chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Two days of feeling fatigued; Big area on her arm, in the injection site; itchy (area in the injection site); red (area in the injection site; hot (area in the injection site); swollen (area in the injection site); Really severe back pain; muscle plain that she had never experienced before; Chills; Nausea; Fever 99.8; Really bad headache; Fatigue; big welt, red (welt) and hot (welt); This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (big welt, red (welt) and hot (welt)), HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE REACTION (Big area on her arm, in the injection site) and INJECTION SITE PRURITUS (itchy (area in the injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (big welt, red (welt) and hot (welt)). On 12-Jan-2021, the patient experienced HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8). On 18-Jan-2021, the patient experienced INJECTION SITE REACTION (Big area on her arm, in the injection site). On an unknown date, the patient experienced FATIGUE (Two days of feeling fatigued). On 08-Jan-2021, URTICARIA (big welt, red (welt) and hot (welt)) had resolved. On 17-Jan-2021, HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8) had resolved. On 20-Jan-2021, INJECTION SITE REACTION (Big area on her arm, in the injection site) had resolved. At the time of the report, FATIGUE (Two days of feeling fatigued) 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 relevant concomitant medications were reported. Treatment details included Voltaren and Tylenol
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Two days of feeling fatigued; Big area on her arm, in the injection site; itchy (area in the injection site); red (area in the injection site; hot (area in the injection site); swollen (area in the injection site); Really severe back pain; muscle plain that she had never experienced before; Chills; Nausea; Fever 99.8; Really bad headache; Fatigue; big welt, red (welt) and hot (welt); This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (big welt, red (welt) and hot (welt)), HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE REACTION (Big area on her arm, in the injection site) and INJECTION SITE PRURITUS (itchy (area in the injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (big welt, red (welt) and hot (welt)). On 12-Jan-2021, the patient experienced HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8). On 18-Jan-2021, the patient experienced INJECTION SITE REACTION (Big area on her arm, in the injection site). On an unknown date, the patient experienced FATIGUE (Two days of feeling fatigued). On 08-Jan-2021, URTICARIA (big welt, red (welt) and hot (welt)) had resolved. On 17-Jan-2021, HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8) had resolved. On 20-Jan-2021, INJECTION SITE REACTION (Big area on her arm, in the injection site) had resolved. At the time of the report, FATIGUE (Two days of feeling fatigued) 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 relevant concomitant medications were reported. Treatment details included Voltaren and Tylenol
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: Two days of feeling fatigued; Big area on her arm, in the injection site; itchy (area in the injection site); red (area in the injection site; hot (area in the injection site); swollen (area in the injection site); Really severe back pain; muscle plain that she had never experienced before; Chills; Nausea; Fever 99.8; Really bad headache; Fatigue; big welt, red (welt) and hot (welt); This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (big welt, red (welt) and hot (welt)), HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE REACTION (Big area on her arm, in the injection site) and INJECTION SITE PRURITUS (itchy (area in the injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (big welt, red (welt) and hot (welt)). On 12-Jan-2021, the patient experienced HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8). On 18-Jan-2021, the patient experienced INJECTION SITE REACTION (Big area on her arm, in the injection site). On an unknown date, the patient experienced FATIGUE (Two days of feeling fatigued). On 08-Jan-2021, URTICARIA (big welt, red (welt) and hot (welt)) had resolved. On 17-Jan-2021, HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8) had resolved. On 20-Jan-2021, INJECTION SITE REACTION (Big area on her arm, in the injection site) had resolved. At the time of the report, FATIGUE (Two days of feeling fatigued) 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 relevant concomitant medications were reported. Treatment details included Voltaren and Tylenol
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Asthenia, Decreased appetite, Vaccination site pain
Clinical narrative: lost the sense of smell; stopped having appetite; feels really weak in the body and doesn't want to move; feels quite pain in the arm.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00420A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN for Diabetes, LISINOPRIL for Hypertension.    On 25-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 ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.). At the time of the report, ANOSMIA (lost the sense of smell), DECREASED APPETITE (stopped having appetite), ASTHENIA (feels really weak in the body and doesn't want to move) and VACCINATION SITE PAIN (feels quite pain in the arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Acetaminophen for pain.   Reporter did not allow further contact
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and hardness at injection site; Redness at injection site; itchiness at injection site; Swelling and hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling and hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE INDURATION (Swelling and hardness at injection site) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling and hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE INDURATION (Swelling and hardness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling and hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (itchiness at injection site) and INJECTION SITE INDURATION (Swelling and hardness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itching Injection Site; Big rash on injection site; Hot to the touch Injection Site; Red Injection Site; Injection Site was hurting again; Pain Injection Site/; Discomfort Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain Injection Site/), INJECTION SITE DISCOMFORT (Discomfort Injection Site), INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE RASH (Big rash on injection site) and INJECTION SITE WARMTH (Hot to the touch Injection Site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain Injection Site/) and INJECTION SITE DISCOMFORT (Discomfort Injection Site). On 23-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE RASH (Big rash on injection site), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Injection Site was hurting again). On 