chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Dizziness; Flu like symptoms; Concentration impaired; Nauseous; Muscle pain; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-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) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired). At the time of the report, DIZZINESS (Dizziness) had not resolved, NAUSEA (Nauseous) had resolved and HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired) outcome was unknown.      Concomitant medication use was not provided. Treatment information included Anti nausea medicine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin reaction
Clinical narrative: Delayed arm reaction after first dos; redness; Swelling on the arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed arm reaction after first dos), ERYTHEMA (redness) and PERIPHERAL SWELLING (Swelling on the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 27-Jan-2021, the patient experienced SKIN REACTION (Delayed arm reaction after first dos), ERYTHEMA (redness) and PERIPHERAL SWELLING (Swelling on the arm). On 31-Jan-2021, ERYTHEMA (redness) and PERIPHERAL SWELLING (Swelling on the arm) had resolved. At the time of the report, SKIN REACTION (Delayed arm reaction after first dos) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-083316 (E2B Linked Report). This case was linked to MOD-2021-083316 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083316:Case for dose 2
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: pain in the arm when he raises it up; feels like it's pulling his nerve; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in the arm when he raises it up) and FEELING ABNORMAL (feels like it's pulling his nerve) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PAIN IN EXTREMITY (pain in the arm when he raises it up) and FEELING ABNORMAL (feels like it's pulling his nerve). At the time of the report, PAIN IN EXTREMITY (pain in the arm when he raises it up) and FEELING ABNORMAL (feels like it's pulling his nerve) 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.   Concomitants - cholesterol medication, eyedrop, something for the nose. Treatment information as not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Initial arm pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Initial arm pain) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication reported  No treatment medication reported   This case was linked to US-MODERNATX, INC.-MOD-2021-083307 (E2B Linked Report). This case was linked to MOD-2021-083307 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083307:Case for dose 1
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Vaccination site pain
Clinical narrative: feeling shaky about an hour after vaccination; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, NERVOUSNESS (feeling shaky about an hour after vaccination) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: couldn't operate as she usually does, had to take two days off; fever; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Mar-2021, ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided   This case was linked to MOD-2021-083344 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 003B21A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON for Nausea, RIVAROXABAN (XARELTO), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), DILTIAZEM HYDROCHLORIDE (CARTIA XT), CARVEDILOL, LISINOPRIL, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 16-Mar-2021, the patient experienced CONSTIPATION (constipation). On 18-Mar-2021, CONSTIPATION (constipation) had resolved.            This case was linked to MOD-2021-085218 (E2B Linked Report).; Sender's Comments:  MOD-2021-085218:Second Dose Case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site swelling
Clinical narrative: Injection site reactions of a sore arm; circumference of the shot was bigger than when she first got the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection). At the time of the report, INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection) outcome was unknown. Not Provided          Products known to have been used by the patient, within two weeks prior to the event, included type 1 diabetes medication. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Patient reported that patient, did not get any adverse event after the first dose, and was undergoing colonoscopy on 21 Apr 2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: swollen in injection site; red ring in injection site; fever in injection site; soreness of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (soreness of arm), VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (soreness of arm). On 19-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 16-Apr-2021, MYALGIA (soreness of arm) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (swollen in injection site), VACCINATION SITE ERYTHEMA (red ring in injection site) and VACCINATION SITE WARMTH (fever in injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on concomitant medications on birth control shot every 3 months.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: heart beat was very fast. It was like he was running; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (heart beat was very fast. It was like he was running) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HEART RATE INCREASED (heart beat was very fast. It was like he was running). At the time of the report, HEART RATE INCREASED (heart beat was very fast. It was like he was running) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided as the patient doesn't remember the name of the medication. The concomitant medication were changed by the patient's doctor.   Treatment medication were not provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experiencing pain on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing pain on site of injection) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experiencing pain on site of injection). At the time of the report, VACCINATION SITE PAIN (experiencing pain on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Apr-2021 and the estimated date of delivery was 31-Dec-2021. On 16-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 16-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient LMP date was 15-APR-2021. No concomitant medications were added. No treatment medications were added. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Internal review on 26-JUL-2021 resulted in Update of Reporter details, Prospective checked ,Birth type, Fetal outcome , vaccine facility type, country, expiration date ,event start date and end date, outcome of event .
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: small amount of vaccine material came out onto her arm; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (small amount of vaccine material came out onto her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (small amount of vaccine material came out onto her arm). At the time of the report, ACCIDENTAL UNDERDOSE (small amount of vaccine material came out onto her arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is asking the physician if she needs to get the dose repeated or not. Offered the physician information in writing, but he declined. Ok for the safety team to reach out to the physician later if needed
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in one side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in one side of face) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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 PARAESTHESIA (Tingling in one side of face). At the time of the report, PARAESTHESIA (Tingling in one side of face) 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 route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Eating disorder, Feeling abnormal
Clinical narrative: Both arms cold; today its really bad; Nausea for three days; diarrhoea; not eating much; warm; Both arms tingly; Cold; Arm pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much) and VACCINATION SITE WARMTH (warm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Birth control, THYROID MEDS and Gastrointestinal medication for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Arm pain). On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold) and NAUSEA (Nausea for three days). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (today its really bad). On an unknown date, the patient experienced FEELING COLD (Both arms cold). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (today its really bad) and NAUSEA (Nausea for three days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up- AE Contact Update On 25-May-2021: Non Significant Follow up appended for Document Attachment
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nasopharyngitis, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Both arms cold; today its really bad; Nausea for three days; diarrhoea; not eating much; warm; Both arms tingly; Cold; Arm pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much) and VACCINATION SITE WARMTH (warm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Birth control, THYROID MEDS and Gastrointestinal medication for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Arm pain). On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold) and NAUSEA (Nausea for three days). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (today its really bad). On an unknown date, the patient experienced FEELING COLD (Both arms cold). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (today its really bad) and NAUSEA (Nausea for three days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up- AE Contact Update On 25-May-2021: Non Significant Follow up appended for Document Attachment
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Both arms cold; today its really bad; Nausea for three days; diarrhoea; not eating much; warm; Both arms tingly; Cold; Arm pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much) and VACCINATION SITE WARMTH (warm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Birth control, THYROID MEDS and Gastrointestinal medication for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Arm pain). On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold) and NAUSEA (Nausea for three days). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (today its really bad). On an unknown date, the patient experienced FEELING COLD (Both arms cold). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DIARRHOEA (diarrhoea), EATING DISORDER (not eating much), VACCINATION SITE WARMTH (warm), PARAESTHESIA (Both arms tingly), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (today its really bad) and NAUSEA (Nausea for three days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up- AE Contact Update On 25-May-2021: Non Significant Follow up appended for Document Attachment
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm is really bad) and PYREXIA (a slight fever) in a 61-year-old male patient 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) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm is really bad) and PYREXIA (a slight fever). At the time of the report, PAIN IN EXTREMITY (pain in his arm is really bad) and PYREXIA (a slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Nasal congestion
Clinical narrative: very congested due to my seasonal allergies; have an ear infection which is not treated yet; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (very congested due to my seasonal allergies) and EAR INFECTION (have an ear infection which is not treated yet) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.    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 NASAL CONGESTION (very congested due to my seasonal allergies) and EAR INFECTION (have an ear infection which is not treated yet). At the time of the report, NASAL CONGESTION (very congested due to my seasonal allergies) and EAR INFECTION (have an ear infection which is not treated yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state
Clinical narrative: brain fog; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (brain fog) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    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 CONFUSIONAL STATE (brain fog) and CHILLS (Chills). At the time of the report, CONFUSIONAL STATE (brain fog) and CHILLS (Chills) outcome was unknown.            Treatment was included as Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-083391 (E2B Linked Report). This case was linked to MOD-2021-083391 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083391:Second dose case
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Extra dose administered, Fatigue, Feeling abnormal
Clinical narrative: Exhaustion; Very tired; Full body ache; I developed shingles; Received the third dose of Moderna covid-19 vaccine; Lightheadedness; Brain fog; Felt off; Sore arm at the injection site; not stored at the proper temperature; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A, 031A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bicuspid aortic valve since 07-May-1985.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (not stored at the proper temperature) and INJECTION SITE PAIN (Sore arm at the injection site). On 13-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and CONFUSIONAL STATE (Brain fog). 13-Apr-2021, the patient experienced FEELING ABNORMAL (Felt off). On 21-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine). On 23-Apr-2021, the patient experienced HERPES ZOSTER (I developed shingles). On an unknown date, the patient experienced FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache). On 13-Apr-2021, INJECTION SITE PAIN (Sore arm at the injection site) had resolved. On 14-Apr-2021, DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) had resolved. At the time of the report, PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), HERPES ZOSTER (I developed shingles), FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache) outcome was unknown.            No concomitant product was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Date of 3rd dose was updated, New events were added in the follow up outcome of the events are updated On 21-Jul-2021: Follow-up received and updated batch no and patient demography.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pain, Myalgia, Product storage error
