chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain in extremity
Clinical narrative: A sore arm; Full body aches; Headache that was turning to a migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Headache that was turning to a migraine), PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L02A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Headache that was turning to a migraine). On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches). The patient was treated with PARACETAMOL (TYLENOL) for Migraine headache, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Headache that was turning to a migraine) outcome was unknown and PAIN IN EXTREMITY (A sore arm) and MYALGIA (Full body aches) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications reported. Patient stated full body aches and a sore arm which lasted for 2.5 days.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Vommiting; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VOMITING (Vommiting) and HEADACHE (Slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20F) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), VOMITING (Vommiting) and HEADACHE (Slight headache). On 20-Feb-2021, CHILLS (Chills) and VOMITING (Vommiting) had resolved. On 21-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I think it is my lymph node that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I think it is my lymph node that is swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 20-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 LYMPHADENOPATHY (I think it is my lymph node that is swollen). At the time of the report, LYMPHADENOPATHY (I think it is my lymph node that is swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol as treatment for the event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Face felt tight around her mouth; Facial tingling; Diarrhea; Tiredness; Extreme chills; Aches; Headache; Nausea; A fever of 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness) and CHILLS (Extreme chills) in a 42-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.     Concurrent medical conditions included Type II diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Jan-2021, the patient experienced SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness), CHILLS (Extreme chills), MYALGIA (Aches), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (A fever of 101). On 13-Jan-2021, PYREXIA (A fever of 101) had resolved. On 14-Jan-2021, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved. On 23-Jan-2021, SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), CHILLS (Extreme chills), MYALGIA (Aches) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided  by the reporter.  The patient endorsed that her blood sugars were 'all over the place' following the first vaccine administration.  Treatment information was not provided.   This case was linked to MOD-2021-038627 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Events patient experienced during first and second dose, patient's medical history, more details of patient and information about patient's HCP was also provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Pyrexia, Skin tightness
Clinical narrative: Face felt tight around her mouth; Facial tingling; Diarrhea; Tiredness; Extreme chills; Aches; Headache; Nausea; A fever of 101; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness) and CHILLS (Extreme chills) in a 42-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.     Concurrent medical conditions included Type II diabetes mellitus.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Jan-2021, the patient experienced SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), DIARRHOEA (Diarrhea), FATIGUE (Tiredness), CHILLS (Extreme chills), MYALGIA (Aches), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (A fever of 101). On 13-Jan-2021, PYREXIA (A fever of 101) had resolved. On 14-Jan-2021, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved. On 23-Jan-2021, SKIN TIGHTNESS (Face felt tight around her mouth), PARAESTHESIA (Facial tingling), CHILLS (Extreme chills), MYALGIA (Aches) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided  by the reporter.  The patient endorsed that her blood sugars were 'all over the place' following the first vaccine administration.  Treatment information was not provided.   This case was linked to MOD-2021-038627 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Events patient experienced during first and second dose, patient's medical history, more details of patient and information about patient's HCP was also provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (really bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A or O15M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (really bad headache). At the time of the report, CHILLS (chills) and HEADACHE (really bad headache) outcome was unknown.            Treatment details included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itchiness at the injection site; redness at the injection site; swelling at the injection site; A Spondaneous report from was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  redness at the injection site, swelling at the injection site, itchiness at the injection site.  The patient's medical history was not given. No information about the concomitant medication was given. On 18-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 18-01-2021, The patient experienced  redness at the injection site, swelling at the injection site. On 27-01-2021, the patient experienced itchiness at the injection site. . The laboratory information is not given. Treatment information is not given. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Appetite curtailed; Dizzy; Fatigue; Sweats; Upset stomach; Aches; Chills; Nauseas; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy) and PAIN (Aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERHIDROSIS (Sweats), ABDOMINAL DISCOMFORT (Upset stomach), PAIN (Aches), CHILLS (Chills), NAUSEA (Nauseas) and MYALGIA (Muscle aches). On 20-Feb-2021, the patient experienced DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 20-Feb-2021, HYPERHIDROSIS (Sweats), DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy), PAIN (Aches), CHILLS (Chills), NAUSEA (Nauseas) and MYALGIA (Muscle aches) had resolved. On 21-Feb-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-09400 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Pain
