chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased immune responsiveness, Dermatomyositis, Rash erythematous, Swelling face
Clinical narrative: Dermatomyositis; massive swelling on her face; weakness; weakness of her immune system; red rashes; This spontaneous case was reported by a consumer and describes the occurrence of DERMATOMYOSITIS (Dermatomyositis) in a 55-year-old female 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 information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DERMATOMYOSITIS (Dermatomyositis) (seriousness criterion medically significant), SWELLING FACE (massive swelling on her face), ASTHENIA (weakness), DECREASED IMMUNE RESPONSIVENESS (weakness of her immune system) and RASH ERYTHEMATOUS (red rashes). At the time of the report, DERMATOMYOSITIS (Dermatomyositis), SWELLING FACE (massive swelling on her face), ASTHENIA (weakness), DECREASED IMMUNE RESPONSIVENESS (weakness of her immune system) and RASH ERYTHEMATOUS (red rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of the vaccine on February but he said he might be wrong. Patient had stop working because of her symptoms. Her health care professional told her not to receive the second dose of the COVID19 vaccine. It was reported that she was so weak and was not able to shower, that she was now aware that she would have the disease for the rest of her life. Her health care professional stated that dermatomyositis was triggered by the shot.  Treatment included cancer drug injection, unspecified shots, medication, a vegetarian diet and steroids.  Company comment: 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: F
Vaccine: COVID19, UNK
Symptoms: Embolism venous
Clinical narrative: Venous thromboembolism; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a 49-year-old female patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product ORAL CONTRACEPTIVE NOS for Birth control.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On an unknown date, the patient started ORAL CONTRACEPTIVE NOS (Oral) at an unspecified dose. On 08-Apr-2021, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 08-Apr-2021 to 12-Apr-2021 due to EMBOLISM VENOUS. At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown.  For mRNA-1273 (Intramuscular), the reporter considered EMBOLISM VENOUS (Venous thromboembolism) to be unlikely related. Treatment medications included anticoagulant therapy.  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the reported use of oral contraceptive.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the reported use of oral contraceptive.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: MS exacerbation; This spontaneous case was reported by an other and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high, Headache, Malignant hyperthermia, Optic neuritis, Eye disorder, Memory deficit, Pain, Depression and Sleep difficult. Concurrent medical conditions included Relapsing-remitting multiple sclerosis. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), LORATADINE (LORATAB), METOPROLOL, ZOLPIDEM, MEMANTINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), VENLAFAXINE HCL and MEMANTINE HCL for an unknown indication.    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 MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving.  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 medications were provided.  Patient developed myocarditis 48 hours after receiving his first Moderna COVID vaccine.  The patient is still in the cardiac ICU in stable condition and improving.  Treatment of the event was not reported.  Company comment: Based on the 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. Further information has been requested.; Sender's Comments: Based on the 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Weight, Weight increased
Clinical narrative: seizure; 14 pound weight gain; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, APIXABAN (ELIQUIS), EPOPROSTENOL SODIUM (FLOLAN) and SILDENAFIL CITRATE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT INCREASED (14 pound weight gain). The patient was hospitalized from 23-Mar-2021 to 25-Mar-2021 due to SEIZURE. At the time of the report, SEIZURE (seizure) and WEIGHT INCREASED (14 pound weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Weight: abnormal (abnormal) gained 14 pounds in 1-2 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that it was not sure if the patient was getting her diuretic in the hospital.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalization; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criteria hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment information provided.  No concomitant medications reported.; Sender's Comments: Limited information regarding the hospitalization has been provided at this time and a causal relationship cannot be excluded
