chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient got her second dose; This spontaneous prospective pregnancy case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient got her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient got her second dose). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient got her second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Swollen tongue, Taste disorder
Clinical narrative: She could taste the vaccine; Tongue got fat; Dry mouth; metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (She could taste the vaccine), SWOLLEN TONGUE (Tongue got fat), DRY MOUTH (Dry mouth) and DYSGEUSIA (metallic taste) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METHOTREXATE, FOLIC ACID, VIT D [VITAMIN D NOS] and TRASTUZUMAB for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DYSGEUSIA (metallic taste). On 19-Mar-2021, the patient experienced DRY MOUTH (Dry mouth). On an unknown date, the patient experienced TASTE DISORDER (She could taste the vaccine) and SWOLLEN TONGUE (Tongue got fat). At the time of the report, TASTE DISORDER (She could taste the vaccine), SWOLLEN TONGUE (Tongue got fat), DRY MOUTH (Dry mouth) and DYSGEUSIA (metallic taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow up received on 22-Mar-2021. New AE and Concomitants were updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness around the nasal area; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Facial numbness around the nasal area) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 HYPOAESTHESIA (Facial numbness around the nasal area). At the time of the report, HYPOAESTHESIA (Facial numbness around the nasal area) 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.   No concomitant products were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash
Clinical narrative: Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall); Itchiness below the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No past medical history was reported by reporter.  Concomitant products included LISINOPRIL, ATENOLOL and LEVOTHYROXINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site). At the time of the report, RASH (Red butterfly shaped rash below the injection site (3 inches across and 2 inches tall) ) and INJECTION SITE PRURITUS (Itchiness below the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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. Last menstrual period and estimated date of delivery were not provided. On 02-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 02-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. 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.   No concomitant products were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia
Clinical narrative: hard time sleeping; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleeping) and FATIGUE (fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (hard time sleeping) and FATIGUE (fatigue). At the time of the report, INSOMNIA (hard time sleeping) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lip swelling
Clinical narrative: SWOLLEN TOP LIPS; SORENESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE). At the time of the report, LIP SWELLING (SWOLLEN TOP LIPS) and INJECTION SITE PAIN (SORENESS AT INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Injection site pain
Clinical narrative: pain at the injection site; pain in shoulder; pain all the way down her arm under armpit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), ARTHRALGIA (pain in shoulder) and AXILLARY PAIN (pain all the way down her arm under armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at the injection site), ARTHRALGIA (pain in shoulder) and AXILLARY PAIN (pain all the way down her arm under armpit). At the time of the report, INJECTION SITE PAIN (pain at the injection site) and AXILLARY PAIN (pain all the way down her arm under armpit) had resolved and ARTHRALGIA (pain in shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication information provided by the reporter.  No treatment medication information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise
Clinical narrative: Shitty feeling; Not feeling well; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, MALAISE (Not feeling well) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL, MALAISE (Not feeling well) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Shitty feeling), MALAISE (Not feeling well) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medication included unspecified blood pressure and cholesterol medication.  The patient had a goody packet which has Acetaminophen, Aspirin and Caffeine and an extra bottle of Tylenol. The patient was concerned if she could take the goody packet for the symptoms she developed after the 2nd shot.  Treatment details were not provided.   This case was linked to MOD-2021-049382 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: very high temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (very high temperature) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (very high temperature). At the time of the report, BODY TEMPERATURE INCREASED (very high temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema
Clinical narrative: another swollen lymph node an inch and a half higher from her collarbone; lymph nodes on the same side of her injection (left collarbone); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHOEDEMA (lymph nodes on the same side of her injection (left collarbone)) and LYMPHADENOPATHY (another swollen lymph node an inch and a half higher from her collarbone) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced LYMPHOEDEMA (lymph nodes on the same side of her injection (left collarbone)). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (another swollen lymph node an inch and a half higher from her collarbone). On 21-May-2021, LYMPHADENOPATHY (another swollen lymph node an inch and a half higher from her collarbone) had resolved. At the time of the report, LYMPHOEDEMA (lymph nodes on the same side of her injection (left collarbone)) outcome was unknown. Not Provided          Lymph nodes were on the same side of the injection site and they were swollen an inch and a half higher than the collarbone. Patient visited her physician for consultation and was advised to wait 6-8 weeks for the symptoms to go away. Lymph nodes returned back to normal in 4-5 weeks after the second vaccine.  No concomitant medication were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: second dose info added, event outcome updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dosing error ( 2nd dose schedule beyond the recommended interval); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule beyond the recommended interval)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 011J20) with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 011J20) with no associated AEs.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up all night; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Throwing up all night) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Throwing up all night). At the time of the report, VOMITING (Throwing up all night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.          Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain in extremity
Clinical narrative: arm soreness; extreme fatigue; armpit soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), AXILLARY PAIN (armpit soreness) and FATIGUE (extreme fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced AXILLARY PAIN (armpit soreness). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and FATIGUE (extreme fatigue). At the time of the report, PAIN IN EXTREMITY (arm soreness), AXILLARY PAIN (armpit soreness) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced extreme fatigue and arm soreness after 1st shot & lasted the first 24 hours after it.  Concomitant medication information not given.   Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: swelling in the throat; topper lip was numb; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling in the throat) and HYPOAESTHESIA ORAL (topper lip was numb) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history information was provided.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling in the throat) and HYPOAESTHESIA ORAL (topper lip was numb). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swelling in the throat) and HYPOAESTHESIA ORAL (topper lip was numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted Melillo r on 18-mar-2021 Concomitant medication information not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: woke up vey achy; very tired; chills; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up vey achy), FATIGUE (little tired), FATIGUE (very tired) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (little tired). On 18-Mar-2021, the patient experienced PAIN (woke up vey achy), FATIGUE (very tired) and CHILLS (chills). At the time of the report, PAIN (woke up vey achy), FATIGUE (little tired), FATIGUE (very tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment details were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Dysphagia, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Could not drink water; Could not close lips; Numbness of the face; Tingling sensation; Felt strange; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of the face), PARAESTHESIA (Tingling sensation), FEELING ABNORMAL (Felt strange), DYSPHAGIA (Could not drink water) and DYSKINESIA (Could not close lips) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness of the face), PARAESTHESIA (Tingling sensation) and FEELING ABNORMAL (Felt strange). On 04-Mar-2021, the patient experienced DYSPHAGIA (Could not drink water) and DYSKINESIA (Could not close lips). On 26-Feb-2021, HYPOAESTHESIA (Numbness of the face), PARAESTHESIA (Tingling sensation) and FEELING ABNORMAL (Felt strange) had resolved. At the time of the report, DYSPHAGIA (Could not drink water) and DYSKINESIA (Could not close lips) 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.   No concomitant medications provided by reporter. Treatment medications were not provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Hardness at the injection site; injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Vaccination site discolouration
Clinical narrative: fever spiking from 99.1 to 101.6; discoloration at injection site (lighter color compared to her normal skin color); soreness at injection site; Nausea; vomiting; severe headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (5 back surgery). Concurrent medical conditions included Depression and Knee pain. Concomitant products included VENLAFAXINE for Depression, GABAPENTIN for Knee pain.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache). On 18-Mar-2021, the patient experienced PYREXIA (fever spiking from 99.1 to 101.6). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (severe headache) and PYREXIA (fever spiking from 99.1 to 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: high (High) Multiple measurements taken by the patient. Initial value 99.1 to 100.2 to 100.6. Final value 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: fever spiking from 99.1 to 101.6; discoloration at injection site (lighter color compared to her normal skin color); soreness at injection site; Nausea; vomiting; severe headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (5 back surgery). Concurrent medical conditions included Depression and Knee pain. Concomitant products included VENLAFAXINE for Depression, GABAPENTIN for Knee pain.