chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; vomiting; Tired; Headache; Doesnt have an appetite; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, CHILLS, FATIGUE, PYREXIA, and VOMITING in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE 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.   This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, FATIGUE, PYREXIA, VOMITING, and FATIGUE in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old was administered the 1st dose of Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was administered the 1st dose of Moderna COVID19 vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was administered the 1st dose of Moderna COVID19 vaccine). On 04-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was administered the 1st dose of Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 026B21A) with no associated AEs.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment details are not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse events he is having after a week of having gotten his first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose). At the time of the report, VACCINATION COMPLICATION (adverse events he is having after a week of having gotten his first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    Concurrent medical conditions included Cholesterol and Osteoporosis. Concomitant products included ATORVASTATIN for Cholesterol, CALCIUM CITRATE for Osteoporosis, VITAMIN D3 and TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) for Supplementation therapy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient started LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) outcome was unknown.            Treatment medication include: Anti itch cream                                                  eye drops.   This case was linked to US-MODERNATX, INC.-MOD-2021-066665, US-MODERNATX, INC.-MOD-2021-067694 (E2B Linked Report). This case was linked to MOD-2021-066665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: patient information added. On 24-May-2021: Email stated FUP was sent via fax On 24-May-2021: Initial Additional-2 : Unable to fax.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066665:MOD-2021-066647 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-067694:Crosslinked (MOD21-068818)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Feeling fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Feeling fast heartbeat) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Feeling fast heartbeat). At the time of the report, HEART RATE INCREASED (Feeling fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypertension, Illness, Inappropriate schedule of product administration
Clinical narrative: 68 days away from the FIRST shot and she still has not received the second shot; Sick; High Blood Pressure; Tired; Weak; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot), ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak). On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot). On 08-Feb-2021, ILLNESS (Sick), HYPERTENSION (High Blood Pressure), FATIGUE (Tired) and ASTHENIA (Weak) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days away from the FIRST shot and she still has not received the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-066642 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Cough, Diarrhoea, Illness
Clinical narrative: Had covid; Coughing; sick; sore on her chest and body; has diarrhea; Nausea; throwed up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body) and DIARRHOEA (has diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O38A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included nausea medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Had covid; Coughing; sick; sore on her chest and body; has diarrhea; Nausea; throwed up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body) and DIARRHOEA (has diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O38A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (Had covid), COUGH (Coughing), ILLNESS (sick), CHEST PAIN (sore on her chest and body), DIARRHOEA (has diarrhea), NAUSEA (Nausea) and VOMITING (throwed up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included nausea medication.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema
Clinical narrative: Diarrhea; Red Arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm). At the time of the report, DIARRHOEA (Diarrhea) and ERYTHEMA (Red Arm) outcome was unknown.            No treatment medications were provided. No concomitant medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: Left arm was sore and is like some body hit with a base ball; Light headed; Feeling as if he had flu; Feeling weak; Very cold; Entire body aches; Teeth shattering; Feeling tired; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak) and FEELING COLD (Very cold) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated,2nd dose information updated
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Pain in extremity
Clinical narrative: Left arm was sore and is like some body hit with a base ball; Light headed; Feeling as if he had flu; Feeling weak; Very cold; Entire body aches; Teeth shattering; Feeling tired; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak) and FEELING COLD (Very cold) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous). At the time of the report, PAIN IN EXTREMITY (Left arm was sore and is like some body hit with a base ball), DIZZINESS (Light headed), INFLUENZA LIKE ILLNESS (Feeling as if he had flu), ASTHENIA (Feeling weak), FEELING COLD (Very cold), MYALGIA (Entire body aches), CHILLS (Teeth shattering), FATIGUE (Feeling tired), HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome updated,2nd dose information updated
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: arm is sore; 3 inch red rash around injection site; rash is warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm). At the time of the report, PAIN IN EXTREMITY (arm is sore), INJECTION SITE ERYTHEMA (3 inch red rash around injection site) and INJECTION SITE RASH (rash is warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vaccine administered after temperature excursion) had resolved. 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 medications were reported No treatment drugs were reported     This case was linked to MOD21-068786, MOD21-068785, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068784, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068783, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068782, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781 (E2B Linked Report).; Sender's Comments:  MOD21-068786: MOD21-068785: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068784: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068783: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068782: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dysarthria, Memory impairment
Clinical narrative: memory problems; speech was garbled; He wanted to use a magnifying glass as a fork to eat; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy, DOCUSATE SODIUM for Bowel movement irregularity, SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVETIRACETAM (KEPPRA) for Seizures, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat). At the time of the report, MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: achiness all over the body; extremely painful injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PAIN (achiness all over the body) and VACCINATION SITE PAIN (extremely painful injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-066667 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Product dose omission issue
Clinical narrative: My heart was racing for 30 minutes; I was very flushed for 30 minutes; received 1st dose on 4Feb2021. (8 weeks since 1st dose); This spontaneous case was reported by a non-health professional and describes the occurrence of HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, ANASTROZOLE (ARIMIDEX), HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)). On 04-Feb-2021, HEART RATE INCREASED (My heart was racing for 30 minutes), FLUSHING (I was very flushed for 30 minutes) and PRODUCT DOSE OMISSION ISSUE (received 1st dose on 4Feb2021. (8 weeks since 1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received for the events.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter provided email address.TCR attached.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            No relevant concomitant medications reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16-JUN-2021 and outcome of the event updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain
Clinical narrative: very bad pain in right side of the tummy and back pain; back pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain) in a 49-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.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain). At the time of the report, ABDOMINAL PAIN (very bad pain in right side of the tummy and back pain) and BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Patient Consent Denied to save the caller's information within our database and Denied for safety to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Excessive eye blinking, Glossodynia, Lacrimation increased, Mouth swelling
Clinical narrative: eyes watery; need to blink the eye constantly; Mouth soreness; mouth swollen; throat soreness; tongue swollen; whole body itchiness; redness; Tongue Redness; tongue soreness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen) and PRURITUS (whole body itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, CALCIUM CITRATE for Osteoporosis, VITAMIN D3 and DL-ALPHA TOCOPHERYL ACETATE, UBIDECARENONE (COENZYME Q10) for Supplementation therapy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen), PRURITUS (whole body itchiness), ERYTHEMA (redness), TONGUE ERYTHEMA (Tongue Redness) and GLOSSODYNIA (tongue soreness). On 04-Apr-2021, the patient experienced LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly). On 31-Mar-2021, ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness) and SWOLLEN TONGUE (tongue swollen) had resolved. On 02-Apr-2021, PRURITUS (whole body itchiness) and ERYTHEMA (redness) had resolved. At the time of the report, TONGUE ERYTHEMA (Tongue Redness), GLOSSODYNIA (tongue soreness), LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly) outcome was unknown. Not Provided          Treatment medication included Benadryl gel, Anti itch cream and eye drops. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-066647 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: follow up was received on 23 Apr 2021,reporter information and patient initials were updated, cross linked cases were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066647:MOD-2021-066647 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-067694:Crosslinked (MOD21-068818)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal pain, Pruritus, Swollen tongue, Tongue erythema
Clinical narrative: eyes watery; need to blink the eye constantly; Mouth soreness; mouth swollen; throat soreness; tongue swollen; whole body itchiness; redness; Tongue Redness; tongue soreness; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen) and PRURITUS (whole body itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, CALCIUM CITRATE for Osteoporosis, VITAMIN D3 and DL-ALPHA TOCOPHERYL ACETATE, UBIDECARENONE (COENZYME Q10) for Supplementation therapy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness), SWOLLEN TONGUE (tongue swollen), PRURITUS (whole body itchiness), ERYTHEMA (redness), TONGUE ERYTHEMA (Tongue Redness) and GLOSSODYNIA (tongue soreness). On 04-Apr-2021, the patient experienced LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly). On 31-Mar-2021, ORAL PAIN (Mouth soreness), MOUTH SWELLING (mouth swollen), OROPHARYNGEAL PAIN (throat soreness) and SWOLLEN TONGUE (tongue swollen) had resolved. On 02-Apr-2021, PRURITUS (whole body itchiness) and ERYTHEMA (redness) had resolved. At the time of the report, TONGUE ERYTHEMA (Tongue Redness), GLOSSODYNIA (tongue soreness), LACRIMATION INCREASED (eyes watery) and EXCESSIVE EYE BLINKING (need to blink the eye constantly) outcome was unknown. Not Provided          Treatment medication included Benadryl gel, Anti itch cream and eye drops. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-066647 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: follow up was received on 23 Apr 2021,reporter information and patient initials were updated, cross linked cases were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066647:MOD-2021-066647 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-067694:Crosslinked (MOD21-068818)
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash has gone away; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash has gone away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 RASH (Rash has gone away). At the time of the report, RASH (Rash has gone away) had resolved.            No concomitant medicines were reported. No treatment information were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Pyrexia, Vaccination site pain
Clinical narrative: 2 lumps on the neck; Painful to touch; Fever; Pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (2 lumps on the neck), PAIN (Painful to touch), VACCINATION SITE PAIN (Pain in the injection arm) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in the injection arm). On 02-Apr-2021, the patient experienced PYREXIA (Fever). On 03-Apr-2021, the patient experienced NODULE (2 lumps on the neck) and PAIN (Painful to touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NODULE (2 lumps on the neck), PAIN (Painful to touch), VACCINATION SITE PAIN (Pain in the injection arm) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD21-068765 (E2B Linked Report).; Sender's Comments:  MOD21-068765:MOD-2021-066658 1st dose cases
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus
Clinical narrative: nausea; sharp arm pain/soreness in arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), NAUSEA (nausea) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Itching) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm).   On 01-Apr-2021, the patient experienced NAUSEA (nausea).   At the time of the report, PRURITUS (Itching), NAUSEA (nausea) and PAIN IN EXTREMITY (sharp arm pain/soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: A breastfeeding patient received the first dose of Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.) in a 28-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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.). At the time of the report, EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: lower lip and left hand side has been twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (lower lip and left hand side has been twitching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0433B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever, Dust allergy and Hypothyroidism in 2015. Concurrent medical conditions included Fruit allergy.   On 26-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 11:30 AM, the patient experienced MUSCLE TWITCHING (lower lip and left hand side has been twitching). On 04-Jul-2021, MUSCLE TWITCHING (lower lip and left hand side has been twitching) had resolved.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up  received on 17-MAY-2021 in which second dose of vaccination, patient medical history, Event information is updated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age old received vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age old received vaccine) 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.   Concomitant product use was not provided.  Treatment information was not provided.  This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 018B21A) with no associated AEs.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 018B21A) with no associated AEs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Headache, Pain, Pyrexia
Clinical narrative: Bad bodyache; Symptoms were similar to what she experienced when she had the virus.; Fever of 101.3 degrees; Bad Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches). At the time of the report, PAIN (Bad bodyache), ADVERSE DRUG REACTION (Symptoms were similar to what she experienced when she had the virus.), PYREXIA (Fever of 101.3 degrees) and HEADACHE (Bad Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        relevant concomitant products usage were not reported by the reporter.treatment details not included.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Flu-like symptoms; Sore arm; Chills; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (fever of 101) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney function abnormal (50% kidney capacity), Hashimoto's disease and Heart disease, unspecified.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (fever of 101). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pyrexia: 101 (Inconclusive) fever of 101 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications included Blood thinners No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: follow-up received, TCR added