chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Top part of right arm warm to elbow; Top part of right arm red to elbow; Top part of right arm swollen to elbow; Chills; had fever; feeling bad; Top part of right arm sore to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Top part of right arm sore to elbow), FEELING ABNORMAL (feeling bad), VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 015M20A) 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 METOPROLOL, ATORVASTATIN, FAMOTIDINE, COLECALCIFEROL (VIT D3), OXYBUTYNIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Top part of right arm sore to elbow) and FEELING ABNORMAL (feeling bad). On 13-Mar-2021, the patient experienced CHILLS (Chills). 13-Mar-2021, the patient experienced PYREXIA (had fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow), VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (Chills) and PYREXIA (had fever) had resolved. On 19-Mar-2021, VACCINATION SITE PAIN (Top part of right arm sore to elbow) had resolved. At the time of the report, FEELING ABNORMAL (feeling bad) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) outcome was unknown and VACCINATION SITE WARMTH (Top part of right arm warm to elbow) and VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) was resolving.            Concomitant medication include shampoo for lupus in scalp Action taken with mRNA-1273 in response to the events was not applicable. Treatment include alcohol on arm       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Updated reporter's address, updated first dose details, updated concomitant medications, updated treatment details, added two additional events Pyrexia and Feeling abnormal, updated stop date of the events and changed event outcome from recovering to recovered/resolved. On 16-Jun-2021: Follow-up information received on 16-JUN-2021 contains no new information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chills, Feeling hot, Limb discomfort
Clinical narrative: Drowsiness; Fever; Chills; Bleeding at injection site; Sore arm /pain n arm; Pressure in arm; Inability to move arm; Feeling something in the chest; Feeling hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and CHEST DISCOMFORT (Feeling something in the chest) in a 57-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.     Concurrent medical conditions included Hypertension. Concomitant products included METFORMIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm), CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced SOMNOLENCE (Drowsiness). On 13-Mar-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. On 16-Mar-2021, CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and SOMNOLENCE (Drowsiness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood pressure measurement: elevated (Inconclusive) Blood pressure increase was attributed to the pain in her arm following injection of Moderna on 13Mar2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine and pain medicine Treatment medication included Blood pressure medicine dose increase, Pain medicine, Antibiotic and Ice pack
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence, Vaccination site haemorrhage, Vaccination site movement impairment
Clinical narrative: Drowsiness; Fever; Chills; Bleeding at injection site; Sore arm /pain n arm; Pressure in arm; Inability to move arm; Feeling something in the chest; Feeling hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and CHEST DISCOMFORT (Feeling something in the chest) in a 57-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.     Concurrent medical conditions included Hypertension. Concomitant products included METFORMIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm), CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced SOMNOLENCE (Drowsiness). On 13-Mar-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. On 16-Mar-2021, CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and SOMNOLENCE (Drowsiness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood pressure measurement: elevated (Inconclusive) Blood pressure increase was attributed to the pain in her arm following injection of Moderna on 13Mar2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine and pain medicine Treatment medication included Blood pressure medicine dose increase, Pain medicine, Antibiotic and Ice pack
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Fever of 100 degrees F; Headache; Muscle pain; Pain is gradually getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain is gradually getting worse), PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pain is gradually getting worse). On 16-Mar-2021, the patient experienced PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Pain is gradually getting worse), PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100 f (High) 100 F.     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 Concomitant medications was reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: arm is sore/arm still sore; Tired; unwell; overall weakness; achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (unwell), ASTHENIA (overall weakness), MYALGIA (achy), VACCINATION SITE PAIN (arm is sore/arm still sore) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 05-Nov-2020.    On 09-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 MALAISE (unwell), ASTHENIA (overall weakness), MYALGIA (achy) and FATIGUE (Tired). On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore/arm still sore). At the time of the report, MALAISE (unwell), ASTHENIA (overall weakness), MYALGIA (achy), VACCINATION SITE PAIN (arm is sore/arm still sore) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received include no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Pain and Burning/stinging sensation at the injection site; Swelling at the injection site; Rash at the injection site; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain and Burning/stinging sensation at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site) 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 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 (Pain and Burning/stinging sensation at the injection site). In March 2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Pain and Burning/stinging sensation at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information also included the Benadryl Cream
