chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Urine odour abnormal
Clinical narrative: Developed a salty taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 73-years-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (controlled). 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 vaccination. Concomitant medications included hydrochlorothiazide; lisinopril (LISINOPRIL-HCTZ), acetylsalicylic acid (BABY ASPIRIN) and multi vitamin (unspecified); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received olmesartan medoxomil (BENICAR) and experienced drug allergy. On an unknown date in Mar2021, shortly after receiving the first dosage of vaccine, the patient developed a salty taste in the mouth. The patient contacted his primary care physician (PCP) and was suggested to increase the water intake, which the patient did but had no effect. The problem only got worse and now the patient tasted almost nothing but salt. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with increased water intake. The clinical outcome of the event developed a salty taste in the mouth was not recovered at the time of this report.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: Developed a salty taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 73-years-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 28Mar2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (controlled). 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 vaccination. Concomitant medications included hydrochlorothiazide; lisinopril (LISINOPRIL-HCTZ), acetylsalicylic acid (BABY ASPIRIN) and multi vitamin (unspecified); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received olmesartan medoxomil (BENICAR) and experienced drug allergy. On an unknown date in Mar2021, shortly after receiving the first dosage of vaccine, the patient developed a salty taste in the mouth. The patient contacted his primary care physician (PCP) and was suggested to increase the water intake, which the patient did but had no effect. The problem only got worse and now the patient tasted almost nothing but salt. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with increased water intake. The clinical outcome of the event developed a salty taste in the mouth was not recovered at the time of this report.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Dyspnoea, Malaise
Clinical narrative: after the vaccine when I felt unwell; This is a spontaneous report from a contactable consumer (patient) reported. A patient of an unspecified age and gender received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that I got your Covid 19 vaccine in Mar2021. I had been exercising an hour a day prior to the vaccine for the past several years. However, after the vaccine when I felt unwell, I stopped exercising. After the second vaccine I tried to start exercising again and had shortness of breath while doing so. I went to the doctor who sent me for a nuclear stress test. The results are that I have a "fixed defect" in my heart! I never had any heart problems with my heart prior to the vaccine. Outcome of the event malaise was reported as unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise
Clinical narrative: after the vaccine when I felt unwell; This is a spontaneous report from a contactable consumer (patient) reported. A patient of an unspecified age and gender received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that I got your Covid 19 vaccine in Mar2021. I had been exercising an hour a day prior to the vaccine for the past several years. However, after the vaccine when I felt unwell, I stopped exercising. After the second vaccine I tried to start exercising again and had shortness of breath while doing so. I went to the doctor who sent me for a nuclear stress test. The results are that I have a "fixed defect" in my heart! I never had any heart problems with my heart prior to the vaccine. Outcome of the event malaise was reported as unknown.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling face, Swollen tongue
Clinical narrative: started noticing her ears and tongue were feeling swollen; started noticing her ears and tongue were feeling swollen; This is a spontaneous report from a contactable physician. A 39-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 24Jun2021 at 11:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included bcp (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication, and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Jun2021 at 02:00, the patient noticed her ears and tongue were feeling swollen. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with DECADRON 10 mg, methyl prednisone 4mg, hydroxyzine hydrochloride 25mg pack 4mg. The clinical outcome of the events ears and tongue were feeling swollen was recovering at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Swollen tongue
Clinical narrative: started noticing her ears and tongue were feeling swollen; started noticing her ears and tongue were feeling swollen; This is a spontaneous report from a contactable physician. A 39-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 24Jun2021 at 11:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included bcp (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication, and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Jun2021 at 02:00, the patient noticed her ears and tongue were feeling swollen. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with DECADRON 10 mg, methyl prednisone 4mg, hydroxyzine hydrochloride 25mg pack 4mg. The clinical outcome of the events ears and tongue were feeling swollen was recovering at the time of this report.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness postural
