chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash). At the time of the report, RASH (8 inch significant rash on arm) and RASH PRURITIC (very itchy, red and irritating rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-246976, MOD-2021-246976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received on 05-JUL-2021 : Events updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Palpitations
Clinical narrative: Heavy legs and palpitations after 1st dose; Heavy legs and palpitations after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavy legs and palpitations after 1st dose) and PALPITATIONS (Heavy legs and palpitations after 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included FAMOTIDINE (PEPCID AC) and MELATONIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced LIMB DISCOMFORT (Heavy legs and palpitations after 1st dose) and PALPITATIONS (Heavy legs and palpitations after 1st dose). On 15-Feb-2021, LIMB DISCOMFORT (Heavy legs and palpitations after 1st dose) and PALPITATIONS (Heavy legs and palpitations after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, COVID-19, Chest discomfort, Chills
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain) and ARTHRALGIA (Arthralgia) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2020, SARS-CoV-2 test: positive (Inconclusive) POSITIVE.     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 treatment medication was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain) and ARTHRALGIA (Arthralgia) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2020, SARS-CoV-2 test: positive (Inconclusive) POSITIVE.     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 treatment medication was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Vaccination site rash
Clinical narrative: Rash on injection site; Headache and had to sleep early; Low grade fever (100.3°); Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache and had to sleep early), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Sinus allergy was reported.). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (MIGRAINE [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache and had to sleep early), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills). On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site) and HEADACHE (Headache and had to sleep early) outcome was unknown and PAIN IN EXTREMITY (Sore arm), PYREXIA (Low grade fever (100.3°)) and CHILLS (Chills) 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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site, it was itchy and red; rash on her left arm, at the injection site; injection site, it was itchy and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site, it was itchy and red), VACCINATION SITE RASH (rash on her left arm, at the injection site) and VACCINATION SITE ERYTHEMA (injection site, it was itchy and red) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site, it was itchy and red), VACCINATION SITE RASH (rash on her left arm, at the injection site) and VACCINATION SITE ERYTHEMA (injection site, it was itchy and red). On 29-Jan-2021, VACCINATION SITE PRURITUS (injection site, it was itchy and red), VACCINATION SITE RASH (rash on her left arm, at the injection site) and VACCINATION SITE ERYTHEMA (injection site, it was itchy and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was taken. No treatment medication was taken.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Swelling
Clinical narrative: swelling of veins in her head; slightly dizzy; Itching of left arm; head became very itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching of left arm), PRURITUS (head became very itchy), SWELLING (swelling of veins in her head) and DIZZINESS (slightly dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (PMH includes hypertension, high cholesterol and prediabetic), High cholesterol (PMH includes hypertension, high cholesterol and prediabetic), Pre-diabetic (PMH includes hypertension, high cholesterol and prediabetic) and Drug allergy (Allergies include Norvasc and voltaren). Concomitant products included CARVEDILOL (COREG) 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-Feb-2021, the patient experienced PRURITUS (Itching of left arm) and PRURITUS (head became very itchy). On 13-Feb-2021, the patient experienced SWELLING (swelling of veins in her head) and DIZZINESS (slightly dizzy). The patient was treated with PREDNISONE at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching of left arm), PRURITUS (head became very itchy), SWELLING (swelling of veins in her head) and DIZZINESS (slightly dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: sore arm; slight temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history wsa reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (slight temperature) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site induration, Injection site pruritus, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Lump on the arm; Itchy arm; "8-day COVID arm; Red arm; HYPERSENSITIVITY REACTION; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm), VACCINATION SITE ERYTHEMA (Red arm) and HYPERSENSITIVITY (HYPERSENSITIVITY REACTION) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 004M20A) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concurrent medical conditions included Diabetes (DIABETES TYPE 2) since 1998 and Blood pressure high since 1998. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), SERTRALINE HYDROCHLORIDE (ZOLOFT), BUPROPION, SIMVASTATIN, RALOXIFENE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), COLECALCIFEROL (VIT D [COLECALCIFEROL]), AMLODIPINE, EMPAGLIFLOZIN (JARDIANCE), ASCORBIC ACID (VIT C), VITAMIN B COMPLEX (VIT B COMPLEX), CALCIUM and ZINC for an unknown indication.   On 20-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 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm), VACCINATION SITE ERYTHEMA (Red arm) and HYPERSENSITIVITY (HYPERSENSITIVITY REACTION). On 06-Feb-2021, HYPERSENSITIVITY (HYPERSENSITIVITY REACTION) had resolved. At the time of the report, INJECTION SITE INDURATION (Lump on the arm), INJECTION SITE PRURITUS (Itchy arm), VACCINATION SITE REACTION ("8-day COVID arm) and VACCINATION SITE ERYTHEMA (Red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Lantus insulin .  NO TREATMENT DRUGS WERE USED.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADR form addedPATIENT DETAILS WERE ADDED.EVENT WAS ADDED OUTCOME OF EVENT
