chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Respiratory tract infection
Clinical narrative: Respiratory virus infection; Covid arm on 07Jan2023; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:MS, osteoporosis - both conditions she already had prior to getting the Moderna vaccine.  The patient's past medical history included Multiple sclerosis and Osteoporosis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (lot number - EW0217) on 02-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (lot number -EW0181) on 23-Jun-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster dose, lot number SF8764) on 09-Dec-2021 and HERPES SIMPLEX 1 VACCINE; for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (2nd booster dose and lot number 059A22A) on 21-Jun-2022. Past adverse reactions to the above products included No adverse event with HERPES SIMPLEX 1 VACCINE, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included TRIAMCINOLONE and HERPES SIMPLEX 1 VACCINE from 21-Jun-2021 to an unknown date for an unknown indication.    On 05-Jan-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 07-Jan-2023, the patient experienced RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023). At the time of the report, RESPIRATORY TRACT INFECTION (Respiratory virus infection) and IMMUNISATION REACTION (Covid arm on 07Jan2023) 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.   No concomitant medicine were reported. It was reported that the patient got the shingles vaccine on the same day (05Jan2023) on the same arm (left). Also reported that last year when the patient got her 1st Moderna booster dose on 21Jun2021, she also had the shingles vaccine but on the opposite arm. She did not have COVID arm then. She started applying Triamcinolone Cream to the COVID arm area since 08Jan2023 and the area looks smaller today.  Also reported that she had a respiratory virus infection prior to getting the bivalent booster dose.  No treatment medicine were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient administered a bivalent vaccine on January 9, 2023, instead of a monovalent vaccine for the second dose in Moderna primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered a bivalent vaccine on January 9, 2023, instead of a monovalent vaccine for the second dose in Moderna primary series) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-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 09-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered a bivalent vaccine on January 9, 2023, instead of a monovalent vaccine for the second dose in Moderna primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered a bivalent vaccine on January 9, 2023, instead of a monovalent vaccine for the second dose in Moderna primary series) 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 (Patient administered a bivalent vaccine on January 9, 2023, instead of a monovalent vaccine for the second dose in Moderna primary series).    Concomitant product information was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Son is calling to report his elderly father's side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Son is calling to report his elderly father's side effects) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to after. On an unknown date, the patient experienced IMMUNISATION REACTION (Son is calling to report his elderly father's side effects). At the time of the report, IMMUNISATION REACTION (Son is calling to report his elderly father's side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that on  09JAN2023 patient Son is calling to report his elderly father's side effects. Inadvertently he reported that he has seen reports from other patients on the internet regarding having 'Burning Tongue Syndrome" after receiving Modern COVID-19 vaccine.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23).    No concomitant medication was provided by reporter.  Unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided by reporter.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: our fridge being out of range on 12/02/22 for one hour; No adverse event; 10 patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT STORAGE ERROR (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) in an 11-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT STORAGE ERROR (our fridge being out of range on 12/02/22 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (10 patients vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT STORAGE ERROR (our fridge being out of range on 12/02/22 for one hour).    No concomitant medicine were reported. HCP stated 10 patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09Dec2022 and 9 patients were vaccinated on 16Dec2022. Excursion happened on 02Dec2022 during 1 hour and minimum temperature reached was 1.2°C. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live Follow-up received and contains event 'Product temperature excursion issue'
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation).    Concomitant medications were not reported. Nurse reported that they had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years on 09Dec2022. They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation.                                   No treatment information was provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019H22A) for COVID-19 prophylaxis.     The patient's past medical history included Peripheral vascular disorder and Hyperlipidemia. Concurrent medical conditions included Hypertension and Type II diabetes mellitus.    On 05-Jan-2023 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Jan-2023 at 10:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm).    Concomitant medication was not reported.  