chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in an 86-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Rash at injection site) 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 provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness of left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (soreness of left arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness of left arm). At the time of the report, INJECTION SITE PAIN (soreness of left 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Swollen tongue, Urticaria
Clinical narrative: swollen tongue; hives on the left side of her body including the back of her arm, hip, elbow and foot; muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of SWOLLEN TONGUE (swollen tongue), URTICARIA (hives on the left side of her body including the back of her arm, hip, elbow and foot) and MYALGIA (muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 12:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SWOLLEN TONGUE (swollen tongue), URTICARIA (hives on the left side of her body including the back of her arm, hip, elbow and foot) and MYALGIA (muscle pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (swollen tongue), URTICARIA (hives on the left side of her body including the back of her arm, hip, elbow and foot) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SWOLLEN TONGUE (swollen tongue), URTICARIA (hives on the left side of her body including the back of her arm, hip, elbow and foot) and MYALGIA (muscle pain) to be probably related.    No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient demographics, event start date added
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Food poisoning
Clinical narrative: Food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-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. On an unknown date, the patient experienced FOOD POISONING (Food poisoning). At the time of the report, FOOD POISONING (Food poisoning) outcome was unknown.            No concomitant medications were provided by the reporter.   Patient was able to get the second shot within the recommend time frame.Treatment information was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Product dose omission event deleted. Hospitalization was added.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. However based on know profile of the vaccine and common source of food poisoning; it is unlikely related to vaccine.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Catheter management, No adverse event
Clinical narrative: patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port"; Patient has no other symptoms after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine). At the time of the report, CATHETER MANAGEMENT (patients port has not been working properly /they have been using a solution they called draino to help flush out the port"/they have been using a solution they called draino to help flush out the port") and NO ADVERSE EVENT (Patient has no other symptoms after receiving the vaccine) outcome was unknown. 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 medication was reported. Treatment information was not provided.  Patient reported that they used a solution called draino to help flush out the port.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (No complications, live full time birth) on 15-Feb-2016, Pregnancy (No complications, live full time birth) on 07-Apr-2018 and Alcohol use (social). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 12-Mar-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 19-Oct-2020 and the estimated date of delivery was 26-Jul-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Ultrasound foetal: normal (normal) all were normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prenatal care has been established.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Red itchy bump at the injection site; Red itchy bump at the injection site; Red itchy bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red itchy bump at the injection site), VACCINATION SITE PRURITUS (Red itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Red itchy bump at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Red itchy bump at the injection site), VACCINATION SITE PRURITUS (Red itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Red itchy bump at the injection site). At the time of the report, VACCINATION SITE MASS (Red itchy bump at the injection site), VACCINATION SITE PRURITUS (Red itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Red itchy bump at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, White blood cell count, White blood cell count increased
Clinical narrative: elevated WBC count one week after the first injection; elevated WBC count one week after the first injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection) 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 THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (elevated WBC count one week after the first injection) and WHITE BLOOD CELL COUNT INCREASED (elevated WBC count one week after the first injection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: elevated (High) Elevated WBC count.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided by the reporter.  Treatment medication were not reported by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Gingival swelling, Oral discomfort, Paraesthesia oral, Tongue discomfort
