chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Injection site pruritus
Clinical narrative: patient awoke with rash all over arms and trunk; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0179, expiration date: unknown) via an unspecified route of administration in the left arm, on 09May2021 at 10:30 (at the age of 55-year-old) as single dose for COVID-19 immunization. The patient's medical history included anaphylactic reaction to bee sting from 1978 and relevant past drug history and known allergies to amoxicillin, sulfa, OTC cough medicine. Concomitant medications included fish oil, ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS, women's multivitamin), vitamin b complex and calcium citrate, all were from an unknown date and for unspecified indication. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 11May2021 at 06:30, 2 days after vaccine, patient awoke with rash all over arms and trunk. Seriousness of the event was non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. The patient did not receive treatment for event. Outcome of event was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Rash
Clinical narrative: patient awoke with rash all over arms and trunk; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0179, expiration date: unknown) via an unspecified route of administration in the left arm, on 09May2021 at 10:30 (at the age of 55-year-old) as single dose for COVID-19 immunization. The patient's medical history included anaphylactic reaction to bee sting from 1978 and relevant past drug history and known allergies to amoxicillin, sulfa, OTC cough medicine. Concomitant medications included fish oil, ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS, women's multivitamin), vitamin b complex and calcium citrate, all were from an unknown date and for unspecified indication. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 11May2021 at 06:30, 2 days after vaccine, patient awoke with rash all over arms and trunk. Seriousness of the event was non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. The patient did not receive treatment for event. Outcome of event was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: patient awoke with rash all over arms and trunk; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 55-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0179, expiration date: unknown) via an unspecified route of administration in the left arm, on 09May2021 at 10:30 (at the age of 55-year-old) as single dose for COVID-19 immunization. The patient's medical history included anaphylactic reaction to bee sting from 1978 and relevant past drug history and known allergies to amoxicillin, sulfa, OTC cough medicine. Concomitant medications included fish oil, ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS, women's multivitamin), vitamin b complex and calcium citrate, all were from an unknown date and for unspecified indication. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 11May2021 at 06:30, 2 days after vaccine, patient awoke with rash all over arms and trunk. Seriousness of the event was non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination. The patient did not receive treatment for event. Outcome of event was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Mechanical ventilation, Movement disorder
Clinical narrative: Patient stated that about a month after getting his vaccine, he fell down the step bc his legs felt numb. Once he went to doctor, he was guillain barre syndrome. Patient did not get his 2nd vaccine bc he was in the hospital at the time.  Patient stated that he can't walk and that he's in a wheelchair now.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Patient stated that about a month after getting his vaccine, he fell down the step bc his legs felt numb. Once he went to doctor, he was guillain barre syndrome. Patient did not get his 2nd vaccine bc he was in the hospital at the time.  Patient stated that he can't walk and that he's in a wheelchair now.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Incomplete course of vaccination
Clinical narrative: Patient stated that about a month after getting his vaccine, he fell down the step bc his legs felt numb. Once he went to doctor, he was guillain barre syndrome. Patient did not get his 2nd vaccine bc he was in the hospital at the time.  Patient stated that he can't walk and that he's in a wheelchair now.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness
Clinical narrative: Odd Tightness in his Throat; Face turned a little bit red; This is a spontaneous report from a contactable pharmacist (patient). A 55years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Feb2021 at 13:30 (at the age of 55years-old) as dose 1, single for covid-19 immunisation (prevention of Covid). Medical history included ongoing multiple sclerosis (MS; Diagnosed 25 years ago) and allergy to bee venom, (he was not 100% sure he is he has been stung since and not had an issue). Investigation assessment was none. Concomitant medication included fingolimod hydrochloride (GILENYA) for MS. The patient did not receive any recent vaccines for any other conditions prior to the event being reported and no other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. On 15Feb2021, 04:00, the patient experienced odd tightness in his throat, face turned a little bit red. The patient required medical intervention (the patient seen in the Emergency Department). The patient was not hospitalized and was not admitted to an Intensive Care Unit. The treatment drug for these events were BENADRYL and PREDNISONE. He continues to take them; PREDNISONE once a day, BENADRYL every 6 hours by mouth. No laboratory or diagnostic studies performed. Clinical course was as follow: On 15Feb2021, 04:00, tightness in the throat almost like you had a chicken bone stuck sideways, but no problem breathing, the doctor said there was plenty of space. Organ involvement was none. Outcome of the events face turned a little bit red was recovered/resolved on 10Mar2021 and odd tightness in his throat was resolving. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Throat tightness
