chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Muscular weakness
Clinical narrative: Weak knees; Dizzy; Shakes and chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy) and CHILLS (Shakes and chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy) and CHILLS (Shakes and chills). At the time of the report, MUSCULAR WEAKNESS (Weak knees), DIZZINESS (Dizzy) and CHILLS (Shakes and chills) outcome was unknown.        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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Cough maybe not be from vaccine; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F). At the time of the report, COUGH (Cough maybe not be from vaccine) and PYREXIA (fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101f High.         Patient reported that after first dose the patient had no symptoms No concomitant medication reported  No treatment medication reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), COUGH (Cough), OROPHARYNGEAL PAIN (throat started hurting), PAIN (where I got the shot was sore) and PAIN (achy all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 085B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced NASAL CONGESTION (congested), OROPHARYNGEAL PAIN (throat started hurting) and PAIN (achy all over). 01-Apr-2021, the patient experienced COUGH (Cough), PAIN (where I got the shot was sore), HEADACHE (head started hurting) and CHILLS (chills really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (congested), COUGH (Cough), OROPHARYNGEAL PAIN (throat started hurting), PAIN (where I got the shot was sore), PAIN (achy all over), HEADACHE (head started hurting) and CHILLS (chills really bad) outcome was unknown. Concomitant product use was not provided by the reporter. Patient  has taken 2 Tylenol for her symptoms about 15 minutes ago and is making some tea for herself currently.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), COUGH (Cough), OROPHARYNGEAL PAIN (throat started hurting), PAIN (where I got the shot was sore) and PAIN (achy all over) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 085B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced NASAL CONGESTION (congested), OROPHARYNGEAL PAIN (throat started hurting) and PAIN (achy all over). 01-Apr-2021, the patient experienced COUGH (Cough), PAIN (where I got the shot was sore), HEADACHE (head started hurting) and CHILLS (chills really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (congested), COUGH (Cough), OROPHARYNGEAL PAIN (throat started hurting), PAIN (where I got the shot was sore), PAIN (achy all over), HEADACHE (head started hurting) and CHILLS (chills really bad) outcome was unknown. Concomitant product use was not provided by the reporter. Patient  has taken 2 Tylenol for her symptoms about 15 minutes ago and is making some tea for herself currently.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nose bleed. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-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 EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.            This case was linked to MOD-2021-131250, MOD-2021-131250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: form added - related to first dose
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm pain; swelling; redness; swelling; redness; sorness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling), the first episode of VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (sorness), PAIN IN EXTREMITY (arm pain) and SWELLING (swelling) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling), the first episode of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (sorness). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), SWELLING (swelling) and the second episode of VACCINATION SITE ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of UNK dosage form, qd. On 26-Mar-2021, VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PAIN (sorness) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), SWELLING (swelling) and the last episode of VACCINATION SITE ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment include Asper cream.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: A follow up was received on 30-APR-2021 which contained no new information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Insomnia
Clinical narrative: feels light headed; tired; not sleeping deeply; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feels light headed), FATIGUE (tired) and INSOMNIA (not sleeping deeply) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (feels light headed), FATIGUE (tired) and INSOMNIA (not sleeping deeply). At the time of the report, DIZZINESS (feels light headed), FATIGUE (tired) and INSOMNIA (not sleeping deeply) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Dizziness, Headache, Inflammation
Clinical narrative: inflammation all over body; headach; dizziness; nausea; can not lift her arm; lethargic; body ache; chills; can not get out of bed for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm) and LETHARGY (lethargic) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm), LETHARGY (lethargic), PAIN (body ache), CHILLS (chills) and BED REST (can not get out of bed for 2 days). On 01-Apr-2021, the patient experienced INFLAMMATION (inflammation all over body). At the time of the report, HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm), LETHARGY (lethargic), PAIN (body ache), CHILLS (chills), BED REST (can not get out of bed for 2 days) and INFLAMMATION (inflammation all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Limb discomfort, Nausea, Pain
