chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: fast heartbeat; pains in her upper chest; seriously ill; dizziness; weakness; pain in her legs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs). At the time of the report, PALPITATIONS (fast heartbeat), NON-CARDIAC CHEST PAIN (pains in her upper chest), ILLNESS (seriously ill), DIZZINESS (dizziness), ASTHENIA (weakness) and PAIN IN EXTREMITY (pain in her legs) outcome was unknown.            No relevant concomitant medications were reported. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received: Second dose and hospitalization reported via email to be reported with Dose 2
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Insomnia, Nausea
Clinical narrative: Weak; Chills; Feeling nauseous; Headache; Injection site area was sore; Couldnot sleep; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Couldnot sleep), ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous) and HEADACHE (Headache) 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 25-Jan-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INSOMNIA (Couldnot sleep) and VACCINATION SITE PAIN (Injection site area was sore). On 26-Jan-2021 at 2:00 AM, the patient experienced ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous) and HEADACHE (Headache). On 27-Jan-2021, INSOMNIA (Couldnot sleep), ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site area was sore) had resolved.            Treatment and concomitant medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Weak; Chills; Feeling nauseous; Headache; Injection site area was sore; Couldnot sleep; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Couldnot sleep), ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous) and HEADACHE (Headache) 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 25-Jan-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INSOMNIA (Couldnot sleep) and VACCINATION SITE PAIN (Injection site area was sore). On 26-Jan-2021 at 2:00 AM, the patient experienced ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous) and HEADACHE (Headache). On 27-Jan-2021, INSOMNIA (Couldnot sleep), ASTHENIA (Weak), CHILLS (Chills), NAUSEA (Feeling nauseous), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site area was sore) had resolved.            Treatment and concomitant medications were not provided by reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems) and FATIGUE (felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lymph node dissection (She had some lymph nodes on her right arm removed about 40 years ago.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen). On 25-Jan-2021, PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point) and PRURITUS (Right arm was itchy up to two inches below the injection point) had resolved. At the time of the report, ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Voltaren and heat application.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems) and FATIGUE (felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lymph node dissection (She had some lymph nodes on her right arm removed about 40 years ago.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point), PRURITUS (Right arm was itchy up to two inches below the injection point), ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen). On 25-Jan-2021, PAIN IN EXTREMITY (Right arm was sore, up to two inches below the injection point), ERYTHEMA (Right arm was red, up to two inches below the injection point) and PRURITUS (Right arm was itchy up to two inches below the injection point) had resolved. At the time of the report, ARTHRALGIA (Joint problems), FATIGUE (felt tired) and LYMPHADENOPATHY (Lymph nodes in the neck were also swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Voltaren and heat application.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Malaise, Oral discomfort, Pain
Clinical narrative: Tongue and lips are burning; The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg); She is achy; She is not feeling that well; She is having chills; Eyes were burning like when you have a reaction to the chlorine of the pool; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool), ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy) and MALAISE (She is not feeling that well) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer 3 times, nowokay), Kidney absent since an unknown date, Blood pressure high since an unknown date and Vertigo since an unknown date.    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 EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool). On 28-Jan-2021, the patient experienced ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills). On 27-Jan-2021, EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool) had resolved. At the time of the report, ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication mentioned something for the thyroid and something for the blood pressure NOS. Treatment information mentioned Benadryl.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tongue and lips are burning; The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg); She is achy; She is not feeling that well; She is having chills; Eyes were burning like when you have a reaction to the chlorine of the pool; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool), ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy) and MALAISE (She is not feeling that well) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer 3 times, nowokay), Kidney absent since an unknown date, Blood pressure high since an unknown date and Vertigo since an unknown date.    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 EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool). On 28-Jan-2021, the patient experienced ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills). On 27-Jan-2021, EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool) had resolved. At the time of the report, ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication mentioned something for the thyroid and something for the blood pressure NOS. Treatment information mentioned Benadryl.