27-Jan-2021, INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Injection Site was hurting again) had resolved. At the time of the report, INJECTION SITE PAIN (Pain Injection Site/), INJECTION SITE DISCOMFORT (Discomfort Injection Site) and INJECTION SITE RASH (Big rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol , Advil, and Cold Compress. No concomitant medications were provided by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Itching Injection Site; Big rash on injection site; Hot to the touch Injection Site; Red Injection Site; Injection Site was hurting again; Pain Injection Site/; Discomfort Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain Injection Site/), INJECTION SITE DISCOMFORT (Discomfort Injection Site), INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE RASH (Big rash on injection site) and INJECTION SITE WARMTH (Hot to the touch Injection Site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain Injection Site/) and INJECTION SITE DISCOMFORT (Discomfort Injection Site). On 23-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE RASH (Big rash on injection site), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Injection Site was hurting again). On 27-Jan-2021, INJECTION SITE PRURITUS (Itching Injection Site), INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site) and INJECTION SITE PAIN (Injection Site was hurting again) had resolved. At the time of the report, INJECTION SITE PAIN (Pain Injection Site/), INJECTION SITE DISCOMFORT (Discomfort Injection Site) and INJECTION SITE RASH (Big rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol , Advil, and Cold Compress. No concomitant medications were provided by reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Extreme fatigue; low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), PYREXIA (low grade fever) and HEADACHE (Headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (Extreme fatigue), PYREXIA (low grade fever) and HEADACHE (Headache). At the time of the report, FATIGUE (Extreme fatigue), PYREXIA (low grade fever) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medications were not provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication of the patient was not provided. Concomitant medication of the patient was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Pain in extremity
Clinical narrative: could not sleep; legs ache pretty hard; hips ache pretty hard; soreness on the arm; fatigue; pretty hard headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included high blood pressure medication and Lipitor and cancer pills and depression medication and matafor medication for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm), FATIGUE (fatigue) and HEADACHE (pretty hard headache). At the time of the report, INSOMNIA (could not sleep), PAIN IN EXTREMITY (legs ache pretty hard), MYALGIA (hips ache pretty hard), MYALGIA (soreness on the arm), FATIGUE (fatigue) and HEADACHE (pretty hard headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product also included high blood pressure ,depression medication and cancer pills. Medical history is unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Somnolence
Clinical narrative: Felt drowsy; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic). At the time of the report, SOMNOLENCE (Felt drowsy) and LETHARGY (Lethargic) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was not provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast discolouration, Fatigue, Injection site rash, Injection site urticaria
Clinical narrative: Fever of 100.6F; Tired; Stomach area pink underneath breast; Little mosquito bumps at injection site; Soreness at injection site; Pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast) and PYREXIA (Fever of 100.6F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site) and INJECTION SITE RASH (Pink at injection site). On 25-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Little mosquito bumps at injection site). On 26-Jan-2021, the patient experienced BREAST DISCOLOURATION (Stomach area pink underneath breast). On 27-Jan-2021, the patient experienced PYREXIA (Fever of 100.6F) and FATIGUE (Tired). On 27-Jan-2021, ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast), PYREXIA (Fever of 100.6F) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.6F; Tired; Stomach area pink underneath breast; Little mosquito bumps at injection site; Soreness at injection site; Pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast) and PYREXIA (Fever of 100.6F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site) and INJECTION SITE RASH (Pink at injection site). On 25-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Little mosquito bumps at injection site). On 26-Jan-2021, the patient experienced BREAST DISCOLOURATION (Stomach area pink underneath breast). On 27-Jan-2021, the patient experienced PYREXIA (Fever of 100.6F) and FATIGUE (Tired). On 27-Jan-2021, ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast), PYREXIA (Fever of 100.6F) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: hot area around the injection site; angry" area around the injection site; some bruising at the injection site/ bruising became worse/ bruising starting to fade; red area around the injection site; swollen area around the injection site/ raised area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Handicap and Hydrocephalus. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM CONTROL) for Gastroesophageal reflux, LISINOPRIL for Hypertension, MULTI VITAMINS & MINERALS for an unknown indication.    On 11-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 INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (red area around the injection site), INJECTION SITE WARMTH (hot area around the injection site), INJECTION SITE SWELLING (swollen area around the injection site/ raised area around the injection site), INJECTION SITE DISCOMFORT (angry" area around the injection site) and INJECTION SITE BRUISING (some bruising at the injection site/ bruising became worse/ bruising starting to fade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast; Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast; Pain on the injection site/Discomfort; Itching in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site/Discomfort), VACCINATION SITE PRURITUS (Itching in the injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site/Discomfort) and VACCINATION SITE PRURITUS (Itching in the injection site). On 23-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Pain on the injection site/Discomfort), VACCINATION SITE PRURITUS (Itching in the injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) and LYMPH NODE PAIN (Soreness in the lymph nodes on the side of the injection - left - under the arm and on the side of her breast) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pyrexia, Ultrasound scan
