chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urinary tract infection, Urticaria
Clinical narrative: Consumer missed her 36 days mark for 2nd dose; UTI; Hives from bactrim; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), URTICARIA (Hives from bactrim) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Asthma chronic, Urinary tract infection and Heart disease, unspecified. Concomitant products included NITROFURANTOIN for UTI, NITROGLYCERIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI) and URTICARIA (Hives from bactrim). On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for UTI, at an unspecified dose and frequency. On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) was resolving and URTICARIA (Hives from bactrim) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient medical history included blood pressure. It was reported that on 17-Mar-2021 UTI was subsided.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#036A21A with AEs of Urticaria and UTI. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dermatitis contact, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pain; Flu like symptoms; Itching and rash under the central line dressing; Temperature of 104; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS CONTACT (Itching and rash under the central line dressing) and PYREXIA (Temperature of 104) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2101713) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included SILDENAFIL and MACITENTAN (OPSUMIT) for an unknown indication.   On 09-Apr-2021, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) 1 milligram per millilitre. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS CONTACT (Itching and rash under the central line dressing) and PYREXIA (Temperature of 104). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DERMATITIS CONTACT (Itching and rash under the central line dressing) outcome was unknown and PYREXIA (Temperature of 104) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 104 Farad (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site rash
Clinical narrative: 3 inch diameter red rash at the injection site; 3 inch diameter red rash at the injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (3 inch diameter red rash at the injection site), VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site) and MYALGIA (Soreness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient was on cancer remission). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MYALGIA (Soreness). On an unknown date, the patient experienced VACCINATION SITE RASH (3 inch diameter red rash at the injection site) and VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site). At the time of the report, VACCINATION SITE RASH (3 inch diameter red rash at the injection site), VACCINATION SITE ERYTHEMA (3 inch diameter red rash at the injection site) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications also included supplements and drug for cancer remission. No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tissue injury, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tissue loss; Muscles more defined on the left arm; Tenderness on the left arm; Injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of TISSUE INJURY (Tissue loss), VACCINATION SITE PRURITUS (Injection site is itchy), MYALGIA (Muscles more defined on the left arm) and VACCINATION SITE PAIN (Tenderness on the left arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the left arm). In March 2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy). On an unknown date, the patient experienced TISSUE INJURY (Tissue loss) and MYALGIA (Muscles more defined on the left arm). In March 2021, VACCINATION SITE PAIN (Tenderness on the left arm) had resolved. At the time of the report, TISSUE INJURY (Tissue loss), VACCINATION SITE PRURITUS (Injection site is itchy) and MYALGIA (Muscles more defined on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Dizziness; Pain; Runny nose; Sore throat; Tired; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.Other treatment for the event included juice.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Dizziness; Pain; Runny nose; Sore throat; Tired; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), PAIN (Pain), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.Other treatment for the event included juice.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Vaccination site pain
Clinical narrative: Chills; Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-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 CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: unknown (High) Heart beating much faster.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Severe Side Effects after the Second Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe Side Effects after the Second Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 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. In March 2021, the patient experienced ADVERSE EVENT (Severe Side Effects after the Second Vaccine). At the time of the report, ADVERSE EVENT (Severe Side Effects after the Second Vaccine) outcome was unknown. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to -MODERNATX, INC.-MOD-2021-071353 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071353:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: beyond the recommended dosing interval; This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval). On 28-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the recommended dosing interval) had resolved.            Concurrent medication not available. Treatment medication not available.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: dry cough; hot sensation in throat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to the company on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and THROAT IRRITATION (hot sensation in throat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U2B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT IRRITATION (hot sensation in throat). On 06-Apr-2021, the patient experienced COUGH (dry cough). At the time of the report, COUGH (dry cough) and THROAT IRRITATION (hot sensation in throat) outcome was unknown.            There are no Adverse events to report after the first dose.