chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Voice lowered; bronchioles are pretty swollen; Cough; horrible headache; Queasy; fire red at inner and upper thigh; Rash peripheral; red rash at injection site; Rash on leg; Rash trunk; fever 101.2; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice lowered), PAIN (Pain), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg) and COUGH (Cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain). On 06-Feb-2021, the patient experienced RASH (Rash trunk) and PYREXIA (fever 101.2). On 07-Feb-2021, the patient experienced ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), RASH (Rash peripheral) and INJECTION SITE RASH (red rash at injection site). On 08-Feb-2021, the patient experienced DYSPHONIA (Voice lowered), COUGH (Cough), BRONCHITIS (bronchioles are pretty swollen), HEADACHE (horrible headache) and NAUSEA (Queasy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once daily; FAMOTIDINE at a dose of twice daily; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL) at a dose of 50 mg every 4 hours and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Pain) had resolved. On 08-Feb-2021, NAUSEA (Queasy) had resolved. At the time of the report, DYSPHONIA (Voice lowered), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), COUGH (Cough), RASH (Rash trunk), RASH (Rash peripheral), BRONCHITIS (bronchioles are pretty swollen), INJECTION SITE RASH (red rash at injection site), HEADACHE (horrible headache) and PYREXIA (fever 101.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin M: Low. On an unknown date, Body temperature: 101.2 (Inconclusive) 101.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking antihistamines. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up received on 08/02/2021. included patient demographic information. Second dose information, concomitant medication, Additional events are included On 07-May-2021: Patient given permission to contact the mentioned healthcare professional
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disorientation, Feeling abnormal, Head discomfort, Vertigo positional
Clinical narrative: Brain fog; Foggy feeling; Pressure on their head; Memory loss; Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021. The most recent information was received on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection). At the time of the report, DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment for the events included unspecified steroids for about a week that resulted in better results, however, patient reported that symptoms came back.   This case was linked to MOD-2021-005650 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Additional information_01 On 08-Jun-2021: Diagnosis of new AE reported in FU. Event added; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site urticaria, Musculoskeletal stiffness, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red swollen itchy area; Sore and stiffness in neck and shoulder; Experienced a lot of dizziness; Rash at the injection site; Hives at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), INJECTION SITE URTICARIA (Hives at the injection site), VACCINATION SITE PRURITUS (Red swollen itchy area), DIZZINESS (Experienced a lot of dizziness) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder) in a 55-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.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site) and INJECTION SITE URTICARIA (Hives at the injection site). On 22-Jan-2021, the patient experienced DIZZINESS (Experienced a lot of dizziness). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red swollen itchy area) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), INJECTION SITE URTICARIA (Hives at the injection site), VACCINATION SITE PRURITUS (Red swollen itchy area), DIZZINESS (Experienced a lot of dizziness) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder) 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.   Treatment included Benadryl and Sertac.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Dyskinesia, Gait disturbance, Headache
Clinical narrative: memory loss; walking but not going anywhere; waving her hands as if playing the piano; headache; shivering; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-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 adverse event was reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 information was not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 032L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2020, Pregnancy test: positive (Positive) positive.         No Treatment medications was provided by the reporter. Multiple test and ultrasounds were performed and results were normal. NIPT was performed on sep 2020 resulted in normal test results.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: still was experiencing nausea; chills; fever of 101.5 degrees F; fatigue; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue), NAUSEA (nausea) and NAUSEA (still was experiencing nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety, Celiac disease, Hypertension, Stress, Lipids increased, Osteopenia and Vitamin D deficiency. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE, Wixela Inhaler, HYDROCHLOROTHIAZIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MONTELUKAST SODIUM (SINGULAIR).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue) and NAUSEA (nausea). On 25-Jan-2021, the patient experienced NAUSEA (still was experiencing nausea). At the time of the report, CHILLS (chills), PYREXIA (fever of 101.5 degrees F), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown and NAUSEA (still was experiencing nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchiness; redness; Sorenes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sorenes) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sorenes). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sorenes) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis in my hand is killing me/ arthritis in left hand has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis in my hand is killing me/ arthritis in left hand has gotten worse) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis (arthritis in her left hand) since an unknown date. Concomitant products included CORTISONE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and PROBIOTIC 10 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (arthritis in my hand is killing me/ arthritis in left hand has gotten worse). At the time of the report, ARTHRITIS (arthritis in my hand is killing me/ arthritis in left hand has gotten worse) had not resolved. Not Provided      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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Arm  is itchy; Red all around the shot; Hot to the touch; Sore arm; Hardness and lump in her arm; A spontaneous report was received from a Consumer concerning a 66Years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, hardness, lump in her arm, a delayed reaction in her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013M20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 02-FEB-2021, The patient experienced  sore arm, hardness, lump in her arm,  on 14-FEB-2021, a delayed reaction in her arm.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: leg started hurting and had difficulty walking; He can barely walk; Couldn't sleep last night; Left knee is in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg started hurting and had difficulty walking), GAIT DISTURBANCE (He can barely walk), INSOMNIA (Couldn't sleep last night) and ARTHRALGIA (Left knee is in pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (3 years ago).    