chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Accidental overdose, Pyrexia
Clinical narrative: Was given 0.5 ml when it needed to be 0.25 ml; Fever for about 24 hours; This spontaneous case was reported by a medical assistant and describes the occurrence of PYREXIA (Fever for about 24 hours) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) in a 2-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3914B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication.    No Medical History information was reported.   On 24-Oct-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter and first dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (Intramuscular use) 1 dosage form. In 2023, the patient experienced PYREXIA (Fever for about 24 hours). On 24-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml). At the time of the report, PYREXIA (Fever for about 24 hours) and ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (Was given 0.5 ml when it needed to be 0.25 ml) to be not related. No further causality assessment was provided for PYREXIA (Fever for about 24 hours).    Patient had no known allergies. Unknown if patient was diagnosed/tested positive for COVID-19. Patient had no acute or chronic long-standing health conditions at the time of vaccination.  Concomitant product use was not provided by the reporter.   The patient had fever for about 24 hours after.  Treatment information was not provided.  This case contains information for 9th patient out of 29 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:master case
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Pyrexia
Clinical narrative: The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when he should have had 0.25 ml; low-grade fever for about 48 hrs after administration of the vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of PYREXIA (low-grade fever for about 48 hrs after administration of the vaccine) and ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when he should have had 0.25 ml) in a 19-month-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2023, the patient received fourth dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter. In October 2023, the patient experienced PYREXIA (low-grade fever for about 48 hrs after administration of the vaccine). On 25-Oct-2023,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when he should have had 0.25 ml). In October 2023, PYREXIA (low-grade fever for about 48 hrs after administration of the vaccine) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when he should have had 0.25 ml) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter considered ACCIDENTAL OVERDOSE (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when he should have had 0.25 ml) to be not related. No further causality assessment was provided for PYREXIA (low-grade fever for about 48 hrs after administration of the vaccine).    Patient had no known allergies. Patient haven't been diagnosed/tested positive for COVID-19. Patient had no acute or chronic long-standing health conditions at the time of vaccination.  No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747540 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:Master case (Patient 1)
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Feeling abnormal, Premature delivery, Premature labour, Vaginal discharge
Clinical narrative: was feeling weird/Feeling abnormal; Premature delivery; Premature labour; Vaginal discharge; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2719753-1 (VAERS ID).  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Oct2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. She did not have current illness, history and allergies. The patient was 3 trimester pregnant (35 weeks, 6 days pregnant) at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was expected to deliver on 10Nov2023. Concomitant medications included: ZOLOFT; PRENATAL + DHA. The following information was reported: PREMATURE DELIVERY (hospitalization) with onset 18Oct2023, outcome "recovered"; PREMATURE LABOUR (hospitalization) with onset 18Oct2023, outcome "recovered"; VAGINAL DISCHARGE (hospitalization) with onset 13Oct2023, outcome "recovered"; FEELING ABNORMAL (hospitalization) with onset 18Oct2023, outcome "recovered", described as "was feeling weird/Feeling abnormal". Patient noticed excess discharge starting the morning after the vaccine and was feeling weird up until she went into labor days later. The patient was hospitalized for feeling abnormal, vaginal discharge (start date: Oct2023, discharge date: Oct2023, hospitalization duration: 4 days). The events did not lead to emergency room or office visit. The baby was delivered premature, delivery date. The baby was healthy. The baby weighed 7 lbs 5 oz.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previous information: add new event Premature delivery and Premature labour and previously reported event Maternal exposure during pregnancy, third trimester was removed since this vaccine is aimed for pregnant patient.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006076 baby case;