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache). On 18-Mar-2021, the patient experienced PYREXIA (fever spiking from 99.1 to 101.6). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (severe headache) and PYREXIA (fever spiking from 99.1 to 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: high (High) Multiple measurements taken by the patient. Initial value 99.1 to 100.2 to 100.6. Final value 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives post Penicillin use (after first shot); Raised Rash on upper Torso and both Arms (After first shot); This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives post Penicillin use (after first shot)) and RASH (Raised Rash on upper Torso and both Arms (After first shot)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 015M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PROBIOTICS 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 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (Hives post Penicillin use (after first shot)) and RASH (Raised Rash on upper Torso and both Arms (After first shot)). On 10-Feb-2021, URTICARIA (Hives post Penicillin use (after first shot)) and RASH (Raised Rash on upper Torso and both Arms (After first shot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD21-057129, MOD-2021-049366 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS,  concomitant medication added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate increased, Pain in extremity, Palpitations
Clinical narrative: Usual sore arm; She is a "walker" but could only walk ½ mile; her heart would "pump"; palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Usual sore arm), GAIT DISTURBANCE (She is a "walker" but could only walk ½ mile), HEART RATE INCREASED (her heart would "pump") and PALPITATIONS (palpitations) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Low blood pressure and GERD. Concurrent medical conditions included Sulfonamide allergy and Food allergy (Allergic to crab meat).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Usual sore arm), GAIT DISTURBANCE (She is a "walker" but could only walk ½ mile), HEART RATE INCREASED (her heart would "pump") and PALPITATIONS (palpitations). At the time of the report, PAIN IN EXTREMITY (Usual sore arm), GAIT DISTURBANCE (She is a "walker" but could only walk ½ mile), HEART RATE INCREASED (her heart would "pump") and PALPITATIONS (palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-049370 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE contact information updated
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: a sore arm; he felt weak; he felt tired; a headache; a fever for 20 minutes; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak), HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired). On 03-Mar-2021, HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) had resolved. On 04-Mar-2021, PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative. On 13-Mar-2021, SARS-CoV-2 test negative: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that he was exposed to someone positive for Covid.  Concomitant medication is not given. The treatment information was unknown.  Patient states that he was exposed to someone positive for Covid.  Treatment information was unknown..   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received and contains non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: a sore arm; he felt weak; he felt tired; a headache; a fever for 20 minutes; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak), HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired). On 03-Mar-2021, HEADACHE (a headache), PYREXIA (a fever for 20 minutes) and NAUSEA (nausea) had resolved. On 04-Mar-2021, PAIN IN EXTREMITY (a sore arm), ASTHENIA (he felt weak) and FATIGUE (he felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test negative: negative (Negative) Negative. On 13-Mar-2021, SARS-CoV-2 test negative: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that he was exposed to someone positive for Covid.  Concomitant medication is not given. The treatment information was unknown.  Patient states that he was exposed to someone positive for Covid.  Treatment information was unknown..   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received and contains non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: arm was sore; swollen; can't move it; hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of 1 dosage form twice a day. At the time of the report, PAIN IN EXTREMITY (arm was sore), PERIPHERAL SWELLING (swollen), MOBILITY DECREASED (can't move it) and FEELING HOT (hot) outcome was unknown.            No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR attached: NNi
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch around injection site after 2nd dose; Swelling around injection site after 2nd dose; Redness around injection site after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch around injection site after 2nd dose), VACCINATION SITE SWELLING (Swelling around injection site after 2nd dose) and VACCINATION SITE ERYTHEMA (Redness around injection site after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch around injection site after 2nd dose), VACCINATION SITE SWELLING (Swelling around injection site after 2nd dose) and VACCINATION SITE ERYTHEMA (Redness around injection site after 2nd dose). At the time of the report, VACCINATION SITE WARMTH (Warm to touch around injection site after 2nd dose) and VACCINATION SITE ERYTHEMA (Redness around injection site after 2nd dose) outcome was unknown and VACCINATION SITE SWELLING (Swelling around injection site after 2nd dose) was resolving.            No concomitant medication information was provided.  No treatment information was provided.
