chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: U
Vaccine: COVID19, 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 59-year-old patient received BNT162b2 (BNT162B2), on 01May2022 as dose 1, single (Batch/Lot number: unknown), in left arm and on 29May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Brain injury" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: About 4 days after treatment and testing negative two times 48 hours apart; (Nov2022) Negative, notes: About 4 days after treatment and testing negative two times 48 hours apart; (Nov2022) Positive, notes: I started feeling sick again and tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: About 4 days after treatment and testing negative two times 48 hours apart, patient started feeling sick again and tested positive for COVID. Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion. Vaccine administration date was 19Dec2021, vaccine dose number: 3.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue; Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years 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 26Nov2022, outcome "not recovered" and all described as "Tested positive for COVID on 26Nov2022/ Coughing, muscle aches, fatigue". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Nov2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.". 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.  Clinical information: The two family members over the age of 50 have been prescribed Paxlovid. Event took place after use of product.  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-PV202200112164 same product and event, different patient;US-PFIZER INC-202201333385 same product and event, different patient;
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna, vaccine dose number:3; Vaccine brand other: Moderna, vaccine dose number:4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 12:00 as dose 1, single (Lot number: E128733), in left arm and on 26Apr2021 at 12:00 as dose 2, single (Lot number: Ew0175) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 032fz1a), in left arm and on 16Sep2022 at 12:00 as dose 4 (booster), single (Lot number: As7147B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Mild liver disease" (unspecified if ongoing), notes: Mild liver disease; "Autoimmune" (unspecified if ongoing), notes: Autoimmune. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021 at 14:00, outcome "unknown", described as "Vaccine brand other: Moderna, vaccine dose number:3; Vaccine brand other: Moderna, vaccine dose number:4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid for COVID-19, Treatment start date was 18Nov2022, Treatment stop date was 22Nov2022. The patient had no known allergies.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant) all with onset 11Nov2022, outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I just tested positive for COVID but I have been dealing with COVID for the last 16 days; (11Nov2022) Positive, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today; (22Nov2022) Negative, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today; (26Nov2022) Positive, notes: I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Consumer stated, Well I am vaccinated with Pfizer (Clarified as Pfizer covid-19 vaccine) and I just tested positive for COVID but I have been dealing with COVID for the last 16 days. So, I was on paxlovid, I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today. Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Consumer was provided with the number of Pfizer Medical Information # (number withheld) and was requested to select option 3, timings. Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. Consumer stated, Well I am vaccinated with Pfizer (Clarified as Pfizer covid-19 vaccine) and I just tested positive for COVID but I have been dealing with COVID for the last 16 days. So, I was on paxlovid, I tested positive 16 days ago, 5 days past and I was negative and during that time I started the paxlovid but I just tested positive today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FF8829) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV currently undetectable" (unspecified if ongoing), notes: HIV currently undetectable; "On therapy for TB exposure" (unspecified if ongoing), notes: On therapy for TB exposure; "Known allergies: Plums" (unspecified if ongoing), notes: Known allergies: Plums. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, 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 information in the case, the causal association between the events COVID-19 and DRUG INEFFECTIVE and the suspect drug BNT162B2 cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19-2, PPV
Symptoms: Arthralgia, Neck pain
Clinical narrative: Shoulder and neck pain; Shoulder and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: taking blood pressure medications; "Dialysis" (unspecified if ongoing), notes: Dialysis. Concomitant medication(s) included: LOSARTAN taken for hypertension; METOPROLOL taken for hypertension; HYDRALAZINE taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Shoulder and neck pain". Therapeutic measures were not taken as a result of arthralgia, neck pain.  Additional information: Two or three weeks ago, the patient had also a pneumococcal shot. I have a caller on the other line. She is a consumer. She is reporting that she has shoulder and neck pain after receiving the COVID-19 vaccine, the booster dose and she would like to know if this is one of the side-effects of the booster dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Covid-19 vaccine associated myocarditis; This is a literature report for the following literature source(s): "Cardiac magnetic resonance imaging midterm follow up of Covid-19 vaccine associated myocarditis. 