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Itchy; Hot to the touch; Pain in my upper arm; Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of topical cream; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy), FEELING HOT (Hot to the touch), PAIN IN EXTREMITY (Pain in my upper arm) and ERYTHEMA (Red raised skin/  It was 3.5 inches at the longest point and 2.5 inches at the next biggest point, and at the thinnest point it was 1 inch and 5/8ths) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: I was calling to get on the pregnancy something list; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (I was calling to get on the pregnancy something list) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (I was calling to get on the pregnancy something list). At the time of the report, PREGNANCY (I was calling to get on the pregnancy something list) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during expected pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer 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 reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: upset stomach; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase increased: 569 (High) 569. On an unknown date, Aspartate aminotransferase increased: 526 (High) 526.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: High fever; Chills; Queasiness; Malaise; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (High fever), CHILLS (Chills), NAUSEA (Queasiness), MALAISE (Malaise) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever), CHILLS (Chills), NAUSEA (Queasiness), MALAISE (Malaise) and FATIGUE (Fatigue). At the time of the report, PYREXIA (High fever), CHILLS (Chills), NAUSEA (Queasiness), MALAISE (Malaise) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Pain in extremity
Clinical narrative: Still a little exhausted; awful taste in mouth/taste in her mouth like she was eating steel; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (Still a little exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CHLORTALIDONE 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 05-Feb-2021, the patient experienced DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel) and PAIN IN EXTREMITY (soreness in arm). On 06-Feb-2021, the patient experienced FATIGUE (Still a little exhausted). At the time of the report, DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (Still a little exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported to be taken by the patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: large Itchy rash; developed a large Itchy red rash on Left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (large Itchy rash) and RASH ERYTHEMATOUS (developed a large Itchy red rash on Left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH PRURITIC (large Itchy rash) and RASH ERYTHEMATOUS (developed a large Itchy red rash on Left arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (large Itchy rash) and RASH ERYTHEMATOUS (developed a large Itchy red rash on Left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Ice, Benadryl cream.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Lip swelling, Paraesthesia, Rash pruritic
Clinical narrative: Tingling; Wheezing; Hives; the area around the injection site itchy; the area around the injection site red; he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild; itchiness on his tongue and a rash, which he describes as "nothing serious all mild; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild), RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild), PARAESTHESIA (Tingling), WHEEZING (Wheezing) and URTICARIA (Hives) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (widespread rash), Drug allergy (wide spread rash), Hypertension, Gout and Chronic kidney disease. Concomitant products included LISINOPRIL and ALLOPURINOL for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild) and RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild). On 27-Jan-2021, the patient experienced INJECTION SITE PRURITUS (the area around the injection site itchy) and INJECTION SITE ERYTHEMA (the area around the injection site red). On an unknown date, the patient experienced PARAESTHESIA (Tingling), WHEEZING (Wheezing) and URTICARIA (Hives). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) (oral) 19-Jan-2021 at a dose of 1 dosage form; CORTISONE at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Jan-2021, LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild) and RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild) had resolved. At the time of the report, PARAESTHESIA (Tingling), WHEEZING (Wheezing), URTICARIA (Hives), INJECTION SITE PRURITUS (the area around the injection site itchy) and INJECTION SITE ERYTHEMA (the area around the injection site red) outcome was unknown.            Concomitant medications reported was provided as Blood pressure medications and Gout medications. Treatment medication also included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Correspondence email attached- Information of second dose like batch no. added
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Tingling; Wheezing; Hives; the area around the injection site itchy; the area around the injection site red; he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild; itchiness on his tongue and a rash, which he describes as "nothing serious all mild; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild), RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild), PARAESTHESIA (Tingling), WHEEZING (Wheezing) and URTICARIA (Hives) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (widespread rash), Drug allergy (wide spread rash), Hypertension, Gout and Chronic kidney disease. Concomitant products included LISINOPRIL and ALLOPURINOL for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild) and RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild). On 27-Jan-2021, the patient experienced INJECTION SITE PRURITUS (the area around the injection site itchy) and INJECTION SITE ERYTHEMA (the area around the injection site red). On an unknown date, the patient experienced PARAESTHESIA (Tingling), WHEEZING (Wheezing) and URTICARIA (Hives). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) (oral) 19-Jan-2021 at a dose of 1 dosage form; CORTISONE at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Jan-2021, LIP SWELLING (he felt puffy lips, a itchiness on his tongue and a rash, which he describes as "nothing serious all mild) and RASH PRURITIC ( itchiness on his tongue and a rash, which he describes as "nothing serious all mild) had resolved. At the time of the report, PARAESTHESIA (Tingling), WHEEZING (Wheezing), URTICARIA (Hives), INJECTION SITE PRURITUS (the area around the injection site itchy) and INJECTION SITE ERYTHEMA (the area around the injection site red) outcome was unknown.            Concomitant medications reported was provided as Blood pressure medications and Gout medications. Treatment medication also included antihistamines.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Correspondence email attached- Information of second dose like batch no. added
