chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: Muscle spasms that started in legs and have moved to the rest of the body. Spasms are severe and have not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Lot number: EW0164) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Walnuts" (unspecified if ongoing), notes: Known allergies: Walnuts; "Known allergies: Cyprus trees" (unspecified if ongoing), notes: Known allergies: Cyprus trees. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin.  The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "not recovered", described as "Muscle spasms that started in legs and have moved to the rest of the body. Spasms are severe and have not gone away". The events "muscle spasms that started in legs and have moved to the rest of the body. spasms are severe and have not gone away" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms.  Additional information: The patient did not receive any other vaccine in four weeks. He received supplements. He did not have covid prior to vaccination and was tested for covid post vaccination. The patient was not hospitalized. The device date was 23Jul2022.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Quality of life decreased
Clinical narrative: Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone; significant degradation of life quality; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 at 13:00 as dose 2, single (Lot number: FG3527) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS(Polycystic ovarian syndrome)" (unspecified if ongoing), notes: PCOS; "Eczema" (unspecified if ongoing), notes: I had only had minor eczema when I was a kid. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Batch/Lot No: FF2589; Location of injection: Arm Left; Vaccine Administration Time: 07:00 PM), administration date: 01Oct2021, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: ECZEMA (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone"; QUALITY OF LIFE DECREASED (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "significant degradation of life quality". The events "development of severe eczema in left arm - near injection site, ears, face, neck, collar bone" and "significant degradation of life quality" required physician office visit. Therapeutic measures were taken as a result of eczema, quality of life decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19, prior to vaccination and the patient has been tested for COVID-19, post the vaccination. Patient developed with severe eczema in left arm - near injection site, ears, face, neck, collar bone with significant degradation of life quality. Prior to the vaccine patient had only had minor eczema when she was a kid. She was 36 at vaccine application. Her dad and aunt had a similar reaction to the vaccine, also like me, 2 weeks after application. Averse Event resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with steroid and anti-histaminic.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone; significant degradation of life quality; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 at 13:00 as dose 2, single (Lot number: FG3527) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS(Polycystic ovarian syndrome)" (unspecified if ongoing), notes: PCOS; "Eczema" (unspecified if ongoing), notes: I had only had minor eczema when I was a kid. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Batch/Lot No: FF2589; Location of injection: Arm Left; Vaccine Administration Time: 07:00 PM), administration date: 01Oct2021, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: ECZEMA (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "Development of Severe eczema in left arm - near injection site, ears, face, neck, collar bone"; QUALITY OF LIFE DECREASED (non-serious) with onset 15Nov2021 at 14:30, outcome "not recovered", described as "significant degradation of life quality". The events "development of severe eczema in left arm - near injection site, ears, face, neck, collar bone" and "significant degradation of life quality" required physician office visit. Therapeutic measures were taken as a result of eczema, quality of life decreased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19, prior to vaccination and the patient has been tested for COVID-19, post the vaccination. Patient developed with severe eczema in left arm - near injection site, ears, face, neck, collar bone with significant degradation of life quality. Prior to the vaccine patient had only had minor eczema when she was a kid. She was 36 at vaccine application. Her dad and aunt had a similar reaction to the vaccine, also like me, 2 weeks after application. Averse Event resulted in doctor or other healthcare professional office/clinic visit. Patient was treated with steroid and anti-histaminic.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Quality of life decreased
Clinical narrative: Covid test date=15Apr2022, covid test result=Positive; Covid test date=15Apr2022, covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 19:00 as dose 1, single (Lot number: FF2589), in left arm and on 30Oct2021 at 13:00 as dose 2, single (Lot number: FG3527) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing), notes: other medical history: PCOS; "minor eczema" (unspecified if ongoing), notes: I had only had minor eczema when I was a kid. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Apr2022, outcome "unknown" and all described as "Covid test date=15Apr2022, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2022) Positive, notes: Nasal Swab.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test date=15Apr2022, covid test result=Positive; Covid test date=15Apr2022, covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 19:00 as dose 1, single (Lot number: FF2589), in left arm and on 30Oct2021 at 13:00 as dose 2, single (Lot number: FG3527) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing), notes: other medical history: PCOS; "minor eczema" (unspecified if ongoing), notes: I had only had minor eczema when I was a kid. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Apr2022, outcome "unknown" and all described as "Covid test date=15Apr2022, covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2022) Positive, notes: Nasal Swab.