chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Pain in extremity
Clinical narrative: sore arm; She is a little dizzy; Feels weak and like having a typicla flu; Feels weak and like having a typicla flu; chills; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; She is a little dizzy; Feels weak and like having a typicla flu; Feels weak and like having a typicla flu; chills; fever of 100ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (She is a little dizzy), INFLUENZA LIKE ILLNESS (Feels weak and like having a typicla flu), ASTHENIA (Feels weak and like having a typicla flu), CHILLS (chills) and PYREXIA (fever of 100ºF) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: his face was all red; he broke out in sweats; couldn't breath; could not get up from couch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Apr-2021, the patient experienced ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-Apr-2021, ERYTHEMA (his face was all red), HYPERHIDROSIS (he broke out in sweats), DYSPNOEA (couldn't breath) and DYSKINESIA (could not get up from couch) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Pyrexia
Clinical narrative: Ill; Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever) 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 an unknown date, the patient experienced MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site injury, Vaccination site erythema, Vaccination site swelling, Wrong technique in product usage process
Clinical narrative: bee sting looking puncture at injection site; bainaid applied on spot other than injection site; injection site swelling; injection site redness; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness), INJECTION SITE INJURY (bee sting looking puncture at injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On an unknown date, the patient experienced INJECTION SITE INJURY (bee sting looking puncture at injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site). On 23-Apr-2021, VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and INJECTION SITE INJURY (bee sting looking puncture at injection site) was resolving. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (bainaid applied on spot other than injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information is not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint swelling
Clinical narrative: legs went numb; arms went numb; knees are swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (legs went numb), HYPOAESTHESIA (arms went numb) and JOINT SWELLING (knees are swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concomitant products included CALCIUM, Centrum Silver, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), DEXLANSOPRAZOLE (DEXILANT), BUSPIRONE, LAMOTRIGINE, SIMVASTATIN and FAMOTIDINE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (legs went numb), HYPOAESTHESIA (arms went numb) and JOINT SWELLING (knees are swollen). At the time of the report, HYPOAESTHESIA (legs went numb), HYPOAESTHESIA (arms went numb) and JOINT SWELLING (knees are swollen) 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 treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non significant Followup Appended
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Fluid intake reduced, Headache
Clinical narrative: couldn't eat; couldn't drink,; whole body aches; really bad headache; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included METFORMIN, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, DOCUSATE SODIUM (STOOL SOFTENER), CRANBERRY [VACCINIUM MACROCARPON], CYANOCOBALAMIN (B12-VITAMIIN), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), LINAGLIPTIN (TRAJENTA), DENOSUMAB (PROLIA), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (LOSARTIN), ANASTROZOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications included allergy medicine and "andapamin".  No treatment information was provided.   This case was linked to MOD-2021-089546 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: couldn't eat; couldn't drink,; whole body aches; really bad headache; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included METFORMIN, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, DOCUSATE SODIUM (STOOL SOFTENER), CRANBERRY [VACCINIUM MACROCARPON], CYANOCOBALAMIN (B12-VITAMIIN), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID]), LINAGLIPTIN (TRAJENTA), DENOSUMAB (PROLIA), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (LOSARTIN), ANASTROZOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, FEEDING DISORDER (couldn't eat), FLUID INTAKE REDUCED (couldn't drink,), PAIN (whole body aches), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications included allergy medicine and "andapamin".  No treatment information was provided.   This case was linked to MOD-2021-089546 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Ocular hyperaemia, Pain, Parosmia
Clinical narrative: soreness; phantom smell; Red spots in vision; Irritated brain; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 27-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 PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness). At the time of the report, PAIN (soreness), PAROSMIA (phantom smell), OCULAR HYPERAEMIA (Red spots in vision), IRRITABILITY (Irritated brain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No Treatment medications was provided by the reporter.    Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Nausea
Clinical narrative: so cold all the time; not feeling well; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous). At the time of the report, FEELING COLD (so cold all the time), MALAISE (not feeling well) and NAUSEA (nauseous) outcome was unknown.            No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngitis
Clinical narrative: swollen lymph nodes; feels like cold is coming on; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 650 milligram. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and NASOPHARYNGITIS (feels like cold is coming on) outcome was unknown. Not Provided          Treatment medications also included ethylprednisione. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-089498 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case reported by a patient family member or friend, describes the occurrence of COVID-19 (positive for COVID-19) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038K20A) for COVID-19 immunization. No medical history reported. On Mar 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient had COVID-19 (positive for COVID-19). At the time of the report, COVID-19 (positive for COVID-19): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported. The patient got sick and went to the emergency department on Apr 21, 2021 to be tested for COVID-19. Sent home same day. Reporter did not allow further contact.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain in jaw, Pyrexia
