chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
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 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: I tested positive within two days after testing negative and I have symptoms again; (17Dec2023) Positive, notes: I tested positive within two days after testing negative and I have symptoms again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient used Paxlovid from 08Dec2023 to 13Dec2023 for the COVID 19 treatment. Patient was tested positive within two days after testing negative and she has symptoms again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 77.0
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 77-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 15:00 as dose 1, single (Lot number: 1147595) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "bronchitis" (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing); "allergies: sulfa" (unspecified if ongoing); "allergies: dairy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Jul1990; SINGULAIR, start date: Jul1990; DEXILANT, start date: Jul1990. The patient also took other concomitant therapy. Vaccination history included: Covid 19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 09Dec2023 to 13Dec2023 for the treatment of COVID-19. The patient received other medication in 2 weeks was vitamins and its start date was Jul1990.   No follow-up attempts are possible.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 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 3 (Booster), Single; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single; Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The anti-viral Paxlovid Pfizer from 08Dec2023 to 13Dec2023 used for the treatment of COVID-19. Vaccine administration time: 12:00 AM. The 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: 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 an Other HCP.  A 52-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 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 07Dec2023 to 11Dec2023.  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 the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 30-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 14:15 as dose 1, single (Lot number: HG2649) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type two diabetes" (unspecified if ongoing); "elevated blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing), notes: history of asthma; "attention deficit disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 06Dec2023 to 11Dec2023.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Therapeutic response unexpected
Clinical narrative: vaccine helping with herpes; feels like getting run over by a car; the numbness; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Bell's palsy" (unspecified if ongoing), notes: Bell's palsy. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vaccine helping with herpes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like getting run over by a car"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "the numbness".  Additional information: First took Pfizer vaccine, was a little reluctant after he took first 2 doses. Realized, health problems he had, before having the vaccines, that the vaccines were beneficial for that problem. Clarified, Pfizer Covid vaccine was beneficial for problems he had prior to having the vaccines. Has taken between 7 or 8 vaccines. Has suffered with virus, herpes, for quite some time. Once he took first vaccine, it helped a lot. Helped to point, everything completely disappeared. For that reason, is taking more shots because those things come and go. Vaccine has been helping a lot. It goes in genitals, eyes, nostrils, it goes everywhere. With this vaccine, it has been getting better and better, does not get it as much as he used to. Is almost a thing of the past. It is not curing it 100 percent but, the  benefits are just extremely great. Has a few pills, the doctor prescribed. They were not even one third good as the vaccine, not as effective. Also, used to have and, still has Bell's palsy in face. After taking first vaccine, started feeling better and the numbness, the side effects. He could move his lips properly, got better. Hardly stayed better since then.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300449350 Same patient, same drug/different dose, different AEs;
Age: 44.0
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 44-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 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: Gm9694, Location of injection: Arm Right), administration date: 22Sep2022, when the patient was 43-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Fh8020, Location of injection: Arm Right), administration date: 15Oct2021, when the patient was 42-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: Ew1062, Location of injection: Arm Right), administration date: 14Apr2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Er8733, Location of injection: Arm Right), administration date: 24Mar2021, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 06Dec2023 to 11Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First Symptom: 08Dec2023; First Symptom: 08Dec2023; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: HH7595) at the age of 66 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: Bnt162b2 (DOSE 1, SINGLE, Batch/lot Number: EW0153, Anatomical Location: Left arm), administration date: Apr2021, when the patient was 63 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Batch/lot Number: EW0167, Anatomical Location: Left arm), administration date: May2021, when the patient was 63 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot Number: FH8028, Anatomical Location: Left arm), administration date: Nov2021, when the patient was 64 years old, for COVID-19 immunisation; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/lot Number: GH9693, Anatomical Location: Left arm), administration date: Oct2022, when the patient was 65 years old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Dec2023, outcome "recovered" (Dec2023) and all described as "First Symptom: 08Dec2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2023) Positive; (15Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 09Dec2023 to 14Dec2023. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after receiving the vaccine.; Tested positive for Covid after receiving the vaccine.; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster); manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "Tested positive for Covid after receiving the vaccine.". The event "tested positive for covid after receiving the vaccine." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid after receiving the vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: AE treatment reported with Paxlovid.  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-202300450520 Same reporter, patient, product / different event;
Age: 80.0
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.  An 80-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 80 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertonia" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Allergic to almonds, shrimp" (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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 09Dec2023 to 13Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
