chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 12:15 as dose 4 (booster), single (Lot number: 8841) at the age of 72 years, in right 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not receive any other medication in 2weeks. The patient received treatment for COVID 19 with Brand: Paxlovid 150(X2)-100mg Pk(eua). Treatment start date: 23Jul2022, Treatment stop date: 28Jul2022.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 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 was not reported. Concomitant medication(s) included: PROGESTERON, start date: 01Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Jul2022) Negative, notes: I tested negative on Thu 28Jul; (01Aug2022) Positive, notes: tested positive to covid again on Monday 01Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included paxlovid was used in treatment of COVID-19 from 23Jul2022 to 27Jul2022. After finishing the 5 day treatment she tested negative on Thu 28Jul. Symptoms starting to reappear on Sat 30Jul and tested positive to covid again on Monday 01Aug.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 45 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 included: "Psoriatic Arthritis" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metronidazole, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Coordination abnormal, Dysphonia, Fatigue, Feeling abnormal
Clinical narrative: Having balance and coordination issues; Having balance and coordination issues; walking issues; muscular pain; issues projecting voice; fatigue; brainfog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2021 at 12:00 as dose 2, single (Lot number: Ew0198) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "balance and coordination issues" (unspecified if ongoing); "balance and coordination issues" (unspecified if ongoing); "walking gate issues" (unspecified if ongoing); "young onset parkinsons" (unspecified if ongoing); "Known allergy: Sulfa drugs" (unspecified if ongoing); "Known allergy: latex" (unspecified if ongoing); "problems with right hand" (unspecified if ongoing); "Vocal problems" (unspecified if ongoing). Concomitant medication(s) included: VALTRAX; DOXYCYCLINE; MYRBETRIC; METHOCARBAMOL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0217, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Jun2021, when the patient was 51-year-old, for COVID-19 immunization.  The following information was reported: BALANCE DISORDER (disability), COORDINATION ABNORMAL (disability) all with onset 15Jul2021, outcome "not recovered" and all described as "Having balance and coordination issues"; FEELING ABNORMAL (disability) with onset 15Jul2021, outcome "not recovered", described as "brainfog"; FATIGUE (disability) with onset 15Jul2021, outcome "not recovered"; DYSPHONIA (disability) with onset 15Jul2021, outcome "not recovered", described as "issues projecting voice"; MYALGIA (disability) with onset 15Jul2021, outcome "not recovered", described as "muscular pain"; GAIT DISTURBANCE (disability) with onset 15Jul2021, outcome "not recovered", described as "walking issues". The events "having balance and coordination issues", "walking issues", "muscular pain", "issues projecting voice", "fatigue" and "brainfog" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2022) Positive. It was unknown if therapeutic measures were taken as a result of balance disorder, coordination abnormal, gait disturbance, myalgia, dysphonia, fatigue, feeling abnormal.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, SARS-CoV-2 test
Clinical narrative: Having balance and coordination issues; Having balance and coordination issues; walking issues; muscular pain; issues projecting voice; fatigue; brainfog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2021 at 12:00 as dose 2, single (Lot number: Ew0198) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "balance and coordination issues" (unspecified if ongoing); "balance and coordination issues" (unspecified if ongoing); "walking gate issues" (unspecified if ongoing); "young onset parkinsons" (unspecified if ongoing); "Known allergy: Sulfa drugs" (unspecified if ongoing); "Known allergy: latex" (unspecified if ongoing); "problems with right hand" (unspecified if ongoing); "Vocal problems" (unspecified if ongoing). Concomitant medication(s) included: VALTRAX; DOXYCYCLINE; MYRBETRIC; METHOCARBAMOL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0217, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Jun2021, when the patient was 51-year-old, for COVID-19 immunization.  The following information was reported: BALANCE DISORDER (disability), COORDINATION ABNORMAL (disability) all with onset 15Jul2021, outcome "not recovered" and all described as "Having balance and coordination issues"; FEELING ABNORMAL (disability) with onset 15Jul2021, outcome "not recovered", described as "brainfog"; FATIGUE (disability) with onset 15Jul2021, outcome "not recovered"; DYSPHONIA (disability) with onset 15Jul2021, outcome "not recovered", described as "issues projecting voice"; MYALGIA (disability) with onset 15Jul2021, outcome "not recovered", described as "muscular pain"; GAIT DISTURBANCE (disability) with onset 15Jul2021, outcome "not recovered", described as "walking issues". The events "having balance and coordination issues", "walking issues", "muscular pain", "issues projecting voice", "fatigue" and "brainfog" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2022) Positive. It was unknown if therapeutic measures were taken as a result of balance disorder, coordination abnormal, gait disturbance, myalgia, dysphonia, fatigue, feeling abnormal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 11:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 11:00 as dose 2, single (Lot number: EK4176), in left arm and on 25Sep2021 at 14:00 as dose 3 (booster), single (Lot number: PF2587) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 066K2VA), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound positive COVID 5 days after completing Paxlovid. Negative COVID test 02Aug2022, then mild symptoms and positive test 03Aug2022. Took Paxlovid 25Jul2022 to 29Jul2022 after symptoms started on 23Jul2022 and positive COVID test on 25Jul2022.