chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weak; achy; He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm; he started having pain in his right knee and right shoulder.; he started having pain in his right knee and right shoulder.; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) and the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-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 ASTHENIA (Weak), PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm), the first episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), the second episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.), FATIGUE (Tired) and PYREXIA (Fever). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), FATIGUE (Tired) and PYREXIA (Fever) had resolved and PAIN (achy), MYALGIA (He symptoms has moved to his arm, muscles aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm) and the last episode of ARTHRALGIA (he started having pain in his right knee and right shoulder.) had not resolved.            Patient had symptoms  after second dose of Covid-19 Vaccination. Patient took treatment medication Nyquil . Patient went to Doctor for pain in his right knee and shoulder. He had the X-Ray and other labs done as reported. He was given steroid shot which gave relief from his symptoms for about 5 to 10 days. The pain returned later and Patient to urgent care and he was given steroid shot again for his symptoms. Patient had been to 5 different doctors and had repeated steroid treatments for his symptoms which had spread to his arm, muscle aches in both of his arms and legs, joint pain in his right knee, right shoulder and right arm as reported. No information is reported for the outcome of events.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: minister of received 1st dose with AstraZeneca and 2nd dose with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (minister of  received 1st dose with AstraZeneca and 2nd dose with Moderna 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 INTERCHANGE OF VACCINE PRODUCTS (Prime minister of Germany received 1st dose with AstraZeneca and 2nd dose with Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Prime minister of Germany received 1st dose with AstraZeneca and 2nd dose with Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pyrexia, Urticaria
Clinical narrative: Pityriasis rosea; Hives; fever probably close to 101; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PITYRIASIS ROSEA (Pityriasis rosea) and PYREXIA (fever probably close to 101) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PYREXIA (fever probably close to 101). On 17-May-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis rosea). At the time of the report, URTICARIA (Hives), PITYRIASIS ROSEA (Pityriasis rosea) and PYREXIA (fever probably close to 101) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.   It was reported that patient received a shot from the dermatologist, which subsided the hives a bit. He had a second dose of that injection three weeks later. Today 12Jul2021 his hives are minimum compared to what it was, but it's starting to grow again. He is going in for his third appointment on Thursday 15Jul2021. Consent given for safety to contact the patient and his dermatologist. He states he will not be taking the booster shot if he doesn't have to   This case was linked to MOD-2021-254038 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Myalgia, Pain in extremity
Clinical narrative: cough; Hot to touch; red spot at the injection site; Arm hurt couple of days; Swelling; body ache; excruciating headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), PAIN IN EXTREMITY (Arm hurt couple of days) and VACCINATION SITE SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-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 COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), PAIN IN EXTREMITY (Arm hurt couple of days), VACCINATION SITE SWELLING (Swelling), MYALGIA (body ache), HEADACHE (excruciating headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every four hours. At the time of the report, COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), VACCINATION SITE SWELLING (Swelling), MYALGIA (body ache), HEADACHE (excruciating headache) and PYREXIA (fever) outcome was unknown and PAIN IN EXTREMITY (Arm hurt couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever 102F for 2 days.         No concomitant medications were reported. It was reported that she being in bed since 10-Jun-2021. she was so much pain.   This case was linked to MOD-2021-254036 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: cough; Hot to touch; red spot at the injection site; Arm hurt couple of days; Swelling; body ache; excruciating headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), PAIN IN EXTREMITY (Arm hurt couple of days) and VACCINATION SITE SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-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 COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), PAIN IN EXTREMITY (Arm hurt couple of days), VACCINATION SITE SWELLING (Swelling), MYALGIA (body ache), HEADACHE (excruciating headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every four hours. At the time of the report, COUGH (cough), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE ERYTHEMA (red spot at the injection site), VACCINATION SITE SWELLING (Swelling), MYALGIA (body ache), HEADACHE (excruciating headache) and PYREXIA (fever) outcome was unknown and PAIN IN EXTREMITY (Arm hurt couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever 102F for 2 days.         No concomitant medications were reported. It was reported that she being in bed since 10-Jun-2021. she was so much pain.   This case was linked to MOD-2021-254036 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 35 days from the first dose and still did not get the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old was inadvertently vaccinated with the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently vaccinated with the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (migraine headaches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, ISOSORBIDE, OMEPRAZOLE, HYDRALAZINE, SERTRALINE, VALSARTAN, DILTIAZEM, CARVEDILOL, MESALAZINE (PENTASA), DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), GLYCERYL TRINITRATE (NITROGLYCERINE), CLOPIDOGREL, LORAZEPAM and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine headaches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Intentional product use issue
