chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Hypertension.    On 19-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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) 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.   The Patient took the first shot of Moderna vaccine on Feb 19 2021 and started experiencing diarrhea since 06-Mar-2021.    For Treatment she took  2 pills of an unknown medication used for allergies.   According to her daughter, she also ate spaghetti that she believes "messed with her".  She has a medical history of allergies. She takes allergy medication. She has hypertension and takes hypertensive medication   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter declined further follow-up; reporter also stated she doesn't remember having any side effects from vaccine
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness and hurt her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and hurt her 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 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 (Soreness and hurt her arm). At the time of the report, PAIN IN EXTREMITY (Soreness and hurt her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) in a 67-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 27-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 PRURITUS (itchy) and RASH (rash). At the time of the report, PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included no information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dry mouth, Fatigue, Hypersensitivity
Clinical narrative: Nauseated; very tired; Threw everything up; Dry mouth; Dizzy; Weak; Allergy attack / Allergies kicked in; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SAZiA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus disorder.    On 02-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 DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in). On 04-Mar-2021, the patient experienced NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up). At the time of the report, DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack), HYPERSENSITIVITY (Allergies kicked in), NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseated; very tired; Threw everything up; Dry mouth; Dizzy; Weak; Allergy attack / Allergies kicked in; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SAZiA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus disorder.    On 02-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 DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack) and HYPERSENSITIVITY (Allergies kicked in). On 04-Mar-2021, the patient experienced NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up). At the time of the report, DRY MOUTH (Dry mouth), DIZZINESS (Dizzy), ASTHENIA (Weak), HYPERSENSITIVITY (Allergy attack), HYPERSENSITIVITY (Allergies kicked in), NAUSEA (Nauseated), FATIGUE (very tired) and VOMITING (Threw everything up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess oral
Clinical narrative: Patient developed an abscess in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS ORAL (Patient developed an abscess in her mouth) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-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 ABSCESS ORAL (Patient developed an abscess in her mouth). At the time of the report, ABSCESS ORAL (Patient developed an abscess in her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Nausea
Clinical narrative: dizziness; her stomach feels shaky; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 29K20A) for an unknown indication.     Concurrent medical conditions included Hypothyroidism.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) outcome was unknown. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 29K20A) for an unknown indication.     Concurrent medical conditions included Hypothyroidism.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency; LEVOTHYROXINE at an unspecified dose and frequency and AMLODIPINE at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (her stomach feels shaky) and NAUSEA (nausea) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Nausea
Clinical narrative: Arm pain; Neck pain; Back pain; Shoulder pain; Headache; Nausea; Vomiting; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vomiting
Clinical narrative: Arm pain; Neck pain; Back pain; Shoulder pain; Headache; Nausea; Vomiting; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm pain), NECK PAIN (Neck pain), BACK PAIN (Back pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was provided.   No concomitant medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: non significant information: contact information  was updated
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going) in a 42-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 times a week prior to pregnancy) and Cigarette smoker (Half pack a day prior to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from May 2020 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from May 2020 to an unknown date for Pregnancy.    On 04-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 15-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: every two weeks for four months didn't specify fin (Inconclusive) Every two weeks for four months didn't specify findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was on 01-Sep-2020. Number of fetus was found to be two.   On an unspecified date, lab test included ultrasound scan every two weeks for four months did not specify findings.  Treatment information was not provided.  14-Sep-2020, pregnancy test results positive   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up document received included patient demographics (patient race was updated).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Urticaria
Clinical narrative: Hives; Headache; Muscle pain; Chills; Fever; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Allergy to nuts.    On 04-Mar-2021 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (Fever). On 04-Mar-2021 at 4:00 PM, the patient experienced URTICARIA (Hives) and HEADACHE (Headache). On 05-Mar-2021, URTICARIA (Hives), HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) was resolving. 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 considered URTICARIA (Hives), HEADACHE (Headache) and MYALGIA (Muscle pain) to be possibly related. No further causality assessments were provided for CHILLS (Chills) and PYREXIA (Fever).    On 04-Mar-2021, the patient took Benadryl 50 mg per oral at 16:00 and again at 20:00. On 05-Mar-2021 at 07:35, the patient reported the hives were almost gone.   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: VAERS
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache
Clinical narrative: loss of sense of taste; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of sense of taste) 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 was provided by the reporter.    On 06-Mar-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) (Intramuscular) 1 dosage form.   On 07-Mar-2021, the patient experienced AGEUSIA (loss of sense of taste) and HEADACHE (Headache). At the time of the report, AGEUSIA (loss of sense of taste) and HEADACHE (Headache) had resolved.      No Concomitant  information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated event outcome.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Pain, Tenderness
Clinical narrative: Had so much pain last night; It lasted 4 hours or longer but the first 2 hours the pain was unbearable; Pain in the same place the rod is; Tenderness in the same area. It feels kinda tight but there is no pain; It started in the shoulder and went to the back; Headache; It started in the shoulder and went to the back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain) and BACK PAIN (It started in the shoulder and went to the back) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A D and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (had surgery and has titanium on the back).   On 01-Feb-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 2 dosage form. On 03-Mar-2021, the patient experienced PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain), BACK PAIN (It started in the shoulder and went to the back), HEADACHE (Headache) and ARTHRALGIA (It started in the shoulder and went to the back). At the time of the report, PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain), BACK PAIN (It started in the shoulder and went to the back), HEADACHE (Headache) and ARTHRALGIA (It started in the shoulder and went to the back) outcome was unknown.            Treatment included Tylenol 500   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Sore arm; Itching spots on and off in different parts of the body and diagnosed as hives; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and URTICARIA (Itching spots on and off in different parts of the body and diagnosed as hives) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL and CLONAZEPAM for an unknown indication.    On 14-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 PAIN IN EXTREMITY (Sore arm) and URTICARIA (Itching spots on and off in different parts of the body and diagnosed as hives). At the time of the report, PAIN IN EXTREMITY (Sore arm) and URTICARIA (Itching spots on and off in different parts of the body and diagnosed as hives) 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 treated with antihistamines for the hives.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: Blotchy red rash on face and all over body; Underneath the skin is like a pink rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash). At the time of the report, RASH ERYTHEMATOUS (Blotchy red rash on face and all over body) and SKIN DISCOLOURATION (Underneath the skin is like a pink rash) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Serious diarrhea; extreme muscle ache; It was extreemly painful; swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg); horrible headache; rash across chest; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Serious diarrhea), LYMPH NODE PAIN (It was extreemly painful), LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)), HEADACHE (horrible headache) and RASH (rash across chest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Food allergy (Gluten), Drug allergy (Morphine) and Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for Hashimoto's disease.    On 18-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (rash across chest). On 19-Feb-2021 at 9:00 AM, the patient experienced HEADACHE (horrible headache). On 21-Feb-2021, the patient experienced LYMPH NODE PAIN (It was extreemly painful) and LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)). On an unknown date, the patient experienced DIARRHOEA (Serious diarrhea) and MYALGIA (extreme muscle ache). The patient was treated with Physical therapy (MASSAGE AND COMPRESSION BANDAGE) for Lymphadenopathy. On 21-Feb-2021, HEADACHE (horrible headache) had resolved. At the time of the report, DIARRHOEA (Serious diarrhea) and MYALGIA (extreme muscle ache) outcome was unknown and LYMPH NODE PAIN (It was extreemly painful), LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)) and RASH (rash across chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Added patient demographic details Medical history information is added.. Concomitant drug is added. Events were added. Event outcome is updated. On 05-May-2021: The follow up document does not contain any new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Serious diarrhea; extreme muscle ache; It was extreemly painful; swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg); horrible headache; rash across chest; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Serious diarrhea), LYMPH NODE PAIN (It was extreemly painful), LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)), HEADACHE (horrible headache) and RASH (rash across chest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Food allergy (Gluten), Drug allergy (Morphine) and Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for Hashimoto's disease.    On 18-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (rash across chest). On 19-Feb-2021 at 9:00 AM, the patient experienced HEADACHE (horrible headache). On 21-Feb-2021, the patient experienced LYMPH NODE PAIN (It was extreemly painful) and LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)). On an unknown date, the patient experienced DIARRHOEA (Serious diarrhea) and MYALGIA (extreme muscle ache). The patient was treated with Physical therapy (MASSAGE AND COMPRESSION BANDAGE) for Lymphadenopathy. On 21-Feb-2021, HEADACHE (horrible headache) had resolved. At the time of the report, DIARRHOEA (Serious diarrhea) and MYALGIA (extreme muscle ache) outcome was unknown and LYMPH NODE PAIN (It was extreemly painful), LYMPHADENOPATHY (swelling of lymph node (to neck, left arm, right arm, underarms, trunk and right leg)) and RASH (rash across chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information does not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Added patient demographic details Medical history information is added.. Concomitant drug is added. Events were added. Event outcome is updated. On 05-May-2021: The follow up document does not contain any new information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Sore arm; Muscle pain; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle pain), HEADACHE (Headache) and CHILLS (Chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle pain), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle pain), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Patient did not have email and declined FU
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication were provided. No concomitant medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at 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 22-Feb-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 VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at injection site). On 03-Mar-2021, VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Small bumps on leg. not really pain but feels like a scab; Am soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab) and PAIN IN EXTREMITY (Am soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Am soreness). On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab). On 18-Feb-2021, PAIN IN EXTREMITY (Am soreness) had resolved. At the time of the report, LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood pressure medication.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epidemic polyarthritis, Swelling face
Clinical narrative: root canal that caused an infection; facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of EPIDEMIC POLYARTHRITIS (root canal that caused an infection) and SWELLING FACE (facial swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced EPIDEMIC POLYARTHRITIS (root canal that caused an infection) and SWELLING FACE (facial swelling). At the time of the report, EPIDEMIC POLYARTHRITIS (root canal that caused an infection) and SWELLING FACE (facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Swallowing difficult, Breathing difficult, Heart rate increased, Hives, Itching, Tightness in chest (Couldn't sleep or breathe due to tightness in chest), Weakness and Walking difficulty. Concomitant products included TAFAMIDIS MEGLUMINE (VYNDAQEL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown.            The patient had been pre-approved for Vyndamax and had been using Vyndaqel for the past month and a half and the side effects were deadly. The patient was told there were no side effects with Vyndaqel. The patient experienced difficulty in swallowing and those 4 pills of Vyndaqel were very large and hard to swallow. The patient doesn't have any difficulty in swallowing, but those pills got stuck.  The patient also reported that they tried using applesauce and banana to help get them down, but this might have been part of why the patient felt hard to breathe. The patient also had a fast heart rate and experienced hives, and itching.  The patient stated that they had tightness in their chest, had weakness and could not work. The patient was not able to sleep or breathe due to the tightness in their chest and was so wiped out that they couldn't even walk.   Reportedly, the patient took both the doses of the Moderna COVID vaccine and felt a little tired afterward and was still a little tired. The patient also reported that they had stopped taking Vyndaqel and have been able to sleep and breathe for the past 2 nights.  The patient has scheduled an appointment with their doctor to discuss about this.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Asthenia, Dyspnoea, Pain
Clinical narrative: breathing issue; weakness; aching; wide joint pain; joints coming apart; palpitation; blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vision blurred
Clinical narrative: breathing issue; weakness; aching; wide joint pain; joints coming apart; palpitation; blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Itchy back / Itchy stomach /  itchy chest / itch arms; sick to stomach; Sore arm; Joint Pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms), ABDOMINAL DISCOMFORT (sick to stomach), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included TIMOLOL, lantoprost, CENTRUM SILVER +50, SERTRALINE, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOXYL), GABAPENTIN, SUMATRIPTAN, ONDANSETRON HCL, FISH OIL, MAGNESIUM, CALCIUM, ASCORBIC ACID (VIT C) and VITAMIN D3 for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms), ABDOMINAL DISCOMFORT (sick to stomach), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain). The patient was treated with CORTISONE at an unspecified dose and frequency. On 06-Mar-2021, ABDOMINAL DISCOMFORT (sick to stomach), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in his arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his arm) and FATIGUE (Fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (Fatigue). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm). On 01-Mar-2021, PAIN IN EXTREMITY (Pain in his arm) had resolved. On 06-Mar-2021, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore arm; sore throat; dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth) 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitants were not provided. Treatment was not provided.   This case was linked to MOD-2021-036265 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: muscle pain on the left side of his neck / Pain in left neck; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (muscle pain on the left side of his neck / Pain in left neck) in a 39-year-old male 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced NECK PAIN (muscle pain on the left side of his neck / Pain in left neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Neck pain, at a dose of 50 milligram once a day. At the time of the report, NECK PAIN (muscle pain on the left side of his neck / Pain in left neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Initial Follow up document added. Product information, patient contact information, demographics, vaccine administration date, event outcome updated. On 01-Jul-2021: New Document updated on 01- Jul-2021, patient Initials updated
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm still sore since 26-02-2021, two days after he got his first vaccine; shoulder sore since 26-02-2021, two days after he got his vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm still sore since 26-02-2021, two days after he got his first vaccine) and ARTHRALGIA (shoulder sore since 26-02-2021, two days after he got his vaccine.) 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 24-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 PAIN IN EXTREMITY (arm still sore since 26-02-2021, two days after he got his first vaccine) and ARTHRALGIA (shoulder sore since 26-02-2021, two days after he got his vaccine.). At the time of the report, PAIN IN EXTREMITY (arm still sore since 26-02-2021, two days after he got his first vaccine) and ARTHRALGIA (shoulder sore since 26-02-2021, two days after he got his vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information  received on 03-May-2021 contains non-significant information.