Clinical narrative: inflammation all over body; headach; dizziness; nausea; can not lift her arm; lethargic; body ache; chills; can not get out of bed for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm) and LETHARGY (lethargic) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm), LETHARGY (lethargic), PAIN (body ache), CHILLS (chills) and BED REST (can not get out of bed for 2 days). On 01-Apr-2021, the patient experienced INFLAMMATION (inflammation all over body). At the time of the report, HEADACHE (headach), DIZZINESS (dizziness), NAUSEA (nausea), LIMB DISCOMFORT (can not lift her arm), LETHARGY (lethargic), PAIN (body ache), CHILLS (chills), BED REST (can not get out of bed for 2 days) and INFLAMMATION (inflammation all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: 3 by 3 inches redness on left arm; tenderness on left arm; left arm warm to the touch; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Melanoma (Melanoma scar she has 2 inches below the injection site). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (SLEEPING [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm"). At the time of the report, VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all over body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PRURITUS (Itching all over body). At the time of the report, PRURITUS (Itching all over body) outcome was unknown.            No concomitant medications reported.  The doctor asked the patient to take diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received does not contain any significant information. Reporter's address updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Nausea, SARS-CoV-2 test negative
Clinical narrative: she had no taste or smell; she had no taste or smell; tiny bit of nausea; little bit tired still; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell), NAUSEA (tiny bit of nausea) and FATIGUE (little bit tired still) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell), NAUSEA (tiny bit of nausea) and FATIGUE (little bit tired still). On 06-Feb-2021, NAUSEA (tiny bit of nausea) outcome was unknown. At the time of the report, AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell) and FATIGUE (little bit tired still) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test negative: negative negative and negative negative. On 03-Feb-2021, SARS-CoV-2 test positive: positive positive.     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 specific concomitant medications given for high blood pressure.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she had no taste or smell; she had no taste or smell; tiny bit of nausea; little bit tired still; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell), NAUSEA (tiny bit of nausea) and FATIGUE (little bit tired still) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell), NAUSEA (tiny bit of nausea) and FATIGUE (little bit tired still). On 06-Feb-2021, NAUSEA (tiny bit of nausea) outcome was unknown. At the time of the report, AGEUSIA (she had no taste or smell), ANOSMIA (she had no taste or smell) and FATIGUE (little bit tired still) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test negative: negative negative and negative negative. On 03-Feb-2021, SARS-CoV-2 test positive: positive positive.     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 specific concomitant medications given for high blood pressure.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: itchy; rash on chest and back; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), VACCINATION SITE PAIN (soreness at the injection site) and RASH (rash on chest and back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRURITUS (itchy), VACCINATION SITE PAIN (soreness at the injection site) and RASH (rash on chest and back). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and RASH (rash on chest and back) outcome was unknown and VACCINATION SITE PAIN (soreness at the injection site) had resolved.             No concomitant medication provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information was received on 14-May-2021, The outcome of the event was updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Confusional state, Dizziness, Lethargy
Clinical narrative: confused; couldn't talk well; dizzy; lethargic; fever of 103.4 F; This spontaneous case was reported by a nurse and describes the occurrence of CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Hypertension.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103.4 f (High) 103.4 F.     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) in response to the event was not applicable.  No relevant concomitant medications reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: confused; couldn't talk well; dizzy; lethargic; fever of 103.4 F; This spontaneous case was reported by a nurse and describes the occurrence of CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Hypertension.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103.4 f (High) 103.4 F.     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) in response to the event was not applicable.  No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: leak from the syringe; leak from the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported. ).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe). On 31-Mar-2021, UNDERDOSE (leak from the syringe) and DEVICE CONNECTION ISSUE (leak from the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Ear pain, Eye pruritus, Fatigue, Limb discomfort
