chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Disorientation, Fatigue, Headache
Clinical narrative: 5/9/21: woke up disoriented and with a headache, fatigued and slept all day - took three ibuprofen  5/10/21: less severe headache on and off morning to afternoon, body aches all over, still fatigued and slept all day, felt queasy towards evening  5/11/21: no headache but body aches continued, couldn?t hold down water or food, drank half a glass of water around 5ish and threw it up a minute or so later; I stayed home and slept 5/12/21: body aches less intense but still felt weak all over, continued to struggle holding down liquids, fatigued; I slept it out 5/13/21: finally able to eat, body aches and fatigue continued, some queasiness on and off 5/14/21:  felt weak and sore but not fatigued, some queasiness  5/15/21: felt better, but a little weak - would describe it as an ?in recovery? feeling  5/16/21: a little queasy in the morning, but otherwise on the mend 5/17/21: felt better in the morning and afternoon but drowsy in evening - not sure if it was vaccine related though 5/18/21: felt slightly queasy in the evening but puked around 11:45 pm - not a large amount
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Somnolence, Vomiting
Clinical narrative: 5/9/21: woke up disoriented and with a headache, fatigued and slept all day - took three ibuprofen  5/10/21: less severe headache on and off morning to afternoon, body aches all over, still fatigued and slept all day, felt queasy towards evening  5/11/21: no headache but body aches continued, couldn?t hold down water or food, drank half a glass of water around 5ish and threw it up a minute or so later; I stayed home and slept 5/12/21: body aches less intense but still felt weak all over, continued to struggle holding down liquids, fatigued; I slept it out 5/13/21: finally able to eat, body aches and fatigue continued, some queasiness on and off 5/14/21:  felt weak and sore but not fatigued, some queasiness  5/15/21: felt better, but a little weak - would describe it as an ?in recovery? feeling  5/16/21: a little queasy in the morning, but otherwise on the mend 5/17/21: felt better in the morning and afternoon but drowsy in evening - not sure if it was vaccine related though 5/18/21: felt slightly queasy in the evening but puked around 11:45 pm - not a large amount
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Aortic embolus, Laboratory test, Nausea, Peripheral ischaemia
Clinical narrative: Aortoiliac embolus treated with open aortoiliac embolectomy. Symptoms began 18 days after first injection and included extreme nausea, vomiting, and right leg ischemia.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Thromboembolectomy, Vomiting
Clinical narrative: Aortoiliac embolus treated with open aortoiliac embolectomy. Symptoms began 18 days after first injection and included extreme nausea, vomiting, and right leg ischemia.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache,  Chills, Severe generalized body ache, sore throat.  Runny nose,  generalized  Joint pain, weakness
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Headache,  Chills, Severe generalized body ache, sore throat.  Runny nose,  generalized  Joint pain, weakness
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Laboratory test, Rash, Renal impairment, Scab
Clinical narrative: After 1  shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 days after the second shot I notice these blisters on my right lower leg near ankle filled with clear liquid it was a rash of multiple blisters. After about 7days they begin to go down I did not try to pop them I just took pictures each day and now they have went down today is May 19th 2021. and the area has dark scabs that seem to be going away.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Dizziness, Drug ineffective, Screaming, Suspected COVID-19
Clinical narrative: It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; dizzy; irate; yelling; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 84-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started feeling bad and it may have nothing to do with a side effect of the vaccination. On an unspecified date, the patient felt pretty bad. He was coughing up phlegm. He was supposed to go back on 28Apr2021 but he was sick. It occurred to him that maybe he had COVID when he got the vaccine and it was just developing. He was pretty sick. He was coughing up a lot of grey mucous from his lungs. He felt terrible like he had a bad flu on an unspecified date. He might go to the hospital. He probably should have done that anyways. He was dizzy and terribly sick on an unspecified date. The patient was irate and yelling on an unspecified date. The outcome of events 'it occurred to him that maybe he had COVID when he got the vaccine and it was just developing', 'dizzy', 'irate' and 'yelling' was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated, Dizziness, Facial paralysis, Fatigue
Clinical narrative: Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation.  Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lyme disease, Myalgia, Photopsia
Clinical narrative: Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation.  Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation.  Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Muscular weakness, Syncope
Clinical narrative: Nearly fainted while doing normal activity; Extreme dizziness; Leg muscle weakness; Weight on chest; Difficulty catching breath-lasting; This is a spontaneous report from a contactable consumer.   A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0155), dose 1 via an unspecified route of administration, administered into the  right arm on 10Apr2021, at 16:30 as single dose for covid-19 immunization. Medical history included no significant findings. Concomitant medication included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. No known drug allergies were noted.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 13Apr2021, at 19:30, the patient nearly fainted while doing normal activity, extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting were all noted. The events resulted in doctor or other healthcare professional office/clinic visit.   Details were as follows:  the patient nearly fainted while doing normal activity, had extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting more than seven days. Unspecified therapeutic measures were taken as a result of the events;  treatment was also noted as still pending labs, to identify problem.  There was no COVID-19 diagnosis prior to vaccination. Patient has not been tested for COVID-19 since vaccination. The outcome of events, nearly fainted while doing normal activity, extreme dizziness, leg muscle weakness, weight on chest, difficulty catching breath-lasting  was recovered with sequelae; the patient recovered with lasting effects.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "Nearly fainted while doing normal activity" and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Amnesia, Blood alcohol increased, Emotional distress, Fear
Clinical narrative: I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92; I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Very agitated; Brain fog; psychotic state; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out, elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92, very agitated, brain fog and psychotic state all on unspecified dates. Reporter stated "On 16Apr2021, I got the Pfizer shot, 2nd dose, went to the hospital.  Friday afternoon, went to a friends house, I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out. I lost it, the ambulance came. My alcohol level was elevated, and the ambulance took me to the hospital, hospital reporting that  I had a high alcohol level content. This has never happened to me before. I could understand if I had had 7 or 8 cocktails." Reporter also stated, "On Wednesday morning I had the vaccine, and Thursday and Friday, had brain fog, very agitated, I was just working on some deals, I couldn't get any thing right, it was strange, never had anything like this before. To have had two glasses of wine and one sip of friends drink, this doesn't make sense. My alcohol level was so elevated 1.92, it was ridiculous, I went into some kind of psychotic state. I can't recall any of it, I'm going by what I've been told. The ambulance gave me an amnesia drug, I'm 64 years old, It was frightening, I am emotional, I want some kind of explanation. I would like to have drank a whole bottle for this to happen, The only thing I think was on Wednesday I had the vaccine." The patient underwent lab tests and procedures which included alcohol test: 1.92 on an unspecified date (My alcohol level was so elevated 1.92, it was ridiculous). Therapeutic measures were taken as a result of I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, i kind of just blacked out, i passed out and elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92. Outcome of the events was   Follow-up needed. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired work ability, Laboratory test, Loss of consciousness, Psychotic disorder
Clinical narrative: I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92; I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Very agitated; Brain fog; psychotic state; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out, elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92, very agitated, brain fog and psychotic state all on unspecified dates. Reporter stated "On 16Apr2021, I got the Pfizer shot, 2nd dose, went to the hospital.  Friday afternoon, went to a friends house, I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out. I lost it, the ambulance came. My alcohol level was elevated, and the ambulance took me to the hospital, hospital reporting that  I had a high alcohol level content. This has never happened to me before. I could understand if I had had 7 or 8 cocktails." Reporter also stated, "On Wednesday morning I had the vaccine, and Thursday and Friday, had brain fog, very agitated, I was just working on some deals, I couldn't get any thing right, it was strange, never had anything like this before. To have had two glasses of wine and one sip of friends drink, this doesn't make sense. My alcohol level was so elevated 1.92, it was ridiculous, I went into some kind of psychotic state. I can't recall any of it, I'm going by what I've been told. The ambulance gave me an amnesia drug, I'm 64 years old, It was frightening, I am emotional, I want some kind of explanation. I would like to have drank a whole bottle for this to happen, The only thing I think was on Wednesday I had the vaccine." The patient underwent lab tests and procedures which included alcohol test: 1.92 on an unspecified date (My alcohol level was so elevated 1.92, it was ridiculous). Therapeutic measures were taken as a result of I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, i kind of just blacked out, i passed out and elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92. Outcome of the events was   Follow-up needed. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Social alcohol drinker
Clinical narrative: I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92; I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Very agitated; Brain fog; psychotic state; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out, elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92, very agitated, brain fog and psychotic state all on unspecified dates. Reporter stated "On 16Apr2021, I got the Pfizer shot, 2nd dose, went to the hospital.  Friday afternoon, went to a friends house, I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out. I lost it, the ambulance came. My alcohol level was elevated, and the ambulance took me to the hospital, hospital reporting that  I had a high alcohol level content. This has never happened to me before. I could understand if I had had 7 or 8 cocktails." Reporter also stated, "On Wednesday morning I had the vaccine, and Thursday and Friday, had brain fog, very agitated, I was just working on some deals, I couldn't get any thing right, it was strange, never had anything like this before. To have had two glasses of wine and one sip of friends drink, this doesn't make sense. My alcohol level was so elevated 1.92, it was ridiculous, I went into some kind of psychotic state. I can't recall any of it, I'm going by what I've been told. The ambulance gave me an amnesia drug, I'm 64 years old, It was frightening, I am emotional, I want some kind of explanation. I would like to have drank a whole bottle for this to happen, The only thing I think was on Wednesday I had the vaccine." The patient underwent lab tests and procedures which included alcohol test: 1.92 on an unspecified date (My alcohol level was so elevated 1.92, it was ridiculous). Therapeutic measures were taken as a result of I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, i kind of just blacked out, i passed out and elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92. Outcome of the events was   Follow-up needed. Information about batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Hyperacusis, Tinnitus
