chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022; Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: eI9263), in left arm, on 11Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known Allergies: Bactrim", notes: Known Allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative; (12May2022) Negative; (03May2022) Positive; (18May2022) Positive; (14May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was reported that no other medication were received in 2 weeks.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 13:45 as dose 1, single (Lot number: EL9266), on 08Mar2021 at 11:00 as dose 2, single (Lot number: EN6205) and on 23Oct2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten; "Celiac' s disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (May2002) Positive; (10May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Congestion and runny nose, frequent sneezing, tested positive for COVID-19 again 15 days after positive test and beginning Paxlovid regiment. Had a negative test 7 days after first positive test, which was 2 days after finishing Paxlovid regiment. Felt fine in between until about 8 days after finishing Paxlovid and have now felt sick and tested positive. Antiviral details was product COVID 19 Treatment brand Paxlovid treatment start date on 03May2022 and stop date on 08May2022.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 16:00 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Auto immune disease" (unspecified if ongoing), notes: other medical history: Auto immune disease; "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: VYVANSE, start date: 01Oct2008; TRAZODONE HCL, start date: 01Oct2001; PAXIL CR, start date: 01Oct2001. Vaccination history included: j&j (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 14:00), administration date: 11Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. the patient had known allergies.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the event Drug ineffective, COVID-19 and the administration of the vaccine cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: headache; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17May2022 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18May2022 at 02:00, outcome "unknown"; NAUSEA (non-serious) with onset 18May2022 at 02:00, outcome "unknown"; VOMITING (non-serious) with onset 18May2022 at 02:00, outcome "unknown". The events "headache", "nausea" and "vomiting" required emergency room visit. It was unknown if therapeutic measures were taken as a result of headache, nausea, vomiting.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pfizer dose =1, Pfizer Vaccine dose =2, Moderna Vaccine dose number=3" (unspecified if ongoing), notes: Pfizer dose =1, Pfizer Vaccine dose =2, Moderna Vaccine dose number=3. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Hepatic cancer, Hepatic cirrhosis, Hepatitis viral test, Liver function test
Clinical narrative: cirrhosis of liver; leaking blood; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 54-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: 54 year old kidney transplant patient; "diarrhea" (unspecified if ongoing), notes: (diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "cirrhosis of liver"; HAEMORRHAGE (medically significant), outcome "not recovered", described as "leaking blood". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present, notes: No marker present or tumor found for liver CA; Hepatitis viral test: No hepatitis; Liver function test: No infection, notes: No infection in liver fluid; Stool analysis: No detected blood in diarrhea; Varicose vein: No bleeding, notes: No bleeding of varicose veins in esophagus as suspected. Therapeutic measures were taken as a result of haemorrhage. Clinical course included: Reporter (sister) and Mom met with 54 year old kidney transplant patient's (Patient) (brother's) medical care team at Medical Center. Patient still leaking blood and can't find source. Patient has received 2 units of blood, 30Apr and 10May and will receive more today. Confirmed cirrhosis of liver with no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver Cancer. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Varicose vein
Clinical narrative: cirrhosis of liver; leaking blood; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 54-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant" (unspecified if ongoing), notes: 54 year old kidney transplant patient; "diarrhea" (unspecified if ongoing), notes: (diarrhea may have been for last 7 years). The patient's concomitant medications were not reported. The following information was reported: HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "cirrhosis of liver"; HAEMORRHAGE (medically significant), outcome "not recovered", described as "leaking blood". The patient underwent the following laboratory tests and procedures: Hepatic cancer: No marker present, notes: No marker present or tumor found for liver CA; Hepatitis viral test: No hepatitis; Liver function test: No infection, notes: No infection in liver fluid; Stool analysis: No detected blood in diarrhea; Varicose vein: No bleeding, notes: No bleeding of varicose veins in esophagus as suspected. Therapeutic measures were taken as a result of haemorrhage. Clinical course included: Reporter (sister) and Mom met with 54 year old kidney transplant patient's (Patient) (brother's) medical care team at Medical Center. Patient still leaking blood and can't find source. Patient has received 2 units of blood, 30Apr and 10May and will receive more today. Confirmed cirrhosis of liver with no cause of onset determined. No infection in liver fluid. No bleeding of varicose veins in esophagus as suspected. No marker present or tumor found for liver Cancer. No hepatitis. No detected blood in diarrhea (diarrhea may have been for last 7 years). Using diuretic to get rid of fluid w/o damaging donated kidney. May have to withdraw fluid via needle again.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Aphasia, Chest discomfort, Depression, Dyskinesia