Clinical narrative: left breast pain; sore throat; sore ear; itchiness in ear; itchiness in throat; eyes are watery and itchy; lymph nodes under her arm pit was swollen and painful; fatigue; arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm was hurting), BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear) and PRURITUS (itchiness in ear) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced LIMB DISCOMFORT (arm was hurting). On 22-Mar-2021, the patient experienced BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear), PRURITUS (itchiness in ear), THROAT IRRITATION (itchiness in throat), EYE PRURITUS (eyes are watery and itchy), LYMPHADENOPATHY (lymph nodes under her arm pit was swollen and painful) and FATIGUE (fatigue). At the time of the report, LIMB DISCOMFORT (arm was hurting), BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear), PRURITUS (itchiness in ear), THROAT IRRITATION (itchiness in throat), EYE PRURITUS (eyes are watery and itchy), LYMPHADENOPATHY (lymph nodes under her arm pit was swollen and painful) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. Treatment was not reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pruritus, Throat irritation
Clinical narrative: left breast pain; sore throat; sore ear; itchiness in ear; itchiness in throat; eyes are watery and itchy; lymph nodes under her arm pit was swollen and painful; fatigue; arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm was hurting), BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear) and PRURITUS (itchiness in ear) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced LIMB DISCOMFORT (arm was hurting). On 22-Mar-2021, the patient experienced BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear), PRURITUS (itchiness in ear), THROAT IRRITATION (itchiness in throat), EYE PRURITUS (eyes are watery and itchy), LYMPHADENOPATHY (lymph nodes under her arm pit was swollen and painful) and FATIGUE (fatigue). At the time of the report, LIMB DISCOMFORT (arm was hurting), BREAST PAIN (left breast pain), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (sore ear), PRURITUS (itchiness in ear), THROAT IRRITATION (itchiness in throat), EYE PRURITUS (eyes are watery and itchy), LYMPHADENOPATHY (lymph nodes under her arm pit was swollen and painful) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported. Treatment was not reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Hand and foot was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand and foot was swollen) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Hand and foot was swollen). At the time of the report, PERIPHERAL SWELLING (Hand and foot was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took unspecified concomitant medications.  No treatment medications were taken by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-JUN-2021 contains non-significant information: Contact information updated. On 06-Aug-2021: Follow up information included no new event outcome and the re-challenge for the suspect vaccine were updated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Sweaty; hot; Fever; Headache; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering). On 01-Apr-2021, HYPERHIDROSIS (Sweaty), FEELING HOT (hot), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Shivering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm is hot; swollen arm; arm is red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Pyrexia
Clinical narrative: woke up with a fast heart beat; fever; head ache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (woke up with a fast heart beat), PYREXIA (fever) and HEADACHE (head ache) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (head ache). On 02-Apr-2021, the patient experienced HEART RATE INCREASED (woke up with a fast heart beat). On 31-Mar-2021, PYREXIA (fever) and HEADACHE (head ache) had resolved. At the time of the report, HEART RATE INCREASED (woke up with a fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: excessive pain in the area; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (excessive pain in the area) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (excessive pain in the area). At the time of the report, VACCINATION SITE PAIN (excessive pain in the area) outcome was unknown. Not Provided      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 concomitants were reported. No treatment was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (soreness) and FATIGUE (Fatigue). At the time of the report, PAIN (soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination complication
Clinical narrative: swell; Sore arm; hard like ball; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball) 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 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball). At the time of the report, SWELLING (swell), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (hard like ball) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: FU attempt made, NNI, reporter declined to give email and disconnected the call
