chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 02Mar2021 10:00 (Lot Number: CD3969) (at the age of 43-years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes mellitus from 2016 or 2017, ongoing high blood pressure diagnosed in 2016 or 2017, covid-19 symptoms started on 07Feb2021 and he tested positive for covid on the 10Feb2021 prior to vaccination, pyrexia from Feb2021 and cough from Feb2021 since the covid. The patient was quarantined through the 22Feb2021 after testing positive for covid. The patient had no family medical history relevant to adverse event. Concomitant medications prior to the vaccine up until a week before included chlorphenamine maleate, dextromethorphan hydrobromide, paracetamol (CORICIDIN HBP MAXIMUM STRENGTH FLU) taken for pyrexia and not to raise his blood pressure from 07Feb2021 to 23Feb2021; paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date to Feb2021. The patient had no prior vaccinations within 4 weeks of covid-19 vaccine. After getting the vaccination, the patient fine just a little soreness initially, the injection site got real hard and started hurting then he noticed that the site where the injection went in on his arm was real sore on 02Mar2021 at about 18:00. Later about 03Mar2021 at 12, he woke up with a real bad fever, chills, sweating, body aches, joint pain in his elbows and knees, and his calves felt real tight like a calve strain on the right side; the side he got the shot on. The calve tightness which woke him up. The patient described the calve pain and waking him up kind of like a Charlie horse, a cramp. His wife checked on him to see why he woke up and felt him, saying he was burning up. His temperature was checked, and it was 101.2. At the time of reporting his arm was not as sore but was still tender right now, his muscles were still somewhat sore and his joints still hurt a lot, his body still ached. The patient was hot to the touch and he checked his temperature. The patient took Tylenol 500mg on 03Mar2021 at 12:30 or 13:00 as treatment for body aches and fever but it was not working. The events did not require visit to emergency room or physician office. The patient asked if he was contagious after vaccine. The outcome of vaccination site induration, sweating and calf pain was unknown and outcome of all other events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Feeling cold
Clinical narrative: chest hurt; trouble breathing; My blood oxygen level was at 88. It is normally 97 or 98.; feeling cold; dizzy; couldn't walk hardly at all; shaking violently; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 06Mar2021 10:00 (at the age of 71-years-old) as a single dose for covid-19 immunisation. Medical history included refractory anaemia with ringed sideroblasts, Myelodysplastic syndrome with ringed sideroblasts, tardive dyskinesia from an unknown date and unknown if ongoing. Concomitant medication(s) included DE tetrabenazine, levothyroxine sodium, sertraline, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Austedo, levothyroxine, sertraline, metformin, vit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have known allergies. He had MDS with RARS and tardive dyskinesia. He had his 2nd dose on 06Mar2021 at 10:00 AM. He went home feeling fine all day. He went to bet and woke up at 11;55 at night, shaking violently. He was feeling cold. He got up very dizzy, couldn't walk hardly at all. Went back to bed shaking. He finally fell asleep. When he awoke in the morning his chest hurt, front and back, trouble breathing. His have a pulse oximeter from his wife who passed away from COPD 2 years ago. He bloods oxygen level was at 88. It was normally 97 or 98. It was now Monday 08Mar2021. He feels better not 100% but significantly better. His question was should the vaccine lower your blood oxygen level, he knows that if someone had COPD it may have killed them. He hasn't felt that bad in his 71 years. He probably wouldn't have gotten the 2nd shot if he knew this was going to happen. No treatment was given for adverse events. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Oxygen saturation decreased
Clinical narrative: chest hurt; trouble breathing; My blood oxygen level was at 88. It is normally 97 or 98.; feeling cold; dizzy; couldn't walk hardly at all; shaking violently; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 06Mar2021 10:00 (at the age of 71-years-old) as a single dose for covid-19 immunisation. Medical history included refractory anaemia with ringed sideroblasts, Myelodysplastic syndrome with ringed sideroblasts, tardive dyskinesia from an unknown date and unknown if ongoing. Concomitant medication(s) included DE tetrabenazine, levothyroxine sodium, sertraline, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Austedo, levothyroxine, sertraline, metformin, vit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have known allergies. He had MDS with RARS and tardive dyskinesia. He had his 2nd dose on 06Mar2021 at 10:00 AM. He went home feeling fine all day. He went to bet and woke up at 11;55 at night, shaking violently. He was feeling cold. He got up very dizzy, couldn't walk hardly at all. Went back to bed shaking. He finally fell asleep. When he awoke in the morning his chest hurt, front and back, trouble breathing. His have a pulse oximeter from his wife who passed away from COPD 2 years ago. He bloods oxygen level was at 88. It was normally 97 or 98. It was now Monday 08Mar2021. He feels better not 100% but significantly better. His question was should the vaccine lower your blood oxygen level, he knows that if someone had COPD it may have killed them. He hasn't felt that bad in his 71 years. He probably wouldn't have gotten the 2nd shot if he knew this was going to happen. No treatment was given for adverse events. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Pain in extremity, Rash
