chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20(O)A OR 041LZ0(O)A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow). On 03-Feb-2021, VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Antibody test: 20 (Inconclusive) Patient had a COVID -19 Antibody Test and was resulted having protein spike of 20.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-048204 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; Sore itchy, red, swollen rash over the injection site flared up towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20(O)A OR 041LZ0(O)A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow). On 03-Feb-2021, VACCINATION SITE PRURITUS (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE RASH (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE PAIN (Sore itchy, red, swollen rash over the injection site flared up towards elbow), VACCINATION SITE ERYTHEMA (Sore itchy, red, swollen rash over the injection site flared up towards elbow) and VACCINATION SITE SWELLING (Sore itchy, red, swollen rash over the injection site flared up towards elbow) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Antibody test: 20 (Inconclusive) Patient had a COVID -19 Antibody Test and was resulted having protein spike of 20.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-048204 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Insomnia, Muscle spasms, Pain, Pain in extremity
Clinical narrative: could not walk; Severe pain in the belly; Pain in legs; really bad spasms in the legs; could not sleep for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder (Intestinal problems), Bladder disorder and Neuropathy peripheral.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours). At the time of the report, GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    This case was linked to MOD-2021-048175 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 15-Feb-2021, VACCINATION SITE PAIN (arm sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-046369 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Chills, Micturition urgency, Myalgia
Clinical narrative: Blood in urine; urge to urinate; she had a sensitivity all over her body; Hardness at injection site; chills; Joint pain; body ache; swollen injection site; warm to touch injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body) and VACCINATION SITE INDURATION (Hardness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (root canal problem (tooth problem)) and Multiple injuries. Family history included Blood disorder (not officially diagnosed). Concomitant products included AMOXICILLIN and METRONIDAZOLE for Tooth disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch injection site), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site). On 11-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate) and SENSITIVE SKIN (she had a sensitivity all over her body). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 at a dose of 500 mg. At the time of the report, VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Urine analysis: inconclusive (Inconclusive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Urine analysis, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Blood in urine; urge to urinate; she had a sensitivity all over her body; Hardness at injection site; chills; Joint pain; body ache; swollen injection site; warm to touch injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body) and VACCINATION SITE INDURATION (Hardness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth infection (root canal problem (tooth problem)) and Multiple injuries. Family history included Blood disorder (not officially diagnosed). Concomitant products included AMOXICILLIN and METRONIDAZOLE for Tooth disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch injection site), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site). On 11-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate) and SENSITIVE SKIN (she had a sensitivity all over her body). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 at a dose of 500 mg. At the time of the report, VACCINATION SITE WARMTH (warm to touch injection site), BLOOD URINE PRESENT (Blood in urine), MICTURITION URGENCY (urge to urinate), SENSITIVE SKIN (she had a sensitivity all over her body), VACCINATION SITE INDURATION (Hardness at injection site), CHILLS (chills), ARTHRALGIA (Joint pain), MYALGIA (body ache) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Urine analysis: inconclusive (Inconclusive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: soreness at the injection site; low fever of 99 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit). On 05-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and PYREXIA (low fever of 99 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99°f (Low) low fever of 99°F.         Concomitant medications was not provided.  Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Nausea, Nervousness, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: patients whose age is not within the recommended age group; Nervousness; Sore arm; Feeling jittery; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients whose age is not within the recommended age group), NERVOUSNESS (Nervousness), PAIN IN EXTREMITY (Sore arm), FEELING JITTERY (Feeling jittery) and NAUSEA (Nausea) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (allergy to nuts) and Wheezing. Concomitant products included ALBUTEROL [SALBUTAMOL] from 07-Aug-2020 to an unknown date for Wheezing.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients whose age is not within the recommended age group), NERVOUSNESS (Nervousness), PAIN IN EXTREMITY (Sore arm), FEELING JITTERY (Feeling jittery) and NAUSEA (Nausea). On 23-Mar-2021, NERVOUSNESS (Nervousness), PAIN IN EXTREMITY (Sore arm), FEELING JITTERY (Feeling jittery) and NAUSEA (Nausea) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients whose age is not within the recommended age group) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's race was updated as Black. Patient got her second dose on 01-APR-2021.  Treatment medications was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Reporter details, patient demographics, new events were updated.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 029A21A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Musculoskeletal discomfort, Pain
