chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngeal swab
Clinical narrative: Still today (8 months later) it is still swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2021 at 13:00 as dose 2, single (Lot number: FH8030) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colloidal cyst removal from brain, thyroid" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (prev dose product; COVID 19,, prev dose brand; Pfizer,, prev dose brand unknown; False, prev dose lot number; FF2593, prev dose lot unknown; False,, prev dose administration date=28Nov2021, prev dose administration time; 01:00 PM,, prev dose dose number; 1,, prev dose vaccine location=Left arm), administration date: 28Nov2021, when the patient was 42-year-old, for COVID-19 immunization, reaction(s): "Then a week later my left lymph node swelled", "the injection sight swelled". The following information was reported: LYMPHADENOPATHY, outcome "not recovered", described as "Still today (8 months later) it is still swollen.". The event "still today (8 months later) it is still swollen." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Report about covid treatment: Yes, Reporter type: Patient, Is pregnant: No. Most recent dose details: product: COVID 19, Brand: Pfizer, lot number: FH8030, administration date: 19Dec2021, administration time: 01:00 PM, dose number:2, vaccine location: Right arm. Previous dose details: product: COVID 19, Previous dose Brand: Pfizer, Previous dose lot number: FF2593. Previous dose administration date: 28Nov2021, Previous dose administration time: 01:00 pm, Previous dose dose number:1, if other vaccine in four weeks: No, Other medication in 2weeks: Synthroid. Adverse event: After my first injection in my left arm, the injection sight swelled. Then a week later my left lymph node swelled. Still today (8 months later) it is still swollen. Adverse event start date: 05Dec2021, Adverse event start time: 06:00 AM. Ae resulted in: [Doctor or other healthcare professional office/clinic visit]. If patient recovered: Not recovered, If treatment ae: Yes, ae treatment: Sonographic evaluation of left breast and axilla. if covid prior vaccination: Yes, if covid tested post vaccination: Yes. covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: (Company name), covid test date: 28Jun2022, Known allergies: No. Other medical history: Colloidal cyst removal from brain, thyroid.  No follow-up attempts are possible. No further information expected.
Age: 65.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 20Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Connective tissue disease (unknown autoimmune issue)" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 01Jun2021; LUNESTA, start date: 02May2022. 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: Tested negative after taking full course of Paxlovid; Positive, notes: Tested negative after taking full course of Paxlovid. Symptoms and positive test returned after 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment included paxlovid Treatment start date:14Jul2022 and stop date: 18Jul2022. COVID symptoms rebound after taking Paxlovid. Tested negative after taking full course of Paxlovid. Symptoms and positive test returned after 5 days. The patient received other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Covid test Date: 2Jun2022 Result: positive; Test: Covid test Date: 2Jun2022 Result: positive; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, 0.3 ml single (Lot number: EM9810), on 26Feb2021 as dose 2, 0.3 ml single (Lot number: EN6200) and on 08Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8028) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; CARDIZEM CD; TAMBOCOR; ZOLOFT; MUCINEX DM; TESSALON PERLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "unknown" and all described as "Test: Covid test Date: 2Jun2022 Result: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: Result: positive; Unit: Not Provided.  Clinical course: Patient tested positive for Covid after receiving three doses of vaccine. Had Covid test on 02Jun2022 resulted positive and had received concomitant medications included Multivitamin.  No follow-up attempts are possible. 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 vaccination failure, Covid 19 cannot be completely excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Paroxysmal AFIB" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 16Aug2021.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient took anti-viral drug Paxlovid from 22Jul2022 to 23Jul2022 for COVID-19 treatment.Other medication was received in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
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 contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Dec2020 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Jan2021 at 17:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE taken for antiallergic therapy, start date: 01Apr2022; INDAPAMIDE taken for hypertension, start date: 01Jul2016.  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: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks included antihypertensive medication( Indapamide) and antihistamine (cetirizine). Known allergies included penicillin and sulfa antibiotics and other medical history inclyded HTN. Adverse event reported as rebound in symptoms 5 days after stopping medication, nasal congestion, sneezing and sore throat.  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 known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptoms of nasal congestion, dry cough, headache, COVID-19; Symptoms of nasal congestion, dry cough, headache, COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Fish allergy" (unspecified if ongoing), notes: Known allergies: Fish, but not shell fish. Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2018; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "recovering" and all described as "Symptoms of nasal congestion, dry cough, headache, COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: I had tested negative on 17Jul2022; (27Jul2022) Positive, notes: Tested positive for COVID on 27Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details Product=COVID 19 Treatment, Brand Paxlovid, Treatment start date was 11Jul2022, Treatment stop date was 16Jul2022, Indication for Treatment of COVID-19. Symptoms of nasal congestion, dry cough, headache started again about 25Jul2022. Tested positive for COVID on 27Jul2022, 11 days after completing Paxlovid.Other medication in 2 weeks product was Multivitamin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, 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; (19Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 12Jul2022, Treatment stop date: 16Jul2022, Indication: Treatment of COVID-19. The patient tested negative for Covid 19 on 19Jul.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 42-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "asthmas" (unspecified if ongoing), notes: Other medical history: asthmas. Concomitant medication(s) included: BENZONATATE, start date: 09Jul2022, stop date: 15Jul2022; FLOVENT HFA, start date: 09Jul2022, stop date: 23Jul2022. 