On 17-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep last night) and ARTHRALGIA (Left knee is in pain). On 17-Feb-2021 at 7:00 PM, the patient experienced PAIN IN EXTREMITY (leg started hurting and had difficulty walking) and GAIT DISTURBANCE (He can barely walk). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 17-Feb-2021, INSOMNIA (Couldn't sleep last night) had resolved. At the time of the report, PAIN IN EXTREMITY (leg started hurting and had difficulty walking), GAIT DISTURBANCE (He can barely walk) and ARTHRALGIA (Left knee is in pain) 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 medication included an unspecified blood pressure medication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: itchiness on her neck on the left side; redness on her arm; Spotty rash on her arm; itchiness on her arm; A spontaneous report was received from a consumer concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spotty rash on her arm, itchiness on her arm, redness on her arm, itchiness on her neck on the left side.  The patient's medical history was not provided. Concomitant medications reported were simvastatin, rivaroxaban, levothyroxine, multi vitamin for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events spotty rash on her arm, itchiness on her arm, redness on her arm. On 18 Feb 2021, the patient experienced the event itchiness on her neck on the left side. Consent for safety to follow up with her given.Consent for safety to follow up with her healthcare provider- yes, her primary care doctor retired last week and doesn't know any other information. Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event, spotty rash on her arm was resolved. The outcome of events, itchiness on her arm, redness on her arm, itchiness on her neck on the left side was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node on her chin swelled; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node on her chin swelled) in a 76-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 reported medical history).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node on her chin swelled). At the time of the report, LYMPHADENOPATHY (lymph node on her chin swelled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR: Outcome of the event received no other follow-up
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Motion sickness, Nausea
Clinical narrative: motion sickness; Nausea; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), MOTION SICKNESS (motion sickness) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol. Concomitant products included LOSARTAN for Blood pressure abnormal, NIACIN for Cholesterol.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Lightheaded) and NAUSEA (Nausea). On an unknown date, the patient experienced MOTION SICKNESS (motion sickness). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Nausea, at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (BONINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheaded), MOTION SICKNESS (motion sickness) and NAUSEA (Nausea) 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 26-May-2021: Significant follow up, new AE, treatment meds and con meds
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site discomfort, Injection site pain, Injection site warmth
Clinical narrative: tender at injection site; dull headache; warmth at injection site; hardness at injection site; felt tiredness (3 hours after initial administration); Discomfort at the injection site (3 hours after initial administration); This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)), INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), FATIGUE (felt tiredness (3 hours after initial administration)) and INJECTION SITE PAIN (tender at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)). On 17-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth at injection site) and VACCINATION SITE INDURATION (hardness at injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache). On 12-Feb-2021, INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: tender at injection site; dull headache; warmth at injection site; hardness at injection site; felt tiredness (3 hours after initial administration); Discomfort at the injection site (3 hours after initial administration); This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)), INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), FATIGUE (felt tiredness (3 hours after initial administration)) and INJECTION SITE PAIN (tender at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)). On 17-Feb-2021, the patient experienced INJECTION SITE WARMTH (warmth at injection site) and VACCINATION SITE INDURATION (hardness at injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache). On 12-Feb-2021, INJECTION SITE DISCOMFORT (Discomfort at the injection site (3 hours after initial administration)) and FATIGUE (felt tiredness (3 hours after initial administration)) had resolved. At the time of the report, INJECTION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), INJECTION SITE PAIN (tender at injection site) and HEADACHE (dull headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Inflammation, Vaccination site erythema, Vaccination site pain
Clinical narrative: very hot; feeling hot at injection site; I feel awful; bright red; like a softball; inflamed; coughing badly; pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), INFLAMMATION (inflamed), COUGH (coughing badly) and VACCINATION SITE PAIN (pain at injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE SWELLING (like a softball). In February 2021, the patient experienced INFLAMMATION (inflamed), COUGH (coughing badly) and VACCINATION SITE PAIN (pain at injection). At the time of the report, VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), INFLAMMATION (inflamed), COUGH (coughing badly), VACCINATION SITE PAIN (pain at injection), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE SWELLING (like a softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: very hot; feeling hot at injection site; I feel awful; bright red; like a softball; inflamed; coughing badly; pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), INFLAMMATION (inflamed), COUGH (coughing badly) and VACCINATION SITE PAIN (pain at injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE SWELLING (like a softball). In February 2021, the patient experienced INFLAMMATION (inflamed), COUGH (coughing badly) and VACCINATION SITE PAIN (pain at injection). At the time of the report, VACCINATION SITE WARMTH (very hot; feeling hot at injection site), FEELING ABNORMAL (I feel awful), INFLAMMATION (inflamed), COUGH (coughing badly), VACCINATION SITE PAIN (pain at injection), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE SWELLING (like a softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on her arm following vaccination; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in extremity (pain on her arm following vaccination).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced pain on her arm following vaccination.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Every inch of her body was hurting; nauseous; Chilled but not sweat; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache). On 19-Feb-2021, PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache) had resolved.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-017433 (E2B Linked Report).; Sender's Comments:  MOD-2021-017433:same reporter , different patient.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Discomfort, Fatigue, Heart rate
