chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Swelling, Vaccination site pain
Clinical narrative: she developed swelling between her neck, collarbone, and shoulder; swelling between her shoulder; The site is "extremely tender" to the touch; This is a spontaneous report received from a contactable consumer (patient). A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on 18Apr2021 as single dose for covid-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr-2021, patient developed swelling between her neck, collarbone, and shoulder, on the same side that the vaccine was administered on and the site is "extremely tender" to the touch on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: After 24 hours hearing in left ear was diminished and has not resolved.; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization (Age at vaccination: 52 years). Medical history was reported as none. The patient's concomitant medications were not reported. On 07Apr2021, 08:00, after 24 hours hearing in left ear was diminished and has not resolved. The patient did not received any treatment for the event. Patient was not pregnant The patient did not have COVID prior vaccination. The patient did not test for covid post vaccination. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: respiratory distress; Projectile vomiting; acute bronchitis; high fever; chronic dry cough; decreased oxygen saturation in blood; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 08Apr2021 at 14:00 (batch/lot number: 8735) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Facility type vaccine was public health clinic. Facility type vaccine other: (name). No other vaccine in four weeks. No other medications in two weeks. The patient experienced respiratory distress, projectile vomiting, acute bronchitis, high fever, chronic dry cough, decreased oxygen saturation in blood; all on 08Apr2021 at 19:00 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for the adverse events which included steroids, antibiotics, breathing treatment, inhale. The patient has not had Covid prior to vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 03Apr2021 (nasal swab).  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test, Vomiting projectile
Clinical narrative: respiratory distress; Projectile vomiting; acute bronchitis; high fever; chronic dry cough; decreased oxygen saturation in blood; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 08Apr2021 at 14:00 (batch/lot number: 8735) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Facility type vaccine was public health clinic. Facility type vaccine other: (name). No other vaccine in four weeks. No other medications in two weeks. The patient experienced respiratory distress, projectile vomiting, acute bronchitis, high fever, chronic dry cough, decreased oxygen saturation in blood; all on 08Apr2021 at 19:00 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for the adverse events which included steroids, antibiotics, breathing treatment, inhale. The patient has not had Covid prior to vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 03Apr2021 (nasal swab).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness of her arm is worse; tiredness is worse; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Apr2021 as single dose, Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that patient got 2nd dose yesterday, 16Apr2021 and wants to know if she can continue taking her vitamins since she did not take it yesterday. She also mentioned that the soreness of her arm and her tiredness is worse compare to what she experienced after her first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling hot, Hyperhidrosis, Hypoaesthesia, Memory impairment
Clinical narrative: tingling; numbing; diarrhea; feel the liquid squirting into my arm which is unusual; Fainted; nauseous; Memory lapse upon waking up; Breathing was slow; hot; sweaty; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:30 AM at the age of 32-years-old as single dose for COVID-19 immunization. Vaccine facility type was reported as "Other". The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. On 09Apr2021, the patient fainted within 2 minutes if receiving vaccine. The patient had memory lapse upon waking up. Her breathing was slow. The patient was extremely nauseous, hot, sweaty. The patient was unable to sit up due to nausea for 1 hour. The following 2 days, the patient experienced nausea and diarrhea. Arm pain lasted for 7 days including tingling/numbing sensation down her entire arm on the 4th day (13Apr2021). At time of vaccine (09Apr2021 at 10:30 AM), she could feel the liquid squirting into her arm which was unusual. The patient reported that she gets lots of vaccines for traveling and have never had these reactions or sensations. The patient has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (unspecified) were taken as a result of the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Respiratory rate decreased, Syncope