Age: 51.0
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 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Doctor said that she was experiencing a hypersensitivity reaction; rash in her entire body except for the face and hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her entire body except for the face and hands) and HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency common variable.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced RASH (rash in her entire body except for the face and hands). On an unknown date, the patient experienced HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (rash in her entire body except for the face and hands) and HYPERSENSITIVITY (Doctor said that she was experiencing a hypersensitivity reaction) outcome was unknown.            No concomitant medications were provided. Treatment drugs also included unspecified antibiotics and steroids.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07MAY2021, updated Reporter details, treatment medications and first dose information updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Headache, Malaise, Somnolence
Clinical narrative: Not feeling well; Stomachache; Feeling bad all over; Just wants to sleep it off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), ABDOMINAL PAIN UPPER (Stomachache), FEELING ABNORMAL (Feeling bad all over), SOMNOLENCE (Just wants to sleep it off) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 024M70A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia (Early stage of dementia). Concomitant products included DONEPEZIL and VALSARTAN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (Not feeling well). 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache), FEELING ABNORMAL (Feeling bad all over), SOMNOLENCE (Just wants to sleep it off) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), ABDOMINAL PAIN UPPER (Stomachache), FEELING ABNORMAL (Feeling bad all over), SOMNOLENCE (Just wants to sleep it off) and HEADACHE (Headache) outcome was unknown. Not Provided          No treatment was provided.   This case was linked to MOD-2021-047769 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chapped lips, Headache, Pain, Pyrexia
Clinical narrative: a skin rupture on her lips; body aches; joint pain; a rash on her body/Rash; fever; a very bad headache; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), CHAPPED LIPS (a skin rupture on her lips), PAIN (body aches), RASH (a rash on her body/Rash) and ARTHRALGIA (joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 006N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and TIMOLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (tenderness). On 11-Mar-2021, the patient experienced PYREXIA (fever). 11-Mar-2021, the patient experienced HEADACHE (a very bad headache). On 17-Mar-2021, the patient experienced RASH (a rash on her body/Rash). On 18-Mar-2021, the patient experienced CHAPPED LIPS (a skin rupture on her lips) and PAIN (body aches). 18-Mar-2021, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness), CHAPPED LIPS (a skin rupture on her lips), PAIN (body aches), RASH (a rash on her body/Rash), ARTHRALGIA (joint pain), PYREXIA (fever) and HEADACHE (a very bad headache) outcome was unknown.            Concomitant medications included unspecified supplements.   This case was linked to MOD-2021-059388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Onset date of the event rash was updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tenderness
Clinical narrative: a skin rupture on her lips; body aches; joint pain; a rash on her body/Rash; fever; a very bad headache; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), CHAPPED LIPS (a skin rupture on her lips), PAIN (body aches), RASH (a rash on her body/Rash) and ARTHRALGIA (joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 006N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and TIMOLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (tenderness). On 11-Mar-2021, the patient experienced PYREXIA (fever). 11-Mar-2021, the patient experienced HEADACHE (a very bad headache). On 17-Mar-2021, the patient experienced RASH (a rash on her body/Rash). On 18-Mar-2021, the patient experienced CHAPPED LIPS (a skin rupture on her lips) and PAIN (body aches). 18-Mar-2021, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness), CHAPPED LIPS (a skin rupture on her lips), PAIN (body aches), RASH (a rash on her body/Rash), ARTHRALGIA (joint pain), PYREXIA (fever) and HEADACHE (a very bad headache) outcome was unknown.            Concomitant medications included unspecified supplements.   This case was linked to MOD-2021-059388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Onset date of the event rash was updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: fever of 101.4°F; Chills; Body ache; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), HEADACHE (Headaches), FATIGUE (Fatigue), PYREXIA (fever of 101.4°F) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Body ache), HEADACHE (Headaches) and FATIGUE (Fatigue). On 18-Mar-2021, the patient experienced PYREXIA (fever of 101.4°F) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache and Ache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, PAIN (Body ache), HEADACHE (Headaches), FATIGUE (Fatigue), PYREXIA (fever of 101.4°F) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101.4 f (High) 101.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified vitamins.