chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Vaccination site swelling
Clinical narrative: injection site warmth; injection site hard; The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) and INJECTION SITE ERYTHEMA (injection site red) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039k20-2A and 038K20A) 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 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard), VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE WARMTH (injection site warmth), INJECTION SITE INDURATION (injection site hard) and VACCINATION SITE SWELLING (The area at the injection site on my arm there is a 2" circular swelling which is hard and on the warm  side) had resolved and INJECTION SITE ERYTHEMA (injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Additional info. VAERS
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Vaccination site mass, Vaccination site pain
Clinical narrative: tender hardness on the injection site the size of a silver dollar; tender hardness on the injection site the size of a silver dollar; freezing to death;feels very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold). At the time of the report, VACCINATION SITE PAIN (tender hardness on the injection site the size of a silver dollar), VACCINATION SITE MASS (tender hardness on the injection site the size of a silver dollar) and FEELING COLD (freezing to death;feels very cold) 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.   Treatment and concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Reaction at the injection site; Occasional itching over the whole body; Arm itchy; Arm swollen; Little bit of nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Little bit of nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 NAUSEA (Little bit of nausea). At the time of the report, NAUSEA (Little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan, Vaccination site pain
Clinical narrative: pregnancy; pain at the site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (pain at the site) in a 40-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroiditis NOS, CALCIUM, DOCOSAHEXAENOIC ACID (DHA), VITAMIN D NOS and MAGNESIUM for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Apr-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the site). On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) At 12 weeks; normal, (normal) At 20 weeks ; normal and (normal) At 31 weeks; normal.     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.   Patient previously had live full-term child birth on 2016 and 2018.  Treatment medications were not provided by reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination.     No medical history provided by Reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 11-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-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 24-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.         The date of positive pregnancy test was Oct-2020. The patient has an established prenatal care. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy test, birth type and fetal outcome.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: INJECTION SITE SWELLING; Its Red,Redness is getting bigger and bigger and bigger; Its itchy; Its getting hard; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history is reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard). At the time of the report, VACCINATION SITE SWELLING (INJECTION SITE SWELLING), VACCINATION SITE ERYTHEMA (Its Red,Redness is getting bigger and bigger and bigger), VACCINATION SITE PRURITUS (Its itchy) and VACCINATION SITE INDURATION (Its getting hard) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.    Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site cellulitis, Vaccination site erythema, Vaccination site pain
Clinical narrative: Cellulitis at her injection site; Arm was inflamed and red; Arm was sore and even under armpit; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Accident (She crushed her right arm in May 2020 with 18 screws in place.) in May 2020, Tumor (Stomach Tumor which was operated on at an unmentioned date.) in 2019 and Staphylococcal infection (Staph infection from the stomach tumor surgery.) in 2019.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit). The patient was treated with CEFIXIME (ANCEF O) ongoing from 02-Feb-2021 at a dose of 1 dosage form and CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE CELLULITIS (Cellulitis at her injection site), VACCINATION SITE ERYTHEMA (Arm was inflamed and red) and AXILLARY PAIN (Arm was sore and even under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included 2G IV Ancef with 2 doses total on 02FEB2021and 03FEB2021 and 10 days of Keflex 500mg/280mg. No concomitant medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Type IV hypersensitivity reaction
Clinical narrative: delayed subcutaneous hypersensitivity/Covid arm- delayed; lump on my pinky joint; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph node dissection (Lymph node removed in the second arm.(right or left not specified).).    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 TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed subcutaneous hypersensitivity/Covid arm- delayed) and JOINT SWELLING (lump on my pinky joint) 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.   Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up attached on 08 Feb 2021 and contains information
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had first dose of the vaccine on 21-Jan-2021 and later discovered on 01-Feb-2021 that she was pregnant. she wanted to know if she can still go ahead with the second dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) in a 75-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 (No medical history reported).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm). At the time of the report, VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: barely any soreness at the injection site; A spontaneous case was received from a consumer concerning from social media concerning an unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced barely any soreness at the injection site/injection site pain.  No medical history was reported. No relevant concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-24) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020 a few hours later, the patient experienced barely any soreness at the injection site.