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Baseball size bump; Itchy bump for 3-4 days and went away; Redness at injection site, red bump; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Baseball size bump), VACCINATION SITE PRURITUS (Itchy bump for 3-4 days and went away), VACCINATION SITE ERYTHEMA (Redness at injection site, red bump) and VACCINATION SITE PAIN (Soreness at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE MASS (Baseball size bump), VACCINATION SITE PRURITUS (Itchy bump for 3-4 days and went away), VACCINATION SITE ERYTHEMA (Redness at injection site, red bump) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE MASS (Baseball size bump), VACCINATION SITE PRURITUS (Itchy bump for 3-4 days and went away), VACCINATION SITE ERYTHEMA (Redness at injection site, red bump) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (SHINGLES) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (SHINGLES). At the time of the report, HERPES ZOSTER (SHINGLES) 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.   No relevant concomitant medications were reported. Treatment details not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No Follow up document attached
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Pain on the back of his legs; Burning Sensation on the back of his legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs). At the time of the report, PAIN IN EXTREMITY (Pain on the back of his legs) and BURNING SENSATION (Burning Sensation on the back of his legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itchy arms (and itches that did not go away yet); redness of 7 inches by 4 inches of size , hotness and swelling at the injection site; redness of 7 inches by 4 inches of size , hotness and swelling at the injection site; redness of 7 inches by 4 inches of size , hotness and swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arms (and itches that did not go away yet)), VACCINATION SITE WARMTH (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site), VACCINATION SITE ERYTHEMA (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site) and VACCINATION SITE SWELLING (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchy arms (and itches that did not go away yet)), VACCINATION SITE WARMTH (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site), VACCINATION SITE ERYTHEMA (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site) and VACCINATION SITE SWELLING (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site). At the time of the report, PRURITUS (itchy arms (and itches that did not go away yet)), VACCINATION SITE WARMTH (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site), VACCINATION SITE ERYTHEMA (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site) and VACCINATION SITE SWELLING (redness of 7 inches by 4 inches of size , hotness and swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. On follow up it was reported that the patient felt fine and did not have any reaction.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: TCR : AE outcome
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) 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 06-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: On 29-JUL-2021, A follow up received where Outcome of event was updated from unknown to ongoing/Not recovered and reporter's demographics was added.; Sender's Comments: .
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itches; rash, rash is spreading; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches) and RASH (rash, rash is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 RASH (rash, rash is spreading). On an unknown date, the patient experienced PRURITUS (itches). At the time of the report, PRURITUS (itches) and RASH (rash, rash is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hotness at injection site; itching at the injection site; covid arm; swelling at the injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE WARMTH (hotness at injection site), VACCINATION SITE RASH (covid arm), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (pain at injection site) had resolved and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain in extremity, Paraesthesia
Clinical narrative: Flu like symptoms; Soreness of injection arm; Tingling sensation on face; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of injection arm), PARAESTHESIA (Tingling sensation on face) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of injection arm), PARAESTHESIA (Tingling sensation on face) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of injection arm), PARAESTHESIA (Tingling sensation on face) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow-up received on 08Feb2021: no new information On 21-Apr-2021: Follow-up received on 21Apr2021: Reporter Email ID added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to touch; itchy; redness (inj site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nasal bleeding; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (nasal bleeding) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced EPISTAXIS (nasal bleeding). At the time of the report, EPISTAXIS (nasal bleeding) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Vaccination complication
Clinical narrative: Aches/  Arm pain; Little off; Chills; Fatigued; Injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/  Arm pain), VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Aches/  Arm pain), VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt). At the time of the report, PAIN (Aches/  Arm pain) had not resolved and VACCINATION COMPLICATION (Little off), CHILLS (Chills), FATIGUE (Fatigued) and INJECTION SITE PAIN (Injection site hurt) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Temperature of 99.0 (Fever); Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 99.0 (Fever)) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of 99.0 (Fever)) and HEADACHE (Headache). At the time of the report, PYREXIA (Temperature of 99.0 (Fever)) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 99.0 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Pyrexia, Vaccination site swelling
Clinical narrative: Flu-like symptoms; Arm was swollen from shoulder to hand; Lethargy; Fever; This spontaneous case was reported by an other and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE SWELLING (Arm was swollen from shoulder to hand), LETHARGY (Lethargy) 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 (No medical history reported.).    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE SWELLING (Arm was swollen from shoulder to hand), LETHARGY (Lethargy) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE SWELLING (Arm was swollen from shoulder to hand), LETHARGY (Lethargy) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.