chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Sore Mouth; "Foggy Brain"; Body Ache; Itchiness; Fever of 104 Degrees; Chills; Fatigue; Headache; Nausea; Injection site redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness) and PYREXIA (Fever of 104 Degrees) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ESZOPICLONE (LUNESTA), THYROID (ARMOUR THYROID) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 16-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 degree (plane angle) High.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Sore Mouth; "Foggy Brain"; Body Ache; Itchiness; Fever of 104 Degrees; Chills; Fatigue; Headache; Nausea; Injection site redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness) and PYREXIA (Fever of 104 Degrees) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ESZOPICLONE (LUNESTA), THYROID (ARMOUR THYROID) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 16-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 degree (plane angle) High.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: mild headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (mild headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Colonic obstruction on 19-Feb-2021. Concurrent medical conditions included Urinary tract infection and Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified, CEFDINIR for Urinary tract infection, PARACETAMOL (TYLENOL REGULAR) for an unknown indication.  On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced CHILLS (Chills) and HEADACHE (mild headache). At the time of the report, CHILLS (Chills) and HEADACHE (mild headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Injection site pain, Injection site swelling
Clinical narrative: lethargic; sweating profusely; weak; tenderness at injection site; Injection site swelling; chills; Fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling) and PYREXIA (Fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.  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 INJECTION SITE SWELLING (Injection site swelling) and PYREXIA (Fever). On 23-Jan-2021, INJECTION SITE SWELLING (Injection site swelling) had resolved. On 24-Jan-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) temperature was 100 F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Night sweats, Pyrexia
Clinical narrative: lethargic; sweating profusely; weak; tenderness at injection site; Injection site swelling; chills; Fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling) and PYREXIA (Fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.  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 INJECTION SITE SWELLING (Injection site swelling) and PYREXIA (Fever). On 23-Jan-2021, INJECTION SITE SWELLING (Injection site swelling) had resolved. On 24-Jan-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) temperature was 100 F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Dizziness; Fell to knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FALL (Fell to knees) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Feb-2021, the patient experienced DIZZINESS (Dizziness) and FALL (Fell to knees). On 15-Feb-2021, DIZZINESS (Dizziness) and FALL (Fell to knees) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Migraine
Clinical narrative: Migraine headache; back ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), BACK PAIN (back ache) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MIGRAINE (Migraine headache), BACK PAIN (back ache) and CHILLS (Chills). At the time of the report, MIGRAINE (Migraine headache) and BACK PAIN (back ache) outcome was unknown and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Significant follow up added. New events were mentioned.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ear discomfort, Fatigue, Headache, Hypertension
Clinical narrative: Blood pressure 136; Front and nose filled with mucus; As if her ears were filled with air; Sore arm; Headache; Tiredness; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irregular menstrual cycle (she got her menstrual period after one year). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). At the time of the report, HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown and VACCINATION SITE PAIN (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood pressure measurement: 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: Blood pressure 136; Front and nose filled with mucus; As if her ears were filled with air; Sore arm; Headache; Tiredness; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irregular menstrual cycle (she got her menstrual period after one year). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). At the time of the report, HYPERTENSION (Blood pressure 136), NASAL CONGESTION (Front and nose filled with mucus), EAR DISCOMFORT (As if her ears were filled with air), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown and VACCINATION SITE PAIN (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood pressure measurement: 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Illness, Suspected COVID-19, Vomiting
Clinical narrative: Felt like he had Covid again; Really sick, deathly sick; Throwing up; Had horrible chills. Was shaking really bad; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Felt like he had Covid again), ILLNESS (Really sick, deathly sick), VOMITING (Throwing up) and CHILLS (Had horrible chills. Was shaking really bad) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery and COVID-19 in November 2020. Concomitant products included LEVOTHYROXINE and METOPROLOL for an unknown indication.   On 04-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 SUSPECTED COVID-19 (Felt like he had Covid again), ILLNESS (Really sick, deathly sick), VOMITING (Throwing up) and CHILLS (Had horrible chills. Was shaking really bad).   At the time of the report, SUSPECTED COVID-19 (Felt like he had Covid again), ILLNESS (Really sick, deathly sick), VOMITING (Throwing up) and CHILLS (Had horrible chills. Was shaking really bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Other Concomitant Medication included blood thinner.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Reporter contact details updated
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling abnormal, Hypersensitivity, Hypertension