Clinical narrative: jaw pain; ear pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever). At the time of the report, PAIN IN JAW (jaw pain), EAR PAIN (ear pain) and PYREXIA (fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medicines were reported
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Head ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache) and PYREXIA (Fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Apr-2021, the patient experienced HEADACHE (Head ache) and PYREXIA (Fever). At the time of the report, HEADACHE (Head ache) and PYREXIA (Fever) 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27 May 2021. Event outcome updated
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Swelling behind my ear, near my hairline; Swelling behind myear, near my hairline was sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Defibrillator/pacemaker insertion. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LOSARTAN for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days). In April 2021, SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication was provided.   This case was linked to MOD-2021-211622 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: arm sorness; Redness at injection site; Fever of 100; Body aches; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm soreness), VACCINATION SITE JOINT PAIN (Redness at injection site), PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 Blood pressure pills, METOPROLOL, CHOLESTEROL, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), TADALAFIL (CIALIS) and low dose aspirin 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 22-Apr-2021, the patient experienced PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches), CHILLS (Chills) and FATIGUE (Fatigue). On 24-Apr-2021, the patient experienced VACCINATION SITE JOINT PAIN (Redness at injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (arm soreness). On 23-Apr-2021, PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches) and CHILLS (Chills) had resolved. On 24-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE JOINT PAIN (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site joint pain
Clinical narrative: arm sorness; Redness at injection site; Fever of 100; Body aches; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm soreness), VACCINATION SITE JOINT PAIN (Redness at injection site), PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 Blood pressure pills, METOPROLOL, CHOLESTEROL, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), TADALAFIL (CIALIS) and low dose aspirin 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 22-Apr-2021, the patient experienced PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches), CHILLS (Chills) and FATIGUE (Fatigue). On 24-Apr-2021, the patient experienced VACCINATION SITE JOINT PAIN (Redness at injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (arm soreness). On 23-Apr-2021, PYREXIA (Fever of 100), PAIN IN EXTREMITY (Body aches) and CHILLS (Chills) had resolved. On 24-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE JOINT PAIN (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Aches and pains; Fatigue; Fatigue; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE (Fatigue), MALAISE (Malaise), PAIN (Aches and pains) and the second episode of FATIGUE (Fatigue) in a 78-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 reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FATIGUE (Fatigue) and MALAISE (Malaise). On 11-Mar-2021, the patient experienced PAIN (Aches and pains) and the second episode of FATIGUE (Fatigue). On 13-Feb-2021, MALAISE (Malaise) had resolved. At the time of the report, PAIN (Aches and pains) and the last episode of FATIGUE (Fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-073869 (Linked Report). This case was linked to MOD-2021-089612 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073869:
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: patches in glutes; itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (patches in glutes) and PRURITUS (itch) 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 20-Apr-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 RASH MACULAR (patches in glutes) and PRURITUS (itch). At the time of the report, RASH MACULAR (patches in glutes) and PRURITUS (itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products and treatment medication were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Myalgia, Paraesthesia oral, Pyrexia
Clinical narrative: takes zyrtec for indoor and outdoor allergies; hive reaction; 3 pancake size areas on left arm; tingling lips; fever 102 degrees; body aches and chills; body aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees) and MYALGIA (body aches and chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills) and CHILLS (body aches and chills). On an unknown date, the patient experienced HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies). At the time of the report, URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills), CHILLS (body aches and chills) and HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: takes zyrtec for indoor and outdoor allergies; hive reaction; 3 pancake size areas on left arm; tingling lips; fever 102 degrees; body aches and chills; body aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees) and MYALGIA (body aches and chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills) and CHILLS (body aches and chills). On an unknown date, the patient experienced HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies). At the time of the report, URTICARIA (hive reaction), VACCINATION SITE REACTION (3 pancake size areas on left arm), PARAESTHESIA ORAL (tingling lips), PYREXIA (fever 102 degrees), MYALGIA (body aches and chills), CHILLS (body aches and chills) and HYPERSENSITIVITY (takes zyrtec for indoor and outdoor allergies) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Pain in extremity
Clinical narrative: very thirsty, mouth is very dry; arm pain is a 10, pain under armpit and behind shoulder.; chills; very exhausted; fever; vomiting; These symptoms include tingling down arm; head was starting to throb; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills) and FATIGUE (very exhausted) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Jan-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PARAESTHESIA (These symptoms include tingling down arm) and HEADACHE (head was starting to throb). On 23-Apr-2021, the patient experienced DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), HEADACHE (head was starting to throb), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: very thirsty, mouth is very dry; arm pain is a 10, pain under armpit and behind shoulder.; chills; very exhausted; fever; vomiting; These symptoms include tingling down arm; head was starting to throb; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills) and FATIGUE (very exhausted) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Jan-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PARAESTHESIA (These symptoms include tingling down arm) and HEADACHE (head was starting to throb). On 23-Apr-2021, the patient experienced DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), HEADACHE (head was starting to throb), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), OMALIZUMAB (XOLAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). On 27-Feb-2021, VACCINATION SITE REACTION (Covid arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included steroid cream and triamcinolone, levocitrizine  dexamethasone 4 mg for 4-5 days, doxycycline,Zyrtec   This case was linked to MOD-2021-089555 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Vaccination complication
Clinical narrative: stomach ache; first shot put me in bed for a week and a half; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE and HYDROCODONE for an unknown indication.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), VACCINATION COMPLICATION (first shot put me in bed for a week and a half) and HEADACHE (headache) outcome was unknown.            No treatment medication were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-089545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089545:Second dose
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Influenza like illness, Lymphadenopathy, Peripheral swelling
Clinical narrative: Small ball like swelling, lymph node between left side neck and shoulder; Back and chest hurts; Back and chest hurts; Feels like flu; Swelling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Back and chest hurts), BACK PAIN (Back and chest hurts), INFLUENZA LIKE ILLNESS (Feels like flu), PERIPHERAL SWELLING (Swelling on left arm) and LYMPHADENOPATHY (Small ball like swelling, lymph node between left side neck and shoulder) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling on left arm). On 19-Apr-2021, the patient experienced CHEST PAIN (Back and chest hurts), BACK PAIN (Back and chest hurts) and INFLUENZA LIKE ILLNESS (Feels like flu). On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Small ball like swelling, lymph node between left side neck and shoulder). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Back and chest hurts), BACK PAIN (Back and chest hurts), INFLUENZA LIKE ILLNESS (Feels like flu), PERIPHERAL SWELLING (Swelling on left arm) and LYMPHADENOPATHY (Small ball like swelling, lymph node between left side neck and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Lymphadenopathy, at an unspecified dose and frequency.  Concomitant product information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received and contains non significant information; 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint swelling, Pain, Ultrasound scan, Vaccination complication
Clinical narrative: reaction to the COVID-19 vaccine; my left elbow all the way to wrist was swollen; very painful; where I got the shot, it was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (my left elbow all the way to wrist was swollen), PAIN (very painful), VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) and VACCINATION SITE SWELLING (where I got the shot, it was swollen) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No past medical history were reported.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (where I got the shot, it was swollen). On 08-Apr-2021, the patient experienced JOINT SWELLING (my left elbow all the way to wrist was swollen) and PAIN (very painful). On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the COVID-19 vaccine). The patient was treated with KETOROLAC at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (my left elbow all the way to wrist was swollen), PAIN (very painful), VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) and VACCINATION SITE SWELLING (where I got the shot, it was swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal. On an unknown date, Ultrasound scan: normal. On an unknown date, X-ray: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Went to ER.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, X-ray
Clinical narrative: reaction to the COVID-19 vaccine; my left elbow all the way to wrist was swollen; very painful; where I got the shot, it was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (my left elbow all the way to wrist was swollen), PAIN (very painful), VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) and VACCINATION SITE SWELLING (where I got the shot, it was swollen) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No past medical history were reported.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (where I got the shot, it was swollen). On 08-Apr-2021, the patient experienced JOINT SWELLING (my left elbow all the way to wrist was swollen) and PAIN (very painful). On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the COVID-19 vaccine). The patient was treated with KETOROLAC at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (my left elbow all the way to wrist was swollen), PAIN (very painful), VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) and VACCINATION SITE SWELLING (where I got the shot, it was swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal. On an unknown date, Ultrasound scan: normal. On an unknown date, X-ray: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Went to ER.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: sharp pain started shooting up leg, to my knee; slight headache; sharp pain started shooting up leg, to my knee; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sharp pain started shooting up leg, to my knee), HEADACHE (slight headache) and ARTHRALGIA (sharp pain started shooting up leg, to my knee) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (sharp pain started shooting up leg, to my knee), HEADACHE (slight headache) and ARTHRALGIA (sharp pain started shooting up leg, to my knee). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sharp pain started shooting up leg, to my knee), HEADACHE (slight headache) and ARTHRALGIA (sharp pain started shooting up leg, to my knee) outcome was unknown.            Concomitant medication was not provided.   This case was linked to MOD-2021-089394 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Headache, Illness, Myalgia, Product dose omission issue
Clinical narrative: I was extremely sick; headache; every parts of the body began to hurt; Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot; couldn't eat for up to 6 to 7 days following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), ILLNESS (I was extremely sick), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt). On an unknown date, the patient experienced ILLNESS (I was extremely sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), ILLNESS (I was extremely sick), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.