Clinical narrative: Odd Tightness in his Throat; Face turned a little bit red; This is a spontaneous report from a contactable pharmacist (patient). A 55years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Feb2021 at 13:30 (at the age of 55years-old) as dose 1, single for covid-19 immunisation (prevention of Covid). Medical history included ongoing multiple sclerosis (MS; Diagnosed 25 years ago) and allergy to bee venom, (he was not 100% sure he is he has been stung since and not had an issue). Investigation assessment was none. Concomitant medication included fingolimod hydrochloride (GILENYA) for MS. The patient did not receive any recent vaccines for any other conditions prior to the event being reported and no other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. On 15Feb2021, 04:00, the patient experienced odd tightness in his throat, face turned a little bit red. The patient required medical intervention (the patient seen in the Emergency Department). The patient was not hospitalized and was not admitted to an Intensive Care Unit. The treatment drug for these events were BENADRYL and PREDNISONE. He continues to take them; PREDNISONE once a day, BENADRYL every 6 hours by mouth. No laboratory or diagnostic studies performed. Clinical course was as follow: On 15Feb2021, 04:00, tightness in the throat almost like you had a chicken bone stuck sideways, but no problem breathing, the doctor said there was plenty of space. Organ involvement was none. Outcome of the events face turned a little bit red was recovered/resolved on 10Mar2021 and odd tightness in his throat was resolving. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeding disorder, Headache, Injection site discolouration, Injection site reaction
Clinical narrative: My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Pain, Rash erythematous, Rash pruritic
Clinical narrative: My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Vomiting
Clinical narrative: My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Malaise, Peripheral swelling, Pharyngeal swelling, Rash
Clinical narrative: My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea
Clinical narrative: Patient passed away on 07/04/2021
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away on 07/04/2021
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Cardiomegaly, Catheterisation cardiac, Computerised tomogram, Electrocardiogram
Clinical narrative: Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient).  A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pulmonary oedema, X-ray
Clinical narrative: Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient).  A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiomyopathy, Catheterisation cardiac, Coronary artery stenosis, Dyspnoea, Dyspnoea exertional
Clinical narrative: Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient).  A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Laboratory test
Clinical narrative: Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient).  A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Cardiomegaly, Palpitations, Pulmonary oedema
Clinical narrative: Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient).  A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Developed noticeable DVT in the right leg with left leg also having a clot.; Developed noticeable DVT in the right leg with left leg also having a clot.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0168, Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 03May2021 (age at vaccination was 52 years) as dose 2, single for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533, Expiration Date: Jul2021) via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:00 pm (age at vaccination was 52 years) as dose 1, single for COVID-19 immunization. The patient previously took Sulfa drugs and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17May2021, the patient developed noticeable DVT in the right leg with left leg also having a clot.  The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with blood thinners for the adverse events. The device date was reported as 06Jul2021. The events were reported as serious (disabling/Incapacitating). The outcome of the events at the time of last observation was not resolved.  Follow-up actions are completed. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Thrombosis
