chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: He experienced a fever of 100 degrees F; He experienced body aches; He experienced soreness of the arm at the injection site; He experienced swelling of the arm at the injection site; He experienced headache; He experienced tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (He experienced headache), FATIGUE (He experienced tiredness), PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches) and VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse event. Concomitant products included METFORMIN, GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LISINOPRIL, VITAMIN D3 and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (He experienced headache) and FATIGUE (He experienced tiredness). On 09-Apr-2021, the patient experienced PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches), VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) and VACCINATION SITE SWELLING (He experienced swelling of the arm at the injection site). At the time of the report, HEADACHE (He experienced headache), FATIGUE (He experienced tiredness), PYREXIA (He experienced a fever of 100 degrees F), MYALGIA (He experienced body aches), VACCINATION SITE PAIN (He experienced soreness of the arm at the injection site) and VACCINATION SITE SWELLING (He experienced swelling of the arm at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR form attached on 24-may-2021 , Non - significant information , not interested to report details
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Didn't feel well after his 2nd dose; This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (Didn't feel well after his 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Didn't feel well after his 2nd dose). At the time of the report, VACCINATION COMPLICATION (Didn't feel well after his 2nd dose) outcome was unknown.            No treatment information was reported. Concomitant medication was not provided.   This case was linked to MOD-2021-006025 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Throat tightness
Clinical narrative: Tightening in the throat; Mild soreness in the muscles all over the body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body). At the time of the report, THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Condition aggravated, Discomfort, Dizziness, Fluid retention
Clinical narrative: It kept getting worst; Fluid build up in underarm area; Underarm area with discomfort / When she puts her arm down, it is uncomfortable; It looks like a balloon; Discomfort insider her bra; Lightheadedness; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst) and FLUID RETENTION (Fluid build up in underarm area) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm sore). On 10-Apr-2021, the patient experienced BREAST DISCOMFORT (Discomfort insider her bra ). On 12-Apr-2021, the patient experienced CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon). At the time of the report, DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included warm compress.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up information was received on 12-APR-2021. Added dose unit details & Batch number, events durations, events outcome, and updated Treatment details.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: It kept getting worst; Fluid build up in underarm area; Underarm area with discomfort / When she puts her arm down, it is uncomfortable; It looks like a balloon; Discomfort insider her bra; Lightheadedness; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst) and FLUID RETENTION (Fluid build up in underarm area) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm sore). On 10-Apr-2021, the patient experienced BREAST DISCOMFORT (Discomfort insider her bra ). On 12-Apr-2021, the patient experienced CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon). At the time of the report, DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Arm sore), BREAST DISCOMFORT (Discomfort insider her bra ), CONDITION AGGRAVATED (It kept getting worst), FLUID RETENTION (Fluid build up in underarm area), DISCOMFORT (Underarm area with discomfort / When she puts her arm down, it is uncomfortable) and SWELLING (It looks like a balloon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included warm compress.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up information was received on 12-APR-2021. Added dose unit details & Batch number, events durations, events outcome, and updated Treatment details.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information was not provided.   This case was linked to MOD-2021-250809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received on 8-JUN-2021 updated outcome of the event and action taken.