chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site itching/rash at the injection site with itching; injection site bumps; soreness in her armpit on the left side/tenderness in her armpit on the left side; injection site redness; injection site with itching; injection site became immediately sore/tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching) and VACCINATION SITE PAIN (injection site became immediately sore/tenderness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site became immediately sore/tenderness). On 17-Mar-2021, the patient experienced VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site with itching). On an unknown date, the patient experienced VACCINATION SITE RASH (injection site itching/rash at the injection site with itching). At the time of the report, VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching), VACCINATION SITE PAIN (injection site became immediately sore/tenderness) and VACCINATION SITE PRURITUS (injection site with itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided. No treatment drugs were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: injection site itching/rash at the injection site with itching; injection site bumps; soreness in her armpit on the left side/tenderness in her armpit on the left side; injection site redness; injection site with itching; injection site became immediately sore/tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching) and VACCINATION SITE PAIN (injection site became immediately sore/tenderness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site became immediately sore/tenderness). On 17-Mar-2021, the patient experienced VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site with itching). On an unknown date, the patient experienced VACCINATION SITE RASH (injection site itching/rash at the injection site with itching). At the time of the report, VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching), VACCINATION SITE PAIN (injection site became immediately sore/tenderness) and VACCINATION SITE PRURITUS (injection site with itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided. No treatment drugs were provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Anorectal discomfort, Blood glucose increased, Constipation, Frequent bowel movements
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go). At the time of the report, CONSTIPATION (A sense of constipation), ANORECTAL DISCOMFORT (Burning feeling in the lower rectum, fire burning feeling), BLOOD GLUCOSE INCREASED (blood sugar is a bit higher) and FREQUENT BOWEL MOVEMENTS (The feeling of always needing to go) 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.   Patient had side effect of constipation. He asks if there is any recommendation Patient received the first dose on 16MAR2021 and does not have his vaccination card as it is in a locker at work. He has not gone to work due to the feeling of always needing to go.   It was reported that Patient took a natural vitality anti-stress mix which is vegan verified and restores Magnesium called Calm. Since vaccination, Patient had a sense of constipation, burning feeling in the lower rectum, fire burning feeling, which has gone on 3 days or so. He goes a little each time. Patient has taken 8 oz of prune juice so far. Patient is prediabetic and after eating papaya just now, his blood sugar is a bit higher.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: Sweaty; Hot; Tired; Sore arm; Fever that peaked on 101 F; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), CHILLS (Chills) and PYREXIA (Fever that peaked on 101 F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SIMVASTATIN, CALCIUM, FISH OIL, CICLOSPORIN (RESTASIS) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache). On 17-Mar-2021, the patient experienced FATIGUE (Tired). On 18-Mar-2021, the patient experienced HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Mar-2021, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache) had resolved. On 17-Mar-2021, FATIGUE (Tired) had resolved. On 18-Mar-2021, HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101f (High) 101 F.         Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-051515 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Sweaty; Hot; Tired; Sore arm; Fever that peaked on 101 F; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), CHILLS (Chills) and PYREXIA (Fever that peaked on 101 F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SIMVASTATIN, CALCIUM, FISH OIL, CICLOSPORIN (RESTASIS) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache). On 17-Mar-2021, the patient experienced FATIGUE (Tired). On 18-Mar-2021, the patient experienced HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Mar-2021, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache) had resolved. On 17-Mar-2021, FATIGUE (Tired) had resolved. On 18-Mar-2021, HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101f (High) 101 F.         Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-051515 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node pain; Lymph nodes enlarged; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Mar-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged). At the time of the report, LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (Lymph nodes enlarged) had resolved.            No concomitant medications were reported.  No treatment information was provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Outcome of the event and reporter's contact details updated
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling on left side of body after 1st dose; swollen gland; Foggy after 1st dose; Leg swelling after 1st dos; Dizziness / Ligtheaded; Fatigued after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos) and DIZZINESS (Dizziness / Ligtheaded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a2la) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-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 SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos), DIZZINESS (Dizziness / Ligtheaded) and FATIGUE (Fatigued after 1st dose). At the time of the report, SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos), DIZZINESS (Dizziness / Ligtheaded) and FATIGUE (Fatigued after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant medical history was provided. No treatment details provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on left side of body after 1st dose; swollen gland; Foggy after 1st dose; Leg swelling after 1st dos; Dizziness / Ligtheaded; Fatigued after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos) and DIZZINESS (Dizziness / Ligtheaded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a2la) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-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 SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos), DIZZINESS (Dizziness / Ligtheaded) and FATIGUE (Fatigued after 1st dose). At the time of the report, SWELLING (Swelling on left side of body after 1st dose), LYMPHADENOPATHY (swollen gland), FEELING ABNORMAL (Foggy after 1st dose), PERIPHERAL SWELLING (Leg swelling after 1st dos), DIZZINESS (Dizziness / Ligtheaded) and FATIGUE (Fatigued after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant medical history was provided. No treatment details provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Palpitations, Vaccination site paraesthesia