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: hospitalized; unable to take his second vaccine within the recommended window; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (hospitalized) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, 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 (unable to take his second vaccine within the recommended window). At the time of the report, HOSPITALISATION (hospitalized) and PRODUCT DOSE OMISSION ISSUE (unable to take his second vaccine within the recommended window) outcome was unknown. Not Provided      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.   This case of a 65-year-old male patient who was hospitalized (reason not provided) and  was unable to take his second vaccine within the recommended window(product dose omission).  There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided.  The event of product dose omission is assessed as not applicable.; Sender's Comments: This case of a 65-year-old male patient who was hospitalized (reason not provided) and  was unable to take his second vaccine within the recommended window(product dose omission).  There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided.  The event of product dose omission is assessed as not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Renal mass
Clinical narrative: Mass on Kidney; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RENAL MASS (Mass on Kidney) in a 77-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included Thyrotoxicosis with goiter (Thyrotoxicosis with diffuse goiter without thyrotoxic crisis). Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics) and Chronic lymphocytic leukemia (Chronic Lymphocytic Leukemia of B cell type not having achieved remission). Concomitant products included IBRUTINIB (IMBRUVICA) from 10-Dec-2016 to 23-May-2018 for Chronic lymphocytic leukemia, PARACETAMOL (TYLENOL), METHIMAZOLE, VITAMIN D NOS, ATORVASTATIN CALCIUM, GABAPENTIN, LIDOCAINE, METOPROLOL TARTRATE, OXYCODONE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL MASS (Mass on Kidney) (seriousness criteria hospitalization). At the time of the report, RENAL MASS (Mass on Kidney) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.; Sender's Comments: Based on current available information and the temporal Association between product use and the start date of the events a causal relationship is unlikely. Very little information is available for review. Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Computerised tomogram, Encephalopathy, SARS-CoV-2 test
Clinical narrative: COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia; Encephalopathy; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) and ENCEPHALOPATHY (Encephalopathy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic migraine, Fibromyalgia, DVT, Pulmonary embolism, Clotting disorder, Bipolar disorder, Immunodeficiency, Chronic obstructive pulmonary disease, Congestive heart failure, Hypertension, Arthritis, Drug allergy (Allergy to cephalosporins, NSAIDS, Quinolones, Darvocet, trazodone, lyrica), Peanut allergy (Allergy to peanut, tree nut) and Latex allergy. Concomitant products included ALBUTEROL [SALBUTAMOL], AMLODIPINE, BUSPIRONE, CILOSTAZOL and CYCLOBENZAPRINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) (seriousness criteria hospitalization and medically significant) and ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 28-Mar-2021 due to COVID-19 PNEUMONIA and ENCEPHALOPATHY. At the time of the report, COVID-19 PNEUMONIA (COVID pneumonia, Covid 19 positive, acute respiratory failure, hypoxia) and ENCEPHALOPATHY (Encephalopathy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: Multifocal pneumonia. In March 2021, Computerised tomogram: CT head showed Punctate hyper density in the right hemipons without direct correlation on previous imaging. In March 2021, SARS-CoV-2 test: positive (Positive) positive.     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 Treatment medications were provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, COVID19 pneumonia  a causal relationship may be unlikely related. Encephalopathy may ensue with the widespread infection stemming from COVID19.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, COVID19 pneumonia  a causal relationship may be unlikely related. Encephalopathy may ensue with the widespread infection stemming from COVID19.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, SARS-CoV-2 antibody test, Tachycardia
Clinical narrative: severe diarrhea; tachycardia; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (severe diarrhea), TACHYCARDIA (tachycardia) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and CHEST PAIN (chest pain) (seriousness criterion hospitalization). The patient was hospitalized on 28-Mar-2021 due to DIARRHOEA. At the time of the report, DIARRHOEA (severe diarrhea) was resolving, TACHYCARDIA (tachycardia) had not resolved and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test: positive (Positive) Had no symptoms from Covid 19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided to the patient. Treatment information was not provided.   Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Onset date for events was provided as 28-Apr-2021, which is after the report was submitted.  As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Onset date for events was provided as 28-Apr-2021, which is after the report was submitted.  As vaccine was administered on 17-apr-2021 it is likely the onset date of events was 18-apr-2021 rather than the 28th, but this will need to be clarified on FU.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain in extremity, Productive cough
Clinical narrative: Pain in the arm w/vaccine; chills; lightheaded; severe cough with lots of phlegm; lowgrade fever; sluggish; very tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 10:00 right arm as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any other medications within 2 weeks of vaccination. Allergies to medications, food, or other products reported as no. Prior to vaccination, the patient diagnosed with COVID-19 reported as unknown. Since the vaccination, patient has not been tested for COVID-19. Patient experienced Pain in the arm w/vaccine, chills and lightheaded on 25Jan2021 12:00. Next few days had a severe cough with lots of phlegm low-grade fever, sluggish, very tired on an unspecified date in 2021. My wife called our Primary and he gave me prescribed cough medicine and antibiotics which I am drinking now. Ironically my wife did not get the vaccine but tested positive for covid on 03Feb. She got very ill on 31Jan. As per the reporter seriousness criteria for the events reported as non-serious. The outcome of the events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Pain in the arm w/vaccine; chills; lightheaded; severe cough with lots of phlegm; lowgrade fever; sluggish; very tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 10:00 right arm as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any other medications within 2 weeks of vaccination. Allergies to medications, food, or other products reported as no. Prior to vaccination, the patient diagnosed with COVID-19 reported as unknown. Since the vaccination, patient has not been tested for COVID-19. Patient experienced Pain in the arm w/vaccine, chills and lightheaded on 25Jan2021 12:00. Next few days had a severe cough with lots of phlegm low-grade fever, sluggish, very tired on an unspecified date in 2021. My wife called our Primary and he gave me prescribed cough medicine and antibiotics which I am drinking now. Ironically my wife did not get the vaccine but tested positive for covid on 03Feb. She got very ill on 31Jan. As per the reporter seriousness criteria for the events reported as non-serious. The outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Fever; Congestion, head congestion, chest congestion; Congestion, head congestion, chest congestion; Cough; Stiff neck, it is in upper shoulder, it is real tight; Forearm ache; Sluggish and tired; Sluggish and tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration in right arm on 27Jan2021 09:00 as single dose for covid-19 immunization. The patient was 72-years-old at the time of vaccination. The vaccination facility type was hospital. No prior Vaccinations within 4 weeks.The patients medical history included diabetes mellitus, blood pressure abnormal, blood cholesterol abnormal, thyroid disorder, cardiac disorder, neuropathy peripheral, anxiety from an unknown date and unknown if ongoing. The patient's concomitant medication(s) included atorvastatin strength 80 mg and at a dose of 80 mg once a day at night time, taken for blood cholesterol,  levothyroxine sodium (SYNTHROID), strength 50 mg and at a dose of 50 mg once a day in the morning, taken for thyroid disorder; bisoprolol, strength 5 mg and at a dose of 5mg half a tablet once a day, taken for blood pressure abnormal and cardiac disorder; hydrochlorothiazide, strength 25 mg and at a dose of 25mg once a day, taken for blood pressure abnormal; gabapentin, strength 300 mg and at a dose of 300mg capsule; up to three times a day as needed, taken for neuropathy peripheral, venlafaxine hydrochloride strength 75 mg at a dose of 75mg one capsule once a day, taken for anxiety; aspirin [acetylsalicylic acid] at a dose of 81mg at night, taken for an unspecified indication. The concomitant medications started from an unknown date and were ongoing. The patient experienced sluggish and tired on 27Jan2021, forearm ache on 27Jan2021, fever on 28Jan2021, , congestion, head congestion, chest congestion on 28Jan2021, cough on 28Jan2021, stiff neck, it is in upper shoulder, it is real tight on 28Jan2021. The outcome of the events sluggish and tired, fever, congestion, head congestion, chest congestion were recovering and unknown for the other events.  He is scheduled for the second vaccine on 18Feb2021. He wants to know if that is still recommended? Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sluggishness, Upper respiratory tract congestion
Clinical narrative: Fever; Congestion, head congestion, chest congestion; Congestion, head congestion, chest congestion; Cough; Stiff neck, it is in upper shoulder, it is real tight; Forearm ache; Sluggish and tired; Sluggish and tired; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration in right arm on 27Jan2021 09:00 as single dose for covid-19 immunization. The patient was 72-years-old at the time of vaccination. The vaccination facility type was hospital. No prior Vaccinations within 4 weeks.The patients medical history included diabetes mellitus, blood pressure abnormal, blood cholesterol abnormal, thyroid disorder, cardiac disorder, neuropathy peripheral, anxiety from an unknown date and unknown if ongoing. The patient's concomitant medication(s) included atorvastatin strength 80 mg and at a dose of 80 mg once a day at night time, taken for blood cholesterol,  levothyroxine sodium (SYNTHROID), strength 50 mg and at a dose of 50 mg once a day in the morning, taken for thyroid disorder; bisoprolol, strength 5 mg and at a dose of 5mg half a tablet once a day, taken for blood pressure abnormal and cardiac disorder; hydrochlorothiazide, strength 25 mg and at a dose of 25mg once a day, taken for blood pressure abnormal; gabapentin, strength 300 mg and at a dose of 300mg capsule; up to three times a day as needed, taken for neuropathy peripheral, venlafaxine hydrochloride strength 75 mg at a dose of 75mg one capsule once a day, taken for anxiety; aspirin [acetylsalicylic acid] at a dose of 81mg at night, taken for an unspecified indication. The concomitant medications started from an unknown date and were ongoing. The patient experienced sluggish and tired on 27Jan2021, forearm ache on 27Jan2021, fever on 28Jan2021, , congestion, head congestion, chest congestion on 28Jan2021, cough on 28Jan2021, stiff neck, it is in upper shoulder, it is real tight on 28Jan2021. The outcome of the events sluggish and tired, fever, congestion, head congestion, chest congestion were recovering and unknown for the other events.  He is scheduled for the second vaccine on 18Feb2021. He wants to know if that is still recommended? Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: felt something popped in her hip/knee area when she stepped upstairs; chills; This is a spontaneous report from a sponsored program. A contactable female consumer (patient) reported that A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose and second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, expiration date: unknown), via an unspecified route of administration on 13Feb2021 12:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient experienced after first dose felt something popped in her hip/knee area when stepped upstairs, and patient was taking meloxicam every day. Patient felt something cool in chest, it was like water whooshing through body. It occurred for about 5-6 minutes and patient went to the emergency room to have it checked and the HCPs said that patient was having chills. The outcome of event felt something popped in her hip/knee was unknown and other outcome of event chill was recovered.  Follow-up (13Feb2021): This is a follow-up spontaneous report from a sponsored program.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Jaw clicking, Pain in jaw
Clinical narrative: Sore jaw - painful "clicking"/Jaw pain; Sore jaw - painful "clicking"/Jaw pain; This is a spontaneous report from a contactable consumer. A 69-years-old female patient (Non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318) intramuscular, administered in left arm on 02Feb2021 17:00 at a single dose for COVID-19 immunization. Medical history included ongoing autoimmune Hashimoto's disease, known allergies to sulfa, osteoporosis and she had 2 oral surgeries. Concomitant medication included levothyroxine sodium (LEVOXYL) and probiotics. On 02Feb2021 18:00 The patient experienced sore jaw - painful "clicking"/jaw pain. No covid prior vaccination and No tested covid post vaccination. The caller said that she started taking Fosamax for osteoporosis. She stated for the first 4 doses it caused her joint pain and on the 4th week she got jaw pain. Patient took it once a week. Patient was advised to stop taking it and she did. The caller said that she has had the clicking in her jaw since taking Fosamax and this has been ongoing. She is not a medication taker. She said that she did take Advil for the jaw pain and then she read the next day that you should not take it before or after the Covid vaccine. The caller said that all of the other information that she read said that it was ok to take it after the vaccine, just not before. Her second dose was scheduled for 23Feb2021. Treatment was given for the events. The outcome of the events was recovered on 07Feb2021.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration, administered in arm left on 24Jan2021 13:30 as single dose for covid-19 immunisation (at the age of 87 years). Medical history included macular degeneration, neuropathy and no known allergies. Concomitant medications included metformin, gabapentin and statins. There was no covid prior vaccination and no covid prior vaccination and no other vaccine in four weeks. On 25Jan2021 14:00, the patient experienced light headed. The outcome of event was recovered on an unspecified date in 2021.  Information of Lot/Batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Headache; fatigue; body aches; cold-like symptoms; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 12Feb2021 15:00 as single dose and was previously administered the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248) via an unspecified route of administration in right arm on 19Jan2021 07:30 for covid-19 immunization. Patient was 34-years-old at the time of vaccination. Vaccination facility type was workplace clinic. Patient medical history was not reported. Concomitant medication included fish oil, alprazolam and vitamins nos (DAILY MULTIVITAMIN). On 14Feb2021 at 09:00, the patient experienced headache, fatigue, body aches and cold-like symptoms. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. No treatment was given for the event. The outcome of the events was recovering.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash, Weight