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine; three patients received second Moderna COVID-19 dose over 37 days after first dose; three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving). At the time of the report, COVID-19 (three patients tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and SARS-COV-2 ANTIBODY TEST (three patients received second Moderna COVID-19 Vaccine less than 90 days after receiving) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (three patients received second Moderna COVID-19 dose over 37 days after first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Treatment medications were Monoclonal Antibody Shot on 15Feb2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021621A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in 2020 and the estimated date of delivery was 14-Aug-2021. On 09-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: pregnancy report received on 12-APR-2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; 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 VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Sore area by nose after 2nd dose; Painful swelling by nose after 2nd dose; Excruciating headache between eyes after 2nd dose; Small scab by nose after 2nd dose; Very acidy nasal drip after 2nd dose; Skin raised with blister like bumps by nose after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; Muscle aches after 2nd dose; Headache after 2nd dose; Lymph nodes achy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Body aches after 2nd dose) and PAIN (Sore area by nose after 2nd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer female (Breast cancer right  side 10 years ago).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose). On 04-Apr-2021, the patient experienced SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose) and HEADACHE (Excruciating headache between eyes after 2nd dose). At the time of the report, SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose), HEADACHE (Excruciating headache between eyes after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose) outcome was unknown and PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose) and HEADACHE (Headache after 2nd dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f (High) 101 F.         Concomitant medication history not reported by reporter. Treatment information was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Rhinorrhoea, Scab
Clinical narrative: Sore area by nose after 2nd dose; Painful swelling by nose after 2nd dose; Excruciating headache between eyes after 2nd dose; Small scab by nose after 2nd dose; Very acidy nasal drip after 2nd dose; Skin raised with blister like bumps by nose after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; Muscle aches after 2nd dose; Headache after 2nd dose; Lymph nodes achy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Body aches after 2nd dose) and PAIN (Sore area by nose after 2nd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer female (Breast cancer right  side 10 years ago).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose). On 04-Apr-2021, the patient experienced SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose) and HEADACHE (Excruciating headache between eyes after 2nd dose). At the time of the report, SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose), HEADACHE (Excruciating headache between eyes after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose) outcome was unknown and PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose) and HEADACHE (Headache after 2nd dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f (High) 101 F.         Concomitant medication history not reported by reporter. Treatment information was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Sore area by nose after 2nd dose; Painful swelling by nose after 2nd dose; Excruciating headache between eyes after 2nd dose; Small scab by nose after 2nd dose; Very acidy nasal drip after 2nd dose; Skin raised with blister like bumps by nose after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose; Fatigue after 2nd dose; Muscle aches after 2nd dose; Headache after 2nd dose; Lymph nodes achy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Body aches after 2nd dose) and PAIN (Sore area by nose after 2nd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer female (Breast cancer right  side 10 years ago).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose). On 04-Apr-2021, the patient experienced SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose) and HEADACHE (Excruciating headache between eyes after 2nd dose). At the time of the report, SCAB (Small scab by nose after 2nd dose), RHINORRHOEA (Very acidy nasal drip after 2nd dose), BLISTER (Skin raised with blister like bumps by nose after 2nd dose), PAIN (Sore area by nose after 2nd dose), SWELLING (Painful swelling by nose after 2nd dose), HEADACHE (Excruciating headache between eyes after 2nd dose) and LYMPHADENOPATHY (Lymph nodes achy after 2nd dose) outcome was unknown and PAIN (Body aches after 2nd dose), CHILLS (Chills after 2nd dose), FATIGUE (Fatigue after 2nd dose), MYALGIA (Muscle aches after 2nd dose) and HEADACHE (Headache after 2nd dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 f (High) 101 F.         