chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Dizziness; Missed the recommended window between the two doses; Tiredness; Chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIZZINESS (Dizziness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses), FATIGUE (Tiredness) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIZZINESS (Dizziness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses), FATIGUE (Tiredness) and CHILLS (Chills). At the time of the report, COVID-19 (COVID-19), DIZZINESS (Dizziness), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she might Have taken Motrin for the treatment .  Patient was wondering If she waited too long for the second dose and weather or not she should repeat the first dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter's email id was added. Start date of COVID 19 was updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Contusion, Erythema, Mass, Myalgia
Clinical narrative: Allergic Reaction to this injection; arm hard to touch; arm turned red; arm swollen; arm hurting; arm itchy; feels like a bruise on her arm; bump the size of a dime on her arm/hard to the touch; arm sore/rm slightly soar; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy) and CONTUSION (feels like a bruise on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic obstructive pulmonary disease, Asthma, Brain tumor and Heart disease, unspecified (heart condition). Concomitant products included PARACETAMOL (TYLENOL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch) and MYALGIA (arm sore/rm slightly soar). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch). At the time of the report, ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch), MYALGIA (arm sore/rm slightly soar), ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.   This case was linked to MOD-2021-264349.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: 2nd dose information has updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin induration
Clinical narrative: Allergic Reaction to this injection; arm hard to touch; arm turned red; arm swollen; arm hurting; arm itchy; feels like a bruise on her arm; bump the size of a dime on her arm/hard to the touch; arm sore/rm slightly soar; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy) and CONTUSION (feels like a bruise on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic obstructive pulmonary disease, Asthma, Brain tumor and Heart disease, unspecified (heart condition). Concomitant products included PARACETAMOL (TYLENOL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch) and MYALGIA (arm sore/rm slightly soar). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch). At the time of the report, ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch), MYALGIA (arm sore/rm slightly soar), ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.   This case was linked to MOD-2021-264349.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: 2nd dose information has updated.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: 18 bumps on right forearm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (18 bumps on right forearm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RASH PAPULAR (18 bumps on right forearm). At the time of the report, RASH PAPULAR (18 bumps on right forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-222973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up contain non significant information
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: I feel really sleepy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness) 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 SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (I feel really sleepy) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.; 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Skin odour abnormal
Clinical narrative: i still have little to no body odor in the armpit of the arm that recieved the vaccine; This spontaneous case was reported by a patient and describes the occurrence of SKIN ODOUR ABNORMAL (i still have little to no body odor in the armpit of the arm that recieved the 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN ODOUR ABNORMAL (i still have little to no body odor in the armpit of the arm that recieved the vaccine). At the time of the report, SKIN ODOUR ABNORMAL (i still have little to no body odor in the armpit of the arm that recieved the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. No treatment medications were not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Sore arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and MYALGIA (Sore arm) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007521A) for COVID-19 vaccination.     The patient's past medical history included Vasovagal reaction (Vasovagal syncope) on 30-Oct-2019, Insomnia on 30-Oct-2019, Heartburn on 06-Sep-2017 and Gastritis on 06-Sep-2017. Concurrent medical conditions included Food allergy (Cabbage), Drug allergy (Fomatadine) and Asthma on 07-Apr-2021. Concomitant products included LORATADINE from 07-Apr-2021 to an unknown date and FLUTICASONE from 07-Apr-2021 to an unknown date for Allergy, ALBUTEROL SULFATE from 07-Apr-2021 to an unknown date for Asthma, ETHINYLESTRADIOL, NORGESTIMATE (ORTHO TRI-CYCLEN) from 11-May-2021 to an unknown date for Birth control, DICYCLOVERINE HYDROCHLORIDE (BENTYL) from 04-Mar-2020 to an unknown date for Gastritis, LANSOPRAZOLE (PREVACID) from 03-Jun-2021 to an unknown date for Heartburn, MELATONIN from 30-Oct-2019 to an unknown date for Insomnia.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021 at 2:00 PM, the patient experienced FATIGUE (Tiredness). On 21-Apr-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021, FATIGUE (Tiredness) had resolved. On 27-Apr-2021 at 1:00 PM, MYALGIA (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided by the reporter   This case was linked to MOD-2021-067774 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE, VITAMIN D3, VITAMIN B6 and MAGNESIUM for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included 5HTP.  No treatment information  was provided by reporter.   This case was linked to MOD-2021-222979 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on right arm near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on right arm near injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (rash on right arm near injection site). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (rash on right arm near injection site) had not resolved.            No concomitant medications were reported   This case was linked to MOD-2021-222960 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up was received does not contains any new information On 06-Aug-2021: Follow up received 06-Aug-2021, and  Event outcome updated