Clinical narrative: Developed noticeable DVT in the right leg with left leg also having a clot.; Developed noticeable DVT in the right leg with left leg also having a clot.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0168, Expiration Date: Aug2021) via an unspecified route of administration, administered in left arm on 03May2021 (age at vaccination was 52 years) as dose 2, single for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533, Expiration Date: Jul2021) via an unspecified route of administration, administered in left arm on 05Apr2021 at 16:00 pm (age at vaccination was 52 years) as dose 1, single for COVID-19 immunization. The patient previously took Sulfa drugs and experienced known allergies to it. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17May2021, the patient developed noticeable DVT in the right leg with left leg also having a clot.  The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with blood thinners for the adverse events. The device date was reported as 06Jul2021. The events were reported as serious (disabling/Incapacitating). The outcome of the events at the time of last observation was not resolved.  Follow-up actions are completed. Further information has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Haemoglobin decreased, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21).  The bleeding was very heavy (changing overnight pads every 1.5 hours)  and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate.  Sent for CBCs which showed drop in hemoglobin.  Bleeding stopped 6/29 and restarted briefly on 7/3.  Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Syncope, Thrombosis, Vomiting
Clinical narrative: Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21).  The bleeding was very heavy (changing overnight pads every 1.5 hours)  and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate.  Sent for CBCs which showed drop in hemoglobin.  Bleeding stopped 6/29 and restarted briefly on 7/3.  Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21).  The bleeding was very heavy (changing overnight pads every 1.5 hours)  and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate.  Sent for CBCs which showed drop in hemoglobin.  Bleeding stopped 6/29 and restarted briefly on 7/3.  Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Mean cell volume normal, Menstruation irregular, Nausea, Pallor
Clinical narrative: Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21).  The bleeding was very heavy (changing overnight pads every 1.5 hours)  and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate.  Sent for CBCs which showed drop in hemoglobin.  Bleeding stopped 6/29 and restarted briefly on 7/3.  Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased
Clinical narrative: Patient started a heavy menstrual period the day after her 2nd dose of pfizer vaccine (she had already had her regular period 6/10/21-6/16/21).  The bleeding was very heavy (changing overnight pads every 1.5 hours)  and caused patient to become pale, dizzy,- fatigue, nausea, and hard to concentrate.  Sent for CBCs which showed drop in hemoglobin.  Bleeding stopped 6/29 and restarted briefly on 7/3.  Patient started on iron supplementation and recovered otherwise once bleeding stopped by 7/7.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Paraesthesia oral, Somnolence
Clinical narrative: tongue change sensation, persistent nausea and heavy chest
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaesthesia oral, Chest discomfort, Nausea
Clinical narrative: tongue change sensation, persistent nausea and heavy chest
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Intensive care, Malaise, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinusitis
Clinical narrative: Tested positive for Covid-19
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came with her mother and informed us that she wants moderna vaccine for her son who is 12 years old. My technician typed the prescription as a first dose of moderna vaccine. techinformed me that the vaccine is ready to be injected. I gave the moderna vaccine to the patient and realised that and I spoke to the mother about it and the mother said it is approved by moderna for kids 12years and older and she insisted that, that is what she wants . I advise patient that pfizer vaccine is the only vaccine which is now approved for AUE, for now but patients mother said that is what she wants. There was no reported adverse event. I am reporting because modener has not recievev the AUE aproval from FDA. my recomendation is now as use as off label use
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came with her mother and informed us that she wants moderna vaccine for her son who is 12 years old. My technician typed the prescription as a first dose of moderna vaccine. techinformed me that the vaccine is ready to be injected. I gave the moderna vaccine to the patient and realised that and I spoke to the mother about it and the mother said it is approved by moderna for kids 12years and older and she insisted that, that is what she wants . I advise patient that pfizer vaccine is the only vaccine which is now approved for AUE, for now but patients mother said that is what she wants. There was no reported adverse event. I am reporting because modener has not recievev the AUE aproval from FDA. my recomendation is now as use as off label use
Age: 18.0
Sex: M
Vaccine: COVID19, ADEN_4_7, COVID19, HEPA, MNQ, TDAP, VARCEL
Symptoms: Aspartate aminotransferase increased, Blood calcium decreased, Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation
Clinical narrative: 18 y/o man who was seen on 16 JUL complaining of chest pain.  Reports that his symptoms started on the afternoon of 13 JUL, after receiving the COVID-19 Janssen vaccine and other P4 vaccines in the AM.  The pain was initially mild, located substernal, and constant.  Pain worsened as days progressed.  On 16 JUL, at 0200 the pain woke him up from his sleep and was subsequently brought to the ED.  Associated symptoms include a fever of 101 F on 15JUL that resolved spontaneously, and mild shortness of breath.  In the ED his EKG showed diffuse ST elevations and troponin was 17.5. He was transferred to outside hospital with diagnosis of acute myopericarditis.  Admitted for 3 nights, echocardiogram was normal, troponin was trended and peaked at 36, discharge troponin 16. COVID testing negative.  Was started on colchicine 0.6mg daily and aspirin 325mg TID.
