chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Lethargy, Myalgia
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Neuralgia, Pyrexia, Troponin increased
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Bradycardia, Capillary nail refill test, Chest discomfort, Chest pain, Echocardiogram normal
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Laboratory test, Myalgia, Myocarditis
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Neuralgia, Pyrexia, Troponin I increased, Vaccination complication
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Chills, Delirium, Dyspnoea
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Neuralgia, Pain
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood test, Computerised tomogram, Pyrexia, Ultrasound scan
Clinical narrative: 9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there; I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster.This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Oct2021 at 10:30 (Lot number: 32030BD)at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Achalashia" (unspecified if ongoing), notes: Achalashia Type3; "Complex regional pain syndrome" (unspecified if ongoing), notes: CRPS; "Chronic kidney disease" (unspecified if ongoing), notes: CKD Stage 3; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Seafood allergy" (unspecified if ongoing), notes: Known allergies: Tuna. Concomitant medications included: OXYCONTIN ER; FLOMAX; NORVASC and ALBUTEROL. Past drug history included: Dermabond, reactions: "Drug allergy" and Vicodin, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL9264; Anatomical site: Left arm; Administration time: 10:30), administration date: 08Feb2021, when the patient was 67 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN6203; Anatomical site: Right arm; Administration time: 10:30), administration date: 01Mar2021, when the patient was 67 years old, for COVID-19 immunisation.  The following information was reported: AXILLARY MASS (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there"; PYREXIA (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster". The events "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there" and "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass and pyrexia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the patient's doctors have had done endless tests and could not find the cause. The patient stated whether this might be due to injection. Since the vaccination, the patient had been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: 9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there; I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster.This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Oct2021 at 10:30 (Lot number: 32030BD)at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Achalashia" (unspecified if ongoing), notes: Achalashia Type3; "Complex regional pain syndrome" (unspecified if ongoing), notes: CRPS; "Chronic kidney disease" (unspecified if ongoing), notes: CKD Stage 3; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Seafood allergy" (unspecified if ongoing), notes: Known allergies: Tuna. Concomitant medications included: OXYCONTIN ER; FLOMAX; NORVASC and ALBUTEROL. Past drug history included: Dermabond, reactions: "Drug allergy" and Vicodin, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL9264; Anatomical site: Left arm; Administration time: 10:30), administration date: 08Feb2021, when the patient was 67 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN6203; Anatomical site: Right arm; Administration time: 10:30), administration date: 01Mar2021, when the patient was 67 years old, for COVID-19 immunisation.  The following information was reported: AXILLARY MASS (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there"; PYREXIA (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster". The events "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there" and "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass and pyrexia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the patient's doctors have had done endless tests and could not find the cause. The patient stated whether this might be due to injection. Since the vaccination, the patient had been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: 9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there; I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster.This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Oct2021 at 10:30 (Lot number: 32030BD)at the age of 68 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing); "Achalashia" (unspecified if ongoing), notes: Achalashia Type3; "Complex regional pain syndrome" (unspecified if ongoing), notes: CRPS; "Chronic kidney disease" (unspecified if ongoing), notes: CKD Stage 3; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Seafood allergy" (unspecified if ongoing), notes: Known allergies: Tuna. Concomitant medications included: OXYCONTIN ER; FLOMAX; NORVASC and ALBUTEROL. Past drug history included: Dermabond, reactions: "Drug allergy" and Vicodin, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL9264; Anatomical site: Left arm; Administration time: 10:30), administration date: 08Feb2021, when the patient was 67 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EN6203; Anatomical site: Right arm; Administration time: 10:30), administration date: 01Mar2021, when the patient was 67 years old, for COVID-19 immunisation.  The following information was reported: AXILLARY MASS (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there"; PYREXIA (non-serious) with onset 06Nov2021 at 15:00, outcome "not recovered", described as "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster". The events "9 days after getting my booster, I had a lump under my armpit the size of an egg. Still there" and "I also have been running a fever of 100-103 since Nov 6th , little over a week after my booster." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass and pyrexia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that the patient's doctors have had done endless tests and could not find the cause. The patient stated whether this might be due to injection. Since the vaccination, the patient had been tested for COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pharyngitis
