chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product use issue, Pyrexia, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago.  The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious.  Information on lot/batch has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Arthropathy, Joint swelling, Pain
Clinical narrative: whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety.  Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety.  Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: developed symptomatic COVID and tested positive; developed symptomatic COVID and tested positive; This is a spontaneous report from a contactable physician reporting for himself. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on 22Dec2020 for the first dose and on 18Jan2021 for the second dose, at single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medication included omalizumab (XOLAIR) from an unspecified date and indication. The patient, a physician, board certified in internal medicine, reported to have received 2 doses of the "Pfizer vaccine", in late December and the middle of January. More than 3 weeks after the second dose, the patient developed symptomatic COVID and tested positive using nasal swab on 12Feb2021. The vaccine was administered at a hospital and the patient did not receive any other vaccine 4 weeks prior. The patient went to the emergency room due to the event and it was unknown if treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The reporter considered the events as non-serious and the events did not lead to death or life-threating condition, caused hospitalization, disability, or congenital defect. The outcome of the events was reported as not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptomatic COVID and tested positive using nasal swab 25 days after the second dose of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed symptomatic COVID and tested positive; developed symptomatic COVID and tested positive; This is a spontaneous report from a contactable physician reporting for himself. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on 22Dec2020 for the first dose and on 18Jan2021 for the second dose, at single dose for COVID-19 immunization. Medical history included asthma from an unknown date. Concomitant medication included omalizumab (XOLAIR) from an unspecified date and indication. The patient, a physician, board certified in internal medicine, reported to have received 2 doses of the "Pfizer vaccine", in late December and the middle of January. More than 3 weeks after the second dose, the patient developed symptomatic COVID and tested positive using nasal swab on 12Feb2021. The vaccine was administered at a hospital and the patient did not receive any other vaccine 4 weeks prior. The patient went to the emergency room due to the event and it was unknown if treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination. The reporter considered the events as non-serious and the events did not lead to death or life-threating condition, caused hospitalization, disability, or congenital defect. The outcome of the events was reported as not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptomatic COVID and tested positive using nasal swab 25 days after the second dose of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I received my Covid-19 Moderna vaccine on February 12. Soon afterward, the pharmacy called and told me that they had accidently given me a double dose. They reported it to my primary care physician and both the pharmacy and my doctor stayed in close contact with me to monitor my health. I had the usual sore arm, a headache, and a little achy that evening, but nothing major. I noticed the next day that I had a hard lump about 3.5 inches below where my shot was given (not directly below, more toward the inside of my arm.) A small rash begin to develop, but after a few days the rash was gone, but the lump remained. Twelve days after my shot, the lump became very red and hot. The rash appeared again and basically moved up my arm. I kept putting a cortisone itch cream on it, but it was very uncomfortable. Two days after the rash appeared I became quite sick with what it felt like side effects ? chills that included violent shaking and temperature that reached 100.5. I had that for about 24 hours. Now the lump on my arm is gone, I no longer have rash, and my temperature is back to normal. I feel tired today, but probably because of the previous day?s temps and chills. I find it interesting that 2 weeks after my shot I would have those kind of reactions (unless this had nothing to do with the shot?)  I thought you might want to have this data, as it is an interesting side effect. My doctor wasn?t sure how to explain it either. I would be interested to see if others that might have gotten an overdose of the shot experienced anything similar.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Incorrect dose administered
