chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Muscular weakness, Myalgia
Clinical narrative: Weakness in legs and arms; Not felt good since then; No energy; Headache; Aches all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs and arms), FEELING ABNORMAL (Not felt good since then), ASTHENIA (No energy), HEADACHE (Headache) and MYALGIA (Aches all over) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (Not felt good since then), ASTHENIA (No energy), HEADACHE (Headache) and MYALGIA (Aches all over). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Weakness in legs and arms). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs and arms) had not resolved and FEELING ABNORMAL (Not felt good since then), ASTHENIA (No energy), HEADACHE (Headache) and MYALGIA (Aches all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The first 2 days after the vaccine, she had aches all over,headache and no energy.She later felt better.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Myalgia, Pyrexia, Rash
Clinical narrative: rashes; uncomfortable bumps on his groin and back that come and go; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever). At the time of the report, RASH (rashes), MASS (uncomfortable bumps on his groin and back that come and go), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as IBUPROFEN.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: eczema patches all over including neck, back, arms, face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ECZEMA (eczema patches all over including neck, back, arms, face) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema patches all over including neck, back, arms, face). At the time of the report, ECZEMA (eczema patches all over including neck, back, arms, face) 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.   Please note that treatment information of strong steroid cream was provided by the reporter.   Reporter did not allow further contact; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm pain; Swollen eyes; Red ring around injection site; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Arm pain; Swollen eyes; Red ring around injection site; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), EYE SWELLING (Swollen eyes), VACCINATION SITE ERYTHEMA (Red ring around injection site), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Peripheral swelling
Clinical narrative: Dizzy spells; Left arm sore; Left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells), PAIN IN EXTREMITY (Left arm sore) and PERIPHERAL SWELLING (Left arm swollen) in a 39-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm sore) and PERIPHERAL SWELLING (Left arm swollen). On 16-Apr-2021, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells), PAIN IN EXTREMITY (Left arm sore) and PERIPHERAL SWELLING (Left arm swollen) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus\ ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus\ ringing in both ears) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (Tinnitus\ ringing in both ears). At the time of the report, TINNITUS (Tinnitus\ ringing in both ears) outcome was unknown. Not Provided          Treatment information was not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Below injection site there is a rash that looks like a burn that is the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter). At the time of the report, VACCINATION SITE RASH (Below injection site there is a rash that looks like a burn that is the size of a quarter) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Still has great deal of redness in her arm; Redness at the injection site; Swollen at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Still has great deal of redness in her arm), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM for Anxiety, LEVOTHYROXINE for Thyroid disorder NOS.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ERYTHEMA (Still has great deal of redness in her arm), INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site). At the time of the report, ERYTHEMA (Still has great deal of redness in her arm) had not resolved and INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Swollen at injection site) and INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: slept for 13 hours; feels he's having low sugar because he is diabetic; has not eaten anything all day; unsure if he has a fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever). At the time of the report, SOMNOLENCE (slept for 13 hours), BLOOD GLUCOSE DECREASED (feels he's having low sugar because he is diabetic), DECREASED APPETITE (has not eaten anything all day) and PYREXIA (unsure if he has a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided.  Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchy rash onher  injection arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash onher  injection arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy rash onher  injection arm). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash onher  injection arm) had resolved. Not Provided      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 were not provided. The treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Pain, Pyrexia
Clinical narrative: Metallic taste; Body aches; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills). At the time of the report, DYSGEUSIA (Metallic taste), PAIN (Body aches), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Feeling hot, Headache
Clinical narrative: Not hydrated enough; tired/fatigue; Headaches; Overheated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Overheated), DEHYDRATION (Not hydrated enough), FATIGUE (tired/fatigue) and HEADACHE (Headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FEELING HOT (Overheated), FATIGUE (tired/fatigue) and HEADACHE (Headaches). On an unknown date, the patient experienced DEHYDRATION (Not hydrated enough). On 29-Mar-2021, FEELING HOT (Overheated) had resolved. On 31-Mar-2021, FATIGUE (tired/fatigue) and HEADACHE (Headaches) had resolved. At the time of the report, DEHYDRATION (Not hydrated enough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       2nd dose scheduled for 16Apr2021.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Non Significant - DOB add.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Vomiting
