chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest discomfort, Cough, Erythema, Injection site scar
Clinical narrative: redness / arm was bright red; light skinned; arm was bright red and bumpy like pustules all around; coughing; stuffy nose; sore throat; like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep; Blood absorption was at 95% and now 98%; going to have a permanent scar where the injection was made/it is red, it is raised and it is bumpy; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm on 27Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, she received the first dose of Covid vaccine on February 27 (not clarified) which was now eleven days ago, and it looks like she going to have a permanent scar where the injection was made and is that a known side effect?. Consumer asked received Pfizer 1st dose on 27FEB. Was light skinned and her arm was bright red and bumpy like pustules all around. Now little less red but very noticeable. Worried on getting the 2nd. Has also coughing which never had that before? Her Dr. Died a week before the vaccine so could not get his advice. Also developed stuffy nose, sore throat and like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep. Her body temperature is well. Blood absorption was at 95% and now 98%. Can the Vaccine leave a permanent scar for light skinned people at the injection site?. When paraphrased the concern, consumer stated, she also had other problems. she feels like tightness in her chest, and she feel like she wants to cough, and these things did not exist before. Frequently asked questions do not do anything, she went to the website, and it was ridiculous, you can barely see what you are asking, and she finished the captcha like three, four or five times and it keep saying verification was expired even though it was the next second after getting the verification, so it was useless. She very upset because she asked in advance, would this cause a scar and it was red, it was raised, and it was bumpy and in addition to the tightness in the chest and feeling like coughing. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, and UPC #), purchase details and other details were unknown. Outcome of the events was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pallor, Pustule, Respiration abnormal
Clinical narrative: redness / arm was bright red; light skinned; arm was bright red and bumpy like pustules all around; coughing; stuffy nose; sore throat; like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep; Blood absorption was at 95% and now 98%; going to have a permanent scar where the injection was made/it is red, it is raised and it is bumpy; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm on 27Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, she received the first dose of Covid vaccine on February 27 (not clarified) which was now eleven days ago, and it looks like she going to have a permanent scar where the injection was made and is that a known side effect?. Consumer asked received Pfizer 1st dose on 27FEB. Was light skinned and her arm was bright red and bumpy like pustules all around. Now little less red but very noticeable. Worried on getting the 2nd. Has also coughing which never had that before? Her Dr. Died a week before the vaccine so could not get his advice. Also developed stuffy nose, sore throat and like breathing through a screen and feeing could not breathe deeper but was able but the message to her brain was she cannot breathe deep. Her body temperature is well. Blood absorption was at 95% and now 98%. Can the Vaccine leave a permanent scar for light skinned people at the injection site?. When paraphrased the concern, consumer stated, she also had other problems. she feels like tightness in her chest, and she feel like she wants to cough, and these things did not exist before. Frequently asked questions do not do anything, she went to the website, and it was ridiculous, you can barely see what you are asking, and she finished the captcha like three, four or five times and it keep saying verification was expired even though it was the next second after getting the verification, so it was useless. She very upset because she asked in advance, would this cause a scar and it was red, it was raised, and it was bumpy and in addition to the tightness in the chest and feeling like coughing. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, and UPC #), purchase details and other details were unknown. Outcome of the events was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her back and stomach; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On 04Mar2021, the patient experienced rash on her back and stomach. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Rash, Vaccination site pain
