chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Rash, Vaccination site erythema
Clinical narrative: rash; redness at injection site; very tired; muscle and arm hurts, aches and pain; Slept most of the day; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included PREDNISONE, LOSARTAN, THYROID (ARMOUR THYROID) and ATORVASTATIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day). At the time of the report, RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day) outcome was unknown.            Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     NO Medical History Information was reported.  Concomitant products included PREDNISONE, LOSARTAN, THYROID (ARMOUR THYROID) and ATORVASTATIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day). At the time of the report, RASH (rash), VACCINATION SITE ERYTHEMA (redness at injection site), FATIGUE (very tired), MYALGIA (muscle and arm hurts, aches and pain) and ASTHENIA (Slept most of the day) outcome was unknown.            Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: High fever 101; Chills; Fatigue; Body joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Body joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Vomiting
Clinical narrative: Heartburn; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) and VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heartburn) and VOMITING (Vomiting). At the time of the report, DYSPEPSIA (Heartburn) had not resolved and VOMITING (Vomiting) outcome was unknown.            Treatment information not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, Myalgia
Clinical narrative: Loss of Taste; Loss of Smell; Fatigue; Positive COVID-19 Test; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell), FATIGUE (Fatigue) and MYALGIA (Body Aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (Body Aches) and HEADACHE (Headache). On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test). On 18-Jan-2021, the patient experienced AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue). On 09-Jan-2021, MYALGIA (Body Aches) and HEADACHE (Headache) had resolved. On 16-Jan-2021, SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) had resolved. At the time of the report, AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Loss of Taste; Loss of Smell; Fatigue; Positive COVID-19 Test; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell), FATIGUE (Fatigue) and MYALGIA (Body Aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (Body Aches) and HEADACHE (Headache). On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test). On 18-Jan-2021, the patient experienced AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue). On 09-Jan-2021, MYALGIA (Body Aches) and HEADACHE (Headache) had resolved. On 16-Jan-2021, SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) had resolved. At the time of the report, AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache, Injection site reaction, Nausea
Clinical narrative: Severe reaction at the site; No appetite; Fogginess in the head; Fever; Nausea; Severe headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (Severe reaction at the site), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Fogginess in the head), PYREXIA (Fever) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE REACTION (Severe reaction at the site), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Fogginess in the head), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Severe headache). On 24-Jan-2021, INJECTION SITE REACTION (Severe reaction at the site), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, DECREASED APPETITE (No appetite) had resolved, FEELING ABNORMAL (Fogginess in the head) had not resolved and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe reaction at the site; No appetite; Fogginess in the head; Fever; Nausea; Severe headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (Severe reaction at the site), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Fogginess in the head), PYREXIA (Fever) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE REACTION (Severe reaction at the site), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Fogginess in the head), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Severe headache). On 24-Jan-2021, INJECTION SITE REACTION (Severe reaction at the site), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, DECREASED APPETITE (No appetite) had resolved, FEELING ABNORMAL (Fogginess in the head) had not resolved and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Dizziness, Fatigue, Flushing
Clinical narrative: 2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.; hypersensitivity; joint pain both knees; joint pain right shoulder/joint pain left hand; very tired/sleepy; blurred vision; Blood pressure high; flush left side of face; Light-headedness; back of head/neck soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness) and NECK PAIN (back of head/neck soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Patient is allergic to Propofol which contains polysorbate (gets flu-like symptoms) and Allergy (Patient is also allergic to Demerol.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain both knees), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity). On 13-Jan-2021, VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity) outcome was unknown and ARTHRALGIA (joint pain both knees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 179/89 (High) shot up to 179/89, 172/89 (High) After 15 minutes172/89., 163 (High) After 30 minutes 163/8?. and 121/85 (normal) At 2:00 BP was normal 121/85..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Patient stated that she was allergic to vaccine and asked about the vaccine compounds and product dose omission was reported.Contact information updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypertension, Neck pain, Product dose omission issue, Vision blurred
Clinical narrative: 2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.; hypersensitivity; joint pain both knees; joint pain right shoulder/joint pain left hand; very tired/sleepy; blurred vision; Blood pressure high; flush left side of face; Light-headedness; back of head/neck soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness) and NECK PAIN (back of head/neck soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Patient is allergic to Propofol which contains polysorbate (gets flu-like symptoms) and Allergy (Patient is also allergic to Demerol.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain both knees), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity). On 13-Jan-2021, VISION BLURRED (blurred vision), HYPERTENSION (Blood pressure high), FLUSHING (flush left side of face), DIZZINESS (Light-headedness), NECK PAIN (back of head/neck soreness), ARTHRALGIA (joint pain right shoulder/joint pain left hand) and FATIGUE (very tired/sleepy) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose because she wanted to take the second shot and has been refused by healthcare providers due to her reaction to the first dose.) and HYPERSENSITIVITY (hypersensitivity) outcome was unknown and ARTHRALGIA (joint pain both knees) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 179/89 (High) shot up to 179/89, 172/89 (High) After 15 minutes172/89., 163 (High) After 30 minutes 163/8?. and 121/85 (normal) At 2:00 BP was normal 121/85..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information and concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Patient stated that she was allergic to vaccine and asked about the vaccine compounds and product dose omission was reported.Contact information updated.
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: hot flushing; arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site). On 24-Feb-2021, HOT FLUSH (hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved.            No concomitant product use was reported.   No treatment information was provided   This case was linked to MOD-2021-021490 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: TCR received on 25-FEB-2021. Updated patient identifiers. Added new events
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at vaccination site). On 27-Jan-2021, VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: Positive.         The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-021557 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Vaccination site pain
Clinical narrative: Arm was itching; Arm is now red; white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.); Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itching), ERYTHEMA (Arm is now red), RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)) and VACCINATION SITE PAIN (Pain at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 26-Jan-2021, the patient experienced PRURITUS (Arm was itching), ERYTHEMA (Arm is now red) and RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)). At the time of the report, PRURITUS (Arm was itching), ERYTHEMA (Arm is now red), RASH MACULAR (white spot in middle of the redness that is halfway down her arm (between shoulder and elbow.)) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concerned as white spot in middle of the redness that was halfway down her arm (shoulder and elbow) was few inches away from the injection site.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Fatigue; 99 F temperature; muscle pain; soreness in the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (soreness in the arm), FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: periods of hot flushing; arm soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site). On 24-Feb-2021, HOT FLUSH (periods of hot flushing) and VACCINATION SITE PAIN (arm soreness at vaccination site) had resolved.            Action taken with mRNA-1273 was not applicable. No concomitant medications reported by reporter. No Treatment medication was taken.   This case was linked to MOD-2021-021554 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: TCR received on 25-FEB-2021. Updated patient identifiers. Added new events. Information about dose 1 and dose 2
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort
Clinical narrative: Arm sore; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of   in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Aspirin
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling hot, Peripheral coldness, Pyrexia
Clinical narrative: could feel heat from both legs; hands freezing; soft bowl movements; fever of 101f; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued). At the time of the report, FEELING HOT (could feel heat from both legs), PERIPHERAL COLDNESS (hands freezing), DIARRHOEA (soft bowl movements), PYREXIA (fever of 101f) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Pyrexia: fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Sarna lotion to relief itch.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Swollen at injection site; Itching at injection site; Hives towards neck; Tiny muscle pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tiny muscle pain at injection site), INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METHOTREXATE, MELOXICAM, Plaquenil and Folic acid 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 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Tiny muscle pain at injection site). On 29-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck). At the time of the report, INJECTION SITE PAIN (Tiny muscle pain at injection site), INJECTION SITE SWELLING (Swollen at injection site), INJECTION SITE PRURITUS (Itching at injection site) and URTICARIA (Hives towards neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Steroids
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Coagulopathy, Discomfort, Myalgia
Clinical narrative: blood would not clot; Debilitating joint pain/weak joints were extremely sore; Back really itched; uncomfortable; felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concurrent medical conditions included Arthritis NOS. Concomitant products included GABAPENTIN for Arthritis, ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE), VITAMIN B NOS, LOPERAMIDE, NAPROXEN, PARACETAMOL (TYLENOL) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Back really itched), DISCOMFORT (uncomfortable) and MYALGIA (felt achy). On 30-Jan-2021, the patient experienced ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore). On 04-Feb-2021, the patient experienced COAGULOPATHY (blood would not clot). At the time of the report, PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: abnormal (abnormal) pre-operation bloodwork done and result showed her blood would not clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Due to bloodwork result ,Patient scheduled lung surgery on 05-Feb-2021 which had canceled.  A few lymph nodes were removed robotically and lung nodule removed robotically on 19-Feb-2021.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: New events added and event outcome updated, concomitant medications added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: blood would not clot; Debilitating joint pain/weak joints were extremely sore; Back really itched; uncomfortable; felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concurrent medical conditions included Arthritis NOS. Concomitant products included GABAPENTIN for Arthritis, ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE), VITAMIN B NOS, LOPERAMIDE, NAPROXEN, PARACETAMOL (TYLENOL) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Back really itched), DISCOMFORT (uncomfortable) and MYALGIA (felt achy). On 30-Jan-2021, the patient experienced ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore). On 04-Feb-2021, the patient experienced COAGULOPATHY (blood would not clot). At the time of the report, PRURITUS (Back really itched), COAGULOPATHY (blood would not clot), DISCOMFORT (uncomfortable), MYALGIA (felt achy) and ARTHRALGIA (Debilitating joint pain/weak joints were extremely sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood test: abnormal (abnormal) pre-operation bloodwork done and result showed her blood would not clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Due to bloodwork result ,Patient scheduled lung surgery on 05-Feb-2021 which had canceled.  