chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL3249), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2020, stop date: 05May2022; CITALOPRAM HBR, start date: 01Jan2020, stop date: 12May2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 02May2022, outcome "unknown", COVID-19 (medically significant) with onset 02May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) positive, notes: Tested positive for Covid on 02May2022; (08May2022) negative, notes: Tested negative for Covid with at-home test 08May2022; (11May2022) positive, notes: Tested positive for Covid at home on morning of 11May2022; (12May2022) positive, notes: Tested positive for Covid at (withheld) morning of 12May2022 (day I'm submitting this report). Therapeutic measures were taken as a result of covid-19. Clinical course: Adverse event: Purpose of this submission was to report rebound Covid after completing Paxlovid regimen. Patient not experiencing any symptoms at this time (other than positive Covid tests as detailed below). Tested positive for Covid on 02May2022. Began Paxlovid regimen on 5May2022. Tested negative for Covid with at-home test 08May2022. Completed Paxlovid regimen on evening of 09May2022. Tested positive for Covid at home on morning of 11May2022. Known allergies was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Apr2021 as dose 2, single (Lot number: ew0150) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Sep2021 as dose 3 (booster), single (Lot number: 047c21a), in left arm and on 24Feb2022 as dose 4 (booster), single (Lot number: 027l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prothrombin G2" (unspecified if ongoing), notes: Other medical history: Prothrombin G2; "Asthma" (unspecified if ongoing); "Hidradenitis suppurativa" (unspecified if ongoing), notes: Hidranitis Suppertiva- being treated with Remicade,; "migraines" (unspecified if ongoing), notes: Other medical history: migraines; "environmental allergies" (unspecified if ongoing), notes: Other medical history: environmental allergies; "POTS" (unspecified if ongoing), notes: Other medical history: POTS; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Positive, notes: COVID 19 Treatment; (12May2022) Positive, notes: Today is my first day being positive "again". 12May2022. Therapeutic measures were taken as a result of covid-19 from 03May2022 to 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy
Clinical narrative: Personage Turner Syndrome e salt my in a paralysis of right hand/Brachial Plexitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 12:15 as dose 3 (booster), single (Lot number: FF2590) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 23Feb2021, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 02Feb2021, when the patient was 75-year-old, for Covid-19 immunization.  The following information was reported: NEURALGIC AMYOTROPHY (disability) with onset 26Nov2021, outcome "not recovered", described as "Personage Turner Syndrome e salt my in a paralysis of right hand/Brachial Plexitis". The event "personage turner syndrome e salt my in a paralysis of right hand/brachial plexitis" required emergency room visit. Therapeutic measures were taken as a result of neuralgic amyotrophy. Patient did not receive any other vaccines in 4 weeks. Chiropractor provided some pain relief. No covid prior vaccination and Not tested covid post vaccination. No Known allergies.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 30Jun2022) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; METFORMIN. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2022, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 2022, outcome "not recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: She states she was allergic to Penicillin and takes cholesterol medicine. She stated that she was currently at the hospital and her doctor was planning on giving her Paxlovid but it was not FDA approved. She don't want to take things that are not approved and be used as a guinea pig. She states "she was calling because the doctor was not giving her the information she need that would make herepor feel a lot better utilizing Paxlovid." she was asking "have people died from, been hospitalized, or gotten sick from taking Paxlovid". She was asking "can she take Paxlovid with these medications and allergy to Penicillin". Response: Established and Other Potentially Significant Drug Interactions. VR-Consumer Inquiry Management (Off-Label or No Info) (v17.0)" under "Safety: Adverse Reactions or Side Effects" and "Drug or Food Interaction /Concomitant Administration." Referred patient to follow up with her doctor for clarification." She stated "stop cutting her off and just listen. As a response acknowledged complaint and offered assistance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, 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 included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 12Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "COVID 19"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 at 12:00 as dose 1, single (Lot number: 1111-20-EK5730), in left arm and on 12Jan2021 at 12:00 as dose 2, single (Lot number: 1111-20-EL1283) at the age of 34 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 034F), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna, Vaccine dose number: 3. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: Tested positive for COVID again. Therapeutic measures were taken as a result of vaccination failure, Covid-19 included Paxlovid.
