chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant while receiving first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant while receiving first dose) in a 38-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage and Preterm labor on 19-Mar-2019. Previously administered products included for an unreported indication: ALCOHOL (1 drink a week) until 01-Sep-2020. Concomitant products included PROGESTERONE for Preterm labor, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FISH OIL (OMEGA 3 ELITE) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Sep-2020 and the estimated date of delivery was 02-Jul-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant while receiving first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant while receiving first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. on 23 Feb 2021,She would like to be enrolled to the pregnancy registry.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.8) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 101.8). At the time of the report, PYREXIA (Fever 101.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.8 101.8.         No concomitant medications were provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cognitive disorder, Nausea, Night sweats
Clinical narrative: night sweat; loss of cognitive function; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-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 NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea). At the time of the report, NIGHT SWEATS (night sweat), COGNITIVE DISORDER (loss of cognitive function), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Pink area the size of a baseball at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Pink area the size of a baseball at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Generalised Hives/urticaria; Generalised erythema/redness; Rash from each elbow to each hand/rash; Generalised Itching/pruritus; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalised Itching/pruritus), URTICARIA (Generalised Hives/urticaria), ERYTHEMA (Generalised erythema/redness) and RASH (Rash from each elbow to each hand/rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Generalised Itching/pruritus) and RASH (Rash from each elbow to each hand/rash). On an unknown date, the patient experienced URTICARIA (Generalised Hives/urticaria) and ERYTHEMA (Generalised erythema/redness). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency; HYDROXYZINE on 01-Mar-2021 for Rash, at a dose of 25 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) on 01-Mar-2021 for Rash, at a dose of 25 milligram and FLUOCINONIDE (FLUCINONIDE) on 27-May-2021 for Rash, at a dose of 0.5 percent, ointment. At the time of the report, PRURITUS (Generalised Itching/pruritus) and RASH (Rash from each elbow to each hand/rash) had not resolved and URTICARIA (Generalised Hives/urticaria) and ERYTHEMA (Generalised erythema/redness) outcome was unknown.            Treatment medications include: On 01-MAR-2021 : anti-itch lotion 0.5 percent, steroids-0.5 mg 2x daily and steroids stopped on 10-MAY-2021 On 25-05-2021 Laboratory test include teledermatology and issued ointment. Concomitant medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up includes reporter details , patient information, drug information, events , treatment medication details were added
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: "Symptoms came back"; Fatigue; Headache; Muscle pain in injected arm; Chills; Fever of 103.4; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4). On 22-Feb-2021, the patient experienced SYMPTOM RECURRENCE ("Symptoms came back"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra strength. At the time of the report, SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drug details not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: "Symptoms came back"; Fatigue; Headache; Muscle pain in injected arm; Chills; Fever of 103.4; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4). On 22-Feb-2021, the patient experienced SYMPTOM RECURRENCE ("Symptoms came back"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra strength. At the time of the report, SYMPTOM RECURRENCE ("Symptoms came back"), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 103.4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drug details not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Discomfort, Headache
Clinical narrative: chest in flames when I laid down; Couldn't lay down; Joint pain; Big headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-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 CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 23-Feb-2021, CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Limb discomfort
Clinical narrative: patient could not move her leg even; patient can not even get out of bed; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain) in a 73-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash on arm; rash on back, stomach and waistline; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline). The patient was treated with TRIAMCINOLONE for Rash and Itchy rash, at a dose of 1 % twice a day. At the time of the report, RASH PRURITIC (itchy rash on arm) and RASH (rash on back, stomach and waistline) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-219895, MOD-2021-219895 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 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 an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: sick; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PAIN (body aches) and PYREXIA (fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and BUPROPION for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, 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 experienced ILLNESS (sick), PAIN (body aches) and PYREXIA (fever). At the time of the report, ILLNESS (sick), PAIN (body aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test positive, Urine analysis
Clinical narrative: bacteria in the urine; This spontaneous case was reported by a consumer and describes the occurrence of BACTERIAL TEST POSITIVE (bacteria in the urine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Blood pressure and High cholesterol.   On 15-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 BACTERIAL TEST POSITIVE (bacteria in the urine).   At the time of the report, BACTERIAL TEST POSITIVE (bacteria in the urine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: abnormal (abnormal) Patient's lab results found bacteria in the urine..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Malaise, Muscle tightness