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported   events and the suspect drug cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster) single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and was treated with Paxlovid from 10Jul2022 and 14Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 18Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received Paxlovid from 23Jul2022 to 27Jul2022 for the treatment of COVID-19. Patient had rebound of Covid 5 days after finishing Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral drug PAXLOVID was taken start from 29Jul2022 to stop date 02Aug2022 for the treatment of COVID-19. No other medication in 2 weeks. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 13:00 as dose 1, single (Lot number: EW0150), in left arm and on 23Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: BA7617333), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (31Jul2022) Negative; (01Aug2022) Negative; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was treated with Paxlovid, treatment start date on 26Jul2022 and treatment stop date on 31Jul2022.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: covid test type post vaccination=Nasal Swab,. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Depersonalisation/derealisation disorder, Dizziness, Ear disorder, Fatigue
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: covid test type post vaccination=Nasal Swab,. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Head discomfort, Memory impairment, Nausea, SARS-CoV-2 test
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: covid test type post vaccination=Nasal Swab,. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vision blurred, Visual agnosia
Clinical narrative: Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION; SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive, notes: covid test type post vaccination=Nasal Swab,. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM8910), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 26May2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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.  Clinical course: Patient received treatment of Paxlovid for covid -19 from 22Jul2022 to 26Jul2022. Patient not received Other medication in 2 weeks. COVID rebound after Paxlovid. Patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 1, single (Lot number: 32030BD) at the age of 26 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT HFA, start date: Jul2022, stop date: Jul2022. The following information was reported: COVID-19 (medically significant) with onset 17Dec2021, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 17Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: Positive, notes: Day 3: Positive rapid and PCR tests; SARS-CoV-2 test: Negative, notes: Day 1: Negative rapid result; Positive, notes: Day 8: Last Paxlovid dose in morning. Prominent positive band for rapid test; Positive, notes: Day 10: Slight positive band for positive result on rapid test; Negative, notes: Day 12:Negative rapid test result; Positive, notes: but had a clear/dark band for positive rapid test 9 days after dose; rebound, notes: Confirmed Covid-19 rebound via rapid test on August 3. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient receive Paxlovid as therapeutic measure.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Major depressive disorder", start date: Jun2013 (ongoing); "Graves' disease", start date: Mar2022 (ongoing); "Appendectomy", start date: 1987 (unspecified if ongoing), notes: Appendectomy; "Depression" (unspecified if ongoing); "Gallbladder removal", start date: 1993 (unspecified if ongoing), notes: Gallbladder removal. The patient's family history included: "Type 2 diabetes", start date: Nov2012 (ongoing), notes: Type 2 diabetes, Mother has asthma, diabetes, bipolar disorder (age 76 years old); "Asthma" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disorder (age 76 years old); "bipolar disorder" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disorder (age 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS XR taken for diabetes mellitus (ongoing); PROZAC oral taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). Vaccination history included: BNT162b2 (Dose: 2, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 18Feb2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "felt sick"; BNT162b2 (Dose: 1, Time: unknown, Anatomical site of injection: upper right arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 29Jan2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "felt sick", "very sore arm". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "felt sick".  Additional Information:11Oct2021 3rd dose of vaccine, felt sick 2 days. Complete only if a 3rd dose was administered. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complication). Specific relevant test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts were possible. No further information was expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 24Dec2021, outcome "recovered" (08Jan2022). The patient was hospitalized for chest pain (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of chest pain.  Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 19Jul2022 to 23Jul2022. Admitted for chest pain for first booster. Had rebound covid from Paxlovid.  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 available information, the causal association between the event Chest pain and the suspect drug BNT162b2 cannot be excluded completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Rheumatoid arthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: Jan2019, stop date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no known allergies. Patient received COVID-19 vaccine previously. Paxlovid (anti-viral) treatment started on 21Jul2022 and stopped on 26Jul2022 via oral route of administration. On 31Jul2022, 5 days after completing Paxlovid began more severe coughing, malaise, no fever. Patient did not receive treatment for AE.  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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 13May2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: Tested positive; (31Jul2022) Negative; (03Aug2022) Positive, notes: Positive again. 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.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 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. There were no concomitant medications. The patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. patient had previously received a COVID-19 Vaccine.  There was no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: continued to test positive for COVID-19 on 9th day after starting Paxlovid; (03Aug2022) Positive, notes: Also tested positive on 11th day after starting. Therapeutic measures were taken as a result of covid-19. COVID-19 Treatment of Paxlovid started from 23Jul2022 to 28Jul2022   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Impaired work ability, Lung disorder, Renal disorder
