chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 14:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Astma" (unspecified if ongoing); "Known allergies: Medications and foods" (unspecified if ongoing); "Known allergies: Medications and foods" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "bpd" (unspecified if ongoing); "POTS" (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 Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  Clinical course: Patient had no other medication in 2 weeks. Patient started Paxlovid treatment from 10Dec2022 to 12Dec2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 58.0
Sex: M
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) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: en6198), on 15Mar2021 as dose 2, single (Lot number: EN6208) and on 11Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer - Remission" (unspecified if ongoing), notes: Prostate Cancer - Remission. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Negative, notes: tested Negative twice 07Feb2023 and 09Feb2023; (09Feb2023) Negative, notes: tested Negative twice 07Feb2023 and 09Feb2023; (11Feb2023) Positive, notes: tested Positive 11Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid..
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=2/ vaccine brand other= Moderna; vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 at 14:30 as dose 5 (booster), single (Lot number: GJ6739) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jan2021 at 10:15 as dose 1, single (Lot number: EH9899), in right arm and on 29Jan2021 at 14:45 as dose 2, single (Lot number: EL1283), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 033H21A), in right arm and on 14May2022 at 14:00 as dose 4 (booster), single (Lot number: 001M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "need thyroid medication" (unspecified if ongoing), notes: other medical history: need thyroid medication. Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov1995.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021 at 09:00, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=2/ vaccine brand other= Moderna; vaccine dose number=3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 25.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has COVID-19 Treatment with Paxlovid, treatment start date was on 01Feb2023, treatment stop date was on 05Feb2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 79 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 at 17:00 as dose 1, single (Lot number: EL1284), in left arm, on 18Jan2021 at 12:00 as dose 2, single (Lot number: EL8982), in left arm, on 11Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 03Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "Post cardiac ablation" (unspecified if ongoing); "Kidney issues" (unspecified if ongoing); "Allergy: sulfa medications" (unspecified if ongoing); "Allergy: egg based vaccines" (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 30Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (08Feb2023) Negative; (12Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included Paxlovid from 31Jan2023 to 05Feb2023.
Age: 52.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: rebound infection. tested negative daily for 3 days; Posittive, notes: then felt congested again, tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received dose 5 on Nov2022 at 02:00 PM. Patient received Paxlovid from 01Feb2023 to 06Feb2023 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19, 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 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 027l21a), in right arm, as dose 3 (booster) , single (Lot number: 706221a), in left arm, on 12Mar2022 as dose 2, single (Lot number: 002b21a), in left arm and on 12Feb2022 as dose 1, single (Lot number: 006m20a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; ATORVASTATIN; LISINOPRIL; OXYBUTYNIN; HYDROCHLOROTHIAZIDE; INDOMETHACIN [INDOMETACIN]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid as treatment. Date of start of drug 01Feb2023 and Date of last administration 05Feb2023. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. The patient previously receive a COVID-19 Vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment (headache, cough and congestion); vaccine brand: Other, vaccine brand other: Moderna,vaccine administration date: 01Apr2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 21Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in left arm and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Mar2017; DOXEPIN, start date: Nov2018; RABEPRAZOLE, start date: Jan2003; ESCITALOPRAM, start date: Dec2017; PREMPRO, start date: Aug2016; VITAMIN B 12 [CYANOCOBALAMIN], start date: Sep2020; VITAMIN D3, start date: Jan2018; CALCIUM, start date: Jan2013.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other: Moderna,vaccine administration date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment (headache, cough and congestion)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (09Feb2023) Negative, notes: BinaxNOW COVID-19 Antigen Self Test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took treatment for COVID 19 with Paxlovid from 02Feb2023 to 07Feb2023. The concomitant drugs Vitamin B12 and Vitamin D3 are from nature made brand and Calcium of Citracal brand. Reportedly, Paxlovid completed on 07Feb2023. Tested negative on BinaxNOW COVID-19 Antigen Self Test on 09Feb2023. Became symptomatic again on 11Feb2023 at 06:00 PM. Retested on same test and positive. Symptoms include headache, cough and congestion. Patient did not take any treatment for this.; Sender's Comments: Based on the available information in the case, an association between the reported events INTERCHANGE OF VACCINE PRODUCTS , DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 as dose 5 (booster), single (Lot number: CNS16785) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "some arthritis" (unspecified if ongoing), notes: some arthritis. Concomitant medication(s) included: BUPROPION, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: regimen prescribed by doc day after testing positive; (2023) Negative, notes: tested negative at day 9 post; (2023) Positive, notes: on day 12 post initial positive test; (2023) Positive, notes: converted to positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies no. Other medication in 2weeks Yes. Paxlovid, Treatment start date: 02Feb2023, Treatment stop date: 06Feb2023, Indication: Treatment of COVID-19. I went through regimen prescribed by doc day after testing positive. Included prednisone (decreasing dosage), Famotodine, baby aspirin, extra Vit C, Vit D, and Zinc. I recovered nicely, tested negative at day 9 post, no symptoms. Over weekend started feeling fatigued, and on day 12 post initial positive test, converted to positive again.