Clinical narrative: weakness; dizziness; Fever of 101; fever (100.6); did not feel well; discomfort in her vaginal area, tense in muscles; discomfort in her vaginal area, tense in muscles; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles), MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles), ASTHENIA (weakness) and DIZZINESS (dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20P or 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles) and MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles). On 23-Feb-2021, the patient experienced PYREXIA (fever (100.6)). On 24-Feb-2021, the patient experienced PYREXIA (Fever of 101). On an unknown date, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). At the time of the report, MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles), MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles), ASTHENIA (weakness), DIZZINESS (dizziness), PYREXIA (fever (100.6)) and PYREXIA (Fever of 101) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 100.6f 100.6F. On 24-Feb-2021, Body temperature: 101f 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vulvovaginal discomfort
Clinical narrative: weakness; dizziness; Fever of 101; fever (100.6); did not feel well; discomfort in her vaginal area, tense in muscles; discomfort in her vaginal area, tense in muscles; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles), MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles), ASTHENIA (weakness) and DIZZINESS (dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20P or 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles) and MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles). On 23-Feb-2021, the patient experienced PYREXIA (fever (100.6)). On 24-Feb-2021, the patient experienced PYREXIA (Fever of 101). On an unknown date, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). At the time of the report, MALAISE (did not feel well), VULVOVAGINAL DISCOMFORT (discomfort in her vaginal area, tense in muscles), MUSCLE TIGHTNESS (discomfort in her vaginal area, tense in muscles), ASTHENIA (weakness), DIZZINESS (dizziness), PYREXIA (fever (100.6)) and PYREXIA (Fever of 101) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 100.6f 100.6F. On 24-Feb-2021, Body temperature: 101f 101F.     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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Neck pain
Clinical narrative: shoulder and neck pain; discomfort; shoulder and neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain) 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 23-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 NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain). At the time of the report, NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Chills, Fatigue, Feeling abnormal
Clinical narrative: Felt really bad for a few days; Chills; Fatigue; Severe pain; Back pain; Couldn't get out the bed; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed), FEELING ABNORMAL (Felt really bad for a few days), PAIN (Severe pain) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included TRAMADOL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain). On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain) had not resolved and FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt really bad for a few days; Chills; Fatigue; Severe pain; Back pain; Couldn't get out the bed; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed), FEELING ABNORMAL (Felt really bad for a few days), PAIN (Severe pain) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included TRAMADOL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain). On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, BACK PAIN (Back pain), BEDRIDDEN (Couldn't get out the bed) and PAIN (Severe pain) had not resolved and FEELING ABNORMAL (Felt really bad for a few days), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.            Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Swelling, Swelling face
Clinical narrative: really sick; face is swollen; Under the eye is swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-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 ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen). At the time of the report, ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included antihistamine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Myalgia). At the time of the report, MYALGIA (Myalgia) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Arm Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Arm Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity.    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 RASH ERYTHEMATOUS (Red Arm Rash). At the time of the report, RASH ERYTHEMATOUS (Red Arm Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site erythema
Clinical narrative: Redness at injection site getting bigger; Redness at injection site lasting longer; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Redness at injection site getting bigger), CONDITION AGGRAVATED (Redness at injection site lasting longer) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site). On 24-Feb-2021, the patient experienced CONDITION AGGRAVATED (Redness at injection site getting bigger) and CONDITION AGGRAVATED (Redness at injection site lasting longer). At the time of the report, CONDITION AGGRAVATED (Redness at injection site getting bigger), CONDITION AGGRAVATED (Redness at injection site lasting longer) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT MEDICATIONS WERE NOT USED   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Myalgia, Nasopharyngitis, Tremor
Clinical narrative: Cold; Upset stomach; Shaking; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received 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 NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache).   At the time of the report, NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Broke out with genital herpes; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Broke out with genital herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced GENITAL HERPES (Broke out with genital herpes). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, GENITAL HERPES (Broke out with genital herpes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness
Clinical narrative: dizzy; got down; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (got down) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (chills). On 24-Feb-2021, the patient experienced DIZZINESS (dizzy) and ASTHENIA (got down). At the time of the report, DIZZINESS (dizzy), ASTHENIA (got down) and CHILLS (chills) outcome was unknown.            No concomitant medications were provided. No treatment information provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Neck pain, Vaccination site pain
Clinical narrative: Discomfort; Neck Pain; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, EMPAGLIFLOZIN (JARDIANCE), VALSARTAN, AMLODIPINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain). At the time of the report, DISCOMFORT (Discomfort), NECK PAIN (Neck Pain) and VACCINATION SITE PAIN (Arm Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Decreased appetite, Pain in extremity, Tremor
Clinical narrative: Chills; shakes; loss of apetite; middle back hurt; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), TREMOR (shakes), DECREASED APPETITE (loss of apetite), BACK PAIN (middle back hurt) and PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL), CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE), LOSARTAN and LEVOTHYROXINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced BACK PAIN (middle back hurt) and PAIN IN EXTREMITY (sore arm). On 03-Feb-2021, the patient experienced CHILLS (Chills), TREMOR (shakes) and DECREASED APPETITE (loss of apetite). At the time of the report, CHILLS (Chills), TREMOR (shakes), DECREASED APPETITE (loss of apetite), BACK PAIN (middle back hurt) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient took Tylenol and Excedrin
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site warmth
Clinical narrative: swollen arm; Red; warm arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Red) and VACCINATION SITE WARMTH (warm arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Red) and VACCINATION SITE WARMTH (warm arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Red) and VACCINATION SITE WARMTH (warm arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant  medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection) outcome was unknown. PCP put her on Amoxicillin. Bacterial Sinusitis? if so then it's in medical event list      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: body ache; Fever; headache; fatigue; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PYREXIA (Fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M201A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 03-Feb-2021, the patient experienced PAIN (body ache), PYREXIA (Fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (body ache), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Malaise, Vaccination site erythema, Vaccination site pain
Clinical narrative: swollen left ankle; red hot spot which 2 inch high and 2 inch wide at injection site; Unexpected return of red left arm much larger then before and much larger area; Feeling sick all day; Vaccination site hot spot; Little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot spot), VACCINATION SITE PAIN (Little painful), VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site), ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) and JOINT SWELLING (swollen left ankle) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 LOSARTAN POTASSIUM (LOSARTAN) 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 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little painful). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot spot). On 21-Feb-2021, the patient experienced MALAISE (Feeling sick all day). On 24-Feb-2021, the patient experienced ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area). On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site). On an unknown date, the patient experienced JOINT SWELLING (swollen left ankle). On 25-Jan-2021, VACCINATION SITE PAIN (Little painful) had resolved. On 23-Feb-2021, MALAISE (Feeling sick all day) had resolved. On 25-Feb-2021, ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) had resolved. On 12-Mar-2021, VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot spot) and JOINT SWELLING (swollen left ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: ADR form received: Additional 2 events added, outcome of 3 events updated, concomitant medication added and patient address updated
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: swollen left ankle; red hot spot which 2 inch high and 2 inch wide at injection site; Unexpected return of red left arm much larger then before and much larger area; Feeling sick all day; Vaccination site hot spot; Little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot spot), VACCINATION SITE PAIN (Little painful), VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site), ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) and JOINT SWELLING (swollen left ankle) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 LOSARTAN POTASSIUM (LOSARTAN) 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 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little painful). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot spot). On 21-Feb-2021, the patient experienced MALAISE (Feeling sick all day). On 24-Feb-2021, the patient experienced ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area). On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site). On an unknown date, the patient experienced JOINT SWELLING (swollen left ankle). On 25-Jan-2021, VACCINATION SITE PAIN (Little painful) had resolved. On 23-Feb-2021, MALAISE (Feeling sick all day) had resolved. On 25-Feb-2021, ERYTHEMA (Unexpected return of red left arm much larger then before and much larger area) had resolved. On 12-Mar-2021, VACCINATION SITE ERYTHEMA (red hot spot which 2 inch high and 2 inch wide at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot spot) and JOINT SWELLING (swollen left ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: ADR form received: Additional 2 events added, outcome of 3 events updated, concomitant medication added and patient address updated
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Hurt his back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hurt his back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced BACK PAIN (Hurt his back). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hurt his back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.