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: light pink color developed over the vaccine site; soreness in the arm; bump in the arm; A Spontaneous report was received from consumer concerning a male patient of 80 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Vaccination site pain, Vaccination site mass, Vaccination site erythema .  The patient has no medical history. relevant concomitant medications are Vytorin, Atenolol, Pantoprazole, Xanax, Mirtazapine, V-C Forte, Aspirin, Coenzyme, Selenium, Vitamin C, Colace, Calcium, Metamucil, Turmeric Hydrocortisone.  On 06-Jan-2021, prior to the onset of the events the patient received their  dose of mRNA1273(batch no. unknown) and the route of administration is unknown for prophylaxis of COVID-19 infection.  Treatment information was not provided.   The events Vaccination site pain, Vaccination site mass, Vaccination site erythema . were recovered on 20 Jan 2021. The outcome of the events is unknown.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; Sore at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Hot arm; Diarrhea; Arm swollen; Red arm; Threw up; High fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm) and VOMITING (Threw up) in a 66-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.     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 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Hot arm; Diarrhea; Arm swollen; Red arm; Threw up; High fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm) and VOMITING (Threw up) in a 66-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.     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 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Hot arm), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (Red arm), VOMITING (Threw up), PYREXIA (High fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site was welty; the injection site was welty but now it's flat and warm to the touch; Arm got red; It hurts a little bit; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE PAIN (It hurts a little bit) and VACCINATION SITE URTICARIA (Injection site was welty) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Injection site was welty). On 20-Jan-2021, VACCINATION SITE URTICARIA (Injection site was welty) had resolved. At the time of the report, VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit) 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.   Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 14-Apr-2021 included no new information. The patient denied consent for further follow-up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness; Redness as well as bruise at injection site; It is inflamed, 1 1/2 inch below the shot; Redness as well as bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Eczema. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), VITAMINS NOS and WHITE SOFT PARAFFIN (AQUAPHOR [WHITE SOFT PARAFFIN]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site). On 21-Feb-2021 at 2:00 AM, the patient experienced VACCINATION SITE PRURITUS (Itchiness). The patient was treated with HYDROCORTISONE (CORTAID [HYDROCORTISONE]) in February 2021 at an unspecified dose and frequency. At the time of the report, DERMATITIS (It is inflamed, 1 1/2 inch below the shot), VACCINATION SITE BRUISING (Redness as well as bruise at the injection site), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (Redness as well as bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Lubber derma for an unknown indication.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: coughing; tender arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (tender arm) and COUGH (coughing) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTIROXIN), TOLTERODINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (tender arm). On 14-Feb-2021, the patient experienced COUGH (coughing). At the time of the report, PAIN IN EXTREMITY (tender arm) and COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 27-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) negative- she had no immunity.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 21Jan2021 the patient  tested positive to COVID-19.  On 25Jan2021 the patient was in ER, she was eligible for antibodies and got them on 27Feb2021. She received the clearance from a doctor to discontinue the isolation.  Tx: Antibodies  On 18Feb2021 the patient went to take her second shot which was denied as "she had no immunity" and that she "had to wait 90 days from the antibodies. It was reported that patient had a schedule for a stomach procedure.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: email address updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: sore arm; injection site started to get rash; Redness; Bumpy; Mild headache; It was sore for 1st 2 days of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (It was sore for 1st 2 days of injection). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy), VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) and HEADACHE (Mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided.  Reportedly, it was sore (at injection site) for first 2 days of injection as well but then again it started getting red, bumpy, mild headache, sore from 19-Feb-2021. No treatment was taken by the patient for the symptoms.  The patient's 2nd shot scheduled on 05 Mar 2021. Lot number: 012M20A.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: sore arm; injection site started to get rash; Redness; Bumpy; Mild headache; It was sore for 1st 2 days of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (It was sore for 1st 2 days of injection). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE RASH (injection site started to get rash), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Bumpy), VACCINATION SITE PAIN (It was sore for 1st 2 days of injection) and HEADACHE (Mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were provided.  Reportedly, it was sore (at injection site) for first 2 days of injection as well but then again it started getting red, bumpy, mild headache, sore from 19-Feb-2021. No treatment was taken by the patient for the symptoms.  The patient's 2nd shot scheduled on 05 Mar 2021. Lot number: 012M20A.