Clinical narrative: feel DIZZINESS; positional vertigo; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW10182) via an unspecified route of administration in the right arm on 17May2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included astigmatism. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 21Jun2021 at 09:00, about 1 week ago (1 month after the vaccine), the patient experienced dizziness most specifically positional vertigo. The patient also reported that it was still present at that moment and he never had anything like this before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness most specifically positional vertigo was not recovered at the time of this report.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo positional
Clinical narrative: feel DIZZINESS; positional vertigo; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW10182) via an unspecified route of administration in the right arm on 17May2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included astigmatism. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 21Jun2021 at 09:00, about 1 week ago (1 month after the vaccine), the patient experienced dizziness most specifically positional vertigo. The patient also reported that it was still present at that moment and he never had anything like this before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness most specifically positional vertigo was not recovered at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Itchy rashes over body; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 18Feb2021 at 17:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema. The patient had no known allergy. Concomitant medication included dietary supplements from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 at 17:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021, the patient experienced itchy rashes over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with topical steroid prescription. The clinical outcome of the event itchy rashes over body was not recovered at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itchy rashes over body; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 18Feb2021 at 17:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema. The patient had no known allergy. Concomitant medication included dietary supplements from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 28Jan2021 at 17:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021, the patient experienced itchy rashes over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with topical steroid prescription. The clinical outcome of the event itchy rashes over body was not recovered at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Rash, Rash macular, Urticaria
Clinical narrative: recurrent rash/hives; Developed recurrent rash/hives; This is a spontaneous report from a contactable healthcare professional, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 16May2021 at 16:00 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. 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 vaccination. Concomitant medications were not reported. On 17May2021, the patient developed recurrent rash/hives. It had persisted (now almost 2 months). Sought care a couple times, on 12Jun2021, got a short course of dexamethasone and famotidine. At that same time, started Zyrtec daily as a treatment. The rash came and went all over the body. If skin was scratched, it could break out. This had never happened any time before. Therapeutic measures were taken as a result of the event rash/hives which included treatment with short course of steroids and Zyrtec. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event recurrent rash/hives was not recovered at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: recurrent rash/hives; Developed recurrent rash/hives; This is a spontaneous report from a contactable healthcare professional, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 16May2021 at 16:00 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. 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 vaccination. Concomitant medications were not reported. On 17May2021, the patient developed recurrent rash/hives. It had persisted (now almost 2 months). Sought care a couple times, on 12Jun2021, got a short course of dexamethasone and famotidine. At that same time, started Zyrtec daily as a treatment. The rash came and went all over the body. If skin was scratched, it could break out. This had never happened any time before. Therapeutic measures were taken as a result of the event rash/hives which included treatment with short course of steroids and Zyrtec. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event recurrent rash/hives was not recovered at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash, Rash papular
Clinical narrative: RASH ON FACE; BRUISING; SCABBING ON FACE PAIN; BURNING ON FACE RAISED AREAS COVERING FACE,; PAIN ON FACE; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), vitamin b12 nos (VITAMIN B12), vitamin b complex (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and iron dextran (IRON), all taken for unknown indication, from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jun2021 the patient experienced rash on face bruising, scabbing on face pain and burning on face raised areas covering face, not quite bumps, not quite hives. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash on face bruising, scabbing on face pain and burning on face raised areas covering face was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Contusion, Facial pain, Rash, Scab
Clinical narrative: RASH ON FACE; BRUISING; SCABBING ON FACE PAIN; BURNING ON FACE RAISED AREAS COVERING FACE,; PAIN ON FACE; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), vitamin b12 nos (VITAMIN B12), vitamin b complex (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and iron dextran (IRON), all taken for unknown indication, from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jun2021 the patient experienced rash on face bruising, scabbing on face pain and burning on face raised areas covering face, not quite bumps, not quite hives. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash on face bruising, scabbing on face pain and burning on face raised areas covering face was not resolved at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Dyspnoea, Inflammation, Interstitial lung disease, Laboratory test normal