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Pain, Pain in extremity, Rash
Clinical narrative: rash; arm was swollen; hot; arm was red; arm was itchy; hurt; didn't feel good; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (didn't feel good), VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot) and VACCINATION SITE ERYTHEMA (arm was red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Feb-2021, the patient experienced MALAISE (didn't feel good). On 14-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PRURITUS (arm was itchy) and PAIN (hurt). On 15-Feb-2021, the patient experienced RASH (rash). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (didn't feel good), VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PRURITUS (arm was itchy), PAIN (hurt) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient said via phone call that, patient got the 2nd dose of moderna vaccine and didn't remember being too sick. Patient was remembers only having adverse reactions after the 1st dose as they showed up 10 days after the shot.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant FU/ TCR information was reported and was added in narrative supplement section.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: rash; arm was swollen; hot; arm was red; arm was itchy; hurt; didn't feel good; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (didn't feel good), VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot) and VACCINATION SITE ERYTHEMA (arm was red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Feb-2021, the patient experienced MALAISE (didn't feel good). On 14-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PRURITUS (arm was itchy) and PAIN (hurt). On 15-Feb-2021, the patient experienced RASH (rash). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (didn't feel good), VACCINATION SITE SWELLING (arm was swollen), FEELING HOT (hot), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PRURITUS (arm was itchy), PAIN (hurt) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient said via phone call that, patient got the 2nd dose of moderna vaccine and didn't remember being too sick. Patient was remembers only having adverse reactions after the 1st dose as they showed up 10 days after the shot.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant FU/ TCR information was reported and was added in narrative supplement section.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: I just fell into a deep sleep for about 1.5 hours full of vivid dreams and such; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (I just fell into a deep sleep for about 1.5 hours full of vivid dreams and such) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABNORMAL DREAMS (I just fell into a deep sleep for about 1.5 hours full of vivid dreams and such). At the time of the report, ABNORMAL DREAMS (I just fell into a deep sleep for about 1.5 hours full of vivid dreams and such) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified    Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 contain No New Information(NNI)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (throwing up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history). Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination, DIAZEPAM, OXYCODONE, ESTROGENS CONJUGATED (PREMARIN) and MELOXICAM for an unknown indication, OXYCODONE, ESTROGENS CONJUGATED (PREMARIN) and MELOXICAM.    On 27-Jan-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 NAUSEA (nausea) and VOMITING (throwing up). At the time of the report, NAUSEA (nausea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain in arm; injection site sore to the touch; injection site is swollen (2in diameter); injection site is warm and hot; elbow to shoulder on right arm is puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-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 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site is warm and hot), PERIPHERAL SWELLING (elbow to shoulder on right arm is puffy), PAIN IN EXTREMITY (pain in arm), VACCINATION SITE PAIN (injection site sore to the touch) and VACCINATION SITE SWELLING (injection site is swollen (2in diameter)) outcome was unknown.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up was received. Reporter's address was updated. New event pain in arm was included. Patient went to see a doctor. It contains significant information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Glucose tolerance test, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: Sore arm; chills; body aches and sore arm; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live,full-term birth) on 28-Feb-2018.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021, the patient experienced CHILLS (chills). 13-Feb-2021, the patient experienced MYALGIA (body aches and sore arm). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal normal (normal) normal. On an unknown date, Ultrasound foetal: normal normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-016183 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound foetal