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "recovering" and all described as "Tested positive for COVID-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: Tested positive for COVID 19; Tested positive for COVID 19; runny nose; scratchy throat; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EP7534), in left arm, on 26Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 59 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "If COVID prior vaccination Yes" (unspecified if ongoing), notes: If COVID prior vaccination:Yes. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Jul2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 22Jul2022, outcome "unknown", described as "runny nose"; THROAT IRRITATION (non-serious) with onset 22Jul2022, outcome "unknown", described as "scratchy throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, rhinorrhoea, throat irritation, headache. Clinical course: Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Prior vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Adverse event COVID symptoms (runny nose, scratchy throat, headache) started on 22Jul2022. Tested positive for COVID 19 on 23Jul2022, using home antigen test. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested positive for COVID 19; Tested positive for COVID 19; runny nose; scratchy throat; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EP7534), in left arm, on 26Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 59 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "If COVID prior vaccination Yes" (unspecified if ongoing), notes: If COVID prior vaccination:Yes. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 22Jul2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 22Jul2022, outcome "unknown", described as "runny nose"; THROAT IRRITATION (non-serious) with onset 22Jul2022, outcome "unknown", described as "scratchy throat"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, rhinorrhoea, throat irritation, headache. Clinical course: Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Prior vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Adverse event COVID symptoms (runny nose, scratchy throat, headache) started on 22Jul2022. Tested positive for COVID 19 on 23Jul2022, using home antigen test. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red circle around injection site, approximately 2 inches in diameter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 3-year-old patient received BNT162b2 (BNT162B2), on 22Jul2022 at 18:00 as dose 2, single (Lot number: FL8094) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE. Vaccination history included: BNT162b2 (DOSE 1,SINGLE; Batch/Lot No: FL8095; Anatomical location: Arm Left; Administration Time: 05:30 PM), administration date: 01Jul2022, when the patient was 3-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 23Jul2022 at 12:00, outcome "not recovered", described as "Red circle around injection site, approximately 2 inches in diameter". Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information:  The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Other medications received in two weeks were claritin, elderberry gummies.The patient was not tested for COVID-19 post vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia, Vaccination site erythema
Clinical narrative: slight swelling; redness at site; fever; tiredness; chills; general feeling unwell; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 04:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; IRBESARTAN; SIMVASTATIN; FAMOTIDINE A. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown"; PYREXIA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "fever"; MALAISE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "general feeling unwell"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "redness at site"; VACCINATION SITE SWELLING (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "slight swelling"; FATIGUE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, pyrexia, fatigue, chills, malaise.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the COVID-19 vaccine. About 10 hours after the second booster shot and for another 24 hours the patient experienced slight swelling and redness at site, fever, tiredness, chills, and general feeling unwell. Acetaminophen was taken as treatment for adverse events.The patient had not tested positive for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: slight swelling; redness at site; fever; tiredness; chills; general feeling unwell; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 at 04:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; IRBESARTAN; SIMVASTATIN; FAMOTIDINE A. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown"; PYREXIA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "fever"; MALAISE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "general feeling unwell"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "redness at site"; VACCINATION SITE SWELLING (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "slight swelling"; FATIGUE (non-serious) with onset 22Jul2022 at 14:00, outcome "unknown", described as "tiredness". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, pyrexia, fatigue, chills, malaise.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the COVID-19 vaccine. About 10 hours after the second booster shot and for another 24 hours the patient experienced slight swelling and redness at site, fever, tiredness, chills, and general feeling unwell. Acetaminophen was taken as treatment for adverse events.The patient had not tested positive for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 02Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3147), at the age of 69 years, in the left arm, for COVID-19 immunization. Relevant medical history included: "Allergic reaction to antibiotics" (unspecified if ongoing), notes: Known allergies: cephalosporins. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6199; Anatomical Location: Left arm; Time of administration; 12:00), administration date: 04Mar2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8732; Anatomical Location: Left arm; Time of administration: 12:00), administration date: 25Mar2021, when the patient was 69 years old, for COVID-19 immunization and Tetanus vaccine ("first case of Urticaria began after a tetanus shot."), for Immunization, reaction: "Urticaria".  The following information was reported: URTICARIA CHRONIC (non-serious) with onset 14May2022, outcome "not recovered", described as "Four months after booster I began to have a recurrence of Chronic Urticaria, which I am still experiencing". Therapeutic measures were not taken as a result of urticaria chronic. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was reported that to the patient's knowledge she never had Covid. She also believed that this recurrence could "possibly" be linked to the vaccine, or the compounds used to administer it hence this could be the case since the first case of Urticaria began after a tetanus shot. She had read about the delayed recurrence of Urticaria months after the vaccine and thinks that it was possibly a hyperactive immune response. Although she had no knowledge of the science of how any of this works, she felt it should be reported.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Wheezing: environmental conditions" (unspecified if ongoing), notes: Wheezing: environmental conditions. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative upon completion of Paxlovid; Positive, notes: Tested positive for Covid after testing negative upon completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was reported to take Biotin, starting on Jun2022. Covid rebound occurred 6 days after treatment. Reported Chills first night, wheezing and stuffed up /dripping nose. No fever, no cough, no sore throat mentioned. Similar to a bad cold. Tested positive for Covid after testing negative upon completion of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "anxiety and depression" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "macular degenerative" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE oral taken for hypertension; LISINOPRIL oral taken for blood pressure abnormal; AMLODIPINE oral taken for blood pressure abnormal; FLUOXETINE oral taken for depression; CARVIDIL oral taken for blood pressure abnormal; METFORMIN oral taken for diabetes mellitus; ROSUVASTATIN taken for blood cholesterol abnormal; NOVOLOG; PRESERVISION AREDS 2 oral taken for macular degeneration. Vaccination history included: shingles shot, administration date: 21Oct2021, when the patient was 63-year-old, for Immunization; flu shot, administration date: 21Oct2021, when the patient was 63-year-old, for Immunization; 2nd shingles, administration date: 26Oct2021, when the patient was 63-year-old, for Immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Result: positive; Unit: Not Provided; (18Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive Monday, 18Jul2022. Clarifies she tested positive for COVID on 20Jul2022. She woke up Monday with a bad sore throat and chest was hurting, pain. Thought she had bronchitis and her sore throat was less and thought it was allergies because she was sneezing. Tuesday was not feeling better by Wednesday and doctor wouldn't let her go in. Hasn't been anywhere since Monday. She did a home COVID test. No AE(s) require a visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations: None. No Family Medical History Relevant to AE(s). She has never had this taste with any medication. She has had a metal taste but not like this was. Clarifies this was years ago and recalls it because she was raising kids. Doesn't recall name of medication, NDC, lot or expiry. Patient took Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears, constant, never ending; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Lot number: Fk9894) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: PERTUSSIN [DEQUALINIUM SALICYLATE;GUAIAZULENE]; SYNTHROID; WELLBUTRIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0176, Location of injection: Arm Right), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), administration date: 28May2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: TINNITUS (disability) with onset 04Mar2022, outcome "not recovered", described as "Tinnitus in both ears, constant, never ending". The event "tinnitus in both ears, constant, never ending" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.   Additional information: Patient was diagnosed with vaccine prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient did not received any other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; had COVID-19 virus; A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "had COVID-19 virus". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: A patient that had COVID-19 virus and took the Paxlovid and finished the course already about 2 days ago and now they were asking if that patient can take the booster (Pfizer COVID-19 booster shot) (event captured as per verbatim) or that patient needs to wait for a period of time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 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: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient did take other medications in two weeks. Patient took Paxlovid, starting on 22Jul2022 and (lot G06416) for treatment of COVID-19. other medication in 2 weeks product include NyQuil, Aspirin, Ibuprofen, multivitamin. Reported Event included Bitter taste in mouth, similar to grapefruit started on 22Jul2022, outcome was not recovered without treatment and device date was 23Jul2022.  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 information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
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 40-year-old male patient 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 was not reported. Concomitant medication(s) included: Z-PAK, start date: 17Jul2022, stop date: 23Jul2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Tested negative for covid after completing Paxlovid; (24Jul2022) positive, notes: then tested positive for covid on 8th day. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Coccidioidomycosis, Fatigue, Immune system disorder, Influenza, Night sweats
