chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jun2022 as dose 4 (booster), single (Batch/Lot number: Unknown) at the age of 60 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 relevant medical history included: "Psoriasis" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Other medication in 2 weeks was Unknown. It was reported patient received Covid treatment. Treatment start date: 02Aug2022, Treatment stop date- 05Aug2022. Adverse event was Runny nose, congestion. No known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
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).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 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. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took Paxlovid for COVID 19 treatment from 03Aug2022 to 07Aug2022 via oral route. Recurrence of COVID symptoms on 11Aug2022. No treatment received for the recurrence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported "COVID 19 treatment " after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, Lot Number: Unknown , Anatomical Location: left arm), administration date: 25May2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number: Unknown , Anatomical Location: left arm), administration date: 15Jun2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Lot Number: Unknown , Anatomical Location: left arm), administration date: 17Dec2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 11Aug2022, outcome "unknown", described as "It was hard to sleep last night". Additional information: The patient had no prior vaccinations within 4 weeks prior to administration of suspect dose. The patient did not experience any adverse event following prior vaccinations. The event did not require a visit to an emergency room nor physician office. The event did not require relevant tests. 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: Blood test, Fluid retention, Investigation, SARS-CoV-2 test, X-ray
Clinical narrative: 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 15Apr2021 at 15:00 as dose 1, single (Lot number: ER8732) at the age of 53 years, 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: FLUID RETENTION (non-serious), outcome "unknown", described as "Fluid removed each symptom Started about 1 month after each dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fluid retention. Additional Information: The patient has no known allergies.Sender's Comments: Linked Report(s) : PFIZER INC-202201058175 same patient, vaccine, different dose and event; PFIZER INC-202201058174 same patient, vaccine, different dose and event; PFIZER INC-202201058176 same patient, vaccine, different dose and event.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Pain, Somnolence
Clinical narrative: The reporter is the patient. An 83-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), in Apr2022 as dose 1, single (lot number unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "inclusion body myocitis" (unspecified if ongoing), notes: has her in a wheel chair; "in a wheel chair" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: penicillin family" (unspecified if ongoing). Concomitant medication included: PAXIL. Past drug history included: Codeine, reaction: "allergies". The following information was reported: FATIGUE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "incredible fatigue/ terrible fatigue"; DECREASED APPETITE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "no appetite"; SOMNOLENCE (non-serious) with onset 06Apr2022 at 11:30, outcome "not recovered", described as "sometimes sleeping all day"; PAIN (non-serious) with onset 06Apr2022 at 11:30, outcome "recovered" (08Apr2022 at 11:30), described as "terrible body pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2022, outcome "recovered" (2022), described as "flu like symptoms". Therapeutic measures were not taken as a result of fatigue, somnolence, decreased appetite, pain, influenza like illness. Additional Information: The COVID-19 vaccine was administered in doctor's office/urgent care. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. For four months the patient has had incredible fatigue. Sometimes sleeping all day. No appetite. Terrible body pain in the beginning for 48 hours. When that left, she had flu like symptoms for 3 weeks. Now down to terrible fatigue. The patient wanted to know how long she will deal with this. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19, TTOX
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). A 5-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 1, single (Lot number: FL9095) and on 29Apr2022 as dose 2, single (Lot number: FL8095) at the age of 5 years, all intramuscular for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), on 29Apr2022 (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "known allergies: eggs" (unspecified if ongoing). Concomitant medication(s) included: POLIO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "recovering" and all described as "tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) positive. Therapeutic measures were not taken as a result of covid-19.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 34-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Non-alcoholic fatty liver" (unspecified if ongoing); "pcos" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". 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 covid-19; patient received Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: 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).  A 64-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). No allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "nonischemic cardiomyopathy" (unspecified if ongoing); "CHF" (unspecified if ongoing), notes: CHF; "hypothyroid" (unspecified if ongoing); "former smoker" (unspecified if ongoing), notes: former smoker. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the events Drug ineffective and Covid-19 assessed as related to the suspect drug Comirnaty.