chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sleep disorder, Vomiting
Clinical narrative: couldn't sleep for 2 days because I sleep on my left side; vomiting; chills; Fatigue; joint pain; headaches; still having nausea; haven't eaten in two days; This spontaneous case was reported by a consumer and describes the occurrence of haven't eaten in two days, couldn't sleep for 2 days because I sleep on my left side, vomiting, chills, and Fatigue in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was Provided by Reporter.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced EATING DISORDER (haven't eaten in two days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA. On an unknown date, the patient experienced SLEEP DISORDER (couldn't sleep for 2 days because I sleep on my left side). The patient was treated with ZOFRAN at an unspecified dose and frequency. At the time of the report, EATING DISORDER (haven't eaten in two days), SLEEP DISORDER (couldn't sleep for 2 days), VOMITING, CHILLS, FATIGUE, ARTHRALGIA (joint pain), HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   concomitant medications are not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: The TCR form received does not contain any new information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and INJECTION SITE PAIN in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE. On an unknown date, the patient experienced INJECTION SITE PAIN. The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, HEADACHE and INJECTION SITE PAIN (arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-097682.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: Injection site has a hard lump; Injection site is like a marble; Injection site is red; Injection site is so sore; extreme tiredness that day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS, VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA, INJECTION SITE PAIN, and FATIGUE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE MASS, VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA, INJECTION SITE PAIN, and FATIGUE. At the time of the report, VACCINATION SITE MASS, VACCINATION SITE INDURATION (hard), VACCINATION SITE ERYTHEMA, INJECTION SITE PAIN and FATIGUE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Treatment drugs were not included,  Concomitant medicines were not provided,  Action taken with mRNA-1273 in response to the event was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Burning sensation, Erythema, Pruritus, Rash
Clinical narrative: burning sensation for 15 minutes; redness from left elbow to left hip; crazy episode of the rashes; Itchy; red skin; Burning sensation; bumpy spots; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red skin), BURNING SENSATION (Burning sensation), ACNE (bumpy spots), PRURITUS (Itchy) and BURNING SENSATION (burning sensation for 15 minutes) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ERYTHEMA (red skin), BURNING SENSATION (Burning sensation) and ACNE (bumpy spots). On 29-Apr-2021, the patient experienced PRURITUS (Itchy) and RASH (crazy episode of the rashes). On an unknown date, the patient experienced BURNING SENSATION (burning sensation for 15 minutes) and ERYTHEMA (redness from left elbow to left hip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (red skin), BURNING SENSATION (Burning sensation), ACNE (bumpy spots), PRURITUS (Itchy), BURNING SENSATION (burning sensation for 15 minutes), ERYTHEMA (redness from left elbow to left hip) and RASH (crazy episode of the rashes) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and CHILLS in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA and CHILLS. At the time of the report, PYREXIA and CHILLS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Chills; Feeling tired, fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, FATIGUE, and NAUSEA in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-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 an unknown date, the patient experienced CHILLS, FATIGUE, and NAUSEA. The patient was treated with TYLENOL at a dose of Unknown dosage form. At the time of the report, Chills, FATIGUE, and NAUSEA outcome was unknown. Not Provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling hot, Hypokinesia, Muscular weakness
Clinical narrative: Muscle weakness; Diarhea; Vomitting; Chills; Shaking so bad all over; Fever; Nausea; Could not move; Warm but not running a fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move), Warm but not running a fever, MUSCULAR WEAKNESS, DIARRHOEA, and TREMOR (Shaking so bad all over) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOKINESIA (Could not move), Warm but not running a fever, and Nausea. On 14-Apr-2021, the patient experienced Fever. On 14-Apr-2021 at 11:00 PM, the patient experienced TREMOR (Shaking so bad all over). On 20-Apr-2021 at 6:00 AM, the patient experienced MUSCULAR WEAKNESS, DIARRHOEA, VOMITING, and CHILLS. The patient was treated with TYLENOL for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency and IBUPROFEN for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency. On 15-Apr-2021 at 5:00 AM, TREMOR (Shaking so bad all over) had resolved. On 29-Apr-2021, MUSCULAR WEAKNESS, DIARRHOEA, Fever, VOMITING, and CHILLS had resolved. At the time of the report, HYPOKINESIA (Could not move), Warm but not running a fever, and NAUSEA outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Additional information received on 03-07-2021. Reporter's details product batch number was added and event outcome was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Muscle weakness; Diarhea; Vomitting; Chills; Shaking so bad all over; Fever; Nausea; Could not move; Warm but not running a fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move), Warm but not running a fever, MUSCULAR WEAKNESS, DIARRHOEA, and TREMOR (Shaking so bad all over) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 024m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOKINESIA (Could not move), Warm but not running a fever, and Nausea. On 14-Apr-2021, the patient experienced Fever. On 14-Apr-2021 at 11:00 PM, the patient experienced TREMOR (Shaking so bad all over). On 20-Apr-2021 at 6:00 AM, the patient experienced MUSCULAR WEAKNESS, DIARRHOEA, VOMITING, and CHILLS. The patient was treated with TYLENOL for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency and IBUPROFEN for Nauseous, Hypokinesia, Feeling hot, Tremor, and Fever, at an unspecified dose and frequency. On 15-Apr-2021 at 5:00 AM, TREMOR (Shaking so bad all over) had resolved. On 29-Apr-2021, MUSCULAR WEAKNESS, DIARRHOEA, Fever, VOMITING, and CHILLS had resolved. At the time of the report, HYPOKINESIA (Could not move), Warm but not running a fever, and NAUSEA outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Additional information received on 03-07-2021. Reporter's details product batch number was added and event outcome was updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Huge red rash; The size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS and RASH (The size of a baseball) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MODAFINIL and BABY ASPIRIN for an unknown indication.    On 27-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH ERYTHEMATOUS and RASH (The size of a baseball). At the time of the report, RASH ERYTHEMATOUS and RASH (The size of a baseball) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Cholesterol meds.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29 Apr 2021 contains no new information. On 29-May-2021: Reporter contact number added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Inflammation
