chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Back pain, Chills, Decreased appetite
Clinical narrative: nausea, vomiting, and legs and arm ache; nausea, vomiting, and legs and arm ache; cold from the feet up; chest and back hurt, she is experiencing weakness, and shortness of breathe.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; only able to eat one meal per day.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; tired and fatigue; chills to the bone; unable to eat or drink all day.; nausea, vomiting, and legs and arm ache; headache; "every symptom that was described on that sheet of paper."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills to the bone), FEELING COLD (cold from the feet up), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache) and the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache), HEADACHE (headache) and ADVERSE REACTION ("every symptom that was described on that sheet of paper."). On 28-Feb-2021, the patient experienced FATIGUE (tired and fatigue). On 02-Mar-2021, the patient experienced BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.), DYSPNOEA (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.). On an unknown date, the patient experienced FEELING COLD (cold from the feet up), the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache), the second episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) and ASTHENIA (chest and back hurt, she is experiencing weakness, and shortness of breathe.). At the time of the report, CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), HEADACHE (headache), ADVERSE REACTION ("every symptom that was described on that sheet of paper."), FATIGUE (tired and fatigue), BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeding disorder, Feeling cold, Headache
Clinical narrative: nausea, vomiting, and legs and arm ache; nausea, vomiting, and legs and arm ache; cold from the feet up; chest and back hurt, she is experiencing weakness, and shortness of breathe.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; only able to eat one meal per day.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; tired and fatigue; chills to the bone; unable to eat or drink all day.; nausea, vomiting, and legs and arm ache; headache; "every symptom that was described on that sheet of paper."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills to the bone), FEELING COLD (cold from the feet up), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache) and the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache), HEADACHE (headache) and ADVERSE REACTION ("every symptom that was described on that sheet of paper."). On 28-Feb-2021, the patient experienced FATIGUE (tired and fatigue). On 02-Mar-2021, the patient experienced BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.), DYSPNOEA (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.). On an unknown date, the patient experienced FEELING COLD (cold from the feet up), the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache), the second episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) and ASTHENIA (chest and back hurt, she is experiencing weakness, and shortness of breathe.). At the time of the report, CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), HEADACHE (headache), ADVERSE REACTION ("every symptom that was described on that sheet of paper."), FATIGUE (tired and fatigue), BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea, vomiting, and legs and arm ache; nausea, vomiting, and legs and arm ache; cold from the feet up; chest and back hurt, she is experiencing weakness, and shortness of breathe.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; only able to eat one meal per day.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; tired and fatigue; chills to the bone; unable to eat or drink all day.; nausea, vomiting, and legs and arm ache; headache; "every symptom that was described on that sheet of paper."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills to the bone), FEELING COLD (cold from the feet up), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache) and the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache), HEADACHE (headache) and ADVERSE REACTION ("every symptom that was described on that sheet of paper."). On 28-Feb-2021, the patient experienced FATIGUE (tired and fatigue). On 02-Mar-2021, the patient experienced BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.), DYSPNOEA (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.). On an unknown date, the patient experienced FEELING COLD (cold from the feet up), the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache), the second episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) and ASTHENIA (chest and back hurt, she is experiencing weakness, and shortness of breathe.). At the time of the report, CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), HEADACHE (headache), ADVERSE REACTION ("every symptom that was described on that sheet of paper."), FATIGUE (tired and fatigue), BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dizziness, SARS-CoV-2 test positive
Clinical narrative: Joint pain; Dizziness; Positive COVID-19 test; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test). At the time of the report, ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: sweating; chills; muscle pain; fever; 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 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Details regarding concomitant and treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: bone pain; flu like sumptoms; muscle pain; chills; fever; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received on 27-APR-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bone pain; flu like sumptoms; muscle pain; chills; fever; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, BONE PAIN (bone pain), INFLUENZA LIKE ILLNESS (flu like sumptoms), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received on 27-APR-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: nausea; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness; fever of 100.1°F; couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) and DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cellulitis of leg (Cellulitis on the right leg.) in January 2021 and Bypass surgery (Three bypass).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1°F) and BEDRIDDEN (couldn't get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), CHILLS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), HEADACHE (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), MYALGIA (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), DIZZINESS (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), EAR PAIN (chills and head aches and experienced body aches, head aches, chills , ear pain, and dizziness), PYREXIA (fever of 100.1°F) and BEDRIDDEN (couldn't get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The Patient outcome of the events not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Injection site erythema, Limb discomfort
