chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Oropharyngeal pain, Paraesthesia, Rhinorrhoea
Clinical narrative: Numbness in finger tips, ongoing headache, chest pain, sore throat, Running nose, dizziness, chills, pressure behind eyes, back of head numbness and tingling
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Extreme fatigue began at 8pm on day of shot 8/03. Shortly followed by chills, headache, and a fever of 100°. By 2 am on 08/04  nausea and vomiting started. Nausea ceased by 8 am. Entire day of 08/04 fever remained between 99° and 100°. Arm pain at the site of the injection was very painful and stiff for 72 hours.  After 48 hours most other symptoms began  to decrease. General weakness continued for 4 days after the initial shot when strength began to return, but weakness in the left leg has continued to date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Nausea, Pyrexia, Vomiting
Clinical narrative: Extreme fatigue began at 8pm on day of shot 8/03. Shortly followed by chills, headache, and a fever of 100°. By 2 am on 08/04  nausea and vomiting started. Nausea ceased by 8 am. Entire day of 08/04 fever remained between 99° and 100°. Arm pain at the site of the injection was very painful and stiff for 72 hours.  After 48 hours most other symptoms began  to decrease. General weakness continued for 4 days after the initial shot when strength began to return, but weakness in the left leg has continued to date.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Day 6-itchy rash/hives on bilateral upper arms Day 7- itchy rash/hives on bilateral upper arms and bilateral upper legs  Day 8-itchy rash/hives on bilateral upper arms, bilateral upper legs, and bilateral scapular areas
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Back pain, Limb discomfort, Neck pain
Clinical narrative: Woke up around 2:30am on 8/14  with severe aches in my jaw, neck, middle of back, hips, knees, ankles, pain and a feeling of fullness in my left armpit, and pain in my elbow and wrist on my left arm but not my right. When I got up I could feel a large lump in my armpit and it was very tender, and when I looked it is very visible (at least golf ball size). This continued through Saturday, I took ibuprofen and rested, keeping a pillow between my arm and my side as I could not comfortably put my arm down. When I woke up Sunday 8/15, the aches in my joints were gone, but the lump under my armpit is still there, still about the size of a golf ball. It is still a bit tender, the fullness feeling is not as much.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Tenderness
Clinical narrative: Woke up around 2:30am on 8/14  with severe aches in my jaw, neck, middle of back, hips, knees, ankles, pain and a feeling of fullness in my left armpit, and pain in my elbow and wrist on my left arm but not my right. When I got up I could feel a large lump in my armpit and it was very tender, and when I looked it is very visible (at least golf ball size). This continued through Saturday, I took ibuprofen and rested, keeping a pillow between my arm and my side as I could not comfortably put my arm down. When I woke up Sunday 8/15, the aches in my joints were gone, but the lump under my armpit is still there, still about the size of a golf ball. It is still a bit tender, the fullness feeling is not as much.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, International normalised ratio, Laboratory test, Prothrombin time, Thrombocytopenic purpura
Clinical narrative: ithrombocytopenic purpura blood disorder developed  Severe bruising Worry could have resulted in blood clots and worry could affect future fertility and increases risk of miscarriage
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little soreness with first shot; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness with first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, EMPAGLIFLOZIN (JARDIANCE), METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (THYROXINE), METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (little soreness with first shot). At the time of the report, PAIN (little soreness with first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient mention she didn't even feel the shot go in when administered.  No treatment for the event was reported.   This case was linked to MOD-2021-054477 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: a lot of itching from time to time in the area under the injection and the arm it's red there; a lot of itching from time to time in the area under the injection and the arm it's red there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D BEACONS) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there). At the time of the report, VACCINATION SITE PRURITUS (a lot of itching from time to time in the area under the injection and the arm it's red there) and VACCINATION SITE ERYTHEMA (a lot of itching from time to time in the area under the injection and the arm it's red there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included application of VapoRub to the area.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Injection site which was burning; Injection site which was itchy; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site which was burning), VACCINATION SITE PRURITUS (Injection site which was itchy) and VACCINATION SITE RASH (Rash at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site which was burning), VACCINATION SITE PRURITUS (Injection site which was itchy) and VACCINATION SITE RASH (Rash at the injection site). On 22-Feb-2021, VACCINATION SITE WARMTH (Injection site which was burning), VACCINATION SITE PRURITUS (Injection site which was itchy) and VACCINATION SITE RASH (Rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    No treatment information was provided.    This case was linked to US-MODERNATX, INC.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter name, address and email address were updated. On 29-Jul-2021: Follow-up received included no new information.; Sender's Comments:  US-MODERNATX, INC:Dose 2 case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: a big red warm area on my arm about the size of a softball; a big red warm area on my arm about the size of a softball; a big red warm area on my arm about the size of a softball; throwing up; slightly tired; low grade fever about 99.5; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VOMITING (throwing up), FATIGUE (slightly tired), PYREXIA (low grade fever about 99.5) and VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VOMITING (throwing up), FATIGUE (slightly tired) and PYREXIA (low grade fever about 99.5). On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) and VACCINATION SITE SWELLING (a big red warm area on my arm about the size of a softball). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VOMITING (throwing up), FATIGUE (slightly tired), PYREXIA (low grade fever about 99.5), VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) and VACCINATION SITE SWELLING (a big red warm area on my arm about the size of a softball) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: a big red warm area on my arm about the size of a softball; a big red warm area on my arm about the size of a softball; a big red warm area on my arm about the size of a softball; throwing up; slightly tired; low grade fever about 99.5; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VOMITING (throwing up), FATIGUE (slightly tired), PYREXIA (low grade fever about 99.5) and VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VOMITING (throwing up), FATIGUE (slightly tired) and PYREXIA (low grade fever about 99.5). On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) and VACCINATION SITE SWELLING (a big red warm area on my arm about the size of a softball). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a big red warm area on my arm about the size of a softball), VOMITING (throwing up), FATIGUE (slightly tired), PYREXIA (low grade fever about 99.5), VACCINATION SITE ERYTHEMA (a big red warm area on my arm about the size of a softball) and VACCINATION SITE SWELLING (a big red warm area on my arm about the size of a softball) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE, FUROSEMIDE and APIXABAN (ELIQUIS) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Myalgia
Clinical narrative: "move legs bad"; muscle pain; felt "extremely tired"; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Deep vein thrombosis, Surgery (surgery on lungs-- part of lung was removed) and C-section. Concurrent medical conditions included COPD, Emphysema and Diverticulitis. Concomitant products included ATORVASTATIN, MONTELUKAST and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired"). On 19-Feb-2021, MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included as Advil   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-056898, US-MODERNATX, INC.-MOD-2021-056977 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054493:crosslink US-MODERNATX, INC.-MOD-2021-056898:1st dose case of patient's husband US-MODERNATX, INC.-MOD-2021-056977:2nd dose case of patient's husband
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 029K20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), OLANZAPINE, MELATONIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired). At the time of the report, DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Document received is mostly illegible. Patient demographics updated. On 29-Jul-2021: Non Significant follow up On 02-Aug-2021: Follow-up received : No new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Malaise, Nausea, Pain in extremity
Clinical narrative: Can't fall asleep; Felt very unwell; Fever; Nauseousness; Chills; Feeling pain in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever) and NAUSEA (Nauseousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fatty liver and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Feeling pain in her right arm). On 23-Mar-2021, the patient experienced INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-054422, MOD-2021-054422 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Can't fall asleep; Felt very unwell; Fever; Nauseousness; Chills; Feeling pain in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever) and NAUSEA (Nauseousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fatty liver and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Feeling pain in her right arm). On 23-Mar-2021, the patient experienced INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Feeling pain in her right arm), INSOMNIA (Can't fall asleep), MALAISE (Felt very unwell), PYREXIA (Fever), NAUSEA (Nauseousness) and CHILLS (Chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-054422, MOD-2021-054422 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Fatigue, Mood swings
Clinical narrative: Anxiety; mood swings; Depression; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue). At the time of the report, ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: It has been more than 36 days and the patient did not get the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A/043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 11-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet) outcome was unknown. 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 concomitant medications reported.  No treatment information provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #unknown, with no associated AEs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: Swollen throat in the front under her chin; Her chest was tight and achy; Her chest was tight and achy; She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm; Brain fog; Extremely fatigued; Feverish; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A. and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included METHOTREXATE, GABAPENTIN and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 29-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 IN EXTREMITY (Sore arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm). On 19-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy) and CHEST PAIN (Her chest was tight and achy). At the time of the report, FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache) had not resolved.            Treatment information included Advil and Acyclovir
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: Swollen throat in the front under her chin; Her chest was tight and achy; Her chest was tight and achy; She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm; Brain fog; Extremely fatigued; Feverish; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A. and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included METHOTREXATE, GABAPENTIN and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 29-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 IN EXTREMITY (Sore arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm). On 19-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy) and CHEST PAIN (Her chest was tight and achy). At the time of the report, FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache) had not resolved.            Treatment information included Advil and Acyclovir
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red right arm; itchy right arm; swollen right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm). At the time of the report, ERYTHEMA (Red right arm), PRURITUS (itchy right arm) and PERIPHERAL SWELLING (swollen right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: felt "overall icky"; feverish feeling; felt tired; Body aches; fever; chills; headaches; nausea; swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "overall icky"), PAIN (Body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hypothyroidism, Penicillin allergy and Drug allergy (levaquin). Concomitant products included CARVEDILOL and LEVOTHYROXINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body aches). 23-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm). On 09-Mar-2021, the patient experienced FATIGUE (felt tired). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (felt "overall icky") and PYREXIA (feverish feeling). On 25-Feb-2021, PAIN (Body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm) had resolved. On 20-Mar-2021, PYREXIA (feverish feeling) had resolved. At the time of the report, FEELING ABNORMAL (felt "overall icky") and FATIGUE (felt tired) outcome was unknown.            Past medical history includes four surgeries Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: felt "overall icky"; feverish feeling; felt tired; Body aches; fever; chills; headaches; nausea; swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "overall icky"), PAIN (Body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hypothyroidism, Penicillin allergy and Drug allergy (levaquin). Concomitant products included CARVEDILOL and LEVOTHYROXINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body aches). 23-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm). On 09-Mar-2021, the patient experienced FATIGUE (felt tired). On 19-Mar-2021, the patient experienced FEELING ABNORMAL (felt "overall icky") and PYREXIA (feverish feeling). On 25-Feb-2021, PAIN (Body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea) and LYMPHADENOPATHY (swollen lymph node under the left arm) had resolved. On 20-Mar-2021, PYREXIA (feverish feeling) had resolved. At the time of the report, FEELING ABNORMAL (felt "overall icky") and FATIGUE (felt tired) outcome was unknown.            Past medical history includes four surgeries Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Headache, Illness, Nervousness
Clinical narrative: Weakness; Hot; Felt Sick; Shaky; Headahces; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and HEADACHE (Headahces) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Penicillin allergy, Gluten intolerance, Drug allergy (sulpha drugs) and Adhesive tape allergy (Allergic to bandage adhesive).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky), HEADACHE (Headahces) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and VOMITING (Vomited) had resolved. On 03-Mar-2021, HEADACHE (Headahces) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was taken for Hashimoto's disease.  Treatment details included Tylenol and patient was also drinking plenty of water to alleviate the events she was experiencing.   This case was linked to MOD-2021-117740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received and does not contain any new information On 20-Jul-2021: Additional Information received included no new Significant  information, allergies were added. On 20-Jul-2021: Additional information received  and does not contain any new information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Weakness; Hot; Felt Sick; Shaky; Headahces; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and HEADACHE (Headahces) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease, Penicillin allergy, Gluten intolerance, Drug allergy (sulpha drugs) and Adhesive tape allergy (Allergic to bandage adhesive).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, the patient experienced ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky), HEADACHE (Headahces) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, ASTHENIA (Weakness), FEELING HOT (Hot), ILLNESS (Felt Sick), NERVOUSNESS (Shaky) and VOMITING (Vomited) had resolved. On 03-Mar-2021, HEADACHE (Headahces) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was taken for Hashimoto's disease.  Treatment details included Tylenol and patient was also drinking plenty of water to alleviate the events she was experiencing.   This case was linked to MOD-2021-117740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received and does not contain any new information On 20-Jul-2021: Additional Information received included no new Significant  information, allergies were added. On 20-Jul-2021: Additional information received  and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash
Clinical narrative: still has some blotches on her skin; Shingles on her left leg; Very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very painful), ERYTHEMA (still has some blotches on her skin) and RASH (Shingles on her left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 007B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Very painful) and RASH (Shingles on her left leg). On an unknown date, the patient experienced ERYTHEMA (still has some blotches on her skin). The patient was treated with GABAPENTIN ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (Very painful), ERYTHEMA (still has some blotches on her skin) and RASH (Shingles on her left leg) was resolving.            No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at the injection site; Rash travelling to the arm and wrist and hand; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand). At the time of the report, INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: was warm to the touch; felt "weird"; experienced muscle soreness; low grade fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "weird"), FEELING HOT (was warm to the touch), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness). On 22-Mar-2021, the patient experienced FEELING HOT (was warm to the touch). On 19-Mar-2021, PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 21-Mar-2021, FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness) had resolved. At the time of the report, FEELING HOT (was warm to the touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99.6 (High) 99.6 F  low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: was warm to the touch; felt "weird"; experienced muscle soreness; low grade fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "weird"), FEELING HOT (was warm to the touch), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness). On 22-Mar-2021, the patient experienced FEELING HOT (was warm to the touch). On 19-Mar-2021, PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 21-Mar-2021, FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness) had resolved. At the time of the report, FEELING HOT (was warm to the touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99.6 (High) 99.6 F  low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red spots on the injection arm at the injection site; Itchy at injection site; Rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (red spots on the injection arm at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A84A) for COVID-19 vaccination.     Concurrent medical conditions included Mastocytosis and Acid reflux (esophageal). Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spots on the injection arm at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash at injection site). The patient was treated with PREDNISONE at a dose of 14 mg; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red spots on the injection arm at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided were acid reflux medication. Treatment medications provided were topical ointment, Antihistamines and Ice.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 contain no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Motor dysfunction, Vertigo
Clinical narrative: feeling dizzies; Pt can't drive and is dropping things with their hands; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo). At the time of the report, DIZZINESS (feeling dizzies), MOTOR DYSFUNCTION (Pt can't drive and is dropping things with their hands) and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.