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis".; Sender's Comments: Based on the available information in the case, the causal association between the event MYOCARDITIS and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Covid-19 vaccine associated myocarditis.; This is a literature report for the following literature source(s).  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: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".; Sender's Comments: Based on the available information in the case, the causal association between the event MYOCARDITIS and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: EJ2524) at the age of 62 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "lung cancer" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago; "Lung cancer surgery" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago; "chemo" (unspecified if ongoing), notes: lung cancer surgery with chemo 4 years ago. Concomitant medication(s) included: LEVOTHYROXINE, start date: 12Apr2021.  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. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19-2
Symptoms: Epistaxis, Interchange of vaccine products
Clinical narrative: caller had covid shot yesterday and he got nosebleed; two doses previously and since they don't have a booster dose, the pharmacist recommended he get Pfizer. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 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. Vaccination history included: Janssen covid-19 vaccine (DOSE 2), for COVID-19 immunization; Janssen covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 27Nov2022, outcome "unknown", described as "caller had covid shot yesterday and he got nosebleed"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Nov2022, outcome "unknown", described as "two doses previously and since they don't have a booster dose, the pharmacist recommended he get Pfizer.". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose 1 and Dose 2 Moderna, Dose 3 Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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: BUPROPION; SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL; IBUPROFEN; PREDNISONE; TIZANIDINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and Dose 2 Moderna, Dose 3 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Positive, notes: COVID 19 Treatment; Negative, notes: 5 days of negative tests; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in 2 weeks. Anti-viral details:  product=COVID 19 Treatment, brand=Paxlovid. Treatment start date on 18Nov2022, Treatment stop date on 22Nov2022. Fever returned, sore throat returned, tested positive again after 5 days of negative tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN628), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 at 10:30 as dose 5 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: steriods - red face" (unspecified if ongoing), notes: other medical history: No - healthy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (28Nov2022) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.
Sex: F
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. The patient took concomitant medications. Past drug history included: Cefdinir, reaction(s): "known allergies: Cefdinir", notes: known allergies: Cefdinir. 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GJ3275) at the age of 67 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 included: "Polymyalgia Rhuematica" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lysinopril, reaction(s): "Allergy: Lysinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound after negative for 4 days; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment Paxlovid, Treatment start date on 17Nov2022 and stop date on 21Nov2022.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: Fj6369) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 at 12:30 as dose 5 (booster), single (Lot number: As7143c), 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: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Apr2020; ATORVASTATIN, start date: 01Jun2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022 at 12:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: and after several days of no symptoms and negative antigen tests; Positive, notes: Strong rebound symptoms (sinus congestion, headache, fever) for 5+ days. Strong positive antigen test results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201336672 same patient; different product and event;
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis
Clinical narrative: reactivate hepatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 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: "hepatitis" (unspecified if ongoing), notes: He was diagnosed with hepatitis 30 years ago. The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), outcome "unknown", described as "reactivate hepatitis". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Endocarditis, Sepsis