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; 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 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic hypertension and high cholesterol controlled by medication" (unspecified if ongoing), notes: Chronic hypertension and high cholesterol controlled by medication; "Chronic hypertension and high cholesterol controlled by medication" (unspecified if ongoing), notes: Chronic hypertension and high cholesterol controlled by medication. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Pfizer / BioNTech; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Negative, notes: Tested on 08Feb2023 and test was negative for COVID; (10Feb2023) Positive, notes: Tested again on 10Feb2023. Test was positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient finished a 5-day course of Paxlovid on 03Feb2023. She started feeling better, less fatigue. Tested on 08Feb2023 and test was negative for COVID. Tested again on 10Feb2023. Test was positive for COVID. Started experiencing a recurrence in symptoms on 11Feb2023. Runny nose, congestion, headache, fatigue, no fever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Janssen Dose Number: 1, Pfizer/BioNTech  Dose Number: 2 / Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2, single (Lot number: FF2590) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 at 15:15 as dose 3 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: JENCYCLA, start date: 05Aug2021; FLUOXETINE, start date: 09Apr2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2021, outcome "unknown", described as "Janssen Dose Number: 1, Pfizer/BioNTech Dose Number: 2 / Moderna Dose Number: 3"; 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There were no known allergies. The patient received other medications (Jencycla and Fluoxetine) in 2 weeks. Antiviral details: The patient received Paxlovid from 01Feb2023 to 06Feb2023 for treatment of COVID-19.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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: "fibromyalgia" (unspecified if ongoing); "colitis" (unspecified if ongoing); "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 01Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Dark Positive, notes: by Day 8 I had returning symptoms and a dark POSITIVE result with a follow up rapid antigen test; (01Feb2023) Positive, notes: Took Paxlovid on Day 1 of COVID 19 positive test; (07Feb2023) Negative, notes: I tested negative on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: Paxlovid (Lot number: GF6437) treatment start date was 01Feb2023 and treatment stop date was 06Feb2023, Indication included treatment of COVID-19. Reported that, Rebound. Took Paxlovid on Day 1 of COVID 19 positive test. Did not have symptoms before the positive test confirmed positive COVID, Dr. considered this DAY 1 and Patient began taking the Paxlovid. After completing the 5 days of Paxlovid she tested negative on Day 7 and by Day 8 she had returning symptoms and a dark POSITIVE result with a follow up rapid antigen test. Patient now (at the time of report) at Day 9 and isolating for the required 5 days, with fever, runny nose, body aches, fatigue. Patient just as bad, if not worse, as she was on Day 1. No treatment received for rebound symptoms and not recovered from symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: 9261), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN62012116), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 30135B4), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE oral, start date: 17Nov2021; FAMOTIDINE, start date: 17Nov2021; TYMLOS, start date: 12Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; vaccine dose number=4: Moderna; vaccine dose number=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 26Mar2021 as dose 2, single (Lot number: EP7434), in right arm and on 11Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Sep2022 as dose 4 (booster), single (Lot number: AS 7153M), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown", described as "vaccine dose number=4: Moderna; vaccine dose number=3: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2023) Positive; (27Jan2023) Positive; (29Jan2023) Negative; (30Jan2023) Negative; (04Feb2023) Positive; (05Feb2023) Positive; (06Feb2023) Positive; (07Feb2023) Positive; (08Feb2023) Positive; (09Feb2023) Positive; (10Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid Rebound. Patient tested positive for COVID 20Jan2023. Took Paxlovid 21Jan2023-25Jan2023. Tested positive thru 27Jan2023. Tested negative 29Jan2023 & 30Jan2023. Tested positive again 04Feb2023-10Feb2023.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received antiviral for COVID-19 Treatment which was started on 30Jan2023 and stopped on 03Feb2023. The reason for vaccine lot unknown was reported as not available/provided to reporter at the time of report completion. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Humoral immune defect, Investigation