Vaccine was given after it was expired. The vaccine had already expired on 04-Jan-2023 at 09:43pm. The vaccine was administered on 05-Jan-2023 at 10:59am. Patient was discharges without complications. No adverse events have been reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022; The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax on 22-Feb-2022. Past adverse reactions to the above products included No adverse event with Spikevax. Concomitant products included AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (MPOX CV [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for an unknown indication.    On 07-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022).    As per nurse there was an issue with one patient that had Moderna. The patient had first dose given on 22 Feb 2022 and second dose was Moderna bivalent dose on 07 Nov 2022. The patient was coming for a booster today 09 Jan 2023. The nurse would like to know which vaccine to give patient. No treatment information was provided.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.; No adverse event; Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.), EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.), EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) 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 PRODUCT STORAGE ERROR (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.) and EXPIRED PRODUCT ADMINISTERED (Single dose of Moderna Covid-19 Vaccine was administered beyond 12 hrs.).    No relevant concomitant medications were reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received dose after BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after BUD) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender 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.     It was reported patient did not had relevant medical history/conditions, allergy, concomitant diseases and risk factor and allergies was unknown disease.     On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after BUD) 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 (Patient received dose after BUD).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694650:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine).    No concomitant medications were reported. No treatment medications were reported.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 3 doses were administered from a vial that was involved in a temperature excursion.; 3 doses were administered from a vial that was involved in a temperature excursion.; Product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (3 doses were administered from a vial that was involved in a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (3 doses were administered from a vial that was involved in a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No Concomitant medications were provided. No treatment medications were provided.  This case contains information for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-695788, US-MODERNATX, INC.-MOD-2023-695789.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695788: US-MODERNATX, INC.-MOD-2023-695789:
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; received expired Moderna COVID-19 vaccine on 29DEC2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022) and NO ADVERSE EVENT (no adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022) 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 (received expired Moderna COVID-19 vaccine on 29DEC2022).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-695793.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695793:59 year old patient
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st booster he felt sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site) 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. ASKU) for COVID-19 prophylaxis.     Patient had no previous medical conditions.  Previously administered products included for Drug use for unknown indication: Moderna COVID-19 Vaccine (Dose 1) on 10-Feb-2021 and Moderna COVID-19 Vaccine (Dose 2) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 30-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site) had not resolved.        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.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  After primary series caller did not experienced any adverse event, but after 1st booster he felt sore arm at the injection site and this symptom were still ongoing.  No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered the 30 day beyond use date 27DEC22; No adverse event; received expired Moderna COVID-19 vaccine on 29DEC2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022), PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022), PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (received expired Moderna COVID-19 vaccine on 29DEC2022) and PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. The individual vial size was 2.5 ml. Based on 30 day beyond use date was 27DEC22, the vial was thawed on 27NOV2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-695591.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695591:41 year old patient
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: an elderly patient received expired Bivalent Moderna COVID-19 vaccine beyond 12 hours after first puncture; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an elderly patient received expired Bivalent Moderna COVID-19 vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (an elderly patient received expired Bivalent Moderna COVID-19 vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an elderly patient received expired Bivalent Moderna COVID-19 vaccine beyond 12 hours after first puncture) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (an elderly patient received expired Bivalent Moderna COVID-19 vaccine beyond 12 hours after first puncture).    No Concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: no adverse event; Did not get the whole booster; They put the needle in my arm and and as they administered it, some of the product squirted out; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Did not get the whole booster), DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out) 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Jan-2023, the patient experienced UNDERDOSE (Did not get the whole booster) and DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Did not get the whole booster), DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out) 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 UNDERDOSE (Did not get the whole booster) and DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out).    No concomitant information was reported. It was reported that, at a pharmacy on Saturday, they put the needle in patient arm and as they administered it, some of the product squirted out. Patient did not get the whole booster. Patient did not receive an additional booster dose. No treatment information was reported.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Poor quality product administered, Product administration error, Product temperature excursion issue, Vaccination site pain
