chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lightheaded; Head is not clear; Shortness of Breath; Headache; Fatigue; Erroneously received full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 019B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, FATIGUE, and ACCIDENTAL OVERDOSE. On 25-Oct-2021, ACCIDENTAL OVERDOSE had resolved. At the time of the report, DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Arm pain; A little swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling). At the time of the report, PAIN IN EXTREMITY (Arm pain) and SWELLING (A little swelling) outcome was unknown.      It was reported that the patient is a cancer survivor and has received a triple bypass in the past. He claims to have had 7 surgeries in a row, and has no memory. He takes 20 pills a day as regular medication, but no treatments specific to his symptoms.   This case was linked to MOD-2021-370114 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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 .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: started having Vertigo when walking outside the house; Dizziness/lightheadedness; Gate Problems; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO, DIZZINESS, and GAIT DISTURBANCE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VERTIGO, DIZZINESS, and GAIT DISTURBANCE. At the time of the report, VERTIGO, DIZZINESS, and GAIT DISTURBANCE outcome was unknown.            Concomitant medication of the patient was not reported.  The patient stated that she drank a lot of water when she walks. She had not seen a doctor yet. She was thinking about getting the booster and she was concerned.   No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling injection site after first shot; Tenderness  injection site after first shot; Redness on the injection site after first shot; Tired after first shot; Headache after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE. At the time of the report, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, FATIGUE, and HEADACHE had resolved.            No concomitant medications were mentioned. No treatment details were reported. Patient stated that she was not sure if all that was caused by the vaccine or it was caused by her Anxiety of getting the vaccine. Patient was thinking about getting the booster.  Consent declined for safety to follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Malaise, Myalgia, Vaccination site warmth
Clinical narrative: sweaty; left arm where the shot was given is very hot to the touch; feeling ill; fatigued/ vaccine drained me'.; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill), FATIGUE (fatigued/ vaccine drained me'.) and MYALGIA (muscle ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015F21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-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. On 29-Oct-2021, the patient experienced HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill), FATIGUE (fatigued/ vaccine drained me'.) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 31-Oct-2021, MYALGIA (muscle ache) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill) and FATIGUE (fatigued/ vaccine drained me'.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Fluids.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The pharmacist was unaware if the patient is taking any medications and if patient had any side effects.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site movement impairment, Vaccination site pain, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, VACCINATION SITE PAIN and VACCINATION SITE RASH in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE PAIN. On 23-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, and VACCINATION SITE RASH. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT, RASH, VACCINATION SITE PAIN, VACCINATION SITE PAIN and VACCINATION SITE RASH outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370196 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated past the 12 hour time frame; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated past the 12 hour time frame) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated past the 12 hour time frame). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccinated past the 12 hour time frame) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-370117 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Big bump (1.25"x1/2") on the Injection Site after booster; Hot to the touch Injection Site  (97.9 F) after booster; Hard bump (1.25"x1/2") on the Injection Site after booster; Red on the Injection Site after booster/Redness spreading; Inflamed Injection Site after booster/Throbbing Injection Site after booster; Itching Injection Site after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading) and VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 027A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history report information was reported.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) from 29-Sep-2021 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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. On 29-Oct-2021, the patient experienced VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading), VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) and VACCINATION SITE PRURITUS (Itching Injection Site after booster). At the time of the report, VACCINATION SITE MASS (Big bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE WARMTH (Hot to the touch Injection Site  (97.9 F) after booster), VACCINATION SITE INDURATION (Hard bump (1.25"x1/2") on the Injection Site after booster), VACCINATION SITE ERYTHEMA (Red on the Injection Site after booster/Redness spreading), VACCINATION SITE INFLAMMATION (Inflamed Injection Site after booster/Throbbing Injection Site after booster) and VACCINATION SITE PRURITUS (Itching Injection Site after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.9 fahrenheit (normal) 97.9 Fahrenheit.         Treatment medications was not reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-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 .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13-year-old patient received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 29-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment details were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Gout, and Arthritis.    On 14-Feb-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 PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included high blood pressure medication, cholesterol medication, gout medication, arthritis medication.  No treatment information was provided.   This case was linked to MOD-2021-370207, MOD-2021-370208 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-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 .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My left arm was sore for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-370161 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site swelling
Clinical narrative: arm at the injection site was swollen and hard; arm at the injection site was swollen and hard; a little fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 012M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-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. On 30-Oct-2021, the patient experienced VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at a dose of 2 TYLENOL. On 31-Oct-2021, VACCINATION SITE INDURATION, VACCINATION SITE SWELLING, and PYREXIA had resolved.            No Concomitant medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given on day 22; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22). On 29-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given on day 22) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter wants to know if this patient needs to repeat that second dose or restart the series, how does she proceed?   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Upper respiratory issues; Coughing; Daughter in law gave covid to her son/Tested positive for covid; Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER, COUGH, COVID-19, and FATIGUE in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER, COUGH, COVID-19, and FATIGUE. At the time of the report, RESPIRATORY DISORDER, COUGH, and COVID-19 outcome was unknown and FATIGUE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test Positive COVID-19 virus test.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment- respiratory disorder and fatigue. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Although the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days), the events occurred on an unknown date and does not specify if COVID-19 disease is diagnosed 15 days or more after the second dose of the vaccine, so lack of efficacy situation cannot be properly assessed. This case concerns a 35-year-old male patient with no relevant medical history who experienced non-serious unexpected event of special interest COVID-19, non-serious unexpected events of respiratory disorder, cough, and expected non-serious event of fatigue. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable as the event occurred following the second dose. The concurrent event of COVID-19 is a relevant confounder for the events of cough, respiratory disorder, and fatigue. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Although the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days), the events occurred on an unknown date and does not specify if COVID-19 disease is diagnosed 15 days or more after the second dose of the vaccine, so lack of efficacy situation cannot be properly assessed.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: pretty sick for a day; sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty sick for a day) and VACCINATION SITE PAIN (sore arm after second dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol, Gout and Arthritis.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (pretty sick for a day). In 2021, the patient experienced VACCINATION SITE PAIN (sore arm after second dose). At the time of the report, VACCINATION COMPLICATION (pretty sick for a day) and VACCINATION SITE PAIN (sore arm after second dose) outcome was unknown.            Patient took high blood pressure medication, cholesterol medication, gout medication and arthritis medication.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-370192, MOD-2021-370208 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On 21-Sep-2021, patient experienced Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (On 21-Sep-2021, patient experienced Rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced RASH (On 21-Sep-2021, patient experienced Rash). At the time of the report, RASH (On 21-Sep-2021, patient experienced Rash) 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.   Concomitant products were not provided. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On 31-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Caller stated that Vials were in refrigerated conditions, the vials suffered 2 temperature excursions, temperature went to 34.81°F for 30 minutes. They were moved from the freezer to the refrigerator on 30October2021, and they were applied on 31Oct2021. The first temperature excursion was on 31Oct2021 at 11AM, and the second one on 31Oct2021 at 2PM. After the first excursion, the pharmacist took actions to restore the temperature of the vials. The vial was administered to patients. She did not have information of how many patients were at the moment of the call, but she said that they were around 5. No further information was obtained about the patients. Caller used the online temperature excursion tool after it was provided in the call, and the tool stated that after that one excursion, the vials could be used, no action required. Vials were administered after one temperature excursion to patients without checking the tool before that.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered with the booster dose 28 days after the 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered with the booster dose 28 days after the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Booster dose 2.5mL administered instead of 0.25mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Medical history was not reported. Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.    On 29-Oct-2021 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE. On 29-Oct-2021, ACCIDENTAL OVERDOSE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist stated patient was administered the 2.5 mL dose at 9:45am and left the pharmacy at 10am and did not report any side effects that pharmacist was aware of.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccinated past the 12 hour time frame; a bottle and opened it on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021 in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination of Pfizer vaccine (first PFIZER COVID-19 vaccination intramuscularly with lot number EN6199) on 09-Mar-2021 and Pfizer vaccine (second PFIZER COVID-19 vaccination with Lot number ER8727) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, LISINOPRIL, and SILDENAFIL for an unknown indication.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR (a bottle and opened it on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR on 27Oct2021. They left it open in the refrigerator and gave it to possibly 2 patients on 01Nov2021 had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not specified   This case was linked to MOD-2021-370117 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Swelling face, Vaccination complication
Clinical narrative: she had a reaction 2 hours later; numbness in her tongue; her face was swollen for 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours). At the time of the report, VACCINATION COMPLICATION (she had a reaction 2 hours later), HYPOAESTHESIA ORAL (numbness in her tongue) and SWELLING FACE (her face was swollen for 3 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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 .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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 .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) 1 dosage form. On 01-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. Pharmacist is unaware if patient is taking medication. Pharmacist is unaware if patient had the side effects. Safety consent to follow up with the pharmacist received.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered from a vial punctured greater than 20 times; Dose administered from a vial punctured greater than 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No Treatment medications reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (2nd dose of Pfizer vaccine.) on 30-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (1st dose of Pfizer vaccine). On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Pharmacist was unaware if patient was taking medication. Pharmacist was unaware if patient had the side effects.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-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 .25 ml. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.   This case was linked to MOD-2021-370033 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Patient received 1st Janssen dose on 12 May 2021, lot number was 205A21A.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.