chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: burning pain on thigh; Burning pain on left side of the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body). The patient was treated with ENOXOLONE, GLYCOL SALICYLATE, LEVOMENTHOL, TOCOPHERYL ACETATE (SALONPAS 30) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (burning pain on thigh) and PAIN (Burning pain on left side of the body) outcome was unknown.            No Concomitant medications was reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash morbilliform
Clinical narrative: Looks like measles; Very very bad rash; Sore arm; A spontaneous report (United States) was received from a consumer concerning, a 59-year-old female patient, who received Moderna (mRNA-1273) vaccine and experienced a very severe rash on torso of body (rash) that looks like measles/rash (rash morbilliform) and sore arm (pain in extremity).  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 8 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 8 Mar 2021, the patient experienced soreness of arm.  On 10 Mar 2021, the patient had a very severe rash on torso of body. Rash has spread under their arms and coming down the arms and coming into patient's neck area. It was reported that the rashes on the patient's body looks like measles. The event, looks like Measles considered as Medically significant. Treatment information provided included Benadryl.  Action taken with mRNA-1273 in response to the event(s) was not applicable.  On an unknown date, the outcome of the event, sore arm was considered resolving.  On an unknown date, the outcome of the event, experienced a very severe rash on torso of body that looks like measles were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Swollen gland in axillary area of arm of injection; Tenderness under arm of injection/Area of injection is sore; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen gland in axillary area of arm of injection) and VACCINATION SITE PAIN (Tenderness under arm of injection/Area of injection is sore) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen gland in axillary area of arm of injection) and VACCINATION SITE PAIN (Tenderness under arm of injection/Area of injection is sore). At the time of the report, LYMPHADENOPATHY (Swollen gland in axillary area of arm of injection) and VACCINATION SITE PAIN (Tenderness under arm of injection/Area of injection is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient not taking any treatment medication.  It was reported that on 16-Mar-2021, the Symptoms were persisted
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Feeling abnormal, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Couldn't do anything and it was really weird; Vaccine had "knocked him out; Couldn't stand up and couldn't get out of his chair; Sore spot; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Couldn't stand up and couldn't get out of his chair), FEELING ABNORMAL (Couldn't do anything and it was really weird), VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out) and VACCINATION SITE PAIN (Sore spot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.   Previously administered products included for Product used for unknown indication: Flu, Pneumonia and Shingles. Concurrent medical conditions included Multiple sclerosis (He had a lift chair to help him get up. He went in every 6 weeks for an infusion for his multiple sclerosis.), Blood pressure high and High cholesterol.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore spot). On 14-Mar-2021, the patient experienced DYSSTASIA (Couldn't stand up and couldn't get out of his chair). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Couldn't do anything and it was really weird) and VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out). On 15-Mar-2021, DYSSTASIA (Couldn't stand up and couldn't get out of his chair) had resolved. On 16-Mar-2021, FEELING ABNORMAL (Couldn't do anything and it was really weird), VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out) and VACCINATION SITE PAIN (Sore spot) had resolved.   Relevant concomitant medications included medications for multiple sclerosis, high blood pressure and high cholesterol. The patient went in every 6 weeks for an infusion for his Multiple Sclerosis.  No treatment information was provided.   This case was linked to MOD-2021-219961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information contain information regarding start and stop date of event could not stand up and could not get out of his chair.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blister of one inch on right leg; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister of one inch on right leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A34A2) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-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 07-Mar-2021, the patient experienced BLISTER (Blister of one inch on right leg). The patient was treated with Surgery (Blister was Drained) for Blister. At the time of the report, BLISTER (Blister of one inch on right leg) was resolving.            No concomitant medications were provided by the reporter.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient received first dose of the Moderna Vaccine; A spontaneous report was received from a nurse concerning a 17-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in the left dominant arm for prophylaxis of COVID-19 infection.   On 11-Feb-2021, the 17-year-old patient received first dose of the Moderna Vaccine (product administered to patient of inappropriate age). The pharmacy refused to give the second dose because the patient was under 18 years old.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of 17-year-old patient received first dose of the Moderna Vaccine was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Lacrimation increased, Vitreous floaters
