chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal
Clinical narrative: Feeling like bronchial tubes swelled up; Feeling like bronchial tubes closed; Unable to breathe/difficulty breathing; Could not hold head up; Very fatigued; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up) and BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (first week of Jan2021) in January 2021 and Knee replacement (On physical therapy 3 times a week) on 14-May-2021. Concurrent medical conditions included Shellfish allergy, Grass allergy and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST, SALBUTAMOL (ALBUTEROL HFA) and HYDROCODONE for an unknown indication.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 08-Jun-2021, the patient experienced BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up) (seriousness criterion medically significant), BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) (seriousness criterion medically significant), DYSPNOEA (Unable to breathe/difficulty breathing), POSTURE ABNORMAL (Could not hold head up) and FATIGUE (Very fatigued). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) for Breathing difficult, at a dose of ~10 puffs. On 09-Jun-2021, BRONCHIAL OEDEMA (Feeling like bronchial tubes swelled up), DYSPNOEA (Unable to breathe/difficulty breathing), POSTURE ABNORMAL (Could not hold head up) and FATIGUE (Very fatigued) had resolved, BRONCHIAL OBSTRUCTION (Feeling like bronchial tubes closed) outcome was unknown. On 10-Jun-2021, PAIN IN EXTREMITY (arm was sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 73-year-old male with serious unexpected events of bronchial edema and bronchial obstruction, and nonserious dyspnea, posture abnormal, pain in extremity, and fatigue. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old male with serious unexpected events of bronchial edema and bronchial obstruction, and nonserious dyspnea, posture abnormal, pain in extremity, and fatigue. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I just spent 6 days in the hospital with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I just spent 6 days in the hospital with covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I just spent 6 days in the hospital with covid) (seriousness criterion hospitalization). The patient was hospitalized for 6 days due to COVID-19. At the time of the report, COVID-19 (I just spent 6 days in the hospital with covid) outcome was unknown.            No concomitant medication was reported.  No treatment information was provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Follow up form was sent to clarify if it could be a "lack of efficacy" event.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Palpitations
Clinical narrative: shortness of breath; heart palpitations; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21 and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), PALPITATIONS (heart palpitations) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), PALPITATIONS (heart palpitations) and FATIGUE (fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       On known date, cardiology, pulmonary and blood work were performed with negative results.  Patient was hospitalized for observation over night.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Vision blurred
Clinical narrative: Vision was blurred all week long; Blind; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Blind) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced BLINDNESS (Blind) (seriousness criterion medically significant). On an unknown date, the patient experienced VISION BLURRED (Vision was blurred all week long). At the time of the report, BLINDNESS (Blind) and VISION BLURRED (Vision was blurred all week long) outcome was unknown.            Concomitant medications were not reported . Treatment information was not provided.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Platelet count: 71000 (Inconclusive) Inconclusive. On 06-Apr-2021, Platelet count: 112000 (Inconclusive) Inconclusive. On 12-Apr-2021, Platelet count: 169000 (Inconclusive) Inconclusive.         No concomitant medications were provided. No treatment medications were mentioned.  This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: HOSPITALIZED; BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (HOSPITALIZED) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (HOSPITALIZED) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE). At the time of the report, HOSPITALISATION (HOSPITALIZED) and PRODUCT DOSE OMISSION ISSUE (BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was not given.    No laboratory was not given.   No treatment information was not given.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria
Clinical narrative: Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter. No treatment information was provided.  Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-229259 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Fatigue, Lyme disease, Pain in jaw
Clinical narrative: Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter. No treatment information was provided.  Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-229259 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Reduced facial expression
Clinical narrative: Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter. No treatment information was provided.  Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-229259 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Partial deafness on her right ear; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Rx 1420942-00), via an unspecified route of administration in right arm, on 12May2021 at 03:15 PM (15:15) (at the age 34 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 14May2021, the patient felt partial deafness on her right ear for several weeks. The adverse event resulted in disability or permanent damage. No treatment was administered for the event.  Since the vaccination, the patient has not been tested for COVID-19. At the time of last observation, the patient had not recovered from the event.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Pyrexia, Seizure