Clinical narrative: rash; tingling in my lips; she felt a flushing feeling; Arm Severely Very Sore at Injection Site; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6205) via an unspecified route of administration in arm left on 04Mar2021 11:30 (age at vaccination 47 year) as single dose for COVID-19 immunization and received niacin (lot number: 004114 and expiration date: Apr2022) via an unspecified route of administration from 03Mar2021 to 06Mar2021, at 500 mg and via an unspecified route of administration from 07Mar2021 (lot Number: 004114; Expiration Date: Apr2022) to 08Mar2021, at 500 mg for cholesterol in pharmacy. Medical history included heart arrhythmia and cholesterol. Concomitant medication included heart medications. The patient previously took fenofibrate and experienced itch. On 04Mar2021, the patient experienced arm severely very sore at injection site. On 04Mar2021, the patient had first dose of the Pfizer COVID vaccine and she experienced a rash yesterday in the hip area, lower stomach, near the bra area, between shoulder and armpit, upper thigh, groin, tingling in her lips, and in other places on her skin on 09Mar2021. On 06Mar2021, the patient experienced flushing feeling, skin was on fire, skin and face were red, very unpleasant, all the way down to groin from the face and chest but nothing below her feet. The seriousness of the events was unspecified. On 06Mar2021, the event she felt a flushing feeling and arm severely very sore at injection site resolved. The outcome of the event rash and tingling in my lips was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms.; Fever; Muscle aches; Headache; Fatigue.; Nausea.; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) via an unspecified route of administration (at the age of 38-year-old) on 09Mar2021 at 09:15 AM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included heart disease congenital and drug hypersensitivity. Concomitant medication was not reported. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration on 17Feb2021 12:00 PM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. There were no other vaccine in four weeks. There were no other medications in two weeks. No COVID prior vaccination. Not tested for COVID post vaccination. There were known allergies: Penicillin. On 19Mar2021 at 09:00 PM, the patient experienced flu-like symptoms, fever, muscle aches, headache, fatigue, nausea. Symptoms were most severe until 24 hours after vaccination. Fatigue and headache continued into day 2 after vaccination with pain at the injection site. The patient underwent lab tests and procedures which included body temperature: 102.8. No treatment was received for the events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Flu-like symptoms.; Fever; Muscle aches; Headache; Fatigue.; Nausea.; pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3248) via an unspecified route of administration (at the age of 38-year-old) on 09Mar2021 at 09:15 AM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included heart disease congenital and drug hypersensitivity. Concomitant medication was not reported. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration on 17Feb2021 12:00 PM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. There were no other vaccine in four weeks. There were no other medications in two weeks. No COVID prior vaccination. Not tested for COVID post vaccination. There were known allergies: Penicillin. On 19Mar2021 at 09:00 PM, the patient experienced flu-like symptoms, fever, muscle aches, headache, fatigue, nausea. Symptoms were most severe until 24 hours after vaccination. Fatigue and headache continued into day 2 after vaccination with pain at the injection site. The patient underwent lab tests and procedures which included body temperature: 102.8. No treatment was received for the events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: The side that I got my shot on, my left side lymph node there is swollen roughly the size of a baseball; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration (at the age of 39-years), on 06Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ankylosing spondylitis, psoriatic arthritis, fibromyalgia from an unknown date and unknown if ongoing. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included pregabalin (LYRICA) taken as 50 mg three times a day , duloxetine hydrochloride (CYMBALTA) taken as 60mg once a day and adalimumab (HUMIRA) taken as 40 mg once every two weeks for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced the side that i got my shot on, my left side lymph node there is swollen roughly the size of a baseball. It was further reported that he stated, that I had my Covid, my second Covid shot on Saturday (06Mar2021) and when I woke up this morning. The side that I got my shot on, my left side the lymph node there is swollen roughly the size of a baseball. He stated that no, I am a therapist. He stated that I am not sure if it was 1 or I but it was E19262 (further not clarified). So when she put that on LOT for my first visit, underneath for my second visit they on this bottom I don't know if it's important they put EN6200 (second LOT, captured in the tab). The vaccination facility name, stated by the patient was they did it at stadium. For the expiration date, he stated that I do not have, they do not have that, it was not written on the card. He asked that should I got to the Hospital? Is there anything you guys are recommended what I should do. The clinical outcome of the event was reported as unknown.  No follow up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Dyspnoea, Heart rate