Concomitant medication history not reported by reporter. Treatment information was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling from site of injection to below elbow; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling from site of injection to below elbow) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced SWELLING (swelling from site of injection to below elbow). At the time of the report, SWELLING (swelling from site of injection to below elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported  No treatment reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Mild achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild achiness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Mild achiness). At the time of the report, PAIN (Mild achiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073375 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional Information received and Event Mild achiness outcome was updated from Unknown to Resolved; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073375:2nd dose case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine; patient received second Moderna COVID-19 dose over 37 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 13-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 COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose). At the time of the report, COVID-19 (patient tested positive for COVID-19 virus after first dose of Moderna COVID-19 Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second Moderna COVID-19 dose over 37 days after first dose) 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) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Nonspecific reaction
Clinical narrative: Bad reaction; Patient was in bed for 24 hours after vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of NONSPECIFIC REACTION (Bad reaction) and BEDRIDDEN (Patient was in bed for 24 hours after vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NONSPECIFIC REACTION (Bad reaction) and BEDRIDDEN (Patient was in bed for 24 hours after vaccine). At the time of the report, NONSPECIFIC REACTION (Bad reaction) and BEDRIDDEN (Patient was in bed for 24 hours after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Glossodynia, Lip swelling, Paraesthesia
Clinical narrative: Swelling in lips; Face is itchy; Face is prickly; Tongue is so sore; Could hardly drink and eat food; Mouth sores; Dizziness; Skin rash; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore) and FEEDING DISORDER (Could hardly drink and eat food) in an 81-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.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Myelofibrosis.    The patient's past medical history included Hysterectomy, DEXA scan, Mammogram, Resection of rectum, Blood transfusion, Pacemaker insertion (cardiac), Bone marrow biopsy and Holter monitoring. Concurrent medical conditions included Malignant breast neoplasm, Monoclonal gammopathy, Osteoporosis, Hypertension, Hypothyroidism, Stress urinary incontinence, Chronic cystitis, Diverticulitis, Ex-smoker, Menopause (hot flashes), Splenomegaly, Anemia, Urosepsis, Recurrent atrial fibrillation, Headache, Fatigue, Dyspnoea exertional, Vision loss, GERD, Congestive heart failure, Lactate dehydrogenase increased, Drug allergy (epinephrine), Drug allergy (morphine), Drug allergy (iodine), Drug allergy (penicillin g), Drug allergy (sulfonamide antibiotics), Ankle fracture since 2017 and Arthropathy since 2017. Concomitant products included APIXABAN (ELIQUIS), IRON, FUROSEMIDE (LASIX [FUROSEMIDE]), LOSARTAN, VITAMINS NOS, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), SPIRONOLACTONE, DOFETILIDE (TIKOSYN), ESTRADIOL (VAGIFEM), AMITRIPTYLINE and GABAPENTIN for an unknown indication.   On 04-Sep-2019, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food), STOMATITIS (Mouth sores), DIZZINESS (Dizziness) and RASH (Skin rash). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food) and DIZZINESS (Dizziness) had resolved and STOMATITIS (Mouth sores) and RASH (Skin rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated  lotion ("unsure of the name").
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Stomatitis
Clinical narrative: Swelling in lips; Face is itchy; Face is prickly; Tongue is so sore; Could hardly drink and eat food; Mouth sores; Dizziness; Skin rash; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore) and FEEDING DISORDER (Could hardly drink and eat food) in an 81-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.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Myelofibrosis.    The patient's past medical history included Hysterectomy, DEXA scan, Mammogram, Resection of rectum, Blood transfusion, Pacemaker insertion (cardiac), Bone marrow biopsy and Holter monitoring. Concurrent medical conditions included Malignant breast neoplasm, Monoclonal gammopathy, Osteoporosis, Hypertension, Hypothyroidism, Stress urinary incontinence, Chronic cystitis, Diverticulitis, Ex-smoker, Menopause (hot flashes), Splenomegaly, Anemia, Urosepsis, Recurrent atrial fibrillation, Headache, Fatigue, Dyspnoea exertional, Vision loss, GERD, Congestive heart failure, Lactate dehydrogenase increased, Drug allergy (epinephrine), Drug allergy (morphine), Drug allergy (iodine), Drug allergy (penicillin g), Drug allergy (sulfonamide antibiotics), Ankle fracture since 2017 and Arthropathy since 2017. Concomitant products included APIXABAN (ELIQUIS), IRON, FUROSEMIDE (LASIX [FUROSEMIDE]), LOSARTAN, VITAMINS NOS, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), SPIRONOLACTONE, DOFETILIDE (TIKOSYN), ESTRADIOL (VAGIFEM), AMITRIPTYLINE and GABAPENTIN for an unknown indication.   On 04-Sep-2019, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food), STOMATITIS (Mouth sores), DIZZINESS (Dizziness) and RASH (Skin rash). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food) and DIZZINESS (Dizziness) had resolved and STOMATITIS (Mouth sores) and RASH (Skin rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated  lotion ("unsure of the name").
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe connection issue; Vaccine Underdose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose) 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 (no significant medical history).   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine Underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter asking if he has to repeat the 2nd Dose to the Patient.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered, vaccine stored above 5F frozen was given) and EXPIRED PRODUCT ADMINISTERED (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered, vaccine stored above 5F frozen was given) and EXPIRED PRODUCT ADMINISTERED (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered.). At the time of the report, PRODUCT STORAGE ERROR (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered, vaccine stored above 5F frozen was given) and EXPIRED PRODUCT ADMINISTERED (The vaccine vas punctured and 5 doses have been given with the following dates and times I am needing information if doses 2, 3, 4, an 5 should be readministered.) had 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.   No concomitant medications were provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Action taken, de-challenge and re-challenge was updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site rash, Myalgia, Pain
Clinical narrative: rash got slightly worse; chills; extremely tired; achy body; wanted to sleep all day; rash over injection site; achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body) and SOMNOLENCE (wanted to sleep all day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (achy arm). On 06-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body), SOMNOLENCE (wanted to sleep all day) and INJECTION SITE RASH (rash over injection site). On 07-Apr-2021, the patient experienced RASH (rash got slightly worse). On 07-Apr-2021, MYALGIA (achy body) had resolved. At the time of the report, PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), SOMNOLENCE (wanted to sleep all day), INJECTION SITE RASH (rash over injection site) and RASH (rash got slightly worse) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073365 (E2B Linked Report). This case was linked to MOD-2021-073365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: follow-up received and Patient said all her events are resolved, did not provide email ID, declined further follow up declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073365:2nd dose case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence
Clinical narrative: rash got slightly worse; chills; extremely tired; achy body; wanted to sleep all day; rash over injection site; achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body) and SOMNOLENCE (wanted to sleep all day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (achy arm). On 06-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (extremely tired), MYALGIA (achy body), SOMNOLENCE (wanted to sleep all day) and INJECTION SITE RASH (rash over injection site). On 07-Apr-2021, the patient experienced RASH (rash got slightly worse). On 07-Apr-2021, MYALGIA (achy body) had resolved. At the time of the report, PAIN (achy arm), CHILLS (chills), FATIGUE (extremely tired), SOMNOLENCE (wanted to sleep all day), INJECTION SITE RASH (rash over injection site) and RASH (rash got slightly worse) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-073365 (E2B Linked Report). This case was linked to MOD-2021-073365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: follow-up received and Patient said all her events are resolved, did not provide email ID, declined further follow up declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073365:2nd dose case
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 19-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 Anxiety medication for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: arm swelled up little bit; itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up little bit) and PRURITUS (itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 022M020A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, GABAPENTIN, AMLODIPINE, METOPROLOL, LEVOTHYROXINE, FOLIC ACID, POTASSIUM CHLORIDE, METFORMIN, PANTOPRAZOLE, ROSUVASTATIN, MELOXICAM, TIZANIDINE, DULOXETINE, LETROZOLE, VITAMIN D3, MAGNESIUM and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled up little bit) and PRURITUS (itching). At the time of the report, PERIPHERAL SWELLING (arm swelled up little bit) and PRURITUS (itching) outcome was unknown.            Concomitant medication provided were metro tristate taken 2.5 mg one time weekly. Treatment medication were not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Heart rate increased, Insomnia
Clinical narrative: Fast Heartbeat; Body Aches; Bone Pain; difficulty sleeping; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown, INSOMNIA (difficulty sleeping) had not resolved and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Advil.   This case was linked to MOD-2021-073404 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fast Heartbeat; Body Aches; Bone Pain; difficulty sleeping; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown, INSOMNIA (difficulty sleeping) had not resolved and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Advil.   This case was linked to MOD-2021-073404 (Patient Link).