Clinical narrative: Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours; extreme pain in the hips to where he could not move; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Jun2021 17:00 (Batch/Lot Number: EW0187) (at age 50 years old) as dose 2, single for COVID-19 immunization. The patient's medical history. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient previously received the first dose BNT162B2 on 19May2021 16:00 (lot number: EW167) (at age 50 years old) in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 11Jun2021 21:30, the patient experienced extreme convulsions (uncontrollable shaking), fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours, extreme pain in the hips to where he could not move, and shortness of breath. The events were reported as non-serious. Treatment was not given. The patient was recovering from the events.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Magnetic resonance imaging, Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis documented by MRI; Concomitant diagnosis of Type A inflo; This is a spontaneous report from a contactable physician. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200; Expiration date was not reported), intramuscular on the right arm on 11Mar2021 (15:45) as a 2nd dose, single, for COVID-19 immunization. Medical history included hereditary haemochromatosis. The patient's concomitant medications were not reported. The patient previously took erythromycin and cefaclor (CECLOR), and had allergies with these medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264; Expiration date was not reported) on 17Feb2021 (13:00) (when the patient was 32 years old) intramuscular on the right arm for COVID-19 immunization. On 08Jun2021, the patient had myocarditis documented by magnetic resonance imaging (MRI), and a concomitant diagnosis of "type A inflo". The events had resulted into a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for six days (in Jun2021) due to the reported events, and had received cardvedilol, sacubitril, valsartan (ENTRESTO) and "life vest. diurectics" as treatment for the reported events. The outcome of the events was not recovered. The patient had no COVID-19 prior to vaccination. The patient's COVID-19 nasal swab on 08Jun2021 was negative.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and the event myocarditis cannot be excluded. Event influenza based on the known drug safety profile is assessed as unrelated to  BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Bradycardia, Chest pain, Dizziness
Clinical narrative: Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure; Fatigue; Major Weakness; Oxygen low 80's; Light Headed, Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: EW0150) (at the age of 47 years) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0169) (at the age of 47 years) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included Excessive Factor 8, Seasonal Allergies, Known Allergies: Penicillin, Gluten sensitivity, Inteferon Gold. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (negative). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest Pain, Lung Pain, Difficulty Breathing, High Blood Pressure, Fatigue, Major Weakness, Oxygen low 80's, Heart Rate low 40's (Brady Cardia), Light Headed, Dizzy, on Apr2021. The patient underwent lab tests and procedures which included blood pressure: high on Apr2021, heart rate: low (40) on Apr2021, oxygen saturation: low (80) on Apr2021, sars-cov-2 test: negative on Apr2021 Nasal Swab, sars-cov-2 test: negative on May2021 Nasal Swab. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included Antibiotics, Oral Steroids, Steroid Inhalers. The outcome of events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Hypertension, Oxygen saturation
Clinical narrative: Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure; Fatigue; Major Weakness; Oxygen low 80's; Light Headed, Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: EW0150) (at the age of 47 years) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0169) (at the age of 47 years) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included Excessive Factor 8, Seasonal Allergies, Known Allergies: Penicillin, Gluten sensitivity, Inteferon Gold. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (negative). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest Pain, Lung Pain, Difficulty Breathing, High Blood Pressure, Fatigue, Major Weakness, Oxygen low 80's, Heart Rate low 40's (Brady Cardia), Light Headed, Dizzy, on Apr2021. The patient underwent lab tests and procedures which included blood pressure: high on Apr2021, heart rate: low (40) on Apr2021, oxygen saturation: low (80) on Apr2021, sars-cov-2 test: negative on Apr2021 Nasal Swab, sars-cov-2 test: negative on May2021 Nasal Swab. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included Antibiotics, Oral Steroids, Steroid Inhalers. The outcome of events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure; Fatigue; Major Weakness; Oxygen low 80's; Light Headed, Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: EW0150) (at the age of 47 years) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0169) (at the age of 47 years) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included Excessive Factor 8, Seasonal Allergies, Known Allergies: Penicillin, Gluten sensitivity, Inteferon Gold. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (negative). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest Pain, Lung Pain, Difficulty Breathing, High Blood Pressure, Fatigue, Major Weakness, Oxygen low 80's, Heart Rate low 40's (Brady Cardia), Light Headed, Dizzy, on Apr2021. The patient underwent lab tests and procedures which included blood pressure: high on Apr2021, heart rate: low (40) on Apr2021, oxygen saturation: low (80) on Apr2021, sars-cov-2 test: negative on Apr2021 Nasal Swab, sars-cov-2 test: negative on May2021 Nasal Swab. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included Antibiotics, Oral Steroids, Steroid Inhalers. The outcome of events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Crohn's disease, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's.  The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering.  Information about batch/lot number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Pyrexia
Clinical narrative: Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's.  The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering.  Information about batch/lot number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Transverse Myelitis; This is a spontaneous report from a contactable physician. A 74-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for inhection), via an unspecified route of administration on 25Mar2021 (at the age of 74 years old) (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021, the patient experienced transverse myelitis. The patient was given IV methylprednisolone sodium succinate (SOLU-MEDROL) as treatment. The patient was hospitalized for transverse myelitis for 3 days. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01May2021. The outcome of the event was recovering at the time of report.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported transverse myelitis and the use of BNT162B2 cannot  be fully excluded. There is limited information in this case precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Cold sweat, Dizziness
Clinical narrative: tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. 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 had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Head injury, Headache, Heart rate increased
Clinical narrative: tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. 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 had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain
Clinical narrative: tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. 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 had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pain
Clinical narrative: I have endometriosis and have had the most extreme bleeding and pain in years. Going through 3 pads every hour and hospital gave me morphine for the pain.; I have endometriosis and have had the most extreme bleeding and pain in years. Going through 3 pads every hour and hospital gave me morphine for the pain.; This is a spontaneous report form a contactable consumer (patient) reported for herself.  A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EW0217), via an unspecified route of administration, administered in Arm Left on 21May2021 12:30 (at age of 37 years old) as single dose for COVID-19 immunization. Medical history included Endometriosis, Complex Migraines with Aura, Eggplant allergy, imitrex allergy. Concomitant medications included quetiapine fumarate (SEROQUEL); butalbital, caffeine, paracetamol (FIORICET); diazepam; diphenhydramine hydrochloride (BENADRYL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, lot number: EW0187) at Arm Left as single dose for COVID-19 immunisation. Patient had endometriosis and have had the most extreme bleeding and pain in years. Going through 3 pads every hour and hospital gave patient morphine for the pain. Events started on 11Jun2021 22:00. The adverse event result in: Emergency room/department or urgent care. Treatment received for the adverse events. The outcome of the events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Blood calcium decreased, Blood electrolytes, Blood electrolytes decreased, Chest X-ray
Clinical narrative: CT showed that she had likely passed a gallstone and had pancreatitis; CT showed that she had likely passed a gallstone and had pancreatitis; seriously ill (serum calcium was 5.2), electrolytes all very low; seriously ill (serum calcium was 5.2), electrolytes all very low; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 16Apr2021 10:00 (at the age of 37 years old) (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took her first dose of BNT162B2 administered to right arm on 26Mar2021 08:00 and experienced mild bout of pancreatitis. suspected gallstone and vomiting on 02Apr2021 07:30. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Patient has no known allergies. The patient did not have COVID-19 prior to the vaccination. No prior medical history to the pancreatitis/gallstone events after the vaccine doses. Patient has not taken any other vaccine in four weeks nor other medications in two weeks. The patient was not pregnant at the time of vaccination. One week exactly after patient received the first dose of the vaccine reported as 02Apr2021 07:30, she had a mild bout of pancreatitis and suspected gallstone. Patient's vomiting lasted 7 hours. At the time, she thought it was a short-lived stomach bug, but when the same thing happened after the second dose of the vaccine, it was more severe and patient ended up in the hospital for a week. Patient never had gallbladder or pancreas issues prior to these two events. 3 weeks after her second dose reported as 09May2021 16:00, patient got severely ill, resisted going to the hospital a few days hoping it was another stomach bug. When she ended up in the ER, she was seriously ill (serum calcium was 5.2), electrolytes all very low, difficulty breathing despite a clear chest X-ray and CT scan of my lungs. Another CT showed that she had likely passed a gallstone and had pancreatitis. She spent about a week in the hospital while treatment was focused on stabilizing patient's electrolytes (Electrolytes by IV). She needed to have her gallbladder removed but was sent home to continue recovering as she couldn't undergo an operation while she was still having difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID, post vaccination. The outcome of the event was recovering at the time of report.   Information on the lot/batch number has been requested.