chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Palpitation after 2nd shot; Shortness Of Breath after 2nd shot; Weakness after 2nd shot; Feel Inflammation in the chest after 2nd shot; Dizziness after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 (Never did a PCR test, had COVID symptoms for 1 day only) in 2020.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot). At the time of the report, PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: fast heart beat (High) Fast heart beat. On an unknown date, Electrocardiogram: normal (normal) He is not having a heart attack.         No concomitant medications were reported. No treatment medications were reported. Patient reported that after second dose of vaccination he was not the same, he felt inflammation in his chest, he had experienced symptoms of myocarditis. He went to the Emergency Room several times and after EKG was performed he was told that he is not having a heart attack and to follow up with cardiologist. he did not have any history of myocarditis.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: Palpitation after 2nd shot; Shortness Of Breath after 2nd shot; Weakness after 2nd shot; Feel Inflammation in the chest after 2nd shot; Dizziness after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 (Never did a PCR test, had COVID symptoms for 1 day only) in 2020.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot). At the time of the report, PALPITATIONS (Palpitation after 2nd shot), DYSPNOEA (Shortness Of Breath after 2nd shot), ASTHENIA (Weakness after 2nd shot), CHEST DISCOMFORT (Feel Inflammation in the chest after 2nd shot) and DIZZINESS (Dizziness after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: fast heart beat (High) Fast heart beat. On an unknown date, Electrocardiogram: normal (normal) He is not having a heart attack.         No concomitant medications were reported. No treatment medications were reported. Patient reported that after second dose of vaccination he was not the same, he felt inflammation in his chest, he had experienced symptoms of myocarditis. He went to the Emergency Room several times and after EKG was performed he was told that he is not having a heart attack and to follow up with cardiologist. he did not have any history of myocarditis.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: he could not get out of bed for 2 days after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, 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 BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose). At the time of the report, BEDRIDDEN (he could not get out of bed for 2 days after the 2nd dose) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-432545 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Pain in extremity
Clinical narrative: had a change in body temperature; chills; had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature), PAIN IN EXTREMITY (had arm pain) and CHILLS (chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (had arm pain). On 10-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature) and CHILLS (chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (had a change in body temperature), PAIN IN EXTREMITY (had arm pain) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-433482 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: change in body temperature; chills; First dose on 09 Apr 2021 and second dose on 02 May 2021; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FEELING OF BODY TEMPERATURE CHANGE (change in body temperature), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021). On 03-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (change in body temperature) and CHILLS (chills). On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 09 Apr 2021 and second dose on 02 May 2021) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), FEELING OF BODY TEMPERATURE CHANGE (change in body temperature) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-432983, MOD-2021-433509 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm like 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm like 2 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 (sore arm like 2 days). At the time of the report, PAIN IN EXTREMITY (sore arm like 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on concomitant medication however did not disclose the details.  No treatment was reported by the reporter.   This case was linked to MOD-2021-433559, MOD-2021-433560 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, Palpitations, Sleep disorder
Clinical narrative: Arm was sore; That night I felt an irregular heartbeat/ Pounding heartbeat; It woke me out of my sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep). On 27-Dec-2021, PALPITATIONS (That night I felt an irregular heartbeat/ Pounding heartbeat) and SLEEP DISORDER (It woke me out of my sleep) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Heart rate: irregular heartbeat Irregular heartbeat and pounding heartbeat.         On 27 Dec 2021, night patient felt an irregular heartbeat & pounding heartbeat. It woke patient out of sleep. It lasted about 10 minutes. No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-433482, MOD-2021-432983 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Erythema, Fatigue
Clinical narrative: Swelling; Redness in different parts of the arm; Muscles hurting from shoulder to wrist; The  lower back hurt for a day; Fever 99.2; Chills; Felt fatigued/second day fatigue; The evening of the shot the arm was hurting /last night arm in a ton of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain), SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm), BACK PAIN (The  lower back hurt for a day) and PYREXIA (Fever 99.2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 045A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain) and FATIGUE (Felt fatigued/second day fatigue). On 23-Dec-2021, the patient experienced BACK PAIN (The  lower back hurt for a day), PYREXIA (Fever 99.2) and CHILLS (Chills). On 28-Dec-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm) and MYALGIA (Muscles hurting from shoulder to wrist). On 23-Dec-2021, BACK PAIN (The  lower back hurt for a day) had resolved. On 24-Dec-2021, FATIGUE (Felt fatigued/second day fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain), SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm), PYREXIA (Fever 99.2), CHILLS (Chills) and MYALGIA (Muscles hurting from shoulder to wrist) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, Body temperature: 99.2 (High) 99.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes concomitant medication that did not want to disclose.  Treatment information was not provided.   