chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; chills; Nausea; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body ache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (No medical history reported.) and Cholesterol.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (Nausea) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication included Thyroid Medication and Cholesterol medication
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Oral pruritus, Pharyngeal swelling, Swelling face
Clinical narrative: Itching of the throat; roof of my mouth itching; the back of my throat felt swollen and itching; Red rash at injection site the size of baseball; Red rash at injection site the size of baseball; injection arm hurting; Swelling of lower cheek; Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling of lower cheek), THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching) and VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball) in a 63-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.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SWELLING FACE (Swelling of lower cheek) and ARTHRALGIA (Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed). On an unknown date, the patient experienced THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching), VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball), VACCINATION SITE RASH (Red rash at injection site the size of baseball) and MYALGIA (injection arm hurting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; HISTAMINE at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg and IBUPROFEN at a dose of 800 mg. On 14-Apr-2021, ARTHRALGIA (Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed) had resolved. At the time of the report, SWELLING FACE (Swelling of lower cheek), THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching), VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball), VACCINATION SITE RASH (Red rash at injection site the size of baseball) and MYALGIA (injection arm hurting) outcome was unknown.            Concomitant products included Kidney stone prevention medication for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow up received on 02-JUN-2021.Reporter information was updated, patient demographic details was updated, treatment information was updated, events was updated , dosage information was updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site erythema, Vaccination site rash
Clinical narrative: Itching of the throat; roof of my mouth itching; the back of my throat felt swollen and itching; Red rash at injection site the size of baseball; Red rash at injection site the size of baseball; injection arm hurting; Swelling of lower cheek; Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling of lower cheek), THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching) and VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball) in a 63-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.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SWELLING FACE (Swelling of lower cheek) and ARTHRALGIA (Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed). On an unknown date, the patient experienced THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching), VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball), VACCINATION SITE RASH (Red rash at injection site the size of baseball) and MYALGIA (injection arm hurting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; HISTAMINE at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg and IBUPROFEN at a dose of 800 mg. On 14-Apr-2021, ARTHRALGIA (Shoulder blade pain on same side of injection arm/felt like fracture/hurt when sneezed) had resolved. At the time of the report, SWELLING FACE (Swelling of lower cheek), THROAT IRRITATION (Itching of the throat), ORAL PRURITUS (roof of my mouth itching), PHARYNGEAL SWELLING (the back of my throat felt swollen and itching), VACCINATION SITE ERYTHEMA (Red rash at injection site the size of baseball), VACCINATION SITE RASH (Red rash at injection site the size of baseball) and MYALGIA (injection arm hurting) outcome was unknown.            Concomitant products included Kidney stone prevention medication for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow up received on 02-JUN-2021.Reporter information was updated, patient demographic details was updated, treatment information was updated, events was updated , dosage information was updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Infection
Clinical narrative: infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No relevant medical history was provided.  The patient's past medical history included COVID-19 in October 2020. Concomitant products included METFORMIN, LISINOPRIL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL, INSULIN GLARGINE (LANTUS), NITROGLYCERIN, ATORVASTATIN, METOPROLOL TARTRATE, ISOSORBIDE MONONITRATE (ISORBIDE [ISOSORBIDE MONONITRATE]), TICAGRELOR (BRILINTA), DEXLANSOPRAZOLE (DEXILANT), EMPAGLIFLOZIN (JARDIANCE), CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN), ESTRADIOL, MAGNESIUM and TRAZODONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Infection, at a dose of 1 dosage form and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Infection, at a dose of 1 dosage form. At the time of the report, INFECTION (infection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient finished taking Augmentin antibiotic for an infection on 04Apr2021 and completed Medrol dose pack steroid last week.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Rash, Ultrasound scan