Clinical narrative: Shortness of breath/hard to breathe; Dizziness; fast heart rate/heart is palpitating faster than normal; weak and dizzy; panic attacks; Shortness of breath was reported as worsened/Dizziness was reported as worsened/fast heart rate was reported as worsened/weak and dizzy was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 45-years-old) for Covid-19 immunisation. Medical history included high blood pressure - diagnosed over a year ago. Concomitant medication included losartan (LOSARTAN) taken for high blood pressure, start and stop date were not reported. The patient called about the side effects of Covid vaccine, stated he took the first dose of the vaccine on Friday 05Mar2021 and stated on Saturday and Sunday, he had symptoms. He stated that his problem is that his heart is palpitating faster than normal, it is hard to breathe, and he gets weak and dizzy. He also said it has gotten worse but comes and goes. He has been to his doctor, the doctor told him that it was not caused by the vaccine that he is having panic attacks. The patient did not get a patient card for vaccine info, unable to confirm product details like manufacturer, NDC, Lot and Expiration. The patient wanted to know if he should go to the emergency room. The events had not resolved at the time of the report. The events required a physician office visit.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the event panic attacks and the suspect drug BNT162B2 are assessed as  not related.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Panic attack
Clinical narrative: Shortness of breath/hard to breathe; Dizziness; fast heart rate/heart is palpitating faster than normal; weak and dizzy; panic attacks; Shortness of breath was reported as worsened/Dizziness was reported as worsened/fast heart rate was reported as worsened/weak and dizzy was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 45-years-old) for Covid-19 immunisation. Medical history included high blood pressure - diagnosed over a year ago. Concomitant medication included losartan (LOSARTAN) taken for high blood pressure, start and stop date were not reported. The patient called about the side effects of Covid vaccine, stated he took the first dose of the vaccine on Friday 05Mar2021 and stated on Saturday and Sunday, he had symptoms. He stated that his problem is that his heart is palpitating faster than normal, it is hard to breathe, and he gets weak and dizzy. He also said it has gotten worse but comes and goes. He has been to his doctor, the doctor told him that it was not caused by the vaccine that he is having panic attacks. The patient did not get a patient card for vaccine info, unable to confirm product details like manufacturer, NDC, Lot and Expiration. The patient wanted to know if he should go to the emergency room. The events had not resolved at the time of the report. The events required a physician office visit.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the event panic attacks and the suspect drug BNT162B2 are assessed as  not related.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Headache, Illness
Clinical narrative: Queasiness on stomach; A little shortness of breath; fatigue; Headache; I am very sick; A little rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, at age 60 years, on 09Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the COVID-19 vaccine shot earlier on 09Mar2021 and was very sick. Patient was having fatigue, queasiness on stomach, a little rash at the beginning of this, headache, a little shortness of breath. Patient was going to tell someone not to do this, don't do this because there is something wrong, going to tell don't take this shot. Patient is going to call doctor's office. This was too much. Patient was going to advise anyone who is going to take this, not to do it because this doesn't even sound right. 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: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Queasiness on stomach; A little shortness of breath; fatigue; Headache; I am very sick; A little rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, at age 60 years, on 09Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the COVID-19 vaccine shot earlier on 09Mar2021 and was very sick. Patient was having fatigue, queasiness on stomach, a little rash at the beginning of this, headache, a little shortness of breath. Patient was going to tell someone not to do this, don't do this because there is something wrong, going to tell don't take this shot. Patient is going to call doctor's office. This was too much. Patient was going to advise anyone who is going to take this, not to do it because this doesn't even sound right. 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.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: arm was a little stiff; aches in body; fever; This is a spontaneous report from a contactable Consumer (Patient)  Via Medical Information Team. A 78-year-old female Consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot : Not reported) Via an unspecified route of administration on left arm on 08Mar2021 as a single dose for COVID-19 immunisation. Patient medical history include hospitalization from Dec2020 for covid 19 and pneumonia. Concomitant medication were not reported. On an unspecified date She had a minor reaction: arm was a little stiff, heard a lot of people saying that. Next day aches in body and a fever. Third day she was fine. The patient underwent lab test SARS-CoV-2 antibody test positive on DEC-2020, 02Feb2021, and on 16Feb2021 had a negative covid test. Outcome of the events were recovered on 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Lip swelling, Pain, Pain in extremity
