chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Majority of the vaccine was not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered). On 01-Apr-2021, INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered) had resolved. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old boy got vaccinated by mistake with first dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose). On 11-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old boy got vaccinated by mistake with first dose) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 030A21A) with no associated AEs reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: left side of his face is acting funny, is moving.; tingles.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.). At the time of the report, HYPOAESTHESIA (left side of his face is acting funny, is moving.) and PARAESTHESIA (tingles.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication: Medication for his Back No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Follow Up Received: No New Information was received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills, peripheral swelling (swollen arm) and pruritus (itchy arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003B21A and 024M20A) for COVID-19 vaccination. No medical history reported. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 31, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced pyrexia (fever), chills, peripheral swelling (swollen arm) and pruritus (itchy arm). At the time of the report, pyrexia (fever), chills, peripheral swelling (swollen arm) and pruritus (itchy arm) outcome: unknown/not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received vaccine ahead of dosing schedule; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule). On 05-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received vaccine ahead of dosing schedule) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness; Swelling; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness) and SWELLING (Swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (EQUATE ALLERGY & SINUS HEADACHE) for an unknown indication.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Pain). On 03-Apr-2021, the patient experienced ERYTHEMA (Redness) and SWELLING (Swelling). At the time of the report, PAIN (Pain), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.            Patient's doctor told her to put ice on the area for 20 minutes and rub itching cream on it. (Avon moisture therapy anti-itch spray lotion)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Pyrexia
Clinical narrative: pain in the intestines; fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN and PYREXIA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B4A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 02-Apr-2021, the patient experienced GASTROINTESTINAL PAIN and PYREXIA. At the time of the report, GASTROINTESTINAL PAIN and PYREXIA outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: missed work; Headache; Fatigue; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of missed work, Headache, Fatigue, Nausea, and Joint pain in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced headache, Fatigue, Nausea, Joint pain, and Muscle pain. On 05-Apr-2021, the patient experienced missed work. At the time of the report, missed work, Headache, Fatigue, Nausea, Joint pain, and Muscle pain outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: missed work; Headache; Fatigue; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of missed work, Headache, Fatigue, Nausea, and Joint pain in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced headache, Fatigue, Nausea, Joint pain, and Muscle pain. On 05-Apr-2021, the patient experienced missed work. At the time of the report, missed work, Headache, Fatigue, Nausea, Joint pain, and Muscle pain outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; feeling sick; Red; Swollen/slisghtly swelling/ big bump; Hard mass; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen/slisghtly swelling/ big bump) and VACCINATION SITE INDURATION (Hard mass) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Depression and Cholesterol.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen/slisghtly swelling/ big bump) and VACCINATION SITE INDURATION (Hard mass). At the time of the report, VACCINATION SITE WARMTH (Hot), MALAISE (feeling sick), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen/slisghtly swelling/ big bump) and VACCINATION SITE INDURATION (Hard mass) outcome was unknown.            Concomitant products included supplement for osteoporosis, antidepressants and medication for cholesterol. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-067584 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067584:
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: under 18; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Bed rest, Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; headache; muscle pain; fever; threw up; felt so fatigue; hives; Slept all day 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever) and VOMITING (threw up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, Muscle pain, Chills and Fever.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: chills; headache; muscle pain; fever; threw up; felt so fatigue; hives; Slept all day 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever) and VOMITING (threw up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, Muscle pain, Chills and Fever.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (muscle pain), PYREXIA (fever), VOMITING (threw up), FATIGUE (felt so fatigue), URTICARIA (hives) and BED REST (Slept all day 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in his ears. Still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears. Still ongoing) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A2114) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (ringing in his ears. Still ongoing). At the time of the report, TINNITUS (ringing in his ears. Still ongoing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Diarrhoea, Onychomadesis, Palmar-plantar erythrodysaesthesia syndrome
