chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Urticaria, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Whole body hives), VACCINATION SITE PAIN (Tender injection site), VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue). On 20-Mar-2021, the patient experienced URTICARIA (Whole body hives). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender injection site). The patient was treated with MONTELUKAST at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Mar-2021, VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue) had resolved. On 21-Mar-2021, URTICARIA (Whole body hives) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Body sore; Fatigue; Joint sore; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache). At the time of the report, PAIN (Body sore), FATIGUE (Fatigue), ARTHRALGIA (Joint sore) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information included non significant information. Patient was doing fine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 0120M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Sore arm). On 16-Jan-2021, MYALGIA (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-058884 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: She had called to notify about the Temperature excursion of one of her shipments; A spontaneous report  was received from a  Physician concerning (no patient identifier) Moderna's COVID-19 vaccine (mRNA-1273) temperature excursion of one of the shipments/ product storage error.   The patient's medical history was not provided.  Concomitant medications was not reported.  On an unknown date, the event temperature excursion of one of the shipments occurred. The whole carton was stored at -16 F from 9am to 4 pm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, temperature excursion of one of the shipments/ product storage error was considered resolved. on an unknown date.     .; Sender's Comments: This report refers to a case of Product storage error, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia, Rhinorrhoea
Clinical narrative: Cough; Runny nose; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Erythema, Fatigue, Feeling hot
Clinical narrative: Swelling arm; Red; Hot; Pain; Muscle ache; Headache; Nausea; Exhausted; Tremors in hands; Tremors in head; Diarrhea; Dizziness; Pain in both lower lung lobes; Shooting pain on torse/shooting pains left leg; Intense burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Intense burning). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg). On 04-Mar-2021, the patient experienced TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot) and PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PAIN (Intense burning) had resolved. At the time of the report, PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot), PAIN (Pain), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Head titubation, Headache, Myalgia, Nausea, Pain
Clinical narrative: Swelling arm; Red; Hot; Pain; Muscle ache; Headache; Nausea; Exhausted; Tremors in hands; Tremors in head; Diarrhea; Dizziness; Pain in both lower lung lobes; Shooting pain on torse/shooting pains left leg; Intense burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Intense burning). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg). On 04-Mar-2021, the patient experienced TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot) and PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PAIN (Intense burning) had resolved. At the time of the report, PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot), PAIN (Pain), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary pain, Tremor, Vaccination site pain
Clinical narrative: Swelling arm; Red; Hot; Pain; Muscle ache; Headache; Nausea; Exhausted; Tremors in hands; Tremors in head; Diarrhea; Dizziness; Pain in both lower lung lobes; Shooting pain on torse/shooting pains left leg; Intense burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Intense burning). On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg). On 04-Mar-2021, the patient experienced TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot) and PAIN (Pain). On 01-Mar-2021, VACCINATION SITE PAIN (Intense burning) had resolved. At the time of the report, PAIN IN EXTREMITY (Shooting pain on torse/shooting pains left leg), TREMOR (Tremors in hands), HEAD TITUBATION (Tremors in head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PULMONARY PAIN (Pain in both lower lung lobes), PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Red), FEELING HOT (Hot), PAIN (Pain), MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches fever of 100.6°F and chills; Body aches fever of 100.6°F and chills; Chills; Her hand started to hurt; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Her hand started to hurt), PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Patient on hypertensive medicines.) since an unknown date and Cholesterol (Patient is taking medicines for cholesterol.) since an unknown date. Concomitant products included OMEPRAZOLE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her hand started to hurt). On 24-Mar-2021, the patient experienced PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Her hand started to hurt), PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills) 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Vaccination site erythema
Clinical narrative: Injection site felt hot; Swelling at the injection site; Injection site was red and spread down her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunisation.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm). At the time of the report, INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an invalid dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 22-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose). On 22-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031M20A)  with no associated AEs.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: coughing; fever 100.0; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (coughing), PYREXIA (fever 100.0) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced COUGH (coughing), PYREXIA (fever 100.0) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing), PYREXIA (fever 100.0) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity, Skin irritation