Clinical narrative: dry mouth; discomfort in the mouth; swollen/red gums; tooth aches; tongue is tingling/burning; tongue is tingling/burning; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches) and PARAESTHESIA ORAL (tongue is tingling/burning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (VASTATIN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of 1 dosage form and ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included rinsing with salt water.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up appended: Pregnancy status updated and contact information updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: dry mouth; discomfort in the mouth; swollen/red gums; tooth aches; tongue is tingling/burning; tongue is tingling/burning; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches) and PARAESTHESIA ORAL (tongue is tingling/burning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN (VASTATIN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of 1 dosage form and ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, DRY MOUTH (dry mouth), ORAL DISCOMFORT (discomfort in the mouth), GINGIVAL SWELLING (swollen/red gums), TOOTHACHE (tooth aches), PARAESTHESIA ORAL (tongue is tingling/burning) and TONGUE DISCOMFORT (tongue is tingling/burning) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included rinsing with salt water.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up appended: Pregnancy status updated and contact information updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99 (High) 99 F. On 13-Mar-2021, Body temperature: 99 (High) 99 F.     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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body aches). 12-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (Body aches), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: sore; tired; arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit), PAIN (sore) and FATIGUE (tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, METOPROLOL, SITAGLIPTIN PHOSPHATE (JANUVIA), VITAMIN D2, DIAZEPAM and LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit). On 13-Mar-2021, the patient experienced PAIN (sore) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), PAIN (sore) and FATIGUE (tired) 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.   Patient was taking blood thinners. No treatment medicines were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Vaccination site reaction
Clinical narrative: whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle; in her ankle she had a round spot on the side; She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M29A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Back pain.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle). On 07-Mar-2021, FEELING HOT (whole left arm from the shoulder where she got the shot was hot and it run down the whole side of her body until her ankle), VACCINATION SITE REACTION (in her ankle she had a round spot on the side) and PAIN (She had pain in her whole left arm from the shoulder where she got the shot and down the whole side of her body until her ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) 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 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 14-Mar-2021, VACCINATION SITE PAIN (Sore arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatments were reported.   This case was linked to MOD-2021-045641 (E2B Linked Report).; Sender's Comments:  MOD-2021-045641:same reporter and two patients mentioned in source document. one case is processed in ICSR ID MOD-2021-045641
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Sore shot arms; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (Sore shot arms), PAIN (achy) and FATIGUE (tired) outcome was unknown.            No Treatment medications was available. No concomitant medications was available.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: diarrhea; tired; sore shot arm; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore shot arm), PAIN (achy), DIARRHOEA (diarrhea) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has sensitive stomach and gets diarrhea from eating too much beef, fish, diary products.  The patient's past medical history included Heart attack in 2015, Diverticulitis, Intestinal resection, Hartmann's pouch procedure in 2016 and Stent placement in 2015. Concurrent medical conditions included Type 2 diabetes mellitus, Stomach ache, Food allergy (Beef), Fish allergy and Dairy free diet.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore shot arm), PAIN (achy) and FATIGUE (tired). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, PAIN IN EXTREMITY (sore shot arm), PAIN (achy), DIARRHOEA (diarrhea) and FATIGUE (tired) outcome was unknown.            No treatment details were provided. patient's diarrhea was yellow and smelly and severe   This case was linked to MOD-2021-020083 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Keflex) and Blood pressure.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TINNITUS (Tinnitus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, TINNITUS (Tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medications (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Outcome of the event Tinnitus was changed from Unknown to recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: warmth at injection site; rash around the hand; fever; rash at injection site; swelling at injection site; arm began feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm began feeling sore), VACCINATION SITE WARMTH (warmth at injection site), RASH (rash around the hand), PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A210A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm began feeling sore). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), RASH (rash around the hand), PYREXIA (fever), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 13-Mar-2021, PYREXIA (fever) had resolved. On 14-Mar-2021, RASH (rash around the hand) had resolved. At the time of the report, PAIN IN EXTREMITY (arm began feeling sore) had not resolved and VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-015296 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warmth at injection site; rash around the hand; fever; rash at injection site; swelling at injection site; arm began feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm began feeling sore), VACCINATION SITE WARMTH (warmth at injection site), RASH (rash around the hand), PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A210A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm began feeling sore). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), RASH (rash around the hand), PYREXIA (fever), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 13-Mar-2021, PYREXIA (fever) had resolved. On 14-Mar-2021, RASH (rash around the hand) had resolved. At the time of the report, PAIN IN EXTREMITY (arm began feeling sore) had not resolved and VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-015296 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: negative antibody test; This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (negative antibody test) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (negative antibody test). At the time of the report, ANTIBODY TEST NEGATIVE (negative antibody test) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information is not provided.  Treatment is not given for the event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Throat irritation
