chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 2 weeks apart; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 2 weeks apart) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Disturbance in attention, Fatigue, Malaise
Clinical narrative: Brain was not functioning well; Had burning sensation in the legs; Has no energy; Fatigue; Fever; so sick for 9 weeks that I almost died; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (so sick for 9 weeks that I almost died), DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21 and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy) and FATIGUE (Fatigue). 15-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (so sick for 9 weeks that I almost died). At the time of the report, MALAISE (so sick for 9 weeks that I almost died) had resolved and DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  On 15-APR-2021, the patient felt that she couldn't do anything. Treatment medication was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-106941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Brain was not functioning well; Had burning sensation in the legs; Has no energy; Fatigue; Fever; so sick for 9 weeks that I almost died; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (so sick for 9 weeks that I almost died), DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21 and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy) and FATIGUE (Fatigue). 15-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (so sick for 9 weeks that I almost died). At the time of the report, MALAISE (so sick for 9 weeks that I almost died) had resolved and DISTURBANCE IN ATTENTION (Brain was not functioning well), BURNING SENSATION (Had burning sensation in the legs), ASTHENIA (Has no energy), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  On 15-APR-2021, the patient felt that she couldn't do anything. Treatment medication was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-106941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
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 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 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-044370 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: TCR Received on 05 Jun 2021 and contains no new information. Patient denied further follow up
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given the second dose on day 21 instead of day 28; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the second dose on day 21 instead of day 28) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment information not provided,
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The expired vaccine (Beyond 12 hours) was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (The expired vaccine (Beyond 12 hours) was administered) 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.   No concomitant and treatment medications were provided
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (shooting pain ) and HYPOAESTHESIA (numbness/feeling like "electricity in her hand") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLOMIFENE CITRATE (CLOMID), LABETALOL, LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN, CETIRIZINE, FOLIC ACID, CITALOPRAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), EXENATIDE (BYDUREON), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEPRAZOLE, CEFIXIME (FLEXERIL [CEFIXIME]), NAPROXEN and PANTOPRAZOLE for an unknown indication. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (shooting pain ) and HYPOAESTHESIA (numbness/feeling like "electricity in her hand"). At the time of the report, PAIN (shooting pain ) outcome was unknown and HYPOAESTHESIA (numbness/feeling like "electricity in her hand") had not resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drugs were reported. The patient also has been to her doctor for the condition and provided contact information. This case was linked to MOD-2021-106976.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart; Bruise is slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore). At the time of the report, CONTUSION (Patient has dark bruise below chest and above stomach close to center little bit close to left side near his heart) and PAIN (Bruise is slightly sore) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: achy after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS) (Stage IV cancer in remission.) and Walking difficulty. Concomitant products included PALBOCICLIB (IBRANCE) and LETROZOLE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (achy after first dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (achy after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was also done with Anti-viral medication.   This case was linked to MOD-2021-107109 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: bad headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 HEADACHE (bad headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (bad headache) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 Moderna vaccine was Not applicable
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on back only; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on back only) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on back only). At the time of the report, RASH (rash on back only) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes Letrovole 2.5mg daily. Medical treatment was provided around 25Mar2021 for topical ointment use( 1st dose).   This case was linked to MOD-2021-106967 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site pain
Clinical narrative: Shingles ( outbreak experienced in between the first and second dose of the vaccine); sore arm (right arm- first dose); This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)) and VACCINATION SITE PAIN (sore arm (right arm- first dose)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Polymyalgia rheumatica. Concomitant products included TOCILIZUMAB (ACTEMRA) for Polymyalgia rheumatica.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm (right arm- first dose)). On an unknown date, the patient experienced HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)). At the time of the report, HERPES ZOSTER (Shingles ( outbreak experienced in between the first and second dose of the vaccine)) and VACCINATION SITE PAIN (sore arm (right arm- first dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose of Moderna vaccine on 2-MAR-2021 with lot no. 024M20A in an unknown route. No treatment medications were reported.   This case was linked to MOD-2021-107082.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Physician details added.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered (First Dose); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered (First Dose)) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered (First Dose)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered (First Dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional crosslink reference IDs provided. Date of suspect product administration modified.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Erythromelalgia, Feeling abnormal, Pain, Peripheral swelling