Clinical narrative: left eye watering or "tear"ing; black spots in left eye or "floaters"; anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LACRIMATION INCREASED (left eye watering or "tear"ing), VITREOUS FLOATERS (black spots in left eye or "floaters") and ANXIETY (anxiety) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract operation on 16-Feb-2021. Concomitant products included BUSPIRONE, CARVEDILOL, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), CLONAZEPAM (KLONOPIN), MIRTAZAPINE, PREDNISOLONE, LATANOPROST, LOSARTAN POTASSIUM, ACETYLSALICYLIC ACID (ASPIRIN 81), EZETIMIBE and ROSUVASTATIN CALCIUM for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LACRIMATION INCREASED (left eye watering or "tear"ing), VITREOUS FLOATERS (black spots in left eye or "floaters") and ANXIETY (anxiety). At the time of the report, LACRIMATION INCREASED (left eye watering or "tear"ing), VITREOUS FLOATERS (black spots in left eye or "floaters") and ANXIETY (anxiety) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-055490 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Limb discomfort, Paraesthesia, Vaccination site pain
Clinical narrative: arm feels funny some of the time; fatigue; pain at injection site; numbness and tingling in her left arm and left hand; numbness and tingling in her left arm and left hand; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tingling in her left arm and left hand), PARAESTHESIA (numbness and tingling in her left arm and left hand), LIMB DISCOMFORT (arm feels funny some of the time), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in her left arm and left hand), PARAESTHESIA (numbness and tingling in her left arm and left hand), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (arm feels funny some of the time). On 04-Mar-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, HYPOAESTHESIA (numbness and tingling in her left arm and left hand), PARAESTHESIA (numbness and tingling in her left arm and left hand) and LIMB DISCOMFORT (arm feels funny some of the time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Added reporter phone number, email address and added new event Limb discomfort
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: fatigue; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) in a male 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills). Not Provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Echocardiogram, Erythema, Feeling abnormal, Myalgia
Clinical narrative: Pink at injection site; Pain in back; Not feeling good; Whole body hurting; Pain in muscles; Right arm hurting, swollen; Right arm red, itchy; Right arm hurting, swollen; Right arm red, itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), VACCINATION SITE DISCOLOURATION (Pink at injection site), ERYTHEMA (Right arm red, itchy) and PAIN IN EXTREMITY (Right arm hurting, swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A2A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2011, the patient experienced ERYTHEMA (Right arm red, itchy) and PERIPHERAL SWELLING (Right arm hurting, swollen). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurting, swollen) and PRURITUS (Right arm red, itchy). On 11-Mar-2021, the patient experienced BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), PAIN (Whole body hurting) and MYALGIA (Pain in muscles). On 16-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), VACCINATION SITE DISCOLOURATION (Pink at injection site), ERYTHEMA (Right arm red, itchy), PAIN IN EXTREMITY (Right arm hurting, swollen), PERIPHERAL SWELLING (Right arm hurting, swollen), PRURITUS (Right arm red, itchy), PAIN (Whole body hurting) and MYALGIA (Pain in muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: other (normal) other.          No Concomitant medications was reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site discolouration
Clinical narrative: Pink at injection site; Pain in back; Not feeling good; Whole body hurting; Pain in muscles; Right arm hurting, swollen; Right arm red, itchy; Right arm hurting, swollen; Right arm red, itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), VACCINATION SITE DISCOLOURATION (Pink at injection site), ERYTHEMA (Right arm red, itchy) and PAIN IN EXTREMITY (Right arm hurting, swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A2A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2011, the patient experienced ERYTHEMA (Right arm red, itchy) and PERIPHERAL SWELLING (Right arm hurting, swollen). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurting, swollen) and PRURITUS (Right arm red, itchy). On 11-Mar-2021, the patient experienced BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), PAIN (Whole body hurting) and MYALGIA (Pain in muscles). On 16-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in back), FEELING ABNORMAL (Not feeling good), VACCINATION SITE DISCOLOURATION (Pink at injection site), ERYTHEMA (Right arm red, itchy), PAIN IN EXTREMITY (Right arm hurting, swollen), PERIPHERAL SWELLING (Right arm hurting, swollen), PRURITUS (Right arm red, itchy), PAIN (Whole body hurting) and MYALGIA (Pain in muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: other (normal) other.          No Concomitant medications was reported