Clinical narrative: lump, bigger than a pea but smaller than a marble on the left side above the collarbone; rash on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) and RASH (rash on the chest) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for an unknown indication.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) and RASH (rash on the chest). At the time of the report, NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) outcome was unknown and RASH (rash on the chest) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Ultrasound scan: inconclusive (Inconclusive) Inconclusive.         No concomitant medications were reported.   Patient consulted their dermatologist and was given an unspecified cream. An ultrasound of the lump was performed and the patient was urged to have a CT scan performed following the results.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: whole body was itchy; injection site hot; injection site swollen; injection site red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (whole body was itchy), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) in a 48-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (whole body was itchy), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, PRURITUS (whole body was itchy), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: No newinformation
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Gait disturbance
Clinical narrative: lack of energy; trouble walking up a single flight upstairs; reduced appetite; She overall feels exhausted as of now; About 6 days later, she started with muscle pain; About 6 days later, she started with joint pain; His wife had lethargy and headache for 24 hours after receiving 2nd dose; His wife had lethargy and headache for 24 hours after receiving 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy) and MYALGIA (About 6 days later, she started with muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.  Concomitant products included LISINOPRIL, ROSUVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose). On 23-Feb-2021, the patient experienced MYALGIA (About 6 days later, she started with muscle pain). 23-Feb-2021, the patient experienced ARTHRALGIA (About 6 days later, she started with joint pain). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), ASTHENIA (lack of energy) and FATIGUE (She overall feels exhausted as of now). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy), MYALGIA (About 6 days later, she started with muscle pain), ARTHRALGIA (About 6 days later, she started with joint pain) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose) outcome was unknown and FATIGUE (She overall feels exhausted as of now) had not resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia
Clinical narrative: lack of energy; trouble walking up a single flight upstairs; reduced appetite; She overall feels exhausted as of now; About 6 days later, she started with muscle pain; About 6 days later, she started with joint pain; His wife had lethargy and headache for 24 hours after receiving 2nd dose; His wife had lethargy and headache for 24 hours after receiving 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy) and MYALGIA (About 6 days later, she started with muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided.  Concomitant products included LISINOPRIL, ROSUVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose). On 23-Feb-2021, the patient experienced MYALGIA (About 6 days later, she started with muscle pain). 23-Feb-2021, the patient experienced ARTHRALGIA (About 6 days later, she started with joint pain). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), ASTHENIA (lack of energy) and FATIGUE (She overall feels exhausted as of now). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (trouble walking up a single flight upstairs), DECREASED APPETITE (reduced appetite), LETHARGY (His wife had lethargy and headache for 24 hours after receiving 2nd dose), ASTHENIA (lack of energy), MYALGIA (About 6 days later, she started with muscle pain), ARTHRALGIA (About 6 days later, she started with joint pain) and HEADACHE (His wife had lethargy and headache for 24 hours after receiving 2nd dose) outcome was unknown and FATIGUE (She overall feels exhausted as of now) had not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Headache, Inner ear inflammation
Clinical narrative: losing more hair than normal; cold sores appearing randomly; inflammation of ears; inflammation of pallet randomly; pain when swallowing; pain in hands; weakness at a level 10; fever; chills; muscle pain at a level 8; very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly) and ODYNOPHAGIA (pain when swallowing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (very strong headache). On an unknown date, the patient experienced ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), ASTHENIA (weakness at a level 10), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle pain at a level 8). On 22-Mar-2021, HEADACHE (very strong headache) had resolved. At the time of the report, ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), CHILLS (chills) and MYALGIA (muscle pain at a level 8) had not resolved and ASTHENIA (weakness at a level 10) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Odynophagia, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: losing more hair than normal; cold sores appearing randomly; inflammation of ears; inflammation of pallet randomly; pain when swallowing; pain in hands; weakness at a level 10; fever; chills; muscle pain at a level 8; very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly) and ODYNOPHAGIA (pain when swallowing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (very strong headache). On an unknown date, the patient experienced ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), ASTHENIA (weakness at a level 10), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle pain at a level 8). On 22-Mar-2021, HEADACHE (very strong headache) had resolved. At the time of the report, ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), CHILLS (chills) and MYALGIA (muscle pain at a level 8) had not resolved and ASTHENIA (weakness at a level 10) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: losing more hair than normal; cold sores appearing randomly; inflammation of ears; inflammation of pallet randomly; pain when swallowing; pain in hands; weakness at a level 10; fever; chills; muscle pain at a level 8; very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly) and ODYNOPHAGIA (pain when swallowing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (very strong headache). On an unknown date, the patient experienced ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), ASTHENIA (weakness at a level 10), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle pain at a level 8). On 22-Mar-2021, HEADACHE (very strong headache) had resolved. At the time of the report, ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), CHILLS (chills) and MYALGIA (muscle pain at a level 8) had not resolved and ASTHENIA (weakness at a level 10) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided). Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) 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.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (welts). At the time of the report, URTICARIA (welts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-067731 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Dizziness postural, Dry eye