Clinical narrative: Both feet are swollen, both feet the top part are puffy; Red face and hands; Shooting pain; Feet are still red; red feet and red hands that has been ongoing for three months that goes away and comes back; Feeling bad; Sore arm (left arm- second dose) for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands) and PAIN (Shooting pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Blood pressure high. Concomitant products included TOCILIZUMAB (ACTEMRA) for Polymyalgia rheumatica.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days). On an unknown date, the patient experienced ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands), PAIN (Shooting pain) and ERYTHEMA (Feet are still red). On 05-Mar-2021, VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days) had resolved. At the time of the report, ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back) and ERYTHEMA (Feet are still red) had not resolved, FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy) and PAIN (Shooting pain) outcome was unknown and ERYTHEMA (Red face and hands) had resolved.            No treatment information was provided by the reporter.  The patient had her feet is still red for about four months especially the bottom of the feet. Her doctor was informed.   This case was linked to MOD-2021-107064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Non-significant follow up received, Reporter details added. On 07-Aug-2021: Followup document received on 09-AUG-2021 and the start date of vaccine was changed to 03-FEB-2021. New events added. outcome of the events updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Both feet are swollen, both feet the top part are puffy; Red face and hands; Shooting pain; Feet are still red; red feet and red hands that has been ongoing for three months that goes away and comes back; Feeling bad; Sore arm (left arm- second dose) for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands) and PAIN (Shooting pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Blood pressure high. Concomitant products included TOCILIZUMAB (ACTEMRA) for Polymyalgia rheumatica.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days). On an unknown date, the patient experienced ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy), ERYTHEMA (Red face and hands), PAIN (Shooting pain) and ERYTHEMA (Feet are still red). On 05-Mar-2021, VACCINATION SITE PAIN (Sore arm (left arm- second dose) for 3 days) had resolved. At the time of the report, ERYTHROMELALGIA (red feet and red hands that has been ongoing for three months that goes away and comes back) and ERYTHEMA (Feet are still red) had not resolved, FEELING ABNORMAL (Feeling bad), PERIPHERAL SWELLING (Both feet are swollen, both feet the top part are puffy) and PAIN (Shooting pain) outcome was unknown and ERYTHEMA (Red face and hands) had resolved.            No treatment information was provided by the reporter.  The patient had her feet is still red for about four months especially the bottom of the feet. Her doctor was informed.   This case was linked to MOD-2021-107064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Non-significant follow up received, Reporter details added. On 07-Aug-2021: Followup document received on 09-AUG-2021 and the start date of vaccine was changed to 03-FEB-2021. New events added. outcome of the events updated.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Their arm swelled; Their arm had red welts; 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 PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts) 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 PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts). At the time of the report, PERIPHERAL SWELLING (Their arm swelled) and URTICARIA (Their arm had red welts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-106873, US-MODERNATX, INC.-MOD-2021-106720, US-MODERNATX, INC.-MOD-2021-106972, MOD21-087005 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106873: US-MODERNATX, INC.-MOD-2021-106720: US-MODERNATX, INC.-MOD-2021-106972: MOD21-087005:Crosslink
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site bruising, Vaccination site induration, Vaccination site pain
Clinical narrative: light bruise right arm below injection site; sore right arm; fatigue; little hard right arm (injection site); muscle aches full body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (light bruise right arm below injection site), MYALGIA (muscle aches full body), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (muscle aches full body). On 01-May-2021, the patient experienced VACCINATION SITE BRUISING (light bruise right arm below injection site), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)). At the time of the report, VACCINATION SITE BRUISING (light bruise right arm below injection site), MYALGIA (muscle aches full body), VACCINATION SITE PAIN (sore right arm), FATIGUE (fatigue) and VACCINATION SITE INDURATION (little hard right arm (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Malaise, Somnolence, Tinnitus
Clinical narrative: Tinnitus; malaise; ear pressure and it feels plugged up; you sort of sleep a day or two; tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus), MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus) had not resolved and MALAISE (malaise), EAR DISCOMFORT (ear pressure and it feels plugged up), SOMNOLENCE (you sort of sleep a day or two) and FATIGUE (tired/fatigue) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Treatment included popping of the ear to open the eustachian tube per ENT's recommendation  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-107143 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Experienced side effects after the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Experienced side effects 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 ADVERSE EVENT (Experienced side effects after the second dose). At the time of the report, ADVERSE EVENT (Experienced side effects after the second dose) outcome was unknown. Not Provided          No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Myalgia, Neuralgia, Pyrexia