Clinical narrative: I developed sepsis and endocarditis.; I developed sepsis and endocarditis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 47-year-old patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "synthetic valve in my heart", start date: 1973 (unspecified if ongoing), notes: I've had a synthetic valve in my heart; "plumbing type of heart issue" (unspecified if ongoing), notes: plumbing type of heart issue,; "cold" (unspecified if ongoing), notes: I barely ever got a cold or flu; "flu" (unspecified if ongoing), notes: I barely ever got a cold or flu. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jul2021, for COVID-19 immunization. The following information was reported: SEPSIS (medically significant), ENDOCARDITIS (medically significant) all with onset Oct2021, outcome "unknown" and all described as "I developed sepsis and endocarditis.".  Clinical information: In Oct2021, patient developed sepsis and endocarditis. Patient had a synthetic valve in heart since after patient was born. patient have never had a virus or bacteria enter body that patient didn't fight off on own. patient have traveled and eaten exotic things over life, and at 48, (now 49) other than the plumbing type of heart issue, patient barely ever got a cold or flu. So patient took the 2 Pfizer COVID-19 shots.  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: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Antiphospholipid antibodies, Biopsy kidney, Blood albumin
Clinical narrative: consistent with Primary Membranous Nephropathy Stage II; This is a literature report for the following literature source(s):   A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "consistent with Primary Membranous Nephropathy Stage II". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: negative; Antinuclear antibody: negative; Antiphospholipid antibodies (14-20): 247 IU/ml; Positive, notes: antibody came back positive; Biopsy kidney: showing global 3+ Subendothelial electron dense, notes: deposits (IgG, C3, Kappa, Lambda), 100% foot process effacement, IF staining positive for PLA2R, consistent with Primary Membranous Nephropathy Stage II; Blood albumin: 1.1 g/dl, notes: hypoalbuminemia; Blood cholesterol: 572 mg/dl, notes: elevated; Blood creatinine: 0.85; Blood triglycerides: 220 mg/dl; Blood urea: 9; Creatinine urine: 79.9 mg/dl; DNA antibody: negative; Glomerular filtration rate: greater than 60; Hepatitis viral test: negative; HIV test: negative; Immunology test: positive, notes: PLA2R; Protein urine: 11000 mg/g, notes: 11g/day, 24hr Urinary protein excretion estimation; Protein urine: 869.9 mg/dl, notes: nephrotic-range proteinuria. Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: The patient was having abdominal and lower back swelling, facial edema and foamy urine. Patient received her 3rd dose of COVID-19 vaccine 1-2 weeks symptoms appearance. Patient starts on High-dose steroids and later switched to Tacrolimus 2mg BID, and received Rituximab 2 dose with major improvement in symptoms and proteinuria.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-GLOMERULONEPHRITIS MEMBRANOUS The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood creatinine, Blood triglycerides, Blood urea, Creatinine urine
Clinical narrative: consistent with Primary Membranous Nephropathy Stage II; This is a literature report for the following literature source(s):   A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "consistent with Primary Membranous Nephropathy Stage II". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: negative; Antinuclear antibody: negative; Antiphospholipid antibodies (14-20): 247 IU/ml; Positive, notes: antibody came back positive; Biopsy kidney: showing global 3+ Subendothelial electron dense, notes: deposits (IgG, C3, Kappa, Lambda), 100% foot process effacement, IF staining positive for PLA2R, consistent with Primary Membranous Nephropathy Stage II; Blood albumin: 1.1 g/dl, notes: hypoalbuminemia; Blood cholesterol: 572 mg/dl, notes: elevated; Blood creatinine: 0.85; Blood triglycerides: 220 mg/dl; Blood urea: 9; Creatinine urine: 79.9 mg/dl; DNA antibody: negative; Glomerular filtration rate: greater than 60; Hepatitis viral test: negative; HIV test: negative; Immunology test: positive, notes: PLA2R; Protein urine: 11000 mg/g, notes: 11g/day, 24hr Urinary protein excretion estimation; Protein urine: 869.9 mg/dl, notes: nephrotic-range proteinuria. Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: The patient was having abdominal and lower back swelling, facial edema and foamy urine. Patient received her 3rd dose of COVID-19 vaccine 1-2 weeks symptoms appearance. Patient starts on High-dose steroids and later switched to Tacrolimus 2mg BID, and received Rituximab 2 dose with major improvement in symptoms and proteinuria.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-GLOMERULONEPHRITIS MEMBRANOUS The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: DNA antibody, Glomerular filtration rate, Glomerulonephritis membranous, HIV test, Hepatitis viral test
Clinical narrative: consistent with Primary Membranous Nephropathy Stage II; This is a literature report for the following literature source(s):   A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "consistent with Primary Membranous Nephropathy Stage II". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: negative; Antinuclear antibody: negative; Antiphospholipid antibodies (14-20): 247 IU/ml; Positive, notes: antibody came back positive; Biopsy kidney: showing global 3+ Subendothelial electron dense, notes: deposits (IgG, C3, Kappa, Lambda), 100% foot process effacement, IF staining positive for PLA2R, consistent with Primary Membranous Nephropathy Stage II; Blood albumin: 1.1 g/dl, notes: hypoalbuminemia; Blood cholesterol: 572 mg/dl, notes: elevated; Blood creatinine: 0.85; Blood triglycerides: 220 mg/dl; Blood urea: 9; Creatinine urine: 79.9 mg/dl; DNA antibody: negative; Glomerular filtration rate: greater than 60; Hepatitis viral test: negative; HIV test: negative; Immunology test: positive, notes: PLA2R; Protein urine: 11000 mg/g, notes: 11g/day, 24hr Urinary protein excretion estimation; Protein urine: 869.9 mg/dl, notes: nephrotic-range proteinuria. Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: The patient was having abdominal and lower back swelling, facial edema and foamy urine. Patient received her 3rd dose of COVID-19 vaccine 1-2 weeks symptoms appearance. Patient starts on High-dose steroids and later switched to Tacrolimus 2mg BID, and received Rituximab 2 dose with major improvement in symptoms and proteinuria.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-GLOMERULONEPHRITIS MEMBRANOUS The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Immunology test, Protein urine
