chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 101.4F) and TINNITUS (really loud ringing in her ears and if she moved, it was buzzing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 101.4F) and TINNITUS (really loud ringing in her ears and if she moved, it was buzzing). At the time of the report, CHILLS (Chills), PYREXIA (Fever 101.4F) and TINNITUS (really loud ringing in her ears and if she moved, it was buzzing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: UNCONTROLLABLE SHAKING; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (UNCONTROLLABLE SHAKING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (UNCONTROLLABLE SHAKING). At the time of the report, TREMOR (UNCONTROLLABLE SHAKING) outcome was unknown.        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 MODERNATX, INC.-MOD-2021-022839 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-022839:Crosslinked (MOD21-021326)
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Sore arm for one day now; Itchy rash on upper arm 4 inches by 2 inches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for one day now) and RASH PRURITIC (Itchy rash on upper arm 4 inches by 2 inches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash on upper arm 4 inches by 2 inches). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for one day now). At the time of the report, PAIN IN EXTREMITY (Sore arm for one day now) and RASH PRURITIC (Itchy rash on upper arm 4 inches by 2 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. Lab data was not provided.  No treatment information was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning out; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced BURNING SENSATION (Burning out). At the time of the report, BURNING SENSATION (Burning out) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first vaccine dose and experienced burning out post receiving the vaccine.   On 21-May-2021, the patient reported that they were feeling fine. Reportedly, the patient tool the second dose of vaccine and experienced no side effects.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR report was received on 21-May-2021and additional details were added. Updated the outcome of the event. Updated the action taken for the suspect drug. Included the liner for the second dose in I-narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: warm to the touch; injection site pain re-emerged; injection site redness; pain at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (fatigue), VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness). On 18-Jan-2021, VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch) outcome was unknown and VACCINATION SITE PAIN (injection site pain re-emerged) and INJECTION SITE ERYTHEMA (injection site redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication is not reported No treatment drug has been reported.   This case was linked to MOD-2021-029943 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site scar
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.), TENDERNESS (Arm was tender to the touch), VACCINATION SITE SCAR (3" mark at injection site) and VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included Mastectomy. Concomitant products included ALBUMIN HUMAN, GLUCOSE, INTERFERON BETA (BETASERON [ALBUMIN HUMAN;GLUCOSE;INTERFERON BETA]), OXCARBAZEPINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Arm was tender to the touch). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.) and VACCINATION SITE SCAR (3" mark at injection site). On 08-Feb-2021, the patient experienced VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.). At the time of the report, VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.), TENDERNESS (Arm was tender to the touch), VACCINATION SITE SCAR (3" mark at injection site) and VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included cortisone cream. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rash; This spontaneous case was reported by a nurse and describes the occurrence of RASH (skin rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (skin rash). At the time of the report, RASH (skin rash) outcome was unknown. Not Provided      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 concomitant product information was reported.   Treatment information include some type of topical steroid cream.   This case was linked to US-MODERNATX, INC.-MOD-2021-027273 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027273:Group reporting
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms not rash; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms not rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms not rash). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms not rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: NNI On 22-Apr-2021: Significant follow up-event updated as flu like symptoms and not rash
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site warmth
Clinical narrative: headache; site of injection feels hot; site of injection developed red marks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (site of injection feels hot), VACCINATION SITE ERYTHEMA (site of injection developed red marks) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (site of injection feels hot) and VACCINATION SITE ERYTHEMA (site of injection developed red marks). On 09-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (site of injection feels hot), VACCINATION SITE ERYTHEMA (site of injection developed red marks) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Aspirin.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid positive test done, came back as detected; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included LISINOPRIL for an unknown indication.    On 07-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 SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid positive test done, came back as detected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment were not provided   This case was linked to MOD-2021-008849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Email has been changed and IRD was updated
