chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Got a bumpy itchy rash on both legs which is still present; sweating; arm began to hurt then throb and go numb a bit; arm began to hurt then throb and go numb a bit; The patient was cold; clammy; the first blood pressure was 90 over something/second blood pressure was 70 over 40 something; diarrhea; tired; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 3247), via an unspecified route of administration in the left arm on 18Jan2021 10:00 at a single dose for COVID-19 immunization. The patient's medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 10:10, the patient's arm began to hurt then throb and go numb a bit. On 18Jan2021 10:15, the patient started sweating. She stood up to try and feel better. The patient's husband called the nurse over and they called the paramedics because they said the patient was cold, clammy, and still sweating. The patient sat down again and they put leads on me to check her heart rate, blood pressure (BP), and oxygen on 18Jan2021. Her heart rate and oxygen were fine but the first BP was 90 over something. A few minutes later, she closed her eyes and could have fallen asleep right there. Her second BP was 70 over 40 something. She opened up her eyes and tried to stand up again. After a few more minutes, her BP came up and was OK. They refused an ambulance and went home. She had diarrhea at home on 18Jan2021. She ate, walked and felt better. She just experienced the normal tired and hurt arm in the afternoon on 18Jan2021. She rested the balance of the day. On Wednesday (20Jan2021), she got a bumpy itchy rash on both legs which is still present but with cream, it was OK. No treatment was received for the adverse events. Outcome of the "the first blood pressure was 90 over something/second blood pressure was 70 over 40 something" was recovered on 18Jan2021 and of the remaining events was recovered on Jan2021.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headache; Joint pain; Chills; Vomiting; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 23Jan2021 at 12:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 02Jan2021 at 04:45 PM for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. On 23Jan2021, the patient experienced fever, headache, joint pain, chills, vomiting, and fatigue. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; Headache; Joint pain; Chills; Vomiting; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 23Jan2021 at 12:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 02Jan2021 at 04:45 PM for COVID-19 immunization (right arm). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. On 23Jan2021, the patient experienced fever, headache, joint pain, chills, vomiting, and fatigue. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: swelling in lymph node on left side of neck; Fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 16Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included ulcerative colitis and sulfa drug allergy from an unknown date and unknown if ongoing.  Concomitant medication included mesalazine (APRISO), multivitamin and ergocalciferol (VIT D). The patient was not pregnant at time of vaccination. The patient experienced fatigue and headache on 17Jan2021 for two days. Eight days after vaccination on 24Jan2021, the patient experienced swelling in lymph node on left side of neck. The outcome of the events was not recovered. No treatment given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Department. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Illness, Myalgia
Clinical narrative: Fleeting mild headaches in recovery; 24 hours later, sudden tiredness; Nausea; Fierce diarrhea; Very sick for two hours; Muscle aches instead still there; This is a spontaneous report from a contactable consumer. An 80-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 13:15 at a single dose for COVID-19 immunization.  Medical history included diabetic, Obese and COPD.  The patient's concomitant medications were not reported. It was reported that the patient had fleeting mild headaches in recovery on 20Jan2021 13:30. 24 hours later, sudden tiredness. Two hours later nausea and then fierce diarrhea, very sick for two hours. Waited an hour, took a shower and went to bed. Fatigue and diarrhea lasted two more days but sick feeling gone. Muscle aches instead still there. The outcome of the event sickness was recovered in Jan2021, myalgia was not recovered while recovering for the remaining events.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Fleeting mild headaches in recovery; 24 hours later, sudden tiredness; Nausea; Fierce diarrhea; Very sick for two hours; Muscle aches instead still there; This is a spontaneous report from a contactable consumer. An 80-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 13:15 at a single dose for COVID-19 immunization.  Medical history included diabetic, Obese and COPD.  The patient's concomitant medications were not reported. It was reported that the patient had fleeting mild headaches in recovery on 20Jan2021 13:30. 24 hours later, sudden tiredness. Two hours later nausea and then fierce diarrhea, very sick for two hours. Waited an hour, took a shower and went to bed. Fatigue and diarrhea lasted two more days but sick feeling gone. Muscle aches instead still there. The outcome of the event sickness was recovered in Jan2021, myalgia was not recovered while recovering for the remaining events.