Clinical narrative: electrical tingling feeling in the arm; dizziness; severe heart palpitations; fatigue; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and VALSARTAN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache). At the time of the report, VACCINATION SITE PARAESTHESIA (electrical tingling feeling in the arm), DIZZINESS (dizziness), PALPITATIONS (severe heart palpitations), FATIGUE (fatigue) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant treatment information provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gastrointestinal disorder, Influenza like illness, Myalgia
Clinical narrative: Flu Like Symptoms; GI Symptoms; Body Ache; Joint pain; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (Flu Like Symptoms), GASTROINTESTINAL DISORDER (GI Symptoms), MYALGIA (Body Ache) and ARTHRALGIA (Joint pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Route of administration was reported as Deltoid Muscle (Unknown Arm).  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: huge bruise in his left arm; bruise is painful; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (huge bruise in his left arm) and PAIN (bruise is painful) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced CONTUSION (huge bruise in his left arm) and PAIN (bruise is painful). On 07-May-2021, CONTUSION (huge bruise in his left arm) had resolved. At the time of the report, PAIN (bruise is painful) had not resolved. 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.   Treatment medications were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-112593 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received included outcome of event changed from not recovered to recovered for events bruise, but for the event pain was not changed; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-112593:Second dose case
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Genital herpes, Orchitis, Swelling
Clinical narrative: Herpes flare; Infammation of groin area; Testicle swollen to orange size; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 40A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Genital herpes. Concomitant products included ACYCLOVIR [ACICLOVIR] for Genital herpes.   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 an unknown date, the patient experienced GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size). At the time of the report, GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Diuretics and Heart medications. No treatment information was provided.   This case was linked to MOD-2021-046431 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: lightheadedness; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) and ASTHENIA (felt weak) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (lightheadedness) and ASTHENIA (felt weak). At the time of the report, DIZZINESS (lightheadedness) and ASTHENIA (felt weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore all over the body) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (Sore all over the body). At the time of the report, MYALGIA (Sore all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose.; A spontaneous report was received from a Pharmacist concerning, a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced event The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose. / Inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant medication includes antibodies and steroid.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, patient was due for the 2nd dose of the Moderna COVID 19 vaccine today started a medication therapy of antibodies and anti-steroid yesterday. The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was Unknown.   The outcome of the event The doctor told the patient to wait for 4 weeks after the therapy before getting the 2nd dose was resolved on an unknown date, at the time of this report.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Decreased appetite, Headache
Clinical narrative: leg aches; chest vibrates; chills; body aches; left knee ached unbelievable; headache; five hours after the shot, couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in 2010.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DECREASED APPETITE (five hours after the shot, couldn't eat) and HEADACHE (headache). On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable). At the time of the report, DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information included Acetaminophen every 6 hours around the clock.   This case was linked to MOD21-058251, US-MODERNATX, INC.-MOD-2021-051962 (E2B Linked Report).; Sender's Comments:  MOD21-058251:Husband case US-MODERNATX, INC.-MOD-2021-051962:wife case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: leg aches; chest vibrates; chills; body aches; left knee ached unbelievable; headache; five hours after the shot, couldn't eat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in 2010.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DECREASED APPETITE (five hours after the shot, couldn't eat) and HEADACHE (headache). On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable). At the time of the report, DECREASED APPETITE (five hours after the shot, couldn't eat), PAIN IN EXTREMITY (leg aches), CHEST DISCOMFORT (chest vibrates), HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (left knee ached unbelievable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information included Acetaminophen every 6 hours around the clock.   This case was linked to MOD21-058251, US-MODERNATX, INC.-MOD-2021-051962 (E2B Linked Report).; Sender's Comments:  MOD21-058251:Husband case US-MODERNATX, INC.-MOD-2021-051962:wife case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Nausea