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: feeling weak; have low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak) and PYREXIA (have low grade fever) in a 92-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 No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENIA (feeling weak) and PYREXIA (have low grade fever). At the time of the report, ASTHENIA (feeling weak) and PYREXIA (have low grade fever) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red itchy spot size of half a dollar/ Itchy; Red blotches all over arm and it is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading) in a 76-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 30-Jan-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 VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading). At the time of the report, VACCINATION SITE PRURITUS (Red itchy spot size of half a dollar/ Itchy) and VACCINATION SITE ERYTHEMA (Red blotches all over arm and it is spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID-19/ symptoms of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19/ symptoms of COVID-19) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL for an unknown indication.    On 13-Jan-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 COVID-19 (tested positive for COVID-19/ symptoms of COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19/ symptoms of COVID-19) outcome was unknown. Not Provided      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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: fever; arm was sore and painful to move; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore and painful to move), CHILLS (chills) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore and painful to move) and CHILLS (chills). On 09-Feb-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm was sore and painful to move), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: degree Celsius 37-37.9 degrees Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up information received contains updated outcome - events resolved after 2 days of vaccine. On 27-Jul-2021: No new information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Tachycardia
Clinical narrative: Fast heart beat; tight stomach; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart beat) and MUSCLE TIGHTNESS (tight stomach) in a female patient of an unknown age 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat) and MUSCLE TIGHTNESS (tight stomach). On 08-Mar-2021, TACHYCARDIA (Fast heart beat) had resolved. At the time of the report, MUSCLE TIGHTNESS (tight stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash papular
Clinical narrative: Redness the size of a half dollar; Raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised). At the time of the report, ERYTHEMA (Redness the size of a half dollar) and RASH PAPULAR (Raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio fluctuation
Clinical narrative: INR jumped to 3.9/INR was 3.5/INR was 2.1; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR jumped to 3.9/INR was 3.5/INR was 2.1) 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 No adverse event (No Historical condition reported). Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR jumped to 3.9/INR was 3.5/INR was 2.1). At the time of the report, INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR jumped to 3.9/INR was 3.5/INR was 2.1) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, International normalised ratio: 3.9 (Inconclusive) INR jumped to 3.9. On 05-Feb-2021, International normalised ratio: 3.5 (Inconclusive) INR was 3.5. On 09-Feb-2021, International normalised ratio: 2.1 (Inconclusive) INR dropped to 2.1.     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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: fullness/stuffiness in nasal; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (fullness/stuffiness in nasal) in a 77-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.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NASAL CONGESTION (fullness/stuffiness in nasal). At the time of the report, NASAL CONGESTION (fullness/stuffiness in nasal) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling face
Clinical narrative: her face swollen; Face and neck extremely hot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (her face swollen) and FEELING HOT (Face and neck extremely hot) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (her face swollen) and FEELING HOT (Face and neck extremely hot). At the time of the report, SWELLING FACE (her face swollen) and FEELING HOT (Face and neck extremely hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Nasopharyngitis
Clinical narrative: muscle pain; cold; chills; achy all over; sweating at night; joint pain; left arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over) and HYPERHIDROSIS (sweating at night) in a male 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 No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (left arm was a little sore). On 05-Feb-2021, the patient experienced MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over), HYPERHIDROSIS (sweating at night) and ARTHRALGIA (joint pain). On 06-Feb-2021, MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over), HYPERHIDROSIS (sweating at night) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PAIN (left arm was a little sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: muscle pain; cold; chills; achy all over; sweating at night; joint pain; left arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over) and HYPERHIDROSIS (sweating at night) in a male 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 No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (left arm was a little sore). On 05-Feb-2021, the patient experienced MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over), HYPERHIDROSIS (sweating at night) and ARTHRALGIA (joint pain). On 06-Feb-2021, MYALGIA (muscle pain), NASOPHARYNGITIS (cold), CHILLS (chills), PAIN IN EXTREMITY (achy all over), HYPERHIDROSIS (sweating at night) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PAIN (left arm was a little sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain in extremity