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red Circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Circle around the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Circle around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red Circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm became itchy/arm itches like crazy; left arm bright red; swollen at the injection site; vaccination site warmth; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concomitant products included SPIRONOLACTONE (SPIRONOLACTONE A L), OLMESARTAN MEDOXOMIL (OLMESARTAN [OLMESARTAN MEDOXOMIL]) and BUPROPION HYDROCHLORIDE (BUPROPION BETA) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved and VACCINATION SITE PRURITUS (Left arm became itchy/arm itches like crazy), VACCINATION SITE ERYTHEMA (left arm bright red), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE WARMTH (vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: cough; Nausea; Headache; Fatigue; Sore throat; A spontaneous report,  was received from a health care professional concerning a 33Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 21/01/2020,  prior to the onset of the events, the patient received their first dose of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.    On 21/01/2020, The patient experienced the events list nausea, headache with non-serious.  on 22/01/2020, the patient experienced the events like sore throat, cough, fatigue, body ache but not too much with are non serious.    no treatment provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Leg pain; nerve pain on the left foot; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced leg pain and nerve pain on the left foot. The patient's medical history was reported as history of Lyme disease. Patient is also asthmatic and has COPD. No relevant concomitant medications were reported.    On 12-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 13-JAN-2021, one day after the dose of injection, the patient experienced leg pain and nerve pain on the left foot. No Laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events leg pain and nerve pain on the left foot was Unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain / sharp pain in the stomach; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach pain / sharp pain in the stomach.  The patient medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced Stomach pain/sharp pain in the stomach.  Treatment for the event included Stomach-Aid.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event stomach pain/sharp pain in the stomach was not resolved.; Reporter's Comments: This case concerns a 89 year old female patient, who experienced a unexpected event of stomach pain, 4 days after receiving first dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.  The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Diabetes.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No Concomitant medications were provided No Treatment information provided  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
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Constipation, Vaccination site pain
Clinical narrative: abdominal cramping; pain radiating to lower back; constipation; soreness at the injection; A spontaneous report was received from a consumer concerning that 67 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal cramping and pain radiating to lower back and has constipation, soreness at the injection site.  The patient's past medical history as provided by the reporter includes Knee surgery and shoulder surgery and does not have any allergies and concomitant medication.  On 16 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch No- 0273-99) intramuscularly on the left upper arm for prophylaxis of COVID-19 infection.  On 17 Jan 2021, patient experienced abdominal cramping and pain radiating to lower back. Has constipation. Has soreness at the injection site and no treatment taken for events.   No laboratory details provided.  Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events are 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 events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified and Diabetes.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not provided.  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.; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: little soreness at the injection site; little swelling like a little knot that went little down; A spontaneous report  was received from a  consumer    female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events rash . Patient stated that she got Moderna Covid-19 vaccine yesterday. She got little soreness and little swelling like a little knot that went little down. She took Tylenol after getting the vaccine this morning. She experienced symptoms events  soreness at the vaccine site. The patient's medical history and concominant medication was not provided,. Action taken with mRNA-1273 in response to the events was not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site on my left deltoid region is red; Injection site circular with defined borders; injection site painful; A spontaneous report was received from a consumer/physician/nurse/pharmacist/healthcare facility staff member/literature article concerning a 44 years old, female  patient who experienced injection site redness (vaccination site erythema), Injection site circular with defined borders (injection site urticaria), injection site painful(vaccination site painful).  The patient's medical history included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included biologic. The patient's medication allergies included doxycycline and bactrim.   On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09-Jan-2021, patients experienced injection site redness, Injection site circular with defined borders, injection site painful. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events were considered not resolve/not recovered.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: brain fog; lethargy; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Pt was hospitalized for COVID in October of 2020.) in October 2020.    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 FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (brain fog), LETHARGY (lethargy), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR Was received on 21-JUL-2021 Does not contains any new information
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence
Clinical narrative: tingling in arm; Falling sleep; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep). At the time of the report, PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. The reporter did not allow further contact.