chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Diagnosed with cellulitis in arm of injection; Raised area 5 in X 4 in at site of injection; Redness at site of injection; nduration at site of injection; Redness spread to upper arm and antecubital site of injected arm; Site of injection is cherry red; Itchiness at site of injection; Tenderness at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm) and INJECTION SITE DISCOLOURATION (Site of injection is cherry red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm), INJECTION SITE DISCOLOURATION (Site of injection is cherry red), INJECTION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE PAIN (Tenderness at site of injection). On 24-Feb-2021, the patient experienced INJECTION SITE CELLULITIS (Diagnosed with cellulitis in arm of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 23-Feb-2021 at a dose of UNK dosage form and DOXYCYCLINE on 24-Feb-2021 at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm), INJECTION SITE DISCOLOURATION (Site of injection is cherry red), INJECTION SITE PRURITUS (Itchiness at site of injection), INJECTION SITE PAIN (Tenderness at site of injection) and INJECTION SITE CELLULITIS (Diagnosed with cellulitis in arm of injection) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fall, Headache, Myalgia
Clinical narrative: No appetite; Dizziness; Fall; Vomited; Whole body hurt; Light headache; Whole body was achy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 (Whole body was achy), PYREXIA (Fever), MYALGIA (Whole body hurt) and HEADACHE (Light headache). On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), DIZZINESS (Dizziness) and FALL (Fall). At the time of the report, PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall), PYREXIA (Fever), VOMITING (Vomited), MYALGIA (Whole body hurt) and HEADACHE (Light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information reported
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: No appetite; Dizziness; Fall; Vomited; Whole body hurt; Light headache; Whole body was achy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 (Whole body was achy), PYREXIA (Fever), MYALGIA (Whole body hurt) and HEADACHE (Light headache). On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), DIZZINESS (Dizziness) and FALL (Fall). At the time of the report, PAIN (Whole body was achy), DECREASED APPETITE (No appetite), DIZZINESS (Dizziness), FALL (Fall), PYREXIA (Fever), VOMITING (Vomited), MYALGIA (Whole body hurt) and HEADACHE (Light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information reported
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025J20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), IRON and MAGNESIUM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-May-2021. On 12-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 12-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Glucose tolerance test: normal (normal) Normal. This test was done on 02-MAR-2021. In February 2021, Ultrasound abdomen: normal (normal) Normal.         No relevant treatment medications and  were provided. Action taken with mRNA-123 is not applicable.  On JUN-2018 The previous pregnancy was reported with Live, full-term birth.  There were no chronic or long-standing health conditions. There is no maternal history of subfertility. No complications or acute illnesses during this pregnancy to date
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Liver function test, Pyrexia
Clinical narrative: dizziness; tachypnea; My temperature is 99.3 today; headaches; joint pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Fatty liver.   On 25-Jan-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) at an unspecified dose. On 08-Mar-2021, the patient experienced DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain). At the time of the report, DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Liver function test: (Inconclusive) liver enzymes are elevated. On 08-Mar-2021, White blood cell count: (Inconclusive) over 10,000 13.03 on 06Mar2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received, Contact information updated
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Tachypnoea, White blood cell count
Clinical narrative: dizziness; tachypnea; My temperature is 99.3 today; headaches; joint pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Fatty liver.   On 25-Jan-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) at an unspecified dose. On 08-Mar-2021, the patient experienced DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain). At the time of the report, DIZZINESS (dizziness), TACHYPNOEA (tachypnea), PYREXIA (My temperature is 99.3 today), HEADACHE (headaches) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Liver function test: (Inconclusive) liver enzymes are elevated. On 08-Mar-2021, White blood cell count: (Inconclusive) over 10,000 13.03 on 06Mar2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received, Contact information updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: dizziness; diarrhea; headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ATORVASTATIN, olmesaitan, METHENAMINE and hippurate for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, DIARRHOEA (diarrhea), NAUSEA (nausea) and PYREXIA (fever) had resolved. At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Polymenorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), POLYMENORRHOEA (periods twice a month), PYREXIA (lot of temperature), HEADACHE (headache) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced POLYMENORRHOEA (periods twice a month). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) had resolved and POLYMENORRHOEA (periods twice a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-102397 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information- Outcome and new event added On 12-May-2021: Follow-up information received on 12-MAY-2021 contains non-significant information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), POLYMENORRHOEA (periods twice a month), PYREXIA (lot of temperature), HEADACHE (headache) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced POLYMENORRHOEA (periods twice a month). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) had resolved and POLYMENORRHOEA (periods twice a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-102397 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information- Outcome and new event added On 12-May-2021: Follow-up information received on 12-MAY-2021 contains non-significant information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Potentiating drug interaction
Clinical narrative: Patient received cortisone therapy 2 days after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of POTENTIATING DRUG INTERACTION (Patient received cortisone therapy 2 days after receiving 1st dose of vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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 05-Mar-2021, the patient experienced POTENTIATING DRUG INTERACTION (Patient received cortisone therapy 2 days after receiving 1st dose of vaccine). At the time of the report, POTENTIATING DRUG INTERACTION (Patient received cortisone therapy 2 days after receiving 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received cortisone therapy on 05Mar2021. After receiving therapy, her doctor found out that her efficacy may have decreased. She is not sure whether to repeat the dose and is calling to find out about efficacy.  No treatment was provided. Concomitant medications included an unspecified thyroid medication and an unspecified heart medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Warm to the touch; Little tender; Hard to the touch; Red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Little tender), VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Little tender), VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Red spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Little tender), VACCINATION SITE INDURATION (Hard to the touch) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Patient had took several medications for the treatment.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Muscle twitching, Urticaria, Vaccination site mass
Clinical narrative: increase in blood pressure; Knot on right arm; Twitching of right arm; Welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts), BLOOD PRESSURE INCREASED (increase in blood pressure), VACCINATION SITE MASS (Knot on right arm) and MUSCLE TWITCHING (Twitching of right arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Welts (welts that she gets occasionally) and Hypertension. Concomitant products included CLONIDINE for Hypertension, PANTOPRAZOLE and THYROID (ARMOUR THYROID) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Welts), VACCINATION SITE MASS (Knot on right arm) and MUSCLE TWITCHING (Twitching of right arm). On 23-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (increase in blood pressure). On 15-Feb-2021, VACCINATION SITE MASS (Knot on right arm) and MUSCLE TWITCHING (Twitching of right arm) had resolved. At the time of the report, URTICARIA (Welts) was resolving and BLOOD PRESSURE INCREASED (increase in blood pressure) 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.   Treatment for the events included clonidine and an unspecified antihistamine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Pain in extremity
Clinical narrative: sore arm; abdominal pain; diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN (abdominal pain), DIARRHOEA (diarrhea) and CHILLS (chills) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 031L20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LAMOTRIGINE (LAMICTAL), TOPIRAMATE (TOPAMAC), METOPROLOL and POTASSIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN (abdominal pain), DIARRHOEA (diarrhea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 05-Mar-2021, ABDOMINAL PAIN (abdominal pain) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-224914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received as report
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: elevated lump on the injection site; itchy; arm site hard; arm site bright red swollen; injection site heat /  hot area around the injection site; injection site knot; injection site redness / 2 x 1 inch, red (less intense); injection site soreness; back pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LEVETIRACETAM, PANTOPRAZOLE, SPIRONOLACTONE, LACOSAMIDE (VIMPAT) and BIOTIN for an unknown indication, CYANOCOBALAMIN (VITAMIN B-12), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain). On an unknown date, the patient experienced VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen). On 03-Mar-2021, VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) had resolved. At the time of the report, VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant products include estriol cream, extra strength Acetaminophen.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Significant FU / extra events added On 03-May-2021: Follow up was received on 03 may 2021 included The left arm site was hot, hard, bright red swollen and they all resolved with a darkened spot on skin.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: elevated lump on the injection site; itchy; arm site hard; arm site bright red swollen; injection site heat /  hot area around the injection site; injection site knot; injection site redness / 2 x 1 inch, red (less intense); injection site soreness; back pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LEVETIRACETAM, PANTOPRAZOLE, SPIRONOLACTONE, LACOSAMIDE (VIMPAT) and BIOTIN for an unknown indication, CYANOCOBALAMIN (VITAMIN B-12), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain). On an unknown date, the patient experienced VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen). On 03-Mar-2021, VACCINATION SITE WARMTH (injection site heat /  hot area around the injection site), VACCINATION SITE MASS (injection site knot), VACCINATION SITE ERYTHEMA (injection site redness / 2 x 1 inch, red (less intense)), VACCINATION SITE PAIN (injection site soreness) and BACK PAIN (back pain) had resolved. At the time of the report, VACCINATION SITE MASS (elevated lump on the injection site), PRURITUS (itchy), VACCINATION SITE INDURATION (arm site hard) and VACCINATION SITE SWELLING (arm site bright red swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant products include estriol cream, extra strength Acetaminophen.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Significant FU / extra events added On 03-May-2021: Follow up was received on 03 may 2021 included The left arm site was hot, hard, bright red swollen and they all resolved with a darkened spot on skin.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: my arm became hot to touch at the injection site; my arm became red at the injection site; my arm became itchy at the injection site; a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE RASH (a rash at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disorder.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (a rash at the injection site). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site). At the time of the report, VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE RASH (a rash at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient used Ice packs for treatment.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) 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 NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-037272 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Influenza like illness, Insomnia