Clinical narrative: soreness under both arms and breasts; soreness under both arms and breasts; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts). At the time of the report, BREAST PAIN (soreness under both arms and breasts) and PAIN IN EXTREMITY (soreness under both arms and breasts) had not resolved.        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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: his bottom lip got big on the right side, like is gonna burst.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (his bottom lip got big on the right side, like is gonna burst.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (Unspecified.).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced LIP SWELLING (his bottom lip got big on the right side, like is gonna burst.). On 08-Feb-2021, LIP SWELLING (his bottom lip got big on the right side, like is gonna burst.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Vomiting; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction on hands; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction on hands) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction on hands). At the time of the report, VACCINATION COMPLICATION (Adverse reaction on hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102.7 fever; 103.5 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103.5 fever) and PYREXIA (102.7 fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (103.5 fever). On 10-Feb-2021, the patient experienced PYREXIA (102.7 fever). At the time of the report, PYREXIA (103.5 fever) and PYREXIA (102.7 fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR document was attached. No new information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Oropharyngeal pain
Clinical narrative: Tested COVID19 positive; Sore Throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID19 positive), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced COVID-19 (Tested COVID19 positive). At the time of the report, COVID-19 (Tested COVID19 positive), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles; This spontaneous case was reported by a dietician (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Developed Shingles) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.    Co-suspect product included non-company product VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started VALACYCLOVIR [VALACICLOVIR] (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced HERPES ZOSTER (Developed Shingles). At the time of the report, HERPES ZOSTER (Developed Shingles) outcome was unknown.        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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: couldn't really eat anything; sweating; weakness; fatigue; headache; chills; nausea; fever; arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting) and PYREXIA (fever). On 05-Feb-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Feb-2021, NAUSEA (nausea) had resolved. On 07-Feb-2021, PAIN IN EXTREMITY (arm started hurting) had resolved. At the time of the report, DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: couldn't really eat anything; sweating; weakness; fatigue; headache; chills; nausea; fever; arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting) and PYREXIA (fever). On 05-Feb-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Feb-2021, NAUSEA (nausea) had resolved. On 07-Feb-2021, PAIN IN EXTREMITY (arm started hurting) had resolved. At the time of the report, DECREASED APPETITE (couldn't really eat anything), HYPERHIDROSIS (sweating), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Came down with COVID; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Came down with COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with COVID). At the time of the report, COVID-19 (Came down with COVID) had resolved. Not Provided      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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Illness, Nausea, Neck pain
Clinical narrative: Body aches, Body pain; swollen arm; dizzy; sweating; Sharp pain in my neck; shaking from head to toe; Light headed; Felt like I had Covid all over again; Felt violently ill; nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating) and NECK PAIN (Sharp pain in my neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Tremor, Type IV hypersensitivity reaction
Clinical narrative: Body aches, Body pain; swollen arm; dizzy; sweating; Sharp pain in my neck; shaking from head to toe; Light headed; Felt like I had Covid all over again; Felt violently ill; nausea; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating) and NECK PAIN (Sharp pain in my neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches, Body pain), PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizzy), HYPERHIDROSIS (sweating), NECK PAIN (Sharp pain in my neck), TREMOR (shaking from head to toe), DIZZINESS (Light headed), TYPE IV HYPERSENSITIVITY REACTION (Felt like I had Covid all over again), ILLNESS (Felt violently ill), NAUSEA (nausea) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 test positive, Sinus pain
Clinical narrative: fatigue; chills; woesening sinus issues; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues). At the time of the report, FATIGUE (fatigue), CHILLS (chills) and SINUS PAIN (woesening sinus issues) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Headache, Injection site warmth
Clinical narrative: now arm has redness; its hot; redness at injection site; pain at injection site; weakness; light headedness; severe headache; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness) and HEADACHE (severe headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache) and RASH (rash). On 06-Feb-2021, the patient experienced ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache), RASH (rash), ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain
Clinical narrative: now arm has redness; its hot; redness at injection site; pain at injection site; weakness; light headedness; severe headache; rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness) and HEADACHE (severe headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache) and RASH (rash). On 06-Feb-2021, the patient experienced ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain at injection site), ASTHENIA (weakness), DIZZINESS (light headedness), HEADACHE (severe headache), RASH (rash), ERYTHEMA (now arm has redness) and INJECTION SITE WARMTH (its hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose), MYALGIA (body aches) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Diabetic. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-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 MYALGIA (body aches) and FATIGUE (fatigue). On 01-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose). On 31-Jan-2021, MYALGIA (body aches) and FATIGUE (fatigue) had resolved. At the time of the report, ANTIBODY TEST NEGATIVE (antibody test was negative 2 weeks after the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided.