chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Sx of cough on 07Mar then COVID positive test on 09Mar2023; Sx of cough on 07Mar then COVID positive test on 09Mar2023; Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4; This is a spontaneous report received from a non-contactable reporter (nurse).  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 36 years intramuscular for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 011J20A), on 01Feb2021 as dose 2, single (Lot number: 028L20A) and on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A) 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 30Sep2022, outcome "unknown", described as "Moderna, Dose Number: 1, 2, 3 / Pfizer, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "recovering" and all described as "Sx of cough on 07Mar then COVID positive test on 09Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Mar2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient has no COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events drug ineffective, COVID-19, and interchange of vaccine product. This case will be reassessed upon receipt of additional information.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: I tested negative for covid; (09Mar2023) Positive, notes: tested positive for covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Day 0 of testing positive for Covid; (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
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 (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as DOSE 5 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 59 years old, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: uknown), 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 and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (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: Covid-19 Test (SARS-CoV-2 test): (Feb2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  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, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Initial vaccine was Johnson&Johnson. 2 boosters were Pfizer; Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). 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), as dose 2 (booster), single (Lot number: Unknown) and as dose 3 (booster), single (Lot number: Unknown) for COVID-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: PROZAC. Past drug history included: Known allergies: Keflax, reaction: "Known allergies: Keflax". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Initial vaccine was Johnson&Johnson. 2 boosters were Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Feb2023, outcome "not recovered" and all described as "Paxlovid for COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient experienced sore throat, sneezing, and stuffy nose on 20Feb2023 and was treated with Paxlovid for COVID-19 from 02Mar2023 to 07Mar2023.   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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Name of Drug as Reported ; Moderna; This is a spontaneous report received from a contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 35 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL3246), in right arm and on 28Jan2021 as dose 2, single (Lot number: EL9265), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown", described as "Name of Drug as Reported ; Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Mar2023) Positive, notes: but still positive result on an antigen test; (09Mar2023) Positive, notes: I have a solid, positive antigen test result. No symptoms; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received Paxlovid from 01Mar2023 to 06Mar2023 for COVID-19. The patient had no known allergies.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events drug ineffective, COVID-19, and interchange of vaccine products. This case will be reassessed upon receipt of additional information.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3249), in left arm, as dose 2, single (Lot number: EW5318), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa: Allergy" (unspecified if ongoing), notes: Sulfa: Allergy. The patient's concomitant medications were not reported. Past drug history included: Sudafed, start date: 03Feb2021, stop date: 03Feb2021, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for the event.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 49-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 (batch/lot number: unknown) at the age of 48 years old for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 1, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  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: 69.0
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; Vaccine brand: Pfizer/BioNTech, Vaccine dose number: 5, 4 / Vaccine brand other: Moderna, Vaccine dose number: 3, 2, 1; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 13:00 as dose 5 (booster), single (Lot number: Gh9703) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2022 at 14:00 as dose 4 (booster), single (Lot number: Fn2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Jan2021 at 12:00 as dose 1, single (Lot number: 042l20a), in left arm, on 27Feb2021 at 12:00 as dose 2, single (Lot number: 002a21a), in right arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 011f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing). Concomitant medication(s) included: NAC [ACETYLCYSTEINE], start date: 13Jan2020, stop date: 09Mar2023; QUERCETIN, start date: 13Jan2020, stop date: 09Mar2023; VITAMIN C [ASCORBIC ACID], start date: 13Jan2020, stop date: 09Mar2023; ZINC, start date: 13Jan2020, stop date: 09Mar2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Percocet, reaction(s): "Known allergies: Percocet"; Demerol, reaction(s): "Known allergies: Demerol". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17May2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech, Vaccine dose number: 5, 4 / Vaccine brand other: Moderna, Vaccine dose number: 3, 2, 1"; 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: Negative, notes: Covid rebound 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient received Paxlovid from 27Feb2023 to 28Feb2023 for treatment of COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-1 test
Clinical narrative: COVID-19; COVID-19; vaccine brand other=Moderna,vaccine dose number=1/vaccine brand other=Moderna,vaccine dose number=2; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2021 as dose 1, single (Lot number: 048B21A) and on 19May2021 as dose 2, single (Lot number: 038C21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Albuterol, reaction(s): "Cough"; Albuterol, reaction(s): "Wheezing". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2021, outcome "unknown", described as "vaccine brand other=Moderna,vaccine dose number=1/vaccine brand other=Moderna,vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive, notes: positive home antigen test after 2 negative tests; Negative, notes: positive home antigen test after 2 negative tests; Negative, notes: positive home antigen test after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Mar2023 to 06Mar2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 27Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. COVID 19 Treatment with Paxlovid from 02Mar2023 to 08Mar2023, lot number: GF6436   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid from 28Feb2023 to 04Mar2023. 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 available information, a possible contributory role of the subject vaccine  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: Stem cell transplant