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Herpes zoster, Pruritus
Clinical narrative: Outbreak of shingles Bilateral hips to knees x 2 weeks Valtrex treatment. Dry skin - itching while healing Carmer of Herpes Simplex since 1978
Sex: F
Vaccine: RSV
Symptoms: CSF protein increased, CSF white blood cell count negative, Cervical cord compression, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Guillain-barre syndrome; Use of accessory respiratory muscles; Dysponea; albuminocytologic dissociation; cervical cord compression; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2721726-1.  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0169) intramuscular, in left arm for immunisation, guillain-barre syndrome. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: resected surgically; "laparoscopic sleeve gastrectomy" (unspecified if ongoing); "Mild emphysema" (unspecified if ongoing); "endometrial ca s/p resected" (unspecified if ongoing), notes: endometrial ca s/p resected years ago; "adrenal adenoma" (unspecified if ongoing); "dust mite" (unspecified if ongoing); "mold" (unspecified if ongoing); "grass" (unspecified if ongoing); "trochanteric bursitis", start date: 13Oct2023 (ongoing), notes: saw ortho for trochanteric bursitis on 13Oct2023- received cortisone injection; "Wheezing" (unspecified if ongoing). Concomitant medication(s) included: CORTISONE intravenous; CRESTOR; FLONASE [FLUTICASONE PROPIONATE]; CALCIUM; VITAMIN D NOS; ALBUTEROL [SALBUTAMOL] resp inhalation taken for wheezing; ASTELIN [AZELASTINE HYDROCHLORIDE] nasal; LEXAPRO; TUMS [CALCIUM CARBONATE]. The patient also took other concomitant therapy. The following information was reported: CERVICAL CORD COMPRESSION (hospitalization) with onset 04Dec2023, outcome "not recovered"; CSF PROTEIN INCREASED (hospitalization) with onset 06Dec2023, outcome "not recovered", described as "albuminocytologic dissociation"; GUILLAIN-BARRE SYNDROME (hospitalization), outcome "not recovered"; USE OF ACCESSORY RESPIRATORY MUSCLES (hospitalization), outcome "not recovered"; DYSPNOEA (hospitalization), outcome "not recovered", described as "Dysponea". The patient was hospitalized for guillain-barre syndrome (start date: 05Dec2023). The patient underwent the following laboratory tests and procedures: Lumbar puncture: (06Dec2023) albuminocytologic dissociation: P=196 and W=O; Magnetic resonance imaging: (04Dec2023) mild cord compression, notes: mild cord compression at C5-6 but there is no  cord signal abnormality and no clinical findings of myelopathy. Therapeutic measures were taken as a result of guillain-barre syndrome. Additional information: Patient was also taking multivitamin daily. Patient was admitted to hospital for Guillain Barr T syndrome and started IVIG 35 g daily on 05Dec2023 transferred to critical care unit on 07Dec2023 for closer monitoring due to increased dyspea and respiratory muscle involvement. No follow-up attempts are possible.
Sex: F
Vaccine: RSV
Symptoms: Immunoglobulin therapy, Intensive care, Magnetic resonance imaging spinal abnormal, Use of accessory respiratory muscles
Clinical narrative: Guillain-barre syndrome; Use of accessory respiratory muscles; Dysponea; albuminocytologic dissociation; cervical cord compression; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2721726-1.  A 62-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0169) intramuscular, in left arm for immunisation, guillain-barre syndrome. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: resected surgically; "laparoscopic sleeve gastrectomy" (unspecified if ongoing); "Mild emphysema" (unspecified if ongoing); "endometrial ca s/p resected" (unspecified if ongoing), notes: endometrial ca s/p resected years ago; "adrenal adenoma" (unspecified if ongoing); "dust mite" (unspecified if ongoing); "mold" (unspecified if ongoing); "grass" (unspecified if ongoing); "trochanteric bursitis", start date: 13Oct2023 (ongoing), notes: saw ortho for trochanteric bursitis on 13Oct2023- received cortisone injection; "Wheezing" (unspecified if ongoing). Concomitant medication(s) included: CORTISONE intravenous; CRESTOR; FLONASE [FLUTICASONE PROPIONATE]; CALCIUM; VITAMIN D NOS; ALBUTEROL [SALBUTAMOL] resp inhalation taken for wheezing; ASTELIN [AZELASTINE HYDROCHLORIDE] nasal; LEXAPRO; TUMS [CALCIUM CARBONATE]. The patient also took other concomitant therapy. The following information was reported: CERVICAL CORD COMPRESSION (hospitalization) with onset 04Dec2023, outcome "not recovered"; CSF PROTEIN INCREASED (hospitalization) with onset 06Dec2023, outcome "not recovered", described as "albuminocytologic dissociation"; GUILLAIN-BARRE SYNDROME (hospitalization), outcome "not recovered"; USE OF ACCESSORY RESPIRATORY MUSCLES (hospitalization), outcome "not recovered"; DYSPNOEA (hospitalization), outcome "not recovered", described as "Dysponea". The patient was hospitalized for guillain-barre syndrome (start date: 05Dec2023). The patient underwent the following laboratory tests and procedures: Lumbar puncture: (06Dec2023) albuminocytologic dissociation: P=196 and W=O; Magnetic resonance imaging: (04Dec2023) mild cord compression, notes: mild cord compression at C5-6 but there is no  cord signal abnormality and no clinical findings of myelopathy. Therapeutic measures were taken as a result of guillain-barre syndrome. Additional information: Patient was also taking multivitamin daily. Patient was admitted to hospital for Guillain Barr T syndrome and started IVIG 35 g daily on 05Dec2023 transferred to critical care unit on 07Dec2023 for closer monitoring due to increased dyspea and respiratory muscle involvement. No follow-up attempts are possible.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a dose of MMRII was administered to a patient one day after the expiration date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 08-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) injection, 1 dose, lot #W017556, has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date: 07-JAN-2024, administered for prophylaxis (dose and route of administration were not provided) (Expired product administered). The patient was asymptomatic. No additional details provided. No additional AE.
Age: 1.08
Sex: U
Vaccine: HEPA, PNC15
Symptoms: Product storage error
Clinical narrative: no patient symptoms have been reported; reported VAQTA and VAXNEUVANCE involved in a temperature excursion have been administered to a patient; This spontaneous report was received from a nurse referring to a 13-month-old patient of unknown gender. Information about the patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, hepatitis a vaccine, inactivated (VAQTA) intramuscular injection and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection experienced temperature excursion with 59.45 degree Fahrenheit (F) for 18 hours 30 minutes 0 seconds. Previous temperature excursion showed 53.29 F for 1 hour 45 minutes 0 seconds; 49.73 F for 1 hour 0 minutes 0 seconds. On 19-DEC-2023, the patient was vaccinated with improper stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (1 dose, lot #X010373, expiration date: 13-NOV-2024, strength, route of administration and anatomical site of administration were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (1 dose, lot #X020316, expiration date: 18-OCT-2025, strength, anatomical site of administration and route of administration were not provided) (product storage error), both for prophylaxis. No additional adverse event (AE) (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2401USA006342: US-009507513-2401USA005789: US-009507513-2401USA005734: US-009507513-2401USA005823: US-009507513-2401USA005828: US-009507513-2401USA005851: US-009507513-2401USA006004: US-009507513-2401USA006039: US-009507513-2401USA006082: US-009507513-2401USA006334: US-009507513-2401USA006339:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report AE for administered expired VAQTA. Product expired on 12/14/2023 and administered on 12/26/2023.  No adverse effects reported. No additional information provided.  No additional AE. No PQC.; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 26-DEC-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), prefilled syringe, lot # W021491, expiration date: 14-DEC-2023 for prophylaxis (dose, and routes of administration  were not reported)(expired product administered). No adverse effects reported. No additional information provided. No PQC.
Age: 78.0
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 from product quality group.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Lot number: HG4628) at the age of 78 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Flagyl, reaction(s): "Allergies;flagyl". 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; Covid-19 vaccine (DOSE 6 (BOOSTER); Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER); 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Reported about Covid treatment with Paxlovid with treatment start date on 26Dec2023 and treatment stop date on 31Dec2023,
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: still testing positive.  Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: treatment includes Paxlovid.  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, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  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: Blood cholesterol, Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After I took the Pfizer shot; I tested positive for COVID; After I took the Pfizer shot; I tested positive for COVID; 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 15Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Cholesterol low" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LISINOPRIL HCTZ taken for hypertension; LOVASTATIN taken for blood cholesterol decreased; AMLODIPINE taken for hypertension; FLUTICASONE PROPIONATE. Vaccination history included: Moderna cove-19 vaccine (Dose 1, Moderna for 6), for COVID-19 Immunization; Moderna cove-19 vaccine (Dose 2), for COVID-19 Immunization; Moderna cove-19 vaccine (Dose 3), for COVID-19 Immunization; Moderna cove-19 vaccine (Dose 4), for COVID-19 Immunization; Moderna cove-19 vaccine (Dose 5), for COVID-19 Immunization; Moderna cove-19 vaccine (Dose 6), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After I took the Pfizer shot; I tested positive for COVID". The patient underwent the following laboratory tests and procedures: Blood cholesterol: Low, notes: Cholesterol low; Blood pressure measurement: high, notes: Blood pressure high; SARS-CoV-2 test: Positive, notes: I tested positive for COVID.  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, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2024) Negative; (06Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  The reporter's wife also took Paxlovid starting on 26Dec2023, tested negative on 03Jan and then tested positive on 06Jan2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HG4629) for COVID-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Sporins" (unspecified if ongoing), notes: Known allergies: Sporins. The patient's concomitant medications were not reported. Past drug history included: Moderna, start date: 12May2023, stop date: 12May2023, for COVID-19 immunization, notes: Vaccine dose number=6, Vaccine lot number=066H22A, Vaccine location=Left arm; Moderna, start date: 10Oct2022, stop date: 10Oct2022, for COVID-19 immunization, notes: Vaccine dose number=5, Vaccine lot number=053022A, Vaccine location=Left arm; Moderna, start date: 18Apr2022, stop date: 18Apr2022, for COVID-19 immunization, notes: Vaccine dose number=4, Vaccine lot number=065K21A, Vaccine location=Left arm; Moderna, start date: 23Oct2021, stop date: 23Oct2021, for COVID-19 immunization, notes: Vaccine dose number=3, Vaccine lot number=037C21A, Vaccine location=Left arm; Moderna, start date: 10Mar2021, stop date: 10Mar2021, for COVID-19 Immunization, notes: Vaccine dose number=2, Vaccine lot number=032M20A, Vaccine location=Left arm; Moderna, start date: 10Feb2021, stop date: 10Feb2021, for COVID-19 Immunization, notes: Vaccine dose number=1,, Vaccine lot number=004M20A, Vaccine location=Left arm. 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.
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 48-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: "anxiety" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Dec2023 to 01Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thalassaemia" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 11Dec2023, stop date: 25Dec2023; LEVOTHYROXINE, start date: 11Dec2023. Past drug history included: Clindamycin, reaction(s): "known allergies: intolerance to clindamycin", notes: known allergies: intolerance to clindamycin; Clindamycin, reaction(s): "known allergies: intolerance to clindamycin", notes: known allergies: intolerance to clindamycin. Vaccination history included: moderna (vaccine brand=Other, vaccine brand other=Moderna, vaccine brand unknown=False, vaccine lot unknown=True, vaccine lot unknown reason=Not available/provided to reporter at the time of report completion, vaccine dose number=4, vaccine dose number unknown=False, vaccine location=Right arm), administration date: 27Oct2022, when the patient was 70-year-old, for Covid-19 Immunization; Covid-19 vaccine (Dose: 3; Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2; Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1; Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid administered on 26Dec2023 to 31Dec2023).  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: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This is a spontaneous report received from a Nurse.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Motrin, reaction(s): "known allergies: Motrin". The following information was reported: COVID-19 (non-serious) with onset Dec2023, outcome "unknown". Therapeutic measures were taken as a result of covid-19. Additional information: the patient received PAXLOVID as treatment for COVID-19 from 26Dec2023 until 31Dec2023. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 31Jul2017. Vaccination history included: BNT162b2 (dose 3 (booster), administered in the left arm, Batch/Lot number: unknown), administration date: 02May2023, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (dose 2, administered in the left arm, Batch/Lot number: unknown), administration date: 22Oct2022, when the patient was 75-year-old, for Covid-19 immunization; BNT162b2 (dose 1, administered in the left arm, Batch/Lot number: unknown), administration date: 08Apr2022, when the patient was 74-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 26Dec2023 to 31Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 20:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 28Dec2023 to 02Jan2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 27Dec2023 until 01Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received nirmatrelvir, ritonavir (PAXLOVID) as COVID 19 treatment from 28Dec2023 to 01Jan2024.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005600 Same reporter and patient, different product and event;
Age: 34.0
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 Nurse.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL, start date: 13Jun2007. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE, Vaccine Administration Date=10Oct2022,, Vaccine Location=Left Arm}]), administration date: 10Oct2022, when the patient was 33-year-old, for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many factors. The association between the event lack of effect (COVID-19) with BNT162b2 omi xbb 1.5 can not be fully excluded.