Clinical narrative: vaccination site pain; Palpitations around 130s; Sense of discomfort; Low energy; Low appetite; Fatigue; A spontaneous report was received from a consumer concerning an 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and low appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events, the patient received his 1st dose of mRNA-1273 (lot batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and  low appetite. On an unknown date, pulse rate was 120. Treatment for the events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported. No treatment and concomitant drugs provided. Tthe outcome of event palpitations around 130s was resolved. The outcome for the events fatigue and low appetite was not recovered. The outcome of the events soreness in his arm, sense of discomfort and low energy was not provided.; 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.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Vaccination site pain
Clinical narrative: vaccination site pain; Palpitations around 130s; Sense of discomfort; Low energy; Low appetite; Fatigue; A spontaneous report was received from a consumer concerning an 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and low appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events, the patient received his 1st dose of mRNA-1273 (lot batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced soreness in his arm, palpitations around 130s, sense of discomfort, low energy, fatigue and  low appetite. On an unknown date, pulse rate was 120. Treatment for the events included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported. No treatment and concomitant drugs provided. Tthe outcome of event palpitations around 130s was resolved. The outcome for the events fatigue and low appetite was not recovered. The outcome of the events soreness in his arm, sense of discomfort and low energy was not provided.; 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: soreness; little knot around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site). At the time of the report, VACCINATION SITE PAIN (soreness) and VACCINATION SITE LYMPHADENOPATHY (little knot around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Secretion discharge
Clinical narrative: had a mucus with a pale weird green color; eyes felt like they were burning; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes felt like they were burning) and SECRETION DISCHARGE (had a mucus with a pale weird green color) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYE IRRITATION (eyes felt like they were burning). On 19-Feb-2021, the patient experienced SECRETION DISCHARGE (had a mucus with a pale weird green color). At the time of the report, EYE IRRITATION (eyes felt like they were burning) and SECRETION DISCHARGE (had a mucus with a pale weird green color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for covid-19 the week after first dose; A spontaneous report was received from a (Reporter like HCP ) concerning a41  Years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  the following week became symptomatic to covid-19. The patient's medical history was not provided. No relevant concomitant medications were reported.    On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) intramuscularly  for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient felt covid-19 symptomatic. now she is afebrile, still has a cough and mild flue  like symptoms.  Laboratory details was not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event  became symptomatic to covid-19 is considered as unknown.  The patient is due for their second dose on 3-feb-2021
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive Covid-19 diagnosis after first dose of the vaccine; A Spontaneous report received from a Healthcare Professional concerning, a 33-year-old age male patient who received first dose of the Moderna COVID-19 vaccine and experienced positive COVID-19 diagnosis after first dose of the vaccine. /MedDRA PT: [Positive COVID-19]    The patient's medical history was not included. Patient's concomitant was not included.  On 13JAN2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the first dose of the Moderna COVID-19 vaccine on 13JAN2021 and on 23JAN2021, patient received a positive diagnosis of COVID-19. No other information was report.   Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: red arm/little red; hot to touch; arm began to itch and break out; having some pain in the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PAIN (having some pain in the area) and INJECTION SITE PRURITUS (arm began to itch and break out) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (having some pain in the area). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch) and INJECTION SITE PRURITUS (arm began to itch and break out).   At the time of the report, VACCINATION SITE ERYTHEMA (red arm/little red), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PAIN (having some pain in the area) and INJECTION SITE PRURITUS (arm began to itch and break out) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-021710 (Patient Link).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tachycardia
Clinical narrative: Fever; Chills; little bit Tachycardia; Headache; soreness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache) and VACCINATION SITE PAIN (soreness at injection site) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. Treatment included Advil
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Chills; little bit Tachycardia; Headache; soreness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache) and VACCINATION SITE PAIN (soreness at injection site) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TACHYCARDIA (little bit Tachycardia), HEADACHE (Headache), VACCINATION SITE PAIN (soreness at injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. Treatment included Advil
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Vaccination site mass
Clinical narrative: Itching; Fever; large hard red lump; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large hard red lump), PAIN (Pain), PYREXIA (Fever) and PRURITUS (Itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LORATADINE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MASS (large hard red lump) and PAIN (Pain). On 20-Feb-2021, the patient experienced PYREXIA (Fever). On 22-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE MASS (large hard red lump), PAIN (Pain) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    relevant concomitant medications included Joint supplement ("move free") and vitamins
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site rash
Clinical narrative: little pain in their arm; some redness in their arm; rash near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little pain in their arm), ERYTHEMA (some redness in their arm) and VACCINATION SITE RASH (rash near injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy on 12-Feb-2021. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (little pain in their arm), ERYTHEMA (some redness in their arm) and VACCINATION SITE RASH (rash near injection site). At the time of the report, PAIN IN EXTREMITY (little pain in their arm), ERYTHEMA (some redness in their arm) and VACCINATION SITE RASH (rash near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.