chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: feels weak; feels horrible; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), PREDNISONE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible). At the time of the report, ASTHENIA (feels weak) and FEELING ABNORMAL (feels horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fatigue; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 24-Feb-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Burning sensation, Chills, Depression, Fatigue
Clinical narrative: angry; depressed; slept for 36 hours; Fever; severe fatigue; Really irritable; flu symptoms; chest and thighs were burning hot to touch; body aches; chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable) and INFLUENZA (flu symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypothyroidism (Borderline Hypothyroid.T3 and T4 are normal) since 2012, Penicillin allergy and Drug allergy. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] and EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL] for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches), CHILLS (chills), ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.   This case was linked to MOD-2021-158743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: significant Follow-up received and VAERS REF ID, AE outcome, medical history, concomitant medications were added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Irritability, Pain, Pain in extremity, Pyrexia
Clinical narrative: angry; depressed; slept for 36 hours; Fever; severe fatigue; Really irritable; flu symptoms; chest and thighs were burning hot to touch; body aches; chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable) and INFLUENZA (flu symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypothyroidism (Borderline Hypothyroid.T3 and T4 are normal) since 2012, Penicillin allergy and Drug allergy. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] and EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL] for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches), CHILLS (chills), ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.   This case was linked to MOD-2021-158743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: significant Follow-up received and VAERS REF ID, AE outcome, medical history, concomitant medications were added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: angry; depressed; slept for 36 hours; Fever; severe fatigue; Really irritable; flu symptoms; chest and thighs were burning hot to touch; body aches; chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable) and INFLUENZA (flu symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypothyroidism (Borderline Hypothyroid.T3 and T4 are normal) since 2012, Penicillin allergy and Drug allergy. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] and EVENING PRIMROSE OIL [OENOTHERA BIENNIS OIL] for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), FATIGUE (severe fatigue), IRRITABILITY (Really irritable), INFLUENZA (flu symptoms), BURNING SENSATION (chest and thighs were burning hot to touch), PAIN (body aches), CHILLS (chills), ANGER (angry), DEPRESSION (depressed) and SOMNOLENCE (slept for 36 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided.   This case was linked to MOD-2021-158743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: significant Follow-up received and VAERS REF ID, AE outcome, medical history, concomitant medications were added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: extreme abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN (extreme abdominal pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 024M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE and AMLODIPINE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL PAIN (extreme abdominal pain). The patient was treated with DOMPERIDONE (PERIDIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (extreme abdominal pain) 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Lethargy, Pain
Clinical narrative: significant immune response; Lethargy; Aches; Chills; Fever for 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION (significant immune response), LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever for 101) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Nov-2020 and Neuropathy in 1995. Concomitant products included METHYLCELLULOSE (CITRUCEL) for Gastrointestinal disorder NOS, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for Osteopenia, IPRATROPIUM for Rhinitis, FISH OIL for Routine health maintenance, ESTRADIOL for Vaginal dryness.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced IMMUNISATION (significant immune response), LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills), PYREXIA (Fever for 101) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK, as necessary. On 29-Jan-2021, LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills), PYREXIA (Fever for 101) and HEADACHE (headache) had resolved. At the time of the report, IMMUNISATION (significant immune response) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics(Height, Weight, Race, Ethnicity) provided; Past medical history(Neuropathy) provided; concomitant medications provided; stop date and outcome for events provided; treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: significant immune response; Lethargy; Aches; Chills; Fever for 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION (significant immune response), LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fever for 101) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Nov-2020 and Neuropathy in 1995. Concomitant products included METHYLCELLULOSE (CITRUCEL) for Gastrointestinal disorder NOS, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for Osteopenia, IPRATROPIUM for Rhinitis, FISH OIL for Routine health maintenance, ESTRADIOL for Vaginal dryness.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced IMMUNISATION (significant immune response), LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills), PYREXIA (Fever for 101) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK, as necessary. On 29-Jan-2021, LETHARGY (Lethargy), PAIN (Aches), CHILLS (Chills), PYREXIA (Fever for 101) and HEADACHE (headache) had resolved. At the time of the report, IMMUNISATION (significant immune response) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics(Height, Weight, Race, Ethnicity) provided; Past medical history(Neuropathy) provided; concomitant medications provided; stop date and outcome for events provided; treatment information provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 01-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: bruising; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) and PAIN IN EXTREMITY (arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CONTUSION (bruising) and PAIN IN EXTREMITY (arm pain). On 08-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, CONTUSION (bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Myalgia