Clinical narrative: tingling; numbing; diarrhea; feel the liquid squirting into my arm which is unusual; Fainted; nauseous; Memory lapse upon waking up; Breathing was slow; hot; sweaty; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:30 AM at the age of 32-years-old as single dose for COVID-19 immunization. Vaccine facility type was reported as "Other". The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. On 09Apr2021, the patient fainted within 2 minutes if receiving vaccine. The patient had memory lapse upon waking up. Her breathing was slow. The patient was extremely nauseous, hot, sweaty. The patient was unable to sit up due to nausea for 1 hour. The following 2 days, the patient experienced nausea and diarrhea. Arm pain lasted for 7 days including tingling/numbing sensation down her entire arm on the 4th day (13Apr2021). At time of vaccine (09Apr2021 at 10:30 AM), she could feel the liquid squirting into her arm which was unusual. The patient reported that she gets lots of vaccines for traveling and have never had these reactions or sensations. The patient has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (unspecified) were taken as a result of the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: tingling; numbing; diarrhea; feel the liquid squirting into my arm which is unusual; Fainted; nauseous; Memory lapse upon waking up; Breathing was slow; hot; sweaty; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:30 AM at the age of 32-years-old as single dose for COVID-19 immunization. Vaccine facility type was reported as "Other". The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. On 09Apr2021, the patient fainted within 2 minutes if receiving vaccine. The patient had memory lapse upon waking up. Her breathing was slow. The patient was extremely nauseous, hot, sweaty. The patient was unable to sit up due to nausea for 1 hour. The following 2 days, the patient experienced nausea and diarrhea. Arm pain lasted for 7 days including tingling/numbing sensation down her entire arm on the 4th day (13Apr2021). At time of vaccine (09Apr2021 at 10:30 AM), she could feel the liquid squirting into her arm which was unusual. The patient reported that she gets lots of vaccines for traveling and have never had these reactions or sensations. The patient has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (unspecified) were taken as a result of the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Malaise
Clinical narrative: Bleeding; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 12Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included haven't had the period in 4 years. The patient's concomitant medications were not reported. The patient got the vaccine 3 days ago and the patient was feeling sick for the last two days (13Apr2021) but today (15Apr2021), the patient went to go to bathroom and she was bleeding (patient haven't had the period in 4 years). The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 52-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0161, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Apr2021 14:30 (at the age of 52-years-old) as single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7534), via intramuscular, administration on left arm on 25Mar2021 as a single dose for covid-19 immunization. The patient's medical history included, covid-19 from Dec2020 and concomitant medications were not reported. The patient had no other vaccine within four weeks. On 15Apr2021, the patient had a COVID-19 Virus PCR Test and COVID-19 Virus RPR (rapid) test which was negative. On 16Apr2021, COVID-19 Virus PCR test came back positive. Clarified it was the second time the patient had tested positive for the COVID-19 Virus. As reported, the patient had the COVID-19 Virus in Dec2020 and at that time he had a sore throat and cough. At this time, he didn't have any COVID-19 Virus symptoms. Reported, the patient hadn't gone to the doctor since Jan2021. He had retested for the COVID-19 Virus in Feb2021, so he could fly to Honduras and was negative in Feb2021. The patient did not receive any treatment. Outcome of the events was unknown.  No follow-up attempts are needed. No further Information is expected
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness
Clinical narrative: heart problem; Sunday night I was in the hospital because I have a heart problem, since then I have been feeling dizzy; This is a spontaneous report from contactable consumers (patient and his wife). A male patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), on an unspecified date for COVID-19 immunisation. The patient took the second COVID Vaccine the Pfizer about 12 days prior to this report (in Apr2021). But, Sunday night (unspecified date in Apr2021) he was in the hospital (further clarification unknown) because he had a heart problem. The patient stated he never had a heart problem before. And since then, he has been feeling dizzy. He said he does not know if that was caused by the vaccine or not. Outcome of the events was unknown.   Information on lot number/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: had a natural miscarriage; This is a spontaneous report from a contactable consumer (patient). A 40-year-old pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: G06026), via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 as single dose for COVID-19 immunization in an public health clinic. The patient's medical history was not reported. No known allergies. The patient's concomitant medication includes an unspecified multivitamin. The patient previously received the first dose of bnt162b2 (lot number: not reported) on an unspecified date for COVID-19 immunization. No other vaccinations in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. The patient's last menstrual period was on 25Jan2021 with gestation age at exposure reported as 6 weeks. Expected due date was on 08Nov2021. On 09Apr2021, the patient visited  the emergency room and physicians office and it was reported that the patient had a natural miscarriage, do not know if it was related to the vaccine. Baby stopped developing around time of vaccination at 10 weeks of gestation. The pregnancy resulted in spontaneous abortion. It was unknown if the patient received any treatment. The fetal outcome is intrauterine death. The outcome of the patient was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: two blood clots in his leg; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 08Feb2021 (Lot Number: EM9810, unknown expiration) and second dose on 02Mar2021 (Lot Number: ENU202, unknown expiration; pending clarification), both received at the age of 57 years old via unspecified route of administration as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter called to report that the patient had a Pfizer vaccine, received second COVID vaccine on 02Mar2021, and couples of weeks ago, a week longer that the patient was diagnosed with two blood clots in his leg. The patient got both of COVID-19 vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Inappropriate schedule of product administration, Muscle twitching
