chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash, Rash pruritic, Urticaria
Clinical narrative: Flushed face; Rash was so inflamed and itchy; Rash on her neck and arms that she said may be hives, huge hives; so itchy she was going crazy; Bad rash all over her upper body: shoulders, neck, chest and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Rash on her neck and arms that she said may be hives, huge hives), FLUSHING (Flushed face), PRURITUS (so itchy she was going crazy), RASH PRURITIC (Rash was so inflamed and itchy) and RASH (Bad rash all over her upper body: shoulders, neck, chest and arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031mzoa) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (Bad rash all over her upper body: shoulders, neck, chest and arms). On 22-Feb-2021, the patient experienced PRURITUS (so itchy she was going crazy). On 24-Feb-2021, the patient experienced URTICARIA (Rash on her neck and arms that she said may be hives, huge hives) and RASH PRURITIC (Rash was so inflamed and itchy). On 25-Feb-2021, the patient experienced FLUSHING (Flushed face). On 23-Feb-2021, PRURITUS (so itchy she was going crazy) had resolved. At the time of the report, URTICARIA (Rash on her neck and arms that she said may be hives, huge hives), FLUSHING (Flushed face), RASH PRURITIC (Rash was so inflamed and itchy) and RASH (Bad rash all over her upper body: shoulders, neck, chest and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment was a combination of hydrocortisone cream and tea tree oil on the rash which maybe helped.   This case was linked to MOD-2021-054414 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant Follow up received- The event Pruritus was added. Medical was added. Event outcome was changed to recovered. On 24-Jul-2021: Non Significant Follow up
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling cold, Malaise, Weight decreased
Clinical narrative: Extremely cold; Did not feel good for three days; No appetite; Losing weight; Still not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M200A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well). At the time of the report, FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well) outcome was unknown.            Concomitant product used was not provided by the reporter. The patient has a call into her physician.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Nausea
Clinical narrative: Dizziness; Chills; Fever - Temperature of 101.0F; Body Aches; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches) and FATIGUE (Fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator. Used "Advil" - Self medicating to try to alleviate symptoms   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Chills; Fever - Temperature of 101.0F; Body Aches; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches) and FATIGUE (Fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever - Temperature of 101.0F), MYALGIA (Body Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator. Used "Advil" - Self medicating to try to alleviate symptoms   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Slightly Firm on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Slightly Firm on the Injection Site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Energy decreased and Muscle pain.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Slightly Firm on the Injection Site). On 26-Feb-2021, VACCINATION SITE INDURATION (Slightly Firm on the Injection Site) had resolved.            No concomitant medications were reported Medical history included unspecified genetic disorder. The patient reported that after the second vaccination he felt more energetic and healthier. He believes the vaccine improved his overall health.   This case was linked to MOD-2021-027878 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: pain in kidney; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (pain in kidney) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (pain in kidney). At the time of the report, RENAL PAIN (pain in kidney) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; A spontaneous report was received from a consumer concerning a 29-years old pregnant female patient who experienced exposure to vaccine during pregnancy.   The patient's medical history was not reported. Concomitant medication reported mentions prenatal vitamins, unisom, promethazine and vitamin b-12.   The patient received their first of the two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in the left arm on 30 Jan 2021 for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient received the second of the two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient had a positive pregnancy test on 04 Dec 2020. Her last menstrual period was in 06 Nov 2020 and estimated date of conception was 06 Nov 2020. The patients estimated due date is 13 Aug 2021. On 30 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable as patient took both doses of the vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Skin abrasion, Sticky skin, Swelling of eyelid
Clinical narrative: Felt like scraping; sticky; Swollen Eyelids; Up all night; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swollen Eyelids), INSOMNIA (Up all night), SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced SWELLING OF EYELID (Swollen Eyelids) and INSOMNIA (Up all night). On 25-Feb-2021, the patient experienced SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky). On 23-Feb-2021, INSOMNIA (Up all night) had resolved. At the time of the report, SWELLING OF EYELID (Swollen Eyelids), SKIN ABRASION (Felt like scraping) and STICKY SKIN (sticky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Miliaria, Pruritus, Swelling