Clinical narrative: soreness of arm at site of injection; fatigue; Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 41-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 1 (bivalent), single (Lot number: GJ3277, Expiration Date: 05Dec2022) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2022, outcome "unknown" and all described as "COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022, outcome "unknown", described as "Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of arm at site of injection"; FATIGUE (non-serious), outcome "unknown".  Additional information: NDC number of COVID-19 vaccine bivalent: 59267030402. Pharmacist gave the vaccination and used a vial that was punctured the previous day 22 hours prior (not knowing). The error happened during filling the syringe (dispensing). Vial's date label (date and time of puncture), got unstuck fell off the bottle. Patient didn't report any adverse side effects that were out of the ordinary (soreness of arm at site of injection) and fatigue.  Follow-Up (10Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (05Jan2023): This is a spontaneous follow-up report received from a contactable Pharmacist in response to HCP letter sent to other pharmacist.  Updated information included: reporter details, historical vaccines removed, suspect dose details (Dose number, dose description, Patient Route of Administration, Anatomical Location, Vaccine Facility Information), new suspect added, new events: Wrong vaccine administered, Product administration error, Vaccination site pain, fatigue and additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: soreness of arm at site of injection; fatigue; Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 41-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 1 (bivalent), single (Lot number: GJ3277, Expiration Date: 05Dec2022) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2022, outcome "unknown" and all described as "COVID bivalent vaccine post-puncture vial was stored at room temperature 70F for almost 22 hours and administered to a patient."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 05Oct2022, outcome "unknown", described as "Dose: 1st/ Date: 05Oct2022/ Batch/Lot number: GJ3277"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of arm at site of injection"; FATIGUE (non-serious), outcome "unknown".  Additional information: NDC number of COVID-19 vaccine bivalent: 59267030402. Pharmacist gave the vaccination and used a vial that was punctured the previous day 22 hours prior (not knowing). The error happened during filling the syringe (dispensing). Vial's date label (date and time of puncture), got unstuck fell off the bottle. Patient didn't report any adverse side effects that were out of the ordinary (soreness of arm at site of injection) and fatigue.  Follow-Up (10Oct2022): Follow-up attempts are completed. No further information is expected.  Follow-up (05Jan2023): This is a spontaneous follow-up report received from a contactable Pharmacist in response to HCP letter sent to other pharmacist.  Updated information included: reporter details, historical vaccines removed, suspect dose details (Dose number, dose description, Patient Route of Administration, Anatomical Location, Vaccine Facility Information), new suspect added, new events: Wrong vaccine administered, Product administration error, Vaccination site pain, fatigue and additional information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Age: 35.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Off label use, Pregnancy test, Product use issue
Clinical narrative: Miscarriage occurred at home; Ultrasound revealed no heartbeat; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 3 (booster), single (Lot number: GH9702) at the age of 35 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "Test: Nasal Swab Result: Positive", start date: 05Feb2022 (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181), administration date: 01Jul2022, when the patient was 34-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0178), administration date: 10Jun2022, when the patient was 34-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Oct2022, outcome "unknown" and all described as "Took Flu vaccine and Pfizer covid vaccine on same date of 13Oct2022"; FOETAL HEART RATE ABNORMAL (congenital anomaly) with onset 22Dec2022, outcome "recovering", described as "Ultrasound revealed no heartbeat"; ABORTION SPONTANEOUS (congenital anomaly, medically significant) with onset 26Dec2022, outcome "recovering", described as "Miscarriage occurred at home". The patient underwent the following laboratory tests and procedures: Pregnancy test: (14Nov2022) Positive, notes: Positive pregnancy test recorded at physician 14Nov2022; SARS-CoV-2 test: (05Feb2022) Positive; Ultrasound scan: (22Dec2022) No heartbeat, notes: Ultrasound revealed no heartbeat on 22Dec2022. Therapeutic measures were not taken as a result of abortion spontaneous, foetal heart rate abnormal.  Additional information: Became pregnant approximately 21Oct2022. Positive pregnancy test recorded at physician 14Nov2022. Ultrasound revealed no heartbeat on 22Dec2022. Miscarriage occurred at home on 26Dec2022. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.