19 virus on 18Mar2021, post vaccination and tested negative for the same. The patient received treatment for red, itchy and watery eyes as prednisone (MANUFACTURER UNKNOWN), Benadryl (MANUFACTURER UNKNOWN), CLARITIN, zatidar (MANUFACTURER UNKNOWN) and the adverse events resulted in doctor or other healthcare professional office/clinic visit. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, SARS-CoV-2 test
Clinical narrative: eyes red; itchy eyes; watery eyes; This is a spontaneous report from a contactable consumer. A 36 year old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration in the left arm on 14Mar2021 at 13:30 (at the age of 36 years) as a single first dose for Covid-19 immunisation. The patient's concomitant medications included zzzquil (MANUFACTURER UNKNOWN), junel (MANUFACTURER UNKNOWN), restasis (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN). Allergies to medications, food, or other products was reported as gluten, liquid tylenol. 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. On 15Mar2021 at 06:30AM, the patient experienced events eyes were red and itchy when she woke up the next morning. They were then red, itchy, and watery. The clinical outcome for events red eyes, itchy eyes and watery eyes were not recovered at the time of reporting. The patient underwent nasal swab, PCR test for COVID 19 virus on 18Mar2021, post vaccination and tested negative for the same. The patient received treatment for red, itchy and watery eyes as prednisone (MANUFACTURER UNKNOWN), Benadryl (MANUFACTURER UNKNOWN), CLARITIN, zatidar (MANUFACTURER UNKNOWN) and the adverse events resulted in doctor or other healthcare professional office/clinic visit. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Erythema, Headache, Injection site mass, Injection site pain
Clinical narrative: redness at site; itchiness; hot raised lump; mild headache; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 30-year old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines, allergies, exercise induced asthma. The patient had allergies to all sulfa drugs, polytrim eyedrops, oranges, fire, ants, bees, wasps, hornets, cats. The patients concomitant medication included norethindrone acetate (MANUFACTURER UNKNOWN), dosage: 1mg/20mcg for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 14: 30, day 1 (as reported) patient experienced redness at site, itchiness, hot raised lump, mild headache, arm soreness. On day 9 (as reported) patient experienced still very red, very itchy, lump is still raised and had not reduced in size or redness. no pain, but still hot. The clinical outcomes of the events redness at site, itchiness, hot raised lump, mild headache, arm soreness was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pruritus
Clinical narrative: redness at site; itchiness; hot raised lump; mild headache; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 30-year old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines, allergies, exercise induced asthma. The patient had allergies to all sulfa drugs, polytrim eyedrops, oranges, fire, ants, bees, wasps, hornets, cats. The patients concomitant medication included norethindrone acetate (MANUFACTURER UNKNOWN), dosage: 1mg/20mcg for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 14: 30, day 1 (as reported) patient experienced redness at site, itchiness, hot raised lump, mild headache, arm soreness. On day 9 (as reported) patient experienced still very red, very itchy, lump is still raised and had not reduced in size or redness. no pain, but still hot. The clinical outcomes of the events redness at site, itchiness, hot raised lump, mild headache, arm soreness was not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site erythema, Injection site mass, Pain in extremity, Pruritus
Clinical narrative: redness at site; itchiness; hot raised lump; mild headache; arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 30-year old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines, allergies, exercise induced asthma. The patient had allergies to all sulfa drugs, polytrim eyedrops, oranges, fire, ants, bees, wasps, hornets, cats. The patients concomitant medication included norethindrone acetate (MANUFACTURER UNKNOWN), dosage: 1mg/20mcg for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 14: 30, day 1 (as reported) patient experienced redness at site, itchiness, hot raised lump, mild headache, arm soreness. On day 9 (as reported) patient experienced still very red, very itchy, lump is still raised and had not reduced in size or redness. no pain, but still hot. The clinical outcomes of the events redness at site, itchiness, hot raised lump, mild headache, arm soreness was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Throat closed up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 19Mar2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and medications were not reported. The patient stated she was an emergency room quality control admissions officer. It was reported that patient received the vaccine on 19Mar2021 and then her throat closed up on an unspecified date in Mar2021. Patient went to the allergy doctor and he gave her fourteen shots to see what she was allergic to. Seriousness of event was unspecified.  