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oropharyngeal pain, Pruritus, Swelling face, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Fever 100; Chills; headache; body aches; fever of 101.3; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (body aches), PYREXIA (fever of 101.3), PYREXIA (Fever 100) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 04-Apr-2021, the patient experienced PYREXIA (fever of 101.3). On 05-Apr-2021, the patient experienced PAIN (body aches) and HEADACHE (headache). On 14-Apr-2021, the patient experienced CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever 100). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (body aches), PYREXIA (fever of 101.3), PYREXIA (Fever 100), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Body temperature: 101.3 (abnormal) fever:101.3. On 05-Apr-2021, Body temperature: 100 (abnormal) fever:100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 100; Chills; headache; body aches; fever of 101.3; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (body aches), PYREXIA (fever of 101.3), PYREXIA (Fever 100) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 04-Apr-2021, the patient experienced PYREXIA (fever of 101.3). On 05-Apr-2021, the patient experienced PAIN (body aches) and HEADACHE (headache). On 14-Apr-2021, the patient experienced CHILLS (Chills). On 15-Apr-2021, the patient experienced PYREXIA (Fever 100). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (body aches), PYREXIA (fever of 101.3), PYREXIA (Fever 100), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Body temperature: 101.3 (abnormal) fever:101.3. On 05-Apr-2021, Body temperature: 100 (abnormal) fever:100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Eye pain, Fatigue, Hordeolum
Clinical narrative: sick; awful gastric stomach pain; loose bowels; very tired; sharp pain in eye/Eyes hurt to touch; developed a stye on her left eye/developed stye on my right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (sharp pain in eye/Eyes hurt to touch), HORDEOLUM (developed a stye on her left eye/developed stye on my right eye), ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Arthritis, PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EYE PAIN (sharp pain in eye/Eyes hurt to touch) and FATIGUE (very tired). 27-Mar-2021, the patient experienced HORDEOLUM (developed a stye on her left eye/developed stye on my right eye). On an unknown date, the patient experienced ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels). At the time of the report, EYE PAIN (sharp pain in eye/Eyes hurt to touch) had not resolved, HORDEOLUM (developed a stye on her left eye/developed stye on my right eye) and FATIGUE (very tired) had resolved and ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) outcome was unknown.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067715 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-Jun-2021 content significant information. Dosage information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067715:Dose 1
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; awful gastric stomach pain; loose bowels; very tired; sharp pain in eye/Eyes hurt to touch; developed a stye on her left eye/developed stye on my right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (sharp pain in eye/Eyes hurt to touch), HORDEOLUM (developed a stye on her left eye/developed stye on my right eye), ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Arthritis, PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EYE PAIN (sharp pain in eye/Eyes hurt to touch) and FATIGUE (very tired). 27-Mar-2021, the patient experienced HORDEOLUM (developed a stye on her left eye/developed stye on my right eye). On an unknown date, the patient experienced ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels). At the time of the report, EYE PAIN (sharp pain in eye/Eyes hurt to touch) had not resolved, HORDEOLUM (developed a stye on her left eye/developed stye on my right eye) and FATIGUE (very tired) had resolved and ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) outcome was unknown.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067715 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-Jun-2021 content significant information. Dosage information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067715:Dose 1
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Erythema, Inflammation of wound, Myalgia
Clinical narrative: Hard time breathing; Scrape got all swelled up; Swelling all over; Scrape turned red; Muscle soreness; Joint soreness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), INFLAMMATION OF WOUND (Scrape got all swelled up), SWELLING (Swelling all over), ERYTHEMA (Scrape turned red) and MYALGIA (Muscle soreness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cut wound (6 inches long scrape on the hand.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (Hard time breathing), INFLAMMATION OF WOUND (Scrape got all swelled up), SWELLING (Swelling all over), ERYTHEMA (Scrape turned red), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint soreness). At the time of the report, DYSPNOEA (Hard time breathing), SWELLING (Swelling all over), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint soreness) was resolving and INFLAMMATION OF WOUND (Scrape got all swelled up) and ERYTHEMA (Scrape turned red) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.