chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity
Clinical narrative: ABDOMINAL SPASMS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had no known allergies, no drug abuse or illicit drug usage. The patient had no spasms before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204D21A expiry: 11-DEC-2021) dose was not reported, administered on 06-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. No concomitant medications were reported. On OCT-2021, the patient experienced abdominal spasms. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal spasms. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (COVID-19). On 18-Dec-2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. Vaccination dates were provided as 27-Feb-2021, 20-Mar-2021 and 28-Dec-2021. Reporter did not know which vaccines corresponded to which dates. The patient received one vaccination from Moderna and two vaccinations from Pfizer. It was reported that patient had COVID-19 with previous Pfizer COVID vaccinations. Confirmation via a test was not provided. Reporter became aware that the patient had Pfizer COVID vaccinations on 07-Apr-2023. No treatment medication information was reported.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, Pyrexia
Clinical narrative: ran a slight fever; Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (ran a slight fever) and EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient had no known allergies. The patient had no acute illnesses at the time of vaccination and upto one month before and no chronic or long standing health conditions. The patient had never been tested positive or been diagnosed with COVID-19. It was reported that the patient received other vaccines 4 weeks prior to Moderna Covid-19 vaccine.  Previously administered products included for Product used for unknown indication: Tdap and Hepatitis B (booster). Past adverse reactions to the above products included No adverse event with Hepatitis B and Tdap.    On 19-May-2023 at 2:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023). On 20-May-2023, the patient experienced PYREXIA (ran a slight fever). On 20-May-2023, PYREXIA (ran a slight fever) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given after the published expiration date on 19MAY2023. Lot number 061F22A, expiration date 16MAY2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 19-May-2023 at 2:30 PM, the patient received booster dose of Moderna Covid-19 vaccine.  In the left deltoid, the patient had no soreness.  Concomitant medication information was not provided.  It was reported that the dose was given to the patient after the published expiration date.  The published expiration date of the vaccine was 16-May-2023. No adverse effects were felt by the patient except the fact that the patient felt slight fever in A.M hours of 20-May-2023. The patient felt fine later on that day.  No additional doses, medications, or treatments were provided to the patient.   This case was linked to MOD-2023-725968 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2023: Follow-up received include Patient details (Ethnic, race, height, weight) added, suspect Product (Spikevax Bivalent) dose details updated, event Pyrexia added.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Diabetes, Heart disorder and Kidney disorder.    On 19-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Expiration date was reported as 17-MAY-2023. No PQC was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-725910, US-MODERNATX, INC.-MOD-2023-725921 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725910:(Female patient no-1) US-MODERNATX, INC.-MOD-2023-725921:(Male patient no-2)
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Obesity, Obesity, Renal disease (kidneys disease), Renal disease and Cardiac disorder (heart disease).    In May 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In May 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023.).    Concomitant drugs were not reported.  It was reported that the vaccine which was expired on 17-May-2023 was administered to three patients one on 18-May-2023 and two on 19-May-2023.  Treatment medications were not provided.  This case was reported for 1 male patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-725910 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725910:(Female patient no-1)
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Locally R deltoid Sore (where other two vaccines were given); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies.   Patient has not been ever diagnosed/tested positive for COVID-19.  Patient did not have any chronic/long standing health conditions or any acute illness at the time or 1 month prior to vaccination.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)). At the time of the report, VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was not taking any prescription, over the counter medications, dietary supplements or herbal remedies at the time of vaccination or at the time of adverse event.   Patient had no left deltoid soreness.   No treatment was given to patient.   This case was linked to MOD-2023-725455 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.), UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and UNDERDOSE (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case was created for 19th patient of the 24 patients involved. Concomitant medication was not provided. An under dose bivalent vaccines was administered to the pediatric patients for either their 1st or 2nd dose. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial. The patients age was between 6 months to 5 years. Patient was contacted and revaccinated with correct dose. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case was created for 21 patient of the 24 patients involved. Concomitant medication was not provided. An under dose bivalent vaccines was administered to the pediatric patients for either their 1st or 2nd dose. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial. The patients age was between 6 months to 5 years. Patient was contacted and revaccinated with correct dose. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Incorrect product formulation administered, No adverse event, Underdose