She was calling about the Pfizer COVID shot and had a question. She filled out an adverse report a month ago when she got it. She had a question about who she can talk to. Patient's doctor said that the patient could not get the second shot of the Pfizer or the Moderna and was not sure if patient could mix the shots or not. Patient question was she would like to speak with someone to see if she could get the Johnson and Johnson, since she cannot mix the shots or if she should just leave it alone. It was reported that it was best to contact her through email and her voicemail is full since she lost her dad and she was not deleting the messages. Patient clarified that she did the adverse report in Mar2021 and someone called her about adverse effects. She needs to know what to do, and everyone was telling her something different and would really like to speak with withheld someone that knows. Patient was unwilling to complete the report. The outcome of the event was reported as unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closed up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 19Mar2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and medications were not reported. The patient stated she was an emergency room quality control admissions officer. It was reported that patient received the vaccine on 19Mar2021 and then her throat closed up on an unspecified date in Mar2021. Patient went to the allergy doctor and he gave her fourteen shots to see what she was allergic to. Seriousness of event was unspecified.  She was calling about the Pfizer COVID shot and had a question. She filled out an adverse report a month ago when she got it. She had a question about who she can talk to. Patient's doctor said that the patient could not get the second shot of the Pfizer or the Moderna and was not sure if patient could mix the shots or not. Patient question was she would like to speak with someone to see if she could get the Johnson and Johnson, since she cannot mix the shots or if she should just leave it alone. It was reported that it was best to contact her through email and her voicemail is full since she lost her dad and she was not deleting the messages. Patient clarified that she did the adverse report in Mar2021 and someone called her about adverse effects. She needs to know what to do, and everyone was telling her something different and would really like to speak with withheld someone that knows. Patient was unwilling to complete the report. The outcome of the event was reported as unknown.  Information about batch/lot number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Upset stomach; upset stomach and swollen and itchy; Body ache; Itchy rash; fever of 102.4 F; Extremely bad headache; This is a spontaneous report received from a contactable patient. A 52-year-old adult non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 16Mar2021 at 13:15 (at the age of 52 years) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced rash, fever of 102.4 F, upset stomach and swollen and itchy, extremely bad headache and body ache. The patient underwent lab tests and procedures, which included body temperature measurement on 16Mar2021 at 16:00 and result was 102.4 F. No therapeutic measures were taken in response to the events. The clinical outcome of events itchy rash, fever, upset stomach, swelling extremely bad headache and body ache was recovered with sequalae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Upset stomach; upset stomach and swollen and itchy; Body ache; Itchy rash; fever of 102.4 F; Extremely bad headache; This is a spontaneous report received from a contactable patient. A 52-year-old adult non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 16Mar2021 at 13:15 (at the age of 52 years) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced rash, fever of 102.4 F, upset stomach and swollen and itchy, extremely bad headache and body ache. The patient underwent lab tests and procedures, which included body temperature measurement on 16Mar2021 at 16:00 and result was 102.4 F. No therapeutic measures were taken in response to the events. The clinical outcome of events itchy rash, fever, upset stomach, swelling extremely bad headache and body ache was recovered with sequalae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Swelling
Clinical narrative: Upset stomach; upset stomach and swollen and itchy; Body ache; Itchy rash; fever of 102.4 F; Extremely bad headache; This is a spontaneous report received from a contactable patient. A 52-year-old adult non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 16Mar2021 at 13:15 (at the age of 52 years) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient experienced rash, fever of 102.4 F, upset stomach and swollen and itchy, extremely bad headache and body ache. The patient underwent lab tests and procedures, which included body temperature measurement on 16Mar2021 at 16:00 and result was 102.4 F. No therapeutic measures were taken in response to the events. The clinical outcome of events itchy rash, fever, upset stomach, swelling extremely bad headache and body ache was recovered with sequalae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Flushing
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm 19Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The medical history included fibromyalgia, chronic fatigue, allergies, migraines, cervical stenosis, restless legs and pain. The patient had a history of allergy to penicillin, sulfa, Keflex, adhesives, iodine contrast, cats, ropinirole and others. Concomitant medication included plaquenil (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), ASPIRIN, clonazepam (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since vaccination. On 19Mar2021 at 11.15, the patient experienced some itching on right arm, but thought it was a scrape irritated by sun, the arm that was not the injection arm was still pretty red and face was fairly flushed and there was a single hive. When patient took shower, she started to feel itchy burning on scalp, ears, and nose, which was not terrible. While in the shower, her arm started to ache and felt dizzy. When she went out, the itching continues at almost 17:00. The patient was not having a bad time breathing. The patient had taken allergy medicine before the shot. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the reported events were unknown. The clinical outcome of the events itching, hives, pain in arm, flushing and dizzy were not recovered. Information about lot number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm 19Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The medical history included fibromyalgia, chronic fatigue, allergies, migraines, cervical stenosis, restless legs and pain. The patient had a history of allergy to penicillin, sulfa, Keflex, adhesives, iodine contrast, cats, ropinirole and others. Concomitant medication included plaquenil (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), ASPIRIN, clonazepam (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since vaccination. On 19Mar2021 at 11.15, the patient experienced some itching on right arm, but thought it was a scrape irritated by sun, the arm that was not the injection arm was still pretty red and face was fairly flushed and there was a single hive. When patient took shower, she started to feel itchy burning on scalp, ears, and nose, which was not terrible. While in the shower, her arm started to ache and felt dizzy. When she went out, the itching continues at almost 17:00. The patient was not having a bad time breathing. The patient had taken allergy medicine before the shot. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the reported events were unknown. The clinical outcome of the events itching, hives, pain in arm, flushing and dizzy were not recovered. Information about lot number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm 19Mar2021 at 10:30 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The medical history included fibromyalgia, chronic fatigue, allergies, migraines, cervical stenosis, restless legs and pain. The patient had a history of allergy to penicillin, sulfa, Keflex, adhesives, iodine contrast, cats, ropinirole and others. Concomitant medication included plaquenil (MANUFACTURER UNKNOWN), tolterodine (MANUFACTURER UNKNOWN), ASPIRIN, clonazepam (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since vaccination. On 19Mar2021 at 11.15, the patient experienced some itching on right arm, but thought it was a scrape irritated by sun, the arm that was not the injection arm was still pretty red and face was fairly flushed and there was a single hive. When patient took shower, she started to feel itchy burning on scalp, ears, and nose, which was not terrible. While in the shower, her arm started to ache and felt dizzy. When she went out, the itching continues at almost 17:00. The patient was not having a bad time breathing. The patient had taken allergy medicine before the shot. The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the reported events were unknown. The clinical outcome of the events itching, hives, pain in arm, flushing and dizzy were not recovered. Information about lot number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospice patient was hospitalized  multiple times within 60 days of receiving a COVID vaccine series and later died
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Hospice patient was hospitalized  multiple times within 60 days of receiving a COVID vaccine series and later died
Age: 92.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: increased joint pain, fatigue, chills, night sweats
Age: 92.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Night sweats
Clinical narrative: increased joint pain, fatigue, chills, night sweats
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Anxiety, Malaise, Swollen tongue
Clinical narrative: About 20 minutes after shot it felt like my throat and tongue swelled up and my throat swelled up.   I had difficulty swallowing.About 8 hours later my throat was just really sore.    My thinking was also confused.  I should have went to the emergency room but I did not,  I felt very unwell right away.  I also had feeling of anxiety.  I stayed in bed for three days - unable to work etc.  I had chills exhaustion, dizziness.  On the fourth day I still was unwell but was able to get out of bed and shower etc.  My doctor has indicated I can?t get 2nd vaccine as I had allergic reaction.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Anxiety, Chills, Confusional state, Dizziness
Clinical narrative: About 20 minutes after shot it felt like my throat and tongue swelled up and my throat swelled up.   I had difficulty swallowing.About 8 hours later my throat was just really sore.    My thinking was also confused.  I should have went to the emergency room but I did not,  I felt very unwell right away.  I also had feeling of anxiety.  I stayed in bed for three days - unable to work etc.  I had chills exhaustion, dizziness.  On the fourth day I still was unwell but was able to get out of bed and shower etc.  My doctor has indicated I can?t get 2nd vaccine as I had allergic reaction.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Impaired work ability, Loss of personal independence in daily activities, Malaise
Clinical narrative: About 20 minutes after shot it felt like my throat and tongue swelled up and my throat swelled up.   I had difficulty swallowing.About 8 hours later my throat was just really sore.    My thinking was also confused.  I should have went to the emergency room but I did not,  I felt very unwell right away.  I also had feeling of anxiety.  I stayed in bed for three days - unable to work etc.  I had chills exhaustion, dizziness.  On the fourth day I still was unwell but was able to get out of bed and shower etc.  My doctor has indicated I can?t get 2nd vaccine as I had allergic reaction.