chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: left arm red; left arm hurt to touch; left arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (left arm red), VACCINATION SITE PAIN (left arm hurt to touch) and VACCINATION SITE SWELLING (left arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals, Latex allergy and Food allergy. Concomitant products included SERTRALINE and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 15-May-2020 to an unknown date for an unknown indication.   On 07-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 05-Feb-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2020, Pregnancy test: positive (Positive) Positive. On 02-Oct-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 28-Dec-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 17-Feb-2021, Blood glucose: passed (Inconclusive) Passed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Patient demographic, second dose details, Concomitant medication details, Lab test were updated.Gestation Period, Delivery Date, Birth Type and Fetal Outcome has been updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of vaccination site warmth (arm had heat around the site), pyrexia (fever), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. No medical history reported. On Jan 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 12, 2021, patient experienced vaccination site warmth (arm had heat around the site), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site). On an unknown date, patient experienced pyrexia (fever). At the time of the report, vaccination site warmth (arm had heat around the site), pyrexia (fever), vaccination site swelling (arm had swelling around the site) and vaccination site erythema (arm had redness around the site) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant product use. Treatment medications included unspecified steroids and clindamycin. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch; Area around upper arm and shoulder muscle where injection is swollen; Rash around the injection site; Black and blue right at the injection site; Mild soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site), VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PAIN (Mild soreness in the arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness in the arm). On 13-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site) and VACCINATION SITE RASH (Rash around the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site), VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PAIN (Mild soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact; 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.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: left cheek is slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (left cheek is slightly swollen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (no reports of individual history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced SWELLING (left cheek is slightly swollen). On 14-Jan-2021, SWELLING (left cheek is slightly swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event include antihistamine.   Reporter did not allow further contact; Reporter's Comments: patient is asking wheather she can go with the  second shot or not?because she is not sure if she had an allergic reaction?
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at the injection site; Lump in my arm and big at Injection site; Itchy at the injection site; Erythema/Red at the injection; Swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE MASS (Lump in my arm and big at Injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Erythema/Red at the injection) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE MASS (Lump in my arm and big at Injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Erythema/Red at the injection) and VACCINATION SITE SWELLING (Swollen at the injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE MASS (Lump in my arm and big at Injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Erythema/Red at the injection) and VACCINATION SITE SWELLING (Swollen at the injection site) 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.   No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Frequent bowel movements
Clinical narrative: had frequent bowel movements; This spontaneous case was reported by a patient and describes the occurrence of FREQUENT BOWEL MOVEMENTS (had frequent bowel movements) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (had frequent bowel movements). At the time of the report, FREQUENT BOWEL MOVEMENTS (had frequent bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient drank the poly glyco prep on 14-Jan-2021 as treatment. Patient did  colonoscopy prep for his procedure 15-Jan-2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itchy at the injection site; sore rump near the deltoid; pain in the neck; fever of 100F; swollen lymph nodes; redness at the injection site; rash at the injection site; intense pain; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site) and TENDERNESS (sore rump near the deltoid) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment include zyrtec
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Itchy at the injection site; sore rump near the deltoid; pain in the neck; fever of 100F; swollen lymph nodes; redness at the injection site; rash at the injection site; intense pain; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site) and TENDERNESS (sore rump near the deltoid) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment include zyrtec
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: face itches; flared up (hot, red) and spread; localized redness, hot, hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch), INJECTION SITE WARMTH (flared up (hot, red) and spread) and PRURITUS (face itches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch). On 04-Jan-2021, the patient experienced INJECTION SITE WARMTH (flared up (hot, red) and spread). On an unknown date, the patient experienced PRURITUS (face itches). At the time of the report, INJECTION SITE ERYTHEMA (localized redness, hot, hard to touch) and INJECTION SITE WARMTH (flared up (hot, red) and spread) had not resolved and PRURITUS (face itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information include zyrtec
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Palpitations
Clinical narrative: Headache; Dizziness; Heart Palpitations; difficulty breathing; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness), PALPITATIONS (Heart Palpitations), DYSPNOEA (difficulty breathing) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Dizziness since 17-Jan-2021, Palpitations since 17-Jan-2021, Difficulty breathing since 17-Jan-2021, Dizziness since 17-Jan-2021 and Headache since 17-Jan-2021.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced DIZZINESS (Dizziness), PALPITATIONS (Heart Palpitations) and DYSPNOEA (difficulty breathing). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), PALPITATIONS (Heart Palpitations), DYSPNOEA (difficulty breathing) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for an unknown indication. The patient's past medical history included no adverse event. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 30, 2020, patient had a SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine). At the time of the report, SARS-CoV-2 positive test (patient tested positive for COVID after 1st dose of Moderna vaccine) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, treatment information or concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: extreme hard red lump; itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (extreme hard red lump) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Cardiac stent).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (extreme hard red lump). At the time of the report, VACCINATION SITE ERYTHEMA (extreme hard red lump) had not 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.   Treatment medication include Zyrtec. Concomitant product use was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Tenderness
Clinical narrative: warm touch; Sore knot; Red knot; Fatigue; Tender; A spontaneous report  was received from a consumer, concerning a female patient born on 1 Jun 1960 (60years) who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced sore knot, red knot, fatigue, warm touch and tender  The patient's medical history was not provided. Concomitant was not provided. On 15 Jan 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number 012L20A) intramuscularly on left arm for prophylaxis of COVID-19 infection and later at bed around 23:00 experienced more sore Red, tender and warm touch knot above the arm pit.  Treatment reported was Tylenol and symptoms are ongoing.  Consent for follow-up given.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events  sore knot, red knot, fatigue, warm touch and tender is not resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial discomfort, Hypoaesthesia, Injection site pain, Malaise
Clinical narrative: Rash; Numbness on the left arm from her wrist down; Not feeling well; Pain at the injection site; Numbness on the left arm from her wrist down; Fever; Pain; Achiness; Chills; Parts of her face feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever) and PAIN (Pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20-A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny) and the second episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down). On 02-Jan-2021, the patient experienced RASH (Rash). At the time of the report, MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny), RASH (Rash) and the last episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash; Numbness on the left arm from her wrist down; Not feeling well; Pain at the injection site; Numbness on the left arm from her wrist down; Fever; Pain; Achiness; Chills; Parts of her face feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever) and PAIN (Pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20-A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny) and the second episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down). On 02-Jan-2021, the patient experienced RASH (Rash). At the time of the report, MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny), RASH (Rash) and the last episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: A sore arm for a couple of days; Arm became very red; Swollen; Eruption on her arm started 12 days after receiving vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Eruption on her arm started 12 days after receiving vaccine), VACCINATION SITE ERYTHEMA (Arm became very red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (A sore arm for a couple of days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concomitant products included PREDNISONE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE RASH (Eruption on her arm started 12 days after receiving vaccine). On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm became very red) and VACCINATION SITE SWELLING (Swollen). On an unknown date, the patient experienced VACCINATION SITE PAIN (A sore arm for a couple of days). At the time of the report, VACCINATION SITE RASH (Eruption on her arm started 12 days after receiving vaccine), VACCINATION SITE ERYTHEMA (Arm became very red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (A sore arm for a couple of days) 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.   Patient hasrecieved chemotherapy and immunotherapy in the past.  Treatment medication included a topical cream.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever 100.1 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 100.1 F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Splenectomy (she also on biologic and does not have spleen).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PYREXIA (fever 100.1 F). At the time of the report, PYREXIA (fever 100.1 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temperature raised to 100.06; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature raised to 100.06) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (temperature raised to 100.06). At the time of the report, PYREXIA (temperature raised to 100.06) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.06 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age." No relevant concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezing cough; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing cough) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal asthma.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced WHEEZING (Wheezing cough). At the time of the report, WHEEZING (Wheezing cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Arm getting worse more swollen; Arm getting worse more swollen, red; High fever; Vomiting still; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still). At the time of the report, PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still) 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.  Treatment information was not provided.; 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Hand shake; Headache; Muscle pain; Nausea; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Hand shake; Headache; Muscle pain; Nausea; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, TREMOR (Hand shake), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Dermatitis, Gingival discomfort, Headache, Limb discomfort
