chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Myalgia, Nausea, Night sweats
Clinical narrative: Night sweats; No appetite; Stomach nausea; Fatigue; Complete muscle ache and body ache from her head to her toes; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes). At the time of the report, NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Tension headache; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 31-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) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TENSION HEADACHE (Tension headache). At the time of the report, TENSION HEADACHE (Tension headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate increased, Hypersensitivity, Rash
Clinical narrative: immediate allergic reaction; immediate rash all over body; immediate dizziness for one minute; immediate fast heartbeat for one minute; immediate heat; This spontaneous case was reported by a health care professional and describes the occurrence of HYPERSENSITIVITY (immediate allergic reaction), RASH (immediate rash all over body), DIZZINESS (immediate dizziness for one minute), HEART RATE INCREASED (immediate fast heartbeat for one minute) and FEELING HOT (immediate heat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (allergic to walnut).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERSENSITIVITY (immediate allergic reaction), RASH (immediate rash all over body), DIZZINESS (immediate dizziness for one minute), HEART RATE INCREASED (immediate fast heartbeat for one minute) and FEELING HOT (immediate heat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, HYPERSENSITIVITY (immediate allergic reaction), DIZZINESS (immediate dizziness for one minute), HEART RATE INCREASED (immediate fast heartbeat for one minute) and FEELING HOT (immediate heat) had resolved. At the time of the report, RASH (immediate rash all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Body itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body itchiness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Body itchiness). At the time of the report, PRURITUS (Body itchiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported years ago when she took zyrtec, she had a reaction. No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DYSPNEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was provided by the reporter as COPD medicines. Treatment information was not provided.  Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up was received on 17-MAY-2021 included Telephone Contact Report - Event outcome updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles worsen after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles worsen after the second shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles worsen after the second shot). At the time of the report, HERPES ZOSTER (Shingles worsen after the second shot) outcome was unknown. Not Provided          No concomitant medications reported. No treatment reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065349 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065349:Cross-linked
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pregnancy, Ultrasound abdomen
Clinical narrative: I have received the Moderna shot, and I would like to register my pregnancy.; vaccination exposure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and MAGNESIUM for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Jul-2021. On an unknown date, the patient experienced PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure). At the time of the report, PREGNANCY (I have received the Moderna shot, and I would like to register my pregnancy.) and IMMUNISATION (vaccination exposure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: normal NORMAL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has a history of prior alcohol intake. No treatment information was provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Therapeutic response unexpected
Clinical narrative: Lot of pain in the upper arm; Pain radiating to my back; Struggle to sleep; Port wine birth mark - red and purple has disappeared; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared), PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Birth mark (port wine birth mark). Concurrent medical conditions included Migraine since 1980. Concomitant products included ESTRADIOL for Hormone replacement therapy, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for Routine health maintenance, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for Vitamin supplementation.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared). On an unknown date, the patient experienced PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep). In March 2021, THERAPEUTIC RESPONSE UNEXPECTED (Port wine birth mark - red and purple has disappeared) had resolved. At the time of the report, PAIN IN EXTREMITY (Lot of pain in the upper arm), PAIN (Pain radiating to my back) and INSOMNIA (Struggle to sleep) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment Information was not provided.   This case was linked to MOD-2021-136043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient demographics were updated.Concomitant product details were updated. Added new events pain in upper arm, radiating to back and struggled to sleep.Causality of event unexpected therapeutic benefit was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Lightheaded; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, PYREXIA, and NAUSEA in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS, PYREXIA, and NAUSEA. At the time of the report, DIZZINESS, PYREXIA, and NAUSEA outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site plaque, Vaccination site reaction
