chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a parent via media via a company representative concerned a 45 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from blood clots. The reporter stated "My healthy 45 year old son died of blood clots after the jab". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221164062- blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOTS
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHOOK VIOLENTLY AFTER 48 HOURS AFTER SHE TOOK VACCINE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shook violently after 48 hours after she took vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shook violently after 48 hours after she took vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart palpitations was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: BALD PATCHES ON HEAD; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bald patches on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bald patches on head was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epistaxis
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of EPISTAXIS (Several incidences of bloody nose) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019h22a) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Nov-2022, the patient experienced EPISTAXIS (Several incidences of bloody nose). At the time of the report, EPISTAXIS (Several incidences of bloody nose) had resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine. No treatment medications are reported. Reporter did not allow further contact.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 001B21A, 039F4A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included ATORVASTATIN for Cholesterol, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            Reportedly, patient also experienced tinnitus on 12-Mar-2021 and 09-Nov-2021 which was still ongoing.  Treatment medication was not provided by the reporter.  It was reported that patient did not know exactly when and realized that patient had 1000 cicadas chirping in her head. If Patient was not concentrating on something or distracted, patient noticed the noise, the noises started after the vaccinations.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Follow-up document contains updated patient demographics, concurrent conditions, suspect product information, updated event details, report type and narrative updated accordingly.
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Dyspepsia, Fatigue
Clinical narrative: 1. Nausea 2.  Terrible Stomach Ache burning below ribs 3. Achy all over 4. Major fatigue 5.  No appetite 6.  Chills 7.  Headache 8. Slept for many, many hours 9.  Left  Arm swollen  like a balloon 10. Arm itches,  still swollen on day 4 11. Arm rash from elbow to shoulder
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Headache, Hypersomnia, Nausea, Pain, Peripheral swelling
Clinical narrative: 1. Nausea 2.  Terrible Stomach Ache burning below ribs 3. Achy all over 4. Major fatigue 5.  No appetite 6.  Chills 7.  Headache 8. Slept for many, many hours 9.  Left  Arm swollen  like a balloon 10. Arm itches,  still swollen on day 4 11. Arm rash from elbow to shoulder
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: 1. Nausea 2.  Terrible Stomach Ache burning below ribs 3. Achy all over 4. Major fatigue 5.  No appetite 6.  Chills 7.  Headache 8. Slept for many, many hours 9.  Left  Arm swollen  like a balloon 10. Arm itches,  still swollen on day 4 11. Arm rash from elbow to shoulder
Age: 75.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Anticoagulant therapy, Cardio-respiratory arrest, Cardiogenic shock, Cardiovascular disorder, Catheterisation cardiac abnormal
Clinical narrative: Patient was admitted to hospital with cardiac ischemia on the 29th of November.  He subsequently coded and was taken to cath lab and found to have clot in RCA.  Clot removed and stent placed.  He then became unstable again and found to have clotted off his brand new stent.  He was already taking eliquis and ASA prior to admit and was started on heparin gtt on admission.  He was transferred to our facility on November 30th for cardiogenic shock with in stent re-thrombosis despite anticoagulation.  He underwent repeat RCA PCI and impella LVAD device.
Age: 75.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Coronary arterial stent insertion, Coronary artery thrombosis, Ejection fraction decreased, Mechanical ventilation, Myocardial ischaemia
Clinical narrative: Patient was admitted to hospital with cardiac ischemia on the 29th of November.  He subsequently coded and was taken to cath lab and found to have clot in RCA.  Clot removed and stent placed.  He then became unstable again and found to have clotted off his brand new stent.  He was already taking eliquis and ASA prior to admit and was started on heparin gtt on admission.  He was transferred to our facility on November 30th for cardiogenic shock with in stent re-thrombosis despite anticoagulation.  He underwent repeat RCA PCI and impella LVAD device.
Age: 75.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Percutaneous coronary intervention, Thrombectomy, Vascular stent thrombosis, Ventricular assist device insertion
Clinical narrative: Patient was admitted to hospital with cardiac ischemia on the 29th of November.  He subsequently coded and was taken to cath lab and found to have clot in RCA.  Clot removed and stent placed.  He then became unstable again and found to have clotted off his brand new stent.  He was already taking eliquis and ASA prior to admit and was started on heparin gtt on admission.  He was transferred to our facility on November 30th for cardiogenic shock with in stent re-thrombosis despite anticoagulation.  He underwent repeat RCA PCI and impella LVAD device.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Diffuse hives starting 9 days after dose, continuing for 10 days (seen in office on day 10, not resolved).
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient given vaccine after BUD date.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2022: Live follow-up received included- iNarrative updated. On 29-Nov-2022: Significant Follow-Up information received: Reporter, patient details added and dosage information, reporter causality updated.
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient had a Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine.  No treatment information was provided by the reporter.  Company Comment: This is a Spontaneous case reported by a nurse, concerning a male patient of unknown age, with underlying Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease aggravated, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. Crohn´s disease can present relapses as part of the natural history of disease, confounding this case. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a nurse, concerning a male patient of unknown age, with underlying Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease aggravated, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. Crohn´s disease can present relapses as part of the natural history of disease, confounding this case. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Moderna first dose was administered on 13-May-2021 and second dose was administered on 27-Oct-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose was administered on 13-May-2021 and second dose was administered on 27-Oct-2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 071F211 and 0018221A) for COVID-19 prophylaxis.     Concurrent medical conditions included Atrial fibrillation and Arthritis.   On 13-May-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 5:00 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose was administered on 13-May-2021 and second dose was administered on 27-Oct-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose was administered on 13-May-2021 and second dose was administered on 27-Oct-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient previously received a COVID-19 Vaccine. Patient received a fourth dose of moderna bivalent vaccine (Batch number: Unknown) in the right arm on 27-Sep-2022 at 12:30 PM. Concomitant medications details were not reported by the reporter. Device date was reported as 24-Nov-2022. Treatment details were not reported by the reporter.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Fibrin D dimer, Myocarditis, Troponin I
Clinical narrative: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Nov-2022, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Brain natriuretic peptide: Mildly elevated. In November 2022, Fibrin D dimer: Mildly elevated. In November 2022, Troponin I: 7.04.         No concomitant medications were reported.  It was reported that symptoms started on 24-Nov-2022 with chest pain. Escalated to orthopnea, diaphoresis and tachypnea with worsening chest pain by 25-Nov-2022.  No treatment medications were reported.  Company comment This spontaneous case concerns 19-year-old patient of an unknown gender with no medical history reported, who experienced the expected, serious (medically significant and hospitalization) AESI of myocarditis, which occurred six days after a dose of mRNA-1273.222 (BA.4/BA.5) vaccine (Spikevax Bivalent Original/Omicron BA.4-5). It was reported that the patient started with symptoms of chest pain, then added orthopnea, diaphoresis, tachypnea with worsening chest pain. The patient went to the emergency department, and was admitted with Troponin I of 7.04, mildly elevated BNP and D-Dimer. The patient was diagnosed with myocarditis. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 19-year-old patient of an unknown gender with no medical history reported, who experienced the expected, serious (medically significant and hospitalization) AESI of myocarditis, which occurred six days after a dose of mRNA-1273.222 (BA.4/BA.5) vaccine (Spikevax Bivalent Original/Omicron BA.4-5). It was reported that the patient started with symptoms of chest pain, then added orthopnea, diaphoresis, tachypnea with worsening chest pain. The patient went to the emergency department, and was admitted with Troponin I of 7.04, mildly elevated BNP and D-Dimer. The patient was diagnosed with myocarditis. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient unintentionally received a 0.25mL dose of the Moderna Bivalent Booster).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-679425 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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.    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 URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient was taking some unspecified medication and had some side effects. The patient was taking Macrobid for 6 weeks as a low dose antibiotic to prevent urinary tract infection. She had side effects with that medication for 2 weeks including dry mouth and a raspy voice. She is scheduled to take her updated booster on Wednesday.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022; No adverse event; Moderna Monovalent administered to patient 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent administered to patient 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on: 24-Oct-2022 and was administered by patient on 25-Nov-2022).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679107, US-MODERNATX, INC.-MOD-2022-679108 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679107:same reporter (crosslink MOD22-029943) US-MODERNATX, INC.-MOD-2022-679108:same reporter (crosslink MOD22-029943)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022; No adverse event; On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) 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 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022).    No concomitant medication details was reported. It was reported that individual vails was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 24-Oct-2022. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to MODERNATX, INC.-MOD-2022-679103 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-679103:same reporter (crosslink MOD22-029943)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022), PRODUCT STORAGE ERROR (Product storage error) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Single dose of expired Moderna Covid-19 was administered on 27-Nov-2022) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. Vial size reported as 5.5 mL. Vial was initially stored in the refrigerator 27-Nov-2022.. Vial did not undergo any temperature excursions. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness in his arm / on and off numbness in face; Tingling in arm/ on and off tingling in face; Pain in my arms and hands; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in my arms and hands), HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had no allergies. The patient never had COVID positive test or diagnosis.     On 16-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced PAIN IN EXTREMITY (Pain in my arms and hands). On 20-Nov-2022, the patient experienced HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face). At the time of the report, PAIN IN EXTREMITY (Pain in my arms and hands), HYPOAESTHESIA (Numbness in his arm / on and off numbness in face) and PARAESTHESIA (Tingling in arm/ on and off tingling in face) had not resolved.            No concomitant medications were provided.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient received first dose, second dose, third dose and fourth dose of Moderna but details were unknown. It was reported that after vaccination, 2 days later patient started experiencing pain in patient's arm and hands. Patient also started having numbness and tingling in patient's arm. 2 days after this, patient started getting on and off numbness and tingling in patient's face. It had been about 10-11 days and patient's symptoms have not subsided. patient was not sure if this was due to the Moderna bivalent vaccine and wants to find out what the possible side effects could be. He will be seeing patient's family physician for further evaluation regarding the symptoms. The patient does not experienced a similar event in the past.  No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received the vaccine after it was in the refrigerator for more than 30 days; Product storage error; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) 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 an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Product storage error) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after it was in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication were reported.   A patient received the vaccine after it was in the refrigerator for more than 30 days. The Nurse did not wish to stay on the phone any longer to report the adverse event information.  No vaccine lot numbers or past vaccine history was provided. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 4 adult patients received Monovalent vaccine 1 day after MFG expiration date; no adverse event; 4 adult patients received Monovalent vaccine 1 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date).    Pharmacist is calling to report that 8 adult patients received Moderna COVID-19 vaccine Beyond manufacture Expiration Date.  No concomitant medications were reported.  MFG Expiration date was 20May2022 (agent checked, it has not been extended).  It was unbroken cartons.  Vial size was reported as 5.5 ml.  The vial was initially stored in the refrigerator on 20MAY2022 and 28MMAY2022  4 adult patients on 21MAY2022 and 4 more adult patients on 29MAY2022  The vial did not undergo any temperature excursions.  No concomitant medications were reported.  This case contains information for the 1st of 8 adult patients described by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose) 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 (received expired dose).    Concomitant medications were not reported.  It was reported that the vial was individual monovalent vial of size 5.5 ml and initially stored in refrigerator on 01-Nov-2022. The vial had not undergone any temperature excursion.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; no adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date).    No concomitant medications were reported.  Pharmacist was calling to report that 8 adult patients received Moderna COVID-19 vaccine Beyond manufacture Expiration Date.  MFG Expiration date was 20 May 2022 (MI agent checked, it has not been extended).  It was unbroken cartons.  Vial size was reported as 5.5 ml.  The vial was initially stored in the refrigerator on 20-MAY-2022 and 28-MAY-2022  4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022  The vial did not undergo any temperature excursions.  This case contains information for the 8th of 8 adult patients described by the reporter.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Felt a lot of headache and 38 degree C fever; Felt a lot of headache and 38 degree C fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 042B21A and 046A217) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included HbA1C increased (because of inactive insulin she was taking). Concurrent medical conditions included Type 1 diabetes mellitus (started 8 or 9 years ago), Hypothyroidism (Started 8 or 9 years ago), Allergic reaction to analgesics (Paracetamol) and Allergic reaction to analgesics (Acetaminophen). Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN GLULISINE (APIDRA SOLOSTAR) and INSULIN DEGLUDEC (TRESIBA) for Type 1 diabetes mellitus, VITAMIN D NOS and IRON for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever). On 15-Apr-2021, PYREXIA (Felt a lot of headache and 38 degree C fever) and HEADACHE (Felt a lot of headache and 38 degree C fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 38 degree Celsius. On 01-Dec-2021, Body temperature: 38 degree Celsius.         .  On 01-Dec-2021, after receiving first booster dose, the patient felt a lot of headache and 38 degree Celsius fever. That lasted until the second day of 02-Dec-2021.  No treatment information was reported.   This case was linked to MOD-2022-675472, MOD-2022-679419 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain
Clinical narrative: aches and chills with all Moderna shots; aches and chills with all Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot (she has a history of reaction to the flu shot in the past including one time where she had pneumonia 1 day after getting the flu shot.). Past adverse reactions to the above products included Pneumonia with flu shot.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots). At the time of the report, PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Upon further probing, caller stated that she has had aches and chills with all Moderna COVID-19 shots.   No treatment medications were reported.   This case was linked to MOD-2022-679862, MOD-2022-679863 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Immunisation reaction, Pain, Pyrexia
Clinical narrative: aches and chills with all Moderna shots; aches and chills with all Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot (she has a history of reaction to the flu shot in the past including one time where she had pneumonia 1 day after getting the flu shot.). Past adverse reactions to the above products included Pneumonia with flu shot.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots). At the time of the report, PAIN (aches and chills with all Moderna shots) and CHILLS (aches and chills with all Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Upon further probing, caller stated that she has had aches and chills with all Moderna COVID-19 shots.   No treatment medications were reported.   This case was linked to MOD-2022-679862, MOD-2022-679863 (Patient Link).