chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation reaction, Myalgia, Parosmia
Clinical narrative: patient reported having side effects from the vaccines/she started to have a different smell in her DNA and her skin and her system, a very strong smell, different, but she did not feel hot or sweaty,; also she felt aches in joints and muscles; her skin and her system, a very strong smell, different,; she felt aches in joints and muscles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she felt aches in joints and muscles), IMMUNISATION REACTION (patient reported having side effects from the vaccines/she started to have a different smell in her DNA and her skin and her system, a very strong smell, different, but she did not feel hot or sweaty,), ARTHRALGIA (also she felt aches in joints and muscles) and PAROSMIA (her skin and her system, a very strong smell, different,) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 003C21A and 021B21A) for COVID-19 prophylaxis.     The patient's past medical history included Brain injury (patient suffered brain injury after a car accident,), Coma (she was in a coma for a little bit) and Accident.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced MYALGIA (she felt aches in joints and muscles). On an unknown date, the patient experienced IMMUNISATION REACTION (patient reported having side effects from the vaccines/she started to have a different smell in her DNA and her skin and her system, a very strong smell, different, but she did not feel hot or sweaty,), ARTHRALGIA (also she felt aches in joints and muscles) and PAROSMIA (her skin and her system, a very strong smell, different,). At the time of the report, MYALGIA (she felt aches in joints and muscles) had not resolved and IMMUNISATION REACTION (patient reported having side effects from the vaccines/she started to have a different smell in her DNA and her skin and her system, a very strong smell, different, but she did not feel hot or sweaty,), ARTHRALGIA (also she felt aches in joints and muscles) and PAROSMIA (her skin and her system, a very strong smell, different,) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient started to have a different smell in her DNA and her skin and her system, a very strong smell, different, but she did not feel hot or sweaty, and also she felt aches in joints and muscles. Patient mentioned the vaccine changed her body and her DNA and it was attacking organs and the immune system. These symptoms were still ongoing.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: have had covid 5x; still not having my second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose). At the time of the report, COVID-19 (have had covid 5x) and PRODUCT DOSE OMISSION ISSUE (still not having my second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient too came down with symptoms but tested negative twice and Positive.     The action taken with 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 medication was provided.  Patient was due for second shot in January of 2022 and her husband had tested positive the day before patient shot.   It was reported that patient had covid 5 times in their household which here patient now still not had second dose.   Patient tried last week to find the second dose of the Moderna series.  Treatment medication was not provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No Adverse Event; Moderna COVID19 vaccine bivalent dose to a patient that had already received a Pfizer bivalent vaccine Patient received in the past; interchange of vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (Moderna COVID19 vaccine bivalent dose to a patient that had already received a Pfizer bivalent vaccine Patient received in the past), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023h22a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE ( 0.3ml ) on 14-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 15-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) .5 milliliter. On an unknown date, the patient experienced COVID-19 IMMUNISATION (Moderna COVID19 vaccine bivalent dose to a patient that had already received a Pfizer bivalent vaccine Patient received in the past), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, COVID-19 IMMUNISATION (Moderna COVID19 vaccine bivalent dose to a patient that had already received a Pfizer bivalent vaccine Patient received in the past), INTERCHANGE OF VACCINE PRODUCTS (interchange of 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 assessments were provided for COVID-19 IMMUNISATION (Moderna COVID19 vaccine bivalent dose to a patient that had already received a Pfizer bivalent vaccine Patient received in the past) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-688242 (Patient Link).
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Bivalent vaccine was given past the 12 hrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs) and NO ADVERSE EVENT (no adverse event) in a 67-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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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 15-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 (Bivalent vaccine was given past the 12 hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given past the 12 hrs).    Concomitant medication was not reported.  It was noticed that, patient received Bivalent vaccine was given past the 12 hrs. Treatment medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 2), Moderna COVID-19 Vaccine (Dose 1) and Moderna COVID-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 31-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 16-DEC-22, patient did not had any COVID symptoms. She was advised by her doctor to wait for 2 weeks after COVID to receive a bivalent booster. She was asking whether she can go ahead and had a Moderna COVID-19 bivalent booster on that day.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: We have Moderna that was left out for more than 12 hrs & used.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and 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 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 EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used.) 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 EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs &amp; used.).    No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: They administered a vaccine on 15Dec2022 at 10 AM after the excursion; No Adverse Event; administered a vaccine on 15Dec2022 at 10 AM after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) and NO ADVERSE EVENT (No Adverse Event) in a 50-year-old male 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 15-Dec-2022 at 10:00 AM, 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 15-Dec-2022 at 10:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion).    Concomitant products were not reported.  It was reported that overnight 14-15-Dec-2022 the power went out, so the fridge got out of range. In the morning, the power turned back on, so the fridge was back within range. The vaccines in the fridge went to room temperature from 6:20 AM to 7:30 AM. They administered a vaccine on 15-Dec-2022 at 10 AM after the excursion because they didn't know there was an excursion. It was unknown did patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022) and NO ADVERSE EVENT (No adverse event) in a 21-year-old 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 28-Oct-2022, 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 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022) 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 (received Bivalent Moderna COVID-19 vaccine as her first primary dose on 28OCT2022).    No concomitant medication was reported.  The parental vaccine exposure was reported as no.  On 28-Oct-2022, a 21-year-old patient received Bivalent Moderna COVID-19 vaccine as first primary dose. Pharmacist asked about what should be done or to get re-vaccination.  No treatment medication was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  The patient's past medical history included COVID-19. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received dose 1 on 29-Jan-2021 and dose 2 on 19-Feb-2021).    The patient received dose 1 and dose 2 of Moderna vaccine in P.M hours.  