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case was created for 21 patient of the 24 patients involved. Concomitant medication was not provided. An under dose bivalent vaccines was administered to the pediatric patients for either their 1st or 2nd dose. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial. The patients age was between 6 months to 5 years. Patient was contacted and revaccinated with correct dose. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023; No adverse event; patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient was given a dose of the Moderna Bivalent vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023/Vaccine administered on 22-May-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vaccine was moved from the freezer to the refrigerator on 21-Apr-2023.  No reported symptoms.  No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Did get sick with first booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Did get sick with first booster) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 08-Jan-2021, Pfizer vaccine on 30-Jan-2021 and Pfizer vaccine on 21-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Did get sick with first booster). At the time of the report, ILLNESS (Did get sick with first booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2023-725767 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Booster dose. Last menstrual period and estimated date of delivery were not provided. On 19-Oct-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy).    Concomitant and treatment medications were not reported.  The patient did not have any medical history/conditions, allergy, concomitant diseases and risk factor including any previous COVID-19 diagnosis.  Company comment This spontaneous case concerns an adult female patient with no medical history reported, who received a booster dose of mRNA-1273.222 (BA.4/BA.5) vaccine and no adverse event was reported. Last menstrual period and estimated date of delivery were not provided. The outcome of pregnancy was not reported. There is no further clinical information provided for medical review. No adverse event was captured as not related following the SMP because there were no associated adverse events. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in 4 week prior to COVID-19 vaccine.  Concurrent medical conditions included Diabetes, Obesity, Heart disease, unspecified and Renal disease.    In May 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In May 2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one patient on 18May2023 and two patients on 19May2023. Patients are 1 female and 2 males.).    Concomitant drugs were not reported.  It was reported that the vaccine which was expired on 17-May-2023 was administered to three patients one on 18-May-2023 and two on 19-May-2023.  Treatment medications were not provided.  This case was reported for 1 female patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-725921, US-MODERNATX, INC.-MOD-2023-725912 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725921:(Male Patient no-2) US-MODERNATX, INC.-MOD-2023-725912:(Male patient no-1)
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.; No adverse event; they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.), PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 20-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.), PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.) and PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.).    No other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 20 May 2023. The vial did not undergo any temperature excursions. Concomitant medication not reported.  Treatment medication not reported.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine).    It was reported that the patient does not had information about previous COVID-19 vaccination doses. No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Cardiac failure congestive, Cardiogenic shock, Condition aggravated, Hypotension
Clinical narrative: Pfizer vaccine was administered outside - reported by patient- NO LOT NUMBER WERE SUPPLIED; I95.9 HYPOTENSION 9/8/2022 CHF EXACERBATION, UNSPECIFIED; J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022; CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 10/19/2022 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 12/2/2022 CHF EXACERBATION, UNSPECIFIED I95.9 HYPOTENSION 9/8/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 10/19/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R57.0 CARDIOGENIC SHOCK 12/2/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Respiratory failure
Clinical narrative: Pfizer vaccine was administered outside - reported by patient- NO LOT NUMBER WERE SUPPLIED; I95.9 HYPOTENSION 9/8/2022 CHF EXACERBATION, UNSPECIFIED; J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022; CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 10/19/2022 CHF EXACERBATION, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 12/2/2022 CHF EXACERBATION, UNSPECIFIED I95.9 HYPOTENSION 9/8/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 10/19/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE R57.0 CARDIOGENIC SHOCK 12/2/2022 COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE, ACUTE