Clinical narrative: High red blood count; Feeling tired; Interstitial lung disease; Trouble breathing/Shortness of breath; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reactions.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL 9269), dose 2 intramuscular, administered in left arm on 04Feb2021 13:15 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization.  Medical history included High cholesterol and high blood pressure. Concomitant medications included montelukast sodium (SINGULAIR); ezetimibe, simvastatin (VYTORIN); amlodipine; meloxicam; and an unspecified vitamin. The patient previously received the first dose of bnt162b2 (lot no.: EL8982), via intramuscular on administered in left arm on 04Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. On 08Feb2021 the patient experienced shortness of breath/ trouble breathing and Interstitial lung disease. On 11Feb2021, the patient experienced feeling tired. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab: negative on 14Jun2021 and negative on 15Mar2021, EKG: Normal on 12Feb2021, Chest X-ray: Normal on 22Feb2021, Echocardiogram: Normal on 26Feb2021, CT Chest scan: Interstitial lung disease on 26Feb2021, Blood tests: High red blood count on 03Mar2021, Pulmonary function test: Diffusing capacity of 58/0, Inflammation of lungs oxygen not getting to lungs although lungs are okay on 15Mar2021. The adverse events shortness of breath/ trouble breathing, Interstitial lung disease and feeling tired resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events shortness of breath/ trouble breathing and feeling tired which included prednisone. Treatment for Interstitial lung disease included Mycophenolate. The outcome of High red blood count was unknown and the remaining events was recovering. The events shortness of breath/ trouble breathing, and Interstitial lung disease were assessed as serious (Persistent/significant disability/incapacity). The reporter consider that the Pfizer product had a casual effect to the adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test normal, SARS-CoV-2 test negative, X-ray normal
Clinical narrative: High red blood count; Feeling tired; Interstitial lung disease; Trouble breathing/Shortness of breath; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reactions.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL 9269), dose 2 intramuscular, administered in left arm on 04Feb2021 13:15 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization.  Medical history included High cholesterol and high blood pressure. Concomitant medications included montelukast sodium (SINGULAIR); ezetimibe, simvastatin (VYTORIN); amlodipine; meloxicam; and an unspecified vitamin. The patient previously received the first dose of bnt162b2 (lot no.: EL8982), via intramuscular on administered in left arm on 04Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. On 08Feb2021 the patient experienced shortness of breath/ trouble breathing and Interstitial lung disease. On 11Feb2021, the patient experienced feeling tired. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab: negative on 14Jun2021 and negative on 15Mar2021, EKG: Normal on 12Feb2021, Chest X-ray: Normal on 22Feb2021, Echocardiogram: Normal on 26Feb2021, CT Chest scan: Interstitial lung disease on 26Feb2021, Blood tests: High red blood count on 03Mar2021, Pulmonary function test: Diffusing capacity of 58/0, Inflammation of lungs oxygen not getting to lungs although lungs are okay on 15Mar2021. The adverse events shortness of breath/ trouble breathing, Interstitial lung disease and feeling tired resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events shortness of breath/ trouble breathing and feeling tired which included prednisone. Treatment for Interstitial lung disease included Mycophenolate. The outcome of High red blood count was unknown and the remaining events was recovering. The events shortness of breath/ trouble breathing, and Interstitial lung disease were assessed as serious (Persistent/significant disability/incapacity). The reporter consider that the Pfizer product had a casual effect to the adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest scan, Dyspnoea, Echocardiogram
Clinical narrative: High red blood count; Feeling tired; Interstitial lung disease; Trouble breathing/Shortness of breath; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reactions.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL 9269), dose 2 intramuscular, administered in left arm on 04Feb2021 13:15 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization.  Medical history included High cholesterol and high blood pressure. Concomitant medications included montelukast sodium (SINGULAIR); ezetimibe, simvastatin (VYTORIN); amlodipine; meloxicam; and an unspecified vitamin. The patient previously received the first dose of bnt162b2 (lot no.: EL8982), via intramuscular on administered in left arm on 04Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. On 08Feb2021 the patient experienced shortness of breath/ trouble breathing and Interstitial lung disease. On 11Feb2021, the patient experienced feeling tired. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab: negative on 14Jun2021 and negative on 15Mar2021, EKG: Normal on 12Feb2021, Chest X-ray: Normal on 22Feb2021, Echocardiogram: Normal on 26Feb2021, CT Chest scan: Interstitial lung disease on 26Feb2021, Blood tests: High red blood count on 03Mar2021, Pulmonary function test: Diffusing capacity of 58/0, Inflammation of lungs oxygen not getting to lungs although lungs are okay on 15Mar2021. The adverse events shortness of breath/ trouble breathing, Interstitial lung disease and feeling tired resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events shortness of breath/ trouble breathing and feeling tired which included prednisone. Treatment for Interstitial lung disease included Mycophenolate. The outcome of High red blood count was unknown and the remaining events was recovering. The events shortness of breath/ trouble breathing, and Interstitial lung disease were assessed as serious (Persistent/significant disability/incapacity). The reporter consider that the Pfizer product had a casual effect to the adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Interstitial lung disease, Pulmonary function test, Red blood cell count increased