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fleeting mild headaches in recovery; 24 hours later, sudden tiredness; Nausea; Fierce diarrhea; Very sick for two hours; Muscle aches instead still there; This is a spontaneous report from a contactable consumer. An 80-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 13:15 at a single dose for COVID-19 immunization.  Medical history included diabetic, Obese and COPD.  The patient's concomitant medications were not reported. It was reported that the patient had fleeting mild headaches in recovery on 20Jan2021 13:30. 24 hours later, sudden tiredness. Two hours later nausea and then fierce diarrhea, very sick for two hours. Waited an hour, took a shower and went to bed. Fatigue and diarrhea lasted two more days but sick feeling gone. Muscle aches instead still there. The outcome of the event sickness was recovered in Jan2021, myalgia was not recovered while recovering for the remaining events.  Information about batch/lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue; High fever (102-103 degrees F); severe body aches; head ache; This is a spontaneous report from a non-contactable other hcp (patient). A 38-year-old male patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included slight hypertension and acid reflux from an unknown date and unknown if ongoing. Concomitant medication included propranolol and lansoprazole (PREVACID). The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on 01Jan2021 at the age of 38 years for COVID-19 immunization. The patient experienced fatigue, high fever, severe body aches and head ache on 22Jan2021 21:00. The patient underwent lab tests and procedures which included body temperature: 102-103 degrees fahrenheit on 22Jan2021. The patient was recovering from the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Productive cough, Vomiting
Clinical narrative: Vomiting; Phlegm; Headache; Dizziness; This is a spontaneous report from a contactable consumer (patient).   This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number unknown), via an unspecified route of administration at single dose in the left arm on 20Jan2021 14:00 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took hydrocodone and experienced drug allergy. On 20Jan2021 15:00, the patient experienced vomiting, phlegm, headache, dizziness. No treatment required. The outcome of  the events was recovered on an unspecified date in Jan2021.The patient had not had symptoms associated with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post the vaccination. The patient was not pregnant at the time of vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: 8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we are now over a week a later and still runny nose; sore throat; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), at age 47 years, via an unspecified route of administration on the left arm, on 16Jan2021 13:15, at single dose, for COVID-19 vaccination. Medical history included low level diabetic, knee issues and milk allergy from an unspecified date. Patient had not had COVID prior to vaccination. Patient had not had other vaccine in four weeks. Concomitant medication included calcium (CALCIUM), fish oil (FISH OIL), glucosamine sulfate (GLUCOSAM), methylsulfonylmethane (MSM [METHYLSULFONYLMETHANE]), magnesium (MAGNESIUM) , cetirizine hydrochloride (ZYTREC) from unspecified dates. The patient previously took ASPRIN and was sensitive to it on an unspecified date. It was reported that on 16Jan2021 21:30, 8-10 hrs post injection bad arm pain, like yellow fever shot, then with in 16- 24 hours cold symptoms that are getting worse, at the time of report, over a week a later and still runny nose, and sore throat, no symptoms prior to shot. There was no treatment for the events. Patient was not tested for COVID post vaccination. Facility type vaccine: Doctor's office/urgent care. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in right arm on 13Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included varenicline tartrate (CHANTIX), duloxetine hydrochloride (CYMBALTA), linaclotide (LINZESS), famotidine (PEPCID) and bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced headache and fatigue on 13Jan2021 12:00. The outcome of the events was recovered on unspecified date. No treatment was given to the patient for the events.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; Two days later I developed fever and shaking and headache; This is a spontaneous report from a contactable healthcare professional. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on her left arm on 22Jan2021 09:00 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included terconazole, duloxetine hydrochloride (CYMBALTA), fluconazole. The patient reported that two days later, she developed fever and shaking and headache; all on 24Jan2021 11:00AM. No treatment was received for the events. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: muscle pain; red, warmth, and puffiness of injection site; red, warmth, and puffiness of injection site; red, warmth, and puffiness of injection site; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included sulfa drug allergy and shellfish allergy from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that 1 week post vaccination, the patient experienced muscle pain and red, warmth, and puffiness of injection site in Jan2021. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, SARS-CoV-2 test, Skin exfoliation