Clinical narrative: had to stop working; vaccine affected her kidneys, her lungs and the lining of her heart; vaccine affected her kidneys, her lungs and the lining of her heart; vaccine affected her kidneys, her lungs and the lining of her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 30's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "had to stop working"; RENAL DISORDER (non-serious), LUNG DISORDER (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "vaccine affected her kidneys, her lungs and the lining of her heart".  Additional information: Caller stated he had a friend in her 30s and had to stop working with the police because the vaccine affected her kidneys, her lungs and the lining of her heart. Caller stated she was fine before the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: brother and sister took the Pfizer Vaccine shot and are both dead now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). This case refers to reporters sister.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "brother and sister took the Pfizer Vaccine shot and are both dead now". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036809 Same drug, same event, different patient;; Reported Cause(s) of Death: brother and sister took the Pfizer Vaccine shot and are both dead now
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-PV202200036809 Same drug, same event, different patient; Reported Cause(s) of Death: dead.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram head, Computerised tomogram neck, Drug ineffective, Electrocardiogram
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 83 years 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 included: "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: Amlodipine; Aspirin [Acetylsalicylic Acid]; Hydrochlorothiazide; Levothyroxine; Klor-Con M20; Glucosamine + Chondroitin Sulphate; Calcium. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (unspecified date) Closed fracture of nasal bone and, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose; Computerised tomogram neck: (unspecified date) Closed fracture of nasal bone, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; Electrocardiogram: (unspecified date) Unknown results, notes: EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; SARS-CoV-2 test: (25Jul2022) Positive, notes: COVID positive 25Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks includes Amlodipine, aspirin, hydrochlorothiazide, Levothyroxine, Klor con M20, Glucosamine/Chondroitin and Calcium. COVID positive 25Jul. started Paxlovid that evening. Developed diarrhea on 27Jul. stood from toilet, took several steps, syncopal episode and hit head. to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures. Patient received treatment for AE and AE stop on 29Jul2022.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 83 years 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 included: "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: Amlodipine; Aspirin [Acetylsalicylic Acid]; Hydrochlorothiazide; Levothyroxine; Klor-Con M20; Glucosamine + Chondroitin Sulphate; Calcium. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (unspecified date) Closed fracture of nasal bone and, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose; Computerised tomogram neck: (unspecified date) Closed fracture of nasal bone, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; Electrocardiogram: (unspecified date) Unknown results, notes: EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; SARS-CoV-2 test: (25Jul2022) Positive, notes: COVID positive 25Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks includes Amlodipine, aspirin, hydrochlorothiazide, Levothyroxine, Klor con M20, Glucosamine/Chondroitin and Calcium. COVID positive 25Jul. started Paxlovid that evening. Developed diarrhea on 27Jul. stood from toilet, took several steps, syncopal episode and hit head. to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures. Patient received treatment for AE and AE stop on 29Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "High BMI" (unspecified if ongoing), notes: Other medical history: High BMI; "High Triglycerides" (unspecified if ongoing), notes: Other medical history: High Triglycerides. Concomitant medication(s) included: DILTIAZEM HCL; FENOFIBRATE; LOSARTAN POTASSIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: Tested positive again on 26Jul2022 via two different home antigen tests; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course: the patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 25-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 25 years, in right arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had any known allergies were reported as none. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 03Aug2022, Lot number: GD9454, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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 included: "COPD" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for covid-19 treatment from 26Jul2022 to 30Jul2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid in Jul2022.  Clinical course: The patient had no known allergies. patient received any other medications with in 2weeks was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.