Clinical narrative: had stem cell transplant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (ongoing). The patient's concomitant medications were not reported. The following information was reported: STEM CELL TRANSPLANT (medically significant), outcome "unknown", described as "had stem cell transplant".  Clinical course: Reporter asked whether the patient can be vaccinated with third dose of Original series of Pfizer covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. The reported 'stem cell transplant' was most likely from an intercurrent medical condition not related to vaccination with BNT162B2.  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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023; Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; MELATONIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2023, outcome "unknown" and all described as "Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient has no Known allergies. Facility type vaccine: Workplace clinic. Patient had not received any other vaccine in four weeks. Patient had no covid prior vaccination. If Patient was tested covid positive post vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the use of suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 16Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, 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) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in 2weeks. Patient received Paxlovid treatment from 26Feb2023 till 05Mar2023. Patient had no known allergies. Other medical history was none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Apr2021 at 11:00 as dose 1, single (Lot number: EW0164), in left arm, on 09May2021 at 17:00 as dose 2, single (Lot number: EW0179), in left arm, on 11Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 05Jul2022 at 14:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BIOTIN, start date: Jan2015; PREGNENOLONE, start date: Apr2018. Patient received also as supplements Thyroid Synergy (Designs for Health) and O.N.E. multivitamin (Pure Encapsulations) from Apr2018 to unknown date. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment with Paxlovid.  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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine_brand_other=J&J, vaccine administration date: 06Apr2021/vaccine_brand_other=Moderna, vaccine administration date: 15Sep2021; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=J&J, vaccine administration date: 06Apr2021/vaccine_brand_other=Moderna, vaccine administration date: 15Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: days since my first dose and I still am testing positive (have never tested negative during or after the course of treatment). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Brand Paxlovid treatment start date was 03Mar2023 and treatment stop date was 08Mar2023,Indication reported Treatment of COVID-19. Other medication in 2weeks was reported as yes.  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: 63.0
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) (Other HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EL0140), in left arm, on 30Apr2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Acid reflux" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. The patient was treated with Paxlovid from 03Mar2023 to 08Mar2023. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-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: "Crohns" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 15:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 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 immunisation. The patient's relevant medical history included: "hypothyroidism (mild)" (unspecified if ongoing), notes: hypothyroidism (mild), cll (0 stage, no treatment needed); "cll" (unspecified if ongoing), notes: hypothyroidism (mild), cll (0 stage, no treatment needed). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 01Mar2023 to 06Mar2023, day 2 of 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.
Age: 69.0
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; Dose number=5/ Dose number=4; 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EL9261), in right arm, on 12Mar2021 at 13:00 as dose 2, single (Lot number: EN9809), in right arm and on 19Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: 038A22A), in left arm and on 01Nov2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16May2022 at 13:00, outcome "unknown", described as "Dose number=5/ Dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Mar2023) positive, notes: tested positive for Covid on 03Mar2023; (10Mar2023) negative, notes: tested negative for Covid on 10Mar2023; (12Mar2023) positive, notes: tested positive today, 12Mar2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with other medications in 2 weeks of Paxlovid. Patent was tested positive for Covid on 03Mar2023, and immediately started taking Paxlovid, then tested negative for Covid on 10Mar2023. On 11Mar2023, patient stated sneezing and blowing her nose, which continued today, 12Mar2023. So far, the patient not had any sore throat, coughing or fevers, like she did when she first got Covid. Patient coughed for 3 days with the initial infection, and although she still had phlegm on her chest and not coughing much now. She was again tested positive 12Mar2023. No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-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) 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), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment was given from 28Feb2023 to 04Mar2023. Adverse event Rebound on 10Mar2023 02:00 PM and the patient was not recovered and No treatment received. Other medication in 2 weeks was Unknown.  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, 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) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:30 as dose 4 (booster), single (Lot number: GH9694), 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: "Diabetes" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: JANUMET, start date: Feb2008; HYDROCHLOROTHIAZIDE, start date: Feb2008; LEVOTHYROXINE, start date: Jan2004; ATORVASTATIN, start date: Jan2010; LOSARTAN, start date: Jan2015; AMLODIPINE, start date: Jan2015; VITAMIN D [VITAMIN D NOS], start date: Jan2005; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI, start date: Jan2000; MAGNESIUM, start date: Jan2022; BAYER LOW DOSE, start date: Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Feb2023) Positive; (06Mar2023) Positive; (12Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: No known allergies. The patient tested positive for COVID on 21Feb2023 and exhibited symptoms until the 26th. On 06Mar2023, I developed symptoms, i.e. runny nose, fever, etc. and again tested positive for COVID. Patient was still testing positive 7 days later (12Mar). Patient received Paxlovid from 21Feb2023 to 26Feb2023 as anti viral COVID 19 treatment.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8733), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Mar2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Mar2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PF-07321332, ritonavir (PAXLOVID), from 03Mar2023 to 08Mar2023 as covid-19 treatment.
Age: 54.0
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) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 15Oct2022 at 12:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (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 Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 28Feb2023 to 04Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment/ Contracted COVID-19; COVID 19 Treatment/ Contracted COVID-19; 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 68-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 (Lot number: GJ5342) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), on 17Feb2021 as dose 2, single (Lot number: EN6200), on 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: FOSAMAX, start date: 18May2018. Past drug history included: Known allergies: lomotil, reaction(s): "Known allergies: LOMOTIL", notes: Known allergies: LOMOTIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "COVID 19 Treatment/ Contracted COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 25Feb2023 to 02Mar2023.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 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), 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 included: "Hypertension" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "known allergies: Aspirin" (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 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 25Feb2023 to 01Mar2023.  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: Linked Report(s) : US-PFIZER INC-202300107549 same patient, different drug and event.;
Age: 42.0
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).  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, 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 was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient did previously receive a COVID-19 Vaccine. The patient was treated with Paxlovid from 04Mar2023 to 08Mar2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107531 Same patient, different drug and event.;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH99694) at the age of 69 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 included: "osteoarthritis" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 21Feb2023.; Sender's Comments: Based on available information, a possible contributory role of BNT162b2, BNT162b2 omi ba.4-5  vaccine can not be excluded for the reported events of COVID-19 and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.