chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in arm for 4 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included ATORVASTATINA [ATORVASTATIN] for Cholesterol, METFORMIN and GLIMEPIRIDE for Diabetes.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm for 4 days). On 20-Jan-2021, PAIN IN EXTREMITY (Severe pain in arm for 4 days) had 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.   Tylenol used as a Treatment medication, did not help. Concomitant medication was not provided.   This case was linked to MOD-2021-023604, MOD-2021-023581 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient doing fine and declined for further follow up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio fluctuation
Clinical narrative: INR has been fluctuating; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32L20A) for COVID-19 vaccination.     Concurrent medical conditions included Coronary artery disease. Concomitant products included blood thinners and medication for coronary artery diseases for an unknown indication.    On 05-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 INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating). At the time of the report, INTERNATIONAL NORMALISED RATIO FLUCTUATION (INR has been fluctuating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: feels a bit achy in his arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (feels a bit achy in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-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 PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PAIN (feels a bit achy in his arm). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PAIN (feels a bit achy in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia
Clinical narrative: metal taste; no taste; no smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metal taste), AGEUSIA (no taste) and ANOSMIA (no smell) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer. Concomitant products included PANCREATIN (CREON), LOSARTAN POTASSIUM (COZAAR) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DYSGEUSIA (metal taste), AGEUSIA (no taste) and ANOSMIA (no smell). At the time of the report, DYSGEUSIA (metal taste) had resolved and AGEUSIA (no taste) and ANOSMIA (no smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Treponema test
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 36-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperemesis (in 1st trimester), Induced abortion and Alcohol use (1 drink per month) in March 2020. Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Allergy to nuts and Asthma (Worsened in last 5 years) since 1992. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and MONTELUKAST SODIUM (SINGULAIR) for Asthma, DOCUSATE SODIUM (COLACE) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 18-Jun-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 18-Jun-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2020, Pregnancy test: positive (Positive) positive. On 07-Dec-2020, Glucose tolerance test: normal (normal) on borderline. On 17-Feb-2021, Full blood count: normal (normal) normal. On 17-Feb-2021, Treponema test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (diagnosed with covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid). At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Lesions over body month after vaccine series; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BLISTER (Lesions over body month after vaccine series) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 0111J20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 1998. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for Migraine.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BLISTER (Lesions over body month after vaccine series). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and Manual therapy (high dose Prednisone x 7 days, 20mg daily.) for Blister. In March 2021, BLISTER (Lesions over body month after vaccine series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-111413 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: NNI On 06-May-2021: Patient demographics, medical history and concomitant medications were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-111413:Same reporter
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: blisters; pain (due to shingles); This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (pain (due to shingles)) and BLISTER (blisters) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Heart attack.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced HERPES ZOSTER (pain (due to shingles)). On 22-Feb-2021, the patient experienced BLISTER (blisters). At the time of the report, HERPES ZOSTER (pain (due to shingles)) and BLISTER (blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Sleep deficit, Vaccination site pain
Clinical narrative: Could not get comfortable due to arm pain; Did not sleep well; Pain at the injection site; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided.Treatment information was not provided. Action taken with the drug in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received. Added new AE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash pruritic, Type IV hypersensitivity reaction, Vaccination site erythema
Clinical narrative: rash that was itchy; large red ring about 2 inches in size at the area; delayed allergic reaction; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm). At the time of the report, RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: started to experience a burning sensation as he urinated and now he has a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 032l20a) for COVID-19 vaccination.     Concurrent medical conditions included UTI and Bladder cancer. Concomitant products included MONTELUKAST, OMEPRAZOLE (OMEPRAZOL 1 A PHARMA), ROSUVASTATIN CALCIUM (CRESTOR) and Presidon for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI). At the time of the report, URINARY TRACT INFECTION (started to experience a burning sensation as he urinated and now he has a UTI) outcome was unknown.            No treatment details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional info-1
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Diarrhoea, Limb discomfort