Clinical narrative: little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly; mouth was hot; mouth sores; gum irritation; headaches were more persistent the first couple of weeks; Pain at the injection site; Arm became swollen; Arm quite sore; Dermatitis; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Glaucoma, Allergy to grains (Gluten allergy.), Allergy to allopathic drugs (Vicodin and Codeine allergy.) and Lactose intolerant. Concomitant products included Travoprost (Travoprost eye drops) for Glaucoma, LEVOTHYROXINE for Hypothyroidism.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise). On 30-Dec-2020, the patient experienced HEADACHE (headaches were more persistent the first couple of weeks). On 03-Jan-2021, the patient experienced STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation). On 15-Jan-2021, the patient experienced CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly). On 03-Jan-2021, HEADACHE (headaches were more persistent the first couple of weeks), STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation) had resolved. On 05-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore) and DERMATITIS (Dermatitis) had resolved. At the time of the report, MALAISE (malaise) had resolved and CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mouth ulceration, Peripheral swelling, Stomatitis, Vaccination site pain
Clinical narrative: little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly; mouth was hot; mouth sores; gum irritation; headaches were more persistent the first couple of weeks; Pain at the injection site; Arm became swollen; Arm quite sore; Dermatitis; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Glaucoma, Allergy to grains (Gluten allergy.), Allergy to allopathic drugs (Vicodin and Codeine allergy.) and Lactose intolerant. Concomitant products included Travoprost (Travoprost eye drops) for Glaucoma, LEVOTHYROXINE for Hypothyroidism.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore), DERMATITIS (Dermatitis) and MALAISE (malaise). On 30-Dec-2020, the patient experienced HEADACHE (headaches were more persistent the first couple of weeks). On 03-Jan-2021, the patient experienced STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation). On 15-Jan-2021, the patient experienced CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly). On 03-Jan-2021, HEADACHE (headaches were more persistent the first couple of weeks), STOMATITIS (mouth was hot), MOUTH ULCERATION (mouth sores) and GINGIVAL DISCOMFORT (gum irritation) had resolved. On 05-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), PERIPHERAL SWELLING (Arm became swollen), LIMB DISCOMFORT (Arm quite sore) and DERMATITIS (Dermatitis) had resolved. At the time of the report, MALAISE (malaise) had resolved and CLUSTER HEADACHE (little, sudden bursts of headaches that last 1 to 2 minutes and go away/ (headache) episodes are subsiding slowly) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: So tired; chills; Have some muscle pain; Low-level headache and headache kind of weird; I feel like I had a fever but when I take it I don't; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (taking bloodpressure medication). Concomitant products included AMLODIPINE for Blood pressure.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't). At the time of the report, FATIGUE (So tired), CHILLS (chills), MYALGIA (Have some muscle pain), HEADACHE (Low-level headache and headache kind of weird) and PYREXIA (I feel like I had a fever but when I take it I don't) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) 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.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching face; rash face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching face) and RASH (rash face) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PRURITUS (Itching face) and RASH (rash face). At the time of the report, PRURITUS (Itching face) and RASH (rash face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Malaise, Oropharyngeal pain
Clinical narrative: Injection site warm; Injection site induration; General malaise; Sore throat; Achey; headache; Chills; Diarrhea; Injection site red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise) and OROPHARYNGEAL PAIN (Sore throat) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar affective disorder, Headache, Insomnia and Drug allergy (ibuprofen). Concomitant products included TRAZODONE, ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC), SERTRALINE, BUSPIRONE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red), CHILLS (Chills) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey) and HEADACHE (headache). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey), HEADACHE (headache), CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Injection site warm; Injection site induration; General malaise; Sore throat; Achey; headache; Chills; Diarrhea; Injection site red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise) and OROPHARYNGEAL PAIN (Sore throat) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar affective disorder, Headache, Insomnia and Drug allergy (ibuprofen). Concomitant products included TRAZODONE, ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC), SERTRALINE, BUSPIRONE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red), CHILLS (Chills) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey) and HEADACHE (headache). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey), HEADACHE (headache), CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.