chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: big area with some itchiness; swelling and redness which covers the injection site; swelling and redness which covers the injection site; chills; fever; headache; A spontaneous report was received from a consumer, a female patient, who received Moderna's COVID-19 Vaccine and experienced chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness.  The patient's medical history was not provided. Relevant concomitant medications included simvastatin, amlodipine besilate, lisinopril, and hydrochlorothiazide.   On 04 Jan 2021, a day prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis.   On 05 Jan 2021, the patient had chills, fever, and a headache.   On 06 Jan 2021, the patient had a side effect of swelling and redness which covers the injection site. She also stated that around the injection site there was a big area with some itchiness. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness, was considered 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: big area with some itchiness; swelling and redness which covers the injection site; swelling and redness which covers the injection site; chills; fever; headache; A spontaneous report was received from a consumer, a female patient, who received Moderna's COVID-19 Vaccine and experienced chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness.  The patient's medical history was not provided. Relevant concomitant medications included simvastatin, amlodipine besilate, lisinopril, and hydrochlorothiazide.   On 04 Jan 2021, a day prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 intramuscularly for COVID-19 infection prophylaxis.   On 05 Jan 2021, the patient had chills, fever, and a headache.   On 06 Jan 2021, the patient had a side effect of swelling and redness which covers the injection site. She also stated that around the injection site there was a big area with some itchiness. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, fever, headache, swelling and redness which covers the injection site, and big area with some itchiness, was considered 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: temporary numbness of tongue; A spontaneous report was received from a consumer concerning his wife, a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced temporary numbness of tongue.  The patient's medical history was not provided nor were concomitant products.   On 08 Jan 2021 approximately two days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 10 Jan 2021, it was reported that the patient experienced temporary tongue numbness after waking from a nap.  It disappeared and returned to normal that same day.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, temporary numbness of tongue, was considered 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Heat at the injection site; Slight bruise at the injection site; Feeling of inflammation; One small hive, fairly large, underneath the injection site; Swollen at the injection site; Soreness at the injection site/Tiny bit of aching at the injection site; Red with a slight wheel at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 02-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 VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site). On 10-Jan-2021, VACCINATION SITE WARMTH (Heat at the injection site), VACCINATION SITE BRUISING (Slight bruise at the injection site), VACCINATION SITE INFLAMMATION (Feeling of inflammation), VACCINATION SITE URTICARIA (One small hive, fairly large, underneath the injection site), VACCINATION SITE SWELLING (Swollen at the injection site), VACCINATION SITE PAIN (Soreness at the injection site/Tiny bit of aching at the injection site) and VACCINATION SITE ERYTHEMA (Red with a slight wheel at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included betamethasone topically and fexofenadine.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: NNI; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Injection site pain, injection site swelling and injection site redness are consistent with the known safety profile of the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site warmth; injection site redness; hard lump underneath the injection site approximately 2 inches in size/lump increases to 3.75 in size; arm Sorenes; This spontaneous case was reported by a nurse and describes the occurrence of   in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMINS [VITAMINS NOS] for Immune disorder (NOS), CALCIUM CARBONATE, MAGNESIUM CARBONATE (MAGNESIUM CALCIUM) for an unknown indication.    On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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 medication includes ice packs and Ibuprofen400mg one tablet; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Red rash to chheeks and neck; A spontaneous report was received from a nurse concerning a 46-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed red rash to cheeks and neck.    The patient's medical history, as provided by the reporter, included drug allergies to codeine, penicillin, azithromycin and budesomide which cause red facial rash. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 027L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced, rash to cheeks and neck. Emergency medical services (EMS) was called to evaluate. Treatment for the event included EMS started intravenous access and administered 50mg diphenhydramine.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, developed red rash to cheeks and neck, were considered unknown.; Reporter's Comments: There is not enough information to assess the event as onset from treatment cannot be established and critical details about the case as well as other triggers cannot be established
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is swollen; Significant itching on the injection site; She may have chills; Injection site is red; Itching on her back and legs; Very little redness at the injection site; Very little pain; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching on her back and legs), INJECTION SITE ERYTHEMA (Very little redness at the injection site), INJECTION SITE PAIN (Very little pain), INJECTION SITE SWELLING (Injection site is swollen) and INJECTION SITE PRURITUS (Significant itching on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RB7K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (Very little redness at the injection site) and INJECTION SITE PAIN (Very little pain). On 07-Jan-2021, the patient experienced PRURITUS (Itching on her back and legs), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PRURITUS (Significant itching on the injection site), CHILLS (She may have chills) and INJECTION SITE ERYTHEMA (Injection site is red). On 31-Dec-2020, INJECTION SITE ERYTHEMA (Very little redness at the injection site) and INJECTION SITE PAIN (Very little pain) had resolved. On 07-Jan-2021, PRURITUS (Itching on her back and legs), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PRURITUS (Significant itching on the injection site), CHILLS (She may have chills) and INJECTION SITE ERYTHEMA (Injection site is red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   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.; Reporter'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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Injection site is swollen; Significant