chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: "real nasty body aches"/ "kicking hard"; fever; making him "a little sick"; dizziness; being "sweaty"; "everything hurts"; heart beat a little elevated; chills; "everything but vomiting"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts") and HEART RATE INCREASED (heart beat a little elevated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts"), HEART RATE INCREASED (heart beat a little elevated), CHILLS (chills), VOMITING ("everything but vomiting") and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA ("real nasty body aches"/ "kicking hard"). At the time of the report, ILLNESS (making him "a little sick"), DIZZINESS (dizziness), HYPERHIDROSIS (being "sweaty"), PAIN ("everything hurts"), HEART RATE INCREASED (heart beat a little elevated), CHILLS (chills), VOMITING ("everything but vomiting"), MYALGIA ("real nasty body aches"/ "kicking hard") and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (Inconclusive) heart beat a little elevated..
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blister, Chest pain, Dermatitis contact, Fatigue
Clinical narrative: Felt like someone shot him in his back due to the pain after second dose; When laying down on the side pain shoots from back to the chest after second dose; 8 inch outbreak of shingles after second dose; Feels rough scaly blisters in the back after second dose; Feels like poison ivy after second dose; Tiredness after second dose; Sore arm at the injection site after second dose; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox.   On 20-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 20-Apr-2021, the patient experienced FATIGUE (Tiredness after second dose) and VACCINATION SITE PAIN (Sore arm at the injection site after second dose). On an unknown date, the patient experienced BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose). On 21-Apr-2021, FATIGUE (Tiredness after second dose) and VACCINATION SITE PAIN (Sore arm at the injection site after second dose) had resolved. At the time of the report, BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose) outcome was unknown.            This case was linked to MOD-2021-114590 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site pain
Clinical narrative: Felt like someone shot him in his back due to the pain after second dose; When laying down on the side pain shoots from back to the chest after second dose; 8 inch outbreak of shingles after second dose; Feels rough scaly blisters in the back after second dose; Feels like poison ivy after second dose; Tiredness after second dose; Sore arm at the injection site after second dose; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox.   On 20-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 20-Apr-2021, the patient experienced FATIGUE (Tiredness after second dose) and VACCINATION SITE PAIN (Sore arm at the injection site after second dose). On an unknown date, the patient experienced BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose). On 21-Apr-2021, FATIGUE (Tiredness after second dose) and VACCINATION SITE PAIN (Sore arm at the injection site after second dose) had resolved. At the time of the report, BACK PAIN (Felt like someone shot him in his back due to the pain after second dose), CHEST PAIN (When laying down on the side pain shoots from back to the chest after second dose), HERPES ZOSTER (8 inch outbreak of shingles after second dose), BLISTER (Feels rough scaly blisters in the back after second dose) and DERMATITIS CONTACT (Feels like poison ivy after second dose) outcome was unknown.            This case was linked to MOD-2021-114590 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 24 hours) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 13-Apr-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 for 24 hours). At the time of the report, PAIN IN EXTREMITY (Sore arm for 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains non-significant information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial septal defect, Cardiac disorder, Fatigue, Intentional product use issue
Clinical narrative: More than 36 days have passed since first dose; He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.; felt tired; did not have energy; heart felt hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose), ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.) and FATIGUE (felt tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold) and FATIGUE (felt tired). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose) and ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.). The patient was treated with VITAMIN D3 for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose), ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Vaccination site lymphadenopathy
Clinical narrative: Headaches; Swollen glands on the right side of her neck; Swollen glands on the right side of her left; lymph nodes on the arm of injection are swollen; Feels terrible; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen) and FEELING ABNORMAL (Feels terrible) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FEELING ABNORMAL (Feels terrible). On an unknown date, the patient experienced HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen). At the time of the report, HEADACHE (Headaches), LYMPHADENOPATHY (Swollen glands on the right side of her neck), LYMPHADENOPATHY (Swollen glands on the right side of her left), VACCINATION SITE LYMPHADENOPATHY (lymph nodes on the arm of injection are swollen) and FEELING ABNORMAL (Feels terrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, Heart rate increased, Hot flush