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; sweaty; clammy; vomiting; bodyaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting) and MYALGIA (bodyaches) in an 86-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-215671 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: flu like symptoms; sweaty; clammy; vomiting; bodyaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting) and MYALGIA (bodyaches) in an 86-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VOMITING (vomiting), MYALGIA (bodyaches) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-215671 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depression, Fatigue, Pain in extremity, Vaccination complication
Clinical narrative: depression (lasted a long while); left arm felt sore again at the injection site/ left arm pain came back; fatigue; "great pain" in the left arm/ pain in her left leg; bad reaction; weakness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), DEPRESSION (depression (lasted a long while)), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg) and VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury. Concurrent medical conditions included Osteoporosis, Asthma (mild (slight cough)) and Allergy (allergic to preservatives like in sweets that causes sneezing and runny nose.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg) and FATIGUE (fatigue). On an unknown date, the patient experienced DEPRESSION (depression (lasted a long while)) and VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back). At the time of the report, VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg), VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back) and FATIGUE (fatigue) outcome was unknown and DEPRESSION (depression (lasted a long while)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on unspecified concomitant medications. On an unspecified date patient experienced pain in her left leg that she never experienced before. The outcome for pain in her left leg was unknown. No treatment information was provided.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: depression (lasted a long while); left arm felt sore again at the injection site/ left arm pain came back; fatigue; "great pain" in the left arm/ pain in her left leg; bad reaction; weakness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), DEPRESSION (depression (lasted a long while)), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg) and VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury. Concurrent medical conditions included Osteoporosis, Asthma (mild (slight cough)) and Allergy (allergic to preservatives like in sweets that causes sneezing and runny nose.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg) and FATIGUE (fatigue). On an unknown date, the patient experienced DEPRESSION (depression (lasted a long while)) and VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back). At the time of the report, VACCINATION COMPLICATION (bad reaction), ASTHENIA (weakness), PAIN IN EXTREMITY ("great pain" in the left arm/ pain in her left leg), VACCINATION SITE PAIN (left arm felt sore again at the injection site/ left arm pain came back) and FATIGUE (fatigue) outcome was unknown and DEPRESSION (depression (lasted a long while)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on unspecified concomitant medications. On an unspecified date patient experienced pain in her left leg that she never experienced before. The outcome for pain in her left leg was unknown. No treatment information was provided.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: she had a red patch, it swollen with a knots and warm to touch; she had a red patch, it swollen with a knots and warm to touch; Itching at injection site; arm was sore/ it was also hurting at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (she had a red patch, it swollen with a knots and warm to touch), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (arm was sore/ it was also hurting at injection site) and VACCINATION SITE ERYTHEMA (she had a red patch, it swollen with a knots and warm to touch) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included CEPHALEXIN [CEFALEXIN] for an unknown indication.    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 VACCINATION SITE PAIN (arm was sore/ it was also hurting at injection site). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (she had a red patch, it swollen with a knots and warm to touch) and VACCINATION SITE ERYTHEMA (she had a red patch, it swollen with a knots and warm to touch). At the time of the report, VACCINATION SITE WARMTH (she had a red patch, it swollen with a knots and warm to touch), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (she had a red patch, it swollen with a knots and warm to touch) outcome was unknown and VACCINATION SITE PAIN (arm was sore/ it was also hurting at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pruritus