Clinical narrative: it's making my body not fighting of anything else; I have to go to ER, it was that bad; I had my 3rd Booster; I broke out with shingles; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 Immunization; Shingles vaccine. The following information was reported: HUMORAL IMMUNE DEFECT (medically significant), outcome "unknown", described as "it's making my body not fighting of anything else; I have to go to ER, it was that bad"; HERPES ZOSTER (non-serious), outcome "unknown", described as "I had my 3rd Booster; I broke out with shingles". The events "it's making my body not fighting of anything else; i have to go to er, it was that bad" and "i had my 3rd booster; i broke out with shingles" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Work: Unknown results. Therapeutic measures were taken as a result of humoral immune defect, herpes zoster.  Clinical course: Nurse stated that the patient got her shingles vaccine (Further name could not be clarified hence, suspect captured as Unspecified vaccine) so, she should not have gotten the shingles and she thought that they are saying that it's by having the third booster, it made her body not fighting of anything else. So, she has to go to ER, it was that bad. She did not have liver issues because they had to give me antiviral drugs (Intent: Treatment) because of the shingles.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral treatment (Paxlovid) from 03Feb2023 to 07Feb2022 for COVID-19. Patient did not other medications in 2 weeks. Patient did not have known allergies. Patient did not have any other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Psoriasis" (unspecified if ongoing), notes: on a biologic medication for treatment of Psoriasis; "Nut allergy" (unspecified if ongoing); "Dairy allergy" (unspecified if ongoing); "food allergies" (unspecified if ongoing); "mildly immunocompromised" (unspecified if ongoing), notes: was prescribed Paxlovid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Positive; (08Feb2023) Negative; (12Feb2023) Positive; (13Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Feb2023 to 07Feb2023.   Clinical course: The patient initially tested positive on 31Jan2023. The patient started Paxlovid on 02Feb20223 and completed the five days of treatment on 07Feb2023. The patient carefully took each dose 12 hours apart at 9:00 am and 9:00 pm each day. The patient started testing negative on 08Feb2023 and continued to test daily afterward.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Jan2023 to 05Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second; She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second".  Clinical course: She received the first dose in Aug, then got Covid and was advised to wait 3 months before getting the second, and by then (Dec) no one had it.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 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 included: "Osteoporosis" (unspecified if ongoing); "Hypercalcemia" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies.  The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Feb2023 to 13Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9014) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: Er8732), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: Ff3590), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: Fk9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "overweight" (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 12Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive. Therapeutic measures were taken (paxlovid) as a result of vaccination failure, covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: 0H9694) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 030L20A), on 25Feb2021 as dose 2, single (Lot number: 010A21A) and on 04Nov2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Surgical Hypothyroidism" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Feb2015; AMLODIPINE, start date: Jan2011; ESCITALOPRAM, start date: May2022; LIOTHYRONINE, start date: Feb2017; RALOXIFENE, start date: Mar2021. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Feb2023) Positive, notes: tested positive on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 01feb2023 to 06feb2023.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: Illness
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: 0H9694) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 030L20A), on 25Feb2021 as dose 2, single (Lot number: 010A21A) and on 04Nov2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Surgical Hypothyroidism" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Feb2015; AMLODIPINE, start date: Jan2011; ESCITALOPRAM, start date: May2022; LIOTHYRONINE, start date: Feb2017; RALOXIFENE, start date: Mar2021. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Feb2023) Positive, notes: tested positive on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 01feb2023 to 06feb2023.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: 0H9694) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 030L20A), on 25Feb2021 as dose 2, single (Lot number: 010A21A) and on 04Nov2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Surgical Hypothyroidism" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Feb2015; AMLODIPINE, start date: Jan2011; ESCITALOPRAM, start date: May2022; LIOTHYRONINE, start date: Feb2017; RALOXIFENE, start date: Mar2021. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Feb2023) Positive, notes: tested positive on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 01feb2023 to 06feb2023.
Age: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EN6203), in left arm, on 31Mar2021 at 13:00 as dose 2, single (Lot number: ER8730), in left arm, on 08Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (05Feb2023) Negative; (07Feb2023) Negative; (11Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: 1923798A) from 01Feb2023 to 05Feb2023. Clinical course: The patient first tested positive on 30Jan2023 with no symptoms. Then tested negative on 05Feb2023 and 07Feb2023. But again, tested positive on 11Feb2023 with cold symptoms, slight fever.