Clinical narrative: Redness; itching; swelling; heat; headache; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itching), SWELLING (swelling), MILIARIA (heat) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD028L2) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia, Diabetes and High cholesterol. Concomitant products included METOPROLOL, METFORMIN, LEVOTHYROXINE, PRAVASTATIN, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), ASCORBIC ACID, ZINC (VITAMIN C + ZINC), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL, COLECALCIFEROL, UBIDECARENONE (CO-Q10+VITAMIN D3), GLUCOSAMINE, ELDERBERRY [SAMBUCUS NIGRA] and ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for an unknown indication.    On 22-Jan-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (itching), SWELLING (swelling), MILIARIA (heat) and HEADACHE (headache). At the time of the report, ERYTHEMA (Redness), PRURITUS (itching), SWELLING (swelling), MILIARIA (heat) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has ever had any adverse event following any prior vaccination
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on left side of neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     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 09-Feb-2021, the patient experienced SWELLING (Swelling on left side of neck). At the time of the report, SWELLING (Swelling on left side of neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dry mouth, Irritable bowel syndrome, Nausea, Vaccination site pain
Clinical narrative: cramping in her stomach; IBS may be acting up; nausea; dry mouth at night; pain at the injection site; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cramping in her stomach, nausea, dry mouth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Don't have this with her) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) cramping in her stomach, nausea, dry mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cramping in her stomach, nausea, dry mouth was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Herpes zoster
Clinical narrative: Serious Constipation; shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03CM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles). At the time of the report, CONSTIPATION (Serious Constipation) and HERPES ZOSTER (shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in her hand; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in her hand/ paraesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced the event tingling in her hand/ paraesthesia. No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  tingling in her hand/ paraesthesia was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Stomach discomfort; Headache; Fever; Chills; is exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), PYREXIA (Fever) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (Headache), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), PYREXIA (Fever) and CHILLS (Chills). On 23-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, HEADACHE (Headache), DIZZINESS (Dizziness) and ABDOMINAL DISCOMFORT (Stomach discomfort) outcome was unknown.      Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant follow up appended - Email address updated.; 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: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Stomach discomfort; Headache; Fever; Chills; is exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), PYREXIA (Fever) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (Headache), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), PYREXIA (Fever) and CHILLS (Chills). On 23-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, HEADACHE (Headache), DIZZINESS (Dizziness) and ABDOMINAL DISCOMFORT (Stomach discomfort) outcome was unknown.      Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant follow up appended - Email address updated.; 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: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Vaccination site erythema
Clinical narrative: vaccination site erythema; right arm hurt.; "a feeling of a rapid heartbeat"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (vaccination site erythema), PALPITATIONS ("a feeling of a rapid heartbeat") and PAIN IN EXTREMITY (right arm hurt.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date, Hypertension since an unknown date, Migraine since an unknown date, Burning mouth syndrome since an unknown date, Sore throat since an unknown date, Coronary stent placement in 2016 and Coronary stent placement in February 2020. Concomitant products included PROPRANOLOL for Migraine, CLINDAMYCIN, DULOXETINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), OLMESARTAN, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), MONTELUKAST, VITAMIN D3, CALCIUM, VITAMIN C [ASCORBIC ACID] and VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PALPITATIONS ("a feeling of a rapid heartbeat"). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm hurt.). On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema), PALPITATIONS ("a feeling of a rapid heartbeat") and PAIN IN EXTREMITY (right arm hurt.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a little tired; sore arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm). At the time of the report, FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Axillary pain, Chest pain, Discomfort, Lymphadenopathy
Clinical narrative: side effects; in his upper right chest, next to his breast, is sore; it runs from his right breast to his right arm armpit; swelling of lymph nodes but he's unsure; soreness at the injection site; in his upper right chest, next to his breast, is discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit) and LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C16M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DISCOMFORT (in his upper right chest, next to his breast, is discomfort). On 09-Feb-2021, the patient experienced ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient stated that he had the vaccine but his only side effect was the sore arm and it has gone away. Provided up-to-date contact information. Does not want safety to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: side effects; in his upper right chest, next to his breast, is sore; it runs from his right breast to his right arm armpit; swelling of lymph nodes but he's unsure; soreness at the injection site; in his upper right chest, next to his breast, is discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit) and LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C16M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DISCOMFORT (in his upper right chest, next to his breast, is discomfort). On 09-Feb-2021, the patient experienced ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, ADVERSE DRUG REACTION (side effects), CHEST PAIN (in his upper right chest, next to his breast, is sore), DISCOMFORT (in his upper right chest, next to his breast, is discomfort), AXILLARY PAIN (it runs from his right breast to his right arm armpit), LYMPHADENOPATHY (swelling of lymph nodes but he's unsure) and VACCINATION SITE PAIN (soreness at the 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient stated that he had the vaccine but his only side effect was the sore arm and it has gone away. Provided up-to-date contact information. Does not want safety to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had sore arm for one day; A spontaneous report was received from a consumer  concerning a 79year old, female patient who developed arm sore and 2nd drug dose administration interval too long.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included aendronate (70mg), eye medication, aspirin and vitamin C.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A) on 19 Jan 2021.   The patient had arm sore for one day. She had an appointment on 05 March 2021 for her second dose administration. The dose interval was 45 days which she had tried to reschedule the 2nd dose but there was no result.   Treatment for the event include one acetaminophen on 19Jan2021.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events was unknown.; Reporter's Comments: This report refers to a case of Inappropriate schedule of Vaccine administration for mRNA-1273 with a reported event of Vaccination site pain. 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 for the event of Vaccination site pain.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up for 12 hours) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (throwing up for 12 hours). At the time of the report, VOMITING (throwing up for 12 hours) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-040393, MOD21-040423 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pyrexia
Clinical narrative: no energy; feeling terrible; fever; tired; This spontaneous case was reported by an other caregiver and describes the occurrence of ASTHENIA (no energy), MALAISE (feeling terrible), PYREXIA (fever) and FATIGUE (tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced ASTHENIA (no energy), MALAISE (feeling terrible), PYREXIA (fever) and FATIGUE (tired). At the time of the report, ASTHENIA (no energy), MALAISE (feeling terrible), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant (received vaccine); This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live full time birth) on 19-Nov-2019 and Complication of pregnancy (High Blood Pressure).    On 25-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 20-Dec-2020 and the estimated date of delivery was 26-Sep-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2020, Pregnancy test: 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.   Estimated date conception was reported on an unknown date in unknown month of 2020. Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; Fever; nausea; Muscle pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), NAUSEA (nausea) and MYALGIA (Muscle pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), NAUSEA (nausea) and MYALGIA (Muscle pains). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever), NAUSEA (nausea) and MYALGIA (Muscle pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot to touch; Arm of the injection started itching; Redness the color changed to red like 3 inches size; Nodule on injection site; Same arm sore on the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE NODULE (Nodule on injection site), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE PRURITUS (Arm of the injection started itching), VACCINATION SITE PAIN (Same arm sore on the injection site) and VACCINATION SITE ERYTHEMA (Redness the color changed to red like 3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE NODULE (Nodule on injection site) and VACCINATION SITE PAIN (Same arm sore on the injection site). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE PRURITUS (Arm of the injection started itching) and VACCINATION SITE ERYTHEMA (Redness the color changed to red like 3 inches size). On 18-Feb-2021, VACCINATION SITE NODULE (Nodule on injection site) and VACCINATION SITE PAIN (Same arm sore on the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE PRURITUS (Arm of the injection started itching) and VACCINATION SITE ERYTHEMA (Redness the color changed to red like 3 inches size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included paracetamol 325 mg two tablets/day and Claritin (antihistaminic).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Myalgia, Neck pain
Clinical narrative: Neck muscle soreness; Soreness radiated through entire skull; Pyrexia; felt enormously fatigued; myalgia; Arm soreness; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), INJECTION SITE ERYTHEMA (Redness at injection site), NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site). On 20-Feb-2021, the patient experienced NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull), PYREXIA (Pyrexia), FATIGUE (Felt enormously fatigue) and MYALGIA (myalgia). On 15-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved. On 23-Feb-2021, PYREXIA (Pyrexia) had resolved. On 25-Feb-2021, MYALGIA (myalgia) had resolved. At the time of the report, NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and FATIGUE (Felt enormously fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101.0 (High) 101.0 degree F low grade fever stayed for 3days. On 20-Feb-2021, COVID-19:. On 22-Feb-2021, COVID-19: Negative.         Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient Demographics added. New event added. Information of 2nd dose of vaccine added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination complication, Vaccination site erythema
Clinical narrative: Neck muscle soreness; Soreness radiated through entire skull; Pyrexia; felt enormously fatigued; myalgia; Arm soreness; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), INJECTION SITE ERYTHEMA (Redness at injection site), NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and PYREXIA (Pyrexia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site). On 20-Feb-2021, the patient experienced NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull), PYREXIA (Pyrexia), FATIGUE (Felt enormously fatigue) and MYALGIA (myalgia). On 15-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved. On 23-Feb-2021, PYREXIA (Pyrexia) had resolved. On 25-Feb-2021, MYALGIA (myalgia) had resolved. At the time of the report, NECK PAIN (Neck muscle soreness), VACCINATION COMPLICATION (Soreness radiated through entire skull) and FATIGUE (Felt enormously fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101.0 (High) 101.0 degree F low grade fever stayed for 3days. On 20-Feb-2021, COVID-19:. On 22-Feb-2021, COVID-19: Negative.         Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient Demographics added. New event added. Information of 2nd dose of vaccine added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Rash on legs; rash on chest; rash on ankles; red dots; Rash on arms; this spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of rash (rash on ankles), erythema (red dots), rash (rash on arms), rash (rash on legs) and rash (rash on chest) in a 78-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for covid-19 vaccination.     the patient's past medical history included chronic kidney disease stage 3 (patients report stage 3 kidney disease), cardiovascular disease, unspecified (patients report cardiovascular disease), hypertension (patients report hypertension), hypercholesterolemia (patients report hypercholesterolemia), hyperkalemia (patients report hyperkalemia) and obesity (patients report obesity). concomitant products included hydrocodone, paracetamol (tylenol), cholecalciferol, diclofenac sodium, diltiazem, furosemide, hydralazine, magnesium oxide, omeprazole, simvastatin, venlafaxine, hydrocortisone (hydrocortisone 1% in absorbase) and hydrocortisone (hydrocortisone 1% in absorbase).  the action taken with mrna-1273 (moderna covid-19 vaccine) (intramuscular) was unknown. Treatment medication include hydrocortisone cream.  on 22-feb-2021, the patient received first dose of mrna-1273 (moderna covid-19 vaccine) (intramuscular) 1 dosage form. on 24-feb-2021, the patient experienced rash (rash on ankles), erythema (red dots), rash (rash on arms) and rash (rash on chest). on an unknown date, the patient experienced rash (rash on legs). at the time of the report, rash (rash on ankles), erythema (red dots) and rash (rash on arms) outcome was unknown.        for mrna-1273 (moderna covid-19 vaccine) (intramuscular), the reporter did not provide any causality assessments .
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Swelling
Clinical narrative: aches; dizziness; swollen a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), DIZZINESS (dizziness) and SWELLING (swollen a little) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Bypass surgery. Previously administered products included for an unreported indication: STEROIDS and REMDESIVIR. Concurrent medical conditions included Diabetic.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (aches), DIZZINESS (dizziness) and SWELLING (swollen a little). At the time of the report, PAIN (aches), DIZZINESS (dizziness) and SWELLING (swollen a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports being hospitalized with COVID In July of 2020 treated with REMDESIVIR and a STEROID (NOS).  No concomitant medication reported.  No treatment information reported.  Patient reports being hospitalized with COVID In July of 2020 treated with REMDESIVIR and a STEROID (NOS).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR form attached
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling, Vaccination site rash
Clinical narrative: Covid arm which enlarged; Big red rash at injection site; Sore and tender to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch). At the time of the report, PERIPHERAL SWELLING (Covid arm which enlarged), INJECTION SITE RASH (Big red rash at injection site) and AXILLARY PAIN (Sore and tender to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports treating big red rash at injection site with ICE.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Nasopharyngitis, Pain
Clinical narrative: Soreness/achiness; Cold; Flu like symptoms; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness/achiness), NASOPHARYNGITIS (Cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant product use was not provided.   Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains :Reporter denied consent to follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Soreness; Mild swelling; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness) and SWELLING (Mild swelling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025j20A) for COVID-19 vaccination.     No Medical History information was reported.   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. On 11-Jan-2021, the patient experienced PAIN (Soreness) and SWELLING (Mild swelling). At the time of the report, PAIN (Soreness) and SWELLING (Mild swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.