chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Submandibular lymph node swelling; Pain/swelling at injection site; Pain/swelling at injection site; Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site), VACCINATION SITE SWELLING (Pain/swelling at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 039A21A and 029A21A) for COVID-19 prophylaxis.     Patient did not had any known allergies.  Patient was never been diagnosed with or tested positive for COVID-19.  Patient did not had any acute illness at the time of vaccination and up to one month before. Patient did not had any chronic or long-standing health conditions.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021). On an unknown date, the patient experienced LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site) and VACCINATION SITE SWELLING (Pain/swelling at injection site). At the time of the report, LYMPHADENOPATHY (Submandibular lymph node swelling), VACCINATION SITE PAIN (Pain/swelling at injection site), VACCINATION SITE SWELLING (Pain/swelling at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administerd dose 2 on 10-Apr-2021 and dose 3 on 31-Aug-2021) outcome was unknown.            Patient did not had any prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event.  It was reported that the patient experienced pain or swelling at injection site and submandibular lymph node swelling in past COVID-19 vaccinations.  No treatment information was reported.   This case was linked to MOD-2022-642860 (Patient Link).
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator for more than 12 hours post puncture; No adverse event; 1 pediatric patient received a Moderna Covid-19 vaccine primary dose 15/16 hours post punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 pediatric patient received a Moderna Covid-19 vaccine primary dose 15/16 hours post punctured), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator for more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     Patient did not have any allergies or never tested positive for COVID. No acute and chronic illnesses were reported at the time of vaccination.     On 13-Sep-2022 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 pediatric patient received a Moderna Covid-19 vaccine primary dose 15/16 hours post punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator for more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 pediatric patient received a Moderna Covid-19 vaccine primary dose 15/16 hours post punctured), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator for more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 pediatric patient received a Moderna Covid-19 vaccine primary dose 15/16 hours post punctured) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator for more than 12 hours post puncture).    No concomitant medications were reported.  Flu Vaccine was given to the patient on 13-Sep-2022, the same day as the Moderna Vaccine. The vial was initially stored in the refrigerator on 8 Sep 2022. Date and time the vial was first punctured at 5:10pm on 12 Sep 2022. Post the puncture Vial was stored in refrigerator the whole time. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for less than 5 minutes.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: checked blood pressure which had spiked to 176/100; Headache; This spontaneous case was reported by a physician and describes the occurrence of HYPERTENSION (checked blood pressure which had spiked to 176/100) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced HYPERTENSION (checked blood pressure which had spiked to 176/100) and HEADACHE (Headache). At the time of the report, HYPERTENSION (checked blood pressure which had spiked to 176/100) was resolving and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Blood pressure measurement: spiked to 176/100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Within hours patient experienced headache and checked blood pressure which had spiked to 176/100. Blood pressure remained elevated until 27-Nov-2021 and had moderate relief with a few unspecified blood pressure medications.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: very mild reaction to Moderna/very little reaction to the Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (1st dose), Johnson and Johnson (1st Booster dose) and Johnson and Johnson (2nd dose). Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson, Johnson and Johnson and Johnson and Johnson.    In 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna). At the time of the report, IMMUNISATION REACTION (very mild reaction to Moderna/very little reaction to the Moderna) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-645554 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-645554:Wife's case
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I have had 4 Moderna's previous with very intense reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I have had 4 Moderna's previous with very intense reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have had 4 Moderna's previous with very intense reactions). At the time of the report, IMMUNISATION REACTION (I have had 4 Moderna's previous with very intense reactions) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-645552 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-645552:Husband's case
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Morfin allergy). Concomitant products included LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for Anticoagulant therapy.    On 14-Sep-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose 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 (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna Covid-19 vaccine first dose after 30-day Use By Date).    The patient does not know the history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  HCP explained she did not have any other medical history information since she was not a facility regular patient.  The patient never ever had COVID positive test or diagnosis.  Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was reported that HCP called because a patient received a Moderna Covid-19 vaccine first dose after 30-day use by date.  HCP confirmed that no side effects had been yet reported. HCP asked if she needed to call the patient or re-vaccinate her.  On 15-Aug-2022 7:50 am EST time, the vial was initially stored in the refrigerator.  The vial does not undergo any temperature excursions.  Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20-2A, 039K20A and 004PWA) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine). In 2021, PAIN IN EXTREMITY (soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine) had resolved.            Concomitant medications were not reported. it was reported that the soreness lasted for about a day. Patient not seek medical care for event. Reporter was unsure whether his wife took Tylenol for soreness or not.   This case was linked to MOD-2022-645565 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever after the 2nd dose; chills after the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever after the 2nd dose) and CHILLS (chills after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after the 2nd dose) and CHILLS (chills after the 2nd dose). At the time of the report, PYREXIA (fever after the 2nd dose) and CHILLS (chills after the 2nd dose) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-645572, MOD-2022-645567 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: She was really very sick; arm became swollen after the 1st booster; arm became swollen and it itched; chills after the 1st booster; fever after the 1st booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was really very sick), PERIPHERAL SWELLING (arm became swollen after the 1st booster), PRURITUS (arm became swollen and it itched), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was really very sick), PERIPHERAL SWELLING (arm became swollen after the 1st booster), PRURITUS (arm became swollen and it itched), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster). The patient was treated with TRIAMCINOLONE for Swollen arm and Itching, at an unspecified dose and frequency. At the time of the report, ILLNESS (She was really very sick), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster) outcome was unknown and PERIPHERAL SWELLING (arm became swollen after the 1st booster) and PRURITUS (arm became swollen and it itched) had resolved.            No Concomitant medication were reported.  On an unknown date patient received Moderna Covid-19 vaccines Dose 1 and Dose 2.    Patient had to apply Triamcinolone and it went away after a week and a half.   This case was linked to MOD-2022-645567, MOD-2022-645571 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: soreness/some soreness on his arm; I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots. Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him). At the time of the report, PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient says that something unusual did occur after receiving the 1st dose of the Moderna vaccine. There was a red circle about a quarter inch from where the injection was given to him. No treatment medications was reported.   This case was linked to MOD-2022-645575, MOD-2022-645576 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Biopsy, Pain in extremity
Clinical narrative: soreness/some soreness on his arm; I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots. Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him). At the time of the report, PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient says that something unusual did occur after receiving the 1st dose of the Moderna vaccine. There was a red circle about a quarter inch from where the injection was given to him. No treatment medications was reported.   This case was linked to MOD-2022-645575, MOD-2022-645576 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness/some soreness on his arm; I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots. Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him). At the time of the report, PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient says that something unusual did occur after receiving the 1st dose of the Moderna vaccine. There was a red circle about a quarter inch from where the injection was given to him. No treatment medications was reported.   This case was linked to MOD-2022-645575, MOD-2022-645576 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: some soreness on arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some soreness on arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004PWA, 039K20A and 039K20-2A) for COVID-19 vaccination.     The patient never diagnosed or tested positive with COVID.  Previously administered products included for Product used for unknown indication: Flu shots since an unknown date. Past adverse reactions to the above products included Pain in arm with Flu shots. Concurrent medical conditions included Penicillin allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some soreness on arm). At the time of the report, PAIN IN EXTREMITY (some soreness on arm) had resolved.            Patient's weight was reported as 170 and height was reported as 5' 11".  No concomitant medications were provided by the reporter.  Patient did not seek medical care for the event soreness on arm.  The soreness only lasted for a day.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-645575, MOD-2022-645573 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Biopsy, Pain in extremity
Clinical narrative: some soreness on arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some soreness on arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004PWA, 039K20A and 039K20-2A) for COVID-19 vaccination.     The patient never diagnosed or tested positive with COVID.  Previously administered products included for Product used for unknown indication: Flu shots since an unknown date. Past adverse reactions to the above products included Pain in arm with Flu shots. Concurrent medical conditions included Penicillin allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some soreness on arm). At the time of the report, PAIN IN EXTREMITY (some soreness on arm) had resolved.            Patient's weight was reported as 170 and height was reported as 5' 11".  No concomitant medications were provided by the reporter.  Patient did not seek medical care for the event soreness on arm.  The soreness only lasted for a day.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-645575, MOD-2022-645573 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: some soreness on arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some soreness on arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004PWA, 039K20A and 039K20-2A) for COVID-19 vaccination.     The patient never diagnosed or tested positive with COVID.  Previously administered products included for Product used for unknown indication: Flu shots since an unknown date. Past adverse reactions to the above products included Pain in arm with Flu shots. Concurrent medical conditions included Penicillin allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some soreness on arm). At the time of the report, PAIN IN EXTREMITY (some soreness on arm) had resolved.            Patient's weight was reported as 170 and height was reported as 5' 11".  No concomitant medications were provided by the reporter.  Patient did not seek medical care for the event soreness on arm.  The soreness only lasted for a day.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-645575, MOD-2022-645573 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Portal vein thrombosis
Clinical narrative: Acute portal vein thrombosis; This literature-non-study case was reported in a literature article and describes the occurrence of PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) (seriousness criterion medically significant). At the time of the report, PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered PORTAL VEIN THROMBOSIS (Acute portal vein thrombosis) to be related.    No concomitant and treatment medications were reported.  Patient had no significant risk factors for pathologic clotting and was diagnosed with an acute portal vein thrombosis several days after receiving the Moderna COVID-19 vaccine.  Company comment: This literature-non-study case concerns a 34-year-old, female patient with no significant risk factors for pathologic clotting and no other medical history information provided, who experienced the unexpected serious (medically significant) AESI of portal vein thrombosis. The event occurred several days after the 2nd dose of mRNA-1273 and outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 34-year-old, female patient with no significant risk factors for pathologic clotting and no other medical history information provided, who experienced the unexpected serious (medically significant) AESI of portal vein thrombosis. The event occurred several days after the 2nd dose of mRNA-1273 and outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster) 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 INCORRECT DOSE ADMINISTERED (patient was administered 1 dose of the monovalent vaccine instead of the bivalent booster).    It is unknown if patient was under any concomitant or regular medication.   Reporter did not allow further contact
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was moved from the freezer to place in the refrigerator the day before it was used; No adverse event; Patient was administered with expired Moderna Covid-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 (Dose 1.), COVID-19 (Dose 3 (First booster).) and COVID-19 (Dose 2.). Past adverse reactions to the above products included No adverse event with COVID-19, COVID-19 and COVID-19.    On 16-Aug-2022 at 2:20 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Aug-2022 at 2:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used).    No concomitant medication were reported.  It was reported that the (Clinic) provided scheduled vaccines, no walk-ins. At this location, vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date. Only removed one vial from the freezer to place in the refrigerator the day before it was used i.e on 15-AUG-2022  the vial was removed from the freezer and placed in the refrigerator. The vial was initially stored in the freezer on 18-Apr-2022. The size of the vial was reported as 5.5ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 01), COVID-19 Vaccine (Dose 03 (Booster dose)) and COVID-19 Vaccine (Dose 02). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 30-Aug-2022 at 3:41 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 3:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022).    No concomitant medications was reported.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  No treatment drug details was reported.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2022 at 10:52 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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. On 13-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022 and stored in refrigerator on 12-Sep-2022 and administered to the patient on 13-Sep-2022).    Concomitant medication information was not provided by the reporter.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  Treatment information was not provided by the reporter.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration; No adverse event; Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 2) and COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On 30-Aug-2022 at 4:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 4:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022) 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 assessments were provided for PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 30-Aug-2022).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (First booster dose), COVID-19 VACCINE (second dose) and COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 16-Aug-2022 at 10:28 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022) 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 assessments were provided for PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator) and EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022).    No relevant concomitant medications were reported.  No treatment information was provided.