Age: 36.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Positive, notes: Tested positive again for COVID. 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: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Menstrual disorder, SARS-CoV-2 test positive
Clinical narrative: eczema around my eyes; a period that lasted two weeks and then no evident menstrual cycles 2 months after; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 17Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications(in two weeks). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2593), for COVID-19 Immunization.  Patient has not received other vaccine in four weeks. The following information was reported: MENSTRUAL DISORDER (medically significant) with onset 27Nov2021, outcome "recovering", described as "a period that lasted two weeks and then no evident menstrual cycles 2 months after"; ECZEMA (medically significant) with onset 27Nov2021, outcome "recovering", described as "eczema around my eyes". The events "eczema around my eyes" and "a period that lasted two weeks and then no evident menstrual cycles 2 months after" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (25Dec2021) Positive. Therapeutic measures were taken as a result of eczema, menstrual disorder. AE treatment: corticosteroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events eczema, menstrual disorder and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: eczema around my eyes; a period that lasted two weeks and then no evident menstrual cycles 2 months after; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 17Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications(in two weeks). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2593), for COVID-19 Immunization.  Patient has not received other vaccine in four weeks. The following information was reported: MENSTRUAL DISORDER (medically significant) with onset 27Nov2021, outcome "recovering", described as "a period that lasted two weeks and then no evident menstrual cycles 2 months after"; ECZEMA (medically significant) with onset 27Nov2021, outcome "recovering", described as "eczema around my eyes". The events "eczema around my eyes" and "a period that lasted two weeks and then no evident menstrual cycles 2 months after" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (25Dec2021) Positive. Therapeutic measures were taken as a result of eczema, menstrual disorder. AE treatment: corticosteroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events eczema, menstrual disorder and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FP4774) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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: (07May2022) Negative, notes: tested negative Day 6; (12May2022) Positive, notes: Day 11 stuffy nose, tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: Antiviral details product COVID 19 Treatment Paxlovid, treatment start date on 02May2022 and treatment stop date on 07May2022, 5 Day course of Paxlovid, tested negative Day 6, felt great, symptoms gone. Day 11 stuffy nose, tested positive.  No follow-up attempts are possible. No further information was expected.  Follow-Up (17May2022): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 14:00 as dose 2, single (Lot number: EP7534), in left arm and on 30Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 74 years, 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 had no relevant medical history. Concomitant medication(s) included: TAMIFLU, start date: 25Apr2022, stop date: 29Apr2022. Past drug history included: Cyclobenzadrine, reaction(s): "Allergy_Cyclobenzadrine". 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. Therapeutic measures were taken as a result of covid-19.  Follow-up (18May2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid; I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Patient tested positive after patient came into contact with someone that had covid on 28Apr and immediately went on paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: patient tested negative a few days after and was negative for a week with no symptoms; (08May2022) Positive, notes: I started getting symptoms again and testing positive on 08May; (13May2022) Positive, notes: patient still experiencing symptoms now (13May) and testing positive as of this morning. Therapeutic measures were taken as a result of covid-19.  Clinical course:  The patient reported that she was on triple vaxxed. This form is ridiculous. No wonder no one is reporting it. I tested positive after I came into contact with someone that had covid on 28Apr and immediately went on paxlovid. I tested negative a few days after and was negative for a week with no symptoms. I started getting symptoms again and testing positive on 8May and am still experiencing symptoms now (13May) and testing positive as of this morning. I have typical cold symptoms but no fever or chills. No known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FG8757) at the age of 45 years, in left arm for Covid-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "lower motor neuron symptoms" (unspecified if ongoing), notes: lower motor neuron symptoms (without a diagnosis yet). The patient's concomitant medications were not reported. Past drug history included: Known allergies: salicylates, reaction(s): "Known allergies: salicylates", notes: Known allergies: salicylates. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) faint positive line, notes: Still faint positive line on test this morning. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Therapeutic measures for COVID 19 included Paxlovid (Treatment start date: 08May2022, Treatment stop date: 12May2022, Lot number: FX4465). The patient took 5-day course after bad COVID illness. Had 2 shots plus booster, plus prolonged exposure in Nov21. Last dose of Paxlovid was last night and still faint positive line on test this morning. Follow-Up (17May2022): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An elderly male patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "well controlled hypertension" (unspecified if ongoing), notes: well controlled hypertension. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of antigen test positivity after testing negative immediately after finishing Paxlovid 5 day course". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positivity, notes: antigen test positivity after testing negative; negative, notes: after finishing Paxlovid 5 day course. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Return of antigen test positivity after testing negative immediately after finishing Paxlovid 5 day course. No other medication was received within two weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: other medical history:HTN. The patient's concomitant medications were not reported. Past drug history included: Known allergies: aspirin, reaction(s): "Known allergies: aspirin", notes: Known allergies: aspirin. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative; (10May2022) Negative; (13May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 06Apr2021 as dose 2, single (Lot number: ER8737) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Moderate asthma" (unspecified if ongoing); "Interchange of vaccine products" (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 11May2022, outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 1: 16Mar2021, Dose Number: 2: 06Apr2021; Plaxovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient had no known allergies and it was unknown if received other medications in two weeks. Patient was treated with paxlovid for Covid-19. Treatment start date was 13Apr2022. Treatment stop date was 17Apr2022. Patient began testing positive again and experiencing moderate symptoms 5 days after taking last dose of Paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Product=COVID 19 Treatment, Brand=Pfizer; Product=COVID 19 Treatment, Brand=Pfizer; This is a spontaneous report received from 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 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure slightly elevated" (unspecified if ongoing), notes: Blood pressure slightly elevated; "Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2009; AMLODIPINE, start date: 01Oct2021; FETZIMA, start date: 01Mar2018; ACYCLOVIR [ACICLOVIR SODIUM], start date: 01Jun2006; VIVELLE DOT, start date: 31Oct2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Product=COVID 19 Treatment, Brand=Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Tested positive after negative test two days earlier runny nose sneezing not same symptoms as original. Was cleared to travel on Day 10 by doctor w no symptoms New symptoms appeared more than a week later.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4491), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "celiac" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; SYNTHROID; ROSUVASTATIN; LISINOPRIL; VITAMIN D. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative; (06May2022) Negative; (08May2022) Positive; (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: The patient had no known allergies. The patient received other medication in 2weeks product: Multivitamin. The patient had rebound Covid infection. Initial Covid. The patient had symptoms and positive antigen test on 01May2022 and started Paxlovid that evening. The patient completed full course of Paxlovid on 06May2022, symptoms resolved and had negative antigen test on 06May2022 and 08May2022. On 12May2022 had Covid symptoms reappear and positive antigen test.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE], start date: 26Apr2021. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.It was reported that If vaccine received: Yes.Other medication in 2weeks: Yes. Patient started Paxlovid as treatment for COVID 19 on 02May2022 and stopped on 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Indication for use in the case: Treatment of COVID-19; Indication for use in the case: 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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9262) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to dust" (unspecified if ongoing), notes: Allergies to dust, seasonal; "Seasonal" (unspecified if ongoing), notes: Allergies to dust, seasonal. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medication in 2weeks. Paxlovid used in COVID 19 Treatment. Treatment start date was 03May2022 and stop date was 07May2022. 02May woke up with sore throat and congestion. Body pain and fatigue. The patient had no Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
