chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Shoulder is sore/Shoulder with the rotator cuff tear is sore right now; rotatorcuff tear is aggravated due to something he did.; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not had positive covid test or diagnosis.  The patient's past medical history included Shoulder arthroplasty (The patient stated that he has artificial shoulder since 2016 and a rotator cuff partial tear shoulder since 2017 and stated that both were before he received the 1st dose of Moderna vaccine) in 2016. Concurrent medical conditions included Drug intolerance (Percocet and Ibuprofen) and Lactose intolerant. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.). At the time of the report, ARTHRALGIA (Shoulder is sore/Shoulder with the rotator cuff tear is sore right now) and CONDITION AGGRAVATED (rotatorcuff tear is aggravated due to something he did.) outcome was unknown.            The patient reported that all 3 doses so far were administered in recommended time frame but was unable to provide dates for the first 2 doses and lot numbers and expiration dates.  The patient reported that all the shots were intramuscular injections into the left shoulder that is the non-artificial one with a tear in it.  No treatment medication details reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose
Clinical narrative: Booster received instead of full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster received instead of full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster received instead of full dose). At the time of the report, ACCIDENTAL OVERDOSE (Booster received instead of full dose) outcome was unknown.     No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-608531 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster received instead of full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster received instead of full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster received instead of full dose). At the time of the report, ACCIDENTAL OVERDOSE (Booster received instead of full dose) outcome was unknown.     No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-608531 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose
Clinical narrative: Fourth dose administered earlier than recommended interval of at least four months; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-608527 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Fourth dose administered earlier than recommended interval of at least four months; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fourth dose administered earlier than recommended interval of at least four months) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-608527 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022; Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 31-May-2022 and the doses were administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  On 31-May-2022 at 4pm, The vial was initially stored in the refrigerator.   It was reported that moderna COVID 19 vaccine got a 30 day BUD out of the freezer and was administration of vaccine on 01-Jul-2022 between  9am and 12noon.   The vial did not undergo any temperature excursions.  No treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired booster dose beyond 30-day Use By Date; Received expired booster dose beyond 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  One dose was administered to the adult patient of age more than 45 year old.  On 11-Jun-2022 or 12-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Treatment information was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Illness, Immunisation reaction, Peripheral swelling
Clinical narrative: she felt sick for 48 hours; she experienced a severe reaction during 1 week; her left arm was swollen from the shoulder to the elbow; her left arm was hot from the shoulder to the elbow; her left arm was red from the shoulder to the elbow; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she felt sick for 48 hours), IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 prophylaxis.     Concurrent condition included high cholesterol.  Concurrent medical conditions included Blood pressure high (Started 10 years ago), Egg allergy, Environmental allergy, Allergy to antibiotic (Tetracycline,), Allergy to antibiotic (Erythromycin), Sulfonamide allergy (Sulfa), Penicillin allergy and Rheumatoid arthritis (started 3 years ago). Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure high, ROSUVASTATIN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced ILLNESS (she felt sick for 48 hours), IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow). On 01-Sep-2021, ILLNESS (she felt sick for 48 hours) had resolved. On 06-Sep-2021, IMMUNISATION REACTION (she experienced a severe reaction during 1 week), PERIPHERAL SWELLING (her left arm was swollen from the shoulder to the elbow), FEELING HOT (her left arm was hot from the shoulder to the elbow) and ERYTHEMA (her left arm was red from the shoulder to the elbow) had resolved.            No treatment drug details was reported.   This case was linked to MOD-2022-608551 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-May-2022 and the dose was administered on 01-Jul-2022; Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the dose was administered on 01-Jul-2022) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the dose was administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the dose was administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored from freezer to refrigerator on 31-May-2022 at 4 PM. The vaccine was administered on 01-Jul-2022 between 9 AM to 12 noon. The vial did not undergo any temperature excursions. it was reported that the days were miscalculated.  No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) outcome 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 the patient received first booster dose of Moderna vaccine on 11-Jul-2022 from a vial containing 3 doses.  It was reported that the vial was initially stored in the refrigerator on 11-Jul-2022. The vial was thawed for the first time on 11-Jul-2022.  The vial did not undergo any temperature excursions. The reporter asked what action needs to be taken further in regards to the expired vaccine administration.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-608564, US-MODERNATX, INC.-MOD-2022-608562 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608564:3rd Patient (same reporter) US-MODERNATX, INC.-MOD-2022-608562:2nd Patient (same reporter)
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (dose administered after manufacturer date of expiry) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine/lot# batch/lot# 048L21A) for COVID-19 immunization. No medical history reported. On Jul 11, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 11, 2022, patient administered expired product (dose administered after manufacturer date of expiry). At the time of the report, administered expired product (dose administered after manufacturer date of expiry) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient administered the second booster dose. Vial thawed for the first time on Jul 11, 2022. The number of doses per vial: 3. On Jul 11, 2022, vial initially stored in the refrigerator. Vial did not undergo any temperature excursions. This case linked to MOD-2022-608564 (patient link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient was administered with first Booster dose. The vial was thawed for the first time on 11Jul2022. On 11Jul2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication information was provided.   This case was linked to MOD-2022-608562, MOD-2022-608557 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date) and product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 054A22A) for COVID-19 immunization. No medical history reported. On Jul 1, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 1, 2022, patient administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date). On an unknown date, patient experienced product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022). At the time of the report, administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date) and product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. On May 31, 2022, at 4 pm, vial went from freezer to refrigerator. It did not undergo any temperature excursions. Administered Jul 1, 2022 between 9 am and 12 noon.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022; HCP reported dose of Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The occupation of the reporter was reported as clinic manager.  No concomitant medications were reported.  The healthcare professional (HCP) stated the total number of doses was actually 8 doses.  On 31-May-2022 4 PM, the vial went from freezer to refrigerator.  The vial was administered on 01-Jul-2022 between 9 AM and 12 noon. It was reported that, the days were miscalculated. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer; Vial got a 30 day BUD out of the freezer and I had someone administer it past that.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.) and PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial got a 30 day BUD out of the freezer and I had someone administer it past that.) and PRODUCT STORAGE ERROR (have a Moderna COVID 19 vaccine and it's got a 30 day BUD out of the freezer) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vail was initially stored from freezer to refrigerator on 31-May-2022 at 4 PM. The vaccine was administered on 01-Jul-2022 between 9 AM to 12 noon. The vial did not undergo any temperature excursions. it was reported that, the days were miscalculated.  No treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 31-May-2022 and vaccine was administrated on 01-Jul-2022.; doses of Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 31-May-2022 and vaccine was administrated on 01-Jul-2022.) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses of Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 31-May-2022 and vaccine was administrated on 01-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 31-May-2022 and vaccine was administrated on 01-Jul-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. It was reported that 8 doses were administered from the expired vial. vial was initially stored in the refrigerator  on 31-May-2022 4PM ,went from freezer to refrigerator and vaccine was administrated on 01-Jul-2022 between 9am and 12noon. No temperature excursions. Treatment details were not reported by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo; This spontaneous case was reported by a patient and describes the occurrence of VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (cleaning substance used for surgeries) and Lichen planopilaris (pre-existing autoimmune condition which is a form of alopecia, in remission and in stable status) since 2019.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In April 2021, the patient experienced VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo). The patient was treated with RUXOLITINIB PHOSPHATE (OPZELURA) for Adverse event, at an unspecified dose and frequency; TACROLIMUS (topical) for Adverse event, at an unspecified dose and frequency and DESONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, VITILIGO (saw a Dermatologist on or about 1APR2021 and was diagnosed with vitiligo) 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 after receiving the 2nd dose, the discoloration started to show much more and became the size of a quarter. After 2 weeks of applying the medications, the discoloration became bigger and started spreading towards the neck area. Patient never had positive COVID test.   This case was linked to MOD-2022-608387 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Bypass surgery. Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Quadruple bypass) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes blood pressure medication, diabetes medication and medicine to stop rapid heart beat.  Patient had open heart surgery and quadruple bypass as a treatment.  Patient was unsure if it was vaccine related.  Company comment: This is a spontaneous case concerns a 68-year-old male patient, without any reported medical history who experienced the unexpected, serious (medically significant, hospitalization) adverse event of special interest Myocardial infarction. The event occurred 8 days after receiving the first dose of mRNA1273. The patient suffered from heart attack post vaccination and was treated via open heart surgery and quadruple bypass. Further details regarding the clinical course, diagnostic test done and complete treatment protocols on the patient were not provided. It was also reported that the patient was taking medications for blood pressure, diabetes and treatments to stop rapid heart beat, these concurrent conditions along with the elderly age of the patient may be considered as risk factors for myocardial infarction. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-608597 (Patient Link).; Sender's Comments: This is a spontaneous case concerns a 68-year-old male patient, without any reported medical history who experienced the unexpected, serious (medically significant, hospitalization) adverse event of special interest Myocardial infarction. The event occurred 8 days after receiving the first dose of mRNA1273. The patient suffered from heart attack post vaccination and was treated via open heart surgery and quadruple bypass. Further details regarding the clinical course, diagnostic test done and complete treatment protocols on the patient were not provided. It was also reported that the patient was taking medications for blood pressure, diabetes and treatments to stop rapid heart beat, these concurrent conditions along with the elderly age of the patient may be considered as risk factors for myocardial infarction. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022; Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient received first booster dose and second booster dose. It was reported that two warm temperature excursions occurred with two different batches of the same lot number of the Moderna COVID-19 Vaccine. The two different batches of vaccine were stored in the facilities freezer. The first set of Moderna COVID-19 vaccine reached 7.9 degrees Fahrenheit in a freezer for 10 minutes. This excursion occurred on 23-May-2022. The second lot number of Moderna COVID-19 vaccine that underwent an excursion on 08-Jul-2022 10 vials of vaccine reached 6.24 degrees Fahrenheit for 39 minutes. No side effects or Adverse Reactions were known from the Primary Series.   This case was linked to MOD-2022-608601 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccine had undergone 1 temperature excursion was administered to 2 patients; vaccine had undergone 1 temperature excursion was administered to 2 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccine had undergone 1 temperature excursion was administered to 2 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine had undergone 1 temperature excursion was administered to 2 patients) outcome 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 two warm temperature excursions occurred with two different batches of the same lot number of the Moderna COVID-19 Vaccine. The two different batches of vaccine were stored in the facilities freezer.   The first set of Moderna Covid-19 vaccine lot number was 060A22A the vaccine reached 7.9 degrees Farenhight in a freezer for 10 minutes. This excursion occurred on 23MAY2022. The second lot number of Moderna Covid-19 vaccine that underwent an excursion was 060A22A. On 8JUL2022 10 vials of vaccine reached 6.24 degrees Farenheigt for 39 minutes.The second lot number of Moderna COVID-19 vaccine that underwent an excursion was 060A22A. On 08-Jul-2022 10 vials of vaccine reached 6.24 degrees Fahrenheit for 39 minutes.  No side effects or Adverse Reactions were known from the Primary Series.  No treatment medications were reported.   This case was linked to MOD-2022-608600 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH (Rash on arm). In 2021, RASH (Rash on arm) had resolved.            Patient height was reported as 5. No concomitant medication was provided. It was reported that patient had no allergic history. Patient had never test positive or diagnosis of COVID. No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient was perfectly healthy. No treatment medication were provided.   This case was linked to MOD-2022-608619 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Rash on arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH (Rash on arm). In 2021, RASH (Rash on arm) had resolved.            Patient height was reported as 5. No concomitant medication was provided. It was reported that patient had no allergic history. Patient had never test positive or diagnosis of COVID. No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient was perfectly healthy. No treatment medication were provided.   This case was linked to MOD-2022-608619 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Pain in the lower back, pain that went up to her left shoulder; Pain in the lower back, pain that went up to her left shoulder; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products). Patient never had COVID positive test or diagnosis. Had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Jul-2022, BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder) had resolved.            Patient was not under any concomitant or regular medications.  On 13-Jul-2022, after first booster, patient started to experience very rapid heartbeats that woke her up and pain in the lower back, that went up to left shoulder. Patient took Tylenol for pain and symptoms were currently resolved. AE did not caused patient to seek medical care.  Patient mentioned being perfectly healthy.   This case was linked to MOD-2022-608617 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Pain in the lower back, pain that went up to her left shoulder; Pain in the lower back, pain that went up to her left shoulder; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 vaccination.     Patient had no allergies (medications, food and other products). Patient never had COVID positive test or diagnosis. Had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Jul-2022, BACK PAIN (Pain in the lower back, pain that went up to her left shoulder) and ARTHRALGIA (Pain in the lower back, pain that went up to her left shoulder) had resolved.            Patient was not under any concomitant or regular medications.  On 13-Jul-2022, after first booster, patient started to experience very rapid heartbeats that woke her up and pain in the lower back, that went up to left shoulder. Patient took Tylenol for pain and symptoms were currently resolved. AE did not caused patient to seek medical care.  Patient mentioned being perfectly healthy.   This case was linked to MOD-2022-608617 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received half dose of Moderna vaccine on 30-Dec-2021 followed by full dose on 08-Feb-2022 for the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received half dose of Moderna vaccine on 30-Dec-2021 followed by full dose on 08-Feb-2022 for the primary series) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received half dose of Moderna vaccine on 30-Dec-2021 followed by full dose on 08-Feb-2022 for the primary series). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received half dose of Moderna vaccine on 30-Dec-2021 followed by full dose on 08-Feb-2022 for the primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-607775 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received Full Dose first booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Received Full Dose first booster of Moderna COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL OVERDOSE (Received Full Dose first booster of Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Received Full Dose first booster of Moderna COVID-19 vaccine) outcome was unknown.            No concomitant medications were reported. No treatment details were reported. Patient was not immunocompromised.   Reporter did not allow further contact