Clinical narrative: itchy throat; headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (itchy throat) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced THROAT IRRITATION (itchy throat) and HEADACHE (headache). At the time of the report, THROAT IRRITATION (itchy throat) and HEADACHE (headache) 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 considered THROAT IRRITATION (itchy throat) and HEADACHE (headache) to be probably related.    No concomitant product was reported.  Patient's treatment information include Benadryl 25 mg po. She was monitored an additional 30 minutes at which time, she was doing well and instructed to follow-up with our onsite nurse as needed.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07 may 2021 included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Posture abnormal, Renal pain
Clinical narrative: excruciating kidney pain; couldn't stand up straight had to walk at 45 degree angle, totally bent over, in agony, as if someone was pulling out my kidneys; fluid in throat was so thick I couldn't expel it; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (excruciating kidney pain), POSTURE ABNORMAL (couldn't stand up straight had to walk at 45 degree angle, totally bent over, in agony, as if someone was pulling out my kidneys) and OROPHARYNGEAL DISCOMFORT (fluid in throat was so thick I couldn't expel it) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RENAL PAIN (excruciating kidney pain), POSTURE ABNORMAL (couldn't stand up straight had to walk at 45 degree angle, totally bent over, in agony, as if someone was pulling out my kidneys) and OROPHARYNGEAL DISCOMFORT (fluid in throat was so thick I couldn't expel it). At the time of the report, RENAL PAIN (excruciating kidney pain) and OROPHARYNGEAL DISCOMFORT (fluid in throat was so thick I couldn't expel it) had not resolved and POSTURE ABNORMAL (couldn't stand up straight had to walk at 45 degree angle, totally bent over, in agony, as if someone was pulling out my kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: dx with shingles; Sore throat; Very sore arm; Felt unwell; "Weird" headache; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache) in a 70-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache). At the time of the report, HERPES ZOSTER (dx with shingles), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Very sore arm), MALAISE (Felt unwell) and HEADACHE ("Weird" headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood cholesterol abnormal and Blood pressure abnormal.    On 03-Mar-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache). On 04-Mar-2021, PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitantly the patient was receiving unspecified diabetes medication, cholesterol medication and blood pressure medication.  The patient did not receive any treatment for these events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Itchy on arms; Arm is aching; Rash on arm, breaking out on both of her arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy on arms), PAIN IN EXTREMITY (Arm is aching) and RASH (Rash on arm, breaking out on both of her arms) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, VENLAFAXINE and OMEPRAZOLE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itchy on arms), PAIN IN EXTREMITY (Arm is aching) and RASH (Rash on arm, breaking out on both of her arms). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and COCONUT OIL on 14-Mar-2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy on arms) had resolved and PAIN IN EXTREMITY (Arm is aching) and RASH (Rash on arm, breaking out on both of her arms) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment included unspecified prescription cream that kind of burned her arm so she stopped that. The patient said that she had a treatment done for her psoriasis prior to receiving first vaccine dose on 9Feb2021 and was given a cream to put on in the infected places. The patient is due for a steroid shot.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; Headache; Body ache; A spontaneous report was received from a consumer concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, headache, body ache (myalgia)   No medical history was provided. No concomitant medications were provided.   On 09-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 036A21A), intramuscularly in right arm for prophylaxis of COVID-19 infection.   On 10-Mar-2021, the patient experienced fever, chills, body ache and headache. The patient was concerned when his symptoms would be over.  The treatment medication included ibuprofen.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events fever, chills, headache, bodyache (myalgia) were considered unresolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Inflammation, Pyrexia
Clinical narrative: Inflammation on her right side; Redness on her right side and leg; Hives; Chills; Temperature of just over 100 degrees F; Mild reaction at the time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction at the time), INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives) and CHILLS (Chills) in a female 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (Mild reaction at the time). On 07-Mar-2021, the patient experienced INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives), CHILLS (Chills) and PYREXIA (Temperature of just over 100 degrees F). On 19-Feb-2021, VACCINATION COMPLICATION (Mild reaction at the time) had resolved. At the time of the report, INFLAMMATION (Inflammation on her right side), ERYTHEMA (Redness on her right side and leg), URTICARIA (Hives), CHILLS (Chills) and PYREXIA (Temperature of just over 100 degrees F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: high (High) Temperature of just over 100 degrees F.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.