Clinical narrative: Blood pressure was very very high; Felt terrible; Itching; Rash goin gall the way to elbow; Left arm was hot; Swollen; allergic reaction unspecified/adverse allergic reaction; Didn't feel good; Feel very tired; Left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high) and FEELING ABNORMAL (Felt terrible) in a 70-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.     Concurrent medical conditions included Blood pressure high (Unspecified blood pressure) and Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for Blood pressure abnormal, NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, SIMVASTATIN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Left arm was sore). On 18-Jan-2021, the patient experienced MALAISE (Didn't feel good) and FATIGUE (Feel very tired).   On 21-Jan-2021, the patient experienced SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), RASH (Rash goin gall the way to elbow) and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction).   On 22-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible) and PRURITUS (Itching). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; PEPSIN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible), PRURITUS (Itching), INJECTION SITE PAIN (Left arm was sore) and FATIGUE (Feel very tired) had resolved, RASH (Rash goin gall the way to elbow) was resolving and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 166/100 166/100.   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 23-Mar-2021: NNI No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Pruritus, Rash, Skin warm
Clinical narrative: Blood pressure was very very high; Felt terrible; Itching; Rash goin gall the way to elbow; Left arm was hot; Swollen; allergic reaction unspecified/adverse allergic reaction; Didn't feel good; Feel very tired; Left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high) and FEELING ABNORMAL (Felt terrible) in a 70-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.     Concurrent medical conditions included Blood pressure high (Unspecified blood pressure) and Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for Blood pressure abnormal, NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, SIMVASTATIN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Left arm was sore). On 18-Jan-2021, the patient experienced MALAISE (Didn't feel good) and FATIGUE (Feel very tired).   On 21-Jan-2021, the patient experienced SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), RASH (Rash goin gall the way to elbow) and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction).   On 22-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible) and PRURITUS (Itching). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; PEPSIN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible), PRURITUS (Itching), INJECTION SITE PAIN (Left arm was sore) and FATIGUE (Feel very tired) had resolved, RASH (Rash goin gall the way to elbow) was resolving and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 166/100 166/100.   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 23-Mar-2021: NNI No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Blood pressure was very very high; Felt terrible; Itching; Rash goin gall the way to elbow; Left arm was hot; Swollen; allergic reaction unspecified/adverse allergic reaction; Didn't feel good; Feel very tired; Left arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high) and FEELING ABNORMAL (Felt terrible) in a 70-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.     Concurrent medical conditions included Blood pressure high (Unspecified blood pressure) and Glaucoma. Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for Blood pressure abnormal, NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, SIMVASTATIN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Left arm was sore). On 18-Jan-2021, the patient experienced MALAISE (Didn't feel good) and FATIGUE (Feel very tired).   On 21-Jan-2021, the patient experienced SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), RASH (Rash goin gall the way to elbow) and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction).   On 22-Jan-2021, the patient experienced HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible) and PRURITUS (Itching). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; PEPSIN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, MALAISE (Didn't feel good), SKIN WARM (Left arm was hot), VACCINATION SITE SWELLING (Swollen), HYPERTENSION (Blood pressure was very very high), FEELING ABNORMAL (Felt terrible), PRURITUS (Itching), INJECTION SITE PAIN (Left arm was sore) and FATIGUE (Feel very tired) had resolved, RASH (Rash goin gall the way to elbow) was resolving and HYPERSENSITIVITY (allergic reaction unspecified/adverse allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 166/100 166/100.   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 23-Mar-2021: NNI No specific follow-up information recorded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Dizzy; Headache; Soreness in his body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness in his body), DIZZINESS (Dizzy) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced PAIN (Soreness in his body) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced DIZZINESS (Dizzy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PAIN (Soreness in his body), DIZZINESS (Dizzy) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is currently taking medicine for blood pressure, anxiety and depression
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Feeling hot, Rash pruritic, Urticaria
Clinical narrative: Hives; Feeling hot; Sensation to throat closing; redness; Rash all over the body, it was itchy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing), RASH PRURITIC (Rash all over the body, it was itchy) and ERYTHEMA (redness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (allergy to dairy), Penicillin allergy (allergy to penicillin), Asthma since 10-Mar-1982, Gluten sensitivity (allergy to gluten), Drug allergy (allergy to Tramadol) and Drug allergy (allergy to Imitrex). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 01-Jan-2020 to 05-Jan-2020 for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) from 01-Jan-2019 to an unknown date for Anxiety and Depression, DOCUSATE SODIUM (LAXOPOL [DOCUSATE SODIUM]) 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 21-Jan-2021, the patient experienced RASH PRURITIC (Rash all over the body, it was itchy). On an unknown date, the patient experienced URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing) and ERYTHEMA (redness). At the time of the report, URTICARIA (Hives), FEELING HOT (Feeling hot), DYSPHAGIA (Sensation to throat closing) and ERYTHEMA (redness) outcome was unknown and RASH PRURITIC (Rash all over the body, it was itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included a steroid shot and she took a six day pack of steroids. 13 day pack steroid cream, start date-22jan2021, stop date-07mar2021 pill daily for allegra(24hours), start date-22jan2021 ongoing.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient demographic was updated. New events added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Sleep disorder, Toothache, Vaccination site pain
Clinical narrative: Like Toothache; Woke up During the Night; Left Jaw was sore; Sore Shoulder blade (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Like Toothache), SLEEP DISORDER (Woke up During the Night), PAIN IN JAW (Left Jaw was sore) and VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced TOOTHACHE (Like Toothache), SLEEP DISORDER (Woke up During the Night), PAIN IN JAW (Left Jaw was sore) and VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)).   On 09-Feb-2021, VACCINATION SITE PAIN (Sore Shoulder blade (Injected Arm)) had resolved.   At the time of the report, TOOTHACHE (Like Toothache) and PAIN IN JAW (Left Jaw was sore) had not resolved and SLEEP DISORDER (Woke up During the Night) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is currently taking Blood Pressure Medication. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Myalgia, Nausea