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: feeling horrible; chills; body aches; 102.2 fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FEELING ABNORMAL (feeling horrible), MYALGIA (body aches) and PYREXIA (102.2 fever) 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 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 CHILLS (chills), FEELING ABNORMAL (feeling horrible), MYALGIA (body aches) and PYREXIA (102.2 fever). At the time of the report, CHILLS (chills), FEELING ABNORMAL (feeling horrible), MYALGIA (body aches) and PYREXIA (102.2 fever) 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: throbbing a little bit; a little sore on arm by the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Indigestion. Concomitant products included FAMOTIDINE for Acid indigestion.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site). At the time of the report, PAIN (throbbing a little bit) and VACCINATION SITE PAIN (a little sore on arm by the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment details included ibuprofen and icepack.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm soreness; muscle pains; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle pains), FATIGUE (tiredness) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle pains), FATIGUE (tiredness) and CHILLS (chills). On 30-Mar-2021, CHILLS (chills) had resolved. On 31-Mar-2021, MYALGIA (muscle pains) and FATIGUE (tiredness) had resolved. On 01-Apr-2021, PAIN IN EXTREMITY (arm soreness) had resolved.            Treatment medications were not provided. No concomitant medications were reported. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable   This case was linked to MOD-2021-066124 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Pyrexia; Headache; Fatigue; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A02A and 002A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Significant Medical History). Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), MELOXICAM, ANASTROZOLE (ANASTRAZOLE DENK), VITAMIN D [VITAMIN D NOS] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 01-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Ache). On 29-Mar-2021 at 11:00 PM, the patient experienced PYREXIA (Pyrexia), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Ache), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Pyrexia) had not resolved.            Treatment Medicines include Tylenol and Meloxicam  Action taken with mRNA-1273 in response to the event was not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness and soreness at injection site; Soreness at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        Products known to have been used by the patient, within two weeks prior to the event, included blood thinners  Treatment for the event included paracetamol.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071383, MOD-2021-070988, MOD-2021-071416, MOD-2021-077195, MOD-2021-070997 (Patient Link).; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discolouration, Peripheral swelling, Rash, Rash pruritic, Wound
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose), PERIPHERAL SWELLING (arm swelling), RASH PRURITIC (Itchiness of rash), WOUND (use a special medication for cuts) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZ1A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose). On 12-Mar-2021, the patient experienced BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose) and RASH PRURITIC (Itchiness of rash). On an unknown date, the patient experienced WOUND (use a special medication for cuts). At the time of the report, BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose), PERIPHERAL SWELLING (arm swelling) and RASH PRURITIC (Itchiness of rash) had not resolved and WOUND (use a special medication for cuts) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose) outcome was unknown.            Additional information: Says she has to go to hospital this upcoming Monday and will be getting anesthesia so the "doctor can look inside stomach". Says the symptoms went from arm swelling, to a bad rash of arm down to elbow which started the evening of the day she got second dose, which then spread to shoulder and the rash "spread to chest in between breasts". Feels itchy. Ongoing symptoms. "I use a special medication for cuts", cortisone.  Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-070263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070263:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; muscle pain; fever (103 F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.            Treatment information was not provided.  Concomitant product used was not provided by the reporter.   This case was linked to MOD-2021-072148 (E2B Linked Report). This case was linked to MOD-2021-025595 (Patient Link).; Sender's Comments:  MOD-2021-072148:Husband's Second Vaccine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: full body itching began; Hives on my trunk; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (full body itching began) and URTICARIA (Hives on my trunk) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2015, Anxiety since 2015, Arthritis since 2000 and Drug allergy (Allergy to Sulfa drugs). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DICLOFENAC for Arthritis, ROSUVASTATIN for Cholesterol total abnormal NOS, AMLODIPINE and HYDROCHLOROTHIAZIDE for Hypertension.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (full body itching began) and URTICARIA (Hives on my trunk). On 17-Mar-2021, PRURITUS (full body itching began) and URTICARIA (Hives on my trunk) had resolved.            Treatment information provided included Benadryl.   This case was linked to MOD-2021-015415 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and PYREXIA (99.4 degree temperature) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Asthma since an unknown date, Hypoglycemia since an unknown date, COVID-19 ("I had Covid-19 probably, in December 29,2018 when the USA didn't know anything about it") on 29-Dec-2018 and Hearing loss (Reported as "I lost my hearing in the left year and it eventually mostly returned"). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and PYREXIA (99.4 degree temperature). At the time of the report, FATIGUE (Tiredness) and PYREXIA (99.4 degree temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 degree for 2 days. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported No treatment information was provided. This case was linked to MOD-2021-072202.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches and pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of PAIN (Body aches and pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-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 PAIN (Body aches and pain). At the time of the report, PAIN (Body aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under the recommended age to receive vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine). On 19-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided, treatment medication not provided   This case was linked to MOD-2021-078863 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm; Bodyache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date, Depression since an unknown date and Anxiety since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue) had resolved.            There was no treatment  received. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-005858 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: back itching; headache behind left eye; nausea; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (back itching), HEADACHE (headache behind left eye) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (back itching), HEADACHE (headache behind left eye) and NAUSEA (nausea). At the time of the report, PRURITUS (back itching), HEADACHE (headache behind left eye) and NAUSEA (nausea) 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.   Treatment information not provided. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: lower body extremity aches; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    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.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Discomfort, Headache
Clinical narrative: weakness; Cant sleep; Discomfort; aches every place [like he has been in a fight ]; Headache; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint pain), ASTHENIA (weakness), CHILLS (Chills) and INSOMNIA (Cant sleep) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]) outcome was unknown.            concomitant medications are not provided. No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: weakness; Cant sleep; Discomfort; aches every place [like he has been in a fight ]; Headache; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint pain), ASTHENIA (weakness), CHILLS (Chills) and INSOMNIA (Cant sleep) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills), INSOMNIA (Cant sleep), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (aches every place [like he has been in a fight]) outcome was unknown.            concomitant medications are not provided. No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination site pain
Clinical narrative: the burning pain in legs; Pain at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (the burning pain in legs) and VACCINATION SITE PAIN (Pain at the site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection). On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (the burning pain in legs). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (the burning pain in legs) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-116618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 contains Reporter demographics added, Adverse Event updated, treatment information was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Weakness; Muscles hurt; Small amount of vomiting; Nausea; Chills; Fever, low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Muscles hurt), VOMITING (Small amount of vomiting), NAUSEA (Nausea) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Muscles hurt), VOMITING (Small amount of vomiting), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever, low grade fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 4 hours; IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) ongoing since an unknown date at a dose of 1 dosage form. On 09-Apr-2021, ASTHENIA (Weakness), VOMITING (Small amount of vomiting), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscles hurt) and PYREXIA (Fever, low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Transfusion: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow up does not contain any new information. On 18-Jun-2021: The follow up received on 16-JUN-2021. Event information is added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Transfusion, Vomiting
Clinical narrative: Weakness; Muscles hurt; Small amount of vomiting; Nausea; Chills; Fever, low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Muscles hurt), VOMITING (Small amount of vomiting), NAUSEA (Nausea) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ASTHENIA (Weakness), MYALGIA (Muscles hurt), VOMITING (Small amount of vomiting), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever, low grade fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 4 hours; IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form and PROMETHAZINE (PHENERGAN [PROMETHAZINE]) ongoing since an unknown date at a dose of 1 dosage form. On 09-Apr-2021, ASTHENIA (Weakness), VOMITING (Small amount of vomiting), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscles hurt) and PYREXIA (Fever, low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Transfusion: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow up does not contain any new information. On 18-Jun-2021: The follow up received on 16-JUN-2021. Event information is added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is hurting a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is hurting a little) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is hurting a little). At the time of the report, VACCINATION SITE PAIN (arm is hurting a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: feel like she wants to vomit; on and off headaches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 04-Apr-2021, the patient experienced VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches). At the time of the report, VOMITING (feel like she wants to vomit) and HEADACHE (on and off headaches) outcome was unknown.            Concomitant included Prenatal.   Treatment Tx: Tylenol.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: Swollen arm about the size of a baseball; Hot at the injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysarthria, Headache
Clinical narrative: Diarrhea; Slurred speech; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.