chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Lot number: HF9300) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history nor known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) positive; (13Jan2024) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Haemoptysis
Clinical narrative: hemoptysis; ANA+; This is a spontaneous report received from a Physician.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunisation, reaction(s): "syncope"; Comirnaty (DOSE 2), for COVID-19 immunisation, reaction(s): "hemoptysis", "cavitary pulmonary disease", "syncope". The patient received the first dose and had a syncope, he was treated and back to the baseline. Then after the second dose, the patient had another episode of syncope and hemoptysis. After that, he was diagnosed with cavitary pulmonary disease. The patient received a treatment and follow up with the specialist. The following information was reported: ANTINUCLEAR ANTIBODY POSITIVE (hospitalization) with onset 12Jan2024 at 16:30, outcome "unknown", described as "ANA+"; HAEMOPTYSIS (hospitalization) with onset 12Jan2024 at 16:30, outcome "unknown", described as "hemoptysis". The events "hemoptysis" and "ana+" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (12Jan2024) Positive.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: A possible contribution of suspect drug BNT162B2 OMI XBB.1.5 cannot be totally excluded for the reported events. However, information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  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.,Linked Report(s) : US-PFIZER INC-202400013874 Same reporter and patient, different dose and event;US-PFIZER INC-202400013049 Same reporter and patient, different dose and event;
Age: 35.0
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 Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2022 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01Feb2018; TESTOSTERONE CYPIONATE, start date: 17Oct2013; LYRICA, start date: 10Oct2022. 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.  Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
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 Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE. Past drug history included: Penicillin, reaction(s): "penicillin Allergy". Vaccination history included: Bnt162b2 (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 3, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 4, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jan2024) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Paxlovid used for COVID 19 Treatment from 03Jan2024 to 07Jan2024. Other medication in 2weeks product: Famotidine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Lot number: HG4629) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: pfizer biontech (DOSE 4 (BOOSTER), SINGLE (Batch/Lot No: FM9992, Location of injection: Arm Left)), administration date: 06May2023, when the patient was 59-year-old, for Covid-19 immunization; pfizer biontech (DOSE 3 (BOOSTER), SINGLE (Batch/Lot No: FJ1620, Location of injection: Arm Left)), administration date: 09Dec2022, when the patient was 58-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing); "Allergy: Penicillib" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Levoflaxacin, reaction(s): "Drug Allergies:  Levofloxacin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Patient took Paxlovid from 03Jan2024 to 08Jan2024. 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.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other Moderna, vaccine dose number 5; Vaccine brand Pfizer BioNTech, vaccine dose number 4; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Oct2023 at 12:00 as dose 5 (booster), single), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: IPRATROPIUM BROMIDE, start date: 10Nov2023, stop date: 01Jan2024. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2023 at 12:00, outcome "unknown", described as "Vaccine brand other Moderna, vaccine dose number 5; Vaccine brand Pfizer BioNTech, vaccine dose number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Jan2024 to 09Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Nurse.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: Ace inhibitor" (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". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 03Jan2024 to 08Jan2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy may vary from person to person and is subject to multiple factors. The possibility of an association between the event Drug ineffective (COVID19) and the suspect drug BNT162B2 OM BA.4-5 cannot be fully excluded. This case will be reassessed when additional information becomes available.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 07Jun2021; THERAFLU [DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 02Jan2024, stop date: 08Jan2024. Vaccination history included: moderna (DOSE 1, SINGLE, vaccine location: Left arm), administration date: 28May2021, when the patient was 35-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, vaccine location: Left arm), administration date: 19Nov2021, when the patient was 35-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE,), administration date: 20Oct2022, when the patient was 36-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 Included Paxlovid from 08Jan2024 to 04Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy (COVID-19 and Vaccination failure) with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 72.0
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 Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccine administration time=11:30 AM, Vaccine location=Left arm), administration date: 20Jan2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Vaccine administration time=07:00 PM, Vaccine location=Left arm), administration date: 29Sep2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine administration time=10:30 AM, vaccine location=Left arm), administration date: 20Apr2022, when the patient was 71-year-old, for COVID-19 immunization. The patient had no known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2024, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2024) Positive; (08Jan2024) Negative; (13Jan2024) Posititve. The patient tested positive on 02Jan2024 and took Paxlovid for 5 days.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400015030 Same patient/Vaccine,different event,different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient received Paxlovid as COVID 19 Treatment from 03Jan2024 to 08Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, Location of injection: Arm Left), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 02Jan2024 to 06Jan2024 were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 12:00 as dose 1, single (Lot number: HG4629) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Known allergies:Penicillin" (unspecified if ongoing); "Known allergies: Crab" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: 28Nov2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies:Amoxicillin"; Atorvastatin, reaction(s): "Known allergies:Atorvastatin". Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 05, Manufacturer: Unknown), for COVID-19 Immunization. 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.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) 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". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment was Paxlovid from 04Jan2024 to 08Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 in Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient did not have known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures including Paxlovid from 15Aug2023 to 19Aug2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no know allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01Jan2024 to 06Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Lot number: H64628) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8732), administration date: 06Apr2021, when the patient was 53-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Er8737), administration date: 27Apr2021, when the patient was 53-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER); SINGLE, Batch/Lot No: 032F21A), administration date: 01Dec2021, when the patient was 54-year-old, for COVID-19 immunization; moderna COVID-19 vaccine (DOSE 4 (BOOSTER); SINGLE, Batch/Lot No: AS7163B), administration date: 28Sep2022, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (10Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2024) negative, notes: Had negative test on 10Jan. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Jan2024 to 06Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: In the initial infection, I had only head congestion/ COVID 19 Treatment; In the initial infection, I had only head congestion/ COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS (vascular)" (unspecified if ongoing), notes: vascular. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "In the initial infection, I had only head congestion/ COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Dec2023 to 05Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Laboratory test, Pneumothorax, Pulmonary embolism