Age: 18.0
Sex: M
Vaccine: COVID19, ADEN_4_7, COVID19, HEPA, MNQ, TDAP, VARCEL
Symptoms: Laboratory test, Pyrexia, Troponin increased
Clinical narrative: 18 y/o man who was seen on 16 JUL complaining of chest pain.  Reports that his symptoms started on the afternoon of 13 JUL, after receiving the COVID-19 Janssen vaccine and other P4 vaccines in the AM.  The pain was initially mild, located substernal, and constant.  Pain worsened as days progressed.  On 16 JUL, at 0200 the pain woke him up from his sleep and was subsequently brought to the ED.  Associated symptoms include a fever of 101 F on 15JUL that resolved spontaneously, and mild shortness of breath.  In the ED his EKG showed diffuse ST elevations and troponin was 17.5. He was transferred to outside hospital with diagnosis of acute myopericarditis.  Admitted for 3 nights, echocardiogram was normal, troponin was trended and peaked at 36, discharge troponin 16. COVID testing negative.  Was started on colchicine 0.6mg daily and aspirin 325mg TID.
Age: 18.0
Sex: M
Vaccine: COVID19, ADEN_4_7, COVID19, HEPA, MNQ, TDAP, VARCEL
Symptoms: Anticoagulant therapy, Chest pain, Dyspnoea, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: 18 y/o man who was seen on 16 JUL complaining of chest pain.  Reports that his symptoms started on the afternoon of 13 JUL, after receiving the COVID-19 Janssen vaccine and other P4 vaccines in the AM.  The pain was initially mild, located substernal, and constant.  Pain worsened as days progressed.  On 16 JUL, at 0200 the pain woke him up from his sleep and was subsequently brought to the ED.  Associated symptoms include a fever of 101 F on 15JUL that resolved spontaneously, and mild shortness of breath.  In the ED his EKG showed diffuse ST elevations and troponin was 17.5. He was transferred to outside hospital with diagnosis of acute myopericarditis.  Admitted for 3 nights, echocardiogram was normal, troponin was trended and peaked at 36, discharge troponin 16. COVID testing negative.  Was started on colchicine 0.6mg daily and aspirin 325mg TID.
Age: 18.0
Sex: M
Vaccine: COVID19, ADEN_4_7, COVID19, HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, SARS-CoV-2 test negative, Sleep disorder, Troponin
Clinical narrative: 18 y/o man who was seen on 16 JUL complaining of chest pain.  Reports that his symptoms started on the afternoon of 13 JUL, after receiving the COVID-19 Janssen vaccine and other P4 vaccines in the AM.  The pain was initially mild, located substernal, and constant.  Pain worsened as days progressed.  On 16 JUL, at 0200 the pain woke him up from his sleep and was subsequently brought to the ED.  Associated symptoms include a fever of 101 F on 15JUL that resolved spontaneously, and mild shortness of breath.  In the ED his EKG showed diffuse ST elevations and troponin was 17.5. He was transferred to outside hospital with diagnosis of acute myopericarditis.  Admitted for 3 nights, echocardiogram was normal, troponin was trended and peaked at 36, discharge troponin 16. COVID testing negative.  Was started on colchicine 0.6mg daily and aspirin 325mg TID.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Arthralgia, Balance disorder, Dizziness, Limb discomfort
Clinical narrative: Diffuse myalgia and arthralgia with proximal girdle muscle weakness of hips.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Diffuse myalgia and arthralgia with proximal girdle muscle weakness of hips.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase normal, C-reactive protein, Metabolic function test
Clinical narrative: Diffuse myalgia and arthralgia with proximal girdle muscle weakness of hips.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Diffuse myalgia and arthralgia with proximal girdle muscle weakness of hips.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Member was given the J&J Covid vaccine.  Should have been scheduled at other facility for the Pfizer.  Staff was having technical difficulty with mobile device that is used when scanning and entering member vaccine information.  Instead of waiting and taking time to figure out what the problem was and then administering vaccine, the vaccine wrong was given.  It was afterwards while member was sitting during the waiting period that the issue was taken to the supervisor to help figure out.  This is when it was discovered that this was an immunization error and not the device.  Supervisor immediately consulted with the pediatrician in office and building manager. Member was asked to wait an additional 15 minutes for observation.