chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid with symptoms; Tested positive for covid with symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 as dose 3 (booster), single (Lot number: GJ6796) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP6955) and on 06Dec2021 as dose 2, single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Metachlopramide, reaction(s): "known allergies: Metachlopramide". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2023, outcome "not recovered" and all described as "Tested positive for covid with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient tested for covid post vaccination.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: muscle/body ache; muscle/body ache; achy joints; chills; tiredness; headache; feeling unwell; decreased appetite; arm pain; administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 06Jan2023 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Asthma" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "bronchialstasis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "known allergies: Oxycodeine", notes: known allergies: Oxycodeine. Vaccination history included: Covid 19 vaccine (Dose 1; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 2; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 3; MANUFACTURER UNKNOWN). The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jan2023 at 15:00, outcome "unknown", described as "administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4"; PAIN IN EXTREMITY (non-serious) with onset 07Jan2023, outcome "recovering", described as "arm pain"; ARTHRALGIA (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "achy joints"; CHILLS (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MALAISE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MYALGIA (non-serious), PAIN (non-serious) all with onset 07Jan2023 at 04:00, outcome "recovering" and all described as "muscle/body ache"; FATIGUE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of myalgia, pain, arthralgia, chills, fatigue, headache, malaise, decreased appetite, pain in extremity.  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: COVID19-2
Symptoms: Inappropriate schedule of product administration, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: muscle/body ache; muscle/body ache; achy joints; chills; tiredness; headache; feeling unwell; decreased appetite; arm pain; administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 06Jan2023 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Asthma" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "allergies" (unspecified if ongoing), notes: allergies; "bronchialstasis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oxycodone, reaction(s): "known allergies: Oxycodeine", notes: known allergies: Oxycodeine. Vaccination history included: Covid 19 vaccine (Dose 1; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 2; MANUFACTURER UNKNOWN); Covid 19 vaccine (Dose 3; MANUFACTURER UNKNOWN). The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jan2023 at 15:00, outcome "unknown", described as "administration_date=06Jan2023/dose_number=5/other_vaccine_same_date_dose_number=4"; PAIN IN EXTREMITY (non-serious) with onset 07Jan2023, outcome "recovering", described as "arm pain"; ARTHRALGIA (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "achy joints"; CHILLS (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MALAISE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "feeling unwell"; HEADACHE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering"; MYALGIA (non-serious), PAIN (non-serious) all with onset 07Jan2023 at 04:00, outcome "recovering" and all described as "muscle/body ache"; FATIGUE (non-serious) with onset 07Jan2023 at 04:00, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of myalgia, pain, arthralgia, chills, fatigue, headache, malaise, decreased appetite, pain in extremity.  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: Cerebrovascular accident, Facial paralysis, Language disorder
Clinical narrative: strokes; She spoke haltingly and had a drooping mouth; She spoke haltingly and had a drooping mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, chest discomfort and shooting pain down her left arm; suffered a minor heart attack), administration date: Feb2021, for COVID-19 immunization, reaction(s): "She suffered a minor heart attack". The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "recovered", described as "strokes"; FACIAL PARALYSIS (hospitalization, medically significant), LANGUAGE DISORDER (hospitalization), outcome "recovered" and all described as "She spoke haltingly and had a drooping mouth".Clinical course: In early Feb2021, patient complained of chest discomfort and shooting pain down her left arm. She suffered a minor heart attack, which was treated at a nearby hospital. She had two strokes five days after her second shot in Mar2021, but she recovered within five days and was back to normal after that. She initially didn't recognize that she was having a stroke, and as a result, her condition worsened. She spoke haltingly and had a drooping mouth. She was admitted to the hospital for the strokes again (at the same hospital), and she made a full recovery in a matter of hours. Private conversations with her doctors revealed that the Pfizer vaccine was the direct cause of her heart attack and two strokes.  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: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Dec2022 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 completed, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: CARDIAC ARREST (medically significant), outcome "unknown".  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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; Dose 1 , 2 and 3  Moderna,  Dose 4 and 5 Pfizer; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 13Feb2021 as dose 2, single (Lot number: 031L20A), in left arm and on 01Nov2021 as dose 3 (booster),single (Lot number: 045C?1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Slightly high cholesterol" (unspecified if ongoing), notes: Slightly high cholesterol. The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin", notes: known allergies: Neosporin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Mar2022, outcome "unknown", described as "Dose 1 , 2 and 3  Moderna,  Dose 4 and 5 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive, notes: positive urgent care test; (30Dec2022) Negative; (04Jan2023) Negative; (07Jan2023) Positive, notes: COVID home test. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PH necrotizing pneumonia" (unspecified if ongoing); "Known allergies: Pcn" (unspecified if ongoing), notes: Known allergies: Pcn. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test. Therapeutic measures were taken as a result of covid-19, drug ineffective (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective and COVID-19 cannot be ruled out.
Age: 71.0
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) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Obesity" (unspecified if ongoing), notes: Other medical history: obesity. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 27Dec2022 to 31Dec2022.  Clinical information : It was reported as, No known allergies.  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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Known allergies: Anti-inflammatories" (unspecified if ongoing), notes: Known allergies: Anti-inflammatories. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 06Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: The patient received Paxlovid (anti-viral) for COVID-19 Treatment, started from 08Dec2022 to 13Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: 635342) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9809), on 19Mar2021 as dose 2, single (Lot number: EP6955), on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 21Mar2022 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  RITONAVIR (PAXLOVID) from 29Dec2022 to 03Jan2023.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporte (Other HCP). The reporter is the patient.  A 75-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: GH9702) at the age of 75 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6203), in right arm, on 21Oct2021 as dose 3 (booster), single (Lot number: EW0172), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing); "reoccurring diarrhea" (unspecified if ongoing); "reoccurring arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mastic, reaction(s): "Reaction: Allergy", notes: known allergies Mastic. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure: Paxlovid.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 3 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Sep2021 as dose 1, single (Lot number: 301258A), in left arm and on 30Mar2022 as dose 2, single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300008782 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna/vaccine administration date=24Mar2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GJ3277) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 at 13:30 as dose 1, single (Lot number: 025A21A), in left arm, on 15Apr2021 at 14:15 as dose 2, single (Lot number: 03B21A), in left arm, on 10Sep2021 at 10:30 as dose 3 (booster), single (Lot number: 048F21A), in left arm and on 24Mar2022 at 10:00 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Knonw allergies: Lactose intolerant" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "vaccine brand other=Moderna/vaccine administration date=24Mar2022". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 24Dec2022 to 29Dec2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 06Aug2021 as dose 3 (booster), single (Lot number: EQ0217), in left arm and in May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Dec2021 as dose 4 (booster), single (Lot number: 041J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Skin cancer" (unspecified if ongoing); "Known allergies:Penicillin" (unspecified if ongoing); "Known allergies:NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Paxlovid-rebound (converted back to positive test). Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 19Dec2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SEASONIQUE taken for contraception, start date: 01May2019; LEXAPRO taken for depression, start date: 02Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: METFORMIN, start date: 01Dec2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) negative; (06Jan2023) postive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (bivalent), single (Batch/Lot number: unknown) 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 4 (booster), 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: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: after negative tests for 3 days during the paxlovid course; (04Jan2023) Positive, notes: 2 days later tested positive again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  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: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 049l21a), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4". Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.  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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: LJ5372) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 14Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF8851), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Familial Mediterranean Fever" (unspecified if ongoing); "Prinzmetal angina" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: green tea" (unspecified if ongoing). Concomitant medication(s) included: COLCHIQUIM, start date: Nov1985. The following information was reported: COVID-19 (medically significant) with onset 28Dec2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 28Dec2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) positive; (28Dec2022) positive; (04Jan2023) negative, notes: First negative rapid test; (06Jan2023) positive, notes: Rebound case, showing positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19, included Paxlovid.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: F39943), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). The patient has no known allergies. Concomitant medications included: ARMOUR THYROID; ATORVASTATIN; MELOXICAM; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: On 07Jan2023, the patient had a positive rapid test following previous 2 negative tests post 5 days after completing Paxlovid.
Age: 37.0
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks was reported as yes. Patient received Paxlovid treatment from 28Dec2022 to 01Jan2023 for Covid-19, other medication in 2 weeks product Levothyroxine 25 mcg, other medication in 2 weeks product: nifedipine, other medication in 2 weeks start date: 04Dec2021, other medication in 2 weeks stop date: 27Dec2022, other medication in 2 weeks product lisinopril, other medication in 2 weeks start date: 29Dec2022. Paxlovid/COVID Rebound 5 days after testing negative and symptoms had gone away. The sore throat returned. adverse event start date: 05Jan2023.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: treatment of COVID-19; treatment of COVID-19; his is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (batch/lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history included: "cardiac background" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: covid: negative, notes: Covid rebound 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included ZPack, Paxlovid with treatment start date 26Dec2022 and treatment stop date 31Dec2022.  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 provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Postive, notes: Negative test on 4th. Positive again on 6th. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient took any other medications/products within two weeks of starting COVID-19 treatment was mentioned as yes. Tylenol was received as treatment for the adverse event. The patient was previously received a COVID-19 vaccine. Product COVID-19 Treatment, brand paxlovid, treatment start date on 24Dec2022 and  treatment stop date on 29Dec2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in right arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Ff2590), in right arm and on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative; (05Jan2023) Positive, notes: After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid rebound. After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 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 was not reported. No known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2009, stop date: 28Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 07:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 37 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ER8732), on 30Mar2021 as dose 2, single (Lot number: ER8732), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "urinary incontinence" (unspecified if ongoing); "OAB (overactive bladder)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (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 Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Sunflower seeds" (unspecified if ongoing); "known allergies: nectarines" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (06Jan2023) Positive, notes: Rebound positive test after return of symptoms 5 days after end of paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; Vaccine brand=Pfizer / BioNTech/Vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 041620A), in left arm, on 12Mar2021 as dose 2, single (Lot number: 001B21A), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 939905), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Abnormal heart" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Oct2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech/Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative for 2 days; (unspecified date) Negative, notes: Tested negative for 2 days; (21Dec2022) Positive; (04Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient called her doctor and was sent in nirmatrelvir, ritonavir (PAXLOVID) prescription. Patient took it for five days (also reported as from 21Dec2022 to 27Dec2022). It worked great, she tested negative for 2 days and returned to work. On 04Jan2023, she tested positive again and was having bad symptoms again.