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 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Nov2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and 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; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 07Dec2023 to 12Dec2023.  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: 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 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 09:15 as dose 1, single (Batch/Lot number: unknown) at the age of 65 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: COVID-19 vaccine (DOSE 1, SINGLE), administration date: 10Apr2021, when the patient was 63-year-old, for COVID-19 immunization; COVID-19 vaccine (DOSE 2, SINGLE), administration date: 01May2021, when the patient was 63-year-old, for COVID-19 immunization; COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 23Nov2021, when the patient was 64-year-old; COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 18Apr2022, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 30Sep2022, when the patient was 64-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (13Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2023) negative; (15Dec2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 07Dec2023 to 12Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine  brand  other=moderna/ vaccine brand=Pfizer / BioNTech/ vaccine brand other=moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:00 as dose number unknown, single (Lot number: GJ6665) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jun2022 as dose number unknown, single (Lot number: 056A22A), in left arm and on 21Sep2023 at 11:00 as dose number unknown, single (Lot number: 3030368), in left arm for covid-19 immunisation. The patient's relevant medical history included: "glaucoma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: 09Oct2012, stop date: 18Dec2023; ATORVASTATIN, start date: 04Oct2018, stop date: 18Dec2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Oct2022 at 14:00, outcome "unknown", described as "vaccine  brand  other=moderna/ vaccine brand=Pfizer / BioNTech/ vaccine brand other=moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Dec2023 to 12Dec2023. Clinical course: Patient had no known allergies.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand Other: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 5 (booster), single (Lot number: 067H22A) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 20Mar2021 as dose 2, single (Lot number: EP6955) and on 29Sep2021 as dose 3 (booster), single (Lot number: EW0185) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 067H22A), in left arm and on 18Oct2023 as dose 6 (booster), single (Lot number: 027E22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic back pain" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand Other: Moderna". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19 from 09Dec2023 to 14Dec2023. Clinical course: Patient had denied for any allergies.  No follow-up attempts are possible.
Age: 67.0
Sex: M
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 from product quality group.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Dec2023 as dose 1, single (Lot number: HGy628) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Aortic Anurysm" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Bath/lot number: GH9703), administration date: 26Sep2022, when the patient was 66-year-old, for COVID-19 immunization; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from Dec2023 to Dec2023. Patient had no known allergies.
Age: 30.0
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 Consumer or other non HCP.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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 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 "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive, notes: initial positive test; (Dec2023) Negative, notes: negative test. Therapeutic measures (Paxlovid treatment start date: 07Dec2023,stop date: 11Dec2023) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EN6198) at the age of 68 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). Concomitant medication included: MELOXICAM taken for osteoarthritis. Past drug history included: Aspirin for Joint pain. Vaccination history included: BNT162b2 (dose 1, single; lot number: EN5318), administration date: 26Jan2021, for COVID-19 immunisation, reaction: "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "I had 5 Pfizer shots and after everyone of them the arthritis pain disappeared". Additional information: The patient wanted to discuss some really unusual and positive after effects of the Pfizer COVID-19 vaccines, which happened multiple times, and it also happened with Moderna. The patient was mentioning this because he thinks that Pfizer is much closer than it thinks in helping people with arthritis. The patient has horrible osteoarthritis and the pain in every joint is unbearable and best thing he can do is some Aspirin and that's about it. But after the Pfizer shot, all of the pain in his joints went away. It was not just once, he has taken four or five shots and after each one his arthritis went away between 3 days in a week. He had more flexibility. He doesn't know if it was adding some kind of moisture into the joint or restoring it, some of it to some degree. That is why he thinks it is important for Pfizer to look into this for medical purpose or research. There is something here and whatever in the product, there is a piece of it that works for arthritis that works for both Pfizer and Moderna oddly enough.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300449913 same patient, vaccine and event; different dose;
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 a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 04Dec2023 to 09Dec2023.  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: Pfizer / BioNTech /Dose Number: 5: COVID 19 Treatment; Pfizer / BioNTech /Dose Number: 5: COVID 19 Treatment; 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 26Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Bipolar II Disorder" (unspecified if ongoing); "Penicllin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER:UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER:UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER:UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER:UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Pfizer / BioNTech /Dose Number: 5: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid treatment from 11Dec2023 to 15Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 43.0
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 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroid. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 08Dec2023 to 13Dec2023. Clinical course: Symptoms had resolved as of 15Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech/ Dose Number: 3/ COVID-19 Treatment; Pfizer / BioNTech/ Dose Number: 3/ COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA, start date: 01Sep2023. 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Pfizer / BioNTech/ Dose Number: 3/ COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 04Dec2023 to 09Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 61.0
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 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: 4g4589) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ankylosing spondylitis and asthma" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin and sulfa based drugs" (unspecified if ongoing); "Known allergies: Penicillin and sulfa based drugs" (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; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Dec2023, outcome "recovered" (11Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Dec2023) Negative, notes: Tested negative on Monday; (12Dec2023) Negative, notes: Tested negative on Tuesday. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 03Dec2023 to 07Dec2023. Clinical Course: On 02Dec2023 the patient had contracted Covid for the first time ever. Patient started Paxlovid and had very mild symptoms for the first 3 days, and then no symptoms. She was Isolated and quarantined for 5 days and tested negative on Monday, 11Dec2023 and negative on Tuesday 12Dec2023.