Clinical narrative: Chills; Flu like symptoms; Insomnia; losing appetite; aching; Fever (highest 102.9); Joint pain; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching) and PYREXIA (Fever (highest 102.9)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Hyperthyroidism, Menopause, Neck pain, Neck tightness and Sleep disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hyperthyroidism, ESTRADIOL for Menopause, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Neck pain and Neck tightness, MELATONIN for Sleep disorder.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching), PYREXIA (Fever (highest 102.9)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches). On 05-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 05-Mar-2021, INSOMNIA (Insomnia) had resolved. On 06-Mar-2021, PYREXIA (Fever (highest 102.9)) and CHILLS (Chills) had resolved. On 07-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (losing appetite), PAIN (aching), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose on 01Apr2021 Intramuscular at right arm (Lot no: 017B21A)   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Reporter details updated, Dose details updated, concomitant medication, lab data and medical history added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Flu like symptoms; Insomnia; losing appetite; aching; Fever (highest 102.9); Joint pain; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching) and PYREXIA (Fever (highest 102.9)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Hyperthyroidism, Menopause, Neck pain, Neck tightness and Sleep disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hyperthyroidism, ESTRADIOL for Menopause, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Neck pain and Neck tightness, MELATONIN for Sleep disorder.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (Insomnia), DECREASED APPETITE (losing appetite), PAIN (aching), PYREXIA (Fever (highest 102.9)), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches). On 05-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 05-Mar-2021, INSOMNIA (Insomnia) had resolved. On 06-Mar-2021, PYREXIA (Fever (highest 102.9)) and CHILLS (Chills) had resolved. On 07-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (losing appetite), PAIN (aching), ARTHRALGIA (Joint pain) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose on 01Apr2021 Intramuscular at right arm (Lot no: 017B21A)   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Reporter details updated, Dose details updated, concomitant medication, lab data and medical history added.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Facial pain, Headache, Injection site mass
Clinical narrative: arm pain; throat pain; Face Pain; Red Spots on Face; Diarrhea; chills; Swollen Lymph Nodes - in Chest/right neck lymph node pain; Bump Near Injection Site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face) and DIARRHOEA (Diarrhea) in a 55-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 19-Feb-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 PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face), DIARRHOEA (Diarrhea), CHILLS (chills), LYMPHADENOPATHY (Swollen Lymph Nodes - in Chest/right neck lymph node pain), INJECTION SITE MASS (Bump Near Injection Site) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), CHILLS (chills) and HEADACHE (headache) had resolved and FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen Lymph Nodes - in Chest/right neck lymph node pain) and INJECTION SITE MASS (Bump Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: follow-up received on 10-mar-2021 and Event information was updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain in extremity, Rash erythematous
Clinical narrative: arm pain; throat pain; Face Pain; Red Spots on Face; Diarrhea; chills; Swollen Lymph Nodes - in Chest/right neck lymph node pain; Bump Near Injection Site; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face) and DIARRHOEA (Diarrhea) in a 55-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 19-Feb-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 PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face), DIARRHOEA (Diarrhea), CHILLS (chills), LYMPHADENOPATHY (Swollen Lymph Nodes - in Chest/right neck lymph node pain), INJECTION SITE MASS (Bump Near Injection Site) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm pain), OROPHARYNGEAL PAIN (throat pain), CHILLS (chills) and HEADACHE (headache) had resolved and FACIAL PAIN (Face Pain), RASH ERYTHEMATOUS (Red Spots on Face), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen Lymph Nodes - in Chest/right neck lymph node pain) and INJECTION SITE MASS (Bump Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: follow-up received on 10-mar-2021 and Event information was updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) in left arm for prophylaxis of COVID-19 infection.   On 7 Feb 2021, the patient experienced sore arm.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, sore arm, was considered resolved after a couple of days.; Reporter'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.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Hand was "puffy"/ Swollen hand; Redness; Rash going up the arm / like a heat rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand), ERYTHEMA (Redness) and RASH (Rash going up the arm / like a heat rash) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of prostate (Patient is taking 3 medications.) since 11-Feb-2021. Concomitant products included RELUGOLIX from 11-Feb-2021 to an unknown date for Prostate cancer.    On 22-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 PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand), ERYTHEMA (Redness) and RASH (Rash going up the arm / like a heat rash). On 05-Mar-2021, PERIPHERAL SWELLING (Hand was "puffy"/ Swollen hand) and RASH (Rash going up the arm / like a heat rash) had resolved and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Urticaria
Clinical narrative: significant, extreme hives all over patient's body; Fatigue; Weak/unable to get out of bed or care for themselves; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Hyperlipidemia (since 20 years) since an unknown date. Concurrent medical conditions included Sulfonamide allergy (years ago, rash, no hives or shortness of breath) and Osteoporosis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from an unknown date to 15-Nov-2020.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves). At the time of the report, URTICARIA (significant, extreme hives all over patient's body) and ASTHENIA (Weak/unable to get out of bed or care for themselves) was resolving and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered URTICARIA (significant, extreme hives all over patient's body), FATIGUE (Fatigue) and ASTHENIA (Weak/unable to get out of bed or care for themselves) to be possibly related.    Treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-037358 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: reporter contact details, patient demographic's and event outcome of the events, and reporter causality of all the events was updated.; Reporter'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; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-037358:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: very significant aches in her legs; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (very significant aches in her legs) and MYALGIA (Body aches) outcome was unknown.
Age: 67.0
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 67-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 (No medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Treatment included Tylenol   This case was linked to MOD-2021-037334 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI - info to be given over the phone