Clinical narrative: Backache; Headache; Chills; Fever over 100F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CODEINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high units: F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up contains non-significant information (city and state updated).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Backache; Headache; Chills; Fever over 100F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CODEINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (THERAFLU ALERGIA) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Backache), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever over 100F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high units: F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up contains non-significant information (city and state updated).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Myalgia, Nasopharyngitis
Clinical narrative: cold; no energy at all; chills; fever of 99 degrees Celsius; achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID], ZINC, PROBIOTICS NOS, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTECNO), METOPROLOL SUCCINATE (TOPROL), PRAVASTATIN SODIUM (PRAVASTINE), CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN LOW), CLOPIDOGREL BISULFATE (PLAVIX) and LANSOPRAZOLE (PREVACID) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99 (High) 99 degree F.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-051556 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: cold; no energy at all; chills; fever of 99 degrees Celsius; achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID], ZINC, PROBIOTICS NOS, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTECNO), METOPROLOL SUCCINATE (TOPROL), PRAVASTATIN SODIUM (PRAVASTINE), CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN LOW), CLOPIDOGREL BISULFATE (PLAVIX) and LANSOPRAZOLE (PREVACID) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), ASTHENIA (no energy at all), CHILLS (chills), PYREXIA (fever of 99 degrees Celsius) and MYALGIA (achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99 (High) 99 degree F.         Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-051556 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Injected an expired dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Injected an expired dose of the vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Injected an expired dose of the vaccine). On 20-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Injected an expired dose of the vaccine) 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.   This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 045A21A)  with no associated AEs.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 045A21A)  with no associated AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Fatigue, Headache, Injection
Clinical narrative: Constipation; headache; really tired; injection into the leg; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), HEADACHE (headache), FATIGUE (really tired) and INJECTION (injection into the leg) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Immune disorder (NOS) (immune disease) and Irradiation cystitis (chest irradiation).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation), HEADACHE (headache), FATIGUE (really tired) and INJECTION (injection into the leg). At the time of the report, CONSTIPATION (Constipation), HEADACHE (headache), FATIGUE (really tired) and INJECTION (injection into the leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history stated Implantable Cardiac Device No concomitant medications provided. No treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Malaise, Pain in extremity, Somnolence
Clinical narrative: was sleepy; around noon pain in chest, goes away and then starts again, hurts me a lot; experienced arm sore and a lot of pain; was not feeling very well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced arm sore and a lot of pain), MALAISE (was not feeling very well), SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Colitis and Thyroiditis, unspecified.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (experienced arm sore and a lot of pain) and MALAISE (was not feeling very well). On 19-Mar-2021, the patient experienced SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced arm sore and a lot of pain), MALAISE (was not feeling very well), SOMNOLENCE (was sleepy) and CHEST PAIN (around noon pain in chest, goes away and then starts again, hurts me a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included deep breaths. Patient reported that she takes lots of medications.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed Dose for the second administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Dose for the second administration) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Dose for the second administration). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Dose for the second administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 68-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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) 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 conmed medication was included.  no treatment was mentioned.   This case was linked to US-MODERNATX, INC.-MOD-2021-052287 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052287:crosslink - second dose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule
Clinical narrative: red, round 2x2 inch lasted for one week; lumpy arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (lumpy arm) and ERYTHEMA (red, round 2x2 inch lasted for one week) in a 78-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced NODULE (lumpy arm). On an unknown date, the patient experienced ERYTHEMA (red, round 2x2 inch lasted for one week). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NODULE (lumpy arm) and ERYTHEMA (red, round 2x2 inch lasted for one week) outcome was unknown. Not Provided          The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.   This case was linked to MOD-2021-051536 (Linked Report).; Sender's Comments:  MOD-2021-051536:Companion case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination complication
Clinical narrative: Most side effect on vaccine card; Fever with temperature of 100.5; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5). At the time of the report, VACCINATION COMPLICATION (Most side effect on vaccine card) and PYREXIA (Fever with temperature of 100.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (Inconclusive) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Pyrexia
Clinical narrative: Dehydration; Fever; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 dosage form. On 03-Feb-2021, the patient experienced DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache). In February 2021, DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was provided. No treatment information was provided  Action taken with mRNA-1273 in response to the events was not applicable.