Clinical narrative: Intentional deviation from dosage regimen; horrendous flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (horrendous flu like symptoms) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (horrendous flu like symptoms). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (horrendous flu like symptoms) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) outcome was unknown.            No Concomitant medications and No Treatment medications were reported.  Patient would prefer to be contacted by her brother's email   This case was linked to MOD-2021-027485 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is beyond 35 days for 2nd dose and has not yet received it; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is beyond 35 days for 2nd dose and has not yet received it) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is beyond 35 days for 2nd dose and has not yet received it). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is beyond 35 days for 2nd dose and has not yet received it) 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.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity, Urticaria
Clinical narrative: he is very concerned; he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.; it hurts him to walk; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.), PAIN IN EXTREMITY (it hurts him to walk) and ANXIETY (he is very concerned) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.) and PAIN IN EXTREMITY (it hurts him to walk). On an unknown date, the patient experienced ANXIETY (he is very concerned). At the time of the report, URTICARIA (he's had an uncontrolled hives breakout,It's now on his feet,It looks like jellyfish bites.), PAIN IN EXTREMITY (it hurts him to walk) and ANXIETY (he is very concerned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Moderna Covid-19 vaccine in March or May or 2021. Patient going to see 3rd dermatologist.   No concomitant medication listed.  No treatment information provide.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Exposure to SARS-CoV-2, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Missed 2nd dose in recommended time frame; Slight cough/senses for 2 days after possible exposure to covid; close proximity of people infected with covid and may have been exposed to the virus; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in recommended time frame), COUGH (Slight cough/senses for 2 days after possible exposure to covid) and EXPOSURE TO SARS-COV-2 (close proximity of people infected with covid and may have been exposed to the virus) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in recommended time frame), COUGH (Slight cough/senses for 2 days after possible exposure to covid) and EXPOSURE TO SARS-COV-2 (close proximity of people infected with covid and may have been exposed to the virus). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in recommended time frame) had resolved and COUGH (Slight cough/senses for 2 days after possible exposure to covid) and EXPOSURE TO SARS-COV-2 (close proximity of people infected with covid and may have been exposed to the virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old patient received her 1st dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine) 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.   This case was linked to MOD-2021-254074 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash; random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.) and RASH PRURITIC (itchy rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.). On an unknown date, the patient experienced RASH PRURITIC (itchy rash). The patient was treated with AZITHROMYCIN at a dose of 250 mg once a day and LORATADINE at a dose of 2 mg once a day. At the time of the report, RASH (random small raised round spots about the size of a finger on different parts of his body, mildly itchy and reddish pink in color.) and RASH PRURITIC (itchy rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; 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 NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.            The action taken with mRNA-1273 in response to the events were not applicable.  No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-254070 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain, Pain in jaw, Pruritus
Clinical narrative: right arm was itching; the right side of jaw was sore, and it hurt to chew; right arm was immobile; could not lift her am; very faint rash; had redness and a slight swelling at injection site; Nausea; injection site pain; swelling at injection site; swelling; She had pain and it was excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching) and SWELLING (swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (She had pain and it was excruciating), SWELLING (swelling), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile) and MOBILITY DECREASED (could not lift her am). On 21-Feb-2021, the patient experienced PAIN IN JAW (the right side of jaw was sore, and it hurt to chew). On 28-Feb-2021, the patient experienced PRURITUS (right arm was itching). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Swelling, at a dose of UNK, bid. At the time of the report, PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching), SWELLING (swelling), MOBILITY DECREASED (could not lift her am), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided. The patient feels that no further follow-up is needed for the 2nd shot because she does not have any further information. She is fine now and has full mobility of her arm. She reiterated that she will not take the Moderna shot again   This case was linked to MOD-2021-021353 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination site erythema, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: right arm was itching; the right side of jaw was sore, and it hurt to chew; right arm was immobile; could not lift her am; very faint rash; had redness and a slight swelling at injection site; Nausea; injection site pain; swelling at injection site; swelling; She had pain and it was excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching) and SWELLING (swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (She had pain and it was excruciating), SWELLING (swelling), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile) and MOBILITY DECREASED (could not lift her am). On 21-Feb-2021, the patient experienced PAIN IN JAW (the right side of jaw was sore, and it hurt to chew). On 28-Feb-2021, the patient experienced PRURITUS (right arm was itching). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Swelling, at a dose of UNK, bid. At the time of the report, PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching), SWELLING (swelling), MOBILITY DECREASED (could not lift her am), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided. The patient feels that no further follow-up is needed for the 2nd shot because she does not have any further information. She is fine now and has full mobility of her arm. She reiterated that she will not take the Moderna shot again   This case was linked to MOD-2021-021353 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: right arm was itching; the right side of jaw was sore, and it hurt to chew; right arm was immobile; could not lift her am; very faint rash; had redness and a slight swelling at injection site; Nausea; injection site pain; swelling at injection site; swelling; She had pain and it was excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching) and SWELLING (swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN (She had pain and it was excruciating), SWELLING (swelling), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile) and MOBILITY DECREASED (could not lift her am). On 21-Feb-2021, the patient experienced PAIN IN JAW (the right side of jaw was sore, and it hurt to chew). On 28-Feb-2021, the patient experienced PRURITUS (right arm was itching). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Swelling, at a dose of UNK, bid. At the time of the report, PAIN (She had pain and it was excruciating), PAIN IN JAW (the right side of jaw was sore, and it hurt to chew), VACCINATION SITE MOVEMENT IMPAIRMENT (right arm was immobile), PRURITUS (right arm was itching), SWELLING (swelling), MOBILITY DECREASED (could not lift her am), RASH (very faint rash), VACCINATION SITE ERYTHEMA (had redness and a slight swelling at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (swelling at injection site) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided. The patient feels that no further follow-up is needed for the 2nd shot because she does not have any further information. She is fine now and has full mobility of her arm. She reiterated that she will not take the Moderna shot again   This case was linked to MOD-2021-021353 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: hasnt had period; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (hasnt had period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (hasnt had period). At the time of the report, AMENORRHOEA (hasnt had period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were given
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: third dose; 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 EXTRA DOSE ADMINISTERED (third 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 provided by the reporter.     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 EXTRA DOSE ADMINISTERED (third dose). At the time of the report, EXTRA DOSE ADMINISTERED (third dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Urticaria
Clinical narrative: Headache (After Second Dose); Hives all over the body (After Second Dose); Dizziness (After Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 UNK. In 2021, the patient experienced HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and RUPATADINE FUMARATE (RUPALL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache (After Second Dose)), URTICARIA (Hives all over the body (After Second Dose)) and DIZZINESS (Dizziness (After Second Dose)) outcome was unknown.            No concomitant medication were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Insomnia
Clinical narrative: Diarrhea; Had a difficult time sleeping; Really sick; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    On 04-Jun-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 DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), INSOMNIA (Had a difficult time sleeping), ILLNESS (Really sick) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Caller's husband was exposed to someone who tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Caller's husband was exposed to someone who tested positive for Covid-19) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old got the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine) in a 16-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymph nodes scan abnormal
Clinical narrative: "they saw something on her lymph nodes" but was so small "they couldn't put a size on it"; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ovarian cancer stage IV in February 2020 and Hysterectomy. Concomitant products included Lynparza , DICYCLOMINE HCL, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), ATORVASTATIN CALCIUM ANHYDROUS, GABAPENTIN (GABAPENTIN "PCD"), Pain medicine as needed, Infusion through port, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE) and Eye drops for an unknown indication, MONTELUKAST SODIUM.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it"). At the time of the report, LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: lymph nodes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Her marker numbers are also going up: Jan 2021 - 54 May 2021 - 155 Jul 2021 - 255
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersomnia, Pruritus, Urticaria
Clinical narrative: She slept for 24 hours; Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives; They are big, itchy, burning hives; They are big, itchy, burning hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CALAMINE (topical) for Hives, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives) outcome was unknown.            No concomitant drug details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Micturition urgency
Clinical narrative: Using the bathroom every 2 minutes; This spontaneous case was reported by a patient and describes the occurrence of MICTURITION URGENCY (Using the bathroom every 2 minutes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MICTURITION URGENCY (Using the bathroom every 2 minutes). At the time of the report, MICTURITION URGENCY (Using the bathroom every 2 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine) 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 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago/ Moderna COVID19 Vaccine on 16May2021 and is currently seeking the second dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (for 40 years).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Started to feel better,better balance on her leg,leg are stronger,can raise her arm,able to move her arm) outcome was unknown.            Concomitant medications included MS medication.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.