Clinical narrative: High red blood count; Feeling tired; Interstitial lung disease; Trouble breathing/Shortness of breath; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reactions.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL 9269), dose 2 intramuscular, administered in left arm on 04Feb2021 13:15 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization.  Medical history included High cholesterol and high blood pressure. Concomitant medications included montelukast sodium (SINGULAIR); ezetimibe, simvastatin (VYTORIN); amlodipine; meloxicam; and an unspecified vitamin. The patient previously received the first dose of bnt162b2 (lot no.: EL8982), via intramuscular on administered in left arm on 04Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. On 08Feb2021 the patient experienced shortness of breath/ trouble breathing and Interstitial lung disease. On 11Feb2021, the patient experienced feeling tired. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab: negative on 14Jun2021 and negative on 15Mar2021, EKG: Normal on 12Feb2021, Chest X-ray: Normal on 22Feb2021, Echocardiogram: Normal on 26Feb2021, CT Chest scan: Interstitial lung disease on 26Feb2021, Blood tests: High red blood count on 03Mar2021, Pulmonary function test: Diffusing capacity of 58/0, Inflammation of lungs oxygen not getting to lungs although lungs are okay on 15Mar2021. The adverse events shortness of breath/ trouble breathing, Interstitial lung disease and feeling tired resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events shortness of breath/ trouble breathing and feeling tired which included prednisone. Treatment for Interstitial lung disease included Mycophenolate. The outcome of High red blood count was unknown and the remaining events was recovering. The events shortness of breath/ trouble breathing, and Interstitial lung disease were assessed as serious (Persistent/significant disability/incapacity). The reporter consider that the Pfizer product had a casual effect to the adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: High red blood count; Feeling tired; Interstitial lung disease; Trouble breathing/Shortness of breath; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reactions.  This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL 9269), dose 2 intramuscular, administered in left arm on 04Feb2021 13:15 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization.  Medical history included High cholesterol and high blood pressure. Concomitant medications included montelukast sodium (SINGULAIR); ezetimibe, simvastatin (VYTORIN); amlodipine; meloxicam; and an unspecified vitamin. The patient previously received the first dose of bnt162b2 (lot no.: EL8982), via intramuscular on administered in left arm on 04Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. On 08Feb2021 the patient experienced shortness of breath/ trouble breathing and Interstitial lung disease. On 11Feb2021, the patient experienced feeling tired. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal swab: negative on 14Jun2021 and negative on 15Mar2021, EKG: Normal on 12Feb2021, Chest X-ray: Normal on 22Feb2021, Echocardiogram: Normal on 26Feb2021, CT Chest scan: Interstitial lung disease on 26Feb2021, Blood tests: High red blood count on 03Mar2021, Pulmonary function test: Diffusing capacity of 58/0, Inflammation of lungs oxygen not getting to lungs although lungs are okay on 15Mar2021. The adverse events shortness of breath/ trouble breathing, Interstitial lung disease and feeling tired resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events shortness of breath/ trouble breathing and feeling tired which included prednisone. Treatment for Interstitial lung disease included Mycophenolate. The outcome of High red blood count was unknown and the remaining events was recovering. The events shortness of breath/ trouble breathing, and Interstitial lung disease were assessed as serious (Persistent/significant disability/incapacity). The reporter consider that the Pfizer product had a casual effect to the adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: low grade fever; rapid heart beat; headache; nausea; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; This is a spontaneous report from a contactable consumer (patient reported for herself). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Fa6780), via an unspecified route of administration, administered in arm left on 02Jul2021 at 14:30 (02:30 PM) (at the age of 55-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included autoimmune thyroiditis, diverticula disease. The patient concomitant medications included estradiol, levothyroxine, tramadol, colecalciferol (D-3), (received within 2 weeks of vaccination) all drugs taken for an unspecified indication, start and stop date were not reported. Patient had known allergies: Aspirin, Codeine. The patient previously took aspirin [acetylsalicylic acid], codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Jul2021, the patient experienced headache, nausea, 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching. On 04Jul2021 at 17:00 (05:00 PM), the patient experienced low grade fever, rapid heartbeat. Adverse event: The1st day was headache and nausea 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching, rapid heartbeat and low-grade fever day 3 still rapid heartbeat, low grade fever, headache and bumps. I contacted my medical provider and was only told to take Benadryl. The patient underwent lab tests and procedures which included heartbeat was rapid on 03Jul2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Mass, Nausea