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Palpitations, Pyrexia
Clinical narrative: heart pounding; fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart pounding), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event, Atrial fibrillation since 2016, High cholesterol since an unknown date, Acid reflux (esophageal) since an unknown date, Shoulder discomfort (Reported as Bad shoulder) since an unknown date and Cardiac ablation (Failed) in 2019. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, DRONEDARONE HYDROCHLORIDE (MULTAQ), PANTOPRAZOLE and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 15-Mar-2021, the patient experienced PALPITATIONS (heart pounding). On 15-Mar-2021, FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. At the time of the report, PALPITATIONS (heart pounding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: difficulty breathing that night but it cleared up the next day; sore arm but no rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing that night but it cleared up the next day) and PAIN IN EXTREMITY (sore arm but no rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing that night but it cleared up the next day) and PAIN IN EXTREMITY (sore arm but no rash). On 02-Mar-2021, DYSPNOEA (difficulty breathing that night but it cleared up the next day) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm but no rash) 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.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Eye pain, Fatigue, Heart rate increased
Clinical narrative: every time he stand up his heart going faste; dizzy; sweat; Doesn't sleep very much; really tired; he was not urinating so much; migraine headache; hurting all over his body; muscle aches; Nothings seems good; lost his appetite; high blood pressure; hurt behind his eyes; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite) and HYPERTENSION (high blood pressure) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Mar-2021, the patient experienced MIGRAINE (migraine headache), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), PAIN (hurting all over his body) and MYALGIA (muscle aches). On 14-Mar-2021, the patient experienced URINE OUTPUT DECREASED (he was not urinating so much). On an unknown date, the patient experienced HEART RATE INCREASED (every time he stand up his heart going faste), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much) and FATIGUE (really tired). At the time of the report, MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), URINE OUTPUT DECREASED (he was not urinating so much), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much), PAIN (hurting all over his body), MYALGIA (muscle aches) and FATIGUE (really tired) outcome was unknown. 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 for the events included ibuprofen for pain
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Insomnia, Malaise, Migraine
Clinical narrative: every time he stand up his heart going faste; dizzy; sweat; Doesn't sleep very much; really tired; he was not urinating so much; migraine headache; hurting all over his body; muscle aches; Nothings seems good; lost his appetite; high blood pressure; hurt behind his eyes; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite) and HYPERTENSION (high blood pressure) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Mar-2021, the patient experienced MIGRAINE (migraine headache), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), PAIN (hurting all over his body) and MYALGIA (muscle aches). On 14-Mar-2021, the patient experienced URINE OUTPUT DECREASED (he was not urinating so much). On an unknown date, the patient experienced HEART RATE INCREASED (every time he stand up his heart going faste), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much) and FATIGUE (really tired). At the time of the report, MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), URINE OUTPUT DECREASED (he was not urinating so much), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much), PAIN (hurting all over his body), MYALGIA (muscle aches) and FATIGUE (really tired) outcome was unknown. 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 for the events included ibuprofen for pain
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Urine output decreased
Clinical narrative: every time he stand up his heart going faste; dizzy; sweat; Doesn't sleep very much; really tired; he was not urinating so much; migraine headache; hurting all over his body; muscle aches; Nothings seems good; lost his appetite; high blood pressure; hurt behind his eyes; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite) and HYPERTENSION (high blood pressure) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Mar-2021, the patient experienced MIGRAINE (migraine headache), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), PAIN (hurting all over his body) and MYALGIA (muscle aches). On 14-Mar-2021, the patient experienced URINE OUTPUT DECREASED (he was not urinating so much). On an unknown date, the patient experienced HEART RATE INCREASED (every time he stand up his heart going faste), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much) and FATIGUE (really tired). At the time of the report, MIGRAINE (migraine headache), HEART RATE INCREASED (every time he stand up his heart going faste), MALAISE (Nothings seems good), DECREASED APPETITE (lost his appetite), HYPERTENSION (high blood pressure), EYE PAIN (hurt behind his eyes), URINE OUTPUT DECREASED (he was not urinating so much), DIZZINESS (dizzy), HYPERHIDROSIS (sweat), INSOMNIA (Doesn't sleep very much), PAIN (hurting all over his body), MYALGIA (muscle aches) and FATIGUE (really tired) outcome was unknown. 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 for the events included ibuprofen for pain
