chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Headache, Insomnia, Pain in extremity
Clinical narrative: inflammatory burning sensation, throughout her whole body and into the back of her head; Slept for about an hour that night; Throat and neck were burning; Sore arm; Reaction was painful; Headache; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm) and RASH (Reaction was painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm), RASH (Reaction was painful), HEADACHE (Headache) and ARTHRALGIA (Joint ache). On 05-Mar-2021, BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), RASH (Reaction was painful) and ARTHRALGIA (Joint ache) had resolved. On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat irritation
Clinical narrative: inflammatory burning sensation, throughout her whole body and into the back of her head; Slept for about an hour that night; Throat and neck were burning; Sore arm; Reaction was painful; Headache; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm) and RASH (Reaction was painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), PAIN IN EXTREMITY (Sore arm), RASH (Reaction was painful), HEADACHE (Headache) and ARTHRALGIA (Joint ache). On 05-Mar-2021, BURNING SENSATION (inflammatory burning sensation, throughout her whole body and into the back of her head), INSOMNIA (Slept for about an hour that night), THROAT IRRITATION (Throat and neck were burning), RASH (Reaction was painful) and ARTHRALGIA (Joint ache) had resolved. On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was at refrigerated temperature and transferred at frozen temperature at -5C under 15 minutes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was at refrigerated temperature and transferred at frozen temperature at -5C under 15 minutes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was at refrigerated temperature and transferred at frozen temperature at -5C under 15 minutes). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was at refrigerated temperature and transferred at frozen temperature at -5C under 15 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was available. No relevant concomitant medications were reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 001A21A)  with no associated AEs.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Dysgeusia, Taste disorder
Clinical narrative: Terrible taste; patient tested positive for Covid19; salty taste in her mouth; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of smell), DYSGEUSIA (salty taste in her mouth), TASTE DISORDER (Terrible taste) and COVID-19 (patient tested positive for Covid19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ANOSMIA (lost sense of smell). On 05-Mar-2021, the patient experienced DYSGEUSIA (salty taste in her mouth). On 11-Mar-2021, the patient experienced COVID-19 (patient tested positive for Covid19). On an unknown date, the patient experienced TASTE DISORDER (Terrible taste). At the time of the report, ANOSMIA (lost sense of smell), DYSGEUSIA (salty taste in her mouth), TASTE DISORDER (Terrible taste) and COVID-19 (patient tested positive for Covid19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up appended for Event update
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Nausea, Oropharyngeal pain
Clinical narrative: Cough; Diarrhea; sore throat; Nausea/vomiting; Nausea/vomiting; Runny nose; tested positive (+) for COVID-19; Covid19 symptoms; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 relevant medical history reported).    On 09-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 PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced COVID-19 (Covid19 symptoms). On 21-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19). On an unknown date, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting). At the time of the report, PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included intravenous infusion of Bamlanivimav.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021, Events updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Cough; Diarrhea; sore throat; Nausea/vomiting; Nausea/vomiting; Runny nose; tested positive (+) for COVID-19; Covid19 symptoms; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 relevant medical history reported).    On 09-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 PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced COVID-19 (Covid19 symptoms). On 21-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19). On an unknown date, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting). At the time of the report, PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included intravenous infusion of Bamlanivimav.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021, Events updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgeries), Infection (infection in mouth) in December 2020, TMJ syndrome and Sore tongue (teeth filling sore under tongue,mouth sores and gum aching which resolved with mouth wash.). Concurrent medical conditions included Diabetes (type 2 diabetes), Carcinoid tumor (carcinoid cancer) and Colon cancer (colon cancer 11 years ago). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, LINAGLIPTIN (TRAJENTA), VITAMIN D3 and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-270115, MOD-2021-270115 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-significant follow-up Added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Heart rate increased, Myalgia
Clinical narrative: Bruise at the site of injection; Heart rate increased from 60 to 113; Felt like a mac truck run over her; Muscle ache; Fatigue; Low graded fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the site of injection), HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 62-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.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the site of injection), HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (Low graded fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruise at the site of injection) had not resolved and HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (Low graded fever) and CHILLS (Chills) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment for the events included acetaminophen.   This case was linked to MODERNATX, INC.-MOD-2021-038174 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-038174:wife case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site bruising
Clinical narrative: Bruise at the site of injection; Heart rate increased from 60 to 113; Felt like a mac truck run over her; Muscle ache; Fatigue; Low graded fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the site of injection), HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 62-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.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the site of injection), HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (Low graded fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruise at the site of injection) had not resolved and HEART RATE INCREASED (Heart rate increased from 60 to 113), FEELING ABNORMAL (Felt like a mac truck run over her), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (Low graded fever) and CHILLS (Chills) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment for the events included acetaminophen.   This case was linked to MODERNATX, INC.-MOD-2021-038174 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-038174:wife case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Joint swelling
Clinical narrative: Both of his ankles are swollen; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Patient has stent implanted in his left heart and one in his right leg.). Concurrent medical conditions included Leukemia.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath). At the time of the report, JOINT SWELLING (Both of his ankles are swollen) and DYSPNOEA (Short of breath) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Patient stated that he was sleep sitting up in a chair   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 and does not contain any new information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Erythema, Injection site pruritus, Malaise, Pain
Clinical narrative: very painful; spread down to elbow; itching at the injection site; red at the injection site; couldn't get out of bed; very bad reaction; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (couldn't get out of bed), ADVERSE EVENT (very bad reaction), PAIN (very painful), ERYTHEMA (spread down to elbow) and INJECTION SITE PRURITUS (itching at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 05-Mar-2021, the patient experienced MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction). On an unknown date, the patient experienced PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction) had resolved. At the time of the report, PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.            Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: very painful; spread down to elbow; itching at the injection site; red at the injection site; couldn't get out of bed; very bad reaction; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (couldn't get out of bed), ADVERSE EVENT (very bad reaction), PAIN (very painful), ERYTHEMA (spread down to elbow) and INJECTION SITE PRURITUS (itching at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 05-Mar-2021, the patient experienced MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction). On an unknown date, the patient experienced PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction) had resolved. At the time of the report, PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.            Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Palpitations
Clinical narrative: rash itch; reoccuring palpitations; reoccuring tachycardia/ tachycardia; palpitations; fatigue; pressure in head; fever; hot; chills; pain at injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PALPITATIONS (reoccuring palpitations), TACHYCARDIA (reoccuring tachycardia/ tachycardia), RASH (rash itch) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site (left)). On 04-Feb-2021, the patient experienced PYREXIA (fever), FEELING HOT (hot), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (pressure in head). On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations) and TACHYCARDIA (reoccuring tachycardia/ tachycardia). On 09-Feb-2021, the patient experienced PALPITATIONS (reoccuring palpitations). On 11-Feb-2021, the patient experienced RASH (rash itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (left)) had resolved. On 08-Feb-2021, PALPITATIONS (palpitations), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 09-Feb-2021, TACHYCARDIA (reoccuring tachycardia/ tachycardia) had resolved. On 13-Feb-2021, PALPITATIONS (reoccuring palpitations) had resolved. On 25-Feb-2021, RASH (rash itch) had resolved. At the time of the report, FEELING HOT (hot) and HEADACHE (pressure in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tachycardia, Vaccination site pain
Clinical narrative: rash itch; reoccuring palpitations; reoccuring tachycardia/ tachycardia; palpitations; fatigue; pressure in head; fever; hot; chills; pain at injection site (left); This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PALPITATIONS (reoccuring palpitations), TACHYCARDIA (reoccuring tachycardia/ tachycardia), RASH (rash itch) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site (left)). On 04-Feb-2021, the patient experienced PYREXIA (fever), FEELING HOT (hot), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (pressure in head). On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations) and TACHYCARDIA (reoccuring tachycardia/ tachycardia). On 09-Feb-2021, the patient experienced PALPITATIONS (reoccuring palpitations). On 11-Feb-2021, the patient experienced RASH (rash itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (left)) had resolved. On 08-Feb-2021, PALPITATIONS (palpitations), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 09-Feb-2021, TACHYCARDIA (reoccuring tachycardia/ tachycardia) had resolved. On 13-Feb-2021, PALPITATIONS (reoccuring palpitations) had resolved. On 25-Feb-2021, RASH (rash itch) had resolved. At the time of the report, FEELING HOT (hot) and HEADACHE (pressure in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: sore body; Headache; Arm soreness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever), CHILLS (Chills), MYALGIA (sore body) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AUA) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (sore body). At the time of the report, VACCINATION SITE PAIN (Arm soreness), PYREXIA (Fever) and HEADACHE (Headache) was resolving and CHILLS (Chills) and MYALGIA (sore body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were Blood pressure medication and Thyroid medication.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Significant follow-up : Added  new events Headache  and Arm soreness and changed outcome for the event fever from unknown to recovering.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: bad rash on lower legs that is very itchy; small red spots on bilateral legs spreading to upper legs; bad rash on lower legs that is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy). On 20-Feb-2021, PRURITUS (bad rash on lower legs that is very itchy), RASH MACULAR (small red spots on bilateral legs spreading to upper legs) and RASH (bad rash on lower legs that is very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Patient used topical cream to help relieve symptoms.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Somnolence