Clinical narrative: nerve pain; shingles/still has shingles; rash; really tired/feels tired; achy after second dose; feverish; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain), HERPES ZOSTER (shingles), FATIGUE (really tired), MYALGIA (achy after second dose) and PYREXIA (feverish) in a 64-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 Cancer (Stage 4 cancer ). Concomitant products included PALBOCICLIB (IBRANCE) and LETROZOLE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced FATIGUE (really tired), MYALGIA (achy after second dose) and PYREXIA (feverish). On 25-Apr-2021, the patient experienced RASH (rash). On 27-Apr-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced NEURALGIA (nerve pain). At the time of the report, NEURALGIA (nerve pain), HERPES ZOSTER (shingles), FATIGUE (really tired), MYALGIA (achy after second dose), PYREXIA (feverish) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Anti-viral medication and Tylenol.    This case was linked to MOD-2021-107025 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: nerve pain; shingles/still has shingles; rash; really tired/feels tired; achy after second dose; feverish; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain), HERPES ZOSTER (shingles), FATIGUE (really tired), MYALGIA (achy after second dose) and PYREXIA (feverish) in a 64-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 Cancer (Stage 4 cancer ). Concomitant products included PALBOCICLIB (IBRANCE) and LETROZOLE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced FATIGUE (really tired), MYALGIA (achy after second dose) and PYREXIA (feverish). On 25-Apr-2021, the patient experienced RASH (rash). On 27-Apr-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced NEURALGIA (nerve pain). At the time of the report, NEURALGIA (nerve pain), HERPES ZOSTER (shingles), FATIGUE (really tired), MYALGIA (achy after second dose), PYREXIA (feverish) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Anti-viral medication and Tylenol.    This case was linked to MOD-2021-107025 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: started to experience fever of 100.4 temperature; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (started to experience fever of 100.4 temperature) in a 59-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 PREDNISONE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PYREXIA (started to experience fever of 100.4 temperature). At the time of the report, PYREXIA (started to experience fever of 100.4 temperature) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, Body temperature: 100.4 (High) Temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-106992 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106992:Wife case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second shot of Moderna Vccine passed 67days .; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypothyroidism, Sleep disorder and Asthma. Concomitant products included LEVOTHYROXINE for Hypothyroidism, IMIPRAMINE for Sleep disorder.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second shot of Moderna Vccine passed 67days .) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment information was not provided.  concomitant medicine include ProAir inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: fallow up received on 8-jun-2021 and fax number was updated.  patent race and Ethnic Group was updated and vaccine facility information was updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Erythema, Lymph node pain, Rash pruritic, Scab
Clinical narrative: can still see tiny scabs; (left lymph node under his jaw) sore; 9 or 10 itchy bumps; including 2 or 3 itchy bumps on left lower back; Pain at the injection site; Felt a little bit of bruise; Slightly swollen; red; very sore for next two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days). On 26-Apr-2021, the patient experienced RASH PRURITIC (9 or 10 itchy bumps) and RASH PRURITIC (including 2 or 3 itchy bumps on left lower back). On 03-May-2021, the patient experienced LYMPH NODE PAIN ((left lymph node under his jaw) sore). On 05-May-2021, the patient experienced SCAB (can still see tiny scabs). On 27-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) had resolved. On 05-May-2021, RASH PRURITIC (9 or 10 itchy bumps), RASH PRURITIC (including 2 or 3 itchy bumps on left lower back) and LYMPH NODE PAIN ((left lymph node under his jaw) sore) had resolved. At the time of the report, SCAB (can still see tiny scabs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: can still see tiny scabs; (left lymph node under his jaw) sore; 9 or 10 itchy bumps; including 2 or 3 itchy bumps on left lower back; Pain at the injection site; Felt a little bit of bruise; Slightly swollen; red; very sore for next two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days). On 26-Apr-2021, the patient experienced RASH PRURITIC (9 or 10 itchy bumps) and RASH PRURITIC (including 2 or 3 itchy bumps on left lower back). On 03-May-2021, the patient experienced LYMPH NODE PAIN ((left lymph node under his jaw) sore). On 05-May-2021, the patient experienced SCAB (can still see tiny scabs). On 27-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site), CONTUSION (Felt a little bit of bruise), SWELLING (Slightly swollen), ERYTHEMA (red) and VACCINATION SITE PAIN (very sore for next two days) had resolved. On 05-May-2021, RASH PRURITIC (9 or 10 itchy bumps), RASH PRURITIC (including 2 or 3 itchy bumps on left lower back) and LYMPH NODE PAIN ((left lymph node under his jaw) sore) had resolved. At the time of the report, SCAB (can still see tiny scabs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood disorder, Chest pain, Chills, Dyspepsia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), HYPERHIDROSIS (perspiration), DYSPEPSIA (horrendous heartburn) and EAR PAIN (could feel pain in ears) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 001c21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced EYE PAIN (hurts to look at things), HYPERHIDROSIS (perspiration), CHILLS (chills), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night). On 29-Apr-2021, the patient experienced CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach) and BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.). On an unknown date, the patient experienced NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 29-Apr-2021, HYPERHIDROSIS (perspiration) and CHILLS (chills) had resolved. At the time of the report, EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach), BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.), NAUSEA (nauseous), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-106919.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Gastritis, Headache, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), HYPERHIDROSIS (perspiration), DYSPEPSIA (horrendous heartburn) and EAR PAIN (could feel pain in ears) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 001c21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced EYE PAIN (hurts to look at things), HYPERHIDROSIS (perspiration), CHILLS (chills), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night). On 29-Apr-2021, the patient experienced CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach) and BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.). On an unknown date, the patient experienced NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 29-Apr-2021, HYPERHIDROSIS (perspiration) and CHILLS (chills) had resolved. At the time of the report, EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach), BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.), NAUSEA (nauseous), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-106919.