Clinical narrative: swollen upper lip; her arm was very sore; little bit short of breath; she was tired; achy; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3302, Expiry Date: Unknown) via an unspecified route of administration, administered in deltoid left on 09Mar2021 at 11:55 as dose 1, single for COVID-19 immunisation (age at vaccination was 47 years). The patient medical history included gluten intolerant, allergy multiple, allergic to bell peppers, cinnamon and environmental factors like smoke. The patient's concomitant medications were not reported. It was reported that after receiving the dose of vaccine on 09Mar2021, that night the patient was tired but it was not anything she couldn't manage and achy which she expected. On the next day on 10Mar2021, she was really tired and the and the arm soreness was like she had been working out and stated that her arm was very sore and little bit short of breath. On 11Mar2021, the patient experienced her lips were very swollen this morning, and her upper lip looks like she has been punched in the face. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever; had slight arm pain; headache; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7534; Expiration date: unknown) via an unspecified route of administration on 09Mar2021 (at the age of 68-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 16Feb2021 (at the age of 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization and had no reactions. Caller reported that, after receiving his second vaccination on this past Tuesday, 09Mar2021, caller stated he experienced a fever for the first on last night, 10Mar2021. Caller stated his fever started at 100.1, went up to 100.8, 100.5 and a 100.4, dropped down to 99.8. Caller stated he felt "feverish" and had a headache. Caller asked was this something to worry about or not. Patient also experienced head hurt and had slight arm pain on an unspecified date in Mar2021. This report was not serious. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.8, 100.5, 100.4 and 99.8 on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; had slight arm pain; headache; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7534; Expiration date: unknown) via an unspecified route of administration on 09Mar2021 (at the age of 68-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 16Feb2021 (at the age of 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization and had no reactions. Caller reported that, after receiving his second vaccination on this past Tuesday, 09Mar2021, caller stated he experienced a fever for the first on last night, 10Mar2021. Caller stated his fever started at 100.1, went up to 100.8, 100.5 and a 100.4, dropped down to 99.8. Caller stated he felt "feverish" and had a headache. Caller asked was this something to worry about or not. Patient also experienced head hurt and had slight arm pain on an unspecified date in Mar2021. This report was not serious. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.8, 100.5, 100.4 and 99.8 on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic, Vaccination site pruritus
Clinical narrative: Injection site itched; red spots on his back; itchy rash on his back; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on 28Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itchy rash on his back on 04Mar2021, injection site itched on an unspecified date, red spots on his back on an unspecified date. Therapeutic measures were taken as a result of itchy rash on his back, injection site itched, red spots on his back was Caladryl. The outcome of the events rash pruritic, vaccination site pruritus, rash macular was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Cough, Dizziness, Dysstasia
Clinical narrative: nausea; she can't stand; coughing, it feels like wants to cough something up but can't; Throat feels funny, doesn't normally talk like this; headache; Head feels like it is going to bust; just horrible on the left side; fever; chills; Caller states that she hasn't slept at all and can't close eyes; Cold and Sweating at the Same Time; Body feels like it has been hit with a baseball bat all over; Ears Pounding; Feels dizzy when she tries to move fast; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 14:27 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis from 2000 and ongoing Verbatim: Arthritis, spinal operation from 2005 to an unknown date, back surgery, knee arthroplasty from 2008 to an unknown date, right knee replacement, knee arthroplasty from Oct2018 to an unknown date, left knee replacement. The patient's concomitant medications were not reported.  