chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Can hardly walk; Aches/ pain in her legs and thighs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Can hardly walk) and PAIN IN EXTREMITY (Aches/ pain in her legs and thighs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C10M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk) and PAIN IN EXTREMITY (Aches/ pain in her legs and thighs).   At the time of the report, GAIT DISTURBANCE (Can hardly walk) and PAIN IN EXTREMITY (Aches/ pain in her legs and thighs) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included pain medication. Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Gait disturbance, Insomnia
Clinical narrative: Unable to walk well; Couldn't eat; Weakness; Insomnia; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 03-Feb-2021, the patient experienced GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills).   At the time of the report, GAIT DISTURBANCE (Unable to walk well), DECREASED APPETITE (Couldn't eat), ASTHENIA (Weakness), INSOMNIA (Insomnia) and CHILLS (Chills) 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: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Tachycardia; Shortness of breath; Arm soreness; Headache; Redness around injection site; Small bumps around the injection site; Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 020M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON and ASCORBIC ACID, FERROUS FUMARATE, FOLIC ACID, RETINOL (PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 in June 2020 and the estimated date of delivery was 01-Apr-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 06-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Small bumps around the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) for Headache, at an unspecified dose and frequency. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE RASH (Small bumps around the injection site) outcome was unknown and PAIN IN EXTREMITY (Arm soreness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included Butalbital-Acetaminophen-Caffeine for unknown indication.  Treatment medication Butalbital-Acetaminophen-Caffeine was taken after the second dose.; Sender's Comments: This case concerns a 30 year-old, female patient, who experienced an event of exposure during pregnancy after receiving her first and second dose of mRNA-1273 vaccine.  In addition, the patient experienced arm soreness, headache, shortness of breath, tachycardia, redness around injection site, and small bumps around the injection site after her first dose of mRNA-1273 and experienced headache after her second dose. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 19-Dec-2018. Concurrent medical conditions included Asthma (Mild, No maintenance medicine.). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 06-Jun-2021. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 28-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) abnormal.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Itchy Injection Site; Red 4" X 2" near Injection Site; Swollen Injection Site; Little Spot on the Left Arm First day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little Spot on the Left Arm First day), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Little Spot on the Left Arm First day). On 13-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). On 12-Feb-2021, VACCINATION SITE REACTION (Little Spot on the Left Arm First day) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included anti-itch lotion. concomitant medication was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Migraine, Nasopharyngitis
Clinical narrative: cold; sweating; migraine with bight flashing; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue). At the time of the report, NASOPHARYNGITIS (cold), HYPERHIDROSIS (sweating), MIGRAINE (migraine with bight flashing) and FATIGUE (extreme fatigue) outcome was unknown.            concomitant medication was not provided.  Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Catheterisation cardiac, Dizziness, Dyspnoea, Vomiting
Clinical narrative: pre-scheduled cardiac procedure; Shortness of breath; Vomiting; Light headed; Weakness; A spontaneous report was received from a 77-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, light headedness, weakness, and shortness of breath after a pre-scheduled cardiac procedure to check for arterial blockage.  The patient's medical history included congestive heart failure. No concomitant product use was reported.  On 03-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: SWHHS) intramuscularly in upper right arm  for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, the patient underwent a pre-scheduled procedure to check blockages in the heart. On an unspecified date the patient was hospitalized as precautionary measure.  On 22-FEB-2021, the patient walked a mile. On 23-FEB-2021, it was reported that the patient vomited, felt light headedness, weakness and some shortness of breath.  The patient was scheduled to receive the second dose of vaccine on 03-MAR-2021.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vomiting, light headedness, weakness, and shortness of breath was unknown. The outcome for the cardiac catheterization was resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The medical history of congestive heart failure may be contributory to the development of the events. Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Vaccination site swelling
Clinical narrative: delayed reaction shot site red rash; delayed reaction shot site itchy; delayed reaction shot site swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-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) at an unspecified dose. On an unknown date, the patient experienced RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen). At the time of the report, RASH ERYTHEMATOUS (delayed reaction shot site red rash), PRURITUS (delayed reaction shot site itchy) and VACCINATION SITE SWELLING (delayed reaction shot site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided. Concomitant medication was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) and DIZZINESS (Dizzy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Light headed) and DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Light headed) and DIZZINESS (Dizzy) outcome was unknown.            Treatment information not reported. No concomitant medications reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: arm is now itchy; felt fatigued and tired; naseous; severe headache; chills; I think I had a fever; swollen lymph nodes; I did vomit once; soreness in arm right away; felt hot and sweaty; felt hot and sweaty; diarrhea; sometimes difficulty breathing; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea) and DYSPNOEA (sometimes difficulty breathing) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported.). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CITALOPRAM and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once). On 23-Feb-2021, the patient experienced PRURITUS (arm is now itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm right away) and PRURITUS (arm is now itchy) had not resolved and FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included birth control pills.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: arm is now itchy; felt fatigued and tired; naseous; severe headache; chills; I think I had a fever; swollen lymph nodes; I did vomit once; soreness in arm right away; felt hot and sweaty; felt hot and sweaty; diarrhea; sometimes difficulty breathing; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea) and DYSPNOEA (sometimes difficulty breathing) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported.). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CITALOPRAM and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once). On 23-Feb-2021, the patient experienced PRURITUS (arm is now itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm right away) and PRURITUS (arm is now itchy) had not resolved and FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included birth control pills.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: arm is now itchy; felt fatigued and tired; naseous; severe headache; chills; I think I had a fever; swollen lymph nodes; I did vomit once; soreness in arm right away; felt hot and sweaty; felt hot and sweaty; diarrhea; sometimes difficulty breathing; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea) and DYSPNOEA (sometimes difficulty breathing) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported.). Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), CITALOPRAM and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm right away), FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once). On 23-Feb-2021, the patient experienced PRURITUS (arm is now itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm right away) and PRURITUS (arm is now itchy) had not resolved and FEELING HOT (felt hot and sweaty), HYPERHIDROSIS (felt hot and sweaty), DIARRHOEA (diarrhea), DYSPNOEA (sometimes difficulty breathing), FATIGUE (felt fatigued and tired), NAUSEA (naseous), HEADACHE (severe headache), CHILLS (chills), PYREXIA (I think I had a fever), LYMPHADENOPATHY (swollen lymph nodes) and VOMITING (I did vomit once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included birth control pills.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Rash erythematous, Vaccination site induration, Vaccination site rash
Clinical narrative: red rash extending down arm approx. 6"/Rash; hot arm; sore when moving arm; Hardness at the injection site; Rash at the injection site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm), MYALGIA (sore when moving arm), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thrombocytopenia and Osteoporosis. Concomitant products included METOPROLOL TARTRATE for Heart disorder, LORAZEPAM for Sleep difficult, RALOXIFENE for Supplementation therapy and Supplementation therapy, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and SALMON OIL for Vitamin supplementation, VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm). On 30-Jan-2021, VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm) 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.   For treatment patient applied cold compresses   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include patient demographics, medical history, concomitants, and some new events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red rash extending down arm approx. 6"/Rash; hot arm; sore when moving arm; Hardness at the injection site; Rash at the injection site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm), MYALGIA (sore when moving arm), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thrombocytopenia and Osteoporosis. Concomitant products included METOPROLOL TARTRATE for Heart disorder, LORAZEPAM for Sleep difficult, RALOXIFENE for Supplementation therapy and Supplementation therapy, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and SALMON OIL for Vitamin supplementation, VITAMINS NOS for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm). On 30-Jan-2021, VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE SWELLING (Swelling on the site) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash extending down arm approx. 6"/Rash), FEELING HOT (hot arm) and MYALGIA (sore when moving arm) 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.   For treatment patient applied cold compresses   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include patient demographics, medical history, concomitants, and some new events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Upper Respiratory Symptoms post vaccination; COVID Rapid Test was Positive post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination). At the time of the report, RESPIRATORY DISORDER (Upper Respiratory Symptoms post vaccination) and COVID-19 (COVID Rapid Test was Positive post vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow up received on 08-JUL 2021, Event  outcome updated. second dose added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Headache, Pyrexia, Swelling
Clinical narrative: Her right underarm got swollen; Chills; Headache; Fever; Back of her neck swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Back of her neck swollen), AXILLARY MASS (Her right underarm got swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant past medical history was provided.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SWELLING (Back of her neck swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 22-Feb-2021, the patient experienced AXILLARY MASS (Her right underarm got swollen). On 07-Feb-2021, SWELLING (Back of her neck swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, AXILLARY MASS (Her right underarm got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product details not provided. no treatment details reported.   This case was linked to MOD21-087211 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: F/U received on 06-MAY-2021,reporter contact details updated.; Sender's Comments:  MOD21-087211:follow up - contact information updated -email , address , phone
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oral herpes, Vaccination site pruritus
Clinical narrative: Cold sore; Itching; A slight allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (A slight allergic reaction), ORAL HERPES (Cold sore) and VACCINATION SITE PRURITUS (Itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced HYPERSENSITIVITY (A slight allergic reaction) and VACCINATION SITE PRURITUS (Itching). On 21-Feb-2021, the patient experienced ORAL HERPES (Cold sore). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Cold sores, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (A slight allergic reaction) and VACCINATION SITE PRURITUS (Itching) had resolved and ORAL HERPES (Cold sore) outcome was unknown.            Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) 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.   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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Feb-2021, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously) 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 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 09-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously). On 09-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (It was not given in the center of the arm/ received an injection too far back than recommended from the injection site/chance that it went subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15-Jul -2021and does not contain any new information.; Reporter's Comments: This report refers to a case of inappropriate route of vaccination for mRNA-1273, lot # unknown with no associated AEs
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain
Clinical narrative: Weakness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and PAIN (Aches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (Weakness) and PAIN (Aches). On 28-Jan-2021, ASTHENIA (Weakness) had resolved. On 28-Feb-2021, PAIN (Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) 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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid shoulder). On 21-Jan-2021, VACCINATION SITE REACTION (Covid shoulder) 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 relevant concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-023511 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information include email details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 44-year-old female patient (gravida 5, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior Use), Induced abortion (2 times in 2000 and in 2001) and Miscarriage (Spontaneous abortion) on 14-Oct-2011. Concurrent medical conditions included Hypothyroidism (since 2009). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and SERTRALINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On 29-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 29-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported Induced abortion Nov2001 and Apr2000,also history of Spontaneous abortion on 14OCT2011 and had a full term child birth.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy details
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Nodule, Rash erythematous, Rash pruritic, Vaccination site erythema
Clinical narrative: Appearance of small bumps; small red bumps on my hands/elbows/knees/feet; Small itchy bumps on my hands/ elbows/knees/feet; Bumps have a white head on them; Injection site was hot; Injection site was itchy; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them) and VACCINATION SITE WARMTH (Injection site was hot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Appearance of small bumps; small red bumps on my hands/elbows/knees/feet; Small itchy bumps on my hands/ elbows/knees/feet; Bumps have a white head on them; Injection site was hot; Injection site was itchy; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them) and VACCINATION SITE WARMTH (Injection site was hot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Induration
Clinical narrative: Arm hard like a tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm hard like a tennis ball) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INDURATION (Arm hard like a tennis ball). At the time of the report, INDURATION (Arm hard like a tennis ball) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: felt bad the entire day/feeling not great/feeling sort of off; Arm slightly sore; feeling woozy; fatigued; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt bad the entire day/feeling not great/feeling sort of off), PAIN IN EXTREMITY (Arm slightly sore), DIZZINESS (feeling woozy) and FATIGUE (fatigued) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021 at 10:24 AM, 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) at an unspecified dose. On 26-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad the entire day/feeling not great/feeling sort of off), PAIN IN EXTREMITY (Arm slightly sore), DIZZINESS (feeling woozy) and FATIGUE (fatigued). At the time of the report, FEELING ABNORMAL (felt bad the entire day/feeling not great/feeling sort of off), DIZZINESS (feeling woozy) and FATIGUE (fatigued) was resolving and PAIN IN EXTREMITY (Arm slightly sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant medication was not provided.  Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness; Tiredeness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and FATIGUE (Tiredeness/Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in 2019, Bacterial pneumonia, unspecified in September 2020, Aneurysm (Had previous diagnosis of 2 aneurysms and 2 strokes in 1993 and 1999) in 1993 and Stroke (Had previous diagnosis of 2 aneurysms and 2 strokes in 1993 and 1999.) in 1993.   On 22-Feb-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) at an unspecified dose. On 23-Feb-2021, the patient experienced ASTHENIA (Weakness) and FATIGUE (Tiredeness/Fatigue). At the time of the report, ASTHENIA (Weakness) and FATIGUE (Tiredeness/Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Sig Fup- patient  symptoms have resolved(outcome)