Clinical narrative: I suffered with Pneumothorax Pulmonary Embolism; I suffered with Pneumothorax Pulmonary Embolism; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:00 as dose 1, single (Lot number: HG4664) at the age of 59 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 11Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "caffeine allergy" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. Past drug history included: Loratab, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (dose 3; manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 2; manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 1; manufacturer unknown), for Covid-19 Immunization. The following information was reported: PNEUMOTHORAX (hospitalization, medically significant), PULMONARY EMBOLISM (hospitalization, medically significant) all with onset 03Nov2023 at 18:00, outcome "recovering" and all described as "I suffered with Pneumothorax Pulmonary Embolism". The patient was hospitalized for pneumothorax, pulmonary embolism (start date: 05Nov2023, discharge date: 08Nov2023, hospitalization duration: 4 day(s)). The event "i suffered with pneumothorax pulmonary embolism" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: lab test: Unknown results, notes: whole bunch was done when he was hospitalized. Therapeutic measures were taken as a result of pneumothorax, pulmonary embolism.  Clinical course: The patient reported that he suffered with Pneumothorax Pulmonary Embolism due to the Comirnaty booster shot. The patient got it in his shoulder, and he just do not remember which shoulder. 4 weeks prior vaccination, he got a Flu vaccine (unspecified vaccine). The patient was hospitalized on 05Nov2023, and was discharge on 08Nov2023. The patient was not taking Blood thinners. He was not taking that until he was hospitalized. A whole bunch of laboratory tests were done when he was hospitalized. It was not in the recent two weeks, but there was a bunch of them when he was, including right after he got out of the hospital.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Cardiomyopathy" (unspecified if ongoing); "Hot AAA" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 4, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from04Jan2024 to 08Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events vaccination failure and Covid-19 are  related to BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)) cannot be excluded.  This case will be reassessed should additional information become available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 04Jan2024 to 10Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: M
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 Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jan2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative, notes: tested negative five days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 04Jan2024 to 08Jan2024. Clinical course: Treatment worked. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
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 Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Diabetes II" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Sep2019; HYDROCHLOROTHIAZIDE, start date: 01Jun2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2024, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2024) Positive. Therapeutic measures included Paxlovid from 01Jan2024 to 05Jan2024 were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 73.0
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 Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Known allergies: Mustard" (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 31Dec2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2023) negative; (31Dec2023) positive; (04Jan2024) negative; (10Jan2024) negative; (13Jan2024) positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 31Dec2023 to 05Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
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 Physician.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (13Jan2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Negative. Therapeutic measures (Paxlovid treatment start date: 07Jan2024, stop date: 11Jan2024) were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Relevant past drug history was reported as none.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID 19 cannot be ruled out.
Age: 34.0
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 Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 01Jan2024 to 06Jan2024. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
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 Consumer or other non HCP.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jul2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "Unknown" and all described as "COVID 19 Treatment". Therapeutic measures including Paxlovid from 01Jan2024 to 05Jan2024 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOL; PRAVASTATIN; LOSARTIN; BENADRYL; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GJ5342), administration date: 20Sep2022, when the patient was 69-year-old, for COVID-19 immunization; moderna (Dose Number: 3, Batch/Lot No: 032F21A), administration date: 02Nov2021, when the patient was 68-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 013A21A), administration date: 04Mar2021, when the patient was 68-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 042L20A), administration date: 02Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, latency 13 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Positive, notes: positive test after 2, previously negative tests; (Jan2024) Negative, notes: positive test after 2 previously negative tests; (Jan2024) Negative, notes: positive test after 2, previously negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Rebound of COVID symptoms and positive test after 2 previously negative tests following initial case of COVID and Paxlovid treatment
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 04Jan2024 to 09Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 33.0
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 Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG (Eli Lilly), start date: 07Feb2002. 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 included Paxlovid from 30Dec2023 to 03Jan2024 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Low thyroid" (unspecified if ongoing), notes: Low thyroid; "Known allergies to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levoquin, reaction(s): "Known allergies to Levoquin"; Clindamycin, reaction(s): "Known allergies to Clindamycin". Vaccination history included: Covid-19 vaccine DOSE 1, DOSE 2, DOSE 3, DOSE 4 and DOSE 5 all are MANUFACTURER UNKNOWN, all for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2024) Positive. Therapeutic measures including Paxlovid from 04Jan2024 to 09Jan2024 were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; initial 2 doses of PFE Covid vaccine in Mar2021; then a PFE Covid booster in Oct2021, a Moderna booster in Sep2022; another Moderna booster in Sep2023; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2022 as dose 4 (booster), single) and on 19Sep2023 as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "initial 2 doses of PFE Covid vaccine in Mar2021; then a PFE Covid booster in Oct2021, a Moderna booster in Sep2022; another Moderna booster in Sep2023". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE;Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE;Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE;Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE;Manufacturer: Unknown), for Covid-19 Immunization.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative two days in a row; Negative, notes: testing negative two days in a row. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: treatment included paxlovid from 04Jan2024 to 08Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Environmental allergies" (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 Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Jan2024 to 11Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.