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 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment of Paxlovid from 11Jul2022 to 15Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Tested positive six days after testing negative, and 17 days after my first dose of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 13Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 778839) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "Dry Eye" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jan2021; SERTRALINE, start date: 01Jan2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2022. he following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "recovering", described as "Tested positive six days after testing negative, and 17 days after my first dose of Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive six days after testing negative; (unspecified date) Negative, notes: Tested positive six days after testing negative; (26Jul2022) Positive, notes: Tested positive six days after testing negative, and 17 days after my first dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical Course: The patient received anti viral treatment with Paxlovid from 09Jul2022 to 14Jul2022 for treatment of COVID-19. The patient had tested positive six days after testing negative, and 17 days after my first dose of Paxlovid.  No follow-up attempts are possible. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 treatment"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a 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 13May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 63 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Positive, notes: a positive antigen test, 5 days after completion of the dose pack. Therapeutic measures were taken as a result of drug ineffective, covid-19,drug ineffective with paxlovid started on 16Jul2022and stop date 20Jul2022  Clinical information: Return of Covid symptoms and a positive antigen test, 5 days after completion of the dose pack.Adverse event start date: 25Jul2022 ;12:00 PM. No treatment done for return of Covid symptoms.No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; 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 female patient received BNT162b2 (BNT162B2), 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 "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". It was reported that patient was 90 percent good and eat the same thing and have been married for over 40 years. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201014623 Same reporter, different patient/ drug/ AE;
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (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), 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: "Obesity htn" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; BENAZEPRIL; TRAMADOL; XANAX; ZOLOFT. 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: (unspecified date) Positive; (27Jul2022) Positive, notes: We are both Sick and COVID + today 27Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Three days after completion of Plaxovid, symptoms came back. Severe cold symptoms. This happened to the patient and her husband. Patient and her husband were very diligent in taking the medication as prescribed. Patient and her husband are Sick and COVID positive on 27Jul. Other medication in 2weeks: Yes. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 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: "Spontaneous pneumomedia stinums" (unspecified if ongoing), notes: Two spontaneous pneumomedia, stinums at age 17. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; LOESTRIN; ZYRTEC DAIICHI. Past drug history included: No, reaction(s): "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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: If vaccine received Yes. Other medication in 2weeks Yes. Anti-viral details: Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=11Jul2022, Treatment stop date=15Jul2022, Indication=Treatment of COVID-19.Adverse event. I took my last dose of Paxlovid on Friday evening 15Jul2022. By Sunday morning 17Jul2022 I had a small rebound. My sore throat and swollen glands came back (had previously subsided since Wednesday or day 3 of Paxlovid). Rebound lasted 2 days. Symptoms were not as bad as the firsttime. I also experienced bad nausea on Paxlovid and was prescribed Zofran. Adverse event country. Adverse event start date 17Jul2022. Adverse event start time 12:00 AM. Ae resulted in [None of the above]. If patient recovered: Recovered. If treatment ae Yes. Ae treatment Zofran. Known allergies No. Other medical history Two spontaneous pneumomedia stinums at age 17.
Age: 48.0
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) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730), on 07Jan2021 as dose 2, single (Lot number: EL1284) and on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "post surgical hypothyroidism" (unspecified if ongoing); "secondary to papillary carcinoma of the thyroid" (unspecified if ongoing); "seronegative inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OLMESARTAN; HYDROXYCHLOROQUINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Negative; (27Jul2022) Positive; (11Jul2022) Positive, notes: I tested positive on PCR on 11Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient developed rebound COVID on 27Jul2022 after taking Paxlovid. Patient tested positive on PCR on 11Jul2022 I started Paxlovid on 12Jul2022 and finished on 16Jul2022. Patient tested negative on the home antigen test 18Jul2022 patient developed symptoms again on 26Jul2022 Patient tested positive on the home antigen test 27Jul2022.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 29.0
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GAD" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown", DRUG INEFFECTIVE (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: Rebound of COVID symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information:  The patient had COVID 19 Treatment Paxlovid, from 19Jul2022, to 23Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "bariatric surgery" (unspecified if ongoing); "resolved hypertension" (unspecified if ongoing); "OSA" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [MOMETASONE FUROATE]; IRON. 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: Paxlovid rebound. Symptoms came back and testing become positive. Therapeutic measures were taken as a result of  covid-19.  Clinical course: Patient received Paxlovid Anti-viral COVID 19 Treatment which start date was 15Jul2022 and stop date was 20Jul2022.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 47.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 17Jul2022 to 21Jul2022  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccinated and took first Booster COVID Vaccine on 01Oct and still tested or kept on being tested positive with COVID; Vaccinated and took first Booster COVID Vaccine on 01Oct and still tested or kept on being tested positive with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: GD3007) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) 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 "Vaccinated and took first Booster COVID Vaccine on 01Oct and still tested or kept on being tested positive with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: I tested positive last Saturday night, ok, with an isolation quarantine for a whole week, I keep testing positive. Clinical course: Call was transferred form Pfizer (Name withheld) (ID: 159558). Concern, transferring agent stated, "We have caller, she is a consumer, caller mentioned that she is vaccinated (COVID Vaccine) and took her first Booster (COVID Vaccine; manufacture name not clarified hence left unchecked in tab) on 01Oct. However, she still tested or she kept on being tested positive with COVID. That's all the information she provided."   