Clinical narrative: Exhaustion; Very tired; Full body ache; I developed shingles; Received the third dose of Moderna covid-19 vaccine; Lightheadedness; Brain fog; Felt off; Sore arm at the injection site; not stored at the proper temperature; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A, 031A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bicuspid aortic valve since 07-May-1985.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (not stored at the proper temperature) and INJECTION SITE PAIN (Sore arm at the injection site). On 13-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and CONFUSIONAL STATE (Brain fog). 13-Apr-2021, the patient experienced FEELING ABNORMAL (Felt off). On 21-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine). On 23-Apr-2021, the patient experienced HERPES ZOSTER (I developed shingles). On an unknown date, the patient experienced FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache). On 13-Apr-2021, INJECTION SITE PAIN (Sore arm at the injection site) had resolved. On 14-Apr-2021, DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) had resolved. At the time of the report, PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), HERPES ZOSTER (I developed shingles), FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache) outcome was unknown.            No concomitant product was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Date of 3rd dose was updated, New events were added in the follow up outcome of the events are updated On 21-Jul-2021: Follow-up received and updated batch no and patient demography.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fall, Fatigue, Gait disturbance
Clinical narrative: couldn't even walk from kitchen to living room; almost collapsed in the kitchen; extremely fatigue; Joint pains; Fever around 100; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't even walk from kitchen to living room), FALL (almost collapsed in the kitchen), FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) had resolved. At the time of the report, GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen) outcome was unknown and FATIGUE (extremely fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-083581 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083581:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: couldn't even walk from kitchen to living room; almost collapsed in the kitchen; extremely fatigue; Joint pains; Fever around 100; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't even walk from kitchen to living room), FALL (almost collapsed in the kitchen), FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) had resolved. At the time of the report, GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen) outcome was unknown and FATIGUE (extremely fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-083581 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083581:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Flushing
Clinical narrative: Feels flushed all the time; feels weak; shortness of breath; kind of stumbles around a little bit; ittle bit light-headed; muscle pain from his fingers down to his toes; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit) and DIZZINESS (ittle bit light-headed) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PAROXETINE HCL, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), TAMSULOSIN HCL, FLUTICASONE PROPIONATE and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes) outcome was unknown. Not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Feels flushed all the time; feels weak; shortness of breath; kind of stumbles around a little bit; ittle bit light-headed; muscle pain from his fingers down to his toes; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit) and DIZZINESS (ittle bit light-headed) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included PAROXETINE HCL, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), TAMSULOSIN HCL, FLUTICASONE PROPIONATE and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FLUSHING (Feels flushed all the time), ASTHENIA (feels weak), DYSPNOEA (shortness of breath), BALANCE DISORDER (kind of stumbles around a little bit), DIZZINESS (ittle bit light-headed) and MYALGIA (muscle pain from his fingers down to his toes) outcome was unknown. Not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Nausea, Pain in extremity, Tachycardia
Clinical narrative: "I felt faint"; started seeing red spots; heart rate increased; pain in finger; pain in shoulder, elbow; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger) and ARTHRALGIA (pain in shoulder, elbow) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ehlers-Danlos syndrome.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger), ARTHRALGIA (pain in shoulder, elbow) and NAUSEA (Nausea). The patient was treated with METOPROLOL TARTRATE at an unspecified dose and frequency and ATOMOXETINE HYDROCHLORIDE (STRATTERA) at an unspecified dose and frequency. At the time of the report, ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger), ARTHRALGIA (pain in shoulder, elbow) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: "I felt faint"; started seeing red spots; heart rate increased; pain in finger; pain in shoulder, elbow; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger) and ARTHRALGIA (pain in shoulder, elbow) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ehlers-Danlos syndrome.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger), ARTHRALGIA (pain in shoulder, elbow) and NAUSEA (Nausea). The patient was treated with METOPROLOL TARTRATE at an unspecified dose and frequency and ATOMOXETINE HYDROCHLORIDE (STRATTERA) at an unspecified dose and frequency. At the time of the report, ASTHENIA ("I felt faint"), VISUAL IMPAIRMENT (started seeing red spots), TACHYCARDIA (heart rate increased), PAIN IN EXTREMITY (pain in finger), ARTHRALGIA (pain in shoulder, elbow) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Limb discomfort, Pain, Pain in extremity
Clinical narrative: had discomfort on her right arm; could not go to work due to the pain; could not move it and had it elevated for the pain; strong pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in the arm of the injection ), LIMB DISCOMFORT (had discomfort on her right arm), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (strong pain in the arm of the injection ), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ). On an unknown date, the patient experienced LIMB DISCOMFORT (had discomfort on her right arm). At the time of the report, PAIN IN EXTREMITY (strong pain in the arm of the injection ), LIMB DISCOMFORT (had discomfort on her right arm), IMPAIRED WORK ABILITY (could not go to work due to the pain) and PAIN (could not move it and had it elevated for the pain ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol(paracetamol).  Concomitant medication included unspecified allergy medication.   This case was linked to MOD-2021-083718 (E2B Linked Report).; Sender's Comments:  MOD-2021-083718:Same reporter, Husband's case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication included Advil and Tylenol. Action taken with mRNA-1273 in response to the events was not applicable.