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- ACUTE RESPIRATORY FAILURE 7/14/2022 HX OF INTRACRANIAL HEMORRHAGE HYPOXIA 7/14/2022 HX OF INTRACRANIAL HEMORRHAGE
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient reported fever, redness, pain and swelling at injection site. Symptoms/adverse reaction started on 4/24/2023 approx 8 pm and lasted for 4-5 days post-injection administration. Patient further reported that injection solution radiated to her free-style libre sensor located under left arm. Patient reported above on 5/11/2023.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Parent reports the day following immunization administration, the patient developed redness, swelling, and tenderness to the right thigh overlying the injection site that has been worsening.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Immobile, Mobility decreased, Pain in extremity
Clinical narrative: PATIENT CALLED STORE ON 5/25/23 TO ASK ABOUT PAIN IN HIS ARM AFTER GETTING TDAP SHOT ON 5/17/23. HE COMPLAINED ABOUT PAIN THAT WOULD NOT LET HIM RISE HIS ARM ABOVE HIS HEAD AND NEEDED TO KEEP HIS ARM IMMOBILE. AT THAT TIME HE HAD TRIED TYLENOL WITH NO IMPROVEMENT AND PER PATIENT PAIN WAS WORSENING
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy bone marrow, Blood test abnormal, Computerised tomogram, Contusion, Immune thrombocytopenia
Clinical narrative: On March 14, 2023 after a doctor's visit about his bruising, blood lab test shows very low platelets. Advised to go to ER and from there got admitted to hospital and was diagnosed with Immune thrombocytopenia (ITP).   Prior to this, he had several big bruising on his leg and body that might have span 3-5 weeks. This led to the visit to doctor and blood test on March 14, 2023.  While at hospital, he did some testing including scans, xray, and bone marrow biopsy and received infusion of IVIG and Platelets as well as steroids. The steroids medication continued as out patient for the next 2 weeks or so where his platelets did not show increase count. He then went to next treatment of Rituximab infusion for the next 4 weeks and he recently completed this also not showing a good increase in his platelets.  During above treatment, he did blood transfusion a couple of times and another round of platelets transfusion.  Most recently, he got admitted to ER again then in hospital due to fever and possible infection where he received another blood transfusion and infusion of IVIG and platelets.  This week, he started on the next viable treatment of Promacta medication
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunoglobulin therapy, Platelet count decreased, Platelet transfusion, Pyrexia, Transfusion
Clinical narrative: On March 14, 2023 after a doctor's visit about his bruising, blood lab test shows very low platelets. Advised to go to ER and from there got admitted to hospital and was diagnosed with Immune thrombocytopenia (ITP).   Prior to this, he had several big bruising on his leg and body that might have span 3-5 weeks. This led to the visit to doctor and blood test on March 14, 2023.  While at hospital, he did some testing including scans, xray, and bone marrow biopsy and received infusion of IVIG and Platelets as well as steroids. The steroids medication continued as out patient for the next 2 weeks or so where his platelets did not show increase count. He then went to next treatment of Rituximab infusion for the next 4 weeks and he recently completed this also not showing a good increase in his platelets.  During above treatment, he did blood transfusion a couple of times and another round of platelets transfusion.  Most recently, he got admitted to ER again then in hospital due to fever and possible infection where he received another blood transfusion and infusion of IVIG and platelets.  This week, he started on the next viable treatment of Promacta medication
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: X-ray
Clinical narrative: On March 14, 2023 after a doctor's visit about his bruising, blood lab test shows very low platelets. Advised to go to ER and from there got admitted to hospital and was diagnosed with Immune thrombocytopenia (ITP).   Prior to this, he had several big bruising on his leg and body that might have span 3-5 weeks. This led to the visit to doctor and blood test on March 14, 2023.  While at hospital, he did some testing including scans, xray, and bone marrow biopsy and received infusion of IVIG and Platelets as well as steroids. The steroids medication continued as out patient for the next 2 weeks or so where his platelets did not show increase count. He then went to next treatment of Rituximab infusion for the next 4 weeks and he recently completed this also not showing a good increase in his platelets.  During above treatment, he did blood transfusion a couple of times and another round of platelets transfusion.  Most recently, he got admitted to ER again then in hospital due to fever and possible infection where he received another blood transfusion and infusion of IVIG and platelets.  This week, he started on the next viable treatment of Promacta medication
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Obstructive airways disorder, Pneumonitis, Spirometry abnormal
Clinical narrative: I started having breathing issues around 09/2022 and subsequently was in and out of my PCP office for several months. I was prescribed oral allergy medications and a steroid inhaler. I eventually saw an allergy/asthma doctor, after no improvement, and had breathing testing which indicated high levels of inflammation in my lungs.