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of chest pain (my whole right side of her chest hurts"), feeling abnormal ("starting feeling weird"), increased heart rate (racing heart), dyspnea (difficulty breathing) and hot flush (hot flashes about 2 minutes apart") in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 00C421A) for COVID-19 immunization. Concurrent medical conditions included anxiety. Concomitant products included Zoloft (sertraline hydrochloride) for an unknown indication. On May 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 4, 2021, patient experienced chest pain ("my whole right side of her chest hurts"),  feeling abnormal ("starting feeling weird"), increased heart rate (racing heart), dyspnea (difficulty breathing) and hot flush (hot flashes about 2 minutes apart"). The patient was treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, chest pain ("my whole right side of her chest hurts"), feeling abnormal ("starting feeling weird"), increased heart rate (racing heart), dyspnea (difficulty breathing) and hot flush (hot flashes about 2 minutes apart") outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Muscle twitching, Pain in extremity
Clinical narrative: Right leg numbness; Right leg twitch; left side facial twitch; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HYPOAESTHESIA (Right leg numbness), MUSCLE TWITCHING (Right leg twitch), MUSCLE TWITCHING (left side facial twitch) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills). On 30-Apr-2021, the patient experienced MUSCLE TWITCHING (left side facial twitch). On 08-May-2021, the patient experienced HYPOAESTHESIA (Right leg numbness) and MUSCLE TWITCHING (Right leg twitch). On 23-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills) had resolved. On 08-May-2021, HYPOAESTHESIA (Right leg numbness) had resolved. At the time of the report, MUSCLE TWITCHING (Right leg twitch) and MUSCLE TWITCHING (left side facial twitch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD21-088359, MOD21-088360, MOD21-088361, MOD21-088363, US-MODERNATX, INC.-MOD-2021-114641, US-MODERNATX, INC.-MOD-2021-114834 (Linked Report).; Sender's Comments:  MOD21-088359:crosslink MOD21-088360:crosslink MOD21-088361:crosslink MOD21-088363:crosslink US-MODERNATX, INC.-MOD-2021-114641:crosslink US-MODERNATX, INC.-MOD-2021-114834:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Libido decreased, Pain, Pain in extremity
Clinical narrative: I had my period and I bled for 15 days. I have never had a such a long period ever; My sex drive has just depleted and I have no drive; sore arm; hurting me a lot; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (I had my period and I bled for 15 days. I have never had a such a long period ever), LIBIDO DECREASED (My sex drive has just depleted and I have no drive), PAIN IN EXTREMITY (sore arm) and PAIN (hurting me a lot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (I had my period and I bled for 15 days. I have never had a such a long period ever), LIBIDO DECREASED (My sex drive has just depleted and I have no drive), PAIN IN EXTREMITY (sore arm) and PAIN (hurting me a lot). At the time of the report, PAIN IN EXTREMITY (sore arm) and PAIN (hurting me a lot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114650 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drooling, Headache, Hypoaesthesia oral, Pain in extremity, Paraesthesia oral
Clinical narrative: while chewing the right corner on my lip was tingly; numbness on the right corner of my lip.; drooled out of right side of mouth; pain around right arm; small headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (while chewing the right corner on my lip was tingly), HYPOAESTHESIA ORAL (numbness on the right corner of my lip.), DROOLING (drooled out of right side of mouth), PAIN IN EXTREMITY (pain around right arm) and HEADACHE (small headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE BESILATE (NORVASC), SIMVASTATIN (ZOCOR), GLICLAZIDE (MICROZIDE [GLICLAZIDE]), SITAGLIPTIN PHOSPHATE (JANUVIA), INSULIN GLARGINE (LANTUS), DOXEPIN, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE (FLOVENT) and SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PARAESTHESIA ORAL (while chewing the right corner on my lip was tingly), HYPOAESTHESIA ORAL (numbness on the right corner of my lip.), DROOLING (drooled out of right side of mouth), PAIN IN EXTREMITY (pain around right arm) and HEADACHE (small headache). At the time of the report, PARAESTHESIA ORAL (while chewing the right corner on my lip was tingly), HYPOAESTHESIA ORAL (numbness on the right corner of my lip.), DROOLING (drooled out of right side of mouth), PAIN IN EXTREMITY (pain around right arm) and HEADACHE (small headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: Right leg twitch; Right leg numbness; Left side facial twitch; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Left side facial twitch), MUSCLE TWITCHING (Right leg twitch) and HYPOAESTHESIA (Right leg numbness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced MUSCLE TWITCHING (Left side facial twitch). On 08-May-2021, the patient experienced MUSCLE TWITCHING (Right leg twitch) and HYPOAESTHESIA (Right leg numbness). On 08-May-2021, HYPOAESTHESIA (Right leg numbness) had resolved. At the time of the report, MUSCLE TWITCHING (Left side facial twitch) and MUSCLE TWITCHING (Right leg twitch) outcome was unknown.            The patient called with complains of possible delayed symptoms following their second vaccine dose. On an estimated date 30-Apr-2021, the patient developed a left side facial twitch, twitch close to nose going to cheek that persists most of the day as well as minor right leg twitching that began as numbness on 8-May-2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-114625 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 medication was reported .
Sex: F
Vaccine: COVID19
Symptoms: Illness, Job dissatisfaction
Clinical narrative: Sick again from the second vaccine shot; missed a few days of work after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose). At the time of the report, ILLNESS (Sick again from the second vaccine shot) and JOB DISSATISFACTION (missed a few days of work after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   This case was linked to MOD21-088258, MOD21-088310, MOD21-088311, US-MODERNATX, INC.-MOD-2021-114755, US-MODERNATX, INC.-MOD-2021-114654 (E2B Linked Report).; Sender's Comments:  MOD21-088258: MOD21-088310: MOD21-088311: US-MODERNATX, INC.-MOD-2021-114654: US-MODERNATX, INC.-MOD-2021-114755:
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter and no concomitant medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Back burning; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Back burning) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013LZOA) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BURNING SENSATION (Back burning). On 02-Feb-2021, BURNING SENSATION (Back burning) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-114659 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant Follow up appended for Doc attachment On 08-Jun-2021: The follow up was received on 08Jun2021 and it contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.  Pharmacist stated that she saw a mostly full vial in the refrigerator from the previous day that had been punctured and exposed for 12 hours and was no longer valid.   This case was linked to US-MODERNATX, INC.-MOD-2021-114456, US-MODERNATX, INC.-MOD-2021-114420, US-MODERNATX, INC.-MOD-2021-114626 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non-significant follow-up On 10-May-2021: non significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114456: US-MODERNATX, INC.-MOD-2021-114420: US-MODERNATX, INC.-MOD-2021-114626:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rash
Clinical narrative: Rash; Does not feel well; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and MALAISE (Does not feel well) 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 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RASH (Rash) and MALAISE (Does not feel well). At the time of the report, RASH (Rash) and MALAISE (Does not feel well) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: Vvery bad bone pain for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Vvery bad bone pain for 48 hours) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included to treat diabetes, to treat high blood pressure, to treat asthma and to treat high cholesterol for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced BONE PAIN (Vvery bad bone pain for 48 hours). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Minor muscle aches, ache from top to the bottom of body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Minor muscle aches, ache from top to the bottom of body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PRAVASTATIN, LISINOPRIL and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Minor muscle aches, ache from top to the bottom of body). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. At the time of the report, MYALGIA (Minor muscle aches, ache from top to the bottom of body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included unspecified over the counter medications for unknown indication.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in both arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), BEMPEDOIC ACID (NEXLETOL), METOPROLOL, Ozempic                                                        Taken once a week, FISH OIL, MULTIVITAMINS & MINERALS PLUS LUTEIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CURCUMA LONGA, PIPER NIGRUM (TURMERIC & BLACK PEPPAR) and UBIDECARENONE (CO Q-10) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in both arms). At the time of the report, PAIN IN EXTREMITY (Pain in both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was  not provided.   This case was linked to MOD-2021-114670 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Cholesterosis
Clinical narrative: cholesterol tripled; This spontaneous case was reported by a consumer and describes the occurrence of CHOLESTEROSIS (cholesterol tripled) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013-M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, LISINOPRIL for Blood pressure management, MELATONIN for an unknown indication.   On 07-Feb-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 05-May-2021, the patient experienced CHOLESTEROSIS (cholesterol tripled). At the time of the report, CHOLESTEROSIS (cholesterol tripled) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood cholesterol: 149 (Inconclusive) 149. On 05-May-2021, Blood cholesterol: 305 (High) Tripled than last year.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Tendon disorder