Clinical narrative: soft bowel; foot has been bothering really bad; joint achiness; blood pressure up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (soft bowel), LIMB DISCOMFORT (foot has been bothering really bad), BLOOD PRESSURE INCREASED (blood pressure up) and ARTHRALGIA (joint achiness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure since 23-Jan-2021.    On 27-Jan-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 BLOOD PRESSURE INCREASED (blood pressure up). On an unknown date, the patient experienced DIARRHOEA (soft bowel), LIMB DISCOMFORT (foot has been bothering really bad) and ARTHRALGIA (joint achiness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (soft bowel), LIMB DISCOMFORT (foot has been bothering really bad), BLOOD PRESSURE INCREASED (blood pressure up) and ARTHRALGIA (joint achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment details was reported as PEPTO (NOS).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: No new medical information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: wants to be registered in teh Moderna pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-May-2021. On 20-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry). On 20-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (wants to be registered in teh Moderna pregnancy registry) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not reported.  No treatment information was provided .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever; body aches; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills). At the time of the report, PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus
Clinical narrative: body ache; fatigue; Lot of itching (mainly in the eyes, throat and face); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)). At the time of the report, PAIN (body ache), FATIGUE (fatigue) and PRURITUS (Lot of itching (mainly in the eyes, throat and face)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: experienced pain for only 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (experienced pain for only 2 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (experienced pain for only 2 days). At the time of the report, PAIN (experienced pain for only 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: headache; fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired). At the time of the report, HEADACHE (headache), PYREXIA (fever) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Minor fever; Blurred vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred vision) and PYREXIA (Minor fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for an unknown indication.     Concurrent medical conditions included Macular degeneration.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VISION BLURRED (Blurred vision). On an unknown date, the patient experienced PYREXIA (Minor fever). At the time of the report, VISION BLURRED (Blurred vision) and PYREXIA (Minor fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Influenza
Clinical narrative: 103 fever for 24 hours; chills; very tired; no energy; nausea; achy muscles; it felt like the flu; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy) and NAUSEA (nausea) in a 61-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 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). On 18-Feb-2021, the patient experienced PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea), PAIN (achy muscles) and INFLUENZA (it felt like the flu). On 19-Feb-2021, PYREXIA (103 fever for 24 hours) had resolved. On 22-Feb-2021, FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea) and PAIN (achy muscles) had resolved. At the time of the report, CHILLS (chills), PAIN IN EXTREMITY (a sore arm) and INFLUENZA (it felt like the flu) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 103 (High) she had a 103 fever for 24 hours..
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: 103 fever for 24 hours; chills; very tired; no energy; nausea; achy muscles; it felt like the flu; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy) and NAUSEA (nausea) in a 61-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 18-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). On 18-Feb-2021, the patient experienced PYREXIA (103 fever for 24 hours), CHILLS (chills), FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea), PAIN (achy muscles) and INFLUENZA (it felt like the flu). On 19-Feb-2021, PYREXIA (103 fever for 24 hours) had resolved. On 22-Feb-2021, FATIGUE (very tired), ASTHENIA (no energy), NAUSEA (nausea) and PAIN (achy muscles) had resolved. At the time of the report, CHILLS (chills), PAIN IN EXTREMITY (a sore arm) and INFLUENZA (it felt like the flu) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 103 (High) she had a 103 fever for 24 hours..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biliary colic, Chills, Fatigue, Headache
Clinical narrative: sharp pains near gall bladder; Sore arm; cold like symptoms; congestion; Body ache; chills; nausea; joint hurt; fatigue; Fever; Sharp pains in right lower side of head towards the bottom of scalp; This spontaneous case was reported by a patient and describes the occurrence of BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion) and MYALGIA (Body ache) in a 68-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.     The patient's past medical history included Gallbladder infection (sepsis).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue), PYREXIA (Fever) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp). On 30-Jan-2021, PYREXIA (Fever) had resolved. On 01-Feb-2021, BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Tylenol (acetaminophen) for sharp pains.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: sharp pains near gall bladder; Sore arm; cold like symptoms; congestion; Body ache; chills; nausea; joint hurt; fatigue; Fever; Sharp pains in right lower side of head towards the bottom of scalp; This spontaneous case was reported by a patient and describes the occurrence of BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion) and MYALGIA (Body ache) in a 68-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.     The patient's past medical history included Gallbladder infection (sepsis).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue), PYREXIA (Fever) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp). On 30-Jan-2021, PYREXIA (Fever) had resolved. On 01-Feb-2021, BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Tylenol (acetaminophen) for sharp pains.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sharp pains near gall bladder; Sore arm; cold like symptoms; congestion; Body ache; chills; nausea; joint hurt; fatigue; Fever; Sharp pains in right lower side of head towards the bottom of scalp; This spontaneous case was reported by a patient and describes the occurrence of BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion) and MYALGIA (Body ache) in a 68-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.     The patient's past medical history included Gallbladder infection (sepsis).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue), PYREXIA (Fever) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp). On 30-Jan-2021, PYREXIA (Fever) had resolved. On 01-Feb-2021, BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Tylenol (acetaminophen) for sharp pains.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Paraesthesia oral
Clinical narrative: dry mouth; tingling lips; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips). At the time of the report, DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history information was provided. No concomitant medications were reported No treatment details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No follow-up information provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 007M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical histor). Concomitant products included VITAMIN 15, CINNAMON [CINNAMOMUM VERUM], TIMOLOL and MAGNESIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Nausea, Vomiting