Clinical narrative: Diarrhea; Appetite comes and goes; Two toenails are falling off; Hand and foot symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Breast cancer.    Concurrent medical conditions included Breast neoplasm malignant female. Concomitant products included CAPECITABINE (XELODA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, TUCATINIB (TUKYSA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms). At the time of the report, DIARRHOEA (Diarrhea), APPETITE DISORDER (Appetite comes and goes), ONYCHOMADESIS (Two toenails are falling off) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Hand and foot symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include fluids and lotion to treat the Hand and foot symptoms. Scan showed tumors are continuing to grow on her liver.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated events and concomitant medication. On 19-May-2021: Updated information regarding patient's use of Tukysa
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria papular, Vaccination site urticaria
Clinical narrative: Hives on the arm; Hives on chest, spreading; Lesions are starting to weep with fluid that is crusted over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-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 VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over). At the time of the report, VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nail injury, Tetanus immunisation
Clinical narrative: stepped on a nail; had to get a tetanus shot; stepped on a nail; had to get a tetanus shot; This spontaneous case was reported by a consumer and describes the occurrence of NAIL INJURY (stepped on a nail; had to get a tetanus shot) and TETANUS IMMUNISATION (stepped on a nail; had to get a tetanus shot) in a 28-year-old male patient 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 03-Apr-2021, the patient experienced NAIL INJURY (stepped on a nail; had to get a tetanus shot) and TETANUS IMMUNISATION (stepped on a nail; had to get a tetanus shot). At the time of the report, NAIL INJURY (stepped on a nail; had to get a tetanus shot) and TETANUS IMMUNISATION (stepped on a nail; had to get a tetanus shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersensitivity, Myalgia, Pruritus
Clinical narrative: Running nose; Sneeze a lot; Throat itch occasionally; Itchy nose; Light headed; Allergy symptom; Sore arm muscle on left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose) and DIZZINESS (Light headed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus pain.    On 28-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 RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue). At the time of the report, RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Relevant history added.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinitis, Sneezing, Throat irritation
Clinical narrative: Running nose; Sneeze a lot; Throat itch occasionally; Itchy nose; Light headed; Allergy symptom; Sore arm muscle on left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose) and DIZZINESS (Light headed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus pain.    On 28-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 RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue). At the time of the report, RHINITIS (Running nose), SNEEZING (Sneeze a lot), THROAT IRRITATION (Throat itch occasionally), PRURITUS (Itchy nose), DIZZINESS (Light headed), HYPERSENSITIVITY (Allergy symptom), MYALGIA (Sore arm muscle on left arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographic details updated. Relevant history added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Dose was administered in the back of the arm between the elbow and shoulder, not on the deltoid; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Dose was administered in the back of the arm between the elbow and shoulder, not on the deltoid) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Dose was administered in the back of the arm between the elbow and shoulder, not on the deltoid). On 05-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Dose was administered in the back of the arm between the elbow and shoulder, not on the deltoid) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported by the reporter. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Non-Significant information received-AE contact info updated Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 025A21A) with no associated AEs reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). Not Provided      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.   This case was linked to MOD21-069804, MOD21-069810, MOD21-069811, MOD21-069812, MOD21-069813, US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067250 (E2B Linked Report).; Sender's Comments:  MOD21-069804: MOD21-069810: MOD21-069811: MOD21-069812: MOD21-069813: US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Hot flush, Illness