This case was linked to MOD-2021-433559, MOD-2021-433504 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Swelling; Redness in different parts of the arm; Muscles hurting from shoulder to wrist; The  lower back hurt for a day; Fever 99.2; Chills; Felt fatigued/second day fatigue; The evening of the shot the arm was hurting /last night arm in a ton of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain), SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm), BACK PAIN (The  lower back hurt for a day) and PYREXIA (Fever 99.2) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 045A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain) and FATIGUE (Felt fatigued/second day fatigue). On 23-Dec-2021, the patient experienced BACK PAIN (The  lower back hurt for a day), PYREXIA (Fever 99.2) and CHILLS (Chills). On 28-Dec-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm) and MYALGIA (Muscles hurting from shoulder to wrist). On 23-Dec-2021, BACK PAIN (The  lower back hurt for a day) had resolved. On 24-Dec-2021, FATIGUE (Felt fatigued/second day fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (The evening of the shot the arm was hurting /last night arm in a ton of pain), SWELLING (Swelling), ERYTHEMA (Redness in different parts of the arm), PYREXIA (Fever 99.2), CHILLS (Chills) and MYALGIA (Muscles hurting from shoulder to wrist) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, Body temperature: 99.2 (High) 99.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes concomitant medication that did not want to disclose.  Treatment information was not provided.   This case was linked to MOD-2021-433559, MOD-2021-433504 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: really weird something with my right leg; pain in my right leg in two spots,two different muscles: thigh and calf; could figure out was that it was muscular, almost like I pulled a muscle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (really weird something with my right leg), PAIN IN EXTREMITY (pain in my right leg in two spots,two different muscles: thigh and calf) and MYALGIA (could figure out was that it was muscular, almost like I pulled a muscle) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (really weird something with my right leg), PAIN IN EXTREMITY (pain in my right leg in two spots,two different muscles: thigh and calf) and MYALGIA (could figure out was that it was muscular, almost like I pulled a muscle). At the time of the report, LIMB DISCOMFORT (really weird something with my right leg), PAIN IN EXTREMITY (pain in my right leg in two spots,two different muscles: thigh and calf) and MYALGIA (could figure out was that it was muscular, almost like I pulled a muscle) had resolved.            Patient was treated with physical therapy and acupuncture.  Patient had undergone tons of medical tests but none of them showed how it happened.  No concomitant drug details were reported.    This case was linked to MOD-2021-434057 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess, Urticaria
Clinical narrative: Tooth abscess; Hives/broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A2(z)1A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE for Allergy, SUMATRIPTAN for Headache, LEVOTHYROXINE, SERTRALINE, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), FLUTICASONE, GLUCOSAMINE and MELOXICAM for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, 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 TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency and AMOXICILLIN for Tooth abscess, at an unspecified dose and frequency. At the time of the report, TOOTH ABSCESS (Tooth abscess) and URTICARIA (Hives/broke out in hives) outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Vaccination site pain
Clinical narrative: arm hurt for about 4 days; weak; sickly; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), ILLNESS (sickly) and VACCINATION SITE PAIN (arm hurt for about 4 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHENIA (weak) and ILLNESS (sickly). On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt for about 4 days). In March 2021, VACCINATION SITE PAIN (arm hurt for about 4 days) had resolved. At the time of the report, ASTHENIA (weak) and ILLNESS (sickly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-427703 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccination may have been given in wrong part of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm) 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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little left arm soreness from the needle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little left arm soreness from the needle) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L02A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Hypercholesterolemia (high cholesterol).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little left arm soreness from the needle). At the time of the report, VACCINATION SITE PAIN (a little left arm soreness from the needle) outcome was unknown.            Concomitant medications include many medications for diabetes, high blood pressure and high cholesterol. Treatment information was not provided.   This case was linked to MOD-2021-434957 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Shortness of Breath; Temperature of 102F; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F) 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 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and SOMATROPIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of Breath) and PYREXIA (Temperature of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With the first dose her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With the first dose her arm was sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-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 (With the first dose her arm was sore). At the time of the report, PAIN IN EXTREMITY (With the first dose her arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-435127, MOD-2021-435156 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The first 2 times she received the vaccine, she stated her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The first 2 times she received the vaccine, she stated her arm was sore) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 an unknown date, the patient experienced VACCINATION SITE PAIN (The first 2 times she received the vaccine, she stated her arm was sore). At the time of the report, VACCINATION SITE PAIN (The first 2 times she received the vaccine, she stated her arm was sore) outcome was unknown.            The left arm was the one that was hurting.  No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-435151 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: My wife have go low platelets; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (My wife have go low platelets) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (My wife have go low platelets) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (My wife have go low platelets) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Reported that My wife have go low platelets and I like to ask some questions? Thrombosis with Thrombocytopenia Syndrome (TTS) is a new health condition. It was discovered after the start of COVID-19 immunisation programmes worldwide. TTS is different from the other blood clotting disorders described above. In TTS, blood clots.; Sender's Comments: This case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious (medically significant) unexpected events(s) of Thrombocytopenia. The event(s) occurred on unknown date, the patient received the dose of mRNA-1273, Moderna COVID-19 Vaccine on unknown date. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Lip swelling, Lymphadenopathy, Pyrexia