Clinical narrative: I received my Covid-19 Moderna vaccine on February 12. Soon afterward, the pharmacy called and told me that they had accidently given me a double dose. They reported it to my primary care physician and both the pharmacy and my doctor stayed in close contact with me to monitor my health. I had the usual sore arm, a headache, and a little achy that evening, but nothing major. I noticed the next day that I had a hard lump about 3.5 inches below where my shot was given (not directly below, more toward the inside of my arm.) A small rash begin to develop, but after a few days the rash was gone, but the lump remained. Twelve days after my shot, the lump became very red and hot. The rash appeared again and basically moved up my arm. I kept putting a cortisone itch cream on it, but it was very uncomfortable. Two days after the rash appeared I became quite sick with what it felt like side effects ? chills that included violent shaking and temperature that reached 100.5. I had that for about 24 hours. Now the lump on my arm is gone, I no longer have rash, and my temperature is back to normal. I feel tired today, but probably because of the previous day?s temps and chills. I find it interesting that 2 weeks after my shot I would have those kind of reactions (unless this had nothing to do with the shot?)  I thought you might want to have this data, as it is an interesting side effect. My doctor wasn?t sure how to explain it either. I would be interested to see if others that might have gotten an overdose of the shot experienced anything similar.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Induration, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: I received my Covid-19 Moderna vaccine on February 12. Soon afterward, the pharmacy called and told me that they had accidently given me a double dose. They reported it to my primary care physician and both the pharmacy and my doctor stayed in close contact with me to monitor my health. I had the usual sore arm, a headache, and a little achy that evening, but nothing major. I noticed the next day that I had a hard lump about 3.5 inches below where my shot was given (not directly below, more toward the inside of my arm.) A small rash begin to develop, but after a few days the rash was gone, but the lump remained. Twelve days after my shot, the lump became very red and hot. The rash appeared again and basically moved up my arm. I kept putting a cortisone itch cream on it, but it was very uncomfortable. Two days after the rash appeared I became quite sick with what it felt like side effects ? chills that included violent shaking and temperature that reached 100.5. I had that for about 24 hours. Now the lump on my arm is gone, I no longer have rash, and my temperature is back to normal. I feel tired today, but probably because of the previous day?s temps and chills. I find it interesting that 2 weeks after my shot I would have those kind of reactions (unless this had nothing to do with the shot?)  I thought you might want to have this data, as it is an interesting side effect. My doctor wasn?t sure how to explain it either. I would be interested to see if others that might have gotten an overdose of the shot experienced anything similar.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Tremor
Clinical narrative: I received my Covid-19 Moderna vaccine on February 12. Soon afterward, the pharmacy called and told me that they had accidently given me a double dose. They reported it to my primary care physician and both the pharmacy and my doctor stayed in close contact with me to monitor my health. I had the usual sore arm, a headache, and a little achy that evening, but nothing major. I noticed the next day that I had a hard lump about 3.5 inches below where my shot was given (not directly below, more toward the inside of my arm.) A small rash begin to develop, but after a few days the rash was gone, but the lump remained. Twelve days after my shot, the lump became very red and hot. The rash appeared again and basically moved up my arm. I kept putting a cortisone itch cream on it, but it was very uncomfortable. Two days after the rash appeared I became quite sick with what it felt like side effects ? chills that included violent shaking and temperature that reached 100.5. I had that for about 24 hours. Now the lump on my arm is gone, I no longer have rash, and my temperature is back to normal. I feel tired today, but probably because of the previous day?s temps and chills. I find it interesting that 2 weeks after my shot I would have those kind of reactions (unless this had nothing to do with the shot?)  I thought you might want to have this data, as it is an interesting side effect. My doctor wasn?t sure how to explain it either. I would be interested to see if others that might have gotten an overdose of the shot experienced anything similar.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Injection site paraesthesia, Paraesthesia, Swollen tongue
Clinical narrative: Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest discomfort, Chills, Dizziness, Dysstasia
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Hypertension, Metabolic function test, Nausea
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Body temperature, Body temperature increased
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Dizziness, Dysstasia
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Nausea, Pain, SARS-CoV-2 test, Tremor
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature.  Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Migraine, Pyrexia
Clinical narrative: Patient suffered a local left arm vaccine reaction with angioedema with myositis around 4% of the arm surface area and a syntomic reaction with fever, general malaise and severe orbital headaches after 12 hrs from the COVID vaccine administration 02/16/2021. The systemic symptoms lasted about 24 hrs. She was home in bed with treatments for her symptoms for 48 hrs. Patient left arm local symptoms are improving, but still with mild myositis and mild angioedema. She continue with PRN treatments for pain and inflammation. Currently stable on room air and fit for her duties. We will F/U as needed. Patient oriented.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Headache, Local reaction, Malaise, Myositis
Clinical narrative: Patient suffered a local left arm vaccine reaction with angioedema with myositis around 4% of the arm surface area and a syntomic reaction with fever, general malaise and severe orbital headaches after 12 hrs from the COVID vaccine administration 02/16/2021. The systemic symptoms lasted about 24 hrs. She was home in bed with treatments for her symptoms for 48 hrs. Patient left arm local symptoms are improving, but still with mild myositis and mild angioedema. She continue with PRN treatments for pain and inflammation. Currently stable on room air and fit for her duties. We will F/U as needed. Patient oriented.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Patient suffered a local left arm vaccine reaction with angioedema with myositis around 4% of the arm surface area and a syntomic reaction with fever, general malaise and severe orbital headaches after 12 hrs from the COVID vaccine administration 02/16/2021. The systemic symptoms lasted about 24 hrs. She was home in bed with treatments for her symptoms for 48 hrs. Patient left arm local symptoms are improving, but still with mild myositis and mild angioedema. She continue with PRN treatments for pain and inflammation. Currently stable on room air and fit for her duties. We will F/U as needed. Patient oriented.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous
Clinical narrative: After the vaccine the patient miscarried the baby; This is a spontaneous report from Pfizer-sponsored program via a contactable pharmacist.  A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), 0.3 ml via an unspecified route of administration on 15Jan2021 at 10:00-11:30am as a single dose for COVID-19 immunization, administered in the right arm. Patient has no past medical history. Concomitant medication includes One-a-day vitamin, Ongoing. No prior Vaccinations within 4 weeks prior. First Day of Last menstrual period: 6-13 Dec2020. Patient reports one previous pregnancy: full term live birth via vaginal birth with epidural at 40 weeks and 1 day. The father used marijuana, at an unspecified frequency. Patient was unaware that she was pregnant, guesses she was about 3 weeks when she got the first shot of the vaccine. Ten days after the vaccine, the patient miscarried the baby. The clinical outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Miscarriage of pregnancy cannot be excluded.  The case will be reassessed if 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: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Nausea, Pallor
Clinical narrative: In under two minutes  fainted.  Believed to be  Vasovagal syncope although  patient has never fainted  in the past and even with getting other vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: In under two minutes  fainted.  Believed to be  Vasovagal syncope although  patient has never fainted  in the past and even with getting other vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Abdominal pain upper, Chest X-ray, Chest discomfort, Computerised tomogram head
Clinical narrative: In under two minutes  fainted.  Believed to be  Vasovagal syncope although  patient has never fainted  in the past and even with getting other vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Electrocardiogram, Immediate post-injection reaction, Laboratory test, Nausea
Clinical narrative: In under two minutes  fainted.  Believed to be  Vasovagal syncope although  patient has never fainted  in the past and even with getting other vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: In under two minutes  fainted.  Believed to be  Vasovagal syncope although  patient has never fainted  in the past and even with getting other vaccines.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Onset of severe headache the evening of the injection.  A previous adverse reaction report was filed at that time, but noted that the symptoms had resolved.  The headache and fatigue recurred on the morning of 2/23/2021.  After several hours and Aspirin the headache resolved.  Again this morning the headache was present.  It is not as severe as the two previous headaches, but is still present.  There are no other associated symptoms at this time.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Onset of severe headache the evening of the injection.  A previous adverse reaction report was filed at that time, but noted that the symptoms had resolved.  The headache and fatigue recurred on the morning of 2/23/2021.  After several hours and Aspirin the headache resolved.  Again this morning the headache was present.  It is not as severe as the two previous headaches, but is still present.  There are no other associated symptoms at this time.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Immediate post-injection reaction, Nausea, Swelling face, Swollen tongue
Clinical narrative: tongue swelling, angioedema, denies SOB RR even, unlabored, no hives or rashes Taken to ER by wheelchair
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye pruritus, Nausea, Periorbital swelling, Pruritus, Swollen tongue
Clinical narrative: tongue swelling, angioedema, denies SOB RR even, unlabored, no hives or rashes Taken to ER by wheelchair
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Swollen tongue
Clinical narrative: tongue swelling, angioedema, denies SOB RR even, unlabored, no hives or rashes Taken to ER by wheelchair
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: PATIENT DiED. REPORTED BY FAMiLY MEMBER
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cough, Erythema, Pruritus, Rash macular
Clinical narrative: 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction.   On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction.   On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Choking, Confusional state, Cough, Dyspnoea
Clinical narrative: 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction.   On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.