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) (Physician).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jul2021 as dose 1, single (Lot number: EW0198), in right arm, on 26Jul2021 as dose 2, single (Lot number: EW0198), in right arm and on 27Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency" (unspecified if ongoing), notes: Common Variable Immune Deficiency. Concomitant medication(s) included: IMMUNE GLOBULIN subcutaneous, start date: 02Feb2022. The following information was reported: COVID-19 (medically significant) with onset 13May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Antiviral details: The patient received treatment product: COVID 19 Treatment (Paxlovid). Treatment start date: 04May2022 and stop date: 09May2022. Indication is used for treatment of COVID-19. administrator route: Oral. The patient had no known allergies. Other medications in 2 weeks Immune globulin, Xembify and administrator route: Subcutaneous. Reported Event Patient completed course of Paxlovid then experienced rebound symptoms. The patient not received treatment.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: 07Oct2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 07Oct2021; Paxlovid: 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 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gluten sensitivity" (unspecified if ongoing). Date of last menstrual period: 31Mar2022. The patient is expected to deliver a baby(s) on 05Jan2023. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "Pfizer / BioNTech: 07Oct2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had other medication in 2 weeks of vaccination. The patient had Covid-19 treatment from 30Apr2022 to 04May2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for covid". 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. No other medication in 2weeks. Tested positive for covid. Prescribed Paxlovid due to serious asthma. Did not help make patient felt better and still coughing with terrible congestion 6 days after finishing the 5-day Paxlovid treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 34-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 19:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: CIMZIA, start date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (09May2022) Negative; (11May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking other medication within 2 weeks of starting COVID-19 treatment was Cimzia (Certolizamab) started on 12May2022. The patient experienced Rebound of Covid after taking Paxlovid. Took Paxlovid from 04May2022 to 08May2022. Tested negative on PCR 09May2022 and 11May2022. Negative rapid 11May2022. Became symptomatic with headache, extreme fatigue, congestion in the evening on 14May2022. Tested positive within 5 minutes on a rapid on 15May2022. Positive on at home Cue test as well on 16May2022. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 51 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received Paxlovid for COVID-19 Treatment from start date 04May2022 to stop date 08May2022. Patient tested negative after use of Paxlovid. Three days later symptoms returned and tested positive. No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Conversion disorder
Clinical narrative: Functional neurological disease; Reaction; This spontaneous case was received on 10-May-2022 from other non-health care professional (patient's mother) via regulatory agency (reference number: SEQW22-01387) and concerned a 6-year-old, female patient.   The patient's medical history and concomitant medications were not reported. Patient's mother stated that patient had received four previous influenza vaccinations in previous seasons, but her vaccination records were lost.   On an unknown date in 2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: one dose, route of administration, anatomical location: not reported) for influenza prophylaxis. The batch number reported was 14249221A, expiry date 30-Jun-2017. The patient was supposed to be receiving a second dose 30 days later per the guidelines.  On an unspecified date in 2017, shortly after receiving the first Afluria Quadrivalent vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease.  At the time of initial reporting, the patient had not recovered from the events. She was a 12-year-old and she was still experiencing this condition.   The reporter considered the events as related to Afluria Quadrivalent. As reported, patient had a severe reaction shortly after receiving Afluria vaccine.   The reporter considered the case as serious due to seriousness criterion of hospitalization.  Company comment: A 6-year-old, female patient received the suspect product Afluria Quadrivalent. Reportedly, shortly after receiving vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease. Information regarding medical history and relevant diagnostic findings was not provided. Due to lack of information provided and unclear temporal relationship, causality for the reported events is unassessable.; Reporter's Comments: As reported, patient had a severe reaction shortly after receiving Afluria vaccine.; Sender's Comments: A 6-year-old, female patient received the suspect product Afluria Quadrivalent. Reportedly, shortly after receiving vaccine, the patient experienced a severe reaction and ended up in the hospital. As a result, patient was subsequently diagnosed with functional neurological disease. Information regarding medical history and relevant diagnostic findings was not provided. Due to lack of information provided and unclear temporal relationship, causality for the reported events is unassessable..
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient experienced skin itchiness and a rash on his back. Was given a dose of benadryl. The rash of the patient's back started clearing out after a couple of minutes.