Clinical narrative: shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Fibromyalgia, Headache, Nausea
Clinical narrative: shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Pyrexia, SARS-CoV-2 test
Clinical narrative: shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depressed mood, Dyspnoea, Fatigue, Fibromyalgia, Headache
Clinical narrative: shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Stress
Clinical narrative: shortness of breathe; Fever; Could barely talk; chest pressure; arm pain; woke up with jaw pain hurt to open mouth; severe anxiety; depression; headaches; severe fatigue; nausea; fibromyalgia; hurt to open mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Lung function test showed some scaring from covid pneumonia" (unspecified if ongoing), notes: Lung function test showed some scaring from covid pneumonia; "covid pneumonia" (unspecified if ongoing), notes: covid pneumonia; "myocarditis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: APHASIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Could barely talk"; PYREXIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm pain"; CHEST DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "chest pressure"; DEPRESSION (non-serious) with onset 12Oct2021, outcome "not recovered"; FIBROMYALGIA (non-serious) with onset 12Oct2021, outcome "not recovered"; HEADACHE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "headaches"; DYSKINESIA (non-serious) with onset 12Oct2021, outcome "not recovered", described as "hurt to open mouth"; NAUSEA (non-serious) with onset 12Oct2021, outcome "not recovered"; ANXIETY (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe anxiety"; FATIGUE (non-serious) with onset 12Oct2021, outcome "not recovered", described as "severe fatigue"; DYSPNOEA (medically significant) with onset 12Oct2021, outcome "not recovered", described as "shortness of breathe"; PAIN IN JAW (non-serious) with onset 12Oct2021, outcome "not recovered", described as "woke up with jaw pain hurt to open mouth". The events "shortness of breathe", "fever", "could barely talk", "chest pressure", "arm pain", "woke up with jaw pain hurt to open mouth", "severe anxiety", "depression", "headaches", "severe fatigue", "nausea", "fibromyalgia" and "hurt to open mouth" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Negative, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of dyspnoea, pyrexia, aphasia, chest discomfort, pain in extremity, pain in jaw, anxiety, depression, headache, fatigue, nausea, fibromyalgia, dyskinesia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am still testing positive; I am still testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose number unknown, single (Batch/Lot number: unknown) and on 08Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "I am still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: First positive test; (May2022) Positive, notes: 12 days after the first positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported that after taking the Paxlovid 6 days later I am still testing positive (12 days after the first positive test) I also have a runny nose. It does not seem like the Paxlovid maintained my improvement.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Mixed Connective Tissue Disease (auto-immune)" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received Paxlovid as COVID-19 treatment from 08May2022 to 12May2022. She completed Paxlovid treatment on 12May2022 and had a full relapse of symptoms and positive Rapid Test on 16May2022. The patient at the time of reporting was 3 days into fully symptoms, getting worse each day. The patient did not recover.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Albuterol [Salbutamol]; Symbicort; Azelastine; Vitamin D [Colecalciferol]; Restasis; Voltaren [Diclofenac Diethylamine]; Flaxseed Oil [Linum Usitatissimum Oil]; Flonase [Fluticasone Propionate]; Synthroid; Metamucil [Plantago Ovata]; Miralax; Omeprazole; Probiotic [Bifidobacterium Lactis]; Crestor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course included Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Reoccurrence of COVID symptoms; went from home test negative to home test positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Solitary Fibrous Tumor (Benign)" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Antiviral treatment for COVID 19 were started from 01May2022 to 05May2022. Adverse event: Likely recrudescence two days after stoping Paxlovid. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Reported Event: Likely recrudescence two days after stopped Paxlovid. Device Date on 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: EW0151) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis B" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive for COVID; (May2022) Negative, notes: Tested negative for three days and then symptoms returned; (16May2022) Positive, notes: Fourth days after completing paxlovid, I tested positive again for COVID. Therapeutic measures were taken as a result of covid-19. Report stated that event as non serious. patient did not have any known allergies.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Initial bowel syndrom" (unspecified if ongoing), notes: other medical history: Initial bowel syndrom. Patient had no known allergies. There were no concomitant medications, reported as the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. Clinical course was reported as, on 16May2022, a few days after completing a course of Paxlovid, various Covid symptoms returned; runny nose, scratchy throat, intense fatigue and they continue as of today, 18May2022.     .; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Paraesthesia
Clinical narrative: Bells palsy on right side of face for four hours and went away; Tingling sensation that went down the right side of her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Lot number: EW0158) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 1: , Manufacturer: Pfizer, Date: 27Mar2021 , LOT: ER2613, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm), administration date: 27Mar2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant), outcome "recovered", described as "Bells palsy on right side of face for four hours and went away"; PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling sensation that went down the right side of her arm". Additional information: Bells palsy on right side of face for four hours and went away. Tingling sensation that went down the right side of her arm. Positive COVID-19 virus on 16May2022 after receiving three Pfizer COVID-19 Vaccines.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bells palsy on right side of face for four hours and went away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 27Mar2021 , LOT: ER2613, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm, Had no effects from this dose.), administration date: 27Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 17Apr2021 , LOT: EW0158, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm), administration date: 17Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "Tingling sensation that went down the right side of her arm", "Bells palsy on right side of face for four hours and went away". The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bells palsy on right side of face for four hours and went away.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2021) Positive, notes: Positive for COVID-19 virus on 16May2022. Clinical course: Please specify Antipyretic Use (around the date(s) of Vaccination): None. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Bells palsy on right side of face for four hours and went away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (COVID-19 Vaccine: Dose 1, Manufacturer: Pfizer, Date: 27Mar2021 , LOT: ER2613, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm, Had no effects from this dose.), administration date: 27Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (COVID-19 Vaccine: Dose 2, Manufacturer: Pfizer, Date: 17Apr2021 , LOT: EW0158, NDC/EXP: Unknown, Dose: Unknown, Route: Intramuscular injection to left arm), administration date: 17Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "Tingling sensation that went down the right side of her arm", "Bells palsy on right side of face for four hours and went away". The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "Bells palsy on right side of face for four hours and went away.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2021) Positive, notes: Positive for COVID-19 virus on 16May2022. Clinical course: Please specify Antipyretic Use (around the date(s) of Vaccination): None. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cysts on kidneys" (unspecified if ongoing); "elevated liver enzymes" (unspecified if ongoing); "stroke 7 years ago" (unspecified if ongoing). Concomitant medication(s) included: STATIN [ATORVASTATIN CALCIUM], stop date: 17May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN8955), in right arm, on 14Apr2021 as dose 2, single (Lot number: EW0162), in right leg, on 13Sep2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 18Feb2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Enthethitis" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 15Dec2020; RABEPRAZOLE, start date: 01Feb2021; FAMOTIDINE, start date: 01Feb2021. Past drug history included: Known allergies: uncooked honey, reaction(s): "local dysphasia", notes: Known allergies: Uncooked honey- local dysphasia; Known allergies: trental, reaction(s): "pruritus", notes: Known allergies: trental- Pruritis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. Concomitant medication(s) included: TYLENOL, start date: 03May2022, stop date: 10May2022, other medication in 2weeks product. Past drug history included: Omnicef, reaction(s): "Known allergies: Omnicef". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected Covid-19 included Paxlovid, treatment start date=07May2022, treatment stop date=12May2022. Clinical course: -Taste of bile present beginning 12 hours after first dose and lasting until course completed. Increased alertness. COVID 19 symptoms, including sore throat, cough, congestion, difficulty breathing and headache reappeared 5 days after the final dose of Paxlovid. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.