Age: 29.0
Sex: M
Vaccine: YF
Symptoms: Loss of consciousness, Presyncope, Seizure like phenomena
Clinical narrative: PT STARTED TO HAVE WHAT LOOKED LIKE A VASO VAGAL RESPONSE. HE STARTED TO LEAN BACK FURTHER ON HIS CAR AND LOOKED LIKE HE WAS HAVING A SEIZURE. HE HAD SOMEONE ELSE WITH HIM  AT THE PHARMACY WAITING OUTSIDE. I CALLED HER TO THE VACCINE ROOM. I CALLED EMS IMMEDIATELY AND HE LOST CONSCIOUSNESS WHILE I WAS ON THE PHONE FOR 5 MINUTES OR SO. HE REGAINED CONSCIOUSNESS WHILE I WAS ON THE PHONE WITH EMS. PARAMEDICS ARRIVED AND THEY DID VITALS AND HE WAS CLEARED TO GO
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fear, Hypertension, Laboratory test abnormal
Clinical narrative: Hard to breathe, exhaustion, high blood pressure.  Afraid I was having another heart attack.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Hard to breathe, exhaustion, high blood pressure.  Afraid I was having another heart attack.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Laboratory test, Pruritus
Clinical narrative: 1 week and 1 day after vaccine patient had itching and burning on the hands, feet and knees
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition".  Additional information: She said that she had a daughter-in-law who had a heart condition and she had a covid shot. (She also mentioned that they both had 2 covid shots and 2 boosters).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300197739 same AE./drug,different patients;US-PFIZER INC-202300197463 same AE./drug,different patients;
Sex: U
Vaccine: PNC20
Symptoms: Erythema, Injection site swelling, Pain, Vaccination site swelling
Clinical narrative: redness reaction; pain; localized injection swelling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in May2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "localized injection swelling"; PAIN (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered"; ERYTHEMA (non-serious) with onset May2023, 1 week after the suspect product(s) administration, outcome "not recovered", described as "redness reaction". Additional information: Patient received the shot about a week ago and got localized injection swelling with redness and pain which is still there, caller can see it, so calling to see if Pfizer has any data on how long that would last?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, Blood glucose, Blood glucose increased, Blood sodium
Clinical narrative: Glucose high; Urea Nitrogen high; Creatinine high; EGFR low; Sodium low; Red Blood Cell Count low; Hemoglobin low; Hematocrit low; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID:.  An 88-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (COVID-19. mRNA. LNP-S. PF. 30 mcg/0.3 mL dose (Pfizer- BioNTech)), administration date: 08Feb2021, when the patient was 88-year-old, for COVID-19 Immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Glucose high"; BLOOD UREA INCREASED (non-serious), outcome "unknown", described as "Urea Nitrogen high"; BLOOD CREATININE INCREASED (non-serious), outcome "unknown", described as "Creatinine high"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "EGFR low"; BLOOD SODIUM DECREASED (non-serious), outcome "unknown", described as "Sodium low"; RED BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Red Blood Cell Count low"; HAEMOGLOBIN DECREASED (non-serious), outcome "unknown", described as "Hemoglobin low"; HAEMATOCRIT DECREASED (non-serious), outcome "unknown", described as "Hematocrit low". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter Occupation/Specialty: MD. HPI:  f/u CKD 4/5, recovering from COVID. Fasting reference interval, For someone without known diabetes, a glucose value >125 mg/dL indicates that they may have diabetes and this should be confirmed with a follow-up test. The eGER was based on the CKD-EPI 2021 equation. To calculate the new eGFR from a previous Creatinine or Cystatin C result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.