chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Chills, Fatigue, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Experience little side effects with previous doses of the Moderna COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7008121001, 7006320010 and 7006320005) for COVID-19 vaccination.     The patient had no allergies.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines). At the time of the report, IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) outcome was unknown.            The patient had no concomitant medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-609020 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Experience little side effects with previous doses of the Moderna COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7008121001, 7006320010 and 7006320005) for COVID-19 vaccination.     The patient had no allergies.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines). At the time of the report, IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) outcome was unknown.            The patient had no concomitant medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-609020 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experience little side effects with previous doses of the Moderna COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7008121001, 7006320010 and 7006320005) for COVID-19 vaccination.     The patient had no allergies.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines). At the time of the report, IMMUNISATION REACTION (Experience little side effects with previous doses of the Moderna COVID-19 vaccines) outcome was unknown.            The patient had no concomitant medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-609020 (Patient Link).
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Feeling abnormal, Illness, Neck pain, Product administered to patient of inappropriate age
Clinical narrative: feels sick; feels very terrible; Neck hurts; breathing faster; 10 year old child received a booster dose of the Moderna Covid 19 vaccine; accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR45048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd Dose Lot: FK5217) on 30-Nov-2021, Pfizer (1st dose and Lot: FK127). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Asthma and Milk allergy.    On 14-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. On 14-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts) and RESPIRATION ABNORMAL (breathing faster). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine) outcome was unknown.            Concomitant medication were not reported. It was reported that patient received 1st Booster dose.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: feels sick; feels very terrible; Neck hurts; breathing faster; 10 year old child received a booster dose of the Moderna Covid 19 vaccine; accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR45048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd Dose Lot: FK5217) on 30-Nov-2021, Pfizer (1st dose and Lot: FK127). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Asthma and Milk allergy.    On 14-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. On 14-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine). On an unknown date, the patient experienced ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts) and RESPIRATION ABNORMAL (breathing faster). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (feels sick), FEELING ABNORMAL (feels very terrible), NECK PAIN (Neck hurts), RESPIRATION ABNORMAL (breathing faster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (10 year old child received a booster dose of the Moderna Covid 19 vaccine) and ACCIDENTAL OVERDOSE (accidentally received doses of 2.5 ml of the Moderna Covid 19 vaccine) outcome was unknown.            Concomitant medication were not reported. It was reported that patient received 1st Booster dose.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint dislocation, X-ray
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of JOINT DISLOCATION (shoulder dislocated) and ARTHRALGIA (Joint pain in her elbows, wrists, and shoulders which then spread to her knees, toes and hips.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 prophylaxis. The patient's past medical history included Neck injury and Nerve pain. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced JOINT DISLOCATION (shoulder dislocated) and ARTHRALGIA (Joint pain in her elbows, wrists, and shoulders which then spread to her knees, toes and hips.). At the time of the report, JOINT DISLOCATION (shoulder dislocated) had resolved and ARTHRALGIA (Joint pain in her elbows, wrists, and shoulders which then spread to her knees, toes and hips.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: showed shoulder was fine. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication was provided. The patient shoulder was loosened up. Prior to receiving the Moderna vaccine, patient was being treated for a neck injury and nerve pain, and had continued treatment following vaccination. Neurologist stated the pain was not related to neck injury. This pain has continued up until today. Second dose of Moderna was taken on 11-Mar-2021, Lot number was unknown and expiration date 06-Sep-2021. Patient has taken Pfizer vaccine on 28-Feb-2022. On 01-JUN-2022, patient tested positive for COVID-19. Patient has experienced symptoms including coughing, and cold/flu like symptoms. The joint pain also has become worse. Patient took Tylenol, and ivy leaf cough syrup for symptoms. Patient hands are worse with gripping and toes are worse at night since having COVID-19. Patient has tried to take anti-inflammatories but the kidney doesn't like it. The pain has been so bad at times that  has been in tears. Primary doctor also gave her an injectable anti-inflammatory which helped. No treatment medication was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022; administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered booster dose of the Moderna Covid19 Vaccine on 15Jul2022 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that patient received booster dose. It was reported that 2 doses from 1 vial was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursion. Treatment medications were not provided.   This case was linked to MOD-2022-609202 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.; Booster dose administered after date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A and 077C21B) for COVID-19 vaccination.     Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to antibiotics (Allergic to Amoxicillin).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 08-Jul-2022, stored in refrigerator on 13-Jul-2022 and administered on 13-Jul-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The Number of doses per vial were 2 doses from 1 vial. The patient had received First booster dose of Moderna vaccine on 11-Nov-2021. The patient had received second booster dose of Moderna vaccine on 13-Jul-2022. Frozen vial used had an expiry date of 8-Jul-2022 The vial was initially stored in the refrigerator on 13-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-608757 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.; Vial was first punctured and then stored in room temperature for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.) and PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours). On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given today from a vial greater than 12 hrs after 1st puncture, but not more than 24 hrs.) and PRODUCT STORAGE ERROR (Vial was first punctured and then stored in room temperature for greater than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. It was reported that the dose was given past 12 hours post punctured. Number of doses/vials was 1 dose. Vial was initially stored in the refrigerator on 06-Jul-2022 Vial was first punctured on 14-Jul-2022 Vial was stored in the Room temperature post punctured. Vial did not undergo any temperature excursions. Vial was not exposed to room temperature more than 24 hours.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022; Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 booster doses of the Moderna Covid19 Vaccine on 15Jul2002 from vial that expired on 13Jul2022) and PRODUCT STORAGE ERROR (Vial expired on 13-Jul-2022, stored in refrigerator on 15-Jul-2022 and administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received booster dose of Moderna COVID-19 vaccine.  Concomitant medications were not reported.  It was reported that 2 doses from 1 vial which was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursion.  Treatment medications were not provided.   This case was linked to MOD-2022-609104 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022; Vaccine administered 1 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     Patient had never been diagnosed with/ tested positive for COVID-19. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  Concurrent medical conditions included Blood pressure, Cholesterol and Coagulation disorder. Concomitant products included METOPROLOL for Blood pressure, ATORVASTATIN for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Coagulation disorder.    On 27-Jun-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Jun-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Number of doses or vails were reported as 7. The patient had reported no side effects. The vial did not undergo any temperature excursion. No treatment details were provided.   This case was linked to MODERNATX, INC.-MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-601207:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022; Vaccine administered 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0559A22) for COVID-19 prophylaxis.     Concurrent medical conditions included Headache. Concomitant products included IBUPROFEN and RIZATRIPTAN for Headache.    On 28-Jun-2022 at 4:30 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Jun-2022 at 4:30 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with/ tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none.  The patients had reported no side effects.  Number of doses or vails were reported as 7.  The vial was initially stored in the refrigerator on 26-May-2022. The vial did not undergo any temperature excursion.  Treatment details were not reported by the reporter.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Received 2.5 ml of the Moderna Covid 19 vaccine as a booster dose; Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL OVERDOSE (Received 2.5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 700630007, 700632007 and 7006320005) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Milk allergy, Food allergy (Allergy to corn) and Eosinophilic esophagitis.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2.5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Received 2.5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine) outcome was unknown.            Concomitant medications included medication for eosinophilic esophagitis.  It was reported that patient was part of the clinical trials of the Moderna Covid 19 vaccine and received the second booster dose  No treatment medication was reported.   This case was linked to MOD-2022-609007 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Mobility decreased, Pyrexia
Clinical narrative: bad reaction; couldn't move; fever; real tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031A21A) for COVID-19 prophylaxis.     Concomitant products included CYANOCOBALAMIN (B 12) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired). On 16-Apr-2021, IMMUNISATION REACTION (bad reaction), MOBILITY DECREASED (couldn't move), PYREXIA (fever) and FATIGUE (real tired) had resolved.            No medical history was reported by reporter. Concomitant medication included Men's Vitamin. No treatment information was provided.   This case was linked to MOD-2022-609219, MOD-2022-609018 (Patient Link).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose; Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 700630007, 700632007 and 7006320005) for COVID-19 prophylaxis.     The patient had no allergies.  Concurrent medical conditions included Polycystic ovarian syndrome. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) for Birth control, METFORMIN for Polycystic ovarian syndrome.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Person younger than 18 received a second booster dose of the Moderna Covid 19 vaccine) outcome was unknown.            Concomitant medications included antidepressants. It was reported that patient was part of the clinical trials of the Moderna Covid 19 vaccine and had received in the clinical trial the primary doses and the first booster dose. On 14-Jul-2022, patient received the second booster dose and had accidentally received 2.5ml No treatment medication was reported.   This case was linked to MOD-2022-609021, MOD-2022-609221 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 prophylaxis. No medical history was provided by the reporter.  Concomitant products included CYANOCOBALAMIN (B 12) for an unknown indication. On 14-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved. Concomitant medication were includes men's Vitamin. No treatment medication were provided. This case was linked to MOD-2022-609216, MOD-2022-609018 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of AXILLARY MASS (her second booster for the Moderna on Wednesday, and today she ahs like a lump under her arm, the same side of the injection site) 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 July 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced AXILLARY MASS (her second booster for the Moderna on Wednesday, and today she ahs like a lump under her arm, the same side of the injection site). At the time of the report, AXILLARY MASS (her second booster for the Moderna on Wednesday, and today she ahs like a lump under her arm, the same side of the injection site) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Came down with covid/Covid) in a female patient of an unknown age 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 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 COVID-19 (Came down with covid/Covid). At the time of the report, COVID-19 (Came down with covid/Covid) outcome was unknown.No concomitant medication were provided. Patient received 2 primary series doses and first booster dose but was due for second booster dose in April but was unable to get the second booster dose as patient came down with COVID and stated that patient also got an infusion of antibody on 07-Apr-2022. Company comment: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non-serious event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non-serious event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Immunisation reaction, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness), VACCINATION SITE PAIN (Sore arm in the arm of the injection) and PYREXIA ("running a temperature" with a low-grade fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 27-Jun-2022 and Flu (The caller stated for two weeks he had a" flu" case.). On 17-Jul-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2022, the patient experienced IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness) and VACCINATION SITE PAIN (Sore arm in the arm of the injection). On 18-Jul-2022, the patient experienced PYREXIA ("running a temperature" with a low-grade fever). At the time of the report, IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness) and VACCINATION SITE PAIN (Sore arm in the arm of the injection) was resolving and PYREXIA ("running a temperature" with a low-grade fever) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2022, Body temperature: Running a temperature with a low-grade fever. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-609270 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness), VACCINATION SITE PAIN (Sore arm in the arm of the injection) and PYREXIA ("running a temperature" with a low-grade fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 27-Jun-2022 and Flu (The caller stated for two weeks he had a" flu" case.). On 17-Jul-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2022, the patient experienced IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness) and VACCINATION SITE PAIN (Sore arm in the arm of the injection). On 18-Jul-2022, the patient experienced PYREXIA ("running a temperature" with a low-grade fever). At the time of the report, IMMUNISATION REACTION (he experienced side effects after the injection), ARTHRALGIA (achy shoulder), FATIGUE (tiredness) and VACCINATION SITE PAIN (Sore arm in the arm of the injection) was resolving and PYREXIA ("running a temperature" with a low-grade fever) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2022, Body temperature: Running a temperature with a low-grade fever. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-609270 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Feeling horrible; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling horrible) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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. In July 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling horrible). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling horrible) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive. On an unknown date, Body temperature: 103 103 F. No concomitant product use was provided. The patient tested positive after getting the second booster shot two days before reporting. Patient tested herself twice and both got positive results. She said she was too sick to move to get her vaccination card. Patient experienced symptoms of COVID-19 included Bad cough, Sore throat, Fever at 103F and Body aches. Company comment: This spontaneous case concerns a 63 year old female immunocompromised patient, with no other medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second booster shot of mRNA-1273 vaccine administration. Patient experienced symptoms of COVID-19 included Bad cough, Sore throat, Fever at 103F and Body aches. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 63 year old female immunocompromised patient, with no other medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second booster shot of mRNA-1273 vaccine administration. Patient experienced symptoms of COVID-19 included Bad cough, Sore throat, Fever at 103F and Body aches. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Allergy to antibiotic (Allergic to erythromycin.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand). At the time of the report, HEAVY MENSTRUAL BLEEDING (She is having massive bleeding on and off/bleed through 10 pairs of panties, tremendous blood clots the size of her hand) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On Mar-2020, Patient tested COVID positive. On Mar-2022 patient went to the hospital that said that it was a bad period, but in the article, patient read that after COVID shots, woman had experienced bad bleeding. Also patient mentioned that she bleed through 10 pairs of panties, and patient bleed from the 21-Jan-2022 until 24-May-2022 and again on the 13July2022 . Treatment details was not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-609273 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-609273:Same reporter
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: chronic headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (chronic headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  The patient's past medical history included Heart disease, unspecified. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Allergy to antibiotic, Penicillin allergy, Asthma, Diabetes, Obesity and Drug allergy (Temerol). Concomitant products included VITAMINS NOS for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (chronic headache). At the time of the report, HEADACHE (chronic headache) had not resolved.        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.   diabetes medication blood pressure medicine, Tyrod medications,anticoagulants No treatment information was provided.   This case was linked to MOD-2022-609257 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-2022 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Jul-2022 8.30 and dose adminisitered on 18-Jul-2022 9:30 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vial was initially stored in the refrigerator on 28-Jun-2022. Vial was first punctured on 15-Jul-2022 about 8:30 am. Post Puncture the vial was stored in Fridge.  Vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius - 46 to 77 degree Fahrenheit) was unknown, but only taken out when a dose was to be drawn up. Probably less than an hour in total. Vial was exposed to room temperature for more that 24 hours. No treatment information was provided.