Clinical narrative: delayed irritation at injection site; sore arm; delayed itchy at injection site; delayed red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (delayed irritation at injection site), PAIN IN EXTREMITY (sore arm), INJECTION SITE PRURITUS (delayed itchy at injection site) and INJECTION SITE ERYTHEMA (delayed red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (delayed irritation at injection site), PAIN IN EXTREMITY (sore arm), INJECTION SITE PRURITUS (delayed itchy at injection site) and INJECTION SITE ERYTHEMA (delayed red at injection site). At the time of the report, SKIN IRRITATION (delayed irritation at injection site), INJECTION SITE PRURITUS (delayed itchy at injection site) and INJECTION SITE ERYTHEMA (delayed red at injection site) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dry throat, Flushing, Hypertension, Malaise
Clinical narrative: blood pressure went up again; feeling unwell; face got warm; throat felt dry; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell), FLUSHING (face got warm), DRY THROAT (throat felt dry) and HYPERTENSION (blood pressure went up again) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (feeling unwell), FLUSHING (face got warm) and DRY THROAT (throat felt dry). On 24-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up again). On 23-Mar-2021, MALAISE (feeling unwell), FLUSHING (face got warm) and DRY THROAT (throat felt dry) had resolved. On 24-Mar-2021, HYPERTENSION (blood pressure went up again) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: 150/100 mmHg High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-120821, MOD-2021-120821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on (11-MAY-2021) Reporter information, dose details and events updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: chills (couldn't get warm); fever (101-102F).; Body hurt really bad,; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21P or R or D) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated). At the time of the report, CHILLS (chills (couldn't get warm)), PYREXIA (fever (101-102F).), PAIN (Body hurt really bad,) and NAUSEA (nauseated) outcome was unknown. Not Provided    Treatment information was provided i.e., Tylenol   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Sinusitis
Clinical narrative: nose being plugged; runny nose; sinus infection; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (nose being plugged), RHINORRHOEA (runny nose) and SINUSITIS (sinus infection) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. In March 2021, the patient experienced NASAL CONGESTION (nose being plugged), RHINORRHOEA (runny nose) and SINUSITIS (sinus infection). At the time of the report, NASAL CONGESTION (nose being plugged), RHINORRHOEA (runny nose) and SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details reported : amoxicillin   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Tenderness
Clinical narrative: arm was tender; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) and TENDERNESS (arm was tender) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included 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] and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-May-2021. On 19-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On an unknown date, the patient experienced TENDERNESS (arm was tender). On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. At the time of the report, TENDERNESS (arm was tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicines include blood thinner medications called Lenovax, prenatal vitamins  treatment medicines were not reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm red). At the time of the report, ERYTHEMA (arm red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (on her right arm, it swelled up, it got red, it had a rash on it), INJECTION SITE ERYTHEMA (on her right arm, it swelled up, it got red, it had a rash on it) and INJECTION SITE RASH (on her right arm, it swelled up, it got red, it had a rash on it) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Benadryl cream is the other treatment medication reported by reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Numbness in lips; Tongue tingling; Lips became swollen and tingling; Lips tingling/tingling in lips has not completely resolved; Tongue became swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved), SWOLLEN TONGUE (Tongue became swollen), HYPOAESTHESIA ORAL (Numbness in lips) and PARAESTHESIA ORAL (Tongue tingling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved), SWOLLEN TONGUE (Tongue became swollen) and PARAESTHESIA ORAL (Tongue tingling). On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numbness in lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, SWOLLEN TONGUE (Tongue became swollen) and PARAESTHESIA ORAL (Tongue tingling) had resolved. At the time of the report, LIP SWELLING (Lips became swollen and tingling), PARAESTHESIA ORAL (Lips tingling/tingling in lips has not completely resolved) and HYPOAESTHESIA ORAL (Numbness in lips) 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up was received on 12-MAY-2021. Additional event- numb lips was added and events- tingling lips outcome was updated to not recovered/resolved. Reporter's email was added and address was updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia, Oral disorder, Pain
Clinical narrative: pain in the back of the knee going down to the calf; bump in the mouth; painful to touch; dull, sharp pain like a nerve thing; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (bump in the mouth), PAIN (painful to touch), NEURALGIA (dull, sharp pain like a nerve thing) and ARTHRALGIA (pain in the back of the knee going down to the calf) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ORAL DISORDER (bump in the mouth), PAIN (painful to touch) and NEURALGIA (dull, sharp pain like a nerve thing). On 22-Mar-2021, the patient experienced ARTHRALGIA (pain in the back of the knee going down to the calf). At the time of the report, ORAL DISORDER (bump in the mouth), PAIN (painful to touch), NEURALGIA (dull, sharp pain like a nerve thing) and ARTHRALGIA (pain in the back of the knee going down to the calf) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Vaccination site erythema, Vaccination site induration
Clinical narrative: Arm hot skin; Arm hard; Her arm got sore; Big red circle on arm; Nauseous; Dizzy; Had a hard time breathing/could not catch her breath; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath), VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard) and VACCINATION SITE PAIN (Arm was sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm). On 19-Mar-2021, DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included ice pack application.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU :Updated events outcome
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm hot skin; Arm hard; Her arm got sore; Big red circle on arm; Nauseous; Dizzy; Had a hard time breathing/could not catch her breath; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath), VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard) and VACCINATION SITE PAIN (Arm was sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm). On 19-Mar-2021, DIZZINESS (Dizzy), DYSPNOEA (Had a hard time breathing/could not catch her breath) and NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm hot skin), VACCINATION SITE INDURATION (Arm hard), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE PAIN (Her arm got sore) and VACCINATION SITE ERYTHEMA (Big red circle on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included ice pack application.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU :Updated events outcome
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches from her left arm to her chest, 2 inches below her neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FAMOTIDINE (PEPCID AC), BUDESONIDE and IBUPROFEN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck). On 10-Mar-2021, MYALGIA (Muscle aches from her left arm to her chest, 2 inches below her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received second dose on 24 Mar 2021 (Batch number: 017621a) in left dominate arm . Patient did not report any adverse reaction after the second dose of vaccination. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up was received on 24-May-2021 and contains non-significant information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Illness, Pain in extremity, Peripheral swelling
Clinical narrative: Worried about getting the same or worse side effect for the 2nd dose; Vomiting; Diarrhea; Really sick; Swollen arm; Sore arm/Painful arm; Area below injection site was a little lumpy; Area below injection site very hot; Area below injection site was really red; Area below injection site very sore; Hives; Arm hurting; Black and blue injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea) and ILLNESS (Really sick) in a 67-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE DISCOLOURATION (Black and blue injection site). On 18-Mar-2021, the patient experienced URTICARIA (Hives), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Really sick) and VOMITING (Vomiting). On 24-Mar-2021, the patient experienced ANXIETY (Worried about getting the same or worse side effect for the 2nd dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CEFALEXIN at a dose of 500 mg. At the time of the report, URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea), ILLNESS (Really sick), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE DISCOLOURATION (Black and blue injection site), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site discolouration, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Worried about getting the same or worse side effect for the 2nd dose; Vomiting; Diarrhea; Really sick; Swollen arm; Sore arm/Painful arm; Area below injection site was a little lumpy; Area below injection site very hot; Area below injection site was really red; Area below injection site very sore; Hives; Arm hurting; Black and blue injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea) and ILLNESS (Really sick) in a 67-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE DISCOLOURATION (Black and blue injection site). On 18-Mar-2021, the patient experienced URTICARIA (Hives), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Really sick) and VOMITING (Vomiting). On 24-Mar-2021, the patient experienced ANXIETY (Worried about getting the same or worse side effect for the 2nd dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CEFALEXIN at a dose of 500 mg. At the time of the report, URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea), ILLNESS (Really sick), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE DISCOLOURATION (Black and blue injection site), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Worried about getting the same or worse side effect for the 2nd dose; Vomiting; Diarrhea; Really sick; Swollen arm; Sore arm/Painful arm; Area below injection site was a little lumpy; Area below injection site very hot; Area below injection site was really red; Area below injection site very sore; Hives; Arm hurting; Black and blue injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea) and ILLNESS (Really sick) in a 67-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting) and VACCINATION SITE DISCOLOURATION (Black and blue injection site). On 18-Mar-2021, the patient experienced URTICARIA (Hives), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Really sick) and VOMITING (Vomiting). On 24-Mar-2021, the patient experienced ANXIETY (Worried about getting the same or worse side effect for the 2nd dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CEFALEXIN at a dose of 500 mg. At the time of the report, URTICARIA (Hives), ANXIETY (Worried about getting the same or worse side effect for the 2nd dose), PAIN IN EXTREMITY (Arm hurting), DIARRHOEA (Diarrhea), ILLNESS (Really sick), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Sore arm/Painful arm), VACCINATION SITE DISCOLOURATION (Black and blue injection site), VACCINATION SITE MASS (Area below injection site was a little lumpy), VACCINATION SITE WARMTH (Area below injection site very hot), VACCINATION SITE ERYTHEMA (Area below injection site was really red) and VACCINATION SITE PAIN (Area below injection site very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (  in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (). At the time of the report, TINNITUS  outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.