When paraphrased the concern, consumer stated, "That's not, it's different, my question is I tested positive last Saturday night, ok, with an isolation quarantine for a whole week, I keep testing positive. My question is, how do I stop testing positive or what do I do to stop testing positive for COVID? I have no symptoms, no nothing, ok and then the second question would be when am I eligible or where can I go when can I go and get my second Booster shot (COVID Vaccine) because I just recently had COVID the past week." Consumer was informed about the role of Pfizer Drug Safety. As consumer abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), purchased details and further probing could not be done. Limited information was available over the call and appropriate response could not be provided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pneumonia, SARS-CoV-2 test, Thrombosis
Clinical narrative: pneumonia; blood clots; exposed to COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3; unknown manufacturer), for Covid-19 Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: My wife was also exposed to COVID, had 4th shot end of June. She tested negative. Clinical course: The patient was also exposed to COVID, had 4th shot end of June. She tested negative but had pneumonia. Also got blood clots in right leg most likely from COVID and flying.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 21Sep2021 as dose 3 (booster), single (Lot number: 533592) and on 16May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diagnosed with COVID" (unspecified if ongoing), notes: Diagnosed with COVID on 25Jul tested on 24th when symptoms started.; "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism complex regional pain syndrome with neuropathy right foot post fracture; "Just tumor" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known allergies: multiple food sensitivities- GI issues" (unspecified if ongoing), notes: multiple food sensitivities-GI issues; "neuropathy right foot post fracture" (unspecified if ongoing), notes: Hypothyroidism complex regional pain syndrome with neuropathy right foot post fracture; "right foot post fracture" (unspecified if ongoing), notes: Hypothyroidism complex regional pain syndrome with neuropathy right foot post fracture; "regional pain syndrome" (unspecified if ongoing), notes: Hypothyroidism complex regional pain syndrome with neuropathy right foot post fracture. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline"; Demerol, reaction(s): "Known allergies: Demerol causes acute hallucination"; Minocin, reaction(s): "Known allergies: Minocin". The patient was not received other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid start and stop on 25Jul2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Apr2022 as dose 4 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Dose button did not work. Pfizer dose 2 on 01Mar2021. Pfizer dose 3 on 09Oct2021. Moderna booster on 26Apr2022. Rebound to Paxlovid. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination Failure and COVID 19 and the suspect drug BNT162b2 .
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 at 12:30 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety disorder" (unspecified if ongoing), no known allergies. Concomitant medication(s) included: DAYQUIL, start date: 09Jul2022, stop date: 11Jul2022; ZYTREC, start date: 10Jul2022, stop date: 11Jul2022. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 10Jul2022 to15Jul2022.  Clinical course: Patient had received other medication in 2weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
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 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 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 was not reported. Patient had no known allergies. Date of last menstrual period: 19Feb2022. The patient is expected to deliver a baby(s) on 26Nov2022. Concomitant medication in 2weeks included: PRENATAL VITAMINS [ASCORBICACID; BETACAROTENE; CALCIUMSULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC AC-ID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONO-NITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  Clinical information: The patient is pregnant now and Gestational period: 22.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering", and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (13Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (14Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (15Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (16Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (17Jul2022) Positive, notes: Tested antigen positive daily 12Jul-17Jul; (18Jul2022) Negative, notes: Tested antigen Negative 18Jul, 19Jul, 20Jul; (19Jul2022) Negative, notes: Tested antigen Negative 18Jul, 19Jul, 20Jul; (20Jul2022) Negative, notes: Tested antigen Negative 18Jul, 19Jul, 20Jul; (21Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today); (22Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today); (23Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today); (24Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today); (26Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today); (27Jul2022) Positive, notes: Tested antigen positive daily 21Jul - 27Jul (today). 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.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2 .
Age: 46.0
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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years 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) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Patient was received Paxlovid for treatment of Covid-19 from 11Jul2022 to 15Jul2022. Patient did no receive any other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 01:00 as dose 4 (booster), single (Batch/Lot number: unknown) 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). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022 at 12:00, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (18Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (19Jul2022) Negative, notes: Took paxlovid 5 days. Neg test day 4, 5, 6; (24Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far; (25Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far; (26Jul2022) Positive, notes: Symptoms back day 10 And positive day 11 12 13 so far. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment start date: 14Jul2022, treatment stop date: 18Jul2022, indication: Treatment of COVID-19. No other medication in 2 weeks. No known allergies. Adverse event start time was 12:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.