Clinical narrative: Appetite curtailed; Dizzy; Fatigue; Sweats; Upset stomach; Aches; Chills; Nauseas; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), ABDOMINAL DISCOMFORT (Upset stomach), DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy) and PAIN (Aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERHIDROSIS (Sweats), ABDOMINAL DISCOMFORT (Upset stomach), PAIN (Aches), CHILLS (Chills), NAUSEA (Nauseas) and MYALGIA (Muscle aches). On 20-Feb-2021, the patient experienced DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 20-Feb-2021, HYPERHIDROSIS (Sweats), DECREASED APPETITE (Appetite curtailed), DIZZINESS (Dizzy), PAIN (Aches), CHILLS (Chills), NAUSEA (Nauseas) and MYALGIA (Muscle aches) had resolved. On 21-Feb-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-09400 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Influenza like illness, Injection site pain, Nausea
Clinical narrative: sore arm; GETTING WORSE INSTEAD OF GETTING BETTER; Fever of 101,102 for 2 Days; Chills; Nausea with no Vomiting; HAVING FLU-LIKE SYMPTOMS ON FRIDAY AND SATURDAY; A spontaneous report was received from a consumer concerning a 62 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm /pain in extremity, tiredness /fatigue, hurting for 2 days /pain, fever of 101, 102 for 2 days /pyrexia, chills, shaking /tremor, nausea with no vomiting /nausea, having flu-like symptoms on friday and saturday, getting worse instead of getting better /condition aggravated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   The outcome of event(s), sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; GETTING WORSE INSTEAD OF GETTING BETTER; Fever of 101,102 for 2 Days; Chills; Nausea with no Vomiting; HAVING FLU-LIKE SYMPTOMS ON FRIDAY AND SATURDAY; A spontaneous report was received from a consumer concerning a 62 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm /pain in extremity, tiredness /fatigue, hurting for 2 days /pain, fever of 101, 102 for 2 days /pyrexia, chills, shaking /tremor, nausea with no vomiting /nausea, having flu-like symptoms on friday and saturday, getting worse instead of getting better /condition aggravated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   The outcome of event(s), sore arm, tiredness, hurting for 2 days, fever of 101, 102 for 2 days, chills, shaking, nausea with no vomiting, having flu-like symptoms on friday and saturday, getting worse instead of getting better was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Myalgia, Pyrexia, Ultrasound foetal, Vaccination site reaction
Clinical narrative: received vaccine while pregnant after IUI; arm was very sore; felt feverish; Normal reaction; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol abuse. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) 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 18-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound foetal: 7-8 week ultrasound was good. It confirmed everything was measuring on track..     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.   Concomitant medications Prenatal vitamins. Treatment details were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Chills, Dizziness, Dyspnoea
Clinical narrative: have shortness of breath when she gets up to do stuff; pain in her lower left back; bloated stomach; burping; not feeling up to par; if she turns her head gets dizzy; real tired; real nauseated; ended up throwing up; Chilly; head hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping) and VACCINATION COMPLICATION (not feeling up to par) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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 TOCOPHEROL (VITAMIN E [TOCOPHEROL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), METOPROLOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and POTASSIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency and SIMETICONE (GAS X) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Vitamin E, Hyzaar, Metoprolol ER, Effexor XR, Glipizide, Aspirin 81mg, Potassium.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Fatigue, Headache, Nausea, Vaccination complication
Clinical narrative: have shortness of breath when she gets up to do stuff; pain in her lower left back; bloated stomach; burping; not feeling up to par; if she turns her head gets dizzy; real tired; real nauseated; ended up throwing up; Chilly; head hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping) and VACCINATION COMPLICATION (not feeling up to par) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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 TOCOPHEROL (VITAMIN E [TOCOPHEROL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), METOPROLOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and POTASSIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency and SIMETICONE (GAS X) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Vitamin E, Hyzaar, Metoprolol ER, Effexor XR, Glipizide, Aspirin 81mg, Potassium.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: have shortness of breath when she gets up to do stuff; pain in her lower left back; bloated stomach; burping; not feeling up to par; if she turns her head gets dizzy; real tired; real nauseated; ended up throwing up; Chilly; head hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping) and VACCINATION COMPLICATION (not feeling up to par) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) 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 TOCOPHEROL (VITAMIN E [TOCOPHEROL]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), METOPROLOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GLIPIZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and POTASSIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little). The patient was treated with NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at an unspecified dose and frequency and SIMETICONE (GAS X) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (have shortness of breath when she gets up to do stuff), BACK PAIN (pain in her lower left back), ABDOMINAL DISTENSION (bloated stomach), ERUCTATION (burping), VACCINATION COMPLICATION (not feeling up to par), DIZZINESS (if she turns her head gets dizzy), FATIGUE (real tired), NAUSEA (real nauseated), VOMITING (ended up throwing up), CHILLS (Chilly) and HEADACHE (head hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Vitamin E, Hyzaar, Metoprolol ER, Effexor XR, Glipizide, Aspirin 81mg, Potassium.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Several abdominal pain upside pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Several abdominal pain upside pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 ABDOMINAL PAIN UPPER (Several abdominal pain upside pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Abdominal pain upper, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Several abdominal pain upside pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm red) 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 20-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 ERYTHEMA (Arm red). At the time of the report, ERYTHEMA (Arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 20-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 COVID-19 (Tested positive for covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and UBROGEPANT (UBRELVY) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 antibody test: unknown (Positive) Source of Sample- nasopharyngeal, Type of Test-RT-PCR..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       COVID-19 symptoms were reported which include fever 101 for 4 days, chills for 1 day, muscle aches for 3 days, headache for 1 day, loss of taste and loss of smell. No treatment information was provided.   This case was linked to MOD-2021-022127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2021: Follow up received on 28 Feb 2021: Updated Patient initials and Covid-19 symptoms reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site haemorrhage, Rash erythematous, Rash macular
Clinical narrative: It was bleeding; It left a big bruise on her; She is starting to get red spots; a red rash and streaks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MWA) for COVID-19 vaccination.     Concurrent medical conditions included Gastroparesis and Blood pressure high.    On 18-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 INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks). At the time of the report, INJECTION SITE HAEMORRHAGE (It was bleeding), CONTUSION (It left a big bruise on her), RASH MACULAR (She is starting to get red spots) and RASH ERYTHEMATOUS (a red rash and streaks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Ear pain, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: flu like symptoms; Ear pain; tenderness in arm; Fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old patient of an unknown gender 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nauseous). On 27-Jan-2021, the patient experienced EAR PAIN (Ear pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 28-Jan-2021, EAR PAIN (Ear pain), PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nauseous) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; Ear pain; tenderness in arm; Fever; Chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old patient of an unknown gender 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 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nauseous). On 27-Jan-2021, the patient experienced EAR PAIN (Ear pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 28-Jan-2021, EAR PAIN (Ear pain), PAIN IN EXTREMITY (tenderness in arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nauseous) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: Extremely cold with chills; Body aches; Extremely cold with chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Extremely cold with chills), PAIN (Body aches) and CHILLS (Extremely cold with chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025L20A) 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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FEELING COLD (Extremely cold with chills), PAIN (Body aches) and CHILLS (Extremely cold with chills). At the time of the report, FEELING COLD (Extremely cold with chills), PAIN (Body aches) and CHILLS (Extremely cold with chills) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID test; A spontaneous report was received from a nurse concerning an 71 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a positive COVID test (SARS-CoV-2 test positive).     The patient's medical history was not provided.  Concomitant product use was not provided.  On 19 JAN 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number 041120A) intramuscularly in the arm for the prophylaxis of COVID-19 infection.  On 2 FEB 2021, the patient had a positive COVID test.   No treatment medication information was provided.    Action taken with second dose of mRNA-1273 is unknown.  The patient was due for his second mRNA-1273 vaccination on 23 Feb 2021.  The outcome of the event, positive COVID test, was unknown.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: a little soreness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness) and VACCINATION SITE PAIN (pain at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (a little soreness) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, PAIN IN EXTREMITY (a little soreness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Hypokinesia, Lymphadenopathy
Clinical narrative: severe headache; severe neck ache; fatigue; exhaustion; swollen lymph gland - arm; swollen lymph gland - groin; fever of 100.5; could not move; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion) and LYMPHADENOPATHY (swollen lymph gland - arm) in a 69-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 was provided by the reporter.  Concomitant products included LISINOPRIL (LISINOPRIL +PHARMA) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    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 HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion), LYMPHADENOPATHY (swollen lymph gland - arm), LYMPHADENOPATHY (swollen lymph gland - groin), PYREXIA (fever of 100.5) and HYPOKINESIA (could not move). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion), LYMPHADENOPATHY (swollen lymph gland - arm), LYMPHADENOPATHY (swollen lymph gland - groin), PYREXIA (fever of 100.5) and HYPOKINESIA (could not move) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5f (Low) 100.F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications lisinopril, valacyclovir. Treatment details were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pyrexia
Clinical narrative: severe headache; severe neck ache; fatigue; exhaustion; swollen lymph gland - arm; swollen lymph gland - groin; fever of 100.5; could not move; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion) and LYMPHADENOPATHY (swollen lymph gland - arm) in a 69-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 was provided by the reporter.  Concomitant products included LISINOPRIL (LISINOPRIL +PHARMA) and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    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 HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion), LYMPHADENOPATHY (swollen lymph gland - arm), LYMPHADENOPATHY (swollen lymph gland - groin), PYREXIA (fever of 100.5) and HYPOKINESIA (could not move). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache), MUSCULOSKELETAL DISCOMFORT (severe neck ache), FATIGUE (fatigue), FATIGUE (exhaustion), LYMPHADENOPATHY (swollen lymph gland - arm), LYMPHADENOPATHY (swollen lymph gland - groin), PYREXIA (fever of 100.5) and HYPOKINESIA (could not move) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5f (Low) 100.F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications lisinopril, valacyclovir. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: ran a 106 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (ran a 106 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (ran a 106 fever). At the time of the report, PYREXIA (ran a 106 fever) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 106 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021 and it contains No new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site; Itching injection site; Reddish circle; Warm injection site; Intense Headache; Red injection site; Chills; Left sided headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Left sided headache). On 12-Feb-2021, the patient experienced CHILLS (Chills). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm injection site), INJECTION SITE ERYTHEMA (Red injection site) and HEADACHE (Intense Headache). On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching injection site) and ERYTHEMA (Reddish circle). On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache), CHILLS (Chills), INJECTION SITE ERYTHEMA (Red injection site), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Intense Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Pain at injection site; Itching injection site; Reddish circle; Warm injection site; Intense Headache; Red injection site; Chills; Left sided headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Left sided headache). On 12-Feb-2021, the patient experienced CHILLS (Chills). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm injection site), INJECTION SITE ERYTHEMA (Red injection site) and HEADACHE (Intense Headache). On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching injection site) and ERYTHEMA (Reddish circle). On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, INJECTION SITE WARMTH (Warm injection site), INJECTION SITE PRURITUS (Itching injection site), ERYTHEMA (Reddish circle), HEADACHE (Left sided headache), CHILLS (Chills), INJECTION SITE ERYTHEMA (Red injection site), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Intense Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body / Full body hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives all over the body / Full body hives) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced URTICARIA (Hives all over the body / Full body hives). At the time of the report, URTICARIA (Hives all over the body / Full body hives) 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.   Concomitant medications were not provided. Treatment details were not provided.