itching on the injection site; She may have chills; Injection site is red; Itching on her back and legs; Very little redness at the injection site; Very little pain; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching on her back and legs), INJECTION SITE ERYTHEMA (Very little redness at the injection site), INJECTION SITE PAIN (Very little pain), INJECTION SITE SWELLING (Injection site is swollen) and INJECTION SITE PRURITUS (Significant itching on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RB7K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (Very little redness at the injection site) and INJECTION SITE PAIN (Very little pain). On 07-Jan-2021, the patient experienced PRURITUS (Itching on her back and legs), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PRURITUS (Significant itching on the injection site), CHILLS (She may have chills) and INJECTION SITE ERYTHEMA (Injection site is red). On 31-Dec-2020, INJECTION SITE ERYTHEMA (Very little redness at the injection site) and INJECTION SITE PAIN (Very little pain) had resolved. On 07-Jan-2021, PRURITUS (Itching on her back and legs), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PRURITUS (Significant itching on the injection site), CHILLS (She may have chills) and INJECTION SITE ERYTHEMA (Injection site is red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   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.; Reporter'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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Scan, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (socially) and Marijuana use (handful) in 2014. Concurrent medical conditions included Deafness right ear. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Nausea and Vomiting, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 08-Jan-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 09-Aug-2020 and the estimated date of delivery was 16-May-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Scan: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) 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.   No treatment information was provided. Estimated date of conception was 23 Sep 2020.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received and contains no new information; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Clostridium test, Hypertension, Malaise, Throat tightness
Clinical narrative: Her pressure was high 200/78; She felt her throat tightening/Hard to swallow; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (to erythromycin), Hypertension, Haemoglobin low and Drug allergy (to Compazine). Concomitant products included HYDROCHLOROTHIAZIDE, ROSUVASTATIN, ATENOLOL, TELMISARTAN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse event following immunisation, at a dose of 25 milligram. At the time of the report, HYPERTENSION (Her pressure was high 200/78), THROAT TIGHTNESS (She felt her throat tightening/Hard to swallow) and MALAISE (not feeling well) outcome was unknown. they gave her an injection of Benadryl 25 mg. Took pressure again and it was still high. Ambulance stated she should go to ER. She went to the ER, felt better and went home. Pressure is still high    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 200/78 High. On an unknown date, Clostridium test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin bumps on right lower side of cheek, right side of neck, and under chin.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: Right after getting vaccine she get metallic test in mouth which goes away after 36 to 48 hours; soreness of left arm; A spontaneous report was received from a consumer concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a metallic taste in mouth and soreness of left arm.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 31- Dec 2020, after receiving the vaccine, the patient reported getting a metallic taste in her mouth and had soreness of left arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, developed a metallic taste in mouth, was considered resolved on 02-Jan-2021. The outcome of the event, soreness of left arm, was considered unknown.; Reporter's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Oropharyngeal pain
Clinical narrative: Sore throat; Light-headed; Injection site pain; A spontaneous report was received from a consumer concerning a 46-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced some injection site pain, sore throat and was light-headed.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient had some injection site pain, sore throat and was light-headed which lasted for a couple of days. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events of injection site pain, sore throat and was light-headed was recovered/resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 46-year-old male who had NS events of unexpected oropharyngeal pain, dizziness and expected injection site pain. Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on 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: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Poor quality sleep
Clinical narrative: Poor Sleep; Headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep) in a 55-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 reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 08-Jan-2021, the patient experienced HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep). On 07-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, HEADACHE (Headache) and POOR QUALITY SLEEP (Poor Sleep) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included glucose, potassium citrate, sodium chloride.   Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.; Reporter's Comments: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: GI symptoms, diarrhea; No appetite; Lost her taste; lost her sense of smell; couldn't move her arm, as if "arm was stuck to my body"; rash; Severe headache; Exhaustion; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ) and LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body") in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 03-Dec-2020 to 13-Dec-2020 and IgG subclass deficiency (Source states:  IgG3 Deficiency).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ), LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body"), RASH (rash ), HEADACHE (Severe headache), FATIGUE (Exhaustion) and CHILLS (Chills). On 31-Dec-2020, DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ), LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body"), RASH (rash ), HEADACHE (Severe headache), FATIGUE (Exhaustion) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Rash
Clinical narrative: GI symptoms, diarrhea; No appetite; Lost her taste; lost her sense of smell; couldn't move her arm, as if "arm was stuck to my body"; rash; Severe headache; Exhaustion; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ) and LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body") in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 03-Dec-2020 to 13-Dec-2020 and IgG subclass deficiency (Source states:  IgG3 Deficiency).    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ), LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body"), RASH (rash ), HEADACHE (Severe headache), FATIGUE (Exhaustion) and CHILLS (Chills). On 31-Dec-2020, DIARRHOEA (GI symptoms, diarrhea), DECREASED APPETITE (No appetite), AGEUSIA (Lost her taste ), ANOSMIA (lost her sense of smell ), LIMB DISCOMFORT (couldn't move her arm, as if "arm was stuck to my body"), RASH (rash ), HEADACHE (Severe headache), FATIGUE (Exhaustion) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Dizziness; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On 08-Jan-2021, DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Nausea is consistent with the known safety profile of mRNA-1273.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  Nausea is consistent with the known safety profile of mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: After getting vaccine I tested COVID positive two days later; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later). At the time of the report, SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided; Reporter's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of tested COVID positive and the product use is assessed as unlikely. The patient was most likely exposed to the disease prior to vaccination.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: Sore throat; Tested positive on PCR test; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive on PCR test) and OROPHARYNGEAL PAIN (Sore throat) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Tested positive on PCR test). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, COVID-19 (Tested positive on PCR test) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Polymerase chain reaction: positive (Positive) Positive. On 10-Jan-2021, Laboratory test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity, Pruritus, Rash, Throat tightness
Clinical narrative: Rash under the armpits & body; Itching a little; Tightness in the chest; A little tightness in the throat; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under the armpits & body), PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest), THROAT TIGHTNESS (A little tightness in the throat) and PAIN IN EXTREMITY (Sore left arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 31-Dec-2020, the patient experienced RASH (Rash under the armpits & body), PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest) and THROAT TIGHTNESS (A little tightness in the throat). On 31-Dec-2020, PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, RASH (Rash under the armpits & body) had resolved and PRURITUS (Itching a little), CHEST DISCOMFORT (Tightness in the chest) and THROAT TIGHTNESS (A little tightness in the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included hydrocortisone.  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.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fatigue; Fever; Nausea; Headache; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102.4 (High) 102.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fatigue; Fever; Nausea; Headache; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102.4 (High) 102.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided; Reporter'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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Very large, red, itchy spot on the insertion spot; Very large, red, itchy spot on the insertion spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot). At the time of the report, VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  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; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Swelling face
Clinical narrative: Heart rate went up; Face swelling; A spontaneous report was received from a consumer, concerning herself, a 33-years-old female patient, who received Moderna's COVID-19 Vaccine and experienced heart rate went up and face swelling.  The patient's medical history was not provided. The patient's historical drug included Benadryl. The patient was had allergic. Concomitant product use was not provided by the reporter.  On 13-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, patient developed face swelling and her heart rate went up. Patient confirmed that she received Benadryl prior to administration of vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, heart rate went up and face swelling were not reported.; Reporter's Comments: This case concerns a 33 year-old, female patient, who experienced events of heart rate went up and face swelling. The events occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red knot that is warm touch at the site of injection; Swollen knot at site of injection; Red knot at site of injection; A spontaneous report was received from a 64 years old female patient concerning herself, who received two doses of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, swollen red knot(injection site swelling), swollen red knot(injection site erythema), swollen red knot that was warm to touch at the site of injection(injection site warmth).  The patient's medical history was not provided. Concomitant medications were not reported.  On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient experienced swollen red knot that was warm to touch at the site of injection. Treatment for the events included antibiotics (Unspecified) and Diphenhydramine.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events swollen red knot that was warm to touch at the site of injection  were considered not resolved.; Reporter's Comments: This case concerns a 64-year-old female who experienced nonserious events of unexpected injection site warmth and expected injection site erythema, injection site swelling.  Event onset occurred 8 days after the first dose of mRNA-1273. Treatment with antibiotics and diphenhydramine. Events ongoing. Based on 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Redness at injection site; Pain at injection site; Arm started to hurt; Small bump at injection site; Itchy at injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site) and INJECTION SITE PRURITUS (Itchy at injection site). On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  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; Reporter'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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling of the skin near the site of the injection; Redness in her skin near injection site; Tendernes of the skin near the site of injection; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling of the skin near the site of the injection), VACCINATION SITE ERYTHEMA (Redness in her skin near injection site) and VACCINATION SITE PAIN (Tendernes of the skin near the site of injection) in a 48-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 reported medical history.). Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control pill.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling of the skin near the site of the injection), VACCINATION SITE ERYTHEMA (Redness in her skin near injection site) and VACCINATION SITE PAIN (Tendernes of the skin near the site of injection). At the time of the report, VACCINATION SITE SWELLING (swelling of the skin near the site of the injection), VACCINATION SITE ERYTHEMA (Redness in her skin near injection site) and VACCINATION SITE PAIN (Tendernes of the skin near the site of injection) 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 information was not provided.   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.; Reporter'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.