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy arm). At the time of the report, PAIN IN EXTREMITY (achy arm) had resolved.            Concomitant product included high blood pressure medication. Treatment information included Tylenol.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling hot, Induration, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Arnpit was warm; hard; felt like shooting pain; Lymph node swelling; swelling under her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm), INDURATION (hard), AXILLARY PAIN (felt like shooting pain) and LYMPHADENOPATHY (Lymph node swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Dry cough on 14-Dec-2020, Fatigue on 14-Dec-2020, Exhaustion on 14-Dec-2020 and COVID-19 on 14-Dec-2020. Concurrent medical conditions included Loss of taste since 14-Dec-2020, Loss of smell since 14-Dec-2020, Migraine, Anxiety, Sleep disorder and GERD. Concomitant products included ALPRAZOLAM (XANAX) from 10-Oct-2005 to an unknown date for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for GERD, VERAPAMIL from 05-Oct-1999 to an unknown date for Migraine, TRAZODONE for Sleep disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (swelling under her left armpit). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling). On an unknown date, the patient experienced FEELING HOT (Arnpit was warm), INDURATION (hard) and AXILLARY PAIN (felt like shooting pain). On 08-Apr-2021, LYMPHADENOPATHY (Lymph node swelling) had resolved. At the time of the report, SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm) and INDURATION (hard) outcome was unknown and AXILLARY PAIN (felt like shooting pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported.   This case was linked to MOD-2021-152264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Updated Lab data, Relevant history, Concomitant medication, Action taken change from unknown to Not applicable as 2nd dose information updated, Swollen lymph nodes event added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Arnpit was warm; hard; felt like shooting pain; Lymph node swelling; swelling under her left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm), INDURATION (hard), AXILLARY PAIN (felt like shooting pain) and LYMPHADENOPATHY (Lymph node swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Dry cough on 14-Dec-2020, Fatigue on 14-Dec-2020, Exhaustion on 14-Dec-2020 and COVID-19 on 14-Dec-2020. Concurrent medical conditions included Loss of taste since 14-Dec-2020, Loss of smell since 14-Dec-2020, Migraine, Anxiety, Sleep disorder and GERD. Concomitant products included ALPRAZOLAM (XANAX) from 10-Oct-2005 to an unknown date for Anxiety, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for GERD, VERAPAMIL from 05-Oct-1999 to an unknown date for Migraine, TRAZODONE for Sleep disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (swelling under her left armpit). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling). On an unknown date, the patient experienced FEELING HOT (Arnpit was warm), INDURATION (hard) and AXILLARY PAIN (felt like shooting pain). On 08-Apr-2021, LYMPHADENOPATHY (Lymph node swelling) had resolved. At the time of the report, SWELLING (swelling under her left armpit), FEELING HOT (Arnpit was warm) and INDURATION (hard) outcome was unknown and AXILLARY PAIN (felt like shooting pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported.   This case was linked to MOD-2021-152264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Updated Lab data, Relevant history, Concomitant medication, Action taken change from unknown to Not applicable as 2nd dose information updated, Swollen lymph nodes event added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Sleep disorder
Clinical narrative: Can't sleep due to itching; Very itchy rash; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching). At the time of the report, RASH (Full body rash), RASH PRURITIC (very itchy rash) and SLEEP DISORDER (can't sleep due to itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included antihistamine and an ointment.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021 contains updated reporter information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Exposure via breast milk, Headache, Malaise
Clinical narrative: Rash all over the body that lasted for a month; having diarrhea, 8 times already; feels really sick.; is breastfeeding; Vomiting; headache; Chills; pain in the arm; body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.) and EXPOSURE VIA BREAST MILK (is breastfeeding) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), HEADACHE (headache) and CHILLS (Chills). On 01-Apr-2021, the patient experienced DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding) and VOMITING (Vomiting). On an unknown date, the patient experienced RASH (Rash all over the body that lasted for a month). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding), VOMITING (Vomiting), HEADACHE (headache), CHILLS (Chills) and RASH (Rash all over the body that lasted for a month) outcome was unknown.            Concomitant product use was not provided by the reporter. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Vomiting
Clinical narrative: Rash all over the body that lasted for a month; having diarrhea, 8 times already; feels really sick.; is breastfeeding; Vomiting; headache; Chills; pain in the arm; body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.) and EXPOSURE VIA BREAST MILK (is breastfeeding) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), HEADACHE (headache) and CHILLS (Chills). On 01-Apr-2021, the patient experienced DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding) and VOMITING (Vomiting). On an unknown date, the patient experienced RASH (Rash all over the body that lasted for a month). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding), VOMITING (Vomiting), HEADACHE (headache), CHILLS (Chills) and RASH (Rash all over the body that lasted for a month) outcome was unknown.            Concomitant product use was not provided by the reporter. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.