Age: 36.0
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 36-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Generalized Anxiety" (unspecified if ongoing); "Hashimotos thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jan2018, stop date: 06Jan2024; LEVOTHYROXINE, start date: 01Jan2016, stop date: 06Jan2024; SYEDA taken for contraception, start date: 01Jan2007, stop date: 06Jan2024. Vaccination history included: pfizer/biontech (vaccine brand=Pfizer/BioNTech, vaccine brand unknown=False, vaccine administration date=13Oct2023 , vaccine lot unknown=True, vaccine lot unknown reason=Unable to locate or read the details, vaccine dose number=4, vaccine dose number unknown=False, vaccine location=Right arm), administration date: 13Oct2023, for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2024) Negative, notes: Tested positive with Covid 6 days after testing negative- COVID rebound; (06Jan2024) Positive, notes: Tested positive with Covid 6 days after testing negative- COVID rebound. Therapeutic measures 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors. However, a contributory role of BNT162b2 omi xbb.1.5 to the events Drug Ineffective and Covid-19 cannot be ruled out.
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 64-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 and concomitant medications were not reported. 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. Paxlovid was taken from 30Dec2023 to 03Jan2024.  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: F
Vaccine: COVID19
Symptoms: COVID-19, 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 female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5 Booster, Unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 4 Booster, Unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Dose 3 Booster, Unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19"; Covid-19 vaccine (Primary immunization completed, Unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Paxlovid start date 27Dec2023, treatment stop date 31Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 49.0
Sex: F
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 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypermobility Spectrum Disorder" (unspecified if ongoing); "known allergies" (unspecified if ongoing); "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 4), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 3), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 1), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 02Jan2024 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: 48.0
Sex: M
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 48-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 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: "chronic diarrhea" (unspecified if ongoing); "hiatal hernia" (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 22Dec2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2023) Positive, notes: Diagnosed with COVID, Started Paxlovid; (31Dec2023) Negative; (02Jan2024) Positive; (07Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Diagnosed with COVID 22Dec2023. Started Paxlovid 23Dec2023. Finished 28Dec2023. Negative home test 31Dec2023. Positive home test and symptoms returned 02Jan2024. Appears to be Rebound COVID. Positive test and slight symptoms remaining as of this report 07Jan2024. 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: 68.0
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 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Factor v leiden raynaud's disease" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ROSUVASTATIN; DIGOXIN; ALVESCO. Past drug history included: Fosamax, reaction(s): "Known allergies: Fosamax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2024 at 21:00, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 51.0
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 51-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 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer / biontech (lot number: DR21315, dose number: 4, Vaccine location: Left leg), administration date: 22Sep2022, when the patient was 50-year-old, for Covid-19 immunization; pfizer / biontech (vaccine dose number: 3, vaccine location: Left arm), administration date: 22Oct2021, when the patient was 49-year-old, for Covid-19 immunization; pfizer / biontech (Vaccine dose number: 2, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 48-year-old, for Covid-19 immunization; pfizer / biontech (Vaccine dose number: 1, Vaccine location: Left arm), administration date: 08Jan2021, when the patient was 48-year-old, 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400007658 Same reporter/patient, same drug/different dose, different AE;
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.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HG4659), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Nov2023, stop date: 27Dec2023. Vaccination history included: Covid-19 vaccine (Dose 5 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible.