chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient was treated with Paxlovid from 22Dec2023 to 27Dec2023. Patient had no known allergies.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Sinusitis
Clinical narrative: Body aches, fever and swelling of the left arm and sinus, and fever
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Partnering Event Organizer provided wrong pt DOB and was verified up to the day of the event on which forecasting was based. Pt reported right DOB on the day of the event to RN who was taking care of the patient. Pt got extra doses of vaccine. No adverse effects noted on pt thus far. Pt chart updated and combined to reflect new information containing right DOB and right fist and last name.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site discolouration, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: The patient said after she received the rsv vaccine that she had a purple bruise the size of a tennis ball and after a few days it was waking her up at night throbbing and itching. She received the shot on 12/8 and just brought to my attention.  I asked her to show it to me and at this time there is about a quarter size dark brown spot and it is very hard around the injection site. It almost feels like scar tissue. I told her that I would do this report and a vaers report and see if they have had any of these type of reactions reported.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Sleep disorder
Clinical narrative: The patient said after she received the rsv vaccine that she had a purple bruise the size of a tennis ball and after a few days it was waking her up at night throbbing and itching. She received the shot on 12/8 and just brought to my attention.  I asked her to show it to me and at this time there is about a quarter size dark brown spot and it is very hard around the injection site. It almost feels like scar tissue. I told her that I would do this report and a vaers report and see if they have had any of these type of reactions reported.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Blood chloride decreased, Blood potassium decreased, Decreased appetite, Fatigue
Clinical narrative: muscular pain, nausea, lack of appetite, severe fatigue, intermittent temperature as high as 103.2, shaking . intermittent, sweating,  gi distress causing lack of appetite which lasted 12 days and there was a relapse with repeated symptoms after 6 days of being symptom free that lasted 3 days and a second relapse with repeated symptoms that lasted 3 additional days.  During the time of symptoms I was essentially bed bound.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Hyperhidrosis, Iron binding capacity total decreased, Mobility decreased, Myalgia, Nausea
Clinical narrative: muscular pain, nausea, lack of appetite, severe fatigue, intermittent temperature as high as 103.2, shaking . intermittent, sweating,  gi distress causing lack of appetite which lasted 12 days and there was a relapse with repeated symptoms after 6 days of being symptom free that lasted 3 days and a second relapse with repeated symptoms that lasted 3 additional days.  During the time of symptoms I was essentially bed bound.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Transferrin decreased, Tremor, Urinary sediment present
Clinical narrative: muscular pain, nausea, lack of appetite, severe fatigue, intermittent temperature as high as 103.2, shaking . intermittent, sweating,  gi distress causing lack of appetite which lasted 12 days and there was a relapse with repeated symptoms after 6 days of being symptom free that lasted 3 days and a second relapse with repeated symptoms that lasted 3 additional days.  During the time of symptoms I was essentially bed bound.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: muscular pain, nausea, lack of appetite, severe fatigue, intermittent temperature as high as 103.2, shaking . intermittent, sweating,  gi distress causing lack of appetite which lasted 12 days and there was a relapse with repeated symptoms after 6 days of being symptom free that lasted 3 days and a second relapse with repeated symptoms that lasted 3 additional days.  During the time of symptoms I was essentially bed bound.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE AFFECT EXHIBITED FROM PATIENT. THE PATIENT WAS INADVERTENTLY GIVEN BEXSERO ( MEN B) INSTEAD OF MENQUADFI (MCV4). PATIENT HAS BEEN NOTIFIED AND SCHEUDLED ANOTHER APPOINTMENT TO RECEIVE  THE MCV4 VACCINATION.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received extra doses of Dtap and flu despite having just been vaccinated a week before with with the same set of vaccines. RN went over the screening checklist with the mother, but she was insistent that her son get vaccinated again because "it's a school requirement". The mother primarily speaks another language. The pt was in no apparent distress after the event.
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 Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (ongoing); "sulfa" (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 Dec2023, outcome "recovered" (26Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2023) negative, notes: Day 6 I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment, Brand: Paxlovid, Treatment start date- 20Dec2023, Treatment stop date- 25Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
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 Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFATURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFATURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFATURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid therapy start date: 23Dec2023) were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
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 an Other HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing); "latex sensitivity" (unspecified if ongoing); "bilateral panuveitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergy: Erythromycin"; Codeine, reaction(s): "Drug allergy: codeine"; Kenalog, reaction(s): "Drug allergy: kenalog"; Betadine, reaction(s): "Drug allergy: Betadine". Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster); Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (booster); Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 5 (booster); Manufacturer Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (23Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 24Dec2023 to 29Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 21.0
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 Consumer or other non HCP.  A 21-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 21 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER),Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid treatment from 24Dec2023 to 29Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, Vaccine administration date=22Oct2022, Vaccine lot number=GJ6739, Vaccine location=Right arm), administration date: 22Oct2022, when the patient was 44-year-old, for COVID-19 immunization; 4 doses of Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. 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: Positive, notes: Treatment of Covid-19; Negative, notes: Tested negative days 6 and 7. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment include Paxlovid from 22Dec2023 to 26Dex2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer (patient). A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient has no known allergies. Patient received Paxlovid for COVID 19 Treatment from 22Dec2023 to 26Dec2023.  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the events was recovered.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 58.0
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 Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 14Sep2023 as dose 1, single (Lot number: HH7595) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 5 (BOOSTER), SINGLE, lot number=GH9702, vaccine location=Right arm), administration date: 18Sep2022, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot number=FK9893, Vaccine location=Right arm), administration date: 07Apr2022, when the patient was 57-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, lot number=011F21A, Vaccine location=Right arm), administration date: 24Oct2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot number=EW0161, Vaccine location=Right arm), administration date: 24Apr2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, lot number=ER8734, Vaccine location=Right arm), administration date: 03Apr2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
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 Physician.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known Allergies: Gluten intolerance" (unspecified if ongoing); "Known Allergies: methacrylate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Dec2023 to 02Jan2024. Clinical course: patient received Novavax COVID-19 vaccine as dose 5 (booster), single for covid-19 immunisation.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 21:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure - treating" (unspecified if ongoing). No known allergies. Concomitant medications included: AMLODIPINE, start date: 01May2018; CARVEDILOL, start date: 01May2018. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with nirmatrelvir, ritonavir (PAXLOVID) from 24Dec2023 to 29Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 Consumer (patient). A 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient has no known allergies. Patient received Paxlovid from 06Dec2023 to 11Dec2023 for COVID 19 Treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all 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 omi xbb.1.5 will be requested and submitted if and when received.
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 Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 treatment included Paxlovid.   The information on the batch/lot number for bnt162b2 omi xbb.1.5, has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Muscle discomfort, Musculoskeletal discomfort
Clinical narrative: muscle and joint discomfort; muscle and joint discomfort; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "muscle and joint discomfort". Additional information: Patient stated that he had those symptoms for over a month.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
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 Consumer or other non HCP from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 13:00 as dose 1, single (Lot number: HG4625) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 49694), administration date: 16Sep2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Batch/Lot No: 30155BA), administration date: 05Oct2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6208), administration date: 20Mar2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6198), administration date: 26Feb2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included paxlovid from 15Dec2023 to 20Dec2023 were taken as a result of vaccination failure, covid-19.