Clinical narrative: next day spend it bed again; felt the knee weak; lt tired and that then felt a little better; felt so weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (felt so weak). On an unknown date, the patient experienced SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (felt so weak), SOMNOLENCE (next day spend it bed again), ARTHRALGIA (felt the knee weak) and FATIGUE (lt tired and that then felt a little better) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include Trinitrin-HCTV.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Malaise, Myalgia, Pain
Clinical narrative: Extreme lethargy; Less pain than first dose; Every muscle and bone felt achy; Extreme headache; couldnt even get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed). On 04-Mar-2021, LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed) had resolved.            No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-038188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038188:Crosslinked husbands case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Problems with tooth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), ATORVASTATIN, CETIRIZINE, ACETYLSALICYLIC ACID (ASPRIN), FISH OIL, CALCIUM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and FLUTICASONE for an unknown indication, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced TOOTH DISORDER (Problems with tooth). At the time of the report, TOOTH DISORDER (Problems with tooth) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: neck pain; Stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and MUSCULOSKELETAL STIFFNESS (Stiff neck) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 NECK PAIN (neck pain) and MUSCULOSKELETAL STIFFNESS (Stiff neck). The patient was treated with CYCLOBENZAPRINE at an unspecified dose and frequency; TRAMADOL at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck pain) and MUSCULOSKELETAL STIFFNESS (Stiff neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Physical therapy regiment.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really bad arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad arm pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (really bad arm pain). At the time of the report, PAIN IN EXTREMITY (really bad arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided, treatment to the events are not listed   This case was linked to US-MODERNATX, INC.-MOD-2021-061114 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061114:dose 2
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: Fever Blisters on mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever Blisters on mouth) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Fever). On 08-Mar-2021, the patient experienced ORAL HERPES (Fever Blisters on mouth). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever Blisters on mouth) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt; scratched it and it hurt; upper arm was very sensitive, like it burn; Shingles; had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6; in the opposite side of the injection site in her arm it was sore; red mark the size of a dime /Red mark increased in size, size of a silver dollar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn) and HERPES ZOSTER (Shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease (I have had lyme disease). Concomitant products included THYROID, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar). On 08-Mar-2021, the patient experienced PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 gram. At the time of the report, ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt; scratched it and it hurt; upper arm was very sensitive, like it burn; Shingles; had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6; in the opposite side of the injection site in her arm it was sore; red mark the size of a dime /Red mark increased in size, size of a silver dollar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn) and HERPES ZOSTER (Shingles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease (I have had lyme disease). Concomitant products included THYROID, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar). On 08-Mar-2021, the patient experienced PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 gram. At the time of the report, ERYTHEMA (red mark the size of a dime /Red mark increased in size, size of a silver dollar), PRURITUS (water was hitting my back and all of the sudden my back was really itchy, scratched it and it hurt), PAIN (scratched it and it hurt), BURNING SENSATION (upper arm was very sensitive, like it burn), HERPES ZOSTER (Shingles), RASH (had a very big rash on my back, looked like the halo rash that you get with lyme disease. 6) and VACCINATION SITE PAIN (in the opposite side of the injection site in her arm it was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swelling; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes swelling). At the time of the report, LYMPHADENOPATHY (Lymph nodes swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Hand Went Numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand Went Numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Hand Went Numb). At the time of the report, HYPOAESTHESIA (Hand Went Numb) had resolved.            No concomitant and treatment product was reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable   This case was linked to MOD-2021-060206 (Patient Link).   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Pain in extremity
Clinical narrative: stye on her left eye; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HORDEOLUM (stye on her left eye) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced HORDEOLUM (stye on her left eye). The patient was treated with DOXYCYCLINE on 19-Feb-2021 for Stye, at a dose of UNK dosage form and DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) on 01-Mar-2021 for Stye, at a dose of Tobradex SE drops. On 08-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HORDEOLUM (stye on her left eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded. On 21-Jun-2021: Non-Significant follow up appended; Mailing address and email address are updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Peripheral swelling, Regurgitation, Vomiting
Clinical narrative: regurgitate food 3 hours later; vomiting; stomach would "churn" about 1 hour after eating; swelling on arm; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling on arm), ABDOMINAL DISCOMFORT (upset stomach), REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2 (orQ)0A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling on arm) and ABDOMINAL DISCOMFORT (upset stomach). On 23-Feb-2021, the patient experienced REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling on arm), ABDOMINAL DISCOMFORT (upset stomach), REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter