chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: Fell out of bed; tonic clonic seizure; postictal (confusion); This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 22Feb2021 10:15 (lot number: EN6203) as single dose for COVID-19 immunisation. The patient's medical history included hypertension. The patient's concomitant medications included losartan and OTC vitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 03:45PM (lot number: EL9262) for COVID-19 immunisation. On 12Mar2021 06:30, the patient fell out of bed and wife witnessed tonic clonic seizure of 5+ minutes. And when EMS arrived on 12Mar2021 06:30, the patient was postictal (confusion). The events resulted to Emergency Room visit and patient was hospitalized for 3 days. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures and included blood test and scan, both with unknown results on an unspecified date and nasal swab/NAAT: negative on 12Mar2021. Therapeutic measures were taken as a result of the events and included numerous scans, blood tests and levetiracetam. The vaccination facility type was hospital. The outcome of the events were recovered with sequel.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Glycosylated haemoglobin, Injury
Clinical narrative: severe hair loss/On the left side of my head I had the bald spot 4 cm in diameter bald no hair; physiological traumatic; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration, administered in the left arm on 07Mar2021 14:15 (at the age of 56 years old) at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included type 1 diabetes, psoriasis and sensitive immune system, all from an unknown date and unknown if ongoing. The patient was not pregnant. There was no other vaccine in four weeks. There were no known allergies. Concomitant medications included insulin taken for type 1 diabetes mellitus, start and stop date were not reported.  The patient experienced severe hair loss/on the left side of my head i had the bald spot 4 cm in diameter bald no hair and physiological traumatic, both on 08Mar2021 07:30. It was reported that after the vaccination, on 08Mar2021, the patient had severe hair loss and now she has a bald spot of 4 centimeters. The patient's hair started falling out but she didn't think much of it, from time you brush your hair it just happens but as the day progressed they just kept falling out and she had very thick bulky hair and she didn't even look the same and on the left side of her head which was weird because that was the side where she got the shot, on the left side of her head , she had the bald spot 4 cm in diameter bald no hair. Her hair still continues to fall and she can't brush it or touch it because it becomes more severe. As the day progressed, they just kept falling out. This was emotionally, it's horrible, it's like losing part of her body. No treatment was received.  She doesn't even know what to do, she went to the doctor today to talk to them about that and then she was going to the dermatologist on Thursday, She never had that in her life. Today is 16Mar2021, and her hair was still falling. It was also reported that she is looking for justice since this is physiologically traumatic. She was scared to wash her hair. It was reported that the events resulted in disability/permanent damage. No treatment was received. There was no COVID prior vaccination and not COVID tested post vaccination. The patient underwent lab tests and procedures which included Hemoglobin A1-C: 6.2 (average blood sugar is 6.2) on an unspecified date. The outcome of the events was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling abnormal, Headache
Clinical narrative: joint pain; feels dizzy; weak; drowsy; slight headache; feels like a zombie; stomach is expanding and he has lost six pounds; covid blahs; This is a spontaneous report received from a contactable consumer (patient reported himself). A 73-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration three weeks ago on an unspecified date in Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that he had the first Pfizer Covid 19 vaccine three weeks ago. Caller stated that he had joint pain the first day only. Caller reports that ever since he got the vaccine, he felt dizzy, weak, drowsy and has a slight headache and stated he felt like a zombie like he drank a six pack of beer the night before. Caller stated his HCP said he had the Covid blahs. Caller stated his stomach was expanding and he had lost six pounds. Caller stated that it feels like he had Covid again every morning. Caller stated he felt normal before the vaccine. Caller stated that he was afraid to get the second shot wanting to know if his reaction would be considered a contraindication and will the second dose be worse. Caller was number four in the queue and did not want to hold. AE noted. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Somnolence, Weight decreased
Clinical narrative: joint pain; feels dizzy; weak; drowsy; slight headache; feels like a zombie; stomach is expanding and he has lost six pounds; covid blahs; This is a spontaneous report received from a contactable consumer (patient reported himself). A 73-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration three weeks ago on an unspecified date in Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that he had the first Pfizer Covid 19 vaccine three weeks ago. Caller stated that he had joint pain the first day only. Caller reports that ever since he got the vaccine, he felt dizzy, weak, drowsy and has a slight headache and stated he felt like a zombie like he drank a six pack of beer the night before. Caller stated his HCP said he had the Covid blahs. Caller stated his stomach was expanding and he had lost six pounds. Caller stated that it feels like he had Covid again every morning. Caller stated he felt normal before the vaccine. Caller stated that he was afraid to get the second shot wanting to know if his reaction would be considered a contraindication and will the second dose be worse. Caller was number four in the queue and did not want to hold. AE noted. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: She was exposed to COVID virus on 10Mar2021 but has no symptoms; This is a spontaneous report from a contactable 56-Year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Mar2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of vaccine on 05Mar2021. She was exposed to COVID virus on 10Mar2021 but has no symptoms. Her second dose has been scheduled on 27Mar2021. The patient planned to follow-up with her vaccination provider for further discussion. She was ok with further follow-up. No additional details available.   Information on lot/batch number is requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure measurement, Hypertension, Incorrect dose administered, SARS-CoV-2 antibody test
Clinical narrative: After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown.  No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown.  No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Anxiety, Blood pressure measurement, Headache, Hypertension
Clinical narrative: After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown.  No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown.  No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypokalaemia, SARS-CoV-2 antibody test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; Hypokalemia; This is a spontaneous report from a contactable physician. This physician reported for an 85-year-old male patient (friend's father) that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The physician asked about timing of the second vaccine dose following positive COVID infection and use of monoclonal antibody therapy. Physician reported that the patient received his first dose on 25Feb2021. Following vaccination he tested positive for COVID-19 on 04Mar2021. He saw his doctor and was sent to the hospital for monoclonal antibody infusion on 05Mar2021. On 08Mar2021 he went back to the ER with Hypokalemia. And on his follow up appointment with his doctor on 15Mar2021, the doctor said that he can't receive his second dose until 90 days after the first. Physician reported that he read somewhere about the second dose being up to 42 days after the first and requests clarification in this circumstance. Lab data included patient tested positive for COVID-19 virus test on 04Mar2021. Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Breast discomfort, Breast pain, Condition aggravated, Fatigue, Feeling abnormal
Clinical narrative: pain and discomfort in the arm; tiredness; fogginess in her mind; i cannot sleep; heart palpitations; feeling that something is dislodged from my left  breast/sensation of dislode in her left breast; breast pain; pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator; This is a spontaneous report from a contactable 64-year-old female consumer and other health care professional reported that. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 7:00 PM (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation.  Medical history included diverticulum. patient received other medications within 2 weeks of vaccination were multiple vitamins and melatonin. Patient was not pregnant at the time of vaccination. Patient was not received treatment for the adverse event. Patient was not Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to Penicilline. Caller got the first dose of the Pfizer COVID-19 vaccine on 03Mar2021. After getting vaccinated, she developed pain and discomfort in the arm in which she thought it was normal. Two days after vaccination, on 05Mar2021, the pain increased and it extended to her underarm, her left breast, her neck, and her back. She said the pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator. She also has a sensation of dislode in her left breast. She mentioned that was vaccinated in her left arm. She said that she didn't have fever, but she experienced a little bit of tiredness and also fogginess in her mind. She said her main concern is the pain in her arm that extends to her breast and underarm. She wanted to know if this is a reported adverse event with the Pfizer COVID-19 vaccine. First only pain & discomfort in the arm, but 2 days, after the pain increased and extended underarm, axil and is particularly SUPER-ACUTE in the left breast, to the point that i cannot sleep. Also have heart palpitations, difficulty raising the arm, plus the feeling that something is dislodged from my left breast. The horizontal position in bed is the worst for the breast pain. For the record I have never had any pain in the armas & breasts before I received the Pfizer vaccine on March 3rd. I am very concern. I am scheduled to revive the 2nd. shot in Mach 26th. but before I need to get an explanation of my side effects, how dangerous they are, what to expect, and the assurance that I can safely receive the second dose of Pfizer Covid-19 vaccine. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289248 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Palpitations
Clinical narrative: pain and discomfort in the arm; tiredness; fogginess in her mind; i cannot sleep; heart palpitations; feeling that something is dislodged from my left  breast/sensation of dislode in her left breast; breast pain; pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator; This is a spontaneous report from a contactable 64-year-old female consumer and other health care professional reported that. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Mar2021 7:00 PM (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation.  Medical history included diverticulum. patient received other medications within 2 weeks of vaccination were multiple vitamins and melatonin. Patient was not pregnant at the time of vaccination. Patient was not received treatment for the adverse event. Patient was not Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to Penicilline. Caller got the first dose of the Pfizer COVID-19 vaccine on 03Mar2021. After getting vaccinated, she developed pain and discomfort in the arm in which she thought it was normal. Two days after vaccination, on 05Mar2021, the pain increased and it extended to her underarm, her left breast, her neck, and her back. She said the pain was acute but worsens when she lays horizontally in bed and when she bends like when getting something in the refrigerator. She also has a sensation of dislode in her left breast. She mentioned that was vaccinated in her left arm. She said that she didn't have fever, but she experienced a little bit of tiredness and also fogginess in her mind. She said her main concern is the pain in her arm that extends to her breast and underarm. She wanted to know if this is a reported adverse event with the Pfizer COVID-19 vaccine. First only pain & discomfort in the arm, but 2 days, after the pain increased and extended underarm, axil and is particularly SUPER-ACUTE in the left breast, to the point that i cannot sleep. Also have heart palpitations, difficulty raising the arm, plus the feeling that something is dislodged from my left breast. The horizontal position in bed is the worst for the breast pain. For the record I have never had any pain in the armas & breasts before I received the Pfizer vaccine on March 3rd. I am very concern. I am scheduled to revive the 2nd. shot in Mach 26th. but before I need to get an explanation of my side effects, how dangerous they are, what to expect, and the assurance that I can safely receive the second dose of Pfizer Covid-19 vaccine. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289248 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product administration error, Scratch, Vaccination site pain
Clinical narrative: arm was sore in the evening; so painful; 1.5 inch scratch where he tried to inject her; questioning if it all got in her and out of the syringe; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included ongoing autoimmune disease.  The patient's concomitant medications were not reported.  On an unspecified date the patient arm was sore in the evening, so painful, 1.5 inch scratch where nurse tried to inject her, questioning if it all got in her and out of the syringe. Caller reported she received the first dose of the Pfizer-BioNTech COVID-19 vaccine. She specified the vaccine was administered through a drive-through and she was sitting on the passenger seat. She explained the "nurse guy was standing outside" and didn't notify her before injecting the vaccine, therefore she "flinched" when she got it. She specified she "probably move" and "he jabbed [her] twice. She added the nurse checked the syringe to see how much of the vaccine was administered and "he thought he got it all out". She explained "he couldn't tell where he had injected" to put the band-aid. She further explained when she took out the band-aid, she noticed "1 inch and 1/4" of what appeared as a "needle scratch". She later described the size of the scratch as "1 inch and 1/2".  She then mentioned her "arm was sore in the evening" and a little bit the next day. She said she called the pharmacist who said her soreness was due to the vaccine and not the needle. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Electrocardiogram, Feeling abnormal, Headache
Clinical narrative: losing her sight; headache; blood pressure started fluctuating up and down; heart palpitations; atypical migraines; felt terrible; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), second dose via an unspecified route of administration on 26Feb2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had the first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201; Expiration Date: Jun2021) on an unspecified date for covid-19 immunisation. Historical vaccines include flu shot and got the flu, shingle vaccine and got shingles. Patient does not remember when she got the first vaccine but about 3 days after the second one (2021), she started getting headaches. She has atypical migraines where she just gets the eye symptoms but never gets headaches. She had some of the atypical migraines as well. Her blood pressure started fluctuating up and down and she had heart palpitations. She saw her doctor who did an EKG which didn't show any heart attack. She just felt terrible. The symptoms lasted about a week or a little over a week and it has now all gone away and she feels like herself. When trying to read lot numbers, caller said she is losing her sight. The outcome of the event vision loss was unknown, other events was recovered on 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Palpitations, Visual acuity reduced
Clinical narrative: losing her sight; headache; blood pressure started fluctuating up and down; heart palpitations; atypical migraines; felt terrible; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), second dose via an unspecified route of administration on 26Feb2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had the first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201; Expiration Date: Jun2021) on an unspecified date for covid-19 immunisation. Historical vaccines include flu shot and got the flu, shingle vaccine and got shingles. Patient does not remember when she got the first vaccine but about 3 days after the second one (2021), she started getting headaches. She has atypical migraines where she just gets the eye symptoms but never gets headaches. She had some of the atypical migraines as well. Her blood pressure started fluctuating up and down and she had heart palpitations. She saw her doctor who did an EKG which didn't show any heart attack. She just felt terrible. The symptoms lasted about a week or a little over a week and it has now all gone away and she feels like herself. When trying to read lot numbers, caller said she is losing her sight. The outcome of the event vision loss was unknown, other events was recovered on 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Ear discomfort, Fatigue, Head discomfort
Clinical narrative: losing her sight; headache; blood pressure started fluctuating up and down; heart palpitations; atypical migraines; felt terrible; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), second dose via an unspecified route of administration on 26Feb2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had the first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201; Expiration Date: Jun2021) on an unspecified date for covid-19 immunisation. Historical vaccines include flu shot and got the flu, shingle vaccine and got shingles. Patient does not remember when she got the first vaccine but about 3 days after the second one (2021), she started getting headaches. She has atypical migraines where she just gets the eye symptoms but never gets headaches. She had some of the atypical migraines as well. Her blood pressure started fluctuating up and down and she had heart palpitations. She saw her doctor who did an EKG which didn't show any heart attack. She just felt terrible. The symptoms lasted about a week or a little over a week and it has now all gone away and she feels like herself. When trying to read lot numbers, caller said she is losing her sight. The outcome of the event vision loss was unknown, other events was recovered on 2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; After I got the first dose, I experienced fever, headaches, sore arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 at 16:30 (at age of 57 years old, no pregnant at vaccination) at a single dose, for COVID-19 immunization. Medical history included Known allergies: food reactions to shrimps, crabs, lobsters- and occasionally to pineapples, avocado and eggs; also had reactions to penicillin, sulfa- type medications. Other medical history: none. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. After the patient got the first dose, she experienced fever, headaches, sore arm-however they went away in a couple of days. The outcome of the events was recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Hypoaesthesia, Pain in extremity
Clinical narrative: Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Magnetic resonance imaging, Nodule, Pain in extremity, Paraesthesia
Clinical narrative: Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medication included losartan.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medication included losartan.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test positive
Clinical narrative: had her 1st dose of the vaccine last March 2, 2021 and tested positive for Covid after the 1st dose; had her 1st dose of the vaccine last March 2, 2021 and tested positive for Covid after the 1st dose; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program for a herself. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 02Mar2021 at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient stated had her 1st dose of the vaccine last 02Mar2021 and tested positive for Covid after the 1st dose. It would be her last day of quarantine and she was scheduled to take the 2nd dose on 17Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for Covid 19; he tested positive for Covid 19; This is a spontaneous report from a program. A contactable consumer (patient) reported that a male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 25Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications was unknown. Patient got the first shot on 25Feb2021 and his second dose will be on 18Mar2021 however he tested positive for Covid 19 and he was given Regeneron Bamlanivimab antibody therapy. He was advised by the doctor to get the second dose after 90 days. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293848 same patient, different event and drug dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Epistaxis, Palpitations, Skin discolouration
Clinical narrative: her heart was racing; nose bled; felt dizzy; green mark just below her arm near the veins; Heartburn; This is a spontaneous report from a Pfizer-sponsored program.  A 49-year-old female patient reported that she received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262), intramuscular in righ arm ton 09Mar2021 (at the age of 49-years-old) at single dose for covid-19 immunisation. The subject had a history of cholesterol (she mentions she takes a cholesterol medication as well but she doesn't have it with her at the time), fibromyalgia, blood pressure and muscle relaxant.  Relevant concomitant medications included naproxen for fibromyalgia, lisinopril for blood pressure and methocarbamol for muscle relaxant therapy.  The first day after the vaccine, the patient felt nothing, except heartburn. She clarifies further she felt fine the first day, completely fine.  The next day, she noticed on her arm, not in the place where they put the vaccine (injection site), but lower down the arm, near her hands, there was a big circle where her vein was.  patient may have mentioned the color green,  but could not clarify these details further after multiple attempts. She confirmed that 2 days later, this disappeared.  The patient also reported that her nose bled as well and felt dizzy and her heart was racing.  The reported events were palpitations with unknown outcome, skin discolouration on 10Mar2021 with outcome of recovered, epistaxis on 12Mar2021 with unknown outcome, dizziness on 12Mar2021 with unknown outcome and dyspepsia on 09Mar2021 with unknown outcome.