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: swollen, firm, and there was a lump; red rash that was itchy on her injection arm just below the site of injection; red rash that was itchy on her injection arm just below the site of injection; red rash that was itchy on her injection arm just below the site of injection; swollen, firm, and there was a lump; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection). 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump). At the time of the report, VACCINATION SITE NODULE (swollen, firm, and there was a lump), VACCINATION SITE PRURITUS (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE ERYTHEMA (red rash that was itchy on her injection arm just below the site of injection), VACCINATION SITE RASH (red rash that was itchy on her injection arm just below the site of injection) and VACCINATION SITE SWELLING (swollen, firm, and there was a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Loss of appetite; Fever (low grade); Headache; Chills; Sore injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    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 DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site). On 13-Mar-2021, DECREASED APPETITE (Loss of appetite), PYREXIA (Fever (low grade)), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Sore injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  Patient's father reported that the daughter had adverse events after Moderna vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: pushing up on her arm that her arm was hurting; headache around her ears and on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead). At the time of the report, PAIN IN EXTREMITY (pushing up on her arm that her arm was hurting) and HEADACHE (headache around her ears and on her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Urticaria
Clinical narrative: Arm soreness; Hives on her left arm and all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her left arm and all over body) and MYALGIA (Arm soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.    On 15-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 URTICARIA (Hives on her left arm and all over body). On an unknown date, the patient experienced MYALGIA (Arm soreness). The patient was treated with CALAMINE for Pain in arm, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on her left arm and all over body) and MYALGIA (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness on their arms; Redness on their arms; Bumpyness/bumpiness on their arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms). At the time of the report, PRURITUS (Itchiness on their arms), ERYTHEMA (Redness on their arms) and SWELLING (Bumpyness/bumpiness on their arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Renal pain
Clinical narrative: Kidney pain; Dizziness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 027L20LA) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LITHIUM for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RENAL PAIN (Kidney pain), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, RENAL PAIN (Kidney pain), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received updated reporter contact information and is considered non-significant.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during breast feeding, Myalgia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient is currently breastfeeding; sore arm; swollen underarm in the lymphatic glad area; injection site is very tender and painful; injection site very warm; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding), VACCINATION SITE WARMTH (injection site is very warm), MYALGIA (sore arm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.  No medical history was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding) and MYALGIA (sore arm). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site is very warm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area). On 16-Mar-2021, MYALGIA (sore arm) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is currently breastfeeding), VACCINATION SITE WARMTH (injection site is very warm), VACCINATION SITE PAIN (injection site is very tender and painful) and LYMPHADENOPATHY (swollen underarm in the lymphatic glad area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Additional information was received from the initial reporter: New events Myalgia, vaccination site pain, vaccination site warmth and Lymphadenopathy were added
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Itchy; Hive-like; Developed a rash on her arm that has now spread to her arms, stomach, legs, and back; Fever; Aches and pain from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pain from the vaccine), PRURITUS (Itchy), URTICARIA (Hive-like), RASH (Developed a rash on her arm that has now spread to her arms, stomach, legs, and back) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 630A21A and 037K70A or 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced PAIN (Aches and pain from the vaccine) and PYREXIA (Fever). On 12-Mar-2021, the patient experienced PRURITUS (Itchy), URTICARIA (Hive-like) and RASH (Developed a rash on her arm that has now spread to her arms, stomach, legs, and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Aches and pain from the vaccine), PRURITUS (Itchy), URTICARIA (Hive-like), RASH (Developed a rash on her arm that has now spread to her arms, stomach, legs, and back) and PYREXIA (Fever) outcome was unknown.            No concomitant medications reported by reporter. Action taken with mRNA-1273 was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Very fast heartbeat; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open heart surgery when she was young).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations). At the time of the report, TACHYCARDIA (Very fast heartbeat) and PALPITATIONS (Palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all the way down to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all the way down to her elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all the way down to her elbow). At the time of the report, RASH (Rash all the way down to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Suspected COVID-19
Clinical narrative: terrible sweating to the point where I almost wet a bed; Suspected COVID-19; fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia since an unknown date and Coronavirus test positive in July 2020. Concomitant products included GABAPENTIN, TAMSULOSIN, IBRUTINIB (IMBRUVICA), ATORVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, ZINC and ASCORBIC ACID (VITAMIN C ACID).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F). On 25-Feb-2021, HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), SUSPECTED COVID-19 (Suspected COVID-19) and PYREXIA (fever of 101 F) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TAMSULOSIN, IBRUTINIB (IMBRUVICA), ATORVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, ZINC and ASCORBIC ACID (VITAMIN C ACID).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms). On 25-Feb-2021, HYPERHIDROSIS (terrible sweating to the point where I almost wet a bed), PYREXIA (fever of 101 F) and INFLUENZA LIKE ILLNESS (He felt like he had a Covid symptoms) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Haemoglobin
Clinical narrative: AST  elevated; ALT elevated; This spontaneous case was reported by a nurse and describes the occurrence of ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to codeine.), Allergy (Allergic to antihistamine.), Hypertension and Hypercholesterolaemia. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiac disorder, LABETALOL and LOSARTAN for Hypertension, ATORVASTATIN CALCIUM (LIPITOR) for Lipids increased.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated). On 22-Apr-2021, ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Alanine aminotransferase: normal (normal) ALT-18. On 20-Jan-2021, Aspartate aminotransferase: normal (normal) AST-19. On 20-Jan-2021, Haemoglobin: low (Low) A1C-5.9. On 03-Mar-2021, Alanine aminotransferase: elevated (High) ALT-58. On 03-Mar-2021, Aspartate aminotransferase: elevated (High) AST-37. On 03-Mar-2021, Haemoglobin: low (Low) A1C-6.2. On 20-Apr-2021, Alanine aminotransferase: normal (normal) ALT-18. On 20-Apr-2021, Aspartate aminotransferase: normal (normal) AST-19. On 20-Apr-2021, Haemoglobin: low (Low) A1C-5.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-215591, MOD-2021-046164.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received contains Significant information- Updated reporter information. Updated event outcome: Recovered. Contains New medical history, New concomitant medications. New Lab test information, Contains updated product information-Route of administration, body site. Contains updated patient demographics- Height, weight, race, Ethnicity.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Gastrointestinal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHOEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHOEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness). The patient was treated with LOPERAMIDE for Diarrhoea, at a dose of UNK dosage form. On 15-Mar-2021, GASTROINTESTINAL PAIN (painful intestinal cramping ), DIARRHEA (sort of diarrhoea/loose stool), CHILLS (chills) and FATIGUE (tiredness) had resolved. Not Provided. 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 Concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: itching at the injection; Hives at injection; redness at the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection) 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 06-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 INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection). At the time of the report, INJECTION SITE URTICARIA (Hives at injection), INJECTION SITE ERYTHEMA (redness at the injection) and INJECTION SITE PRURITUS (itching at the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatments were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fatigue; Headache; Chills; Nausea; Low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) had not resolved.            No Concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Rash
Clinical narrative: Very hard; Very itchy; Patient started with rash all over body (arms and legs) like small pimples; This spontaneous case was reported by a consumer and describes the occurrence of Very Hard, PRURITUS, and RASH (arms and legs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, NORVASC, PREDNISONE, and OXYBUTYNIN for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced Very hard, PRURITUS, and RASH (arms and legs). The patient was treated with BENADRYL at an unspecified dose and frequency. At the time of the report, Very hard and PRURITUS outcome was unknown and RASH (arms and legs) had not resolved.            Concomitant medication included Cholesterol medication.