Clinical narrative: My hands are blood red; my finger tips are blood red; Like a rash but it is like a red and white all over my body; My whole arm is killing me, I am in so much pain; taste of foul fish in mouth and I drink and eat taste like nasty salmon; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date not reported) via an unspecified route of administration, on 01Mar2021, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced the hands and finger tips are blood red, like a rash but it is like red and white all over the body, the whole arm is killing with so much of pain on previous day night (02Mar2021) and taste of foul fish in mouth; when drink and eat taste like nasty salmon on Mar2021. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Diarrhea; Fever; I am not feeling well; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiry date: Unknown), via an unspecified route of administration on 20Feb2021 (at the age of 79 year old) as dose 1, single for COVID-19 immunisation.  Medical history included high blood pressure and parkinson's disease from an unknown date. The patient was taking unspecified medications for high blood pressure and parkinson's disease. On 21Feb2021, afternoon, she was not feeling well, she had chills, diarrhea and little bit of a fever. The events resulted in clinic visit. The patient underwent lab tests and procedures which included on an unspecified date in 2021, SARS-COV-2 test, where result was found to be negative. The healthcare professional informed her, that it was a side effect from vaccination. Therapeutic measures were taken in response to the events included, Tylenol and drinking Gatorade. It was reported that, her second dose has been scheduled on 13Mar2021. At the time of report, the outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Ear pain, Fatigue, Influenza like illness
Clinical narrative: Ear pain; Sore throat; sinus drainage; felt like she had a fever, but she did not; flu-like symptoms like her body hurting, and not feeling well; Nausea; Tiredness; flu-like symptoms like her body hurting, and not feeling well; Lightheadedness; flu-like symptoms like her body hurting, and not feeling well; Stomach pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:45 at the age of 55-year-old as dose 1, single for covid-19 immunisation.  Patient medical history and concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no additional vaccines administered on same date of the bnt162b2. On 27Feb2021 patient experienced lightheadedness, nausea, tiredness, flu-like symptoms like her body hurting, and not feeling well. She said she felt like she had a fever, but she did not. She said she had stomach pain, as well. On 03Mar2021 something had developed in her ear and throat, clarifying she believed sinus drainage maybe making her ears and throat sore. Patient did not visit either emergency room or physician office. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: Ear pain; Sore throat; sinus drainage; felt like she had a fever, but she did not; flu-like symptoms like her body hurting, and not feeling well; Nausea; Tiredness; flu-like symptoms like her body hurting, and not feeling well; Lightheadedness; flu-like symptoms like her body hurting, and not feeling well; Stomach pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:45 at the age of 55-year-old as dose 1, single for covid-19 immunisation.  Patient medical history and concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no additional vaccines administered on same date of the bnt162b2. On 27Feb2021 patient experienced lightheadedness, nausea, tiredness, flu-like symptoms like her body hurting, and not feeling well. She said she felt like she had a fever, but she did not. She said she had stomach pain, as well. On 03Mar2021 something had developed in her ear and throat, clarifying she believed sinus drainage maybe making her ears and throat sore. Patient did not visit either emergency room or physician office. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Ear pain; Sore throat; sinus drainage; felt like she had a fever, but she did not; flu-like symptoms like her body hurting, and not feeling well; Nausea; Tiredness; flu-like symptoms like her body hurting, and not feeling well; Lightheadedness; flu-like symptoms like her body hurting, and not feeling well; Stomach pain; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:45 at the age of 55-year-old as dose 1, single for covid-19 immunisation.  Patient medical history and concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no additional vaccines administered on same date of the bnt162b2. On 27Feb2021 patient experienced lightheadedness, nausea, tiredness, flu-like symptoms like her body hurting, and not feeling well. She said she felt like she had a fever, but she did not. She said she had stomach pain, as well. On 03Mar2021 something had developed in her ear and throat, clarifying she believed sinus drainage maybe making her ears and throat sore. Patient did not visit either emergency room or physician office. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: she got a rash; on her left leg there were some of the red spots that were sores that she has suddenly inflamed up; one spot that is still itchy; jillion tiny red dots on her arm, the arm she got the shot in; could have been an allergy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6200 and expiry date not reported), via an unspecified route of administration, on 24Feb2021 (at the age of 86-year-old), as dose 2, single, for COVID-19 immunisation. Patient had no medical history. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN5318 and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. It was reported that, on 26Feb2021, 2 days after the vaccine she got a rash, it was like a jillion tiny red dots on her arm, the arm she got the shot in, and it completely covered her arm with it and on her left leg there were some of the red spots that were sores that had suddenly inflamed up. It was reported that, they resolved before the vaccine, but they reared their ugly head and were inflamed again then the next day they began to subside (as reported). The reporter clarified this happened after the second dose. It was resolved except for one spot that was still itchy other than that, all the jillion little dots were gone. She was a little concerned about that it could have been an allergy and did not know if she should have had her take something for it like Benadryl. The outcome for rash was recovered and the outcome for one spot that was itchy was not recovered and the outcome for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Body temperature, Erythema, Feeling abnormal, Head discomfort
Clinical narrative: Rash; Nausea; Low grade temperatures, 99 to about 101; Had vivid dreams were hard to awake even when I was awaken from it was hard to get out of the dream; Cold sores; Night sweat; red throat; Sweat; brain fog/strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; when I stand up now my head becomes very heavy and I have to sit down because it's such a strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; Right sinus and temple pain when I stand up head becomes very heavy and I have to sit down because it's a strange feeling whether I am going to pass out although it feels different than normal; Body aches and pains; cheeks have gotten red; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 27Feb2021 (at the age of 76-year-old) as DOSE 2,SINGLE for covid-19 immunization. Medical history included blood pressure fluctuation. Concomitant medications included valsartan taken for blood pressure fluctuation and esomeprazole sodium (NEXIUM) taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EL9261 and expiration date: not reported), via an unspecified route of administration, in left arm, on 30Jan2021 (at the age of 76-year-old) as DOSE 1,SINGLE for covid-19 immunization and experienced Headache, nausea, Feeling unwell, Muscle pain and Joint pain. On 27Feb2021, the patient experienced a rash and had taken Tylenol and Benadryl, patient had nausea, low grade temperatures, 99 to about a 101. The patient had vivid dreams that were hard to awake, even when patient was awaken from it was hard to get out of the dream. Cold sores, red throat, right sinus and temple pain standing when she stand up her head becomes very heavy and have to sit down because it's such a strange feeling that she, don't know whether she was going to pass out although it feels different than normal that patient  had experienced in the past. Body aches and pains, sweat, night sweat, brain fog. And also cheeks have gotten red and nausea. Therapeutic measures were taken as a result of events  included Tylenol, Benadryl and included liquid IV. The outcome of all the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Night sweats, Oral herpes, Pain
Clinical narrative: Rash; Nausea; Low grade temperatures, 99 to about 101; Had vivid dreams were hard to awake even when I was awaken from it was hard to get out of the dream; Cold sores; Night sweat; red throat; Sweat; brain fog/strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; when I stand up now my head becomes very heavy and I have to sit down because it's such a strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; Right sinus and temple pain when I stand up head becomes very heavy and I have to sit down because it's a strange feeling whether I am going to pass out although it feels different than normal; Body aches and pains; cheeks have gotten red; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 27Feb2021 (at the age of 76-year-old) as DOSE 2,SINGLE for covid-19 immunization. Medical history included blood pressure fluctuation. Concomitant medications included valsartan taken for blood pressure fluctuation and esomeprazole sodium (NEXIUM) taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EL9261 and expiration date: not reported), via an unspecified route of administration, in left arm, on 30Jan2021 (at the age of 76-year-old) as DOSE 1,SINGLE for covid-19 immunization and experienced Headache, nausea, Feeling unwell, Muscle pain and Joint pain. On 27Feb2021, the patient experienced a rash and had taken Tylenol and Benadryl, patient had nausea, low grade temperatures, 99 to about a 101. The patient had vivid dreams that were hard to awake, even when patient was awaken from it was hard to get out of the dream. Cold sores, red throat, right sinus and temple pain standing when she stand up her head becomes very heavy and have to sit down because it's such a strange feeling that she, don't know whether she was going to pass out although it feels different than normal that patient  had experienced in the past. Body aches and pains, sweat, night sweat, brain fog. And also cheeks have gotten red and nausea. Therapeutic measures were taken as a result of events  included Tylenol, Benadryl and included liquid IV. The outcome of all the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Pyrexia, Rash, Sinus pain
Clinical narrative: Rash; Nausea; Low grade temperatures, 99 to about 101; Had vivid dreams were hard to awake even when I was awaken from it was hard to get out of the dream; Cold sores; Night sweat; red throat; Sweat; brain fog/strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; when I stand up now my head becomes very heavy and I have to sit down because it's such a strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; Right sinus and temple pain when I stand up head becomes very heavy and I have to sit down because it's a strange feeling whether I am going to pass out although it feels different than normal; Body aches and pains; cheeks have gotten red; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 27Feb2021 (at the age of 76-year-old) as DOSE 2,SINGLE for covid-19 immunization. Medical history included blood pressure fluctuation. Concomitant medications included valsartan taken for blood pressure fluctuation and esomeprazole sodium (NEXIUM) taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EL9261 and expiration date: not reported), via an unspecified route of administration, in left arm, on 30Jan2021 (at the age of 76-year-old) as DOSE 1,SINGLE for covid-19 immunization and experienced Headache, nausea, Feeling unwell, Muscle pain and Joint pain. On 27Feb2021, the patient experienced a rash and had taken Tylenol and Benadryl, patient had nausea, low grade temperatures, 99 to about a 101. The patient had vivid dreams that were hard to awake, even when patient was awaken from it was hard to get out of the dream. Cold sores, red throat, right sinus and temple pain standing when she stand up her head becomes very heavy and have to sit down because it's such a strange feeling that she, don't know whether she was going to pass out although it feels different than normal that patient  had experienced in the past. Body aches and pains, sweat, night sweat, brain fog. And also cheeks have gotten red and nausea. Therapeutic measures were taken as a result of events  included Tylenol, Benadryl and included liquid IV. The outcome of all the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Pruritus, Urticaria
Clinical narrative: A normal little soreness on her arm; She developed a some kind of hive on her leg it is itchy and uncomfortable; She developed a some kind of hive on her leg it is itchy and uncomfortable; She developed a some kind of hive on her leg it is itchy and uncomfortable; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included allergy like seasonal. Concomitant medication included loratadine taken for seasonal allergy, start and stop dates were not reported. The patient experienced a normal little soreness on her arm. The patient applied some ice on her arm and she was fine. The patient developed some kind of hive on her leg and it was itchy and uncomfortable on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature decreased, Cough, Fatigue
Clinical narrative: felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over; noticed the aching in my back and the front of my thighs; noticed the aching in my back and the front of my thighs; extremely tired; got up about 7 times during the night; muscle ache; My temperature is 99, last night it was 98; Congestion where in the morning I will have phlegm; Congestion where in the morning I will have phlegm; Dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunization. Medical history included hearing aid user (hearing is not good). The patient's concomitant medications were not reported. The patient experienced dry cough on an unspecified date in 2021, felt achy almost like had the symptoms of the virus/the minute got in bed i started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, extremely tired, got up about 7 times during the night, muscle ache, my temperature is 99, last night it was 98 on 02Mar2021, congestion where in the morning i will have phlegm on an unspecified date in 2021. Patient's daughter is a nurse and she wanted patient to take it, otherwise patient wouldn't have. This morning it (temperature) was 99 even. It was reported that it was just a normal ache, not anything that would even single one come to patient's attention, but what patient want to know because of age can he/she ignore this and just wait and see how it goes. Outcome of event Dry cough was not resolved, felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, muscle ache and My temperature is 99, last night it was 98 were resolved on 03Mar2021. Outcome of extremely tired, got up about 7 times during the night and Congestion where in the morning I will have phlegm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pain, Pain in extremity, Productive cough
Clinical narrative: felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over; noticed the aching in my back and the front of my thighs; noticed the aching in my back and the front of my thighs; extremely tired; got up about 7 times during the night; muscle ache; My temperature is 99, last night it was 98; Congestion where in the morning I will have phlegm; Congestion where in the morning I will have phlegm; Dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunization. Medical history included hearing aid user (hearing is not good). The patient's concomitant medications were not reported. The patient experienced dry cough on an unspecified date in 2021, felt achy almost like had the symptoms of the virus/the minute got in bed i started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, extremely tired, got up about 7 times during the night, muscle ache, my temperature is 99, last night it was 98 on 02Mar2021, congestion where in the morning i will have phlegm on an unspecified date in 2021. Patient's daughter is a nurse and she wanted patient to take it, otherwise patient wouldn't have. This morning it (temperature) was 99 even. It was reported that it was just a normal ache, not anything that would even single one come to patient's attention, but what patient want to know because of age can he/she ignore this and just wait and see how it goes. Outcome of event Dry cough was not resolved, felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, muscle ache and My temperature is 99, last night it was 98 were resolved on 03Mar2021. Outcome of extremely tired, got up about 7 times during the night and Congestion where in the morning I will have phlegm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over; noticed the aching in my back and the front of my thighs; noticed