Clinical narrative: joints and tendons "sounded like rice crispies," and still not back to normal; joints and tendons "sounded like rice crispies," and still not back to normal; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (joints and tendons "sounded like rice crispies," and still not back to normal) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Diabetes, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an Blood thinner.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHROPATHY (joints and tendons "sounded like rice crispies," and still not back to normal). At the time of the report, ARTHROPATHY (joints and tendons "sounded like rice crispies," and still not back to normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.   This case was linked to MOD21-087543 (E2B Linked Report).; Sender's Comments:  MOD21-087543:Same reporter, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pyrexia, Swelling face
Clinical narrative: face was swollen; really hot; face was red; fever 104F; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red), PYREXIA (Fever of 102F) and PYREXIA (fever 104F) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A,) 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 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Fever of 102F). On 08-May-2021, the patient experienced SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red) and PYREXIA (fever 104F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face was swollen), FEELING HOT (really hot), ERYTHEMA (face was red), PYREXIA (Fever of 102F) and PYREXIA (fever 104F) had resolved.            concomitant drug details not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was soo tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was soo tired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage of pregnancy in February 2020.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (I was soo tired). At the time of the report, FATIGUE (I was soo tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-114627 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Vomiting
Clinical narrative: Hugging the toilet; Really bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects). At the time of the report, VOMITING (Hugging the toilet) and ADVERSE EVENT (Really bad side effects) 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 medications were provided. No treatment details were provided.   This case was linked to MOD21-088258, US-MODERNATX, INC.-MOD-2021-114635, US-MODERNATX, INC.-MOD-2021-114755 (E2B Linked Report).; Sender's Comments:  MOD21-088258: US-MODERNATX, INC.-MOD-2021-114635: US-MODERNATX, INC.-MOD-2021-114755:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Headache, Pyrexia
Clinical narrative: tested positive for COVID-19; lost sense of smell; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-May-2021, the patient experienced COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, COVID-19 (tested positive for COVID-19), ANOSMIA (lost sense of smell), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-114621 (Parent-Child Link).   See case MOD-2021-114621 for details regarding the child case.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Around 30 patients received vaccine more than 12 hours after 1st puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture) 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 EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Around 30 patients received vaccine more than 12 hours after 1st puncture) had resolved. 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.   Concomitant medication was not provided. Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling very tired after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling very tired after first shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling very tired after first shot). At the time of the report, FATIGUE (Feeling very tired after first shot) outcome was unknown. Not Provided    Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     This case was linked to MOD-2021-114678 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (stuffy nose), pyrexia (fever) and myalgia (arm hurts) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 7, 2021, patient experienced nasal congestion (stuffy nose), pyrexia (fever) and myalgia (arm hurts). At the time of the report, nasal congestion (stuffy nose), pyrexia (fever) and myalgia (arm hurts) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. Concomitant medications and treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Feb-2021 and the estimated date of delivery was 21-Nov-2021. On 17-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 17-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pregnancy test: positive (Positive) Positive.         The concomitant medications were not provided. The Treatment Information was not provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Wrong technique in device usage process
Clinical narrative: He just got more than one dose; While administering the needle and syringe lost the connection; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection) and OFF LABEL USE (He just got more than one dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 038c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection). On 06-Jun-2021, the patient experienced OFF LABEL USE (He just got more than one dose). On 09-May-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (While administering the needle and syringe lost the connection) had resolved. On 06-Jun-2021, OFF LABEL USE (He just got more than one dose) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was no change No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received. Added the event-Offlabel Use