Clinical narrative: my teeth was opening and closing as if I was having a seizure; My body was involuntarily twitching; I was cold; shaking; shivering; headaches; 1st dose: 28Mar2021/2nd dose: 14Apr2021; 1st dose: 28Mar2021/2nd dose: 14Apr2021; This is a spontaneous report from a contactable consumer (patient). This 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8731) on 14Apr2021 16:45 at single dose in right arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (lot number ER8733) on 28Mar2021 12:00 in right arm. The patient had no Known allergies. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient had not received other vaccine in four weeks. On 15Apr2021 04:00, his body was involuntarily twitching and his teeth was opening and closing as if he was having a seizure. He thought it was because he was cold so he put on 3 layers of clothes and 2 bundles of blankets and turned the heat up, but his body was still shaking and he was still cold. He tried to go back to sleep to see if that would fix it, but it did not until he went to work and around 7:30 a.m., the shivering stopped, but the headaches persisted and he had to ask to go home and he received an occurrence because he did not have a doctor's note. He clocked out at 8 and he went to sleep for an hour in the car in the parking lot because he was in no condition to drive home. Treatment received for the events included Acetaminophen and rest. The outcome of teeth was opening and closing as if I was having a seizure, body was involuntarily twitching, was cold, shaking, was resolving. The outcome of shivering was resolved. The outcome of headaches was not resolved.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Seizure, Tremor
Clinical narrative: my teeth was opening and closing as if I was having a seizure; My body was involuntarily twitching; I was cold; shaking; shivering; headaches; 1st dose: 28Mar2021/2nd dose: 14Apr2021; 1st dose: 28Mar2021/2nd dose: 14Apr2021; This is a spontaneous report from a contactable consumer (patient). This 20-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8731) on 14Apr2021 16:45 at single dose in right arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (lot number ER8733) on 28Mar2021 12:00 in right arm. The patient had no Known allergies. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient had not received other vaccine in four weeks. On 15Apr2021 04:00, his body was involuntarily twitching and his teeth was opening and closing as if he was having a seizure. He thought it was because he was cold so he put on 3 layers of clothes and 2 bundles of blankets and turned the heat up, but his body was still shaking and he was still cold. He tried to go back to sleep to see if that would fix it, but it did not until he went to work and around 7:30 a.m., the shivering stopped, but the headaches persisted and he had to ask to go home and he received an occurrence because he did not have a doctor's note. He clocked out at 8 and he went to sleep for an hour in the car in the parking lot because he was in no condition to drive home. Treatment received for the events included Acetaminophen and rest. The outcome of teeth was opening and closing as if I was having a seizure, body was involuntarily twitching, was cold, shaking, was resolving. The outcome of shivering was resolved. The outcome of headaches was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Faeces discoloured, Haematochezia
Clinical narrative: literally having blood in my stool; Black stools; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Concurrent medical history included that the patient can hardly hear. Concomitant medications were not reported. On an unspecified date the patient was literally having blood in stool, black stools. The patient got the vaccine and experienced things no one else did and now was having more issues. The patient needed to make sure that blood in stool and black stools were rare side effects. Events outcome was unknown. Information on the Lot/Batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Intermittent racing fluttering heart; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in the right arm on 13Mar2021 at 18:30 (at the age of 40-year-old) and the second dose was administered in the left arm on 02Apr2021 at 13:00 (at the age of 40-year-old); both dose were administered via an unspecified route at a pharmacy or drug store facility as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not COVID tested post vaccination. Medical history included known allergies to Penicillin. The patient was on unspecified concomitant medications. On 20Mar2021, the patient experienced intermittent racing fluttering heart. It started the week after the first shot and intensified the week after he second. No treatment was given for the event. The patient had not yet recovered from the event.  Information on the lot/ batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Accident