Clinical narrative: eczema; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; This is a spontaneous report received from a contactable health care professional (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiry date: Unknown) on 28Jan2021 at 11:40 (at the age of 76-years-old) via unknown route at single dose on high on left upper arm for COVID-19 immunization. Relevant medical history included cold sores in nose and mouth. The patient was allergic to morphine and the morphine family drug. She had reaction when she had her hysterectomy (Occurred just one time and was years ago). The patient takes one prescription for her thyroid. The patient also had a medical history of Herpes and shingles. On the same date 28Jan2021, after 4 to 6 hours of vaccination (at 16:00 to 17:00) the patient had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back. The patient did not have rash on arms and legs, only on torso. She had no trouble in breathing and swelling. The patient also had eczema immediately after the COVID-19 Vaccination and she does not know her stress might have triggered it.The patient wants to know whether she should receive the second dose and if the second dose would cause a worse reaction than the first time. The patient prescribing physician told it did not sound like anything serious, just a mild reaction. A week later the patient went to dermatologist. Both her doctor and dermatologist stated it does not sound like it was severe. The patient's dermatologist stated it was a mild reaction rash and itching and told her it was fine to receive the second dose. The patient to get a steroid cream to get rid of the itch and rash. The patient was anxiety and stuff from not living normally. The patient worked in a retirement and nursing home for a very short time, but was never a physician, pharmacist, or nurse. She received treatment with triamcinolone ointment 0.1 percent. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the events had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back' and eczema was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis, Diarrhoea, Fatigue, Headache
Clinical narrative: terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included sore arm as a side effect when she had a pneumonia shot. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation and had a sore arm for 2 days and joint pain for over a week.On an unspecified date after 2 dose of vaccine, patient experienced terrible headaches, fever, nausea, terrible stomach pain, fatigue, diarrhoea, colitis which she had never had before and she was sick. It was reported that at the end of the week patient started feeling better, however she started with diarrhea again and its been for over a week. If she eats anything she had to go right to the bathroom (banana, rice, turkey, eggs (8 pounds to begin), she was trying to hydrate herself. She started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. Patient wanted to know the duration of these symptoms and if vaccine could have been contaminated and if she was going to have this gastric symptom for a long time or the whole time.She would like to know how the vaccine works and how does it leave your system. She says that the minute she got home she had the runs, it went right through her. She says she started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. She says she had done a report before. Caller says that she would like to report that and ask question, since the vaccine was in her, would this always be a problem, it feels like she had colitis which she has never had before. She said she could not get to her doctor for an appointment for a few days, and she would like to know if it could be her IBS. She said with a normal medication she could drink a lot to get it out of her system, but with a vaccine she was not sure of what she could do. She says after the second time she did an online report and then she was starting to feel much better then her stomach exploded again. Caller says she can't eat much, and she was wondering how the vaccine works, since it was still in her and irritating her. The outcome of the event's terrible headaches, fever, nausea, terrible stomach pain, fatigue, colitis and she was sick were reported as unknow and the outcome of diarrhoea was not recovered. Information on batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: terrible headaches; fever; nausea; terrible stomach pain; colitis; fatigue; diarrhea; she was sick; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included sore arm as a side effect when she had a pneumonia shot. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation and had a sore arm for 2 days and joint pain for over a week.On an unspecified date after 2 dose of vaccine, patient experienced terrible headaches, fever, nausea, terrible stomach pain, fatigue, diarrhoea, colitis which she had never had before and she was sick. It was reported that at the end of the week patient started feeling better, however she started with diarrhea again and its been for over a week. If she eats anything she had to go right to the bathroom (banana, rice, turkey, eggs (8 pounds to begin), she was trying to hydrate herself. She started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. Patient wanted to know the duration of these symptoms and if vaccine could have been contaminated and if she was going to have this gastric symptom for a long time or the whole time.She would like to know how the vaccine works and how does it leave your system. She says that the minute she got home she had the runs, it went right through her. She says she started eating lightly trying to heal, and after a week she thought she was better, now her stomach was a wreck. She says she had done a report before. Caller says that she would like to report that and ask question, since the vaccine was in her, would this always be a problem, it feels like she had colitis which she has never had before. She said she could not get to her doctor for an appointment for a few days, and she would like to know if it could be her IBS. She said with a normal medication she could drink a lot to get it out of her system, but with a vaccine she was not sure of what she could do. She says after the second time she did an online report and then she was starting to feel much better then her stomach exploded again. Caller says she can't eat much, and she was wondering how the vaccine works, since it was still in her and irritating her. The outcome of the event's terrible headaches, fever, nausea, terrible stomach pain, fatigue, colitis and she was sick were reported as unknow and the outcome of diarrhoea was not recovered. Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Fatigue, Feeling abnormal, Vaccination site erythema
Clinical narrative: dry mouth; swelling redness at injection site; swelling redness at injection site; tired; chills; wasn't feeling herself; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: EN5318; Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced tired and chills, after 3 days on 13Feb2021, dry mouth, swelling redness at injection site and swelling redness at injection site and wasn't feeling herself. The patient stated that after receiving the vaccine she was fine and went to sleep that day, it was the next day on 11Feb2021 is when she experienced the chills and being tired. She didn't go out, she wasn't feeling herself. The injection site was noticed around the 3rd day, she had a band aid on it, she was instructed to keep the band aid on for a couple days, she noticed the injection site symptoms around the 13Feb2021. She is calling because she wants to know if she can take any kind of medicine like aspirin. She hasn't gotten out of bed, she is tired. She is still experiencing all the symptoms reported. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dry mouth; swelling redness at injection site; swelling redness at injection site; tired; chills; wasn't feeling herself; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: EN5318; Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient experienced tired and chills, after 3 days on 13Feb2021, dry mouth, swelling redness at injection site and swelling redness at injection site and wasn't feeling herself. The patient stated that after receiving the vaccine she was fine and went to sleep that day, it was the next day on 11Feb2021 is when she experienced the chills and being tired. She didn't go out, she wasn't feeling herself. The injection site was noticed around the 3rd day, she had a band aid on it, she was instructed to keep the band aid on for a couple days, she noticed the injection site symptoms around the 13Feb2021. She is calling because she wants to know if she can take any kind of medicine like aspirin. She hasn't gotten out of bed, she is tired. She is still experiencing all the symptoms reported. The outcome of the event was not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: low fever (100F); headache; muscle ache; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 16Feb2021 09:00 as single dose for covid-19 immunization. Patient was 64-years-old at the time of vaccination. Vaccination facility type was workplace clinic. The patient medical history and concomitant medications were not reported. No Known allergies. On 26Jan2021, the patient received other pfizer vaccine within 4 weeks. No other medications in two weeks. No prior covid vaccination. No covid tested post vaccination. On 17Feb2021 at 01:00, patient experienced Low fever (100F), headache, muscle ache. The events assessed as non-serious. No treatment received. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear pruritus, Oral pruritus, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: covid_test_name_post_vaccination= RT-PCR, covid_test_date= 29Jan2021, covid_test_result= Positive; Itching soft palate area; Itching in ears; mild respiratory trouble; This is a spontaneous report received from a contactable health care professional (patient) and from a Pfizer sponsored program. A 44-year-old female patient of received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) left arm on 22Jan2021 at 17:45 (at the age of 40-years-old) via intramuscularly at single dose on the unspecified anatomical location for COVID-19 immunization. Relevant medical history included asthma and psoriasis. The patient had known allergy to penicillin. The patient did not receive any other vaccine in four weeks. The patient was not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLOVENT), ethinylestradiol,/levonorgestrel (SRONYX) and cetirizine. On the same date, two hours (at 19:00) after administration of first dose the patient had Itching soft palate area, itching in ears and mild respiratory trouble. The patient received treatment with diphenhydramine 25mg. On 29Jan2021, nasal swab RT-PCR COVID test was positive for the patient. Outcome of the events Itching soft palate area, itching in ears and mild respiratory trouble was recovered while outcome of the event was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.