Clinical narrative: Ringing in my ears mostly right ear/Echo in ear; Very sensitive to sound; hearing loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8734) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced ringing in her ears, mostly right ear, echo in ear, very sensitive to sound, and hearing loss. The event resulted in doctor or other healthcare professional office/clinic visit. The events were treated with anti-inflammatory ear drops. The outcome of the events recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Facial paralysis, Feeling hot, Peripheral swelling, Swelling face
Clinical narrative: after 2 hours my right eye was completely shut.; 1 hr after my shot my right eye started to drop; sunburn feeling on my cheeks; my face and eye started to swell up; leg swollen; This is a spontaneous report from a contactable consumer reporting for herself, via Medical Information.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 11:00 (Batch/Lot Number: EL0-0162) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced 1 hr after my shot my right eye started to drop  on 28Apr2021 12:00 with outcome of unknown , after 2 hours my right eye was completely shut. on 28Apr2021 13:00 with outcome of unknown , sunburn feeling on my cheeks on 28Apr2021 with outcome of unknown , my face and eye started to swell up  on 28Apr2021 with outcome of unknown; all these events were considered serious because caused the patient to visit the ER. The patient also experienced  swollen legs on an unknown date with outcome of unknown. During ER stay, the patient was treated with IV unknown medications. The patient was monitored for a couple of hours and then discharged home with three days therapy.  Follow up information has been requested. Information about Lot number had already been received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination site pain
Clinical narrative: burning sensation up to the back of the neck and scalp and part of the feet and leg area on the left side; burning sensation at the injection site in the left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number; ER8734), via an unspecified route of administration, Left arm on 02Apr2021 at 14:00 (at the age of 41-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing heart problem (all of his life). The patient was not receiving concomitant medications. The vaccine was administered at pharmacy. No other vaccine was administered on the same day as COVID-19 vaccine. On an unspecified date in Apr2021, 2 or 3 days after the vaccine, the patient had a burning sensation. Has started in more places, so has gotten worse. It first started at the injection site in the left arm, then up to the back of the neck and scalp and part of the feet and leg area on the left side. Therapeutic measures taken as a result of the events included Advil, but it hasn't been working. The events resulted in physician's office visit, the patient went to the doctor on 29Apr2021. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blood test, Pregnancy test urine, Ultrasound foetal
Clinical narrative: Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 30-years-old), administered in Arm Left on 23Apr2021 10:00 (Lot Number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included Nature Made Pre-Natal Vitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:00 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultrasound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OGBYN medical professionals detected NO GROWTH since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient experienced miscarriage / pregnancy loss on 28Apr2021 15:30.No treatment received for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 20Dec2021. The pregnancy resulted in spontaneous abortion. The outcome of the event was recovering. The event was considered as serious (disability, congenital anomaly).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497434 fetal case
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Eye swelling, Palpitations, Pruritus
Clinical narrative: this type of reaction was not exactly anaphylactic even though they were considering it as such; heart racing/heart was racing; eyes swollen shut/eyes swelled shut; red arms/arms turned bright red; itchiness; This is a spontaneous report from a contactable physician (patient's father, a dermatologist) via Medical Information team the Pfizer-sponsored program, Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date, 1.5 weeks prior reporting (batch/lot number and expiration date were not reported) as the 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date within an hour after vaccination, the patient had "red arms, heart racing, itchiness, and her eyes swollen shut." She was given diphenhydramine (BENADRYL), and was advised not to get the second shot. The reporter was seeking recommendation on how to proceed; if the patient could take another COVID-19 vaccine instead to complete the vaccination series. It was further reported that the patient had a Pfizer COVID shot a week and half prior reporting and she had a reaction to it, which included "arms turned bright red, heart was racing, and eyes swelled shut" on an unspecified date. They gave her a shot of Benadryl, and then she drove home. She had no problem after that.  She had no trouble breathing. They told her not to get the second shot. So the reporter went and looked for more information and saw on one website that she could go ahead and get the Johnson and Johnson vaccine or just stick with the one Pfizer shot. The reporter was wondering what was the current recommendation for this and wanted to clarify. The reporter stated that this type of reaction was not exactly anaphylactic even though they were considering it as such. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction  and other reported events.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anaphylactic reaction, Aphonia, Bedridden, Chest pain
Clinical narrative: anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dyspepsia, Erythema, Fatigue
Clinical narrative: anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hypoaesthesia, Malaise, Musculoskeletal stiffness
Clinical narrative: anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Near death experience, Nervousness, Oropharyngeal pain, Palpitations
Clinical narrative: anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information expected.