chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomited about 3 times; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomited about 3 times) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Hypertension, Pyrexia
Clinical narrative: Blood pressure is high(150/100); Fever (99.7F); This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure is high(150/100)) and PYREXIA (Fever (99.7F)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERTENSION (Blood pressure is high(150/100)) and PYREXIA (Fever (99.7F)). At the time of the report, HYPERTENSION (Blood pressure is high(150/100)) and PYREXIA (Fever (99.7F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: 150/100 mmhg (High) High. On 03-Mar-2021, Body temperature: 99.7 (High) Fever (99.7F).         Concomitant medications were not provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Event outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and PAIN (hurting all over) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CELECOXIB (CELEBREX) and PREDNISONE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and PAIN (hurting all over). At the time of the report, CHILLS (chills), PYREXIA (fever) and PAIN (hurting all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Nebulizer, Libutrin and Valirest. Treatment medications include Motrin and Aleve.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Developed swelling/pain in lymph nodes of left armpit about 8 hours after vaccination.  At 10 hours after vaccination, developed chills and fever of 102.7.  Took Tylenol 650 mg every 6 hours for 48 hours.  chills and fever >102.7 lasted for 26 hours.  I could only manage getting up to bathroom and could not stay awake for longer than 15 minutes during that time.  Had fever of 101 for the next 24 hours while taking Tylenol.  Then had fever of 100 for another 24 hours.  The lymph node pain continued for a whole week with some swelling of lymph nodes in left armpit.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Shaking chills, arm pain headache, fever, body aches
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Admitted to the hospital 8/14/2021 with acute pericarditis
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm was red; Arm was bumpy; Arm was warm to the touch; Broke out in bumps all over her back that are itching and she has been scratching; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Seasonal allergy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous). At the time of the report, ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It is reported that the itchiness is not as bad, the bumps are still there, and the nausea continues to reoccur  No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is painful after the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is painful after the 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is painful after the injection). At the time of the report, PAIN IN EXTREMITY (Arm is painful after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details was not provided.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bloody nose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EPISTAXIS (bloody nose). At the time of the report, EPISTAXIS (bloody nose) outcome was unknown.            Concomitant product use was not provided. No treatment was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm sore really bad; Headache (pressure headache in forehead); Pain in the shoulder; stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore really bad), HEADACHE (Headache (pressure headache in forehead)), ARTHRALGIA (Pain in the shoulder) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 63-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.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore really bad), HEADACHE (Headache (pressure headache in forehead)), ARTHRALGIA (Pain in the shoulder) and MUSCULOSKELETAL STIFFNESS (stiff neck). On 02-Mar-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) had resolved. At the time of the report, PAIN IN EXTREMITY (arm sore really bad), HEADACHE (Headache (pressure headache in forehead)) and ARTHRALGIA (Pain in the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported .
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Not sure if the vaccine was administer into the muscle or into the joint; Difficulty of moving it or raising it; Shooting pain down the arm when receiving the vaccine/Arm very tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint), VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint), VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not sure if the vaccine was administer into the muscle or into the joint) and VACCINATION SITE PAIN (Shooting pain down the arm when receiving the vaccine/Arm very tender and sore) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty of moving it or raising it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included paracetamol and advil.  No concomitant medication was provided.   This case was linked to MOD-2021-031708 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate route of vaccination for mRNA-1273, lot# 024M20A, with associated AEs. 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Erythema, Heart rate increased, Swelling
Clinical narrative: LABORED BREATHING; redness; swelling; wheezing; coughing; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic and Obesity.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat). On an unknown date, the patient experienced DYSPNOEA (LABORED BREATHING). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Wheezing and Labored breathing, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (redness), SWELLING (swelling), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) outcome was unknown and WHEEZING (wheezing) and DYSPNOEA (LABORED BREATHING) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she took pocket mouth mas and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-234141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30-APR-2021:Contains  significant information: second dose date, relevant history -obesity, insulin dependent diabetes, treatment medication-Benadryl, event - labored breathing
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: LABORED BREATHING; redness; swelling; wheezing; coughing; fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insulin dependent diabetic and Obesity.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling), WHEEZING (wheezing), COUGH (coughing) and HEART RATE INCREASED (fast heart beat). On an unknown date, the patient experienced DYSPNOEA (LABORED BREATHING). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Wheezing and Labored breathing, at a dose of 1 dosage form. At the time of the report, ERYTHEMA (redness), SWELLING (swelling), COUGH (coughing) and HEART RATE INCREASED (fast heart beat) outcome was unknown and WHEEZING (wheezing) and DYSPNOEA (LABORED BREATHING) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she took pocket mouth mas and an emergency use bag with the help of her husband for breathing difficulty patient stated that due to fear she did not went hospital. Patient had obesity with body mass index30 to 33 No Concomitant medication reported by the reporter Patient experienced COVID-19 March to April   This case was linked to MOD-2021-234141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30-APR-2021:Contains  significant information: second dose date, relevant history -obesity, insulin dependent diabetes, treatment medication-Benadryl, event - labored breathing
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itchy on injection site; Red on injection site; Hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch). At the time of the report, VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment for the event include hydrocortisone 1%.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Headache, Pain
Clinical narrative: This spontaneous pregnancy case was reported by a consumer and describes the occurrence of BREAST FEEDING (breast feeding), PAIN (pain) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced BREAST FEEDING (breast feeding), PAIN (pain) and HEADACHE (headache). At the time of the report, BREAST FEEDING (breast feeding), PAIN (pain) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and  treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non-significant Follow up Appended On 16-Jul-2021 and it mentioned - Reporter Email address updated.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administered below deltoid; A spontaneous report was received from a Consumer concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who was administered vaccine below deltoid.  No patient's medical history was reported. No relevant concomitant medications were provided.  On 08 Mar 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient was administered vaccine below deltoid.No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The event administered vaccine belowdeltoid was considered resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of Vaccine administered at inappropriate site for mRNA-1273, lot # unknown with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: Fast heart beat; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart beat) and MYALGIA (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-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 19-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart beat) and MYALGIA (Sore arm). On 19-Feb-2021, HEART RATE INCREASED (Fast heart beat) and MYALGIA (Sore arm) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable  No concomitant medications reported by investigator  No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Non-significant follow received. Husband's email address provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Heart rate increased, Vaccination site pain
Clinical narrative: Vaccination site pain; red swatches; rapid heartbeat; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (red swatches), HEART RATE INCREASED (rapid heartbeat) and CHEST PAIN (Chest pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (red swatches), HEART RATE INCREASED (rapid heartbeat) and CHEST PAIN (Chest pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (red swatches), HEART RATE INCREASED (rapid heartbeat) and CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
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 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 10-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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 10-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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: Malaise; Achiness; Dizziness; Diarrhea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-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 09-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Malaise; Achiness; Dizziness; Diarrhea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-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 09-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), PAIN (Achiness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Discomfort, Pain
Clinical narrative: hurting; discomfort; is concerned; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned). At the time of the report, PAIN (hurting), DISCOMFORT (discomfort) and ANXIETY (is concerned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given. Treatment information not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Light headed/ Dizzy; Throwing up; Fever; Sick to her stomach, nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed/ Dizzy), VOMITING (Throwing up), PYREXIA (Fever) and NAUSEA (Sick to her stomach, nausea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Light headed/ Dizzy), VOMITING (Throwing up), PYREXIA (Fever) and NAUSEA (Sick to her stomach, nausea). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM CARBONATE (GAVISCON [ALUMINIUM HYDROXIDE;MAGNESIUM CARBONATE]) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Light headed/ Dizzy), VOMITING (Throwing up), PYREXIA (Fever) and NAUSEA (Sick to her stomach, nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Dyspnoea, Lymphadenopathy, Oral discomfort
Clinical narrative: her whole face was very swollen with no pain and she had swollen glands on her face and her; something inside her mouth busted and she experience "the most horrible bitter taste"; bitter taste and a hard time breathing; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; A spontaneous report was received from a consumer concerning a 65-year-old female patient  who experienced bitter taste, a hard time breathing/Dyspnoea, her whole face was very swollen with no pain and she had swollen glands on her face and her/Lymphadenopathy, something inside her mouth burst and she experienced "the most horrible bitter taste"/Oral discomfort , her arm became swollen/vaccination site welling,  she started to experience a bitter taste/dysgeusia, chills/chills.   On 23-Feb-2021, prior to the onset of the symptoms, the patient received their the patient received first of two planned doses of mRNA-1273 (Batch number:031L20A) for prophylaxis of COVID-19 infection.     The patient's past medical history included sinus infection. Concomitant product use was not unknown    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Feb-2021, the patient experienced peripheral swelling (her arm became swollen dysgeusia (she started to experience a bitter taste (like lemon) and chills. On 27-Feb-2021, the patient experienced dyspnea (hard time breathing) (seriousness criterion medically significant). On 28-Feb-2021, the patient experienced lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face and her) and oral discomfort (something inside her mouth busted and she experience "the most horrible bitter taste"). At the time of the report, dyspnea outcome was unknown and lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face ), oral discomfort (something inside her mouth busted and she experience d "the most horrible bitter taste"), peripheral swelling (her arm became swollen) , dysgeusia (she started to experience a bitter taste (like lemon) and chills had not been resolved.     Treatment for the event included Ibuprofen.    The outcome of the events were not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: Vaccination site swelling
Clinical narrative: her whole face was very swollen with no pain and she had swollen glands on her face and her; something inside her mouth busted and she experience "the most horrible bitter taste"; bitter taste and a hard time breathing; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; her arm became swollen and she started to experience a bitter taste (like lemon) and chills 3 or 4; A spontaneous report was received from a consumer concerning a 65-year-old female patient  who experienced bitter taste, a hard time breathing/Dyspnoea, her whole face was very swollen with no pain and she had swollen glands on her face and her/Lymphadenopathy, something inside her mouth burst and she experienced "the most horrible bitter taste"/Oral discomfort , her arm became swollen/vaccination site welling,  she started to experience a bitter taste/dysgeusia, chills/chills.   On 23-Feb-2021, prior to the onset of the symptoms, the patient received their the patient received first of two planned doses of mRNA-1273 (Batch number:031L20A) for prophylaxis of COVID-19 infection.     The patient's past medical history included sinus infection. Concomitant product use was not unknown    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 23-Feb-2021, the patient experienced peripheral swelling (her arm became swollen dysgeusia (she started to experience a bitter taste (like lemon) and chills. On 27-Feb-2021, the patient experienced dyspnea (hard time breathing) (seriousness criterion medically significant). On 28-Feb-2021, the patient experienced lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face and her) and oral discomfort (something inside her mouth busted and she experience "the most horrible bitter taste"). At the time of the report, dyspnea outcome was unknown and lymphadenopathy (her whole face was very swollen with no pain and she had swollen glands on her face ), oral discomfort (something inside her mouth busted and she experience d "the most horrible bitter taste"), peripheral swelling (her arm became swollen) , dysgeusia (she started to experience a bitter taste (like lemon) and chills had not been resolved.     Treatment for the event included Ibuprofen.    The outcome of the events were not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: Aggression, Memory impairment
Clinical narrative: Verbal aggresive; Memory problems; This spontaneous case was reported by a non-health professional and describes the occurrence of AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems) 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 AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems). At the time of the report, AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Allodynia, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: aches; Painful to Touch; swollen lymph node above collar bone on left side; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), ALLODYNIA (Painful to Touch), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (aches), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever). 27-Feb-2021, the patient experienced ALLODYNIA (Painful to Touch). The patient was treated with IBUPROFEN ongoing from 28-Feb-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (aches), ALLODYNIA (Painful to Touch), LYMPHADENOPATHY (swollen lymph node above collar bone on left side) and PYREXIA (Fever) had resolved.            The patient stated they were taking 130 pills a week for different issues.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: event outcome of Lymphadenopathy changed to recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling abnormal, Headache, Lethargy, Pain
Clinical narrative: lost taste; achy; soar arm; feels lousy; Headache; felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LETHARGY (felt lethargic), AGEUSIA (lost taste), PAIN (achy) and PAIN IN EXTREMITY (soar arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rhinitis and Drug allergy (Allergic to anti-inflammatories.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache), LETHARGY (felt lethargic), PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy). On 26-Feb-2021, the patient experienced AGEUSIA (lost taste). On 24-Feb-2021, PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy) had resolved. At the time of the report, HEADACHE (Headache) and LETHARGY (felt lethargic) had not resolved and AGEUSIA (lost taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: lost taste; achy; soar arm; feels lousy; Headache; felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LETHARGY (felt lethargic), AGEUSIA (lost taste), PAIN (achy) and PAIN IN EXTREMITY (soar arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rhinitis and Drug allergy (Allergic to anti-inflammatories.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache), LETHARGY (felt lethargic), PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy). On 26-Feb-2021, the patient experienced AGEUSIA (lost taste). On 24-Feb-2021, PAIN (achy), PAIN IN EXTREMITY (soar arm) and FEELING ABNORMAL (feels lousy) had resolved. At the time of the report, HEADACHE (Headache) and LETHARGY (felt lethargic) had not resolved and AGEUSIA (lost taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Paranasal sinus discomfort, Sinus disorder
Clinical narrative: Stuffy nose; More sinuses problems; Sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion. Concomitant products included METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications include Cholesterol Medications, Flonase
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ASA for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left). At the time of the report, ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Vaccination site pain
Clinical narrative: Last night, evening around 8pm, rash on torso, front and back, between breast and over whole; Sunday felt tired, took a nap for 3-4 hours; Second shot - soreness in location where vaccine administered on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Last night, evening around 8pm, rash on torso, front and back, between breast and over whole), VACCINATION SITE PAIN (Second shot - soreness in location where vaccine administered on arm) and FATIGUE (Sunday felt tired, took a nap for 3-4 hours) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drugs).   On 27-Feb-2021 at 1:30 PM, 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 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Second shot - soreness in location where vaccine administered on arm). On an unknown date, the patient experienced RASH (Last night, evening around 8pm, rash on torso, front and back, between breast and over whole) and FATIGUE (Sunday felt tired, took a nap for 3-4 hours). At the time of the report, RASH (Last night, evening around 8pm, rash on torso, front and back, between breast and over whole) had not resolved and VACCINATION SITE PAIN (Second shot - soreness in location where vaccine administered on arm) and FATIGUE (Sunday felt tired, took a nap for 3-4 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) 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 11-Feb-2021, 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) (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 details included Not provided.