Clinical narrative: Sore arm; chills; body aches and sore arm; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live,full-term birth) on 28-Feb-2018.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021, the patient experienced CHILLS (chills). 13-Feb-2021, the patient experienced MYALGIA (body aches and sore arm). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal normal (normal) normal. On an unknown date, Ultrasound foetal: normal normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-016183 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Incredible pain; could hardly walk; sore throat; hands really hurt; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt) and ARTHRALGIA (joint pain) in a 68-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 Fibromyalgia.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Incredible pain; could hardly walk; sore throat; hands really hurt; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt) and ARTHRALGIA (joint pain) in a 68-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 Fibromyalgia.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) 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: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site warmth; injection site itching; injection site swelling; vaccination site erythema; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (myalgia) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (myalgia). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (myalgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Treatment information was not provided.   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on arms and legs) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH PRURITIC (itchy rash on arms and legs). At the time of the report, RASH PRURITIC (itchy rash on arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on right foot; both hands itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (both hands itching) and RASH (rash on right foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (both hands itching). On 18-Feb-2021, the patient experienced RASH (rash on right foot). At the time of the report, PRURITUS (both hands itching) and RASH (rash on right foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated reporter details
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Mother got first dose of vaccine and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding) in a  infant of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 030m20a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): No medical history was reported.  Concurrent medical conditions included Breast feeding.    No Medical History information was reported.   On 18-Feb-2021 at 2:00 PM, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Feb-2021 at 2:00 PM, the infant was diagnosed with MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding). On 18-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Mother got first dose of vaccine and is breastfeeding) had resolved.            Concomitant medications were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Addt'l info uploaded.  Patient -parent tab: Added parent height, weight, race, ethnicity.  Product tab: Vaccination information was added for 2 doses of parent along with start date, batch number and anatomical location.   Updated event tab stop date and patient has been breast feeding for 8 months and outcome is updated as recovered or resolved.  Patient mentioned that she was breastfeeding at time of vaccination; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of  in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    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 ADVERSE EVENT (Adverse Event). At the time of the report, outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypoaesthesia, Vaccination site pain
Clinical narrative: she woke up and felt weak; difficulty breathing; light headedness (dizzy); some loss of feeling in feet; little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she woke up and felt weak), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness (dizzy)), HYPOAESTHESIA (some loss of feeling in feet) and VACCINATION SITE PAIN (little soreness at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (little soreness at the injection site). On 02-Feb-2021, the patient experienced ASTHENIA (she woke up and felt weak), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness (dizzy)) and HYPOAESTHESIA (some loss of feeling in feet). At the time of the report, ASTHENIA (she woke up and felt weak), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness (dizzy)) and HYPOAESTHESIA (some loss of feeling in feet) outcome was unknown and VACCINATION SITE PAIN (little soreness at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: SWOLLEN AT INJECTION SITE; REDNESS AT INJECTION SITE; INJECTION SITE A LITTLE SORE; TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE; About to have chills; HOT TO THE TOUCH; FEELING COLD; ARM OF THE INJECTION WAS A LITTLE BIT ITCHY; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills). At the time of the report, VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-255975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: no new information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: SWOLLEN AT INJECTION SITE; REDNESS AT INJECTION SITE; INJECTION SITE A LITTLE SORE; TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE; About to have chills; HOT TO THE TOUCH; FEELING COLD; ARM OF THE INJECTION WAS A LITTLE BIT ITCHY; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills). At the time of the report, VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-255975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: no new information
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: rash on his stomach and left arm; his left arm and back is itching,specially his left arm; rash on his stomach and left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm). At the time of the report, RASH PAPULAR (rash on his stomach and left arm), PRURITUS (his left arm and back is itching,specially his left arm) and RASH (rash on his stomach and left arm) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination complication
Clinical narrative: small reaction; nauseous; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (small reaction), FATIGUE (fatigue), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (fatigue). On 30-Jan-2021, the patient experienced NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (small reaction). At the time of the report, VACCINATION COMPLICATION (small reaction), FATIGUE (fatigue), NAUSEA (nauseous), CHILLS (chills) and HEADACHE (headache) had resolved.            Concomitant product use was not provided  by the reporter.  Treatment information was not provided.Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-017643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07 May 2021.Added new event and updated outcome of events.