Clinical narrative: Aches; Arm soreness; Muscle pain; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, CALCIUM, VITAMIN D NOS and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.  On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea).   At the time of the report, PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved and CHILLS (Chills) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100 f (High) 100 F and 100.1 f (High) 100.1 F.   No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; Arm soreness; Muscle pain; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, CALCIUM, VITAMIN D NOS and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.  On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea).   At the time of the report, PAIN (Aches), AXILLARY PAIN (Arm soreness), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved and CHILLS (Chills) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100 f (High) 100 F and 100.1 f (High) 100.1 F.   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Rash
Clinical narrative: rash devleoped under breast left hand side; sore arm; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash devleoped under breast left hand side), AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ABATACEPT (ORENCIA) for Immunosuppressant drug therapy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness). On 18-Feb-2021, the patient experienced RASH (rash devleoped under breast left hand side). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (rash devleoped under breast left hand side), AXILLARY PAIN (sore arm), HEADACHE (headache) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was fine now and doesn't require further follow-ups. Didn't provide email address.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: TCR received.  Event outcome updated.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching at injection site; Big red round circle at injection site; Injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Big red round circle at injection site) and VACCINATION SITE PAIN (Injection site arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN, ALLOPURINOL, OMEPRAZOLE, FAMOTIDINE (PEPCID AC), DULOXETINE HYDROCHLORIDE (CYMBALTA), CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN), LABETALOL, SIMVASTATIN and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm hurt). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Big red round circle at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Big red round circle at injection site) and VACCINATION SITE PAIN (Injection site arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's treatment details included Massages and Compresses.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: fallow up received contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Head ache; Sinus infection/sinus issues/sinus headache (facial pressure and pain); light headedness/brain fog; pains; queasy stomach; fatigue; muscle aches; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (queasy stomach), SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog), PAIN (pains) and HEADACHE (Head ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Low back pain in 2012 and Hip bursitis in 2016. Concurrent medical conditions included Fish allergy. Concomitant products included RALOXIFENE for Breast cancer, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZID) for Water retention.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (FEVER). On 18-Feb-2021, the patient experienced SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog) and HEADACHE (Head ache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK UNK, qid and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, DIZZINESS (light headedness/brain fog), HEADACHE (Head ache) and FATIGUE (fatigue) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), MYALGIA (muscle aches) and PYREXIA (FEVER) was resolving and SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: New events and their outcome updated. Concomitant and treatment drugs details added. Action taken with drug updated. On 06-Jul-2021: NNI FU - No new information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Head ache; Sinus infection/sinus issues/sinus headache (facial pressure and pain); light headedness/brain fog; pains; queasy stomach; fatigue; muscle aches; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (queasy stomach), SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog), PAIN (pains) and HEADACHE (Head ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Low back pain in 2012 and Hip bursitis in 2016. Concurrent medical conditions included Fish allergy. Concomitant products included RALOXIFENE for Breast cancer, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZID) for Water retention.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (FEVER). On 18-Feb-2021, the patient experienced SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)), DIZZINESS (light headedness/brain fog) and HEADACHE (Head ache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK UNK, qid and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, DIZZINESS (light headedness/brain fog), HEADACHE (Head ache) and FATIGUE (fatigue) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (queasy stomach), PAIN (pains), MYALGIA (muscle aches) and PYREXIA (FEVER) was resolving and SINUSITIS (sinus infection/sinus issues/sinus headache (facial pressure and pain)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: New events and their outcome updated. Concomitant and treatment drugs details added. Action taken with drug updated. On 06-Jul-2021: NNI FU - No new information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Vaccination site pain
Clinical narrative: swelling; red; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness), INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness). On 21-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red). On 16-Feb-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, INJECTION SITE SWELLING (swelling) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Swollen shoulder; Swollen arm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever) 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; a little bit of soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE PAIN (a little bit of soreness on her arm) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and OXYBUTYNIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little bit of soreness on her arm). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter). At the time of the report, VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE PAIN (a little bit of soreness on her arm) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information  provided