Patient did not receive other vaccine in four weeks of vaccination. Patient stated she got her flu Shot in Oct2020. Patient said she lived with her mother who was 80 and refused to get it and worked in cafe and was around people. The patient experienced fever on 10Mar2021 with outcome of not recovered, chills on 10Mar2021 with outcome of recovering, nausea on an unspecified date with outcome of unknown, headache; head feels like it is going to bust; just horrible on the left side on 10Mar2021 19:00 with outcome of not recovered, she can't stand on an unspecified date with outcome of unknown, cold and sweating at the same time on 10Mar2021 with outcome of recovering, body feels like it has been hit with a baseball bat all over on 10Mar2021 with outcome of not recovered, coughing, it feels like wants to cough something up but could not on 11Mar2021 with outcome of unknown, caller stated that she did not slept at all and could not close eyes on 10Mar2021 with outcome of not recovered, throat feels funny, doesn't normally talk like this on 11Mar2021 with outcome of not recovered, ears pounding wondering if she has an infection in her ears on 10Mar2021 with outcome of not recovered , feels dizzy when she tries to move fast on 10Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of headache, she took Tylenol and after Tylenol; head feels like it is going to bust; just horrible on the left side. Time the Vaccination Was Given: 14:27 (24-hour clock). Time of Onset (24-hour clock): 19:00, states she felt fine went to laundry mat and came home and by 07:00 PM she was done. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Nausea, Oropharyngeal discomfort
Clinical narrative: nausea; she can't stand; coughing, it feels like wants to cough something up but can't; Throat feels funny, doesn't normally talk like this; headache; Head feels like it is going to bust; just horrible on the left side; fever; chills; Caller states that she hasn't slept at all and can't close eyes; Cold and Sweating at the Same Time; Body feels like it has been hit with a baseball bat all over; Ears Pounding; Feels dizzy when she tries to move fast; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 14:27 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis from 2000 and ongoing Verbatim: Arthritis, spinal operation from 2005 to an unknown date, back surgery, knee arthroplasty from 2008 to an unknown date, right knee replacement, knee arthroplasty from Oct2018 to an unknown date, left knee replacement. The patient's concomitant medications were not reported.  Patient did not receive other vaccine in four weeks of vaccination. Patient stated she got her flu Shot in Oct2020. Patient said she lived with her mother who was 80 and refused to get it and worked in cafe and was around people. The patient experienced fever on 10Mar2021 with outcome of not recovered, chills on 10Mar2021 with outcome of recovering, nausea on an unspecified date with outcome of unknown, headache; head feels like it is going to bust; just horrible on the left side on 10Mar2021 19:00 with outcome of not recovered, she can't stand on an unspecified date with outcome of unknown, cold and sweating at the same time on 10Mar2021 with outcome of recovering, body feels like it has been hit with a baseball bat all over on 10Mar2021 with outcome of not recovered, coughing, it feels like wants to cough something up but could not on 11Mar2021 with outcome of unknown, caller stated that she did not slept at all and could not close eyes on 10Mar2021 with outcome of not recovered, throat feels funny, doesn't normally talk like this on 11Mar2021 with outcome of not recovered, ears pounding wondering if she has an infection in her ears on 10Mar2021 with outcome of not recovered , feels dizzy when she tries to move fast on 10Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of headache, she took Tylenol and after Tylenol; head feels like it is going to bust; just horrible on the left side. Time the Vaccination Was Given: 14:27 (24-hour clock). Time of Onset (24-hour clock): 19:00, states she felt fine went to laundry mat and came home and by 07:00 PM she was done. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: nausea; she can't stand; coughing, it feels like wants to cough something up but can't; Throat feels funny, doesn't normally talk like this; headache; Head feels like it is going to bust; just horrible on the left side; fever; chills; Caller states that she hasn't slept at all and can't close eyes; Cold and Sweating at the Same Time; Body feels like it has been hit with a baseball bat all over; Ears Pounding; Feels dizzy when she tries to move fast; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 14:27 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis from 2000 and ongoing Verbatim: Arthritis, spinal operation from 2005 to an unknown date, back surgery, knee arthroplasty from 2008 to an unknown date, right knee replacement, knee arthroplasty from Oct2018 to an unknown date, left knee replacement. The patient's concomitant medications were not reported.  Patient did not receive other vaccine in four weeks of vaccination. Patient stated she got her flu Shot in Oct2020. Patient said she lived with her mother who was 80 and refused to get it and worked in cafe and was around people. The patient experienced fever on 10Mar2021 with outcome of not recovered, chills on 10Mar2021 with outcome of recovering, nausea on an unspecified date with outcome of unknown, headache; head feels like it is going to bust; just horrible on the left side on 10Mar2021 19:00 with outcome of not recovered, she can't stand on an unspecified date with outcome of unknown, cold and sweating at the same time on 10Mar2021 with outcome of recovering, body feels like it has been hit with a baseball bat all over on 10Mar2021 with outcome of not recovered, coughing, it feels like wants to cough something up but could not on 11Mar2021 with outcome of unknown, caller stated that she did not slept at all and could not close eyes on 10Mar2021 with outcome of not recovered, throat feels funny, doesn't normally talk like this on 11Mar2021 with outcome of not recovered, ears pounding wondering if she has an infection in her ears on 10Mar2021 with outcome of not recovered , feels dizzy when she tries to move fast on 10Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of headache, she took Tylenol and after Tylenol; head feels like it is going to bust; just horrible on the left side. Time the Vaccination Was Given: 14:27 (24-hour clock). Time of Onset (24-hour clock): 19:00, states she felt fine went to laundry mat and came home and by 07:00 PM she was done. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fever; Fatigue; Body aches; Joint pain; Headache; Arm tenderness; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 45-years-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EI3247) via an unspecified route of administration in left arm on 19Feb2021 as dose 1, single (at the age of 45 years-old) and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: El3248) via an unspecified route of administration, administration in left arm on 10Mar2021 14:00 as dose 2, single for COVID-19 immunization. Patient was not a pregnant at the time of vaccination and at the time of reporting. Patient medical history included asthma, had prolonged fatigue, dizziness, tinnitus following covid illness last year, covid illness last year, from 2020 to an unknown date. Patient was not allergic to medications, food, or other products. The concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for an unspecified indication, start and stop date were not reported and it was received within 2 weeks of vaccination. The patient experienced fever, fatigue, body aches, joint pain, headache, arm tenderness on an unspecified date in 2021. patient did not received treatment for adverse events. The patient experienced these symptoms after first dose also. The events are not leads to any seriousness criteria like death, prolonged hospitalization, disabling/incapacitating, life threatening, congenital anomaly/birth defect. The patient was taken Pfizer covid vaccine in four weeks. The patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. The clinical outcome of all events was not recovering.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Fatigue; Body aches; Joint pain; Headache; Arm tenderness; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 45-years-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EI3247) via an unspecified route of administration in left arm on 19Feb2021 as dose 1, single (at the age of 45 years-old) and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: El3248) via an unspecified route of administration, administration in left arm on 10Mar2021 14:00 as dose 2, single for COVID-19 immunization. Patient was not a pregnant at the time of vaccination and at the time of reporting. Patient medical history included asthma, had prolonged fatigue, dizziness, tinnitus following covid illness last year, covid illness last year, from 2020 to an unknown date. Patient was not allergic to medications, food, or other products. The concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for an unspecified indication, start and stop date were not reported and it was received within 2 weeks of vaccination. The patient experienced fever, fatigue, body aches, joint pain, headache, arm tenderness on an unspecified date in 2021. patient did not received treatment for adverse events. The patient experienced these symptoms after first dose also. The events are not leads to any seriousness criteria like death, prolonged hospitalization, disabling/incapacitating, life threatening, congenital anomaly/birth defect. The patient was taken Pfizer covid vaccine in four weeks. The patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. The clinical outcome of all events was not recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: low grade fever; aches; This is a spontaneous report from a contactable consumer or other non hcp. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 09Mar2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether prior to vaccination, the patient diagnosed with COVID-19. It was also unknown whether since the vaccination patient had been tested for COVID-19. The patient experienced low grade fever and aches on 11Mar2021 09:00. Outcome of the events was unknown.   Follow up #1(18Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a male patient that: Email received - Wednesday, 10Mar2021 I reported it within 24 hours on the next business day". No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Throat irritation
