chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I had the TB vaccine scar there and it is very swelled too; [injection site] very warm; Vaccination site pain /  pain in the application site; area surround my vaccine application is red; [injection site] swelled /  the area is a regular oval shape.; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT3002332.) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TUBERCULOSIS VACCINES.    On 31-May-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 PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.). At the time of the report, PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Patient do not know if is because of the vaccine or something else. Patient had TB vaccine scar at the Moderna vaccine Injected site and it is very swelled too
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Exposure during pregnancy, Maternal exposure during breast feeding
Clinical narrative: the patient may be pregnant; patient may be breast feeding; Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (the patient may be pregnant), MATERNAL EXPOSURE DURING BREAST FEEDING (patient may be breast feeding) and EXPIRED PRODUCT ADMINISTERED (Patient administered second dose from an expired vial of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided The patient received the second of the Moderna COVID-19 vaccine from a vial that was in its 31st day of storage. The vial in question was received on 14MAY2021 and kept in constant refrigeration until 14JUN2021, when it was finally punctured at 10:00AM. At 10:15AM two doses were drawn and administered. The reporter stated this patient may be pregnant or breastfeeding. Other relevant medication history included Prenatal Vitamins.   This case was linked to MOD-2021-222161 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: Bad cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough) and FATIGUE (Tired) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced FATIGUE (Tired). On 14-Jun-2021, the patient experienced COUGH (Bad cough). At the time of the report, COUGH (Bad cough) and FATIGUE (Tired) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed my second appointment scheduled for May 21; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (missed my second appointment scheduled for May 21) had resolved.            No concomitant medications were reported.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product dose omission issue, Wrong product administered
Clinical narrative: Johnson and Johnson vaccine given after 1st dose; 2nd dose missed; Johnson and Johnson vaccine given after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose missed), WRONG PRODUCT ADMINISTERED (Johnson and Johnson vaccine given after 1st dose) and INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine given after 1st dose) 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.   Patient took Johnson and Johnson vaccine as her second dose. No concomitant medications were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Shot was a good shot and no complications to slight headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Shot was a good shot and no complications to slight headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Shot was a good shot and no complications to slight headaches). At the time of the report, HEADACHE (Shot was a good shot and no complications to slight headaches) outcome was unknown.            No treatment details were reported. Concomitant medication were not reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accident, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: ear inflammation; Delayed the second vaccine dose/2nd dose was given over 60 days; Got into a car accident; short of breath/shortness of breath; Chest pain; Chest tightness; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Anticoagulant therapy and Blood cholesterol. Concomitant products included TICAGRELOR (BRILINTA) and ASA for Anticoagulant therapy, CARVEDILOL for Blood pressure high, ROSUVASTATIN for Cholesterol.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness). On 22-Apr-2021, the patient experienced ACCIDENT (Got into a car accident). On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days). On an unknown date, the patient experienced INFLAMMATION (ear inflammation). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days) had resolved. At the time of the report, DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Electrocardiogram: normal (normal) normal.     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 included steroids for ear inflammation from 25-Apr-2021 to 23-May-2021.   This case was linked to MOD-2021-222715 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Inflammation
Clinical narrative: ear inflammation; Delayed the second vaccine dose/2nd dose was given over 60 days; Got into a car accident; short of breath/shortness of breath; Chest pain; Chest tightness; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Anticoagulant therapy and Blood cholesterol. Concomitant products included TICAGRELOR (BRILINTA) and ASA for Anticoagulant therapy, CARVEDILOL for Blood pressure high, ROSUVASTATIN for Cholesterol.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness). On 22-Apr-2021, the patient experienced ACCIDENT (Got into a car accident). On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days). On an unknown date, the patient experienced INFLAMMATION (ear inflammation). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed the second vaccine dose/2nd dose was given over 60 days) had resolved. At the time of the report, DYSPNOEA (short of breath/shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest tightness), ACCIDENT (Got into a car accident) and INFLAMMATION (ear inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Electrocardiogram: normal (normal) normal.     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 included steroids for ear inflammation from 25-Apr-2021 to 23-May-2021.   This case was linked to MOD-2021-222715 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye swelling, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Muscle aches; Chills; Nausea; Eye swelling both eyes; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling both eyes), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), MYALGIA (Muscle aches) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Light headed). On 12-Mar-2021, the patient experienced EYE SWELLING (Eye swelling both eyes). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea). On 20-Feb-2021, DIZZINESS (Light headed) had resolved. On 19-Mar-2021, EYE SWELLING (Eye swelling both eyes) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications included unspecified birth control medication.  Treatment details included steroids, not otherwise specified.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-019692 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Flu like symptoms; Muscle aches; Chills; Nausea; Eye swelling both eyes; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling both eyes), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (Light headed), MYALGIA (Muscle aches) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Light headed). On 12-Mar-2021, the patient experienced EYE SWELLING (Eye swelling both eyes). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea). On 20-Feb-2021, DIZZINESS (Light headed) had resolved. On 19-Mar-2021, EYE SWELLING (Eye swelling both eyes) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Muscle aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications included unspecified birth control medication.  Treatment details included steroids, not otherwise specified.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-019692 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID.         Concomitant product information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achness). At the time of the report, MYALGIA (Achness) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy all over my body). At the time of the report, PRURITUS (Itchy all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Limb discomfort