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Came down with COVID symptoms and home tested positive; Came down with COVID symptoms and home tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 1, single (Lot number: EL9267), in left arm and on 15Feb2022 as dose 2, single (Lot number: E6199) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan1990; PRAVASTATIN, start date: Jan2010; LOSARTAN, start date: May2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Came down with COVID symptoms and home tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter (consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 at 17:00 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 18Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine and derivatives, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received Paxlovid as the treatment of COVID-19; Received Paxlovid as the treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "Known allergies: Sulfates" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Received Paxlovid as the treatment of COVID-19". 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: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure timing unspecified
Clinical narrative: Pregnant:Yes; 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 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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. The patient is expected to deliver a baby(s) on 01Feb2023. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy"; Amoxicillin, reaction(s): "Hives". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Pregnant:Yes". Therapeutic measures were taken as a result of covid-19. Clinical course: Rebound of covid symptoms 9 days after initial onset. Initial symptoms mild (aches, fatigue), rebound symptoms more severe including sore throat, productive cough, nasal congestion, aches, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALLEGRA, start date: 01Dec2020, stop date: 03Aug2022; NASONEX, start date: 01Dec2020, stop date: 03Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "unknown", COVID-19 (medically significant) with onset Aug2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 and included treatment with nirmatrelvir;ritonavir (PAXLOVID) from 04Aug2022 to 08Aug2022. Clinical course: When the patient finished her five day course of nirmatrelvir;ritonavir, she felt so much better. For two days, the patient felt really good. Now, the patient have rebounded and have symptoms again. Today is day 12 of having COVID and still feel rotten.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid which started on 23May2022 and stopped on 27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
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 (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 26Dec2021 at 14:30 as dose 2 (booster), single (Lot number: 33130BA), in left arm and on 17Jun2022 at 14:00 as dose 3 (booster), single (Lot number: FP7135) at the age of 53 years, in right arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 20Mar2021 at 15:00 as dose 1, single (Lot number: 1805029), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) positive, notes: Tested positive for COVID 19 on 25Jul; (31Jul2022) Negative, notes: tested negative on 31Jul and 04Aug; (04Aug2022) Negative, notes: tested negative on 31Jul and 04Aug; (07Aug2022) Positive, notes: Tested positive again on 07Aug. Paxlovid was taken on 25Jul2022 to 30Jul2022 as therapeutic measure as a result of drug ineffective, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 30Sep2021 as dose 3 (booster), single (Lot number: PF8839), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 70 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. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including received Paxlovid from 03Aug2022 to 07Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3247), on 10Feb2021 as dose 2, single (Lot number: EL9269), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ5683) for covid-19 immunisation. The patient's relevant medical history included: "OSTEOARTHRITIS" (unspecified if ongoing); "SEASONAL ALLERGIES" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: dose 4 (booster); dose 4 (booster); COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FR4856) at the age of 50 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: "Type 1 diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Apr2022, outcome "unknown" and all described as "dose 4 (booster)"; DRUG INEFFECTIVE (medically significant), 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, covid-19.; Sender's Comments: Based on available information, the events Drug ineffective and Covid-19 is assessed as related to the suspect drug Comirnaty.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myelodysoplastic syndrome" (unspecified if ongoing); "polymyalgia rheumatica" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing); "diatestes" (unspecified if ongoing), notes: diatestes. Concomitant medication(s) included: UNITHROID, start date: 01Jan2020; LOSARTAN, start date: 01Jan2020; DICYCLOMINE, start date: 08Oct2021; ISOSORBIDE, start date: 01Oct2021; ESOMEPRAZOLE, start date: 01Jan2020; CETRIZINE, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 01Aug2022 to 05Aug2022, amoxicillin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 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 included: "Obese" (unspecified if ongoing), notes: Obese; "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including received Paxlovid from 01Aug2022 to 05Aug2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 15:00 as dose 1, single (Lot number: ER8734), in left arm, on 28Apr2021 at 15:00 as dose 2, single (Lot number: EW0171), in left arm and on 01Dec2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish" (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 Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Fatigue, Pyrexia, Sepsis
Clinical narrative: blood infection; lost about 30 pounds; fatigue; didn't think anything of it; 103 degree fever for 10 hours; weakness; acute anemia; 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 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot: EC3248, NDC: unknown , Expiry: unknown), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2, Lot: EL9266, NDC: unknown , Expiry: unknown), administration date: 11Feb2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 3, Lot: FC3182, NDC: unknown , Expiry: unknown), administration date: 07Sep2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: ANAEMIA (non-serious) with onset 06Jun2022, outcome "unknown", described as "acute anemia"; SEPSIS (hospitalization) with onset 06Jun2022, outcome "unknown", described as "blood infection"; WEIGHT DECREASED (hospitalization) with onset 06Jun2022, outcome "unknown", described as "lost about 30 pounds"; FATIGUE (non-serious), outcome "unknown"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "didn't think anything of it"; PYREXIA (non-serious), outcome "unknown", described as "103 degree fever for 10 hours"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: Pyrexia: 103 degree, notes: he went to bed with a 103 degree fever for 10 hours and then though something is wrong; Weight: 30 lbs, notes: Lost 30 pounds. Therapeutic measures were taken as a result of sepsis.  Clinical course: Patient stated during his hospitalization, the doctors ran every test possible and all his vital signs and nothing there identified the infected blood.  Attempted clarification and confirmed there was no cause of infection identified.  His symptoms started occurring before 06Jun but he didn't recognize them 06Jun2022. He had felt fatigue and didn't think anything of it, he went to bed with a 103 degree fever for 10 hours and then thought that something was wrong. Patient had all 4 Covid shots. The last booster he received was 23May2022. On 06Jun2022, he developed acute anemia. Patient's red blood cells were infected and then infection hadn't been identified. For 2 months, patient had weakness, weight loss, and many transfusions.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal, Weight, Weight decreased
Clinical narrative: blood infection; lost about 30 pounds; fatigue; didn't think anything of it; 103 degree fever for 10 hours; weakness; acute anemia; 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 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Lot: EC3248, NDC: unknown , Expiry: unknown), administration date: 21Jan2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2, Lot: EL9266, NDC: unknown , Expiry: unknown), administration date: 11Feb2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 3, Lot: FC3182, NDC: unknown , Expiry: unknown), administration date: 07Sep2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: ANAEMIA (non-serious) with onset 06Jun2022, outcome "unknown", described as "acute anemia"; SEPSIS (hospitalization) with onset 06Jun2022, outcome "unknown", described as "blood infection"; WEIGHT DECREASED (hospitalization) with onset 06Jun2022, outcome "unknown", described as "lost about 30 pounds"; FATIGUE (non-serious), outcome "unknown"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "didn't think anything of it"; PYREXIA (non-serious), outcome "unknown", described as "103 degree fever for 10 hours"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: Pyrexia: 103 degree, notes: he went to bed with a 103 degree fever for 10 hours and then though something is wrong; Weight: 30 lbs, notes: Lost 30 pounds. Therapeutic measures were taken as a result of sepsis.  Clinical course: Patient stated during his hospitalization, the doctors ran every test possible and all his vital signs and nothing there identified the infected blood.  Attempted clarification and confirmed there was no cause of infection identified.  His symptoms started occurring before 06Jun but he didn't recognize them 06Jun2022. He had felt fatigue and didn't think anything of it, he went to bed with a 103 degree fever for 10 hours and then thought that something was wrong. Patient had all 4 Covid shots. The last booster he received was 23May2022. On 06Jun2022, he developed acute anemia. Patient's red blood cells were infected and then infection hadn't been identified. For 2 months, patient had weakness, weight loss, and many transfusions.
Age: 68.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 31May2022 at 14:30 as dose 4 (booster), single (Lot number: FM0173) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Trazadone, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including received Paxlovid from 19Jul2022 to 24Jul2022.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
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 66-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 03Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8714), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Unknown results, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 68 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 had no relevant medical history. No known allergies. There were no 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: SARS-CoV-2 test: Negative, notes: negative 7 days after beginning Paxlovid treatment; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive Covid test; positive Covid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8735) and on 21Apr2021 as dose 2, single (Lot number: Ew0161) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 004F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "long Covid from a Covid infection in Oct2020", start date: Oct2020 (unspecified if ongoing), notes: long Covid from a Covid infection in Oct2020. The patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Having a rebound of Covid symptoms and positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
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) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 04Aug2022 to 08Aug2022.  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 information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Covid 19 and Drug ineffective cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjrogrens" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies:codeine, reaction(s): "Drug Allergy"; Known allergies: iodine, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknon results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.