Clinical narrative: itching at site of injection; tierdness; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at site of injection), FATIGUE (tierdness) and PYREXIA (fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at site of injection) and FATIGUE (tierdness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (itching at site of injection), FATIGUE (tierdness) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 98.7 (High) 98.7 Fahrenheit. On 15-Mar-2021, Body temperature: 99.0 (High) 99.0 Fahrenheit. On 16-Mar-2021, Body temperature: 99.9 (High) 99.9 Fahrenheit.         No relevant concomitant medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: cough; sore throat; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), OROPHARYNGEAL PAIN (sore throat), FATIGUE (Fatigue) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o26a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced COUGH (cough) and OROPHARYNGEAL PAIN (sore throat). On 14-Mar-2021, PYREXIA (Fever) had resolved. On 16-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, COUGH (cough) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified high blood pressure medications. The patient had a sleep as treatment.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Letahrgy; tested positive for Covid-19; felt fever; achy whole day; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), LETHARGY (Letahrgy), PYREXIA (felt fever), PAIN (achy whole day) and FATIGUE (very tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (felt fever). On 14-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On 15-Mar-2021, the patient experienced LETHARGY (Letahrgy). In March 2021, the patient experienced PAIN (achy whole day) and FATIGUE (very tired). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), LETHARGY (Letahrgy), PYREXIA (felt fever), PAIN (achy whole day) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on unspecified concomitant medications.  Treatment medications were not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received and outcome was updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Letahrgy; tested positive for Covid-19; felt fever; achy whole day; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), LETHARGY (Letahrgy), PYREXIA (felt fever), PAIN (achy whole day) and FATIGUE (very tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (felt fever). On 14-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On 15-Mar-2021, the patient experienced LETHARGY (Letahrgy). In March 2021, the patient experienced PAIN (achy whole day) and FATIGUE (very tired). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), LETHARGY (Letahrgy), PYREXIA (felt fever), PAIN (achy whole day) and FATIGUE (very tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on unspecified concomitant medications.  Treatment medications were not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received and outcome was updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 021b21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-116630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received captured reporter contact details, product information and outcome.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Migraine
Clinical narrative: sleeping a lot - slept the whole week day and night for the first week; slight migraine a couple of days ago/migraines; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot - slept the whole week day and night for the first week) and MIGRAINE (slight migraine a couple of days ago/migraines) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy. Previously administered products included for Migraine: Imitrex. Concurrent medical conditions included Migraine.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleeping a lot - slept the whole week day and night for the first week) and MIGRAINE (slight migraine a couple of days ago/migraines). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX [SUMATRIPTAN SUCCINATE]) for Migraine, at a dose of UNK dosage form and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Migraine, at a dose of UNK dosage form. On 12-Mar-2021, MIGRAINE (slight migraine a couple of days ago/migraines) had resolved. At the time of the report, HYPERSOMNIA (sleeping a lot - slept the whole week day and night for the first week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache
Clinical narrative: some lower back pain that traveled down to her feet/ felt like when someone has sciatica pain; slight headache; felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), BACK PAIN (some lower back pain that traveled down to her feet/ felt like when someone has sciatica pain) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (felt dizzy) and HEADACHE (slight headache). On 13-Mar-2021, the patient experienced BACK PAIN (some lower back pain that traveled down to her feet/ felt like when someone has sciatica pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (felt dizzy), BACK PAIN (some lower back pain that traveled down to her feet/ felt like when someone has sciatica pain) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Influenza like illness, Vaccination site induration, Vaccination site pain