Clinical narrative: tired; bruising; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), MYALGIA (Soreness on arm) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CONTUSION (bruising) and MYALGIA (Soreness on arm). On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, CONTUSION (bruising), MYALGIA (Soreness on arm) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved. Not Provided          No concomitant medications were reported. No treatment information were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspepsia, Dyspnoea, Fatigue, Pruritus
Clinical narrative: heartburn; heaviness in chest.; Swelling; difficulty breathing; itchy; rash spread; very tired; Vaccination site induration; Vaccination site swelling; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn) and CHEST DISCOMFORT (heaviness in chest.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced PRURITUS (itchy), RASH (rash spread) and FATIGUE (very tired). On 07-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.) and SWELLING (Swelling). At the time of the report, DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.), SWELLING (Swelling), FATIGUE (very tired), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: heartburn; heaviness in chest.; Swelling; difficulty breathing; itchy; rash spread; very tired; Vaccination site induration; Vaccination site swelling; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn) and CHEST DISCOMFORT (heaviness in chest.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced PRURITUS (itchy), RASH (rash spread) and FATIGUE (very tired). On 07-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.) and SWELLING (Swelling). At the time of the report, DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.), SWELLING (Swelling), FATIGUE (very tired), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pruritus
Clinical narrative: Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching), HEADACHE (Headache) and FATIGUE (Tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Morphine) and Drug allergy (Allergic to Codeine). Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL+HIDROCLOROTIAZIDA), MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 26-Feb-2021, VACCINATION SITE PRURITUS (Itch at the injection site from the shoulder to the elbowon her left arm/ injection site itching) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (Tiredness) 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 are not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021 included: Added patient's demographics, Allergies (morphine and codeine), on 24-Jan-2021 patient received 1st dose (Lot# 030L20A) and on 21-FEB-2021 patient received 2nd dose (Lot# 023M20A), Concomitant medications added, The event (Injection site itching) outcome changed (from unknown to recovered on 26-FEB-2021).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: arm was sore; minor nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included QUINAPRIL for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore) and RHINORRHOEA (minor nasal drip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red patches on her skin that fade out at times and then appear again; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red patches on her skin that fade out at times and then appear again) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Allergy and Arthritis. Concomitant products included Nasal inhaler for Allergy, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Arthritis and.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (red patches on her skin that fade out at times and then appear again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Arthritis and , at an unspecified dose and frequency. At the time of the report, RASH (red patches on her skin that fade out at times and then appear again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: fuzzy head; dizzy; fogginess; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches). At the time of the report, FEELING ABNORMAL (fuzzy head), DIZZINESS (dizzy), FEELING ABNORMAL (fogginess) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on both arms and chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on both arms and chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced URTICARIA (hives on both arms and chest). At the time of the report, URTICARIA (hives on both arms and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; sore arm; bad headache; body aches; chills; Pyrexia 99-100 degree fever; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature (99-100): (Inconclusive) 99-100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-044969 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information received on 12-JUL-2021 contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Flu like symptoms; sore arm; bad headache; body aches; chills; Pyrexia 99-100 degree fever; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (sore arm), HEADACHE (bad headache), MYALGIA (body aches), CHILLS (chills) and PYREXIA (Pyrexia 99-100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature (99-100): (Inconclusive) 99-100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-044969 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up information received on 12-JUL-2021 contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: Can't move her arm from the elbow up; This spontaneous case was reported by a pharmacist and describes the occurrence of MOVEMENT DISORDER (Can't move her arm from the elbow up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MOVEMENT DISORDER (Can't move her arm from the elbow up). At the time of the report, MOVEMENT DISORDER (Can't move her arm from the elbow up) 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.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Heart rate decreased, Respiration abnormal
