chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site mass, Vaccination site pain
Clinical narrative: ache/pain on the left side of her neck (somehow near her left ear, close to the base of her left skull, not in the middle but close to the left side); ear pain; the pain is more bothersome underneath and moved to the base of her skull; she was nervous and does have several allergies; rash on her face; hives; bump in the arm which is sore; bump in the arm which is sore; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (COMIRNATY), first single dose via an unspecified route of administration, administered in arm left on 04Oct2021 at 13:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 52-year-old. Medical history included pre-existing thyroid condition, a little bit overweight, but over-all healthy. The patient's concomitant medications were not reported. Patient reported to have gotten her 1st dose of the COMIRNATY vaccine the day before this report on 04Oct2021. Post-vaccination she developed rash on her face, hives and bump in the arm which was sore. She reported that the rash completely cleared up. However, she observed around 8:30- 9:30 AM the day at this report on 05Oct2021 that she woke up with the ache/pain on the left side of her neck (somehow near her left ear, close to the base of her left skull, not in the middle but close to the left side. She also mentioned that she got the vaccine on her left arm. Patient stated she had the 1st dose of the Pfizer Vaccine and after the shot around 1:00pm she did have a reaction as far as she broke out in a rash on her face with hives and was taking Benadryl; stated she talked to the pharmacist who noticed this an hour after the shot was given and she had waited after her shot because she was nervous and did have several allergies; stated by this morning her face was all cleared up except for one bump which was good and her arm being sore; stated what was bothering her now was that she woke up with some aching up the left side of her neck into her left ear and that is doable and was there so she will see how that pans out. Patient stated the pain went away and then came back and she did not know why this is happening. Patient stated she can ignore the ear thing but what made her nervous was that pain in the base of her skull close to the left side and it is bothersome. Patient stated she did print everything out before she got the shot and did not see anyone reporting anything like neck or ear pain and the neck was what was being annoying now and the ear pain was there. Outcome of the events rash on her face and hives was recovered in Oct2021, while outcome of the other events was unknown. Events rash on her face and hives reported as serious as medically significant.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Illness, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID on Saturday; diagnosed with COVID on Saturday; tunnel vision; sick; I never felt like my self; This is a spontaneous report from a contactable consumer(patient). A 47-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) and  received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The age at both doses was 47-year-old. Medical history included blood pressure high from 2021 to an unknown date, high cholesterol from 2021 to an unknown date. Concomitant medications included amlodipine taken for an unspecified indication by oral from 2021 to an unspecified stop date; atorvastatin taken for an unspecified indication by oral from 2021 to an unspecified stop date. The patient reported in 2021: "I took the two Pfizer covid shots and i was diagnosed with COVID on Saturday and now I'm in quarantine. The 2nd shot made me feel sick, but it was not for long. I never felt like myself or like i used to feel after getting the vaccine, I have tunnel vision. Now they are talking about a booster shot will the booster cause side effects?"  The patient stated he got both shots of the Pfizer COVID-19 vaccine, he had been to the doctor and right now he had been diagnosed with COVID after on Saturday having his nose swabbed. He said they didn't have the rapid test thing so he had to wait 24- 48 hours for results, and it came back positive on 2021. The patient had a physician office visit for all events. The outcome of all events were unknown. The case was serious due to medically significant condition.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tunnel vision
Clinical narrative: diagnosed with COVID on Saturday; diagnosed with COVID on Saturday; tunnel vision; sick; I never felt like my self; This is a spontaneous report from a contactable consumer(patient). A 47-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) and  received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The age at both doses was 47-year-old. Medical history included blood pressure high from 2021 to an unknown date, high cholesterol from 2021 to an unknown date. Concomitant medications included amlodipine taken for an unspecified indication by oral from 2021 to an unspecified stop date; atorvastatin taken for an unspecified indication by oral from 2021 to an unspecified stop date. The patient reported in 2021: "I took the two Pfizer covid shots and i was diagnosed with COVID on Saturday and now I'm in quarantine. The 2nd shot made me feel sick, but it was not for long. I never felt like myself or like i used to feel after getting the vaccine, I have tunnel vision. Now they are talking about a booster shot will the booster cause side effects?"  The patient stated he got both shots of the Pfizer COVID-19 vaccine, he had been to the doctor and right now he had been diagnosed with COVID after on Saturday having his nose swabbed. He said they didn't have the rapid test thing so he had to wait 24- 48 hours for results, and it came back positive on 2021. The patient had a physician office visit for all events. The outcome of all events were unknown. The case was serious due to medically significant condition.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got both doses of the Pfizer COVID vaccine back in Jan2021. He got COVID in August; he got both doses of the Pfizer COVID vaccine back in Jan2021. He got COVID in August; This is a spontaneous report from a contactable consumer(patient).  An 81-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021, as single dose (Batch/Lot number was not reported) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021, as single dose (Batch/Lot number was not reported) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated he got two shots of the Pfizer covid vaccine back in Jan2021. In early Aug2021 he got COVID and the doctor suggested to get a regeneron infusion which he did get. Since he got the two doses in Jan2021 and he got the regeneron in Aug2021, he was asking if he should get the booster. The patient had a physician office visit and got treatment for all events included regeneron infusion. The patient underwent lab tests and procedures which included Covid: positive in Aug2021. The outcome of all events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Immunisation, Loss of consciousness, Off label use
Clinical narrative: Standing up created close to black out conditions; had a fever that broke that night; extremely lightheaded; fatigued; Arm had typical site soreness and swelling.; Arm had typical site soreness and swelling.; Dose number=3; Dose number=3; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (COVID 19, Pfizer), dose 3 via an unspecified route of administration, administered in left arm on 01Oct2021 13:15 (Lot Number: EW0217) as dose 3 (booster), single at the age of 30 years old for COVID-19 immunization. Medical history was not reported. Concomitant medication included sertraline in two weeks. Historic vaccine was bnt162b2 received on 27Jan2021 (lot EN5318) as dose 1, single; on 17Feb2021 (lot EN5318) as dose 2, single, both at the age of 29-year-old for COVID-19 immunization. The patient previously took pancrelipase and experienced allergy. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Starting about 24 hours after injection on 02Oct2021, he was extremely lightheaded and fatigued. It came back at random intervals until 04Oct2021. Standing up created close to black out conditions. Arm had typical site soreness and swelling. On the first day on 02Oct2021, he had a fever that broke that night. He was unable to take his temperature due to misplacing his thermometer. No treatment received. The outcome of fever, extremely lightheaded, fatigued was recovered on 04Oct2021. The outcome of arm had typical site soreness and swelling, standing up created close to black out conditions was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Standing up created close to black out conditions; had a fever that broke that night; extremely lightheaded; fatigued; Arm had typical site soreness and swelling.; Arm had typical site soreness and swelling.; Dose number=3; Dose number=3; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (COVID 19, Pfizer), dose 3 via an unspecified route of administration, administered in left arm on 01Oct2021 13:15 (Lot Number: EW0217) as dose 3 (booster), single at the age of 30 years old for COVID-19 immunization. Medical history was not reported. Concomitant medication included sertraline in two weeks. Historic vaccine was bnt162b2 received on 27Jan2021 (lot EN5318) as dose 1, single; on 17Feb2021 (lot EN5318) as dose 2, single, both at the age of 29-year-old for COVID-19 immunization. The patient previously took pancrelipase and experienced allergy. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Starting about 24 hours after injection on 02Oct2021, he was extremely lightheaded and fatigued. It came back at random intervals until 04Oct2021. Standing up created close to black out conditions. Arm had typical site soreness and swelling. On the first day on 02Oct2021, he had a fever that broke that night. He was unable to take his temperature due to misplacing his thermometer. No treatment received. The outcome of fever, extremely lightheaded, fatigued was recovered on 04Oct2021. The outcome of arm had typical site soreness and swelling, standing up created close to black out conditions was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: got the 1st dose of the vaccine and tested positive from covid-19; got the 1st dose of the vaccine and tested positive from covid-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A female patient of unspecified age received BNT162B2 first dose on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient wanted to know how long does a person have to wait to get the 2nd dose of the Comirnaty vaccine if they tested positive for Covid after getting the 1st dose, if its 90 days or 6 months. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: feeling tired; achy; chills; This is a spontaneous report from a contactable consumer (patient), reported for himself. A 67-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 30Sep2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing (Takes Vyndaqel (tafamidis) for cardiac amyloidosis, otherwise healthy and active). Concomitant medication included tafamidis meglumine (VYNDAQEL) taken for cardiac amyloidosis, start and stop date were not reported. Historical vaccine included dose 1 and dose 2 (Lot number was not reported), received on an unknown date in 2021, for COVID-19 immunization and experienced fatigue, pain and chills, after first and second dose. On an unspecified date in 2021, the patient experienced feeling tired and achy with chills for 24 hours after receiving third dose. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: feeling tired; achy; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac amyloidosis from an unknown date and unknown if ongoing (Takes Vyndaqel (tafamidis) for cardiac amyloidosis, otherwise healthy and active. Concomitant medication(s) included tafamidis meglumine (VYNDAQEL) taken for a cardiac amyloidosis, start and stop date were not reported. On an unspecified date the patient experienced feeling tired, achy and chills. Outcome of all events was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: heavy bleeding; bleeding from her vagina almost daily since she received the second shot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in right arm on 11May2021 11:00 (Lot Number: EW0168) as dose 2, single at the age of 38 years old for COVID-19 immunization. No medical history. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Historic vaccine was bnt162b2 (lot number: EW0162) administered in right arm, received on 16Apr2021 11:00 as dose 1, single at the age of 38 years old for COVID-19 immunization. The patient had been bleeding from her vagina almost daily since she received the second shot. It was sometimes light bleeding and sometimes heavy bleeding. Adverse event start date was 12May2021. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature abnormal, Chills, Fibrin D dimer, Guillain-Barre syndrome, Malaise
Clinical narrative: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Fibrin D dimer, Fibrin D dimer increased, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Neuralgia, Pain assessment, Pain in extremity
Clinical narrative: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Fatigue, Feeling abnormal, Headache
Clinical narrative: Maybe she had COVID; Maybe she had COVID; Tiredness; chills; arm hurts; headaches; feeling funky; It is almost like a light fever that she has; is not feeling too great after the booster; is not feeling too great after the booster; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was receiving booster dose and began experiencing tiredness, chills and arm hurts. Patient was not feeling too well after the booster.  She did fine after the other 2.  Maybe she had COVID.  She has been really tired, and was having chills, headaches, nothing serious, and was feeling funky.  It was almost like a light fever that she had.  Her arm still hurts.  It had been since Friday. She would like to know if what she was feeling is typical and how long will it continue.  She has heard from her pharmacist and she just sort of passed her off and said it could be 5 days, but she said that some people have had a sore arm for weeks.  She did not have any specific information on anyone to report that had a sore arm for weeks. The outcomes of events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity, Pyrexia, Suspected COVID-19
Clinical narrative: Maybe she had COVID; Maybe she had COVID; Tiredness; chills; arm hurts; headaches; feeling funky; It is almost like a light fever that she has; is not feeling too great after the booster; is not feeling too great after the booster; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was receiving booster dose and began experiencing tiredness, chills and arm hurts. Patient was not feeling too well after the booster.  She did fine after the other 2.  Maybe she had COVID.  She has been really tired, and was having chills, headaches, nothing serious, and was feeling funky.  It was almost like a light fever that she had.  Her arm still hurts.  It had been since Friday. She would like to know if what she was feeling is typical and how long will it continue.  She has heard from her pharmacist and she just sort of passed her off and said it could be 5 days, but she said that some people have had a sore arm for weeks.  She did not have any specific information on anyone to report that had a sore arm for weeks. The outcomes of events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tachycardia, X-ray
Clinical narrative: tachycardia; Left sided chest pain and arm pit pain; Left sided chest pain and arm pit pain; aches and soreness on the left side; Non ST segment elevation myocardial infarction; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Support. A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Apr2021 (at the age of 56-year-old; lot number: EW0175; expiry date: 31Aug2021) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunisation. Medical history included coronary artery disease, myocarditis, obesity, hyperlipidemia, smoker, depression, GERD. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Prior Vaccinations (within 4 weeks) was unknown. Events following prior vaccinations and family medical history relevant to events were none. There were no concomitant medications. Patient received the first dose on 22Apr2021, has not received the second dose yet. In Apr2021, the patient experienced non-ST segment elevation myocardial infarction. The clinical course was reported as follows: the reporting nurse noted from patient's chart stating that patient had non-ST segment elevation with myocardial infarction, which cardiology said may have been from the vaccine, and patient was referred to his physician to decide whether or not to get the 2nd dose. The reporting nurse went to speak with the patient to clarify what happened. Clarified that 4 days after receiving the 1st dose of the vaccine (on 26Apr2021), the patient started having left sided chest pain and left sided arm pit pain, as well as aches and soreness on the left side. He went to the ER on 28Apr2021, and had multiple tests done. He then went to the cardiologist and asked if this occurred from the vaccine. Clarified that the cardiologist put him on medication for his heart and said that he didn't think it was directly related to the vaccine, but suggested that the patient wait more than 6 weeks to get the 2nd dose. Events required a visit to emergency room and physician office. Lab data included testing done in the ER on 28Apr2021: EKG was normal, tachycardia; x-ray was normal, no evidence of pulmonary embolism; D-Dimer was elevated to 1.440. Treatment received for events. Outcome of events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events, acute myocardial infarction, chest pain, axillary pain, pain and the suspect drug BNT162B2 cannot be 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: U
Vaccine: COVID19
Symptoms: Antibody test, Drug ineffective, Echocardiogram, Erectile dysfunction, Influenza like illness
Clinical narrative: Confirmed COVID-19 diagnosis; Confirmed COVID-19 diagnosis; Erectile dysfunction; heart palpitations; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, in the arm on unspecified dates, as dose 1, single and dose 2, single both for COVID-19 immunization. Medical history included autoimmune issues. The patient's concomitant medications were not reported. The patient experienced confirmed COVID-19 diagnosis on 04Oct2021. Also, patient experienced heart palpitations leading to ED and echos following the vaccinations on unspecified dates. Patient also experienced flu-like symptoms for weeks after vaccination. Antibody tests following the vaccinations were in the 800s. Patient also experienced magnetism at the shot site on the first arm and the entire length of the arm for the second shot arm. The magnetism persisted. Patient was about to receive REGENERON (at the time of report). The outcome of the events was unknown.  Information on lot/batch number will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Confirmed COVID-19 diagnosis; Confirmed COVID-19 diagnosis; Erectile dysfunction; heart palpitations; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, in the arm on unspecified dates, as dose 1, single and dose 2, single both for COVID-19 immunization. Medical history included autoimmune issues. The patient's concomitant medications were not reported. The patient experienced confirmed COVID-19 diagnosis on 04Oct2021. Also, patient experienced heart palpitations leading to ED and echos following the vaccinations on unspecified dates. Patient also experienced flu-like symptoms for weeks after vaccination. Antibody tests following the vaccinations were in the 800s. Patient also experienced magnetism at the shot site on the first arm and the entire length of the arm for the second shot arm. The magnetism persisted. Patient was about to receive REGENERON (at the time of report). The outcome of the events was unknown.  Information on lot/batch number will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness, Vaccination site discomfort
Clinical narrative: magnetism at the shot site; Confirmed diagnosis of COVID-19; Confirmed diagnosis of COVID-19; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Patient had no underlying medical conditions. The patient's concomitant medications were not reported. The patient was vaccinated as of early summer. Patient experienced flu-like symptoms for 3 days following the vaccination. Patient experienced magnetism at the shot site. Patient had confirmed diagnosis of COVID-19 on 04Oct2021. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Stocking-glove neuropathy, all 4 extremities; This is a spontaneous report from a contactable physician. A 46-years-old female patient (non-pregnant at time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jul2021 (at the age of 46-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included asthma, COVID 19 pneumonia from Jan2021, CVA during COVID hospitalization, hypertension, covid prior vaccination, ophth (disorder). No covid tested post vaccination, no known allergies. No other vaccine in four weeks. Concomitant medications in two weeks included amlodipine; umeclidinium bromide, vilanterol trifenatate (ANORO); atorvastatin; aspirin [acetylsalicylic acid]; brimonidine tartrate (BRIMONIDINE) for ophth; carvedilol; latanoprost for ophth; hydrochlorothiazide; losartan; salbutamol sulfate (ALBUTEROL); montelukast. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on Jun2021 (at the age of 46-years-old) as single dose for COVID-19 immunization. Two weeks after administration of 2nd vaccine dose, on 02Aug2021, the patient reported stocking-glove neuropathy, all 4 extremities. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for event including gabapentin 300 mg TID (thrice a day). Outcome of the event was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuropathy peripheral  and BNT162B2.  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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: Suicidal ideation; This is a spontaneous report from a contactable physician. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration in 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced suicidal ideation 10 days after vaccination in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of suicidal ideation included referral to behavioral treatment. The outcome of the event was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event Suicidal ideation and the suspect drug BNT162B2 cannot be excluded. case can be reassess once additional information becomes 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Heart Attack; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at age of 58 years old as single dose for COVID-19 immunization. Medical history included having risk factors for heart disease, Covid prior vaccination, known allergies: penicillin. Concomitant medications included other medications in two weeks. The patient had no other vaccine in four weeks. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at age of 58 years old for COVID-19 immunization. The patient suffered from a heart attack on 26Feb2021 at 02:30 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. AE treatment was received including cardiac catherization. The patient had Covid test post vaccination with negative result via nasal swab. Outcome of the event was recovered with sequel.   Follow-up attempts are completed. No further information is expected.