chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: Scheduled to receive a booster dose due to Compromised immune system; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system) 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 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 an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system). At the time of the report, IMMUNE SYSTEM DISORDER (Scheduled to receive a booster dose due to Compromised immune system) outcome was unknown.            No concomitant medications were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after receiving both doses of Moderna vaccine; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving both doses of Moderna vaccine) and RHINORRHOEA (Runny nose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19 after receiving both doses of Moderna vaccine) and RHINORRHOEA (Runny nose). At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving both doses of Moderna vaccine) and RHINORRHOEA (Runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication are provided by reporter.  No treatment medications are provided by reporter.   Reporter did not allow further contact
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: cramping in my hands; cramping in my hamstring; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping in my hamstring) and MUSCLE SPASMS (cramping in my hands) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MUSCLE SPASMS (cramping in my hamstring). On 05-Aug-2021, the patient experienced MUSCLE SPASMS (cramping in my hands). At the time of the report, MUSCLE SPASMS (cramping in my hamstring) and MUSCLE SPASMS (cramping in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  During the workout the patient had some cramping in hamstring.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia, Vaccination complication
Clinical narrative: legs will not move; had a horrible time it's just terrible; aching; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (legs will not move), VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced MOBILITY DECREASED (legs will not move). 05-Aug-2021, the patient experienced VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever). At the time of the report, MOBILITY DECREASED (legs will not move), VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Patient was wondering if she can take any kind of ibuprofen or Advil or Tylenol.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose (Today it has been > 2 months after first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (Today it has been > 2 months after first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided. No Treatment medications were provided. Expiry date of that vaccine was unknown. Patient states that she was too busy and forgot about dose.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had the two doses of the vaccine but still doesn't have any antibodies; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (had the two doses of the vaccine but still doesn't have any antibodies) 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, 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 THERAPEUTIC RESPONSE UNEXPECTED (had the two doses of the vaccine but still doesn't have any antibodies). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (had the two doses of the vaccine but still doesn't have any antibodies) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypoaesthesia, Paraesthesia
Clinical narrative: Leg on the knee and below is numb; Is feeling tingling on the other leg too; Feeling like asthma; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma) 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 HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma). At the time of the report, HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: made me ill (flu like)for 48 hrs after the second dose; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose). At the time of the report, INFLUENZA LIKE ILLNESS (made me ill (flu like)for 48 hrs after the second dose) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills and pyrexia (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 088D21A) for COVID-19 immunization. No medical history reported. On Aug 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 5, 2021, patient experienced chills and pyrexia (fever). Patient treated with Tylenol (paracetamol) for fever, at a dose of 325 milligram. At the time of the report, chills and pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 101ºF (high) and 99ºF (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. Concomitant product information not reported. Patient stated symptoms were minor. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Hearing disability, Product dose omission issue
Clinical narrative: Had some hearing issues; Did not get scheduled 2nd Moderna COVID-19 Vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot) 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 HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot). At the time of the report, HEARING DISABILITY (Had some hearing issues) and PRODUCT DOSE OMISSION ISSUE (Did not get scheduled 2nd Moderna COVID-19 Vaccine shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Product dose omission issue
Clinical narrative: felt very tired /run down; more than 35 days between Moderna Covid-19 vaccines.; sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore injection site left arm), FATIGUE (felt very tired /run down) and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Skin infection.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (sore injection site left arm). On an unknown date, the patient experienced FATIGUE (felt very tired /run down) and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.). At the time of the report, INJECTION SITE PAIN (sore injection site left arm) and FATIGUE (felt very tired /run down) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Irritability, Rash macular, Vaccination site rash
Clinical narrative: blotch as red / blotch does not hurt or itch, but visible; Blotch is hot / producing heat; is bothersome; blotch near the injection sit; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient experienced RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (blotch as red / blotch does not hurt or itch, but visible), FEELING HOT (Blotch is hot / producing heat), IRRITABILITY (is bothersome) and VACCINATION SITE RASH (blotch near the injection sit) had not resolved.            Concomitant medication was not reported. The event blotch was 2 inches by 3 inches in oval shape.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: hard; my injection site became itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (hard), INJECTION SITE PRURITUS (my injection site became itchy) and INJECTION SITE ERYTHEMA (red) 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDURATION (hard), INJECTION SITE PRURITUS (my injection site became itchy) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE INDURATION (hard), INJECTION SITE PRURITUS (my injection site became itchy) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Jansen COVID-19 vaccine as 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Jansen COVID-19 vaccine as 2nd dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Jansen COVID-19 vaccine as 2nd dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Jansen COVID-19 vaccine as 2nd dose) had resolved.        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.   On 04 Aug 2021, patient took Dose 2 of Jansen COVID-19 Vaccine, details includes Lot 201A21A,Left arm
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: potentially refrozen vaccine administered to approximately 9 patients; 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 PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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 PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients). At the time of the report, PRODUCT STORAGE ERROR (potentially refrozen vaccine administered to approximately 9 patients) 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 concomitant medications were provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up document contains no new information. On 09-Nov-2021: Non-Significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Paraesthesia
Clinical narrative: lost strenght in her legs and everything; suddenly has some tinglings; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lost strenght in her legs and everything) and PARAESTHESIA (suddenly has some tinglings) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lost strenght in her legs and everything) and PARAESTHESIA (suddenly has some tinglings). At the time of the report, ASTHENIA (lost strenght in her legs and everything) and PARAESTHESIA (suddenly has some tinglings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Product dose omission issue, Pruritus, Rash pruritic, Urticaria
Clinical narrative: itchy rash on both forearms; Rash with extrem itiching; decided not to take secound dose; redness; hives; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hand dermatitis (Allergy to preservatives.).    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives). On 22-Jul-2021, RASH PRURITIC (itchy rash on both forearms), PRURITUS (Rash with extrem itiching), PRODUCT DOSE OMISSION ISSUE (decided not to take secound dose), ERYTHEMA (redness) and URTICARIA (hives) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on 22-Jul-2021.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received 0n 11 AUG 2021 contains significant information about patient i.e;   reporter mail ID added, patient race and ethnicity, allergies and events added. On 03-Sep-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment related information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Sweating during the night after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Sweating during the night after his second shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NIGHT SWEATS (Sweating during the night after his second shot). On 09-Apr-2021, NIGHT SWEATS (Sweating during the night after his second shot) outcome was unknown.            No concomitant medications were reported.   No treatment medications were reported.   This case was linked to MOD-2021-060605 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (6 months since first vaccine dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (6 months since first vaccine dose). At the time of the report, product dose omission issue (6 months since first vaccine dose): resolved.   The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Feeling abnormal, General physical health deterioration
Clinical narrative: It has gone from bad to worse and she can't work; Dizzy off and on; Weak off and on; She has been sleeping 12-13 hours per night which is not normal for her; He shoulder got worse to the point of throwing up; After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work; Arm hurt; She was sick; Feeling very bad the day after; Fever; Headache; achy all over for 3 days - arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on) and ASTHENIA (Weak off and on) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt). On 23-Jun-2021, the patient experienced PAIN (He shoulder got worse to the point of throwing up) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on) and SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Jun-2021, PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt) had resolved. At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on), SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included muscle relaxers and applying dry heat and cold.  Patient took second dose on 20-JUL-2021 (040C21A)   This case was linked to MOD-2021-278689 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Pain, Pain in extremity
Clinical narrative: It has gone from bad to worse and she can't work; Dizzy off and on; Weak off and on; She has been sleeping 12-13 hours per night which is not normal for her; He shoulder got worse to the point of throwing up; After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work; Arm hurt; She was sick; Feeling very bad the day after; Fever; Headache; achy all over for 3 days - arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on) and ASTHENIA (Weak off and on) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt). On 23-Jun-2021, the patient experienced PAIN (He shoulder got worse to the point of throwing up) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on) and SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Jun-2021, PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt) had resolved. At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on), SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included muscle relaxers and applying dry heat and cold.  Patient took second dose on 20-JUL-2021 (040C21A)   This case was linked to MOD-2021-278689 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: It has gone from bad to worse and she can't work; Dizzy off and on; Weak off and on; She has been sleeping 12-13 hours per night which is not normal for her; He shoulder got worse to the point of throwing up; After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work; Arm hurt; She was sick; Feeling very bad the day after; Fever; Headache; achy all over for 3 days - arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on) and ASTHENIA (Weak off and on) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt). On 23-Jun-2021, the patient experienced PAIN (He shoulder got worse to the point of throwing up) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on) and SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Jun-2021, PAIN IN EXTREMITY (Arm hurt), ILLNESS (She was sick), FEELING ABNORMAL (Feeling very bad the day after), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (achy all over for 3 days - arm hurt) had resolved. At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (It has gone from bad to worse and she can't work), PAIN (He shoulder got worse to the point of throwing up), DIZZINESS (Dizzy off and on), ASTHENIA (Weak off and on), SOMNOLENCE (She has been sleeping 12-13 hours per night which is not normal for her) and ARTHRALGIA (After her arm stopped hurting her shoulder was in lots and lots of pain / she can't work) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included muscle relaxers and applying dry heat and cold.  Patient took second dose on 20-JUL-2021 (040C21A)   This case was linked to MOD-2021-278689 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: What to do when I have a fever as a side effect; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (What to do when I have a fever as a side effect) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (What to do when I have a fever as a side effect). At the time of the report, PYREXIA (What to do when I have a fever as a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No Treatment information was provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: An expired vaccine administered as a 2nd dose to a patient; 2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE, IBUPROFEN, PANTOPRAZOLE, TAMSULOSIN, TESTOSTERONE, TRAMADOL and DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021). On 02-Aug-2021, EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) 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 and treatment drug provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Got the vaccine about 30 mins ago and im expreriancing some dizzyness; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-126658) on 04-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Got the vaccine about 30 mins ago and im expreriancing some dizzyness) 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 DIZZINESS (Got the vaccine about 30 mins ago and im expreriancing some dizzyness). At the time of the report, DIZZINESS (Got the vaccine about 30 mins ago and im expreriancing some dizzyness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported  The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) 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 LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided by reporter.  No treatment drug information was provided by reporter.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea
Clinical narrative: Diarrhea; Constipated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and CONSTIPATION (Constipated) outcome was unknown.            Concomitant product information was not provided.  Patient was recommended from doctor to remove dairy from diet.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from an expired vial) 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 concomitant medications were reported. No treatment information was provided. On 03-Aug-2021, the vaccine vial was opened to be administered to the patient but the vaccine was provided on 04-Aug-2021, the next day. The reporter kept the opened vial on the refrigerator at a temperature of 32 to 36 hours until the administration was done.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bronchitis, COVID-19, Feeling abnormal, Infection
Clinical narrative: bronchitis; feeling flu-ey; low grade fever/99-100°F; Covid-19; breakthrough infection; felt bad; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat) and BRONCHITIS (bronchitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced FEELING ABNORMAL (felt bad). 18-Jul-2021, the patient experienced THROAT IRRITATION (scratchy throat). On 23-Jul-2021, the patient experienced COVID-19 (Covid-19) and INFECTION (breakthrough infection). On 24-Jul-2021, the patient experienced BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 30-Jul-2021, COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat), BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Jul-2021, Body temperature: 99-100 (Low) Low grade fever 99-100°F.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: bronchitis; feeling flu-ey; low grade fever/99-100°F; Covid-19; breakthrough infection; felt bad; scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat) and BRONCHITIS (bronchitis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced FEELING ABNORMAL (felt bad). 18-Jul-2021, the patient experienced THROAT IRRITATION (scratchy throat). On 23-Jul-2021, the patient experienced COVID-19 (Covid-19) and INFECTION (breakthrough infection). On 24-Jul-2021, the patient experienced BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 30-Jul-2021, COVID-19 (Covid-19), INFECTION (breakthrough infection), FEELING ABNORMAL (felt bad), THROAT IRRITATION (scratchy throat), BRONCHITIS (bronchitis), INFLUENZA LIKE ILLNESS (feeling flu-ey) and PYREXIA (low grade fever/99-100°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Jul-2021, Body temperature: 99-100 (Low) Low grade fever 99-100°F.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild arm pain, arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm pain, arm soreness) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (mild arm pain, arm soreness). At the time of the report, PAIN IN EXTREMITY (mild arm pain, arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-278822 (Patient Link).