Clinical narrative: Developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back.; They itch when touch; Patient developed rash/They are raised, erythematous spots with scaling in the middle; They are raised, erythematous spots with scaling in the middle; This is a spontaneous report from a contactable Other HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3302, expiry date not reported), via an unspecified route of administration on left arm on 10Jan2021 at a single dose for covid-19 immunization.  Medical history included pollen allergy.  The patient was not pregnant. Concomitant medication included fluoxetine (FLUOXETINE), ethinylestradiol, ferrous fumarate, norethisterone acetate (HAILEY 24 FE); both on unspecified dates for unspecified indications.  The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685, expiry date not reported) on 20Dec2020 on left arm for Covid-19 immunization. On 12Jan2021, the patient developed rash. Started as 3 spots on lower abdomen, then over the course of the week developed more spots on abdomen, under left arm, under right breast, and on back. They are raised, erythematous spots with scaling in the middle. They itch when touched. No ulceration, no oozing. The spots are larger and more red now than when it first began. The patient had nasal swab on 17Jan2021, and it was negative. Outcome of the events was not recovered. The vaccine was given on school or student health clinic. No other vaccines were given in four weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm in Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported (received within 2 weeks of vaccination). On 22Jan2021 17:00 the patient experienced soreness at injection site. No treatment was received for the event. The facility where the vaccine was administered was in a workplace clinic. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a non-contactable consumer (patient herself). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have COVID-19 prior vaccination. The patient did not test for COVID-19 post vaccination. It was reported that the patient did not receive other vaccines in four weeks, "other vaccine same date details" were also provided as 24Jan2021 (as reported). The patient experienced severe diarrhea on 24Jan2021 12:30 which resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of severe diarrhea. Outcome of the event was not recovered.  No follow-up attempts are possible; Information on the lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Hyperhidrosis, Middle insomnia
Clinical narrative: chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Achy; Headache; Throwing up; This is a spontaneous report from a contactable consumer.  A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at single dose in left upper arm for COVID-19 immunisation at the age of 66-year-old. Lot number was EL3249. Medical history and Concomitant medications were none The patient woke up on 24Jan2021 morning and he felt like he was coming down with something. The achiness was first; it started early in the morning, then the headache was in the afternoon, and then at night he started throwing up. While the symptoms were developing, they were worsening, but since they started, they have stayed the same. On 24Jan2021, the patient experienced achy, headache, and threw up. The patient did not recover from the events.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen L axillary lymph nodes 24 hours after receiving vaccine in L deltoid.; This is a spontaneous report from a non-contactable healthcare professional, reporting for herself. A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via an unspecified route of administration at the left deltoid on 23Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was done in a Pharmacy/drug store. Medical history included allergies: penicillin (PCN) from an unknown date and unknown if ongoing. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 at the left arm on 02Jan2021 11:00 for COVID-19 immunization. The patient experienced swollen left axillary lymph nodes on 24Jan2021 07:00 (reported as 24 hours after receiving vaccine in left deltoid). No treatment was received. It was unknown if the patient had COVID prior vaccination. The patient had not had COVID tested post vaccination. There was no other vaccine in four weeks. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram abdomen, Computerised tomogram neck, Computerised tomogram thorax, Lymphadenopathy
Clinical narrative: significant supraclavicular adenopathy on left/virchow's nodes became very inflammed/nodes were very large, tender and multiple in nature; This is a spontaneous report from a contactable physician. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL3249, intramuscular at left arm on 19Jan2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma and allergies with sulfa. Concomitant medication included levothyroxine. Historical vaccine included BNT162B2 on 30Dec2020 for COVID-19 immunization. The patient is not pregnant. On 20Jan2021, the patient experienced significant supraclavicular adenopathy on left (virchow's nodes became very inflamed). The patient was undergoing testing which included blood work, CT of neck, thorax and abdomen to rule out lymphoma, cancer, but nodes were very large, tender and multiple in nature. Nodes are decreasing in size 6 days out. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram normal, Computerised tomogram thorax, Lymphadenopathy, Mammogram
Clinical narrative: significant supraclavicular adenopathy on left/virchow's nodes became very inflammed/nodes were very large, tender and multiple in nature; This is a spontaneous report from a contactable physician. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL3249, intramuscular at left arm on 19Jan2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma and allergies with sulfa. Concomitant medication included levothyroxine. Historical vaccine included BNT162B2 on 30Dec2020 for COVID-19 immunization. The patient is not pregnant. On 20Jan2021, the patient experienced significant supraclavicular adenopathy on left (virchow's nodes became very inflamed). The patient was undergoing testing which included blood work, CT of neck, thorax and abdomen to rule out lymphoma, cancer, but nodes were very large, tender and multiple in nature. Nodes are decreasing in size 6 days out. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Ultrasound breast
Clinical narrative: significant supraclavicular adenopathy on left/virchow's nodes became very inflammed/nodes were very large, tender and multiple in nature; This is a spontaneous report from a contactable physician. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL3249, intramuscular at left arm on 19Jan2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma and allergies with sulfa. Concomitant medication included levothyroxine. Historical vaccine included BNT162B2 on 30Dec2020 for COVID-19 immunization. The patient is not pregnant. On 20Jan2021, the patient experienced significant supraclavicular adenopathy on left (virchow's nodes became very inflamed). The patient was undergoing testing which included blood work, CT of neck, thorax and abdomen to rule out lymphoma, cancer, but nodes were very large, tender and multiple in nature. Nodes are decreasing in size 6 days out. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the second of two reports. Information were collected also from a Pfizer-sponsored program. A 74-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Shortly after the first dose the patient came down with COVID, tested positive for COVID in Jan2021. On 24Jan2021 he received monoclonal antibodies as treatment. He was scheduled for the second dose on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021070373 as same reporter/drug, different event/patient;US-PFIZER INC-2021070373 Same reporter/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm soreness and stiffness; arm soreness and stiffness; This is a spontaneous report from a contactable consumer (patient's husband). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer Covid 19 vaccine yesterday (24Jan2021) and reports arm soreness and stiffness this morning on 25Jan2021 that has already resolved. The outcome of events was on recovered on 25Jan2021.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Neck mass
Clinical narrative: Lump on the left side of neck, pain on the underarm; Lump on the left side of neck, pain on the underarm; This is a spontaneous report from contactable pharmacist. A 52-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246) via intramuscular in the left arm, on 12Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Patient is not pregnant. It was unknown if patient had COVID prior vaccination. It was unknown if patient received other vaccine in four weeks. Patient previously received first dose of BNT162B2 (Lot number: EL0140) via intramuscular in the left arm on 23Dec2020 at the age of 52 years for COVID-19 immunisation. Patient experienced lump on the left side of neck, pain on the underarm on 12Jan2021. It was unknown if patient received treatment for events. It was unknown if patient tested COVID post vaccination.  Outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Mastication disorder, Muscle fatigue, Muscular weakness
Clinical narrative: Moderate muscle fatigue during exercise (as the patient had about 50% of leg strength); Muscles in jaw were weaker and it was difficult to chew gum; Muscles in jaw were weaker and it was difficult to chew gum; This is a spontaneous report from a contactable consumer (patient).   A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. No underlying conditions were reported and no medications have been taken previous month. On an unspecified date, after the vaccination, the patient experienced moderate muscle fatigue during exercise (as the patient had about 50% of leg strength). The patient had noticed that the muscles in jaw were weaker and it was difficult to chew gum. The symptoms only lasted 24 hours after the first dose of the vaccine. Patient's muscle strength return to normal on day two.  The information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain on the injection site/my husband's hurt a little more; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same event for herself and her husband. This is the second of the two reports. An elderly male patient above 75 years old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the arm, on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. After the first vaccination, patient experienced very mild pain on the injection site that went away the next day, the pain hurt a little more than his wife, but by the next day was fine'. Patient took an acetylsalicylic acid and did not experience hematoma/bleeding on the injection site. The wife has been told that some friends experienced a higher incidence/severity of adverse events after the 2nd dose (including pain on the injection site, fever, chills, vomiting) (AER#2021092618). Patient is about to receive their 2nd dose 21 days later (this Friday). The wife is wondering if the diphenhydramine hydrochloride/paracetamol (TYLENOL PM) and aspirin will affect the vaccine-induced antibody response and if it is true that patients get 'sicker' after the 2nd dose. (Is the incidence of AEs higher after the 2nd dose?). She is referring to the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021069500 same product/event, different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Nausea, Rash
Clinical narrative: nauseated; Rash/all over her body/I woke up in a rash and yesterday it was worst; allergic reaction to something because she just woke up in a rash it didn't itch; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249) injected via an unspecified route of administration in the left arm, on 22Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included blood pressure (disorder). Concomitant medications included losartan for blood pressure, montelukast, estradiol (ESTROGEN), metoprolol, esomeprazole, rosuvastatin calcium (ROSUVA). Patient got the COVID vaccine on Friday (22Jan2021), Saturday (23Jan2021) started breaking out in a rash, all over her body. She woke up in a rash and yesterday (24Jan2021) it was worst and she was nauseated; she was having allergic reaction to something because she just woke up in a rash it didn't itch (Jan2021). This was her first dose of the vaccine. She didn't get the vaccine from her doctor, she called into the hospital, the hospital was giving them out on Friday (pending clarification). She was wondering if there is any way she can get something for the rash. Patient did not have treatment for the events. Outcome of rash was not recovered, outcome of other events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Inappropriate schedule of product administration, Nasopharyngitis
Clinical narrative: violently vomiting/ vomited 10-12 times over the next 8 hours; head cold (nasal congestion, postnasal drip, sore throat); chills; fever max temp of 100.8/ fever of 102.6; severe body aches radiating from the left side of my body; feeling fatigued; previously received her first dose on 23Dec2020 /had my second injection on 18Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in the left arm on 18Jan2021 11:30 AM at a single dose for covid-19 immunization. Medical history included eczema and known allergies: NSAIDs, "no gas," eggs, gluten, dairy. Concomitant medications in two weeks included dupilumab (DUPIXENT), levocetirizine dihydrochloride (XYZAL), magnesium, and ergocalciferol (VIT D). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020. She did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior to vaccination. The patient reported "I had my second injection at 11:30 on 18Jan2021. By 20:00, I was feeling fatigued and at 23:00, I got the chills and a fever and severe body aches radiating from the left side of my body. These lasted until around 23:00 on 19Jan2021 with a maximum temperature of 100.8. When I woke up on 20Jan2021, I felt fine, no fever, very mild body aches. Around 16:00, I began to feel fatigued again, and at 20:00 I felt I was coming down with a head cold (nasal congestion, postnasal drip, sore throat). At 23:00, I started violently vomiting and I vomited 10-12 times over the next 8 hours. I also spiked a fever of 102.6. I was prescribed ondansetron (ZOFRAN) on 21Jan2021, which kept the vomiting at bay and on 22Jan2021, I had a negative saliva test for COVID. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of feeling fatigued, severe body aches was not recovered; of chills, fever, head cold, and vomiting was recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: violently vomiting/ vomited 10-12 times over the next 8 hours; head cold (nasal congestion, postnasal drip, sore throat); chills; fever max temp of 100.8/ fever of 102.6; severe body aches radiating from the left side of my body; feeling fatigued; previously received her first dose on 23Dec2020 /had my second injection on 18Jan2021; This is a spontaneous report from a contactable nurse (patient herself). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in the left arm on 18Jan2021 11:30 AM at a single dose for covid-19 immunization. Medical history included eczema and known allergies: NSAIDs, "no gas," eggs, gluten, dairy. Concomitant medications in two weeks included dupilumab (DUPIXENT), levocetirizine dihydrochloride (XYZAL), magnesium, and ergocalciferol (VIT D). The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via an unspecified route of administration in the left arm on 23Dec2020. She did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior to vaccination. The patient reported "I had my second injection at 11:30 on 18Jan2021. By 20:00, I was feeling fatigued and at 23:00, I got the chills and a fever and severe body aches radiating from the left side of my body. These lasted until around 23:00 on 19Jan2021 with a maximum temperature of 100.8. When I woke up on 20Jan2021, I felt fine, no fever, very mild body aches. Around 16:00, I began to feel fatigued again, and at 20:00 I felt I was coming down with a head cold (nasal congestion, postnasal drip, sore throat). At 23:00, I started violently vomiting and I vomited 10-12 times over the next 8 hours. I also spiked a fever of 102.6. I was prescribed ondansetron (ZOFRAN) on 21Jan2021, which kept the vomiting at bay and on 22Jan2021, I had a negative saliva test for COVID. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of feeling fatigued, severe body aches was not recovered; of chills, fever, head cold, and vomiting was recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Nasopharyngitis
Clinical narrative: Headache; Feeling like have a cold; feeling sick; This is a spontaneous report from a contactable consumer (patient).   A 47-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EL3249) at single dose at left shoulder on 14Jan2021 13:00 for covid-19 immunisation.  Medical history included ongoing muscular dystrophy since the age of seven.  There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced headache and feeling like have a cold on 21Jan2021 in first part of the day when he woke up, and has been feeling sick all weekend in Jan2021. He did not know if he had a fever. The events did not require a visit to Emergency Room or physician's office. No relevant test done. The outcome of headache and feeling like have a cold was recovering (also reported as ongoing), of feeling sick was unknown.  He was thinking about getting a test done, clarified as the quick COVID test, but he did not know if it will read a false positive. That is one reason why calling to determine if it would give a false positive.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid infection
Clinical narrative: eye lid infection; This is a spontaneous report from a contactable consumer reported for her husband. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Pfizer product; Batch/lot number: EL3246) via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included pulmonary embolism (PE) diagnosed 3 years ago, treated at (university name) hospital for about 3 weeks and the clot was gone and he went back to his normal routine. Other products were reported as no. Caller stated she and her husband got the first dose of the Covid vaccine 2 weeks ago today, 11Jan2021, stated they were scheduled to get 2nd dose next week 01Feb2021. Caller stated her husband had developed, unrelated to vaccine, an eye lid infection on 18Jan2021 with outcome of not resolved, stated he went to doctor had been treating it with topical antibiotics and anti-inflammatory eye drops, infection was improving but persistent, doctor wanted to put him on an oral antibiotic, they were very reluctant to do so, stated that they considered doxycycline but they read not to be taken with vaccines, stated he would not take that one, caller wanted to know did he need to ride the infection out and possibly end up with an incision and drainage or if he can take an antibiotic. Stated the main concern was that could an antibiotic possibly diminish the efficacy of either the first or second doses of the Covid vaccine and wanted to know if this was possible. Stated her husband was a retired orthopedic surgeon.; Sender's Comments: Eyelid infection is considered unrelated to the vaccine use representing a coincidental skin/ subcutaneous infectious condition.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain
Clinical narrative: has experienced painful lymph nodes in the left arm which was the injection arm; First dose received 05Jan2021, /Second dose received 22Jan2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) second dose on 22Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 for Covid-19 immunization and experienced vomiting. On 23Jan2021, the patient experienced painful lymph nodes in the left arm which was the injection arm. The patient First dose received 05Jan2021 and Second dose received 22Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity, Stress
Clinical narrative: stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) via unspecified route of administration on 19Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history included occupational exposure to COVID-19 (adult foster care, direct line caring for people). The patient's concomitant medications were reported as no. The patient experienced sore arm on 19Jan2021, slight headache on 19Jan2021. Sore arm went away between 20Jan2021 and 21Jan2021. She has recovered completely from sore arm. She is unsure if the headache was from the vaccine or stress, or several different things, such as not sleeping very well. Headache went away, she is not 100% positive, but maybe by the 22Jan2021, and she had recovered completely. The patient asked if she can take paracetamol (TYLENOL) or ibuprofen for side effects if have to. The outcome of sore arm and slight headache was resolved. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092693 same reporter/drug, different patient/ event;US-PFIZER INC-2021092694 same reporter/drug, different patient/ event