Clinical narrative: bruise on the back of their left and right hands; titanium plate in their skull became inflamed; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included Brain operation (Titanium plate insertion in the skull.).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed). At the time of the report, CONTUSION (bruise on the back of their left and right hands) and INFLAMMATION (titanium plate in their skull became inflamed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: in bed for a couple of days; felt fatigued after the first dose and stayed in bed for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (in bed for a couple of days) and FATIGUE in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (in bed for a couple of days) and FATIGUE. At the time of the report, ASTHENIA (in bed for a couple of days) and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication reported. no treatment medication reported.   This case was linked to MOD-2021-097731.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness postural, Fatigue, Headache
Clinical narrative: Weakness; Flu symptoms.; Dizzy standing up; Muscle still hurts.; Chills; Fatigue; Headache; Pink patches the size of a nickel close to the injection site; Arm also hurt/Painful arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), and CHILLS in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site). At the time of the report, ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle still hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) to be related. No further causality assessment was provided for INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site).    Treatment medication included cold compress for pain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Upon in internal review on 04-Aug-2021, the age was corrected to 71 years.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: facility Information updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site rash, Myalgia, Vaccination site pain
Clinical narrative: Weakness; Flu symptoms.; Dizzy standing up; Muscle still hurts.; Chills; Fatigue; Headache; Pink patches the size of a nickel close to the injection site; Arm also hurt/Painful arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), and CHILLS in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ROSUVASTATIN and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site). At the time of the report, ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle still hurts), CHILLS, FATIGUE, HEADACHE, INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site), and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weakness), Flu symptoms, Dizzy standing up, MYALGIA (Muscle hurts), CHILLS, FATIGUE, HEADACHE, and VACCINATION SITE PAIN (Arm also hurt/Painful arm of injection site) to be related. No further causality assessment was provided for INJECTION SITE RASH (Pink patches the size of a nickel close to the injection site).    Treatment medication included cold compress for pain. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Upon in internal review on 04-Aug-2021, the age was corrected to 71 years.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: facility Information updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal discomfort, Neck pain
Clinical narrative: Cannot turn the neck, needs to turn whole body to look right; Pain in right side of neck, Debilitating pain; Sore arm; Arm red; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Cannot turn the neck, needs to turn whole body to look right), NECK PAIN (Pain in right side of neck, Debilitating pain), INJECTION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Arm red) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included DICLOFENAC for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Cannot turn the neck, needs to turn whole body to look right), NECK PAIN (Pain in right side of neck, Debilitating pain), INJECTION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Arm red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Cannot turn the neck, needs to turn whole body to look right), NECK PAIN (Pain in right side of neck, Debilitating pain), INJECTION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: weakness; severe dizziness; felt like the entire room was spinning for 2 days and currently would now just come and go; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS, and VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS, and VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go). On 22-Apr-2021, ASTHENIA (weakness) and DIZZINESS had resolved. At the time of the report, VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Feeling hot, Headache, Myalgia
Clinical narrative: felt weak; felt hot; her throat went shut; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE. At the time of the report, ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure increased: high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. Treatment medication include strong antibiotic.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: felt weak; felt hot; her throat went shut; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE. At the time of the report, ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure increased: high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. Treatment medication include strong antibiotic.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; Cough; Stuffy nose; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), COUGH, NASAL CONGESTION, and fever in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold), COUGH, NASAL CONGESTION, and fever. At the time of the report, NASOPHARYNGITIS (Cold), COUGH (Cough), NASAL CONGESTION, and fever outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication information was provided. No lab data has been provided by the reporter. No treatment product information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Hypoaesthesia oral, Pain in extremity
Clinical narrative: sore arms and legs chest and back; sore arms and legs chest and back; sore arms and legs chest and back; upper inside of mouth going numb; fever up to 100.4; sore arms and legs chest and back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb) and PYREXIA (fever up to 100.4) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back). At the time of the report, BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.4 (High) high.         Concomitant medication include  blood pressure medication. No treatment medication was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: sore arms and legs chest and back; sore arms and legs chest and back; sore arms and legs chest and back; upper inside of mouth going numb; fever up to 100.4; sore arms and legs chest and back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb) and PYREXIA (fever up to 100.4) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and METFORMIN for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back). At the time of the report, BACK PAIN (sore arms and legs chest and back), CHEST PAIN (sore arms and legs chest and back), PAIN IN EXTREMITY (sore arms and legs chest and back), HYPOAESTHESIA ORAL (upper inside of mouth going numb), PYREXIA (fever up to 100.4) and VACCINATION SITE PAIN (sore arms and legs chest and back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 100.4 (High) high.         Concomitant medication include  blood pressure medication. No treatment medication was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Diarrhoea