Clinical narrative: My arm doesn't feel quite right.; I'm not in pain but it feels different.; Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.; Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 24-May-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 LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.). At the time of the report, LIMB DISCOMFORT (My arm doesn't feel quite right.), FEELING ABNORMAL (I'm not in pain but it feels different.), INSOMNIA (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) and FATIGUE (Also ot seems that my entire body has undergone changes.  I'm waking up earlier I feel fatigued.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she is  diabetic but it's controlled well by pill. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I've had a cough ever since taking the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I've had a cough ever since taking the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (I've had a cough ever since taking the vaccine). At the time of the report, COUGH (I've had a cough ever since taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red arm). At the time of the report, ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Heavy head; Tired; Sore throat during evening hours; Stiff arm; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Heavy head), FATIGUE (Tired), OROPHARYNGEAL PAIN (Sore throat during evening hours) and MUSCULOSKELETAL STIFFNESS (Stiff arm) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff arm). On an unknown date, the patient experienced HEAD DISCOMFORT (Heavy head), FATIGUE (Tired) and OROPHARYNGEAL PAIN (Sore throat during evening hours). At the time of the report, HEAD DISCOMFORT (Heavy head), FATIGUE (Tired), OROPHARYNGEAL PAIN (Sore throat during evening hours) and MUSCULOSKELETAL STIFFNESS (Stiff arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Pregnancy test, Product dose omission issue
Clinical narrative: Missed second dose; tested positive for pregnancy; Small headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose), EXPOSURE DURING PREGNANCY (tested positive for pregnancy) and HEADACHE (Small headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-May-2021, the patient experienced HEADACHE (Small headache). On 08-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (tested positive for pregnancy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 25-May-2021, HEADACHE (Small headache) had resolved. On 08-Jun-2021, EXPOSURE DURING PREGNANCY (tested positive for pregnancy) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jun-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine) 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 19-May-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 SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine). On 26-May-2021, SARS-COV-2 TEST POSITIVE (A patient tested positive a week after taking his first dose of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Right arm and shoulder has been hurting for the last week; Shoulder aches; Range of motion is limited in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right 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 information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right arm). At the time of the report, PAIN IN EXTREMITY (Right arm and shoulder has been hurting for the last week), ARTHRALGIA (Shoulder aches) and JOINT RANGE OF MOTION DECREASED (Range of motion is limited in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarea,poop; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarea,poop) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarea,poop). At the time of the report, DIARRHOEA (diarea,poop) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Two weeks later I had chills; Two weeks later I had fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue). At the time of the report, CHILLS (Two weeks later I had chills) and FATIGUE (Two weeks later I had fatigue) outcome was unknown.            No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: When usually side effect start; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When usually side effect start) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (When usually side effect start). At the time of the report, VACCINATION COMPLICATION (When usually side effect start) outcome was unknown.            No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Gingival pain, Hunger
Clinical narrative: weight gain; Hunger; Muscle cramps(legs and toes); Sinus pain; Gum pain; Impatience; brain fog; Tooth pain; Joint pain; Extreme fatigue; Night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain) and GINGIVAL PAIN (Gum pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats). On 30-Apr-2021, the patient experienced WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) on 20-May-2021 at an unspecified dose and frequency. On 01-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has prior history of Gastro esophageal reflex disease, it was cured on February 2020. Concomitant medications were not provided.   This case was linked to MOD-2021-215282 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Impatience, Muscle spasms, Night sweats, Sinus pain, Toothache
Clinical narrative: weight gain; Hunger; Muscle cramps(legs and toes); Sinus pain; Gum pain; Impatience; brain fog; Tooth pain; Joint pain; Extreme fatigue; Night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain) and GINGIVAL PAIN (Gum pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats). On 30-Apr-2021, the patient experienced WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) on 20-May-2021 at an unspecified dose and frequency. On 01-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has prior history of Gastro esophageal reflex disease, it was cured on February 2020. Concomitant medications were not provided.   This case was linked to MOD-2021-215282 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: weight gain; Hunger; Muscle cramps(legs and toes); Sinus pain; Gum pain; Impatience; brain fog; Tooth pain; Joint pain; Extreme fatigue; Night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain) and GINGIVAL PAIN (Gum pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats). On 30-Apr-2021, the patient experienced WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) on 20-May-2021 at an unspecified dose and frequency. On 01-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, WEIGHT INCREASED (weight gain), HUNGER (Hunger), MUSCLE SPASMS (Muscle cramps(legs and toes)), SINUS PAIN (Sinus pain), GINGIVAL PAIN (Gum pain), IMPATIENCE (Impatience), FEELING ABNORMAL (brain fog), TOOTHACHE (Tooth pain), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has prior history of Gastro esophageal reflex disease, it was cured on February 2020. Concomitant medications were not provided.   This case was linked to MOD-2021-215282 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache every night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache every night) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache every night). At the time of the report, HEADACHE (Headache every night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history, lab data, concomitant medications and treatment medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not take any treatment medication ( not applicable).    This case was linked to MOD-2021-222874, MOD-2021-223023 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after it was stored at room temperature for 18 hours; Vaccine administered after it was stored at room temperature for 18 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours). On 15-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered after it was stored at room temperature for 18 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after it was stored at room temperature for 18 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I had COVID in November and I just got my first shot and I have all side affect of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in November).    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 SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid). At the time of the report, SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tenderness
Clinical narrative: Chills; Tender arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender arm) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Hypothyroidism.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (Tender arm). On 13-May-2021, the patient experienced CHILLS (Chills). On 13-May-2021, CHILLS (Chills) had resolved. At the time of the report, TENDERNESS (Tender arm) outcome was unknown.            Concomitant product use include  medications for  diabetes, high blood pressure  and hypothyroid.   At about 3-4am on 13May2021, patient began feeling chills. When she woke up that morning at 8am, they were gone. No medications taken to treat symptoms.  No treatment medications were reported.