chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red, splotchy areas around shoulder above injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red, splotchy areas around shoulder above injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced ERYTHEMA (Red, splotchy areas around shoulder above injection site). On 17-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ERYTHEMA (Red, splotchy areas around shoulder above injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of Moderna vaccine reported that their arm was feeling sore for the following 24 hours but no other side effects. On the day of reporting, the patient noticed at their left arm, they had a few red, splotchy areas on their shoulder area above the injection site.   Reportedly, the patient didn't feel any pain and stated that they would not have noticed if patient had not looked at their arm.  No Concomitant product use was reported.  No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: 2nd dose outside of dosing interval; Pain in arm; Diarrhea; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 33-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            On 08-Jan-2021, the patient received their 1st dose of Moderna vaccine and late on 24-Mar-2021 the patient received their 2nd dose which was outside of dosing interval. The patient reported side effects experienced only post receiving the 2nd dose which included nausea, fever, pain in arm, headache, and diarrhea.   Reportedly these symptoms resolved in 12 hours. The patient also stated that their Health care professional planned to administer the 3rd dose of Moderna vaccine since their 2nd dose was given outside the 42 day window and informed that their HCP doesn't believe that the patient was protected.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2nd dose outside of dosing interval; Pain in arm; Diarrhea; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 33-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose outside of dosing interval), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            On 08-Jan-2021, the patient received their 1st dose of Moderna vaccine and late on 24-Mar-2021 the patient received their 2nd dose which was outside of dosing interval. The patient reported side effects experienced only post receiving the 2nd dose which included nausea, fever, pain in arm, headache, and diarrhea.   Reportedly these symptoms resolved in 12 hours. The patient also stated that their Health care professional planned to administer the 3rd dose of Moderna vaccine since their 2nd dose was given outside the 42 day window and informed that their HCP doesn't believe that the patient was protected.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neck pain, Neuralgia, Rash
Clinical narrative: Shingles; Shooting nerve pain from her beck to her ear; Sharp pain throughout her neck; Rash from her scalp to neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), NEURALGIA (Shooting nerve pain from her beck to her ear), NECK PAIN (Sharp pain throughout her neck) and RASH (Rash from her scalp to neck) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced NEURALGIA (Shooting nerve pain from her beck to her ear), NECK PAIN (Sharp pain throughout her neck) and RASH (Rash from her scalp to neck). On 17-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), NEURALGIA (Shooting nerve pain from her beck to her ear), NECK PAIN (Sharp pain throughout her neck) and RASH (Rash from her scalp to neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 03-Mar-2021, the patient received their 1st dose of the Moderna vaccine and on 11-Mar-2021, the patient began to have a sharp pain throughout their neck and a shooting nerve pain from their neck to their ear. The patient later developed rash from their scalp to neck.   Reportedly, on 17-MAR-2021, the patient was diagnosed with shingle and still had an active case of the shingle and the patient was not sure if they would be allowed to take their 2nd dose on the scheduled due date. The shingle was on the same side of the injection site.  No Concomitant product use was reported. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; headache; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 98.5 (normal) temperature was normal around 98.5 degrees F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was done with oxycodone.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Fatigue; headache; muscle pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 immunization.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 98.5 (normal) temperature was normal around 98.5 degrees F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was done with oxycodone.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042721) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Nov-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy). On 03-Mar-2021, EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) had 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.   No concomitant medications were reported. The patient's second dose was scheduled on 31-Mar-2021. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Headache, Neck pain, Pain in extremity
Clinical narrative: sore arm; neck sore; injection spot warm to touch; face felt flushed; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed) and HEADACHE (headache) in a 61-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.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On 24-Mar-2021, PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore) and FLUSHING (face felt flushed) outcome was unknown and VACCINATION SITE WARMTH (injection spot warm to touch), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: sore arm; neck sore; injection spot warm to touch; face felt flushed; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed) and HEADACHE (headache) in a 61-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.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore), VACCINATION SITE WARMTH (injection spot warm to touch), FLUSHING (face felt flushed), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On 24-Mar-2021, PAIN IN EXTREMITY (sore arm), NECK PAIN (neck sore) and FLUSHING (face felt flushed) outcome was unknown and VACCINATION SITE WARMTH (injection spot warm to touch), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration to 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient) had 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.   No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 008B1A) with no associated AEs reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MONTELUKAST SODIUM (SINGULAIR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 26-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 SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included antibiotics for sinus infection.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vomiting
Clinical narrative: ricking in chair makes me dizzy; normal pain in arm; vomiting all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (ricking in chair makes me dizzy), PAIN IN EXTREMITY (normal pain in arm) and VOMITING (vomiting all day) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, SIMVASTATIN, CALCIUM and VITAMIN E [VITAMIN E NOS] for an unknown indication.    On 25-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 DIZZINESS (ricking in chair makes me dizzy), PAIN IN EXTREMITY (normal pain in arm) and VOMITING (vomiting all day). At the time of the report, DIZZINESS (ricking in chair makes me dizzy), PAIN IN EXTREMITY (normal pain in arm) and VOMITING (vomiting all day) 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.   Concomitant medication also included venladaxine
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Light lower back pain; Muscles aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included FLECAINIDE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), BACK PAIN (Light lower back pain) and MYALGIA (Muscles aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication was not reported.   This case was linked to MOD-2021-024726 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: being sick; has not been able to get the second dose due to her being sick and also the weather; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 experienced ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather). At the time of the report, ILLNESS (being sick) and PRODUCT DOSE OMISSION ISSUE (has not been able to get the second dose due to her being sick and also the weather) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: So much fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (So much fever), CHILLS (Chills) and MYALGIA (Body aches) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (So much fever) and CHILLS (Chills). 12-Mar-2021, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (So much fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-043050 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up was received on 05-MAY-2021. All reported event outcomes were updated to recovered/resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Missed second dose; Ill; This spontaneous report was received from a nurse concerning a 74-years-old female patient  who received Moderna's COVID19 vaccine (mRNA-1273) and felt ill and missed second dose.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 18 Jan 2021, prior the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number: 028L20A) Intramuscularly in the left arm for prophylaxis COVID-19 infection.      On 18 Jan 2021, the patient felt ill. On 25 Feb 2021, the patient had a brain surgery due to which missed second dose appointment.    The action taken with mRNA-1273 in response to the events was not reported.  Th e outcome of the event ill was not reported. The outcome of the event missed second dose was considered recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fatigue; Fever; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (Twice last year) and Splenectomy in 2011. Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA) for COPD.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain). On 21-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever) and ARTHRALGIA (Joint pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Pyrexia: 100.6 (High) Reaches to 101. On 21-Mar-2021, Pyrexia: 98.7 degrees normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Food intolerance, Headache, Hyperhidrosis
Clinical narrative: Bad headache; muscle pain; vomiting; chills; fever 100.3 degrees Fahrenheit; nausea; ache all over the body; "throwed away food"; sweating; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 50-year-old male 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 23-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), MYALGIA (muscle pain) and VOMITING (vomiting). On an unknown date, the patient experienced HEADACHE (Bad headache). The patient was treated with ONDANSETRON at a dose of 4 mg and BUTALBITAL, PARACETAMOL (BUTALBITAL/APAP) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), HEADACHE (Bad headache), MYALGIA (muscle pain) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Bad headache; muscle pain; vomiting; chills; fever 100.3 degrees Fahrenheit; nausea; ache all over the body; "throwed away food"; sweating; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 50-year-old male 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 23-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), MYALGIA (muscle pain) and VOMITING (vomiting). On an unknown date, the patient experienced HEADACHE (Bad headache). The patient was treated with ONDANSETRON at a dose of 4 mg and BUTALBITAL, PARACETAMOL (BUTALBITAL/APAP) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), HEADACHE (Bad headache), MYALGIA (muscle pain) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Bad headache; muscle pain; vomiting; chills; fever 100.3 degrees Fahrenheit; nausea; ache all over the body; "throwed away food"; sweating; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 50-year-old male 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 23-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), MYALGIA (muscle pain) and VOMITING (vomiting). On an unknown date, the patient experienced HEADACHE (Bad headache). The patient was treated with ONDANSETRON at a dose of 4 mg and BUTALBITAL, PARACETAMOL (BUTALBITAL/APAP) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, PAIN (ache all over the body), FOOD INTOLERANCE ("throwed away food"), HYPERHIDROSIS (sweating), CHILLS (chills), PYREXIA (fever 100.3 degrees Fahrenheit), NAUSEA (nausea), HEADACHE (Bad headache), MYALGIA (muscle pain) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 72.0
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 a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was provided.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked .
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Swollen tongue, Throat tightness
Clinical narrative: Swelling of tongue and throat; Swelling of tongue and throat; Would not take second shot of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swelling of tongue and throat), THROAT TIGHTNESS (Swelling of tongue and throat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Would not take second shot of vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animals (Allergy to dogs), Allergy to animals (Allergy to cats) and Dust allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Swelling of tongue and throat), THROAT TIGHTNESS (Swelling of tongue and throat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Would not take second shot of vaccine). On 18-Mar-2021, SWOLLEN TONGUE (Swelling of tongue and throat), THROAT TIGHTNESS (Swelling of tongue and throat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Would not take second shot of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. concomitant medicines was not reported by reporter   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient had taken first shot t 10' clock in the after noon,swelling of tongue and throat  had developed at night 10' clock ,went to the hospital on the same day and waited 45 min to an hour until the symptoms went away.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.. No further information is expected at this time as patient wanted to remain anonymous.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Insomnia, Lymphadenopathy, Pyrexia, Trismus
Clinical narrative: bad reaction on his arm; could not sleep on it; lock jaw on the left side of face; fever of 101.5; swollen glands; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE REACTION (bad reaction on his arm), INSOMNIA (could not sleep on it), TRISMUS (lock jaw on the left side of face), PYREXIA (fever of 101.5) and LYMPHADENOPATHY (swollen glands) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0126ZOA) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Patient had Rheumatoid Arthritis for a couple of years but was in remission, hence he was not taking any medication for it. But the second dose of the vaccine made his Rheumatoid Arthritis worse again, could not walk because his toes and fingers hurt. All his blood work for the rheumatoid markers were elevated.).    On 15-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 INJECTION SITE REACTION (bad reaction on his arm), INSOMNIA (could not sleep on it), TRISMUS (lock jaw on the left side of face), PYREXIA (fever of 101.5) and LYMPHADENOPATHY (swollen glands). At the time of the report, INJECTION SITE REACTION (bad reaction on his arm), INSOMNIA (could not sleep on it), TRISMUS (lock jaw on the left side of face), PYREXIA (fever of 101.5) and LYMPHADENOPATHY (swollen glands) 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.   No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-058201 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Suspected COVID-19
Clinical narrative: I feel like I have COVID right now; Kinda feeling muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I feel like I have COVID right now) and MYALGIA (Kinda feeling muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced SUSPECTED COVID-19 (I feel like I have COVID right now) and MYALGIA (Kinda feeling muscle ache). At the time of the report, SUSPECTED COVID-19 (I feel like I have COVID right now) and MYALGIA (Kinda feeling muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.    Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Vaccination site pain
Clinical narrative: Metallic taste on mouth; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste on mouth) and VACCINATION SITE PAIN (Pain on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste on mouth) and VACCINATION SITE PAIN (Pain on injection site). At the time of the report, DYSGEUSIA (Metallic taste on mouth) and VACCINATION SITE PAIN (Pain on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicine includes thyroid medicine (unspecified) Over-the-counter medication for heartburn Cholesterol medication.  treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Pain in extremity, Pharyngeal swelling, Skin indentation, Swelling
Clinical narrative: Left eye hurts; Deep indentations on both sides of the face; Swelling of the face; Swelling of the neck; Swelling of the throat; swelling of the tongue; Arm hurt; Right arm hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck) and PHARYNGEAL SWELLING (Swelling of the throat) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine drugs). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt) and VACCINATION SITE WARMTH (Right arm hot). On 18-Mar-2021, the patient experienced SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat) and SWOLLEN TONGUE (swelling of the tongue). On an unknown date, the patient experienced EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat), SWOLLEN TONGUE (swelling of the tongue), EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face) 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.   The patient had allergic reactions to Bees.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Vaccination site warmth
Clinical narrative: Left eye hurts; Deep indentations on both sides of the face; Swelling of the face; Swelling of the neck; Swelling of the throat; swelling of the tongue; Arm hurt; Right arm hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck) and PHARYNGEAL SWELLING (Swelling of the throat) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine drugs). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt) and VACCINATION SITE WARMTH (Right arm hot). On 18-Mar-2021, the patient experienced SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat) and SWOLLEN TONGUE (swelling of the tongue). On an unknown date, the patient experienced EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat), SWOLLEN TONGUE (swelling of the tongue), EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face) 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.   The patient had allergic reactions to Bees.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Tremor, Vaccination complication
Clinical narrative: Gets real shaky once in a while; Wanted to sit around and do nothing all day - not like me; Vomiting; Achy all over; chills; left shoulder hurt again,sore shoulder - left; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Gets real shaky once in a while), VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over) and CHILLS (chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left). 17-Mar-2021, the patient experienced MYALGIA (Achy all over). On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me). On an unknown date, the patient experienced TREMOR (Gets real shaky once in a while). The patient was treated with ONDANSETRON HCL for Vomiting, at a dose of 4 mg. At the time of the report, TREMOR (Gets real shaky once in a while) outcome was unknown and VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left) had resolved.            No relevant concomitant medications reported.     This case was linked to MOD-2021-249622, MOD-2021-249622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information included no new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Gets real shaky once in a while; Wanted to sit around and do nothing all day - not like me; Vomiting; Achy all over; chills; left shoulder hurt again,sore shoulder - left; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Gets real shaky once in a while), VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over) and CHILLS (chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A. and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left). 17-Mar-2021, the patient experienced MYALGIA (Achy all over). On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me). On an unknown date, the patient experienced TREMOR (Gets real shaky once in a while). The patient was treated with ONDANSETRON HCL for Vomiting, at a dose of 4 mg. At the time of the report, TREMOR (Gets real shaky once in a while) outcome was unknown and VACCINATION COMPLICATION (Wanted to sit around and do nothing all day - not like me), VOMITING (Vomiting), MYALGIA (Achy all over), CHILLS (chills) and ARTHRALGIA (left shoulder hurt again,sore shoulder - left) had resolved.            No relevant concomitant medications reported.     This case was linked to MOD-2021-249622, MOD-2021-249622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nasopharyngitis, Nausea
Clinical narrative: a lot of headache; tired; wanted to throw up; dizzy; cold; neck pains; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), DIZZINESS (dizzy) and NASOPHARYNGITIS (cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0231A904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and NECK PAIN (neck pains). On 24-Mar-2021, DIZZINESS (dizzy) had resolved. At the time of the report, HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), NASOPHARYNGITIS (cold) and NECK PAIN (neck pains) 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.   No concomitant products reported  No treatment products reported