Clinical narrative: have no energy; arm was swollen and felt like someone was burning her arm; chills; fever; nausea; headache; arm was sore; arm was swollen and felt like someone was burning her arm; severe diarrhea; joint pain; lightheaded, dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain) and ASTHENIA (have no energy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (lightheaded, dizzy), DIARRHOEA (severe diarrhea) and ARTHRALGIA (joint pain). On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore). 08-Apr-2021, the patient experienced CHILLS (chills). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Another concomitant included heart medicine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Peripheral swelling
Clinical narrative: have no energy; arm was swollen and felt like someone was burning her arm; chills; fever; nausea; headache; arm was sore; arm was swollen and felt like someone was burning her arm; severe diarrhea; joint pain; lightheaded, dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain) and ASTHENIA (have no energy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (lightheaded, dizzy), DIARRHOEA (severe diarrhea) and ARTHRALGIA (joint pain). On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore). 08-Apr-2021, the patient experienced CHILLS (chills). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Another concomitant included heart medicine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have no energy; arm was swollen and felt like someone was burning her arm; chills; fever; nausea; headache; arm was sore; arm was swollen and felt like someone was burning her arm; severe diarrhea; joint pain; lightheaded, dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain) and ASTHENIA (have no energy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (lightheaded, dizzy), DIARRHOEA (severe diarrhea) and ARTHRALGIA (joint pain). On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore). 08-Apr-2021, the patient experienced CHILLS (chills). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Another concomitant included heart medicine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness; Did not allow him to fall asleep; Joint pain; Slight elevated fever; Splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRSA014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache). The patient was treated with IBUPROFEN on 22-Apr-2021 at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Did not allow him to fall asleep), ARTHRALGIA (Joint pain), PYREXIA (Slight elevated fever) and HEADACHE (Splitting headache) 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Neck pain, Pustule, Rash
Clinical narrative: Shingles diagnosed by physician; Pain in the neck radiating to head; pustules on arms, legs and back; head lesions; rash developed on body; neck pain radiating to head; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles diagnosed by physician), NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs, and back), SKIN LESION (head), and RASH (rash developed on body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by the reporter.     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 HERPES ZOSTER (Shingles diagnosed by physician), NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs, and back), SKIN LESION, RASH, and HEADACHE (neck pain radiating to head). The patient was treated with ACYCLOVIR at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles diagnosed by physician) had not resolved and NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs and back), SKIN LESION, RASH, and HEADACHE (neck pain radiating to head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Shingles diagnosed by physician; Pain in the neck radiating to head; pustules on arms, legs and back; head lesions; rash developed on body; neck pain radiating to head; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles diagnosed by physician), NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs, and back), SKIN LESION (head), and RASH (rash developed on body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by the reporter.     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 HERPES ZOSTER (Shingles diagnosed by physician), NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs, and back), SKIN LESION, RASH, and HEADACHE (neck pain radiating to head). The patient was treated with ACYCLOVIR at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles diagnosed by physician) had not resolved and NECK PAIN (Pain in the neck radiating to head), PUSTULE (pustules on arms, legs and back), SKIN LESION, RASH, and HEADACHE (neck pain radiating to head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 1st dose of Moderna COVID 19 vaccine from expired vial; This case was received via an unknown source no reference has been entered for a health authority on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for an unknown indication.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired vial) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC-MOD-2021-097935.   Reporter did not allow further contact. Sender's Comments:  US-MODERNATX, INC-MOD-2021-097935.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details included monoclonal antibody treatment on 11 Feb 2021.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: huge red rash the size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (huge red rash the size of a baseball) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH ERYTHEMATOUS (huge red rash the size of a baseball). At the time of the report, RASH ERYTHEMATOUS (huge red rash the size of a baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-097697.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received contains no new information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: redness at injection site; tenderness at injection site; mild headache; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PAIN, HEADACHE, and NAUSEA in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D3 and MAGNESIUM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PAIN, HEADACHE, and NAUSEA. On 28-Apr-2021, VACCINATION SITE ERYTHEMA and VACCINATION SITE PAIN had resolved. At the time of the report, HEADACHE had not resolved and NAUSEA had resolved. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No laboratory data was provided. No treatment information was provided.   This case was linked to MOD21-084080. Sender's Comments:  MOD21-084080.