Clinical narrative: Very sick; felt knee problems; feeling clammy; hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), ARTHRALGIA (felt knee problems), COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ARTHRALGIA (felt knee problems), COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes). On 01-Apr-2021, the patient experienced ILLNESS (Very sick). On 04-Mar-2021, ARTHRALGIA (felt knee problems) had resolved. On 01-Apr-2021, ILLNESS (Very sick) had resolved. At the time of the report, COLD SWEAT (feeling clammy) and HOT FLUSH (hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Little more tired; Second dose given 23 days too early; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (Little more tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early). On an unknown date, the patient experienced FATIGUE (Little more tired). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 23 days too early) had resolved. At the time of the report, FATIGUE (Little more tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.  Company comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 008B21A and 026B21A) with associated AEs of fatigue reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up Information was received on 09-APR-2021.Contact Number Updated; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 008B21A and 026B21A) with associated AEs of fatigue reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Lip exfoliation, Mouth swelling, Mouth ulceration, Mucosal pain
Clinical narrative: Ulceration inside mouth,Painful small (oral) ulcers; paintful ulceration; swelling in one area of the mouth; tiny blisters in various stages; Painful peeling lips; Cheilitis; Burning oral mucosa; "moderna arm" (right arm) 12inch long red, indurated area; This spontaneous case was reported by a nurse and describes the occurrence of MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area) and ORAL MUCOSAL BLISTERING (tiny blisters in various stages) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area). On an unknown date, the patient experienced MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Cortisone cream on the lips and Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-067676 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067676:Crosslinked with dose 2
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Oral mucosal blistering, Vaccination site reaction
Clinical narrative: Ulceration inside mouth,Painful small (oral) ulcers; paintful ulceration; swelling in one area of the mouth; tiny blisters in various stages; Painful peeling lips; Cheilitis; Burning oral mucosa; "moderna arm" (right arm) 12inch long red, indurated area; This spontaneous case was reported by a nurse and describes the occurrence of MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area) and ORAL MUCOSAL BLISTERING (tiny blisters in various stages) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area). On an unknown date, the patient experienced MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Cortisone cream on the lips and Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-067676 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067676:Crosslinked with dose 2
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Lip blister, Pain, Pyrexia
Clinical narrative: blisters on her upper lips; sore upper lip; achiness all over; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (blisters on her upper lips), CHEILITIS (sore upper lip), PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever). On 05-Apr-2021, the patient experienced LIP BLISTER (blisters on her upper lips) and CHEILITIS (sore upper lip). On 04-Apr-2021, PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, LIP BLISTER (blisters on her upper lips) and CHEILITIS (sore upper lip) outcome was unknown.            Concomitant drug information not provided. Treatment was not provided. Consent to follow-up safety provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: NNI
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: felt completely "zapped; Slept all night; started feeling weak; fever; full body muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain). At the time of the report, FEELING ABNORMAL (felt completely "zapped), HYPERSOMNIA (Slept all night), ASTHENIA (started feeling weak), PYREXIA (fever) and MYALGIA (full body muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: fever; mild cough; Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Tinnitus
Clinical narrative: Weakness; Tinitis; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and TINNITUS (Tinitis) 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. Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced ASTHENIA (Weakness) and TINNITUS (Tinitis). At the time of the report, ASTHENIA (Weakness) and TINNITUS (Tinitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old person received 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Presyncope, Throat tightness, Vaccination site erythema
Clinical narrative: She felt like she was going to faint; She couldn't focus; Felt her throat closing; Fatigue; Her arm got red; Her arm got tender; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Her arm got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (to antibiotics) and Sun sensitivity.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender). On 06-Jan-2021, PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus) and THROAT TIGHTNESS (Felt her throat closing) had resolved. On 12-Jan-2021, FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication use was not reported. She was in the medical area from 8 - 12 PM but she did not receive any treatment.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She felt like she was going to faint; She couldn't focus; Felt her throat closing; Fatigue; Her arm got red; Her arm got tender; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Her arm got red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (to antibiotics) and Sun sensitivity.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus), THROAT TIGHTNESS (Felt her throat closing), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender). On 06-Jan-2021, PRESYNCOPE (She felt like she was going to faint), DISTURBANCE IN ATTENTION (She couldn't focus) and THROAT TIGHTNESS (Felt her throat closing) had resolved. On 12-Jan-2021, FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Her arm got red) and VACCINATION SITE PAIN (Her arm got tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication use was not reported. She was in the medical area from 8 - 12 PM but she did not receive any treatment.