Clinical narrative: head was foggy; Throwing Up; So Nauseas; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache). On 01-Mar-2021, FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Updated contact number, concurrent medical condition, concomitant medication, added  new events, outcome of the event changed from unknown to recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chills, Decreased appetite, Electrocardiogram
Clinical narrative: chest pain; no hungry; no energy; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever). The patient was treated with MORPHINE at a dose of UNK, bid. At the time of the report, CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No Medical History information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI On 11-May-2021: TCR added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: chest pain; no hungry; no energy; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever). The patient was treated with MORPHINE at a dose of UNK, bid. At the time of the report, CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No Medical History information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI On 11-May-2021: TCR added
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Vaccination site pain, Vaccination site rash
Clinical narrative: She felt the vaccine go down her arm; Rash around 3 inches down from the injection site; Vaccine really hurt; A spontaneous report was received from a consumer concerning 75 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 042L20A) intramuscularly and on 23 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 023M20A)  in for prophylaxis of COVID-19 infection.  On 23 Feb 2021, after the second vaccination, the patient said it really hurt. She stated that the first person who did her vaccine shot, made the injection painless. She was concerned that the person who did the second vaccine dose, did not do the shot properly. She reported that she felt the vaccine go down her arm. She developed a rash around three inches down from the injection site and that was where she felt the vaccine in her skin.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s), therefore action taken with the drug in response to the events is not applicable.  The outcome of the events of felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt was unknown.   The reporter did not provide an assessment for the events felt the vaccine go down her arm,, rash around 3 inches down from the injection site and vaccine really hurt; Reporter's Comments: This report refers to a case of exposure via skin contact mRNA-1273 (lot # unknown)  with associated AEs reported as injection site rash and injection site pain.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Thyroid mass
Clinical narrative: Mass on the right side of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THYROID MASS (Mass on the right side of the neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L80A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021 at 7:00 PM, the patient experienced THYROID MASS (Mass on the right side of the neck). On 18-Jan-2021, THYROID MASS (Mass on the right side of the neck) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Thyroid function lab: unremarkable Unremarkable. On 05-Jan-2021, thyroid ultrasound: ultrasound evaluation of the thyroid was performed Multiple bilateral thyroid cysts, the largest being over 2 cm in diameter on the right side. On 18-Jan-2021, Diagnostic aspiration: thyroid, right Negative for malignant cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was provided  Prior to this vaccine, the patient had no history of thyroid nodules or issues related to thyroid. Patient had never been diagnosed with / tested positive for COVID-19. Action taken with mRNA-1273 in response to the event was not applicable.  Patient saw physician on 04 Jan 2021. Residual effects were reported as thyroid nodules. Patient has to have continued surveillance thyroid ultrasounds to monitor the size of the other nodules.   This case was linked to MOD-2021-166820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: VAER form received; additional event details provided; patient date of birth and age provided; diagnostic results provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: Chills; Body ache; Fever; Horseness in voice; Rash on the arm; A little swelling on the arm; Feels as if had  a cold; Congestion and runny nose; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice) and RASH (Rash on the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice), RASH (Rash on the arm), PERIPHERAL SWELLING (A little swelling on the arm), NASOPHARYNGITIS (Feels as if had  a cold), NASAL CONGESTION (Congestion and runny nose) and RHINORRHOEA (Runny nose). At the time of the report, CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice), RASH (Rash on the arm), PERIPHERAL SWELLING (A little swelling on the arm), NASOPHARYNGITIS (Feels as if had  a cold), NASAL CONGESTION (Congestion and runny nose) and RHINORRHOEA (Runny nose) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-023378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received as TCR on 11/5/21. Follow-up contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Chills; Body ache; Fever; Horseness in voice; Rash on the arm; A little swelling on the arm; Feels as if had  a cold; Congestion and runny nose; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice) and RASH (Rash on the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice), RASH (Rash on the arm), PERIPHERAL SWELLING (A little swelling on the arm), NASOPHARYNGITIS (Feels as if had  a cold), NASAL CONGESTION (Congestion and runny nose) and RHINORRHOEA (Runny nose). At the time of the report, CHILLS (Chills), PAIN (Body ache), PYREXIA (Fever), DYSPHONIA (Horseness in voice), RASH (Rash on the arm), PERIPHERAL SWELLING (A little swelling on the arm), NASOPHARYNGITIS (Feels as if had  a cold), NASAL CONGESTION (Congestion and runny nose) and RHINORRHOEA (Runny nose) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-023378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received as TCR on 11/5/21. Follow-up contains no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash, Rash pruritic
Clinical narrative: Dry skin; itchy (rash); Rash on back; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin), RASH PRURITIC (itchy (rash)) and RASH (Rash on back) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 25-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DRY SKIN (Dry skin), RASH PRURITIC (itchy (rash)) and RASH (Rash on back). At the time of the report, DRY SKIN (Dry skin), RASH PRURITIC (itchy (rash)) and RASH (Rash on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact