chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Scratch, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Aches all over the body; Chills; Headaches; fever of 100.2; Nausea; Itching at the injection site; Swelling at the injection site; Redness at the injection site; Rash at the injection site; Scratch at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratch at the injection site), PAIN (Aches all over the body), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and IRON for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 26-Feb-2021, the patient experienced SCRATCH (Scratch at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 28-Feb-2021, the patient experienced PAIN (Aches all over the body), CHILLS (Chills), HEADACHE (Headaches), PYREXIA (fever of 100.2) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 17-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, SCRATCH (Scratch at the injection site), PAIN (Aches all over the body), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE RASH (Rash at the injection site), HEADACHE (Headaches), PYREXIA (fever of 100.2) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Changed event outcome from unknown to recovering/resolving
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Aches all over the body; Chills; Headaches; fever of 100.2; Nausea; Itching at the injection site; Swelling at the injection site; Redness at the injection site; Rash at the injection site; Scratch at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratch at the injection site), PAIN (Aches all over the body), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and IRON for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 26-Feb-2021, the patient experienced SCRATCH (Scratch at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 28-Feb-2021, the patient experienced PAIN (Aches all over the body), CHILLS (Chills), HEADACHE (Headaches), PYREXIA (fever of 100.2) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 17-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, SCRATCH (Scratch at the injection site), PAIN (Aches all over the body), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE RASH (Rash at the injection site), HEADACHE (Headaches), PYREXIA (fever of 100.2) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Changed event outcome from unknown to recovering/resolving
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: pains; Left shoulder pain; muscle ache; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left shoulder pain, muscle ache, pains.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection and on same day she experienced  left shoulder pain, muscle ache, pains off and on ever since. She also had major surgery on 9Feb21 and is not sure if this could be part of it too.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), left shoulder pain, muscle ache, pains was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: developed a rash at the injection site; got a little bit blown up; It was 2 inches square; it was all red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medial history reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up). At the time of the report, VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication reported.   This case was linked to MOD-2021-031140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: follow up was received on 22-apr-2021 No new information updated
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Pain in extremity
Clinical narrative: Needles and pins on her hands; She couldn't stand up; She crawls on her fours to bed had a hard time getting into bed; Needles and pins on her legs; A spontaneous report was received from a consumer concerning a 90-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in the unknown site for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site erythema
Clinical narrative: her lymph nodes were affected; she is still in pain and she has pain in Wrist, Knee and Ankles; Red bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (her lymph nodes were affected ), PAIN (she is still in pain and she has pain in Wrist, Knee and Ankles) and VACCINATION SITE ERYTHEMA (Red bump at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (her lymph nodes were affected ), PAIN (she is still in pain and she has pain in Wrist, Knee and Ankles) and VACCINATION SITE ERYTHEMA (Red bump at injection site). At the time of the report, LYMPHADENOPATHY (her lymph nodes were affected ) and VACCINATION SITE ERYTHEMA (Red bump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR received
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills in the arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills in the arm). At the time of the report, CHILLS (chills in the arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Fatigue, Muscular weakness, Nasal congestion
Clinical narrative: Nasal congestion; Chest congestion; Sore throat; Hoarseness; Weakness in both legs; Feeling listless; Queasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness) and MUSCULAR WEAKNESS (Weakness in both legs) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUSPIRONE, METOPROLOL, ZOLPIDEM and FEXOFENADINE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach). At the time of the report, NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach) 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Nasal congestion; Chest congestion; Sore throat; Hoarseness; Weakness in both legs; Feeling listless; Queasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness) and MUSCULAR WEAKNESS (Weakness in both legs) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUSPIRONE, METOPROLOL, ZOLPIDEM and FEXOFENADINE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach). At the time of the report, NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach) 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: M
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia
Clinical narrative: Developed arm numbness; His voice changed; A spontaneous report was received from a consumer concerning himself, of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed arm numbness / hypo aesthesia and his voice changed / dysphonia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 25 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 002A21A) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed arm numbness and his voice changed.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s), arm numbness and his voice changed was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle fatigue, Pyrexia
Clinical narrative: Muscle Fatigue; HEADACHE; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants and treatments were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reactions). At the time of the report, VACCINATION COMPLICATION (Adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vaccination site rash
Clinical narrative: swollen arm; arm has circular rash on injection site; rash from shoulder down to the elbows; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE RASH (arm has circular rash on injection site) and RASH (rash from shoulder down to the elbows) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Tachycardia
Clinical narrative: Tachycardia with her heart rate in the 140s; Felt flushed; A spontaneous report was received from  consumer concerning a  female patient, who was administered Moderna's COVID-19 vaccine, and experienced tachycardia with her heart rate in the140s and felt flushed.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, Saturday at 12pm and then at 8 pm, the patient experienced tachycardia with her heart rate in the140s and felt flushed. She is wondering if that's from the vaccine and if she should get the second vaccine. No treatment information provided.   The outcome of the events, tachycardia with her heart rate in the 140s and felt flushed, were unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Nausea, Vertigo
Clinical narrative: Nausea; Woozy/Kind of dizzy-like; Upset stomach; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo). On 16-Feb-2021, NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Pyrexia
Clinical narrative: Cough; Not able to stand up/extremally fatigued; Fever of 101°F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), FATIGUE (Not able to stand up/extremally fatigued), PYREXIA (Fever of 101°F) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 530M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   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 19-Feb-2021, the patient experienced COUGH (Cough), FATIGUE (Not able to stand up/extremally fatigued), PYREXIA (Fever of 101°F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, COUGH (Cough), FATIGUE (Not able to stand up/extremally fatigued), PYREXIA (Fever of 101°F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 101 (High) 101 degree F.         Concomitant medication was not reported. The patient had high blood pressure so is not able to take Advil or Aspirin.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Really sore arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm) and FATIGUE (Very tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (Really sore arm) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Currently patient was undergoing treatment for cancer. No treatment information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Started presenting a very itchy area around the injection site; Soreness at injection site; Experienced redness at injection site; A spontaneous report was received from a consumer concerning herself, a 80-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at injection site / vaccination site erythema, soreness at the injection site / vaccination site pain, started presenting a very itchy area around the injection site / vaccination site pruritus.  The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly on her left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced redness and soreness at the injection site. On 22 Feb 2021, the patient experienced started presenting  a very itchy area around the injection site which seems to be spreading out further.  Treatment details included acetaminophen, hydrochlorothiazide, a statin, atenolol, citalopram.  Action taken with mRNA-1273 in response to the events was not reported.   The event(s), redness and soreness at the injection site got resolved on 15 Feb 2021. The outcome of event, started presenting a very itchy area around the injection site was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Taste disorder
Clinical narrative: Night sweats; dull taste buds; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds) outcome was unknown.            Concomitant medication was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Pruritus, Sleep disorder
Clinical narrative: Severe itching in my face. Makes it so I can?t sleep. Feels line sonething crawling under my skin as well. I never have seasonal allergies or any other condition that causes itching.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate decreased, Palpitations
Clinical narrative: The evening of my first dose I began experiencing heart palpitations, chest pain, and was generally very aware of the sensation of my heart beating, and more slowly than normal. I felt like I was having palpitations every other minute. I was lightheaded but not to a debilitating degree.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cardiac monitoring abnormal, Cardiac stress test normal, Dizziness, Electrocardiogram normal
Clinical narrative: Heart palpitations followed by blood pressure dropping then dizziness and actually collapsed. Continued fatigue   Currently on second heart monitor. My life has changed dramatically. I was very healthy and full of energy. Could exercise in am then play one or two rounds of golf a day.  Not now!
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Heart rate increased, Loss of personal independence in daily activities, Palpitations
Clinical narrative: Heart palpitations followed by blood pressure dropping then dizziness and actually collapsed. Continued fatigue   Currently on second heart monitor. My life has changed dramatically. I was very healthy and full of energy. Could exercise in am then play one or two rounds of golf a day.  Not now!
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Heart palpitations followed by blood pressure dropping then dizziness and actually collapsed. Continued fatigue   Currently on second heart monitor. My life has changed dramatically. I was very healthy and full of energy. Could exercise in am then play one or two rounds of golf a day.  Not now!
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: experienced pain after the first dose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (experienced pain after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (experienced pain after the first dose). At the time of the report, PAIN (experienced pain after the first dose) 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 medication provided no treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR attached. reporter's details updated on 29-apr-2021. no adverse events are reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: I did not feel good in general; I lost a couple of pounds; my appetite wasn't up the part; arm was a little bit sore to the touch; pretty fast heartbeat/irregular heartbeat; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore to the touch), PALPITATIONS (pretty fast heartbeat/irregular heartbeat), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (slight fever). On 27-Feb-2021, the patient experienced PALPITATIONS (pretty fast heartbeat/irregular heartbeat). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore to the touch), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Feb-2021, PYREXIA (slight fever) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore to the touch), PALPITATIONS (pretty fast heartbeat/irregular heartbeat), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part) outcome was unknown.            Action taken with mRNA-1273 in responsible to the events were not applicable no relevant concomitant medications was reported.   This case was linked to MOD-2021-030380 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: I did not feel good in general; I lost a couple of pounds; my appetite wasn't up the part; arm was a little bit sore to the touch; pretty fast heartbeat/irregular heartbeat; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore to the touch), PALPITATIONS (pretty fast heartbeat/irregular heartbeat), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (slight fever). On 27-Feb-2021, the patient experienced PALPITATIONS (pretty fast heartbeat/irregular heartbeat). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore to the touch), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Feb-2021, PYREXIA (slight fever) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore to the touch), PALPITATIONS (pretty fast heartbeat/irregular heartbeat), MALAISE (I did not feel good in general), WEIGHT DECREASED (I lost a couple of pounds) and DECREASED APPETITE (my appetite wasn't up the part) outcome was unknown.            Action taken with mRNA-1273 in responsible to the events were not applicable no relevant concomitant medications was reported.   This case was linked to MOD-2021-030380 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: arm started hurting; couldn't even move her neck; couldn't taste her food right - everything tasted wrong; didn't sleep all night because of the muscle ache and joint pain/elbow also hurt; fever; terrible chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), CHILLS (terrible chills) and ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 CHILLS (terrible chills). On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), CHILLS (terrible chills), ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: arm started hurting; couldn't even move her neck; couldn't taste her food right - everything tasted wrong; didn't sleep all night because of the muscle ache and joint pain/elbow also hurt; fever; terrible chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), CHILLS (terrible chills) and ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-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 CHILLS (terrible chills). On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 22-Feb-2021, PAIN IN EXTREMITY (arm started hurting), MUSCULOSKELETAL STIFFNESS (couldn't even move her neck), TASTE DISORDER (couldn't taste her food right - everything tasted wrong), CHILLS (terrible chills), ARTHRALGIA (didn't sleep all night because of the muscle ache and joint pain/elbow also hurt) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medications was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm; shot site itches; shot site is red; shot site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (shot site itches), VACCINATION SITE ERYTHEMA (shot site is red) and VACCINATION SITE SWELLING (shot site is swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The event outcome was updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: fever and sore throat; fever and sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (fever and sore throat) and PYREXIA (fever and sore throat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (fever and sore throat) and PYREXIA (fever and sore throat). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (fever and sore throat) and PYREXIA (fever and sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Little red rash; 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 RASH ERYTHEMATOUS (Little red rash) 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 an unknown date, the patient experienced RASH ERYTHEMATOUS (Little red rash). At the time of the report, RASH ERYTHEMATOUS (Little red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Heat at injection site; Redness at injection site; Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Injection arm soreness), VACCINATION SITE WARMTH (Heat at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 66-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.    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 PAIN IN EXTREMITY (Injection arm soreness). On 28-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Feb-2021, PAIN IN EXTREMITY (Injection arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Heat at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Flatly soreness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, METOPROLOL and BENAZEPRIL for an unknown indication.   On 25-Feb-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) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (Flatly soreness at injection site) and FATIGUE (fatigue) outcome was unknown.            Action taken with mRNA-1273 in responsible to the events were not applicable.  No treatment information was provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Migraine) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Eliquis                                                        Heart and Metoprolol                                                     Heart for Heart disorder, Amlodipine                                                     Hypertension for Hypertension.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (Headache). On 17-Jan-2021, the patient experienced MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, MIGRAINE (Migraine) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Movement disorder, Pyrexia
Clinical narrative: could not get out of bed; could not move; fever of 103.4; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21a) via unknown route for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of could not get out of bed/asthenia, could not move/movement disorder, fever of 103.4/pyrexia was resolved.