Clinical narrative: Long lasting burning pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, BURNING SENSATION (Long lasting burning pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: unknown An ultrasound test was done in the emergency room to rule out clotting..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Ultrasound done to rule out clotting Treatment given as Tylenol and advil
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site scar, Vaccination site warmth
Clinical narrative: red; 2 inch round circle; has fever on the injection site (Temperature, it's hotter); sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (2 inch round circle), VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore). On 28-Jan-2021, the patient experienced VACCINATION SITE SCAR (2 inch round circle) and VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red). On 19-Jan-2021, VACCINATION SITE PAIN (sore) had resolved. At the time of the report, VACCINATION SITE SCAR (2 inch round circle), VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: achy; fever; head ache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (achy), PYREXIA (fever), HEADACHE (head ache) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), SIMVASTATIN and METOPROLOL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (achy), PYREXIA (fever), HEADACHE (head ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 29-Jan-2021, CHILLS (chills) had resolved. At the time of the report, MYALGIA (achy), PYREXIA (fever) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site warmth, Movement disorder, Peripheral swelling
Clinical narrative: She cannot move hand all the way up; Injection site feels warm to the touch; Injection site is swollen; Injection site is painful; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), PERIPHERAL SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MOVEMENT DISORDER (She cannot move hand all the way up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), PERIPHERAL SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MOVEMENT DISORDER (She cannot move hand all the way up). At the time of the report, ARTHRALGIA (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), PERIPHERAL SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MOVEMENT DISORDER (She cannot move hand all the way up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: CHILLS; BODY ACHE; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and PAIN (BODY ACHE) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (CHILLS) and PAIN (BODY ACHE). At the time of the report, CHILLS (CHILLS) and PAIN (BODY ACHE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was taken. No treatment medication was taken.
Age: 71.0
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 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03020A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-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.       The patient wanted to know if she could take Tylenol. No concomitant medication provided. No treatment medication provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash on injection Site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Rash on injection Site). At the time of the report, INJECTION SITE RASH (Rash on injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Cough; So much pain above her shoulder blade/her arm hurts a lot, not at the inject, above the soulder blade; Body ache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) 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 ( No reported medical history.).    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, COUGH (Cough), PAIN (So much pain above her shoulder blade), PAIN (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Feeling hot, Myalgia
Clinical narrative: Discomfort stomach; low energy; Watery mouth; Her head was hot; Body ache; Nausea; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth) and HEAD DISCOMFORT (Her head was hot) in a female 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.     The patient's past medical history included No adverse event (No reported medical history.).    On 25-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 PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired). At the time of the report, PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Salivary hypersecretion
Clinical narrative: Discomfort stomach; low energy; Watery mouth; Her head was hot; Body ache; Nausea; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth) and HEAD DISCOMFORT (Her head was hot) in a female 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.     The patient's past medical history included No adverse event (No reported medical history.).    On 25-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 PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired). At the time of the report, PAIN (Body ache), ABDOMINAL DISCOMFORT (Discomfort stomach), ASTHENIA (low energy), SALIVARY HYPERSECRETION (Watery mouth), HEAD DISCOMFORT (Her head was hot), NAUSEA (Nausea) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot rash at the injection site; itchiness; rash at the injection site; pain/discomfort and redness at the injection site; redness at the injection site/red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PAIN (pain/discomfort at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain/discomfort at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site). On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE RASH (rash at the injection site). On 22-Jan-2021, VACCINATION SITE PAIN (pain/discomfort at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site/red at the injection site) 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 included Advil.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Incorrect dose administered, Injection site haemorrhage, Pyrexia, Vaccination site bruising
Clinical narrative: Bruise at the injection site; giver intravascularly by accident; Experienced immediate pain/pain/sharp stabbing pain; Bleeding; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever), VACCINATION SITE BRUISING (Bruise at the injection site) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) in a 42-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding), PYREXIA (Fever) and INCORRECT DOSE ADMINISTERED (giver intravascularly by accident).   On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site). The patient was treated with ACETAMINOPHEN for Drug side effect, at an unspecified dose and frequency and IBUPROFEN for Drug side effect, at an unspecified dose and frequency.   On 25-Jan-2021, INCORRECT DOSE ADMINISTERED (giver intravascularly by accident) had resolved. On 28-Jan-2021, VACCINATION SITE PAIN (Experienced immediate pain/pain/sharp stabbing pain), INJECTION SITE HAEMORRHAGE (Bleeding) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 102 f (High) Patient had fever of 102 F on the night when vaccinated.   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.   Patient's treatment included ice packs. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: New events added, accordingly outcome of the events updated. Treatment drug details added.