Clinical narrative: inflammation; sort throat; 1st, dose J&j 2nd Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 16:00 (Lot number: 330368D) at the age of 46 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Period disorder low iron" (unspecified if ongoing), notes: Period disorder low iron; "Period disorder" (unspecified if ongoing), notes: Period disorder low iron, known_allergies: No. Concomitant medication(s) included: VITAMIN C; IRON. Vaccination history included: J &j (Dose: 01), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Jan2022 16:00, outcome "unknown", described as "1st, dose J&j 2nd Pfizer"; INFLAMMATION (non-serious) with onset 23Jan2022 07:00, outcome "not recovered", described as "inflammation"; OROPHARYNGEAL PAIN (non-serious) with onset 23Jan2022 07:00, outcome "not recovered", described as "sort throat". Therapeutic measures were taken as a result of inflammation, oropharyngeal pain.  Additional information: The patient had no other vaccine in four weeks. The patient received Tylenol as treatment for the adverse events. The patient had no known allergies. The patient had no covid prior to vaccination nor was tested post vaccination. The patient was vaccinated in doctor's office.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Interchange of vaccine products, Oropharyngeal pain
Clinical narrative: inflammation; sort throat; 1st, dose J&j 2nd Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 16:00 (Lot number: 330368D) at the age of 46 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Period disorder low iron" (unspecified if ongoing), notes: Period disorder low iron; "Period disorder" (unspecified if ongoing), notes: Period disorder low iron, known_allergies: No. Concomitant medication(s) included: VITAMIN C; IRON. Vaccination history included: J &j (Dose: 01), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Jan2022 16:00, outcome "unknown", described as "1st, dose J&j 2nd Pfizer"; INFLAMMATION (non-serious) with onset 23Jan2022 07:00, outcome "not recovered", described as "inflammation"; OROPHARYNGEAL PAIN (non-serious) with onset 23Jan2022 07:00, outcome "not recovered", described as "sort throat". Therapeutic measures were taken as a result of inflammation, oropharyngeal pain.  Additional information: The patient had no other vaccine in four weeks. The patient received Tylenol as treatment for the adverse events. The patient had no known allergies. The patient had no covid prior to vaccination nor was tested post vaccination. The patient was vaccinated in doctor's office.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pyrexia, Shoulder operation
Clinical narrative: she developed hoarseness; coughing; fever; treatments take away the wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, I didn't have any of this with the first 2 doses of the PBCV (purple formula)), for COVID-19 immunization; Bnt162b2 (Dose: 2, I didn't have any of this with the first 2 doses of the PBCV (purple formula)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "received a PBCV Booster dose"; DYSPHONIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "she developed hoarseness"; COUGH (non-serious) with onset 13Jan2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "fever"; WHEEZING (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "treatments take away the wheezing". Therapeutic measures were taken as a result of dysphonia, cough, pyrexia, wheezing.  Additional information: Patient stated that she received a PBCV Booster dose on 12Jan2022. On 13Jan2022 she developed hoarseness, coughing and fever. Patient asked whether these are normal and should she still be experiencing them one week later. Also stated that "she had an appt with her HCP yesterday via telemedicine, she was taking Tylenol, Robitussin and her Ventolin Inhaler, she also started her breathing treatments at home." She stated these treatments take away the wheezing, "but her voice was still hoarse. She didn't have any of this with the first 2 doses of the PBCV (purple formula), She asked that how long this will last.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pyrexia, Wheezing
Clinical narrative: she developed hoarseness; coughing; fever; treatments take away the wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, I didn't have any of this with the first 2 doses of the PBCV (purple formula)), for COVID-19 immunization; Bnt162b2 (Dose: 2, I didn't have any of this with the first 2 doses of the PBCV (purple formula)), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "received a PBCV Booster dose"; DYSPHONIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "she developed hoarseness"; COUGH (non-serious) with onset 13Jan2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "fever"; WHEEZING (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "treatments take away the wheezing". Therapeutic measures were taken as a result of dysphonia, cough, pyrexia, wheezing.  Additional information: Patient stated that she received a PBCV Booster dose on 12Jan2022. On 13Jan2022 she developed hoarseness, coughing and fever. Patient asked whether these are normal and should she still be experiencing them one week later. Also stated that "she had an appt with her HCP yesterday via telemedicine, she was taking Tylenol, Robitussin and her Ventolin Inhaler, she also started her breathing treatments at home." She stated these treatments take away the wheezing, "but her voice was still hoarse. She didn't have any of this with the first 2 doses of the PBCV (purple formula), She asked that how long this will last.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Feeling abnormal, Insomnia
Clinical narrative: passed down; vomiting; looking thirsty; fell to the ground; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 32-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" [Blood cholesterol abnormal] (unspecified if ongoing). Concomitant medications included: FENOFIBRATE taken for blood cholesterol abnormal; CLONAZEPAM; RANITIDINE; DEPROZOL taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "passed down"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; THIRST (non-serious), outcome "recovered", described as "looking thirsty"; FALL (non-serious), outcome "recovered", described as "fell to the ground". Clinical course details: On an unspecified date, the patient started vomiting, looking thirsty, vomiting, like thirst feel hit his body, he passed down (incomplete sentence), like long story short, it took him an hour but then he fell to the ground, it took him five to ten second to the most to realize that where he was heading in. The patient received the booster shot last Thursday the 23 (further not clarified) of this month. There are so many of them you know just like second dose of Pfizer (further clarification unknown) but they went away within some days but it is not with the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Neck pain, Paraesthesia, Thirst, Vaccination site pain
Clinical narrative: passed down; vomiting; looking thirsty; fell to the ground; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 32-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" [Blood cholesterol abnormal] (unspecified if ongoing). Concomitant medications included: FENOFIBRATE taken for blood cholesterol abnormal; CLONAZEPAM; RANITIDINE; DEPROZOL taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "passed down"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; THIRST (non-serious), outcome "recovered", described as "looking thirsty"; FALL (non-serious), outcome "recovered", described as "fell to the ground". Clinical course details: On an unspecified date, the patient started vomiting, looking thirsty, vomiting, like thirst feel hit his body, he passed down (incomplete sentence), like long story short, it took him an hour but then he fell to the ground, it took him five to ten second to the most to realize that where he was heading in. The patient received the booster shot last Thursday the 23 (further not clarified) of this month. There are so many of them you know just like second dose of Pfizer (further clarification unknown) but they went away within some days but it is not with the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: passed down; vomiting; looking thirsty; fell to the ground; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 32-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" [Blood cholesterol abnormal] (unspecified if ongoing). Concomitant medications included: FENOFIBRATE taken for blood cholesterol abnormal; CLONAZEPAM; RANITIDINE; DEPROZOL taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "passed down"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; THIRST (non-serious), outcome "recovered", described as "looking thirsty"; FALL (non-serious), outcome "recovered", described as "fell to the ground". Clinical course details: On an unspecified date, the patient started vomiting, looking thirsty, vomiting, like thirst feel hit his body, he passed down (incomplete sentence), like long story short, it took him an hour but then he fell to the ground, it took him five to ten second to the most to realize that where he was heading in. The patient received the booster shot last Thursday the 23 (further not clarified) of this month. There are so many of them you know just like second dose of Pfizer (further clarification unknown) but they went away within some days but it is not with the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness, Thirst, Vomiting
Clinical narrative: passed down; vomiting; looking thirsty; fell to the ground; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 32-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" [Blood cholesterol abnormal] (unspecified if ongoing). Concomitant medications included: FENOFIBRATE taken for blood cholesterol abnormal; CLONAZEPAM; RANITIDINE; DEPROZOL taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "passed down"; VOMITING (non-serious), outcome "recovered", described as "vomiting"; THIRST (non-serious), outcome "recovered", described as "looking thirsty"; FALL (non-serious), outcome "recovered", described as "fell to the ground". Clinical course details: On an unspecified date, the patient started vomiting, looking thirsty, vomiting, like thirst feel hit his body, he passed down (incomplete sentence), like long story short, it took him an hour but then he fell to the ground, it took him five to ten second to the most to realize that where he was heading in. The patient received the booster shot last Thursday the 23 (further not clarified) of this month. There are so many of them you know just like second dose of Pfizer (further clarification unknown) but they went away within some days but it is not with the booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has had all three doses / taste was beginning to go away / couldn't taste the food before taking Paxlovid; A little fussy headed sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE. Vaccination history included: Bnt162b2 (1st dose, Caller then states he has had all three doses), for Covid-19 immunization; Bnt162b2 (2nd dose, Caller then states he has had all three doses), for Covid-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "has had all three doses / taste was beginning to go away / couldn't taste the food before taking Paxlovid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "A little fussy headed sometimes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller then states he has had all three doses and now he came back with a new variant of Covid, states his doctor put him on this stuff. Caller states he is also taking another pill with Paxlovid which is called Dexamethasone, 6mg. Caller states his taste was beginning to go away where he couldn't taste the food before taking Paxlovid and now his taste is beginning to come back normal. Caller states he noticed he is a little fussy headed sometimes, which is why he think he must have missed the afternoon dose yesterday.  The lot number for bnt162b2 was not provided and will be requested during follow up.