chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: first positive test. 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 11:30 as dose 1, single (Lot number: EM3809), in left arm and on 28Feb2021 at 12:30 as dose 2, single (Lot number: ENG200) at the age of 68 years, in left arm for COVID-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 at 16:15 as dose 3 (booster), single (Lot number: OHD21A), in left arm and on 01Jul2022 at 15:00 as dose 4 (booster), single (Lot number: 014B22A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "b/k amputee" (unspecified if ongoing); "high bp" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE, start date: May2022; ATORVASTATIN, start date: Sep2003; BENAZEPRIL, start date: Sep2004. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative, notes: on day 6; (Jul2022) Positive, notes: very faint antigen positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19.  Clinical course: The initial COVID infection (very faint antigen positive) included shallow cough and sore throat. This initial infection resolved in a few days (antigen negative on day 6). Anti-viral details: COVID-19 Treatment (Paxlovid) started from 26Jul2022 and stopped on 30Jul2022.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on Day 11 with a resurgence of same symptoms I'd had initially; 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 06Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 04Oct2021 as dose 3, single (Lot number: FF2089), in left arm and on 07Mar2022 as dose 4 (booster), single (Lot number: FE9895) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "autoimmune/stent" (unspecified if ongoing), notes: autoimmune/stent; "autoimmune/stent" (unspecified if ongoing), notes: autoimmune/stent. The patient's concomitant medications were not reported. Past drug history included: Statins, reaction(s): "Known allergies: Statins". The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "not recovered", COVID-19 (medically significant) with onset Jul2022, outcome "recovered" and all described as "COVID-19 treatment"; DISEASE RECURRENCE (medically significant) with onset 06Aug2022, outcome "not recovered", described as "tested positive on Day 11 with a resurgence of same symptoms I'd had initially". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Day 1 after testing positive; (06Aug2022) Positive, notes: tested positive on Day 11; (Aug2022) Negative, notes: I tested negative on Days 7-10. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Day 1 after testing positive, patient began to take paxlovid and completed the course in 5 days. She tested negative on Days 7-10 and then, tested positive on Day 11 with a resurgence of same symptoms she had had initially. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Diabetes, hypertension. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 57 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: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: 01Aug2022, stop date: 01Aug2022; METHOTREXATE, start date: 04Aug2022, stop date: 04Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Symptoms began 05Aug and tested positive on 06Aug. Patient did not had any known allergies. Patient received Paxlovid from 23Jul2022 to 27Jul2022 for covid 19 treatment.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 at 10:00 AM as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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 was not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment started from 27Jul2022 and ended on 31Jul2022. There was no known allergies and no 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: 80.0
Sex: F
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(s) (Other HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 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: "Known allergies: Mango" (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 04Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (lot number: 1910752A) taken orally from 04Aug2022 to 05Aug2022. Clinical course: Vaccine was received and within two weeks other medications were also taken.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 13:00 as dose 1, single (Lot number: EP6955), in left arm, on 02Apr2021 at 04:00 as dose 2, single (Lot number: EW0150), in left arm and on 24Jan2022 at 20:00 as dose 3 (booster), single (Lot number: Fj1614) at the age of 50 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Sep2020, stop date: 05Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Negative; (02Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9266), in right arm, on 13Mar2021 as dose 2, single (Lot number: EN6206), in right arm and on 08Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Patient had none known allergies. Concomitant medication(s) included: PREDNISONE, start date: 29Jul2022, stop date: 01Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Negative, notes: 3 days after testing negative; (03Aug2022) Negative, notes: 3 days after testing negative; (04Aug2022) Negative, notes: 3 days after testing negative; (05Aug2022) Positive, notes: Took home test. Resoundingly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: Paxlovid rebound perhaps. 4 days after finishing 5 day regimen & 3 days after testing negative, symptoms (primarily bad headache) returned. Took home test. Resoundingly positive.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test: Result: positive; Unit: Not Provided; Covid test: Result: positive; Unit: Not Provided; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK9231), on 28Jan2021 as dose 2, single (Lot number: EL8982), on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 27May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Kidney cancer" (unspecified if ongoing), notes: Kidney cancer had almost 20 years. The patient's concomitant medications were not reported. Past drug history included: Opdivo, start date: Nov2017, stop date: 2018, for Kidney cancer, reaction(s): "Had severe side effects and stopped it.", notes: Had severe side effects and stopped it. The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 03Aug2022, outcome "not recovered" and all described as "Covid test: Result: positive; Unit: Not Provided". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown, notes: Took 2 COVID tests; (03Aug2022) Positive. Therapeutic measures were taken as a result of covid-19. Additional information: the patient tested positive for COVID and is all vaccinated and boosted. On Tuesday evening (as reported), the patient started feeling sick and that is why she took the COVID test. The patient started feeling the kind of typical symptoms, her body hurt, was so fatigued, had that scratchy, itchy throat and cough. Her cough has been kind of the worst and has that runny, mucousy nose. She does not have a voice either. On Wednesday, she woke up and felt more sick, with what she assumed were COVID symptoms or flu symptoms. The patient took 2 COVID tests. Wednesday night, she didn't sleep real well. The patient had to sleep in another room on a futon and didn't sleep very well. She thought it was because of that and was just not resting well and not able to get real comfortable. They were like flu symptoms, COVID symptoms and probably the worst she had was the cough. She had kind of a scratchy throat and achy body. Those symptoms seem to be better. It was just this vibrating and not being able to sleep. She had trouble sleeping even though she went in a different room. She had not been able to sleep at all last night. She started feeling sick Tuesday, 02Aug2022 and had positive COVID test 03Aug2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective included COVID 19 treatment Paxlovid from 27Jul2022 to 31Jul2022. Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Paxlovid rebound 3 days after treatment. Positive test, loose cough. Nothing serious so far.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; positive 9 days after paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high bmi" (unspecified if ongoing). There were no concomitant medications. No known allergies. There were no concomitant medications (No other medication in 2weeks). The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "positive 9 days after paxlovid"; 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: Body mass index: (unspecified date) High; SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 2 days after paxlovid; (Aug2022) Positive, notes: positive 9 days after paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 28Jul2022 to 01Aug2022, tested negative 2 days after paxlovid and positive 9 days after paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 20Feb2021 as dose 2, single (Lot number: 022M20A), in right arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 012F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Obesity" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "known allergies gluten" (unspecified if ongoing); "known allergies latex" (unspecified if ongoing); "known allergies dairy" (unspecified if ongoing); "Allergy:Tetracycline" (unspecified if ongoing); "Allergy:Codeine" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement, start date: 07Jul2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown"; 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.  Clinical course: Patient received Paxlovid for COVID 19 Treatment. On 06Aug2022, after taking Paxlovid, the patient had the sour/metallic taste in mouth and also diarrhoea and some nausea/loss of appetite.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive, notes: Tested positive 5 days after finishing Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received PLAXOVID to treatment "drug ineffective" and "covid-19". Treatment start date=26Jul2022; treatment stop date=31Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took 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: (27Jul2022) Negative; (31Jul2022) Faint Positive; (04Aug2022) strong positive. Therapeutic measures were taken as a result of covid-19.   Additional information: Paxlovid rebound-negative rapid tests on 27Jul and 31Jul followed by faint positive on 02Aug, recurrence of symptoms, strong positive on 04Aug, symptoms ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 14:00 as dose 1, single (Lot number: 6198) and on 19Mar2021 at 12:00 as dose 2, single (Lot number: EP6955) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "MECFS" (unspecified if ongoing); "Colitis" (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 Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID 19 treatment included Paxlovid.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: given with COVID 19 Treatment; given with 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 04Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FK9223) at the age of 71 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), notes: which was not triggered during COVID infection; "Certain shellfish allergy" (unspecified if ongoing); "allergy with anything with aluminum" (unspecified if ongoing); "Sulfa drugs allergy" (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 Jul2022, outcome "unknown" and all described as "given with COVID 19 Treatment". Therapeutic measures, Paxlovid from 22Jul2022 to 27Jul2022, were taken as a result of drug ineffective, covid-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 05Apr2021 as dose 2, single (Lot number: EP7533) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment for covid-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course:The patient has received other medication within 2 weeks. Patient received treatment for covid-19, started on 27Jul2022 and stopped on 31Jul2022. Known allergies: Yes.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; CYMBALTA. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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; Negative, notes: Tested negative then positive; Positive, notes: Tested negative then positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks product Lamotrigine 300, other medication in 2 weeks product Cymbalta 20. Adverse event Paxlovid rebound a day or two after 5 day course completed. Tested negative then positive, symptoms, different than original.