Clinical narrative: fatigue; fever; scratchy throat; Chills/chills have gotten worse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 08Mar2021 15:00 (age at vaccination was 35 years) as dose 1, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that on 08Mar201 at evening, he experienced fatigue that transformed into a fever and scratchy throat. The patient also reported that his side effects were still present at the day of reporting. The patient reported that the chills had gotten worse, and he did have a thermometer to check it, but he was pretty sure he had a fever that afternoon. He would like to know if these side effects were normal and if he could take Tylenol for treatment to relieve them. The patient did not take anything yet for his treatment. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/rash on her right leg; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6204, Expiry date was not reported), via an unspecified route of administration on 10Mar2021 09:00 (at the age of 66-years-old) in Arm Left as dose 1, single for COV1ID-19 immunization. The Patient Medical history included kidney disease from 2017 to an unknown date, blood pressure abnormal from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing and other Conditions also on dialysis. Concomitant medication(s) included glipizide (GLIPIZIDE) taken for diabetes mellitus from an unspecified start date and ongoing taking 6 months; furosemide (LASIX [FUROSEMIDE]) taken for hypertension from an unspecified start date and ongoing taking for 6 months; doxazosin (DOXAZOSIN) taken for blood pressure abnormal from an unspecified start date and ongoing taking for a month; olmesartan (OLMESARTAN) taken for blood pressure abnormal from an unspecified start date and ongoing taking for 6 months; carvedilol (CARVEDILOL) taken for blood pressure abnormal from an unspecified start date and ongoing taking for 6 months; amlodipine (AMLODIPINE) taken for blood pressure abnormal from an unspecified start date and ongoing taking for 6 months. History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient had not received prior vaccinations within 4 weeks. Patient had no illness at the time of vaccination. Caller is 66 y/o (year-old) female. States she has already spoke with someone at Pfizer and reported her AE. Will e-transmit as duplicate AE. She received first dose of Pfizer Covid vaccine on 10Mar2021. On 11Mar2021, she states she developed a rash on her right knee that does down to her right calf. She wants to know if we have any guidance for this. Consumer calling regarding the Pfizer Covid-19 vaccine. States she developed something on her leg, very distinctly like a design on her right leg below the knee, like a pattern, and it doesn't hurt. She got the vaccine yesterday and then noticed this today. She would like to ask a professional about it. Clarifies she received the first dose of the Pfizer Covid-19 vaccine 10Mar2021 at 09:00a.m. in the left arm. Noticed the rash on her leg today 11Mar2021. Since she noticed it it has not changed. The patient was not visited to physician or emergency room. The Patient had no relevant test. The outcome for the event rash on her right leg was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Flushing, Headache, Illness
Clinical narrative: overwhelmingly sick; nauseous/nauseousness; Light-headed; Headache; Flush sensation; Fever; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 at 15:00 (Batch/Lot Number: EL8982) as dose 1, single (at the age of 68-years-old) for Covid-19 immunisation. Medical history included Thyroid (as reported). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced felt overwhelmingly sick, got very nauseous - nauseousness is so bad, light-headed, headache, flush sensation and fever. It was reported that the patient has had Thursday on 18Feb2021 (not clarified), and had the shot at 3 o' clock PM. It was reported that the patient usually has reaction to shots (unspecified shots) but was excited that it did not. So, she came with an ice pack and put it on her arm shortly when she got the shot just for ten seconds and then she moved her arm for like thirty minutes and she had no reaction with her arm. But, forty-eight hours later, on Saturday at 20Feb2021, at dinner as she got up from her chair as she was going for the second serving, she felt overwhelmingly sick and just wanted to lay down. She got very nauseous, very light-headed. Since that day, she has been consistently overwhelmed with nauseous, no vomiting but very nauseous. She has been having headache and it was like flush sensation like she has a slight fever and the flushing sensation stopped after a week. But that day, she still has nausea. She has gone to a doctor and he gave her some medication (treatment) for nauseousness and she finally used it last Saturday because the nauseousness was so bad and it helped her but she didn't take on Sunday, Monday or that day. She still has nauseousness but not severe like she can function and a rate to describe it was like she doesn't do vomit, like it is very similar to when a woman is pregnant and is nauseous. It was also reported that the patient had some blood work that day (09Mar2021). The patient was reportedly still experiencing the events, not as severe but she was and guessed that they were still persisting. Treatment for nausea included Zofran 4 mg on Saturday. Due date for the next shot was reportedly on 11Mar2021. Therapeutic measures were taken as a result of the event nauseous/nauseousness. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.