Clinical narrative: felt very mild flu like symptoms; unfocused; injection site was a little hard to touch but it did not hurt; tired; little sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore). At the time of the report, INFLUENZA LIKE ILLNESS (felt very mild flu like symptoms), DISTURBANCE IN ATTENTION (unfocused), VACCINATION SITE INDURATION (injection site was a little hard to touch but it did not hurt), FATIGUE (tired) and VACCINATION SITE PAIN (little sore) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Taste disorder
Clinical narrative: Little Cough; Burping taste of eggs; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Burping taste of eggs) and COUGH (Little Cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TASTE DISORDER (Burping taste of eggs). On 11-Mar-2021, the patient experienced COUGH (Little Cough). On 28-Feb-2021, TASTE DISORDER (Burping taste of eggs) had resolved. At the time of the report, COUGH (Little Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Intercepted product administration error, Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Symptoms were from delivery of the vaccine and not the vaccine; is solid red, it's a dark red; severe arm pain/It hurst so much/it does not look good; swollen; arm started hurting/hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine), PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good), PERIPHERAL SWELLING (swollen), VACCINATION SITE PAIN (arm started hurting/hurt a little bit) and VACCINATION SITE ERYTHEMA (is solid red, it's a dark red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-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. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm started hurting/hurt a little bit). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good) and PERIPHERAL SWELLING (swollen). On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (is solid red, it's a dark red). On an unknown date, the patient experienced INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INTERCEPTED PRODUCT ADMINISTRATION ERROR (Symptoms were from delivery of the vaccine and not the vaccine), PAIN IN EXTREMITY (severe arm pain/It hurst so much/it does not look good), PERIPHERAL SWELLING (swollen), VACCINATION SITE PAIN (arm started hurting/hurt a little bit) and VACCINATION SITE ERYTHEMA (is solid red, it's a dark red) outcome was unknown.            Concomitant drugs including betablockers used for unknown indication    other treatment include hot and cold compresses on it (it bring the swelling down, it has gone but it's still red)     Consent for safety follow up with HCP denied.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received on 25-may-2021,New AE Added On 25-May-2021: Non-significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction, Presyncope
Clinical narrative: vasovagal response; potential atypical reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction). At the time of the report, PRESYNCOPE (vasovagal response) and NONSPECIFIC REACTION (potential atypical reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye swelling, Feeling hot, Food refusal, Malaise
Clinical narrative: left eye swollen; urinary tract infection; felt sick; hives mostly on right arm; fever; didn't eat; felt weak; body felt hot; itch all over, under feet, head, but mostly on right arm; her arm was a little sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), PRURITUS (itch all over, under feet, head, but mostly on right arm) and EYE SWELLING (left eye swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, AMLODIPINE, LOSARTAN POTASSIUM (LOSARTIN), METFORMIN, CINNAMON [CINNAMOMUM VERUM], CALCIUM, VITAMIN C [ASCORBIC ACID], BIOTIN, ACETYLSALICYLIC ACID (ASPRIN), APPLE CIDER VINEGAR and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (her arm was a little sore). On 04-Mar-2021, the patient experienced FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), PRURITUS (itch all over, under feet, head, but mostly on right arm), MALAISE (felt sick), URTICARIA (hives mostly on right arm) and PYREXIA (fever). On 06-Mar-2021, the patient experienced EYE SWELLING (left eye swollen) and URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) for Urinary tract infection, at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urinary tract infection, at a dose of UNK dosage form; PREDNISONE for Urinary tract infection, at a dose of UNK dosage form; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) on 05-Mar-2021 for Itching, at a dose of UNK dosage form and LEVOCETIRIZINE on 15-Mar-2021 for Itching, at a dose of UNK dosage form. On 07-Mar-2021, FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), EYE SWELLING (left eye swollen), MALAISE (felt sick), PYREXIA (fever) and VACCINATION SITE PAIN (her arm was a little sore) had resolved. On 15-Mar-2021, URINARY TRACT INFECTION (urinary tract infection) had resolved. On 16-Mar-2021, PRURITUS (itch all over, under feet, head, but mostly on right arm) had resolved. At the time of the report, URTICARIA (hives mostly on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.