Clinical narrative: Had his first shot of Pfizer vaccine and he had a bad accident; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient's spouse). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had his first shot of Pfizer vaccine and he had a bad accident and was hospitalized. The patient missed the second dose because of hospitalization and wanted to know if it was safe to schedule the second dose as soon as possible. The outcome of the event accident was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diabetes mellitus, Dizziness, Glycosylated haemoglobin
Clinical narrative: heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of consciousness, Magnetic resonance imaging, Nausea, Palpitations
Clinical narrative: heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: she had nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced nausea two days after her second dose on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Pain in extremity
Clinical narrative: Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; Lack of energy; This is a spontaneous report received from a contactable consumer. A 40-year-old male received received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number EP6955 and expiry date was not reported) via an unspecified route of administration, in the left arm, on 14Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medications included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient had previously received first dose of vaccine on 24Mar2021 at 14:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient did not have covid prior vaccination. Patient did not test covid, post vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 15Apr2021 at 09:00, patient experienced mild headache, overall body soreness, worse in left arm and lack of energy. The events were considered non serious. No treatment was received. The outcome of events was recovering.  Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer (patient) reported in response to a letter sent which included that: No new information received.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: husband tested positive for the virus; husband tested positive for the virus; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer reported for a male patient (husband) that he received the COVAX series of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration as a SINGLE DOSE for COVID-19 immunization in Jan2021. The patients past medical history and concomitant medications were not reported. Approximately, on an unknown date in 2021, the patient tested positive for the virus (COVID-19 and drug ineffective). The outcome of the events was unknown. It was unknown if the reporter was a health care professional. Information on the Lot/Batch number has been requested. The reporters contact information available to you or a sub-contracted party. It was unknown if the reporter the prescribing HCP.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This case is for one of the 3 patients with same drug different events. This consumer reported for a 49-Year-old female patient who received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: Unknown), through an unspecified route on 14Apr2021 (age at vaccination: unknown) as single dose for COVID-19 immunization. The concomitant medication and medical history were not reported. The patient had sore arm and the outcome of the event was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Headache, Malaise
Clinical narrative: arm was sore; Feeling unwell; Nausea; headaches; chills; diarrhea; shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Consumer reported that her arm was sore and she started feeling unwell; the patient also experienced nausea, headaches, chills, diarrhea and shortness of breath; all on an unspecified date in Apr2021. The consumer doesn't know if it's connected to the vaccine and she wants more insight on this. She still felt unwell at the time of this report. The outcome of the remaining events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: arm was sore; Feeling unwell; Nausea; headaches; chills; diarrhea; shortness of breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. Consumer reported that her arm was sore and she started feeling unwell; the patient also experienced nausea, headaches, chills, diarrhea and shortness of breath; all on an unspecified date in Apr2021. The consumer doesn't know if it's connected to the vaccine and she wants more insight on this. She still felt unwell at the time of this report. The outcome of the remaining events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hyperhidrosis, Pallor, Syncope, Vomiting
Clinical narrative: fainted five minutes after the vaccination; pale; diaphoretic; vomited; she was extremely anxious about receiving the vaccine; This is a spontaneous report from a contactable nurse. A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: PAA165969, expiry date not reported), intramuscular, administered in left arm on 07Apr2021 10:30 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had known allergies or other medical history. It was unknown if patient had Covid prior vaccination. The patient was not pregnant at the time of the vaccination and report. It was unknown if patient received other vaccine in four weeks and other medications in two weeks. The patient received the vaccine at the doctor's office/urgent care. The patient fainted five minutes after the vaccination on 07Apr2021 10:30. She was pale and diaphoretic. She became responsive within one minute. She was given water and a cold compress, and reported she felt better, but then vomited a small amount of emesis 15 minutes later (07Apr2021). She was evaluated by the physician who determined it was an emotional response to the vaccine. The patient had reported she was extremely anxious about receiving the vaccine (07Apr2021), and had fainted when she tried to give blood, and hadn't eaten anything that day. After sitting for 45 minutes, the doctor felt comfortable letting her leave. A call was placed to the patient at 4:00 pm to check on her. She reported she felt fine. The patient received no treatment for the event vomited, while therapeutic measures were taken as a result of the other reported events. It was unknown if patient was tested for Covid post vaccination. The patient recovered on an unspecified date in 2021 from the events reported.