Dose details of Fluarix was reported as pre-filled syringe, quadrivalent.  No treatment details was reported.   This case was linked to MOD-2022-665705 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H21A) for COVID-19 prophylaxis.     Never diagnosed with COVID-19 Allergies: Sulfite, artificial crab legs Asthma from inhaling certain chemicals and cooking oils. There was no parental vaccine exposure.  The patient's past medical history included Allergy and Asthma. Previously administered products included for COVID-19 prophylaxis: COVID-19 VACCINE on 25-Feb-2021 and COVID-19 VACCINE on 09-Dec-2021; for an unreported indication: COVID-19 VACCINE on 28-Jan-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Allergy and Asthma.    On 14-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 15-Dec-2022, the patient experienced PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches). At the time of the report, PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Dec-2022, SARS-CoV-2 test: Negative.     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 medication was provided by reporter. No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 13-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 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication information provided.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna Covid 19 Bivalent after 30 day use by date.  No treatment information provided.   This case was linked to MOD-2022-687454, MOD-2022-687539, MOD-2022-687540, MOD-2022-687541, MOD-2022-687542 (Linked Report).; Sender's Comments:  MOD-2022-687541:Original Case : MOD-2022-687454 MOD-2022-687540:Original Case : MOD-2022-687454 MOD-2022-687539:Original Case : MOD-2022-687454 MOD-2022-687542:Original Case : MOD-2022-687454 MOD-2022-687454:Original Case : MOD-2022-687454
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 13-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 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 (administered Moderna Covid 19 Bivalent after 30 day use by date).    Concomitant product use was not provided by the reporter. Patients was accidentally administered Moderna Covid 19 Bivalent after 30 day use by date. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687538, US-MODERNATX, INC.-MOD-2022-687454, US-MODERNATX, INC.-MOD-2022-687540, US-MODERNATX, INC.-MOD-2022-687541, US-MODERNATX, INC.-MOD-2022-687542 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687541:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687540:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687454:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687542:Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687538:Original Case : MOD-2022-687454
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 13-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 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant drug information was provided.  It was reported that the HCP had administered bivalent vaccine to 4-5 adult patients beyond 30 days used by date.   No treatment drug medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687538, US-MODERNATX, INC.-MOD-2022-687539, US-MODERNATX, INC.-MOD-2022-687454, US-MODERNATX, INC.-MOD-2022-687541, US-MODERNATX, INC.-MOD-2022-687542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687541:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687454:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687539:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687542:Same reporter, Original Case : MOD-2022-687454 US-MODERNATX, INC.-MOD-2022-687538:Same reporter, Original Case : MOD-2022-687454
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-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 30-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)).    No Concomitant medications were provided.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that temperature excursion was occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2).   No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Vaccination site pain
Clinical narrative: headache; nausea; chills; Sore left arm; stomach problem; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm) and ABDOMINAL DISCOMFORT (stomach problem) in a 79-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:Was there parental vaccine exposure?Answer:No.     On 13-Dec-2022, 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 an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm) and ABDOMINAL DISCOMFORT (stomach problem). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and VACCINATION SITE PAIN (Sore left arm) had not resolved and ABDOMINAL DISCOMFORT (stomach problem) 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 medications were reported. It was reported that patient had taken all previous shots were Moderna COVID-19 vaccine, First Primary monovalent dose on 20-JAN-2021 (Lot# 028L208A & Exp. Date: unknown), second Primary monovalent dose on 7-FEB-2021 (Lot# 031L20A & Exp. Date: unknown) and First Monovalent Booster (Dose 3) dose on 22-OCT-2021 (Lot# 039D21A & Exp. Date unknown).   This case was linked to MOD-2022-687759 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-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-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2).) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:original case US-MODERNATX, INC.-MOD-2022-687786:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29Nov2022; Temperature excursion occurred on 29Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, 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 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022).    Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:original case US-MODERNATX, INC.-MOD-2022-687786:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29Nov2022.; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-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-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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 (Temperature excursion occurred on 29Nov2022.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A total of 16 doses were administered in 6 days. 5 doses on 29-Nov-2022, 4 doses on 30-Nov-2022, 2 doses on 01-Dec-2022, 2 doses on 02-Dec-2022, 1 dose on 03-Dec-2022 and 2 doses on 05-Dec-2022. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687786, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:Original Case : MOD-2022-687690 US-MODERNATX, INC.-MOD-2022-687786: US-MODERNATX, INC.-MOD-2022-687785: US-MODERNATX, INC.-MOD-2022-687787:
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Extremely bad reaction to moderma booster shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Extremely bad reaction to moderma booster shot) in a  patient of an unknown age and 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) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Extremely bad reaction to moderma booster shot). At the time of the report, IMMUNISATION REACTION (Extremely bad reaction to moderma booster shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  The dose patient received was booster shot.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred; Temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) 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 (Temperature excursion occurred) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred).    Concomitant medications details were not reported by the reporter.  Reportedly, Temperature excursion occurred on 29-Nov-2022. A total of 16 doses were administered on 29-Nov-2022 (5 doses), 30-Nov-2022 (4 doses), 01-Dec-2022 (2 doses), 02-Dec-2022 (2 doses), 03-Dec-2022 (1 doses) and 05-Dec-2022 (2 doses).  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment details were not reported by the reporter.  The case was for one patient among the two adult patients who received the vaccine on 01-Dec-2022, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-687665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687665:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 024m20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 11-Feb-2021 and 2nd dose on 30-Mar-2021).    No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2022-688151 (Patient Link).