Age: 65.0
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 Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:00 as dose 1, 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: "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOTENSIN [TIMOLOL MALEATE], start date: 01Dec2023, stop date: 21Dec2023; ATORVASTATIN, start date: 01Dec2023, stop date: 21Dec2023; TRULICITY, start date: 01Dec2023, stop date: 21Dec2023; DICLOFENAC, start date: 01Dec2023, stop date: 21Dec2023. Vaccination history included: moderna COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, vaccine location: Left arm), administration date: 18May2022, when the patient was 64-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, vaccine administration time: 12:00 PM, vaccine location: Left arm), administration date: 01Oct2022, when the patient was 64-year-old, for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid received from 21Dec2023 to 25Dec2023 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 58.0
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 Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" 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 vaccination failure, covid-19.  Clinical course: The patient received anti viral COVID 19 treatment with Paxlovid from 24Dec2023 to 29Dec2023. The patient had no known allergies. The other medical history reported as no.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea
Clinical narrative: at times feeling short of breath or like cannot take a full breath, or yawn.; uncontrollable diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Lot number: Unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacture), for covid-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacture), for covid-19 immunisation; Covid-19 vaccine (dose 3, unknown manufacture), for covid-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 22Dec2023, outcome "unknown", described as "uncontrollable diarrhea"; DYSPNOEA (non-serious), outcome "unknown", described as "at times feeling short of breath or like cannot take a full breath, or yawn.".  Additional information: uncontrollable diarrhea within six hour of the shot and in the two weeks since then, at times feeling short of breath or like cannot take a full breath, or yawn.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: at times feeling short of breath or like cannot take a full breath, or yawn.; uncontrollable diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 as dose 1, single (Lot number: Unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacture), for covid-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacture), for covid-19 immunisation; Covid-19 vaccine (dose 3, unknown manufacture), for covid-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 22Dec2023, outcome "unknown", described as "uncontrollable diarrhea"; DYSPNOEA (non-serious), outcome "unknown", described as "at times feeling short of breath or like cannot take a full breath, or yawn.".  Additional information: uncontrollable diarrhea within six hour of the shot and in the two weeks since then, at times feeling short of breath or like cannot take a full breath, or yawn.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune alopecia" (unspecified if ongoing), notes: Autoimmune alopecia; "lichen planus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 23Dec2023 to 28Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19/sore throat/Tested positive; Treatment of COVID-19/sore throat/Tested positive; This is a spontaneous report received from a Physician from product quality group.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Dec2023 as dose 1, single (Lot number: HG6396) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose number: 5, Batch/Lot No: GH9702), administration date: 27Oct2022, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 4, Batch/Lot No: FK9895), administration date: 26May2022, when the patient was 64-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose number: 3, Batch/Lot No: 061EZIA), administration date: 04Nov2021, when the patient was 63-year-old, for COVID-19 Immunization; astrazeneca COVID-19 vaccine (Dose number: 2, Batch/Lot No: AO3324), administration date: 07Dec2020, when the patient was 62-year-old, for COVID-19 Immunization; astrazeneca COVID-19 vaccine (Dose number: 1, Batch/Lot No: AO3324), administration date: 09Nov2020, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2023, outcome "recovered" (03Jan2024) and all described as "Treatment of COVID-19/sore throat/Tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (02Jan2024) fever up to 99.9; SARS-CoV-2 test: (02Jan2024) Positive, notes: Tested positive again on 02Jan2024; (23Dec2023) Positive, notes: Tested positive AM of 23Dec2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: COVID rebound. Patient developed sore throat evening of 22Dec2023. Tested positive AM of 23Dec2023. Got on Paxlovid immediately (by prescribing it to him (he is an MD (Medical Doctor)) after being told to go to urgent care by the on call service). Had a little fever aching and headache on the 23rd. Felt well after that. He developed recurrence of aching fever and chills on 01Jan2024. Tested positive again on 02Jan2024 yesterday again using the Abbott Binaxnow kit. He did not test himself between the 23Dec2023 and 02Jan2024 tests. Continued to have fever up to 99.9 and chills and aching yesterday. He felt a little worse yesterday than he did on 23Dec2023. He felt fine today (03Jan2024). That second wave lasted a little over 24 hours. Events didn't result in emergency room visit or physician office visit. No known allergies. Other medical history was reported as healthy.; Sender's Comments: Based on available information, a lack of efficacy (VACCINATION FAILURE and COVID-19) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
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 Consumer or other non HCP.  A female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD (Gastrooesophageal reflux disease)" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [FAMOTIDINE], stop date: 19Dec2023; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], stop date: 19Dec2023; SIMVASTATIN, stop date: 19Dec2023; MIRTAZAPINE, stop date: 19Dec2023; TURMERIC [CURCUMA LONGA RHIZOME], stop date: 19Dec2023. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 05, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 06, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 07, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 08, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 09, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Positive, notes: A positive test result 7 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was reported that, After taking Paxlovid for 5 days as prescribed, Patient had recurrence of COVID symptoms (cold like symptoms) and a positive test result 7 days after completing Paxlovid treatment. Other medication: Multivitamins. COVID 19 Treatment: Paxlovid: Treatment start date: 19Dec2023, Treatment stop date: 24Dec2023  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CIPD (localized to left arm)" (unspecified if ongoing), notes: CIPD (localized to left arm); "Hypercholesterolemia" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Alendronate, reaction(s): "Known allergies: alendronate". Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was taken from 23Dec2023 to 27Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
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 Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACUTUER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACUTUER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACUTUER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACUTUER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5; MANUFACUTUER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6; MANUFACUTUER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) Negative, notes: Rebound positive test and symptoms of COVID after 5 days of negative test and symptoms; (03Jan2024) Positive, notes: Rebound positive test and symptoms of COVID after 5 days of negative test and symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 10:00 as dose 1, single at the age of 76 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Mitral valve replacement" (unspecified if ongoing); "known allergies: Fermented cabbage, eg sauerkraut, Cole slaw" (unspecified if ongoing), notes: known allergies: Fermented cabbage, eg sauerkraut, Cole slaw. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HC2649) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia Rheumatica" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. Past drug history included: Prednisone, stop date: 28Apr2023, notes: brand. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 5, Batch/Lot No: GH9702, Location of injection: Arm Left), administration date: 28Oct2022, when the patient was 65-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose: 4, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Positive, notes: Strong positive (at home test; two different brands); (03Jan2024) Positive, notes: Strong positive (at home test; two different brands); (26Dec2023) Negative, notes: three-in a-row negative COVID tests; (27Dec2023) Negative, notes: three-in a-row negative COVID tests; (28Dec2023) Negative, notes: three-in a-row negative COVID tests. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 20Dec2023 to 24Dec2023.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested + (positive); Tested + (positive); This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 47-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HG977) 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), COVID-19 (medically significant) all with onset 19Dec2023, outcome "unknown" and all described as "Tested + (positive)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive; (25Dec2023) Negative; (31Dec2023) Positive; (Jan2024) Positive, notes: continuing to test +. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 19Dec2023 to 24Dec2023.
Age: 53.0
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 an Other HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (vaccine lot unknown reason=Misplaced/discarded,, vaccine location=Left arm, Dose number: Unk), administration date: 02Nov2022, when the patient was 52-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Negative, notes: Tested negative on day 7 and 9; (02Jan2024) Negative, notes: Tested negative on day 7 and 9. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was treated from 25Dec2023 to 29Dec2023. No known allergies.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (VACCINATION FAILURE and COVID-19) with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose number unknown, single at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MVP (Mitral valve prolapse)" (unspecified if ongoing), notes: Mitral valve prolapse; "EDS (Ehlers-Danlos syndromes)" (unspecified if ongoing), notes: EDS (Ehlers-Danlos syndromes); "MSK (Musculoskeletal)" (unspecified if ongoing), notes: MSK (Musculoskeletal); "kidney disease 3" (unspecified if ongoing), notes: kidney disease 3; "gastric ulcer disease" (unspecified if ongoing), notes: gastric ulcer disease; "chronic ear infections" (unspecified if ongoing), notes: chronic ear infections; "arthritis" (unspecified if ongoing); "multiple abdominal hernias" (unspecified if ongoing), notes: multiple abdominal hernias; "many allergies" (unspecified if ongoing), notes: many 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 19Dec2023, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive, notes: Tested positive for COVID 19Dec2023; (26Dec2023) Negative, notes: I tested negative 26Dec2023 and continued to feel better; (02Jan2024) Positive, notes: I retested and there was a very light positive; (03Jan2024) Positive, notes: This time it was clearly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient tested positive for COVID on 19Dec2023, and began taking Paxlovid that day (19Dec2023 to 23Dec2023), along with Zpack. Patient was on the 2-pill/twice daily due to stage 3 kidney disease.