chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Vaccination complication
Clinical narrative: With my eyes shut I was seeing something that looked like a very high technological grid. It was; my whole body felt like it was vibrating very hard and fast; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (With my eyes shut I was seeing something that looked like a very high technological grid. It was) and VACCINATION COMPLICATION (my whole body felt like it was vibrating very hard and fast) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and SUCRALFATE for an unknown indication.    On 25-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 OCULAR DISCOMFORT (With my eyes shut I was seeing something that looked like a very high technological grid. It was) and VACCINATION COMPLICATION (my whole body felt like it was vibrating very hard and fast). At the time of the report, OCULAR DISCOMFORT (With my eyes shut I was seeing something that looked like a very high technological grid. It was) and VACCINATION COMPLICATION (my whole body felt like it was vibrating very hard and fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Chills; Fuzzy feeling in my head; Body aches; Temperature 101 D farenheight; Rash on front of my body; Fatigue; Red ring around my belly button; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight) and RASH (Rash on front of my body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button). At the time of the report, CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: Chills; Fuzzy feeling in my head; Body aches; Temperature 101 D farenheight; Rash on front of my body; Fatigue; Red ring around my belly button; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight) and RASH (Rash on front of my body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button). At the time of the report, CHILLS (Chills), FEELING ABNORMAL (Fuzzy feeling in my head), PAIN (Body aches), BODY TEMPERATURE INCREASED (Temperature 101 D farenheight), RASH (Rash on front of my body), FATIGUE (Fatigue) and ERYTHEMA (Red ring around my belly button) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Patient had hives on sides of body 6 days after receiving 1st dose; Patient's lips were swollen 3 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose) and URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (cataflam). Concomitant products included TAMSULOSIN, FISH OIL and HYDROCORTISONE (GENKORT) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Feb-2021, the patient experienced LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose). On 14-Feb-2021, the patient experienced URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose). On 20-Feb-2021, URTICARIA (Patient had hives on sides of body 6 days after receiving 1st dose) had resolved. At the time of the report, LIP SWELLING (Patient's lips were swollen 3 days after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl.  Patients primary care physician advised not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 7-MAY-2021:  Reporter address was updated, patients race, medical history height, weight, concomitant medication (Tamsulosin) dose, vaccine batch number, event urticaria stop date were updated.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Not feeling well; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and VACCINATION SITE PAIN (Right arm sore) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Breast cancer female NOS (Surgery on left side).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced MALAISE (Not feeling well) and VACCINATION SITE PAIN (Right arm sore). At the time of the report, MALAISE (Not feeling well) and VACCINATION SITE PAIN (Right arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Lab tests not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Oxygen saturation decreased, Pyrexia
Clinical narrative: COVID positive; CHILLS; FEVER; low oxygen levels; A spontaneous report was received from a other healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid positive, chills, fever, low oxygen levels.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date,  patient received first of two planned doses of mRNA-1273 (lot/batch: un known). On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events  covid positive, chills, fever, low oxygen levels.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, covid positive, chills, fever, low oxygen levels was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: burning/warm to touch; redness at the site of injection extending halfway to the shoulder; swollen; soreness/burning sensation at the area of injection; felt tired; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (burning/warm to touch), FATIGUE (felt tired), CHILLS (really bad chills), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) in a 61-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.     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 26-Feb-2021, the patient experienced FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen). On 26-Feb-2021, FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: burning/warm to touch; redness at the site of injection extending halfway to the shoulder; swollen; soreness/burning sensation at the area of injection; felt tired; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (burning/warm to touch), FATIGUE (felt tired), CHILLS (really bad chills), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) in a 61-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.     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 26-Feb-2021, the patient experienced FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen). On 26-Feb-2021, FATIGUE (felt tired), CHILLS (really bad chills) and VACCINATION SITE PAIN (soreness/burning sensation at the area of injection) had resolved. At the time of the report, VACCINATION SITE WARMTH (burning/warm to touch), VACCINATION SITE ERYTHEMA (redness at the site of injection extending halfway to the shoulder) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migrane; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health professional and describes the occurrence of MIGRAINE (migrane) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma (She just finished chemotherapy for lymphoma.).    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 MIGRAINE (migrane). At the time of the report, MIGRAINE (migrane) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Erythema, Hypersensitivity, Nausea
Clinical narrative: injection site is red about the size of a quarter.; Rash come back; went to emergency room -gave her allergy medication and it got better; redness of arm; Chills; Nausea; has not done well with it; redness of arm/ 48 hours later developed a rash on neck, arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.), HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better) and ERYTHEMA (redness of arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LL20A) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), ERYTHEMA (redness of arm), CHILLS (Chills) and NAUSEA (Nausea). On 29-Jan-2021, the patient experienced HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better). On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.) and RASH (Rash come back). At the time of the report, DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.), HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better), ERYTHEMA (redness of arm), CHILLS (Chills), RASH (Rash come back) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site erythema
Clinical narrative: injection site is red about the size of a quarter.; Rash come back; went to emergency room -gave her allergy medication and it got better; redness of arm; Chills; Nausea; has not done well with it; redness of arm/ 48 hours later developed a rash on neck, arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.), HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better) and ERYTHEMA (redness of arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LL20A) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), ERYTHEMA (redness of arm), CHILLS (Chills) and NAUSEA (Nausea). On 29-Jan-2021, the patient experienced HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better). On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.) and RASH (Rash come back). At the time of the report, DISCOMFORT (has not done well with it), RASH ERYTHEMATOUS (redness of arm/ 48 hours later developed a rash on neck, arm and chest), VACCINATION SITE ERYTHEMA (injection site is red about the size of a quarter.), HYPERSENSITIVITY (went to emergency room -gave her allergy medication and it got better), ERYTHEMA (redness of arm), CHILLS (Chills), RASH (Rash come back) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Hypertension, Hypotension
Clinical narrative: Diarrhea; Weakness; High and low blood pressure; High and low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure). At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HYPERTENSION (High and low blood pressure) and HYPOTENSION (High and low blood pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.Concomitant medications was not provided by the reporter. Treatment details included Pedialyte 1L per day, Loperamide 2mg.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills
Clinical narrative: I feel weak; ache on the back of my right shoulder; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills). At the time of the report, ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity, Pruritus, Skin discomfort
Clinical narrative: Skin feels like pins pressing over the body and it comes and goes; Eyes burning; pain in the arm; tchy skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (Skin feels like pins pressing over the body and it comes and goes), OCULAR DISCOMFORT (Eyes burning), PAIN IN EXTREMITY (pain in the arm) and PRURITUS (tchy skin) in a 73-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 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 SKIN DISCOMFORT (Skin feels like pins pressing over the body and it comes and goes), OCULAR DISCOMFORT (Eyes burning), PAIN IN EXTREMITY (pain in the arm) and PRURITUS (tchy skin). At the time of the report, SKIN DISCOMFORT (Skin feels like pins pressing over the body and it comes and goes), OCULAR DISCOMFORT (Eyes burning), PAIN IN EXTREMITY (pain in the arm) and PRURITUS (tchy skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Muscle thing under their arm; 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 LIMB DISCOMFORT (Muscle thing under their arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Muscle thing under their arm). At the time of the report, LIMB DISCOMFORT (Muscle thing under their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired or fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling tired or fatigue). At the time of the report, FATIGUE (Feeling tired or fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up information was received and had no new information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site mass
Clinical narrative: events are worsening; swelling of the left arm; sore left arm; "knot" the size of a fist at the injection site; itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site), PRURITUS (itching) and CONDITION AGGRAVATED (events are worsening) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A021A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Drug allergy, Allergy to antibiotic, Drug allergy (Eliquis (apixaban)) and Latex allergy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site) and PRURITUS (itching). On 02-Mar-2021, the patient experienced CONDITION AGGRAVATED (events are worsening). At the time of the report, PERIPHERAL SWELLING (swelling of the left arm), PAIN IN EXTREMITY (sore left arm), VACCINATION SITE MASS ("knot" the size of a fist at the injection site), PRURITUS (itching) and CONDITION AGGRAVATED (events are worsening) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Dizziness, Fatigue, Pharyngeal swelling
Clinical narrative: DIzziness; Bad overall feeling; Shakes; Swollen throat; Throat swelled; my arms broke out in really bad rash, but it was mostly on my forearms to my elbows; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat) and PHARYNGEAL SWELLING (Throat swelled) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (It's been 10 years since the last time patient had the flu shot) and Asthma. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Asthma.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, q4h. On 08-Feb-2021, RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows) had resolved. At the time of the report, DIZZINESS (DIzziness), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved, DISCOMFORT (Bad overall feeling) was resolving and TREMOR (Shakes) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degree f (Low) 99.9 degree F.     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 Trelegy inhaler, birth control pill
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling, Tremor
Clinical narrative: DIzziness; Bad overall feeling; Shakes; Swollen throat; Throat swelled; my arms broke out in really bad rash, but it was mostly on my forearms to my elbows; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat) and PHARYNGEAL SWELLING (Throat swelled) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (It's been 10 years since the last time patient had the flu shot) and Asthma. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Asthma.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (DIzziness), DISCOMFORT (Bad overall feeling), TREMOR (Shakes), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK, q4h. On 08-Feb-2021, RASH (my arms broke out in really bad rash, but it was mostly on my forearms to my elbows) had resolved. At the time of the report, DIZZINESS (DIzziness), SWELLING (Swollen throat), PHARYNGEAL SWELLING (Throat swelled), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved, DISCOMFORT (Bad overall feeling) was resolving and TREMOR (Shakes) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degree f (Low) 99.9 degree F.     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 Trelegy inhaler, birth control pill
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Neck pain, Vaccination site erythema
Clinical narrative: soreness on right side of neck and behind ear; soreness on right side of neck and behind ear; redness around site of injection; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (soreness on right side of neck and behind ear), EAR PAIN (soreness on right side of neck and behind ear) and VACCINATION SITE ERYTHEMA (redness around site of injection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced NECK PAIN (soreness on right side of neck and behind ear), EAR PAIN (soreness on right side of neck and behind ear) and VACCINATION SITE ERYTHEMA (redness around site of injection). At the time of the report, NECK PAIN (soreness on right side of neck and behind ear), EAR PAIN (soreness on right side of neck and behind ear) and VACCINATION SITE ERYTHEMA (redness around site of injection) outcome was unknown.            Concomitant Medications were not provided  by the reporter. Treatment History includes ibuprofen.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired/fatigued; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (tired/fatigued) and HEADACHE (headache). At the time of the report, FATIGUE (tired/fatigued) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Painful arm; Swollen arm; Red arm; Got the shot way below the deltoid muscle between the shoulder and elbow; A spontaneous report was received from a pharmacist concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid muscle between the shoulder and elbow/ vaccine administered at inappropriate site and developed painful arm/ pain in extremity, red arm/ erythema and swollen arm/ peripheral swelling.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 26 Feb 2021, the patient received his first of the two planned doses of mRNA-1273 (batch number: unknown) intramuscularly way below deltoid muscle for prophylaxis of COVID-19 infection.  On the same day after vaccination, the patient developed painful and red swollen arm.   Treatment medication included with paracetamol for the events.  The action was taken with mRNA-1273 in response to the events was unknown.  The outcome of the received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid muscle between the shoulder and elbow/ vaccine administered at inappropriate site was considered as resolved. The outcome of the events painful arm/ pain in extremity and red arm/ erythema and swollen arm/ peripheral swelling were considered as unkown.; Reporter'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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M204 and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Arm sore). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-031572, US-MODERNATX, INC.-MOD-2021-032594 (E2B Linked Report). This case was linked to MOD-2021-032479, MOD-2021-032479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-MAR-2021 contains no new information; Sender's Comments:  MOD-2021-031572:Crosslinked Case: Same reporter/different patient (husband) US-MODERNATX, INC.-MOD-2021-032594:Crosslinked case: Same reporter (Wife case 1st dose)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash pruritic
Clinical narrative: itchy (rash on her upper chest and upper back); redness around injection site; rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy (rash on her upper chest and upper back)), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE RASH (rash around injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321.20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy (rash on her upper chest and upper back)), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE RASH (rash around injection site). At the time of the report, RASH PRURITIC (itchy (rash on her upper chest and upper back)), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE RASH (rash around injection site) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain in extremity
Clinical narrative: not sure if activated the gout in that foot; Woke up this morning and right foot was killing him; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified. Concomitant products included APIXABAN (ELIQUIS) for Heart disease, unspecified.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him). At the time of the report, GOUT (not sure if activated the gout in that foot) and PAIN IN EXTREMITY (Woke up this morning and right foot was killing him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-034389 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: body aches; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 025J20-2A) 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever) had resolved.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of smell; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). At the time of the report, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Lethargy
Clinical narrative: feel tired; felt like they had the flu; lethargic; chills; achy all over, but mostly in hips; shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's; sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats) and CHILLS (chills). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic). On 01-Mar-2021, the patient experienced FATIGUE (feel tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu), LETHARGY (lethargic) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (feel tired) outcome was unknown.            Concomitant Medications were not provided by the reporter.   This case was linked to MOD-2021-031587 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: feel tired; felt like they had the flu; lethargic; chills; achy all over, but mostly in hips; shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's; sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats) and CHILLS (chills). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic). On 01-Mar-2021, the patient experienced FATIGUE (feel tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu), LETHARGY (lethargic) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (feel tired) outcome was unknown.            Concomitant Medications were not provided by the reporter.   This case was linked to MOD-2021-031587 (Patient Link).