Clinical narrative: arms still a bit raised and itchy; random chills; hurt all over; horrible rash so itchy made her nuts; felt kind of crappy; allergy type of thing like hives on her arms; super bad headache like very bad; couldn't move neck; horrible chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck), CHILLS (horrible chills), RASH (horrible rash so itchy made her nuts) and FEELING ABNORMAL (felt kind of crappy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Breast implant palpable.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck) and CHILLS (horrible chills). On 13-Mar-2021, the patient experienced RASH (horrible rash so itchy made her nuts), FEELING ABNORMAL (felt kind of crappy) and URTICARIA (allergy type of thing like hives on her arms). On 17-Mar-2021, the patient experienced PRURITUS (arms still a bit raised and itchy), CHILLS (random chills) and PAIN (hurt all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck), CHILLS (horrible chills), RASH (horrible rash so itchy made her nuts), FEELING ABNORMAL (felt kind of crappy), URTICARIA (allergy type of thing like hives on her arms), PRURITUS (arms still a bit raised and itchy), CHILLS (random chills) and PAIN (hurt all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: arms still a bit raised and itchy; random chills; hurt all over; horrible rash so itchy made her nuts; felt kind of crappy; allergy type of thing like hives on her arms; super bad headache like very bad; couldn't move neck; horrible chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck), CHILLS (horrible chills), RASH (horrible rash so itchy made her nuts) and FEELING ABNORMAL (felt kind of crappy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Breast implant palpable.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck) and CHILLS (horrible chills). On 13-Mar-2021, the patient experienced RASH (horrible rash so itchy made her nuts), FEELING ABNORMAL (felt kind of crappy) and URTICARIA (allergy type of thing like hives on her arms). On 17-Mar-2021, the patient experienced PRURITUS (arms still a bit raised and itchy), CHILLS (random chills) and PAIN (hurt all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (super bad headache like very bad), MUSCULOSKELETAL DISCOMFORT (couldn't move neck), CHILLS (horrible chills), RASH (horrible rash so itchy made her nuts), FEELING ABNORMAL (felt kind of crappy), URTICARIA (allergy type of thing like hives on her arms), PRURITUS (arms still a bit raised and itchy), CHILLS (random chills) and PAIN (hurt all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia, Pain
Clinical narrative: Difficulty sleeping; body ache; headache; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery in October 2020. Concurrent medical conditions included Anxiety, Depression and Limb discomfort.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping), PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache). At the time of the report, INSOMNIA (Difficulty sleeping) had not resolved and PAIN (body ache), HEADACHE (headache) and MYALGIA (Muscle ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication includes depression, anxiety. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Injection site became swollen and tender; Injection site became swollen; lymph nodes on side of his neck (same side as injection) were swollen and tender; lymph nodes on side of his neck (same side as injection) were swollen and tender; Light headed; Arm Hurt; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender) and VACCINATION SITE SWELLING (Injection site became swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen), LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender). At the time of the report, DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender) outcome was unknown and LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site became swollen and tender; Injection site became swollen; lymph nodes on side of his neck (same side as injection) were swollen and tender; lymph nodes on side of his neck (same side as injection) were swollen and tender; Light headed; Arm Hurt; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender) and VACCINATION SITE SWELLING (Injection site became swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt) and FATIGUE (Fatigue). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen), LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender). At the time of the report, DIZZINESS (Light headed), PAIN IN EXTREMITY (Arm Hurt), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site became swollen and tender), VACCINATION SITE SWELLING (Injection site became swollen) and LYMPH NODE PAIN (lymph nodes on side of his neck (same side as injection) were swollen and tender) outcome was unknown and LYMPHADENOPATHY (lymph nodes on side of his neck (same side as injection) were swollen and tender) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Hypoaesthesia, Paraesthesia, Vaccination site erythema
Clinical narrative: the injection site has a little pimple; Tingling on my right foot; Numbness on my right foot; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on my right foot), HYPOAESTHESIA (Numbness on my right foot), DERMATITIS ACNEIFORM (the injection site has a little pimple) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0061321A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 17-Mar-2021, the patient experienced PARAESTHESIA (Tingling on my right foot) and HYPOAESTHESIA (Numbness on my right foot). On an unknown date, the patient experienced DERMATITIS ACNEIFORM (the injection site has a little pimple). The patient was treated with CORTISONE on 16-Mar-2021 for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling on my right foot), HYPOAESTHESIA (Numbness on my right foot) and DERMATITIS ACNEIFORM (the injection site has a little pimple) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: sore arm; received moderna vaccination as a 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021 at 3:53 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 3:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received moderna vaccination as a 16 years old) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome 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 related information was reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Surgery