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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 (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 4, single (Batch/Lot number: unknown) at the age of 55 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: "HTN" (unspecified if ongoing), notes: HTN. Patient had 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 Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient received Paxlovid to treatment "drug ineffective" and "covid-19"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid given as COVID 19 Treatment; Paxlovid given as 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 29-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Paxlovid given as COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given Paxlovid from 27Jul2022 to 01Aug2022 as COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient had no known allergies. Other medications in 2 weeks was reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 20Jul2022 and stopped on 25Jul2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergy", notes: Known allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) Negative, notes: Antigen test on 03Aug2022 was negative; (06Aug2022) Positive, notes: Antigen test on 06Aug2022 and it was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received COVID 19 Treatment, Paxlovid, Treatment start date= 27Jul2022,  Treatment stop date= 01Aug2022,Indication=Treatment of COVID-19. Antigen test on 03Aug2022 was negative. Cough persisted. Achiness and headache started on 06Aug2022 so took antigen test on 06Aug2022 and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), 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 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". Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid (Oral) from 27Jul2022 to 31Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 81.0
Sex: F
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(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years, in right 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 and concomitant medications were not reported. Past drug history included: Emycin [erythromycin, reaction(s): "Known allergies: Emycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID.  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: tested positive /COVID 19 Treatment; tested positive /COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 69-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: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN; ROSUVASTATIN; LISINOPRIL/HCTZ; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "tested positive /COVID 19 Treatment". The event "tested positive /covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient tested positive for on 02Aug2022. On 03Aug2022 patient had a video visit, prescribed Paxlovid for patient. COVID 19 Treatment included Paxlovid orally from 03Aug2022 to 04Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 antibody 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Lot number: FA7484), in right arm and on 24Aug2021 as dose 2, single (Lot number: FC3182) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Crohns w/resection (dormant for 14 yrs)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 04Jan2018; AHCC, start date: 14Jun2021; VITAMIN D [VITAMIN D NOS], start date: 03Jun2020; CLARITIN [CLARITHROMYCIN], start date: 01Apr2022, stop date: 05Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Pyrexia: 101.2; SARS-CoV-2 antibody test: Unknown results; Negative, notes: antigen negative; Positive, notes: Antigen pos. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: COVID 19 Treatment start date on 28Jul2022 and stop date on 02Aug2022 (Lot Number: GC0490). Other medication in 2weeks start date was 01Apr2022. Other medication in 2weeks stop date was 05Aug2022. Adverse event: Began Paxlovid Day 2 w/very mild symptoms; all gone by Day 5 (Day 3 of Pxlvd). By Day 7, antigen negative & Pxlvd completed. Day 10, rapid onset of moderate symptoms: very enlarged lymph nodes in neck and jaw, throat swelling, runny nose, tonsils so large I cant even drink, dizziness, bp fluctuations. Fever 101.2. Antigen pos. Known allergies was no.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022; BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 21Feb2022 at 10:00 as dose 3 (initial EVUSHELD dose), single (Batch/Lot number: unknown), in left gluteus medius for COVID-19 immunisation; Janssen COVID-19 vaccine (Janssen COVID-19 VACCINE), on 14Aug2021 at 11:00 as dose 2 (initial Janssen dose), single (Batch/Lot number: unknown), in left arm and on 07Jul2022 at 12:00 as dose 4 (second JANSSEN dose), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Auto Immune" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; CALCIUM & VITAMIN D3 (brand: Kirkland); FOLATE (brand: Solgar); MACUGUARD OCULAR SUPPORT (brand: Life Extension); MAGNESIUM (brand: Natures Way); ZENPEP; VITAMIN-A (brand: Solgar); VIT B12 (brand: Solgar); ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Other concomitant therapy included Evening Promrose Oil (brand: Life Extension). The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Aug2021, outcome "unknown" and all described as "BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Anti-viral details: COVID-19 Treatment (Paxlovid) was started from 27Jul2022 and stopped on 01Aug2022. COVID rebound 3 1/2 days after completion of 5 day Paxlovid treatment (rebound from 4Aug2022 12:00 PM and not recovered).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (COMIRNATY) administration cannot be excluded.  The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Osteoarthritis, Pain in extremity, 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 70-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cronic osteo arthritis" (unspecified if ongoing), notes: that was under control with medication, until after this vaccination; "sulfa based drugs" (unspecified if ongoing), notes: known allergies: sulfa based drugs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3), for Covid-19 Immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 05May2022 at 02:00, outcome "recovering", described as "A extreme increase in my osteo arthritis"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 05May2022 at 02:00, outcome "recovering" and all described as "increased pain in my arms and back". The events "increased pain in my arms and back" and "a extreme increase in my osteo arthritis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain, osteoarthritis, pain in extremity. Additional information: The patient did not receive any other vaccine in four weeks. The reporter reported extreme increase in my osteo arthritis, that was still elevated as of this date (at the time of this report). It was very debilitating for about four weeks and was slowly diminishing as time passes. My knees are better but recovery was slow. The patient was treated with increase in doses of pain medications. The patient not had COVID prior vaccination. The patient was tested post vaccination.