Clinical narrative: consistent with Primary Membranous Nephropathy Stage II; This is a literature report for the following literature source(s):   A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "consistent with Primary Membranous Nephropathy Stage II". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: negative; Antinuclear antibody: negative; Antiphospholipid antibodies (14-20): 247 IU/ml; Positive, notes: antibody came back positive; Biopsy kidney: showing global 3+ Subendothelial electron dense, notes: deposits (IgG, C3, Kappa, Lambda), 100% foot process effacement, IF staining positive for PLA2R, consistent with Primary Membranous Nephropathy Stage II; Blood albumin: 1.1 g/dl, notes: hypoalbuminemia; Blood cholesterol: 572 mg/dl, notes: elevated; Blood creatinine: 0.85; Blood triglycerides: 220 mg/dl; Blood urea: 9; Creatinine urine: 79.9 mg/dl; DNA antibody: negative; Glomerular filtration rate: greater than 60; Hepatitis viral test: negative; HIV test: negative; Immunology test: positive, notes: PLA2R; Protein urine: 11000 mg/g, notes: 11g/day, 24hr Urinary protein excretion estimation; Protein urine: 869.9 mg/dl, notes: nephrotic-range proteinuria. Therapeutic measures were taken as a result of glomerulonephritis membranous.  Clinical course: The patient was having abdominal and lower back swelling, facial edema and foamy urine. Patient received her 3rd dose of COVID-19 vaccine 1-2 weeks symptoms appearance. Patient starts on High-dose steroids and later switched to Tacrolimus 2mg BID, and received Rituximab 2 dose with major improvement in symptoms and proteinuria.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-GLOMERULONEPHRITIS MEMBRANOUS The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia, Muscle disorder, Nerve injury
Clinical narrative: left me paralyzed in my left arm; nerve damage; muscles not functioning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  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: MONOPLEGIA (medically significant), outcome "unknown", described as "left me paralyzed in my left arm"; NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "muscles not functioning".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Covid-19 vaccine associated myocarditis.; This is a literature report for the following literature source(s).  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: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".  Clinical course: Subsequently leading to myocardial injury through molecular mimicry. Whether this iatrogenic catalyst of myocardial injury results in a similar duration and cumulative burden of inflammatory injury compared with community-acquired viral myocarditis was previously unknown. recently, a single case series of 5 subjects was published casting preliminary insights from convalescent CMR-based findings following mRNA covid-19 vaccination-induced injury.; Sender's Comments: Based on limited information in the case, a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Loss of personal independence in daily activities, Pelvic pain
Clinical narrative: feeling pain in the Left Pelvic area; The pain limits my daily routine such as put the socks on, move my body side to side, etc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "liver cancer" (unspecified if ongoing), notes: liver cancer. The patient's 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: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Nov2022, outcome "unknown", described as "The pain limits my daily routine such as put the socks on, move my body side to side, etc"; PELVIC PAIN (medically significant) with onset Nov2022, outcome "unknown", described as "feeling pain in the Left Pelvic area". The events "feeling pain in the left pelvic area" and "the pain limits my daily routine such as put the socks on, move my body side to side, etc." required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Negative, notes: all negative.  Clinical course:A week ago, patient was feeling pain in the left pelvic area.The pain keeps on at night and off sometime in the day. The pain limits my daily routine such as put the socks on, move my body side to side, etc. Patient was 81, prostate cancer, liver cancer.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Inflammation
Clinical narrative: Inflammation; Sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) 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: INFLAMMATION (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "Sickness". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: body is attacking itself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  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: AUTOIMMUNE DISORDER (life threatening), outcome "unknown", described as "body is attacking itself". Patient's spouse reported, "My wife like many others are dying from the Pfizer vaccine injections. Her body is attacking itself. I understand that the pure intention was to help the world, but you now need to step up and help the less fortunate in the fight for Covid 19 vaccine side effects."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.