the aching in my back and the front of my thighs; extremely tired; got up about 7 times during the night; muscle ache; My temperature is 99, last night it was 98; Congestion where in the morning I will have phlegm; Congestion where in the morning I will have phlegm; Dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for COVID-19 immunization. Medical history included hearing aid user (hearing is not good). The patient's concomitant medications were not reported. The patient experienced dry cough on an unspecified date in 2021, felt achy almost like had the symptoms of the virus/the minute got in bed i started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, extremely tired, got up about 7 times during the night, muscle ache, my temperature is 99, last night it was 98 on 02Mar2021, congestion where in the morning i will have phlegm on an unspecified date in 2021. Patient's daughter is a nurse and she wanted patient to take it, otherwise patient wouldn't have. This morning it (temperature) was 99 even. It was reported that it was just a normal ache, not anything that would even single one come to patient's attention, but what patient want to know because of age can he/she ignore this and just wait and see how it goes. Outcome of event Dry cough was not resolved, felt achy almost like had the symptoms of the virus/the minute got in bed I started hurting all over, all over my body, ached all over, noticed the aching in my back and the front of my thighs, muscle ache and My temperature is 99, last night it was 98 were resolved on 03Mar2021. Outcome of extremely tired, got up about 7 times during the night and Congestion where in the morning I will have phlegm were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Dyspnoea, Suffocation feeling
Clinical narrative: Going to suffocate; couldn't breathe very well; Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9269, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing stroke. Concomitant medications included warfarin which was taken for stroke; atorvastatin, telmisartan, doxazosin and atenolol were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient had two side effects in which the number one was reported as the patient was going to suffocate and couldn't breathe very well which would be the feeling at bedtime and the second one was diarrhea on an unspecified date. No treatment was received by the patient for these events. The patient had a blood test in the last week with unknown results in Feb2021. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: raised knot at injection site; Redness; Swelling; itches constantly; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6210), via an unspecified route of administration, administered in Left arm on 01Mar2021 16:00 (at the age of 34 year old) as dose 2, single for COVID-19 immunisation.  The patient medical history and family medical history was reported as none. Concomitant medication included sertraline taken for an unspecified indication. The patient has no known allergies, never had an allergic reaction to medication. Prior vaccination, patient did not receive other vaccines within four weeks. Historical vaccine included first dose of 0.3 ml BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261), via an unspecified route of administration on 23Jan2021 (at the age of 34 year old), as single dose for COVID-19 immunization and the patient experienced a little tired. On  01Mar2021 16:00, after received the vaccination, once she reached home, she felt tight like knot under the skin, at the injection site on her left arm, little more than half way down to the elbow. Next day, on 02Mar2021, by the evening time, the knot was raised and kept getting more red and swollen. The redness and swelling spreads, where size of a quarter (that was found on 03Mar2021) became size of a plum or little bigger than a half dollar at the time of report, (on 04Mar2021). At the time of report, it is red and swollen with a white line around it, where it itches constantly. It is super tender and been tender the whole time. It was reported that COVID vaccine was given, on top of her bicep, where she used to get injections towards the top of her shoulder. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: raised knot at injection site; Redness; Swelling; itches constantly; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6210), via an unspecified route of administration, administered in Left arm on 01Mar2021 16:00 (at the age of 34 year old) as dose 2, single for COVID-19 immunisation.  The patient medical history and family medical history was reported as none. Concomitant medication included sertraline taken for an unspecified indication. The patient has no known allergies, never had an allergic reaction to medication. Prior vaccination, patient did not receive other vaccines within four weeks. Historical vaccine included first dose of 0.3 ml BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261), via an unspecified route of administration on 23Jan2021 (at the age of 34 year old), as single dose for COVID-19 immunization and the patient experienced a little tired. On  01Mar2021 16:00, after received the vaccination, once she reached home, she felt tight like knot under the skin, at the injection site on her left arm, little more than half way down to the elbow. Next day, on 02Mar2021, by the evening time, the knot was raised and kept getting more red and swollen. The redness and swelling spreads, where size of a quarter (that was found on 03Mar2021) became size of a plum or little bigger than a half dollar at the time of report, (on 04Mar2021). At the time of report, it is red and swollen with a white line around it, where it itches constantly. It is super tender and been tender the whole time. It was reported that COVID vaccine was given, on top of her bicep, where she used to get injections towards the top of her shoulder. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling, and redness is at the injection site on her left arm; swelling, and redness is at the injection site on her left arm; raised knot at injection site; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6210), via an unspecified route of administration, administered in Left arm on 01Mar2021 16:00 (at the age of 34-years-old) as dose 2, single for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included sertraline 50 mg.  The patient previously took bnt162b2 for covid-19 immunisation and experienced fatigue, sertraline.  Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261), via an unspecified route of administration, administered in Left arm on 23Jan2021 as dose 1,0.3 ml, single for covid-19 immunization and experienced tiredness. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. Patient experienced, swelling, and redness is at the injection site on her left arm. It was a little more than half way down to the elbow. She stated that the COVID vaccine was administered a little low. It was given on top of her bicep and more towards her shoulder. Noticed the tight knot once she got home from receiving the COVID vaccine. On the day of this report the redness and swelling were spreading. It was the size of a quarter yesterday in the morning. Today it is the size of a plum or a little bigger than a half dollar. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: swelling, and redness is at the injection site on her left arm; swelling, and redness is at the injection site on her left arm; raised knot at injection site; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6210), via an unspecified route of administration, administered in Left arm on 01Mar2021 16:00 (at the age of 34-years-old) as dose 2, single for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included sertraline 50 mg.  The patient previously took bnt162b2 for covid-19 immunisation and experienced fatigue, sertraline.  Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261), via an unspecified route of administration, administered in Left arm on 23Jan2021 as dose 1,0.3 ml, single for covid-19 immunization and experienced tiredness. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. Patient experienced, swelling, and redness is at the injection site on her left arm. It was a little more than half way down to the elbow. She stated that the COVID vaccine was administered a little low. It was given on top of her bicep and more towards her shoulder. Noticed the tight knot once she got home from receiving the COVID vaccine. On the day of this report the redness and swelling were spreading. It was the size of a quarter yesterday in the morning. Today it is the size of a plum or a little bigger than a half dollar. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Aches; chills; fever of 104.4; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient). A 21-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 26Feb2021 (at the age of 21-year-old) as dose 2, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No known allergies were reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date (at the age of 21-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other vaccines within 2 weeks of COVID-19 Vaccination included unspecified vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 27Feb2021, the patient experienced aches, chills, fever of 104.4 the following day. The patient underwent lab tests and procedures which included body temperature: 104.4 on 27Feb2021. No treatment was received for the events. The outcome of the event was reported as resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Rash
Clinical narrative: rash under both arms; not really tired, just tired; Diarrhea; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; Batch/Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 72-year-old) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; Batch/Lot Number: EN9581), via an unspecified route of administration, administered in left arm on 03Feb2021 at 12:30 (at the age of 72-year-old) as dose 1, single for COVID-19 immunization and did not have any adverse event. On 26Feb2021, the patient was not really tired, just tired, that started right after got the shot, that she was yawning and yawning and tired and was fine the next day, states she had diarrhea that has lasted 2-3 days and that also started same day as the shot and it was ongoing, but just about gone. On 28Feb2021, the patient had rash under both arms, that started 2 days after the second shot and has remained the same, has not gone anywhere and she has been putting anti itch cream and Neosporin on the rash. Caller stated that she did not take anything for the diarrhea. Caller clarified that these symptoms all happened after the 2nd COVID 19 vaccine that she received 26Feb2021. The outcome was recovered for not really tired, just tired on 27Feb2021 and recovering for diarrhoea whereas the event outcome was not recovered for rash under both arms.  No follow-up attempts are possible; no further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021257924 same reporter/diff patient
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dry mouth, Pain, Pyrexia
Clinical narrative: Loss of taste; Drying mouth; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in upper Left Arm on an unspecified date at dose 1, single for covid-19 immunization. Patient had no medical history. There were no concomitant medications. The patient experienced loss of taste, drying mouth, fever, chills, body aches on an unspecified date. Patient took Tylenol as a treatment for the events fever, chills, body aches. Patient wanted to know if these are common when got the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.