Clinical narrative: erythematous painful indurated red plaques, with a diameter of 7 cm; erythematous painful indurated red plaques, with a diameter of 7 cm; redness with a diameter of 2 cm; local allergic reaction under injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PLAQUE (erythematous painful indurated red plaques, with a diameter of 7 cm), VACCINATION SITE REACTION (local allergic reaction under injection site), VACCINATION SITE INDURATION (erythematous painful indurated red plaques, with a diameter of 7 cm) and VACCINATION SITE ERYTHEMA (redness with a diameter of 2 cm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (oral penicillin: Clamoxin) in 2000. Concomitant products included ACETYLSALICYLATE LYSINE (KARDEGIC), Antihypertensive treatment, Statine and PREGABALIN (LYRICA) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE REACTION (local allergic reaction under injection site) and VACCINATION SITE ERYTHEMA (redness with a diameter of 2 cm). On 29-Mar-2021, the patient experienced VACCINATION SITE PLAQUE (erythematous painful indurated red plaques, with a diameter of 7 cm) and VACCINATION SITE INDURATION (erythematous painful indurated red plaques, with a diameter of 7 cm). At the time of the report, VACCINATION SITE PLAQUE (erythematous painful indurated red plaques, with a diameter of 7 cm), VACCINATION SITE REACTION (local allergic reaction under injection site), VACCINATION SITE INDURATION (erythematous painful indurated red plaques, with a diameter of 7 cm) and VACCINATION SITE ERYTHEMA (redness with a diameter of 2 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Influenza, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y) and MALAISE (did not feel like herself) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029120A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt she had flu), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills). On an unknown date, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported. This case was linked to MOD-2021-060937.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y) and MALAISE (did not feel like herself) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029120A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt she had flu), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills). On an unknown date, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported. This case was linked to MOD-2021-060937.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AMANTADINE HYDROCHLORIDE (GOCOVRI) for Dyskinesia.    The patient's past medical history included Dystonia, Hepatic cirrhosis (From being a fatty liver), Hereditary hemochromatosis since an unknown date, Fibromyalgia, Arthritis and Hepatic steatosis. Previously administered products included for Immunisation: flu vaccine (Rash from flu shot resolved; primary care provider told her it had nothing to do with the flu shot. Rash subsequently resolved.) in September 2020 and tetanus (tet/dip tox (tetanus and diphtheria toxoids)); for Drug therapy: penicillin (Hypersensitivity) and sulfa; for an unreported indication: COVID-19 VACCINE (Second shot) on 03-Mar-2021. Past adverse reactions to the above products included Drug hypersensitivity with penicillin and sulfa; Hypersensitivity with tetanus; and Rash with flu vaccine. Concurrent medical conditions included Parkinson's disease (receiving levodopa-based therapy) and Dyskinesia (Receiving levodopa-based therapy). Concomitant products included DULOXETINE, AMITRIPTYLINE, TIZANIDINE, DESMOPRESSIN ACETATE, GABAPENTIN, PREGABALIN, LOSARTAN POTASSIUM, AMLODIPINE BESYLATE, OXYCODONE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN), VITAMIN D NOS and MELOXICAM from an unknown date to 17-Mar-2021 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 274 mg at bedtime. On 05-Feb-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She did take Benadryl for a couple days after both doses of vaccine, but that didn't really seem to effect it.   This case was linked to MOD-2021-065736 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional underdose, Peripheral swelling, Product availability issue, Rash, Rash erythematous
Clinical narrative: Red Rash; Top of feet swelling up; Product availability; Rash; Intentional underdose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up), PRODUCT AVAILABILITY ISSUE (Product availability), INTENTIONAL UNDERDOSE (Intentional underdose) and RASH (Rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dyskinesia, Parkinson's disease, Dystonia, Cirrhosis liver on 17-Mar-2021, Hemochromatosis on 17-Mar-2021, Fibromyalgia on 17-Mar-2021, Arthritis on 17-Mar-2021 and Hepatic steatosis. Previously administered products included for an unreported indication: FLU in September 2020, PENICILLINS WITH EXTENDED SPECTRUM and TETANUS DIPHTHERIA. Concurrent medical conditions included Rash erythematous, Peripheral swelling, Drug allergy (sulfa drugs cross reactors), Product availability issue, Rash, Intentional underdose on 17-Mar-2021 and Underdose. Concomitant products included DULOXETINE, AMITRIPTYLINE, TIZANIDINE, DESMOPRESSIN ACETATE, GABAPENTIN, PREGABALIN, LOSARTAN POTASSIUM, AMLODIPINE BESYLATE and OXYCODONE for an unknown indication, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MELOXICAM.   On 03-Feb-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Nov-2020, the patient experienced INTENTIONAL UNDERDOSE (Intentional underdose). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up), PRODUCT AVAILABILITY ISSUE (Product availability) and RASH (Rash). The patient was treated with AMANTADINE HYDROCHLORIDE (GOCOVRI) (oral) at a dose of 274 mg at bedtime. At the time of the report, RASH ERYTHEMATOUS (Red Rash), PERIPHERAL SWELLING (Top of feet swelling up) and RASH (Rash) outcome was unknown and PRODUCT AVAILABILITY ISSUE (Product availability) and INTENTIONAL UNDERDOSE (Intentional underdose) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-065722 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: minimal symptoms; This spontaneous case was reported by a patient and describes the occurrence of ILL-DEFINED DISORDER (minimal symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (minimal symptoms). At the time of the report, ILL-DEFINED DISORDER (minimal symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Patient stated for the first dose the vial was swirled, then drawn up, then administered.   No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-028598 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Device malfunction, Occupational exposure to product
Clinical narrative: Dose didn't get in patient's arm instead it went into eyes of vaccine provider.; Mal-function of syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Dose didn't get in patient's arm instead it went into eyes of vaccine provider.) and DEVICE MALFUNCTION (Mal-function of syringe) in a patient of an unknown age and gender 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 (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 30-Mar-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Dose didn't get in patient's arm instead it went into eyes of vaccine provider.) and DEVICE MALFUNCTION (Mal-function of syringe). On 30-Mar-2021, OCCUPATIONAL EXPOSURE TO PRODUCT (Dose didn't get in patient's arm instead it went into eyes of vaccine provider.) and DEVICE MALFUNCTION (Mal-function of syringe) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of occupational exposure to product and device malfunction for mRNA-1273, lot # 018B21A  with no associated AEs.; Sender's Comments: This report refers to a case of occupational exposure to product and device malfunction for mRNA-1273, lot # 018B21A  with no associated AEs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (lymph node swelling) and pain in extremity (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 4, 2021, patient experienced lymphadenopathy (lymph node swelling) and pain in extremity (sore arm). At the time of the report, lymphadenopathy (lymph node swelling) and pain in extremity (sore arm): unresolved. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. No concomitant medication or treatment information reported. This case linked to MOD-2021-061138 (patient link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Woke up drenched in sweat (gown, hair, bed were all wet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L209) for COVID-19 vaccination.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet). At the time of the report, NIGHT SWEATS (Woke up drenched in sweat (gown, hair, bed were all wet) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-062216 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: non significant follow up was received
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchiness on arm of injection; rash on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection). At the time of the report, PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided   Reporter did not allow further contact
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tender arm after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender arm after the first dose) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia (mild mid-stage).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (tender arm after the first dose). At the time of the report, VACCINATION SITE PAIN (tender arm after the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not take any concomitant medications.  Patient did not take any treatment medication for the symptom.   This case was linked to MOD-2021-037288 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: couldn't sleep the night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep the night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (couldn't sleep the night). At the time of the report, INSOMNIA (couldn't sleep the night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided. No concomitant medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a few days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm for a few days). At the time of the report, PAIN IN EXTREMITY (Sore arm for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-065822 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 and it contains NO new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: sore arm at the site of the injection; a large rash that covered the area that had remained sore after the injection; arm  itchy around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm  itchy around the injection site), VACCINATION SITE PAIN (sore arm at the site of the injection) and VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm  itchy around the injection site). On 31-Mar-2021, the patient experienced VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at the site of the injection). At the time of the report, VACCINATION SITE PRURITUS (arm  itchy around the injection site) and VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection) had resolved and VACCINATION SITE PAIN (sore arm at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (pounding headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizzy) and HEADACHE (pounding headache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (pounding headache) outcome was unknown.        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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) 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 reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-015004, US-MODERNATX, INC.-MOD-2021-015004, US-MODERNATX, INC.-MOD-2021-014845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015004:Reporter's co-worker case (male patient) US-MODERNATX, INC.-MOD-2021-014845:Reporter's female patient case US-MODERNATX, INC.-MOD-2021-015004:Reporter's co-worker wife case (female patient)
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. No concomitant mediation was reported. No treatment medication was reported. Reporter did not allow further contact.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Abnormal behaviour, Back pain, Headache
Clinical narrative: Pain in lower abdomen; Pain in lower back; Bowel "spurts"; Developed a Urinary Tract Infection; Vision & hearing dimmed; Vision & hearing dimmed; Behavior changed, not acting normal; Developed a headache for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal), ABDOMINAL DISCOMFORT (Bowel "spurts") and URINARY TRACT INFECTION (Developed a Urinary Tract Infection) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Blood pressure high, Thyroid disorder, Drug allergy (amoxicillin), Drug allergy (ampicillin) and Drug allergy (ciprofloxacin).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal) and HEADACHE (Developed a headache for a couple of days). On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Bowel "spurts") and URINARY TRACT INFECTION (Developed a Urinary Tract Infection). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN LOWER (Pain in lower abdomen) and BACK PAIN (Pain in lower back). At the time of the report, HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal), ABDOMINAL DISCOMFORT (Bowel "spurts"), URINARY TRACT INFECTION (Developed a Urinary Tract Infection), ABDOMINAL PAIN LOWER (Pain in lower abdomen), BACK PAIN (Pain in lower back) and HEADACHE (Developed a headache for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Urinary tract infection, Visual impairment
Clinical narrative: Pain in lower abdomen; Pain in lower back; Bowel "spurts"; Developed a Urinary Tract Infection; Vision & hearing dimmed; Vision & hearing dimmed; Behavior changed, not acting normal; Developed a headache for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal), ABDOMINAL DISCOMFORT (Bowel "spurts") and URINARY TRACT INFECTION (Developed a Urinary Tract Infection) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Blood pressure high, Thyroid disorder, Drug allergy (amoxicillin), Drug allergy (ampicillin) and Drug allergy (ciprofloxacin).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal) and HEADACHE (Developed a headache for a couple of days). On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Bowel "spurts") and URINARY TRACT INFECTION (Developed a Urinary Tract Infection). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN LOWER (Pain in lower abdomen) and BACK PAIN (Pain in lower back). At the time of the report, HYPOACUSIS (Vision & hearing dimmed), VISUAL IMPAIRMENT (Vision & hearing dimmed), ABNORMAL BEHAVIOUR (Behavior changed, not acting normal), ABDOMINAL DISCOMFORT (Bowel "spurts"), URINARY TRACT INFECTION (Developed a Urinary Tract Infection), ABDOMINAL PAIN LOWER (Pain in lower abdomen), BACK PAIN (Pain in lower back) and HEADACHE (Developed a headache for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: felt like he had the flu.; headache; body aches; Has body chill; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AB21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL, RAMIPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 31-Mar-2021, the patient received second  dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date , the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown ) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu.), HEADACHE (headache), MYALGIA (body aches), CHILLS (Has body chill) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site warmth, Pyrexia, Rash, Vaccination site rash
Clinical narrative: rash on left arm; injection site hard; injection site warm to touch; rash getting wider, up to 4 or 5 inches; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on left arm), INJECTION SITE MASS (injection site hard), INJECTION SITE WARMTH (injection site warm to touch), RASH (rash getting wider, up to 4 or 5 inches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on left arm), INJECTION SITE MASS (injection site hard), INJECTION SITE WARMTH (injection site warm to touch), RASH (rash getting wider, up to 4 or 5 inches) and PYREXIA (fever). At the time of the report, VACCINATION SITE RASH (rash on left arm), INJECTION SITE MASS (injection site hard), INJECTION SITE WARMTH (injection site warm to touch), RASH (rash getting wider, up to 4 or 5 inches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Neuritis
Clinical narrative: Fever of 102; chills; Body aches; Vomiting; Sick also, almost like sinus infection; Vestibular neuritis; Nystagmus on both eyes that makes her very dizzy.; joint pain; whole body was sore; severe headaches on and off; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off), DIZZINESS (dizziness) and PYREXIA (Fever of 102) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off) and DIZZINESS (dizziness). On 25-Feb-2021, the patient experienced PYREXIA (Fever of 102), CHILLS (chills), PAIN (Body aches), VOMITING (Vomiting), SINUSITIS (Sick also, almost like sinus infection), NEURITIS (Vestibular neuritis) and NYSTAGMUS (Nystagmus on both eyes that makes her very dizzy.). At the time of the report, ARTHRALGIA (joint pain), TENDERNESS (whole body was sore), HEADACHE (severe headaches on and off), DIZZINESS (dizziness), PYREXIA (Fever of 102), CHILLS (chills), PAIN (Body aches), VOMITING (Vomiting), SINUSITIS (Sick also, almost like sinus infection), NEURITIS (Vestibular neuritis) and NYSTAGMUS (Nystagmus on both eyes that makes her very dizzy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.