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of syncope. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Eyelid vascular disorder, Ocular hyperaemia
Clinical narrative: swelling in his/her eye; redness around the corner of the eye; when he/she lifted the eyelid up there was like red vein visible; very bad like strong pain in the eye; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158), via an unspecified route of administration administered in the left arm on 14Apr2021 (also reported as "14Feb2021") at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on an unspecified date for covid-19 immunization. The patient got the second Pfizer vaccine on Wednesday (14Apr2021) and a day later on 15Apr2021, the patient had swelling in his/her eye, redness around the corner of the eye and then when he/she lifted the eyelid up there was like red vein visible and there was very bad like strong pain in the eye. The patient stated that he/she waited a couple of days just to see (observe) and it did last for a couple of days, but it didn't completely go away. So, the patient called the eye doctor and asked what it might be, and the doctor thought it was like a hemorrhage like a busted blood vessel in the eye - not confirmed. The patient thought it has to do with the vaccination because it appeared a day after getting the vaccine. The eye doctor questioned if the patient has lifted anything heavy or had done anything out of the ordinary that might have caused that to happen to his/her eye and the patient answered "no". The patient was taking it very easy because after the vaccination, he/she was told that one can have some side effects. Hence, the patient wanted to find out if anybody else has reported a similar side effect. The patient added that he/she had not taken anything prior to the vaccination; and he/she did not take any treatment for the reported adverse events. The outcome of the adverse events was unknown.  Information about the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I got a blood clot in my varicose vein in my left leg; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on an unspecified date at single dose for covid-19 immunisation. The patient medical history included varicose vein in the left leg. Concomitant medications were not reported. On an unspecified date in Apr2021, the patient developed a blood clot in the varicose vein in the left leg. Patient clarified that after talking to the doctor patient thought may had the adverse reaction to the first vaccine. Patient was supposed to get Pfizer Vaccine at the day of reporting but when talk to doctor and the urgent care where  was supposed to be getting it, rescheduled it for 04May2021 because 3 days before (in Apr2021) patient got a blood clot in varicose vein in left leg so, they didn't want to go and get the vaccine and rescheduled it for 04May2021. Patient asked if he/she should even get the second vaccine.The final outcome of the event was unknown. Information on the lot/batch number has been requested
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Per caller his friend received the Pfizer COVID 19 Vaccine and tested positive for COVID 4 days after the first vaccine; This is a spontaneous report from a contactable physician via a medical information team and Covax Support. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in Jan2021 (at the age of 80-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Per caller his friend and wife received the Pfizer COVID-19 Vaccine and tested positive for COVID 4 days after the first vaccine on an unspecified date in 2021. They were instructed at the vaccine site they would need to restart the vaccine series. Caller asking if that's correct or not. The patient underwent lab test and procedure which included COVID: Positive on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440874 Same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Per caller his friend and wife received the Pfizer COVID-19 Vaccine and tested positive for COVID 4 days after the first vaccine; This is a spontaneous report from a Pfizer-sponsored program  and medical information team. A contactable physician reported that an 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included bamlanivimab (Bamlan back in January) from an unspecified date in Jan2021. Per caller his friend and wife received the Pfizer COVID-19 Vaccine and tested positive for COVID 4 days after the first vaccine. They were instructed at the vaccine site they would need to restart the vaccine series. Caller asking if that's correct or not. The patient underwent lab test and procedure which included COVID: Positive on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440873 Same reporter/drug/AE, different patients
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chest pain, Head discomfort, Migraine, Nausea
Clinical narrative: lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.