A few lymph nodes were removed robotically and lung nodule removed robotically on 19-Feb-2021.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: New events added and event outcome updated, concomitant medications added.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feeling groggy; Nauseas; High blood pressure (160/80); Arm was swelling; Dizziness; Fatigue/tired; Achiness; Fever of 101.6 F; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness) and FATIGUE (Fatigue/tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril, chlorothiazide and cleocin.), Penicillin allergy, Hypertension and Prediabetes. Concomitant products included AMLODIPINE, METOPROLOL and LOSARTAN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness) and PYREXIA (Fever of 101.6 F). On 19-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling groggy) and NAUSEA (Nauseas). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness), PYREXIA (Fever of 101.6 F) and NAUSEA (Nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 160/80 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Feeling groggy; Nauseas; High blood pressure (160/80); Arm was swelling; Dizziness; Fatigue/tired; Achiness; Fever of 101.6 F; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness) and FATIGUE (Fatigue/tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril, chlorothiazide and cleocin.), Penicillin allergy, Hypertension and Prediabetes. Concomitant products included AMLODIPINE, METOPROLOL and LOSARTAN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness) and PYREXIA (Fever of 101.6 F). On 19-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling groggy) and NAUSEA (Nauseas). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure (160/80)), PERIPHERAL SWELLING (Arm was swelling), FEELING ABNORMAL (Feeling groggy), DIZZINESS (Dizziness), FATIGUE (Fatigue/tired), MYALGIA (Achiness), PYREXIA (Fever of 101.6 F) and NAUSEA (Nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 160/80 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy, Tachycardia
Clinical narrative: Swollen lymphnodes in left side of the neck; An acceleration in her heart rate; Twinges of pain in her chest; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (An acceleration in her heart rate), CHEST PAIN (Twinges of pain in her chest) and LYMPHADENOPATHY (Swollen lymphnodes in left side of the neck) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TACHYCARDIA (An acceleration in her heart rate) and CHEST PAIN (Twinges of pain in her chest). On 22-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymphnodes in left side of the neck). On 17-Feb-2021, TACHYCARDIA (An acceleration in her heart rate) and CHEST PAIN (Twinges of pain in her chest) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymphnodes in left side of the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Skin burning sensation
Clinical narrative: Itching at injection site; Red bump at injection site; Itching in the armpit of the injection; Burning sensation skin; Burning sensation in the arm pit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Red bump at injection site), PRURITUS (Itching in the armpit of the injection), SKIN BURNING SENSATION (Burning sensation skin) and SKIN BURNING SENSATION (Burning sensation in the arm pit) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date and Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Iodine allergy. Concomitant products included LOSARTAN, METFORMIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and INSULIN for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Red bump at injection site), PRURITUS (Itching in the armpit of the injection), SKIN BURNING SENSATION (Burning sensation skin) and SKIN BURNING SENSATION (Burning sensation in the arm pit). On 20-Jan-2021, INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Red bump at injection site) and PRURITUS (Itching in the armpit of the injection) had resolved. At the time of the report, SKIN BURNING SENSATION (Burning sensation skin) and SKIN BURNING SENSATION (Burning sensation in the arm pit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Myalgia
Clinical narrative: Felt Cold; Chills; Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache). On 19-Feb-2021, FEELING COLD (Felt Cold), CHILLS (Chills), MYALGIA (Aches) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tylenoll
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain, Swelling
Clinical narrative: a little swelling; Pain about a 1.5 or 2 out of 10; Fatigue; Insomnia; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (a little swelling), PAIN (Pain about a 1.5 or 2 out of 10), INSOMNIA (Insomnia) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INSOMNIA (Insomnia). On 24-Jan-2021, the patient experienced SWELLING (a little swelling), PAIN (Pain about a 1.5 or 2 out of 10) and FATIGUE (Fatigue). On 25-Jan-2021, PAIN (Pain about a 1.5 or 2 out of 10) and INSOMNIA (Insomnia) had resolved. At the time of the report, SWELLING (a little swelling) and FATIGUE (Fatigue) 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 considered INSOMNIA (Insomnia) and FATIGUE (Fatigue) to be possibly related. No further causality assessments were provided for SWELLING (a little swelling) and PAIN (Pain about a 1.5 or 2 out of 10).    Treatment included Pt preemptively took 800 mg of ibuprofen about 1 hour prior to vaccination. No concomitant medications reported.    This case was linked to MOD-2021-018447 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash on left arm; Swelling; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection), INJECTION SITE RASH (Rash on left arm) and INJECTION SITE SWELLING (Swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection) and INJECTION SITE SWELLING (Swelling).   On 13-Feb-2021, the patient experienced INJECTION SITE RASH (Rash on left arm). The patient was treated with HYDROCORTISONE at a dose of UNK UNK, tid.   On 12-Feb-2021, INJECTION SITE PAIN (Pain at injection) and INJECTION SITE SWELLING (Swelling) had resolved. At the time of the report, INJECTION SITE RASH (Rash on left arm) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.