Clinical narrative: Vomiting; Dizziness; stomach ache/severe stomach pain/Severe stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (stomach ache/severe stomach pain/Severe stomach ache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products were not provided.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VOMITING (Vomiting), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (stomach ache/severe stomach pain/Severe stomach ache). On 10-Mar-2021, VOMITING (Vomiting), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (stomach ache/severe stomach pain/Severe stomach ache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Treatment products included milk of magnesia, Buscapina .   Reporter did not allow further contact
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Lower Back Ache; Fever; Head Ache; Injection site arm sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BACK PAIN (Lower Back Ache), VACCINATION SITE PAIN (Injection site arm sore), PYREXIA (Fever) and HEADACHE (Head Ache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site arm sore). On 16-Apr-2021, the patient experienced BACK PAIN (Lower Back Ache), PYREXIA (Fever) and HEADACHE (Head Ache). On 15-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, BACK PAIN (Lower Back Ache), VACCINATION SITE PAIN (Injection site arm sore), PYREXIA (Fever) and HEADACHE (Head Ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye swelling, Headache, Ocular discomfort, Vision blurred
Clinical narrative: Pain in the shoulders; Eyes are swollen; Headaches; Cannot open eyes in the morning; Blurry eyes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Laser therapy.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-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 ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes). At the time of the report, ARTHRALGIA (Pain in the shoulders), EYE SWELLING (Eyes are swollen), HEADACHE (Headaches), OCULAR DISCOMFORT (Cannot open eyes in the morning) and VISION BLURRED (Blurry eyes) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079251 (E2B Linked Report).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: Swelling in her arm; Pain in her legs; Difficulty standing up from a chair; Becoming short of breath; No Energy/weakness; Difficulty with walking; Pain in her joints; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath) and ASTHENIA (No Energy/weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL/CHLORTHALIDONE), ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LEVOTHYROXINE, MEMANTINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), POTASSIUM, MAGNESIUM and VITAMIN D3 for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), ASTHENIA (No Energy/weakness), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness) outcome was unknown and ASTHENIA (No Energy/weakness) had not resolved.            Patient had no adverse event after first dose. Treatment details include oxygen taken for shortness of breath. Action taken with mRNA-1273 in response to the events was  not applicable Patient still have not recovered with the muscles and weakness. She consents to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received and Outcome of the event "asthenia" was updated from unknown to not recovered
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling in her arm; Pain in her legs; Difficulty standing up from a chair; Becoming short of breath; No Energy/weakness; Difficulty with walking; Pain in her joints; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath) and ASTHENIA (No Energy/weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL/CHLORTHALIDONE), ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LEVOTHYROXINE, MEMANTINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), POTASSIUM, MAGNESIUM and VITAMIN D3 for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), ASTHENIA (No Energy/weakness), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness). At the time of the report, PERIPHERAL SWELLING (Swelling in her arm), PAIN IN EXTREMITY (Pain in her legs), DYSSTASIA (Difficulty standing up from a chair), DYSPNOEA (Becoming short of breath), GAIT DISTURBANCE (Difficulty with walking), ARTHRALGIA (Pain in her joints) and FATIGUE (Extreme tiredness) outcome was unknown and ASTHENIA (No Energy/weakness) had not resolved.            Patient had no adverse event after first dose. Treatment details include oxygen taken for shortness of breath. Action taken with mRNA-1273 in response to the events was  not applicable Patient still have not recovered with the muscles and weakness. She consents to follow up.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received and Outcome of the event "asthenia" was updated from unknown to not recovered
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dyspnoea, Fatigue, Hypoaesthesia
Clinical narrative: Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days; pain when taking a deep breath; numbness on leg and arm; feels like he is having a heart attack and feel like squeezing; Back pain , was extreme pain; felt tired and relaxed with first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing) and BACK PAIN (Back pain , was extreme pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer and Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing), BACK PAIN (Back pain , was extreme pain) and FATIGUE (felt tired and relaxed with first dose). In March 2021, MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing), BACK PAIN (Back pain , was extreme pain) and FATIGUE (felt tired and relaxed with first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.        Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 17-Apr-2021 contains significant information including lot number, location, updated medical conditions, new event was added and outcome of all event were updated from unknown to resolved. On 18-Jun-2021: Follow up received on 18-Apr-2021 contains no new information.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days; pain when taking a deep breath; numbness on leg and arm; feels like he is having a heart attack and feel like squeezing; Back pain , was extreme pain; felt tired and relaxed with first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing) and BACK PAIN (Back pain , was extreme pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer and Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing), BACK PAIN (Back pain , was extreme pain) and FATIGUE (felt tired and relaxed with first dose). In March 2021, MUSCLE SPASMS (Severe muscle spasms size of walnut knot, by the shoulder and injection site/ feels like a cramp in is the leg be going on for 3-5 days), DYSPNOEA (pain when taking a deep breath), HYPOAESTHESIA (numbness on leg and arm), CHEST DISCOMFORT (feels like he is having a heart attack and feel like squeezing), BACK PAIN (Back pain , was extreme pain) and FATIGUE (felt tired and relaxed with first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information not provided.        Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 17-Apr-2021 contains significant information including lot number, location, updated medical conditions, new event was added and outcome of all event were updated from unknown to resolved. On 18-Jun-2021: Follow up received on 18-Apr-2021 contains no new information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site erythema, Vaccination site warmth
Clinical narrative: At the injection site she has a huge red area; Super hot to the touch at injection site; Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I). At the time of the report, VACCINATION SITE ERYTHEMA (At the injection site she has a huge red area), VACCINATION SITE WARMTH (Super hot to the touch at injection site) and AXILLARY MASS (Between my neck bone and shoulder bone I have like a ball inside that literally moves in my skin, I) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Pain in bones; Nausea; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: unknown (Positive) COVID Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-079694, MOD-2021-079062 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pain in bones; Nausea; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: unknown (Positive) COVID Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-079694, MOD-2021-079062 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arrm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arrm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arrm). At the time of the report, PAIN IN EXTREMITY (Sore arrm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-079221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on  29-JUN-2021.Event outcome  updated(from unknown to recovered/resolved).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Gastritis, Pain, Vomiting
Clinical narrative: Constipation; Vomiting; stomach felt inflamed; pain; there was air inside; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside). The patient was treated with MILK OF MAGNESIA at an unspecified dose and frequency and HYOSCINE BUTYLBROMIDE (BUSCAPINA) at an unspecified dose and frequency. On 10-Apr-2021, CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside) had resolved. Not Provided          This case was linked to MOD-2021-079201 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: case; Sender's Comments:  MOD-2021-079201:1st dose
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Sleep disorder
Clinical narrative: sleep pattern is kind of messed up; feeling fatigued; hasn't been able to sleep as normal; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling fatigued), INSOMNIA (hasn't been able to sleep as normal) and SLEEP DISORDER (sleep pattern is kind of messed up) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DEXTROAMPHETAMINE HYDROCHLORIDE, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), AMLODIPINE, LAMOTRIGINE, LISINOPRIL, CETIRIZINE, ATORVASTATIN, SILDENAFIL, SUVOREXANT, MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (feeling fatigued) and INSOMNIA (hasn't been able to sleep as normal). On an unknown date, the patient experienced SLEEP DISORDER (sleep pattern is kind of messed up). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FATIGUE (feeling fatigued), INSOMNIA (hasn't been able to sleep as normal) and SLEEP DISORDER (sleep pattern is kind of messed up) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included DEXTROAMPHETAMINE HYDROCHLORIDE, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), AMLODIPINE, LAMOTRIGINE, LISINOPRIL, CETIRIZINE, ATORVASTATIN, SILDENAFIL, SUVOREXANT, MULTIVITAMINS & MINERALS PLUS LUTEIN and FISH OIL. The patient was treated with IBUPROFEN.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye swelling, Headache, Lymphadenopathy
Clinical narrative: right eye is swollen; breathes and lungs hurt; swollen lymph nodes under the left arm; Headache; fever 102/ 101.6; Chills; achiness; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache) and PYREXIA (fever 102/ 101.6) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), PYREXIA (fever 102/ 101.6), CHILLS (Chills) and MYALGIA (achiness). On 16-Apr-2021, the patient experienced EYE SWELLING (right eye is swollen). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 1 dosage form. At the time of the report, EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (achiness) outcome was unknown and PYREXIA (fever 102/ 101.6) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6-102 (High) Fever of 101.6 to 102. is high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079413:daughter case
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pulmonary pain, Pyrexia
Clinical narrative: right eye is swollen; breathes and lungs hurt; swollen lymph nodes under the left arm; Headache; fever 102/ 101.6; Chills; achiness; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache) and PYREXIA (fever 102/ 101.6) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), PYREXIA (fever 102/ 101.6), CHILLS (Chills) and MYALGIA (achiness). On 16-Apr-2021, the patient experienced EYE SWELLING (right eye is swollen). The patient was treated with IBUPROFEN for Fever and Headache, at a dose of 1 dosage form. At the time of the report, EYE SWELLING (right eye is swollen), PULMONARY PAIN (breathes and lungs hurt), LYMPHADENOPATHY (swollen lymph nodes under the left arm), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (achiness) outcome was unknown and PYREXIA (fever 102/ 101.6) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6-102 (High) Fever of 101.6 to 102. is high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079413:daughter case
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), DIGOXIN, TRAMADOL, DILTIAZEM, MECLIZINE HCL, PANTOPRAZOLE, RIVAROXABAN (XARELTO) and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes ice pack.