Clinical narrative: after sitting "it was hard to walk"; took a while for my heart to kick in/"heart was slow to kick in; respiration was a challenge; very tired/had to lie down/slept for 3 hours/legs tired easily; loss of energy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (after sitting "it was hard to walk"), HEART RATE DECREASED (took a while for my heart to kick in/"heart was slow to kick in), RESPIRATION ABNORMAL (respiration was a challenge), ASTHENIA (loss of energy) and FATIGUE (very tired/had to lie down/slept for 3 hours/legs tired easily) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Amyloidosis, Chronic heart failure, Kidney failure and Dialysis. Concurrent medical conditions included Drug allergy (allergic to NsAIDS). Concomitant products included MIDODRINE HCL and ISOSORBIDE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ASTHENIA (loss of energy). On 01-Feb-2021, the patient experienced GAIT DISTURBANCE (after sitting "it was hard to walk"), HEART RATE DECREASED (took a while for my heart to kick in/"heart was slow to kick in), RESPIRATION ABNORMAL (respiration was a challenge) and FATIGUE (very tired/had to lie down/slept for 3 hours/legs tired easily). At the time of the report, GAIT DISTURBANCE (after sitting "it was hard to walk"), HEART RATE DECREASED (took a while for my heart to kick in/"heart was slow to kick in), RESPIRATION ABNORMAL (respiration was a challenge), ASTHENIA (loss of energy) and FATIGUE (very tired/had to lie down/slept for 3 hours/legs tired easily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID19) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (COVID19). At the time of the report, COVID-19 (COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event include Lilly infusion on 5 Feb 2021.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site extravasation
Clinical narrative: there was a leakage when she received the vaccine; felt exhausted; developed a headache in and off; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine), FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included TRAMADOL, MONTELUKAST, METOPROLOL, ESCITALOPRAM, CLONAZEPAM, LEVOTHYROXINE, FOLIC ACID and ROSUVASTATIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine), FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-Jan-2021, INJECTION SITE EXTRAVASATION (there was a leakage when she received the vaccine) had resolved. On 01-Feb-2021, FATIGUE (felt exhausted) and HEADACHE (developed a headache in and off) had resolved. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 08-jul-2021contain No significant information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles on the left side of torso; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles on the left side of torso) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (developed shingles on the left side of torso). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (developed shingles on the left side of torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up was received on 21 May 2021 included reporter contact details were updated. On 29-Jun-2021: Follow-up information received on 29-Jun-2021 contains non-significant information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchiness on the injection site; Soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness on the injection site) and VACCINATION SITE PAIN (Soreness on the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness on the injection site) and VACCINATION SITE PAIN (Soreness on the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness on the injection site) and VACCINATION SITE PAIN (Soreness on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: extreme fatigue; chills; fatigue; nausea; headache; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, nausea, headache, extreme fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received second dose of mRNA-1273 (lot/batch: 029K20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) chills, fatigue, nausea, headache. On 25 Feb 2021, the patient experienced the event(s) extreme fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, nausea, headache, extreme fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: soreness; tenderness; Swelling; heat; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE WARMTH (heat) and PYREXIA (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 20-Feb-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 PAIN (soreness), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE WARMTH (heat) and PYREXIA (fever). At the time of the report, PAIN (soreness), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (Swelling), VACCINATION SITE WARMTH (heat) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Red; It felt hot; Bright rash 3inches wide by 3.5inches length; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), FEELING HOT (It felt hot) and RASH (Bright rash 3inches wide by 3.5inches length) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced ERYTHEMA (Red), FEELING HOT (It felt hot) and RASH (Bright rash 3inches wide by 3.5inches length). At the time of the report, ERYTHEMA (Red), FEELING HOT (It felt hot) and RASH (Bright rash 3inches wide by 3.5inches length) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included cephalexin (500 mg PO for 10 days).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: getting red below the injection site/ was redder; felt like it was getting pinched; itching and getting red below the injection site; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itching and getting red below the injection site), VACCINATION SITE ERYTHEMA (getting red below the injection site/ was redder) and VACCINATION SITE PAIN (felt like it was getting pinched) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching and getting red below the injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (getting red below the injection site/ was redder) and VACCINATION SITE PAIN (felt like it was getting pinched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itching and getting red below the injection site), VACCINATION SITE ERYTHEMA (getting red below the injection site/ was redder) and VACCINATION SITE PAIN (felt like it was getting pinched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Pain, Rash erythematous
Clinical narrative: Raised red rash on right breast very painful; Raised red rash on right side of back very painful; Raised red rash on right breast very painful, Raised red rash on right breast very painful; Feels very painful, Sore; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Raised red rash on right breast very painful), BACK PAIN (Raised red rash on right side of back very painful), RASH ERYTHEMATOUS (Raised red rash on right breast very painful, Raised red rash on right breast very painful) and PAIN (Feels very painful, Sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced BREAST PAIN (Raised red rash on right breast very painful), BACK PAIN (Raised red rash on right side of back very painful), RASH ERYTHEMATOUS (Raised red rash on right breast very painful, Raised red rash on right breast very painful) and PAIN (Feels very painful, Sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, BREAST PAIN (Raised red rash on right breast very painful), BACK PAIN (Raised red rash on right side of back very painful), RASH ERYTHEMATOUS (Raised red rash on right breast very painful, Raised red rash on right breast very painful) and PAIN (Feels very painful, Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up contains event details updated.; Sender's Comments: 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