Age: 69.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Investigation, Monoplegia, Pain
Clinical narrative: Paralyzed my right arm; Started hurting; This is a spontaneous report and received from Consumer or other non HCPs.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Nov2023 as dose number unknown, single), in left arm for influenza immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MONOPLEGIA (medically significant) with onset 2023, outcome "unknown", described as "Paralyzed my right arm"; PAIN (non-serious) with onset 2023, outcome "unknown", described as "Started hurting". The events "paralyzed my right arm" and "started hurting" required physician office visit. The patient underwent the following laboratory tests and procedures: Laboratory test: Unknown Results. Therapeutic measures were taken as a result of monoplegia, pain. Clinical course: Patient had a reaction to the Pfizer COVID shot, it paralyzed her right arm. Patient took and had to go to the doctor and took Prednisone a course of Prednisone. She had to go back to the doctor after it was paralyzed and they give me some Prednisone (treatment). Patient took a flu shot that same day, It was again the left arm. Patient did not receive any other vaccine prior 4 week of vaccination. Patient did not receive any other Pfizer vaccine on the same day of vaccination. Time of vaccination was 11 O'clock. Patient had vaccine around it was 6 weeks ago, that was all she know. When patient had the vaccine (Covid-19 Vaccine) afterward it felt, it started hurting then and when she woke up the next morning her arm was paralyzed. Patient had to the doctor and they had give her medicine for it Prednisone.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Oct2023 at 09:30 as dose 4 (booster), single), in right arm 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: "benign prostate hyperplasia" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 18Jul2018, stop date: 17Dec2023; TAMSULOSIN, start date: 18Jul2018, stop date: 17Dec2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2023 at 09:30, outcome "unknown"; 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 with Paxlovid from 15Dec2023 to 17Dec2023. Clinical course: The patient had no known allergies  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid 19; got Covid 19; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 005570.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation, in 2023 as dose number unknown, single; FLU VACCINE VII taken for influenza immunisation, in 2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "COVID-19". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "got Covid 19". Clinical course: The patient received the latest Pfizer Covid 19 shot at PRIVACY about a month before patient cruised. Along with the flu and SRV shot (all about a week apart from each other). About a week after patient returned and got Covid 19. Patient lived in PRIVACY and many here have had it as well. The patient had the other brand when lived in PRIVACY but got Covid as well there.  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-PV202300205321 Same reporter/vaccine/event, different patient;
Age: 36.0
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 Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: 59267030402) at the age of 36 years 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: "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Dec2023 to 11Dec2023.  No follow-up attempts are possible.
Age: 48.0
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 49-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Anatomical location: Right arm), administration date: 05Jan2021, when the patient was 46-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 29Jan2021, when the patient was 46-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 05Nov2021, when the patient was 46-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 06Jun2022, when the patient was 47-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 17Oct2022, when the patient was 47-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (12Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Dec2023) Negative, notes: also no symptoms; (13Dec2023) Negative, notes: also no symptoms; (14Dec2023) Negative, notes: also no symptoms; (15Dec2023) Negative, notes: also no symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Dec2023 to 11Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eosinophilic granulomatosis with polyangiitis
Clinical narrative: eosinophilic granulomatosis with polyangiitis; This is a literature report for the following literature source(s).  An elderly female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation.  The following information was reported: EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (medically significant), outcome "unknown".  No follow-up attempts are possible.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Eosinophilic granulomatosis with polyangiitis and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 13:00 as dose 1, single (Lot number: HF9300) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: anti malarial drug" (unspecified if ongoing), notes: Known allergies; "Known allergies: avocado" (unspecified if ongoing), notes: Known allergies; "obesity" (unspecified if ongoing); "pcos" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 09Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, single, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (booster), single, Batch/Lot No: FP7135, Location of injection: Arm Left), administration date: 20Jun2022, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 4 (booster), single, Batch/Lot No: GJ3277, Location of injection: Arm Left), administration date: 25Oct2022, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 5 (booster), single, Batch/Lot No: GJ6743, Location of injection: Arm Left), administration date: 10May2023, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid-19 treatment with Paxlovid from 06Dec2023 to 10Dec2023.