Clinical narrative: low-grade fever/100.6 fever; swollen lymph node; swollen lower lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lower lip), PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced LIP SWELLING (swollen lower lip). On 28-Dec-2021, the patient experienced PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swollen lips, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swollen lower lip), PYREXIA (low-grade fever/100.6 fever) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) Body temperature increased 100.6.         Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-435201 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received booster dose after receiving 3 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received booster dose after receiving 3 doses) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 037F21A, 010A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 21-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received booster dose after receiving 3 doses). On 21-Dec-2021, ACCIDENTAL OVERDOSE (Received booster dose after receiving 3 doses) 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 was received.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rashes after 1st dose but not on injection site below the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH ERYTHEMATOUS (red rashes after 1st dose but not on injection site below the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rashes after 1st dose but not on injection site below the injection site). At the time of the report, RASH ERYTHEMATOUS (red rashes after 1st dose but not on injection site below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) 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 30-Dec-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm sore) had not resolved.            Concomitant medications were not reported.  Patient arm was really sore right now (at the time of report). She was asking for treatment recommendation. Can she take Aleve or ibuprofen. She had received the first two doses from Moderna as well. The soreness started not right after the  injection.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure and AFib. Concomitant products included ATORVASTATIN, PHENYTOIN (DILANTIN [PHENYTOIN]), APIXABAN (ELIQUIS), FUROSEMIDE (LASIX [FUROSEMIDE]) and LACTULOSE for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) to be not related.    No treatment information was reported.   This case was linked to MOD-2021-416295 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported. No concomitant medication were reported.   This case was linked to MOD-2021-416295 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given 12 hours after the puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given 12 hours after the puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple fractures (Multi Fx) and Dementia. Concurrent medical conditions included Type 2 diabetes mellitus (DMT2) and Acute kidney failure (AKF). Concomitant products included CLONIDINE, FENTANYL, HYDRALAZINE, HYOSCYAMINE SULFATE (LEVSIN) and SENNOSIDE A+B (SENNA [SENNOSIDE A+B]) for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given 12 hours after the puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose given 12 hours after the puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported. No adverse outcomes noted.  It was reported that dose was given greater than 12 hours after the vial was punctured.   This case was linked to MOD-2021-416295 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose received from vial opend> 12h; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis (RA). Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine on 04-Oct-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. Concurrent medical conditions included Penicillin allergy, Hypothyroidism, Hyperlipidaemia NOS, Hypertension and Alzheimer's disease (ALZ). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, TICAGRELOR (BRILINTA), DULOXETINE HYDROCHLORIDE (CYMBALTA) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 10-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose received from vial opend> 12h) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported. No adverse event outcomes were noted. It was reported that dose of the vaccine was given greater than 12 hrs after the vial puncture.  Patient had Janssen   This case was linked to MOD-2021-416295 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Bactrim), Coronary artery disease, Low back pain, AFib, Hypertension and Hyperlipidaemia. Concomitant products included  Atorvastatin; Eliquis; Flomex [Fluorometholone]; Prozol [Metronidazole]; Potassium for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) to be not related.    No treatment information was provided.    This case was linked to MOD-2021-416295, MOD-2021-435638 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: immunocompromised patient given 0.25ml instead of full dose; expiration date 18Mar2021; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 03-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021). On 03-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25ml instead of full dose) and EXPIRED PRODUCT ADMINISTERED (expiration date 18Mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included CARVEDILOL (COREG), GABAPENTIN, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-416295.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given 12 hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) 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.  Patient received booster shot 12 hours after vial puncture   This case was linked to MOD-2021-416295 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster given 12hours after vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H213) for an unknown indication.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given 12hours after vial puncture) to be not related.    Patient has not been diagnosed or tested for covid -19. Booster given 12 hrs after puncture of via, specifically 4 days later. No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-416295 (Patient Link).