Clinical narrative: Lowered immune system; fatigue; severe flu symptoms; night sweats; pneumonia; valley fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 25Aug2021 at 10:00 as dose 1, single (Lot number: fc3183) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "Lowered immune system"; FATIGUE (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; NIGHT SWEATS (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; PNEUMONIA (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; INFLUENZA (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "severe flu symptoms"; COCCIDIOIDOMYCOSIS (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "valley fever". The events "lowered immune system", "fatigue", "severe flu symptoms", "night sweats", "pneumonia" and "valley fever" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative. Therapeutic measures were taken as a result of immune system disorder, fatigue, influenza, night sweats, pneumonia, coccidioidomycosis.  Clinical course: Patient took treatment with Fluconazole, doxycycline. No COVID prior vaccination. Patient had COVID tested post vaccination. The patient did not have other medical history and known allergies. Patient was administrated COVID 19, Pfizer fc3183 Dose 2 on 15Sep2021 10.00 to right arm.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test
Clinical narrative: Lowered immune system; fatigue; severe flu symptoms; night sweats; pneumonia; valley fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 25Aug2021 at 10:00 as dose 1, single (Lot number: fc3183) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "Lowered immune system"; FATIGUE (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; NIGHT SWEATS (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; PNEUMONIA (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering"; INFLUENZA (life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "severe flu symptoms"; COCCIDIOIDOMYCOSIS (medically significant, life threatening) with onset 06Sep2021 at 13:00, outcome "recovering", described as "valley fever". The events "lowered immune system", "fatigue", "severe flu symptoms", "night sweats", "pneumonia" and "valley fever" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative. Therapeutic measures were taken as a result of immune system disorder, fatigue, influenza, night sweats, pneumonia, coccidioidomycosis.  Clinical course: Patient took treatment with Fluconazole, doxycycline. No COVID prior vaccination. Patient had COVID tested post vaccination. The patient did not have other medical history and known allergies. Patient was administrated COVID 19, Pfizer fc3183 Dose 2 on 15Sep2021 10.00 to right arm.  No follow-up attempts are possible. No further information is expected.
Sex: U
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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 17May2022 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, brand: Pfizer, Treatment start date: 15Jul2022, Treatment stop date: 19Jul2022, Indication: Treatment of COVID-19. Reported Event: Rebound symptoms 3 days after completion. Positive test again. Symptoms worse than original.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: 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) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 10Jun2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05May2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto; "rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jun2018, stop date: 23Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=05Jul2022, Treatment stop date=09Jul2022, Lot number=GA8849, Indication=Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes. Reported Event: Covid test became negative after taking paxlovid. Then I received my orencia treatment. Then I began to feel sick the next day and tested positive for Covid. My symptoms were WORSE than the first time I had Covid for which the paxlovid was prescribed. Adverse event start date: 20Jul2022. Adverse event start time: 04:00 PM. If patient recovered: Not recovered. If treatment ae: No. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 30.0
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 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 27Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 28Feb2021 as dose 2, single (Lot number: EN6205), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH5030) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "PCOS" (unspecified if ongoing), notes: other medical history: PCOS; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: NIFEDIPINE.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that patient was taking other medications within 2 weeks of starting COVID-19 treatment.
Age: 61.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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 had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: after 5 days of negative; (Jul2022) Positive, notes: Sick again 5 days later testing positive; (Jul2022) Positive, notes: Still positive day 4. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient previously received a COVID-19 Vaccine. Patient was not taking any other medications within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on 07Jul2022; tested positive on 07Jul2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 14:00 as dose 1, single (Lot number: En6202), in right arm, on 19Mar2021 at 13:00 as dose 2, single (Lot number: Ep7534), in right arm, on 26Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Fd8448), in right arm and on 26Feb2022 at 12:00 as dose 4 (booster), single (Lot number: Fm0698) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "not recovered" and all described as "tested positive on 07Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: tested positive on 07Jul2022 and began taking Paxlovid; (11Jul2022) Negative; (12Jul2022) Negative; (23Jul2022) Positive, notes: tested myself again on 23Jul and had two positive tests; (23Jul2022) Positive tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received other medication within 2 weeks. Patient received anti viral for COVID 19 Treatment: Paxlovid. Treatment start date was 07Jul2022 and stop date:11Jul2022. Patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.