Clinical narrative: low grade fever; rapid heart beat; headache; nausea; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; This is a spontaneous report from a contactable consumer (patient reported for herself). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Fa6780), via an unspecified route of administration, administered in arm left on 02Jul2021 at 14:30 (02:30 PM) (at the age of 55-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included autoimmune thyroiditis, diverticula disease. The patient concomitant medications included estradiol, levothyroxine, tramadol, colecalciferol (D-3), (received within 2 weeks of vaccination) all drugs taken for an unspecified indication, start and stop date were not reported. Patient had known allergies: Aspirin, Codeine. The patient previously took aspirin [acetylsalicylic acid], codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Jul2021, the patient experienced headache, nausea, 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching. On 04Jul2021 at 17:00 (05:00 PM), the patient experienced low grade fever, rapid heartbeat. Adverse event: The1st day was headache and nausea 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching, rapid heartbeat and low-grade fever day 3 still rapid heartbeat, low grade fever, headache and bumps. I contacted my medical provider and was only told to take Benadryl. The patient underwent lab tests and procedures which included heartbeat was rapid on 03Jul2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Varicella
Clinical narrative: low grade fever; rapid heart beat; headache; nausea; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching; This is a spontaneous report from a contactable consumer (patient reported for herself). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Fa6780), via an unspecified route of administration, administered in arm left on 02Jul2021 at 14:30 (02:30 PM) (at the age of 55-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included autoimmune thyroiditis, diverticula disease. The patient concomitant medications included estradiol, levothyroxine, tramadol, colecalciferol (D-3), (received within 2 weeks of vaccination) all drugs taken for an unspecified indication, start and stop date were not reported. Patient had known allergies: Aspirin, Codeine. The patient previously took aspirin [acetylsalicylic acid], codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Jul2021, the patient experienced headache, nausea, 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching. On 04Jul2021 at 17:00 (05:00 PM), the patient experienced low grade fever, rapid heartbeat. Adverse event: The1st day was headache and nausea 2nd night on my left side I got bumps (like chickenpox) all over my left arm back and leg with little itching, rapid heartbeat and low-grade fever day 3 still rapid heartbeat, low grade fever, headache and bumps. I contacted my medical provider and was only told to take Benadryl. The patient underwent lab tests and procedures which included heartbeat was rapid on 03Jul2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles all around body; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW198) via an unspecified route of administration in the left arm on 06Jul2021 at 10:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. 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 vaccination. On 06Jul2021 at 11:00, the patient experienced pins and needles all around body. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutics measure were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pins and needles all around body was not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Impaired work ability
Clinical narrative: Slight stomach ache; Loss of appetite; Sore muscles; Chills; Feverish; Very tired and still tired and blah 5 days post shot; Swollen lymph nodes under left armpit; Sore throat; Bad flu like symptoms for two days post shot; Could not get a good sleep; Migraine starting about one hour post shot lasting for 2 days and on and off for up to 5 days; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 07Jul2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, high blood pressure (bp), high cholesterol, gastroesophageal reflux disease (GERD) and asthma. The patient had known allergies to eggs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and rosuvastatin calcium (ROSUVASTIN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 17Jun2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021 at 16:00, about one hour post shot, the patient experienced migraine lasting for two days and on and off for up to five days. On 07Jul2021 at 16:30, the patient experienced very tired, sore throat, sore muscles, bad flu like symptoms for two days post shot, loss of appetite, could not get out of bed as so tired but could not get a good sleep, chills and feverish, swollen lymph nodes under left armpit. On 08Jul2021, second day post shot, the patient also had a slight stomach ache. On 12Jul2021, five days post shot, the patient still felt tired and had to take days off of work. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms was recovered with sequelae on 09Jul2021, after the duration of 2 days; while that of the migraine was recovered with sequelae on 12Jul2021, after the duration of 5 days. The clinical outcome of the events sore throat, poor sleep, loss of appetite, sore muscles, chills, feverish, tiredness, swollen lymph nodes, stomach ache was recovered with sequelae on an unknown date in Jul2021.