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  On an unknown date, the patient did not have adverse event to the COVID-19 vaccine. The patient received shot in the arm with a needle, or was a flu vaccine , the arm had soreness in the particular area for a day or two.       Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received. Event outcome updated. Patient age added from initial.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Insomnia, Neck pain
Clinical narrative: hard time getting to sleep; lower back soreness; neck soreness; shoulder soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, COLECALCIFEROL (VITAMIN D3), MAGNESIUM and PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) for an unknown indication.   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 14-Jun-2021, the patient experienced INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache). At the time of the report, INSOMNIA (hard time getting to sleep), BACK PAIN (lower back soreness), NECK PAIN (neck soreness), ARTHRALGIA (shoulder soreness) and HEADACHE (headache) outcome was unknown.            No laboratory details were  provided.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: Sore effect with first dose of vaccine; Lump just above the collarbone of the same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection) 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 PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection). At the time of the report, PAIN (Sore effect with first dose of vaccine) and MASS (Lump just above the collarbone of the same side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Chills; Nausea; Headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 09-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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. In 2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). In 2021, CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: i havent started a period and all pregnancy tests have read negative; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative) 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 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-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 MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative). At the time of the report, MENSTRUATION IRREGULAR (i havent started a period and all pregnancy tests have read negative) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Slight yeast infection after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Slight yeast infection after the 1st 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FUNGAL INFECTION (Slight yeast infection after the 1st dose). At the time of the report, FUNGAL INFECTION (Slight yeast infection after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Presyncope, Pruritus
Clinical narrative: Feel like passing out; Itching/Itching on and off; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching/Itching on and off) and PRESYNCOPE (Feel like passing out) 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 13-Jun-2021, the patient experienced PRURITUS (Itching/Itching on and off). On an unknown date, the patient experienced PRESYNCOPE (Feel like passing out). At the time of the report, PRURITUS (Itching/Itching on and off) and PRESYNCOPE (Feel like passing out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient that was given a second dose at 21 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient that was given a second dose at 21 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin).   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient that was given a second dose at 21 days). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient that was given a second dose at 21 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16-JUL-2021 contains: Added Reporter details; Added Patient initial- gender; Added dosage information- IM, Left deltoid;
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea after 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(s). On an unknown date, the patient experienced NAUSEA (nausea after second dose). At the time of the report, NAUSEA (nausea after second dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oral pain, Stomatitis
Clinical narrative: Sore Mouth; STOMATITIS; This spontaneous case was reported by a physician and describes the occurrence of ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS). At the time of the report, ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ORAL PAIN (Sore Mouth) and STOMATITIS (STOMATITIS) to be probably related.    Concomitant medications were not provided. Treatment information was not reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Fatigue, Heart rate
Clinical narrative: Anxiety after 2nd Shot; Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot; Warm Head 99F after 2nd Shot,Low grade fever; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness). On an unknown date, the patient experienced ANXIETY (Anxiety after 2nd Shot). At the time of the report, ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/70 mmHg (normal) normal. On an unknown date, Body temperature: 99 °F (High) HIgh. On an unknown date, Heart rate: 120 beats (High) elevated and 110 (normal) normal.         Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Anxiety after 2nd Shot; Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot; Warm Head 99F after 2nd Shot,Low grade fever; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness). On an unknown date, the patient experienced ANXIETY (Anxiety after 2nd Shot). At the time of the report, ANXIETY (Anxiety after 2nd Shot), PAIN IN EXTREMITY (Sore Left  Arm after 2nd Shot/ Body Aches after 2nd Shot), PYREXIA (Warm Head 99F after 2nd Shot,Low grade fever) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/70 mmHg (normal) normal. On an unknown date, Body temperature: 99 °F (High) HIgh. On an unknown date, Heart rate: 120 beats (High) elevated and 110 (normal) normal.         Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site reaction
Clinical narrative: Strong Reaction after First Vaccine; Headache after First Vaccine; Extreme Nausea after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Patient taking Celebrex as needed. She states only 2 or 3 times a year she uses Celebrex.). Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine). On 16-Feb-2021, VACCINATION SITE REACTION (Strong Reaction after First Vaccine), HEADACHE (Headache after First Vaccine) and NAUSEA (Extreme Nausea after First Vaccine) 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.   Treatment information was not provided by reporter.   This case was linked to MOD-2021-223072 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.    This case was linked to MOD-2021-222874, MOD-2021-222826 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Migraine
Clinical narrative: Migraine; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Migraine) and FATIGUE (Tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine) and FATIGUE (Tiredness). At the time of the report, MIGRAINE (Migraine) and FATIGUE (Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired second dose of the Moderna COVID-19 vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, HYDROXYZINE, TRAZODONE and ACAMPROSATE for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired second dose of the Moderna COVID-19 vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired second dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Oedema
Clinical narrative: edema; This spontaneous case was reported by a patient and describes the occurrence of OEDEMA (edema) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 OEDEMA (edema). At the time of the report, OEDEMA (edema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: churning stomach issue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (churning stomach issue) 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 14-Jun-2021, the patient experienced NAUSEA (churning stomach issue). At the time of the report, NAUSEA (churning stomach issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: Memory Impaired; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory Impaired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 642L20A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concomitant products included SIMVASTATIN for Cholesterol, METOPROLOL for product use for unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram. In May 2021, the patient experienced MEMORY IMPAIRMENT (Memory Impaired). At the time of the report, MEMORY IMPAIRMENT (Memory Impaired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MEMORY IMPAIRMENT (Memory Impaired) to be not related.    Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme pain; 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 PAIN (Extreme pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PAIN (Extreme pain). At the time of the report, PAIN (Extreme pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient's lab test data not reported.  Concomitant product use was not provided.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thinking abnormal, Vaccination complication
Clinical narrative: Thinking affected and could not think clear after Second Shot; Stronger Reaction after Second Shot; Severe Pain all over body after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot). On 13-Mar-2021, THINKING ABNORMAL (Thinking affected and could not think clear after Second Shot), VACCINATION COMPLICATION (Stronger Reaction after Second Shot) and PAIN (Severe Pain all over body after Second Shot) had resolved.        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 not applicable.  Patient  was told not to take Anti-Inflammatory.  But patient took Celebrex after 24hours after the second shot.  Treatment medication was not reported.  Patient stated she never consulted with MD regarding her side effects after vaccination.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-223015 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I had it today (side effects)/ Had it few hours ago (side effects); This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) 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 ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)). At the time of the report, ADVERSE EVENT (I had it today (side effects)/ Had it few hours ago (side effects)) outcome was unknown.            Treatment information was not provided by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: sugar level went up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugar level went up) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 0017B12A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced BLOOD GLUCOSE INCREASED (sugar level went up). At the time of the report, BLOOD GLUCOSE INCREASED (sugar level went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood glucose: 9.9 (High) Patient states that blood sugar level increased after getting the second dose of Moderna vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 18-year-old female patient 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      On an unknown date, patient had fever of 101.8 F after 2nd dose of Moderna as reported.   Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included 12 VITAMINS for an unknown indication.   On 09-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-027951 (Patient Link).