Clinical narrative: appendix removal; trying to reschedule their 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose). At the time of the report, SURGERY (appendix removal) and PRODUCT DOSE OMISSION ISSUE (trying to reschedule their 2nd dose) 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.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection) outcome was unknown.            Concomitant product use was not provided by the reporter.   Reportedly, patient was about to take antibiotics (Amoxicillin 500mg) prescribed by her dentist as she was going to have one of her wisdom teeth removed.   Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (arm was red and swollen), erythema (arm was red), pain in extremity (arm is red 4 inches by 3 inches and sore) and pruritus (itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history information was not provided. Concomitant products included lisinopril for an unknown indication. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 4, 2021, patient experienced peripheral swelling (arm was red and swollen) and erythema (arm was red). On an unknown date, patient experienced pain in extremity (arm is red 4 inches by 3 inches and sore) and pruritus (itching). The patient was treated with Benadryl (diphenhydramine hydrochloride) for itching, at an unspecified dose and frequency. At the time of the report, peripheral swelling (arm was red and swollen) and extremity (arm was red): unresolved and pain in extremity  (arm is red 4 inches by 3 inches and sore) and pruritus (itching) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reportedly, patient was scheduled to received the second dose on Mar 31, 2021, however does not know if she should get the second dose since she had a reaction that went away and came back.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site after first dose). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site after first dose) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-048203 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delayed more than 42 days for 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed more than 42 days for 2nd shot) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: hips have become so loose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (hips have become so loose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hip discomfort (She says that she was having problems with her hips for a long time.). Concomitant products included AMLODIPINE, METOPROLOL, BENAZEPRIL, HYDROCHLOROTHIAZIDE, IPRATROPIUM BROMIDE, BUDESONIDE, ARFORMOTEROL TARTRATE (BROVANA), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (hips have become so loose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (hips have become so loose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 10-Jul-2021. On 17-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 17-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.            No concomitant medications were provided.  Treatment medications were unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site pain
Clinical narrative: Soreness at the injection site after second dose; Fatigue after second dose/Feels extremely tired after second dose; Been taking naps after second dose/Going to bed early after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for an unknown indication.     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 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-048199 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Tension, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: very hot to touch; feeling very stressed as her husband surgery is due in 29th march; Not sleeping well; very red; very itchy; much larger; very swollen; progressed down to arm in between right elbow and wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger) and VACCINATION SITE SWELLING (very swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M2/(Z)0(O)A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (very red), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist). On an unknown date, the patient experienced VACCINATION SITE WARMTH (very hot to touch), TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well). On 24-Feb-2021, VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist) had resolved. At the time of the report, TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information was not provided.     This case was linked to MOD-2021-048181 (Linked Report).; Sender's Comments:  MOD-2021-048181:cross linked for first dose
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: very hot to touch; feeling very stressed as her husband surgery is due in 29th march; Not sleeping well; very red; very itchy; much larger; very swollen; progressed down to arm in between right elbow and wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger) and VACCINATION SITE SWELLING (very swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M2/(Z)0(O)A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (very red), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist). On an unknown date, the patient experienced VACCINATION SITE WARMTH (very hot to touch), TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well). On 24-Feb-2021, VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist) had resolved. At the time of the report, TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information was not provided.     This case was linked to MOD-2021-048181 (Linked Report).; Sender's Comments:  MOD-2021-048181:cross linked for first dose
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness
Clinical narrative: dizziness; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and CHEST PAIN (Chest pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (dizziness) and CHEST PAIN (Chest pain). On 22-Feb-2021, DIZZINESS (dizziness) had resolved. On 25-Feb-2021, CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Sinusitis, Throat irritation
Clinical narrative: Sinus infection; Runny nose; Scratchy throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SINUSITIS (Sinus infection), RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever). The patient was treated with DOXYCYCLINE for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection), RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-048239 (Patient Link).