Clinical narrative: tender; redness on her arm appeared 2-3 days later which started on the front of her deltoid; same typical side effects; itchy; fever; tired; felt crappy; arm was really sore; good bit of swelling about 1/2 inch and diameter of 2 inches; redness; itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy), TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (same typical side effects). On 27-Feb-2021, the patient experienced TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid). At the time of the report, VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy) and TENDERNESS (tender) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Swelling, Tenderness, Vaccination complication
Clinical narrative: tender; redness on her arm appeared 2-3 days later which started on the front of her deltoid; same typical side effects; itchy; fever; tired; felt crappy; arm was really sore; good bit of swelling about 1/2 inch and diameter of 2 inches; redness; itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy), TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (same typical side effects). On 27-Feb-2021, the patient experienced TENDERNESS (tender) and INJECTION SITE ERYTHEMA (redness on her arm appeared 2-3 days later which started on the front of her deltoid). At the time of the report, VACCINATION COMPLICATION (same typical side effects), PRURITUS (itchy) and TENDERNESS (tender) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Vaccination site pain, Vaccination site rash
Clinical narrative: rash at the injection site the size of a tennis ball that took almost 5 five days before it started to; massive headache; She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not; did not feel like doing anything; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (did not feel like doing anything), HEADACHE (massive headache), VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not) and VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Stomach cancer (stage 3) in 2010 and Lymph node excision (Removal of abdominal lymph nodes). Concomitant products included CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DISCOMFORT (did not feel like doing anything) and VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not). On 14-Feb-2021, the patient experienced HEADACHE (massive headache). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to). On 16-Feb-2021, DISCOMFORT (did not feel like doing anything) had resolved. On 21-Feb-2021, VACCINATION SITE PAIN (She could not even touch the injection arm for like 3 days, it hurt even to touch it, she could not) had resolved. At the time of the report, HEADACHE (massive headache) and VACCINATION SITE RASH (rash at the injection site the size of a tennis ball that took almost 5 five days before it started to) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fatigue; body aches; headache; fever of 100°F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100°F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-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 FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever of 100°F). At the time of the report, PYREXIA (fever of 100°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo went away (resolved); This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo went away (resolved)) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Dizziness. Concurrent medical conditions included Vertigo.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo went away (resolved)). At the time of the report, VERTIGO (Vertigo went away (resolved)) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Axillary pain, Diarrhoea, Gastrointestinal pain
Clinical narrative: Irritable Bowl Syndrome-diarrhea; Gut ache; Loose stool; Stomach ache; Diarrhea; Hip Pain/Hips hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Diarrhea), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (Patient had IBS-D with monthly occurrences ).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 25-Feb-2021, the patient experienced ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm).   On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache).   On 02-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Gut ache) and DIARRHOEA (Loose stool). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea).   On 26-Feb-2021, ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm) had resolved. On 27-Feb-2021, DIARRHOEA (Diarrhea) had resolved.   At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.      This case was linked to MOD-2021-032382 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: Irritable Bowl Syndrome-diarrhea; Gut ache; Loose stool; Stomach ache; Diarrhea; Hip Pain/Hips hurt; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Diarrhea), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (Patient had IBS-D with monthly occurrences ).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 25-Feb-2021, the patient experienced ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm).   On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache).   On 02-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Gut ache) and DIARRHOEA (Loose stool). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea).   On 26-Feb-2021, ARTHRALGIA (Hip Pain/Hips hurt) and AXILLARY PAIN (Sore arm) had resolved. On 27-Feb-2021, DIARRHOEA (Diarrhea) had resolved.   At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable Bowl Syndrome-diarrhea), GASTROINTESTINAL PAIN (Gut ache), DIARRHOEA (Loose stool) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.      This case was linked to MOD-2021-032382 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Headache, Nausea, Rhinorrhoea
Clinical narrative: Diarrhea; teeth were hurting; nose was dripping; could not even lay down or sit up; severe headache, my head felt like it was going to blow up; Vomiting; nausea; A spontaneous report was received from a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, diarrhea, severe headache/headache, teeth were hurting/toothache, nose was dripping/rhinorrhea, could not even lay down or sit up/discomfort and  nausea.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event included nortriptilina, cranberry [vaccinium macrocarpon], ginger [zingiber officinale rhizome], ubidecarenone, vitamin d3 and diazepam, isopropamide iodide.  On 08-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   In Feb-2021, the patient stated that she had a bad reaction to the vaccine, and she experienced vomiting, diarrhea, severe headache and her head felt like it was going to blow up. The patient's teeth hurt like she had four root canals done without even actually getting anything. The patient also had dripping nose. The patient was not able to lay down or sit up and she felt awful. The patient had been to the emergency room where she was given an intravenous drip (IV) for nausea and medications for pain. Patient felt better after 24 hours but she stated that she still felt like beaten up but was much better. The patient took Motrin (ibuprofen) couple of times a day. The patient had little bit of headache at the time of the report.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vomiting, diarrhea, teeth were hurting, nose was dripping, could not even lay down or sit up and nausea was recovering/resolving and the outcome for severe headache my head felt like it was going to blow up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, Vomiting
Clinical narrative: Diarrhea; teeth were hurting; nose was dripping; could not even lay down or sit up; severe headache, my head felt like it was going to blow up; Vomiting; nausea; A spontaneous report was received from a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, diarrhea, severe headache/headache, teeth were hurting/toothache, nose was dripping/rhinorrhea, could not even lay down or sit up/discomfort and  nausea.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event included nortriptilina, cranberry [vaccinium macrocarpon], ginger [zingiber officinale rhizome], ubidecarenone, vitamin d3 and diazepam, isopropamide iodide.  On 08-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   In Feb-2021, the patient stated that she had a bad reaction to the vaccine, and she experienced vomiting, diarrhea, severe headache and her head felt like it was going to blow up. The patient's teeth hurt like she had four root canals done without even actually getting anything. The patient also had dripping nose. The patient was not able to lay down or sit up and she felt awful. The patient had been to the emergency room where she was given an intravenous drip (IV) for nausea and medications for pain. Patient felt better after 24 hours but she stated that she still felt like beaten up but was much better. The patient took Motrin (ibuprofen) couple of times a day. The patient had little bit of headache at the time of the report.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vomiting, diarrhea, teeth were hurting, nose was dripping, could not even lay down or sit up and nausea was recovering/resolving and the outcome for severe headache my head felt like it was going to blow up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Lacrimation increased, Nasal discomfort, Pain in extremity
Clinical narrative: her eyes are watery; She has a Sore nose; she had a bout of sneezing; some coughing; She also felt a slight ache in the center of her chest; She has Drainage; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), COUGH (some coughing), CHEST PAIN (She also felt a slight ache in the center of her chest) and LACRIMATION INCREASED (her eyes are watery) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided. and concomitant drugs are provided.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), XYLOMETAZOLINE HYDROCHLORIDE (XYZOLINE), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), CARVEDILOL, Low dose aspirin, SPIRONOLACTONE and Labetolol as needed for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (She has Drainage). On 12-Feb-2021, the patient experienced SNEEZING (she had a bout of sneezing), COUGH (some coughing) and CHEST PAIN (She also felt a slight ache in the center of her chest). On an unknown date, the patient experienced LACRIMATION INCREASED (her eyes are watery). On 12-Feb-2021, COUGH (some coughing) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), CHEST PAIN (She also felt a slight ache in the center of her chest) and RHINORRHOEA (She has Drainage) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-033759 (E2B Linked Report).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: her eyes are watery; She has a Sore nose; she had a bout of sneezing; some coughing; She also felt a slight ache in the center of her chest; She has Drainage; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), COUGH (some coughing), CHEST PAIN (She also felt a slight ache in the center of her chest) and LACRIMATION INCREASED (her eyes are watery) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided. and concomitant drugs are provided.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), XYLOMETAZOLINE HYDROCHLORIDE (XYZOLINE), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCT), CARVEDILOL, Low dose aspirin, SPIRONOLACTONE and Labetolol as needed for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (She has Drainage). On 12-Feb-2021, the patient experienced SNEEZING (she had a bout of sneezing), COUGH (some coughing) and CHEST PAIN (She also felt a slight ache in the center of her chest). On an unknown date, the patient experienced LACRIMATION INCREASED (her eyes are watery). On 12-Feb-2021, COUGH (some coughing) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), SNEEZING (she had a bout of sneezing), CHEST PAIN (She also felt a slight ache in the center of her chest) and RHINORRHOEA (She has Drainage) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-033759 (E2B Linked Report).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Eye (RIGHT) swelling; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye (RIGHT) swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 an unknown date, the patient experienced EYE SWELLING (Eye (RIGHT) swelling). At the time of the report, EYE SWELLING (Eye (RIGHT) swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  The treatment for the event  included peroxide and warn cloth.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: fever; chills; body aches; headaches; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; body aches; headaches; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: very itchy; developed a rash below injection site on the right arm about 2 inches in diameter; bumpy; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE PRURITUS (very itchy) had resolved and VACCINATION SITE RASH (developed a rash below injection site on the right arm about 2 inches in diameter), VACCINATION SITE SWELLING (bumpy) and VACCINATION SITE PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information included, Benadryl  was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: follow up information received on 22-apr-2021 added Reporter's address and email ID  was updated
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included polyhydroaminos.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-Jul-2021. On 01-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 01-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: pregnancy Form
Age: 80.0
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 an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE and LISINOPRIL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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.       Concomitant medications include supplements ,statins for cholesterol. No treatment medication details was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Blood pressure measurement, Dizziness, Electrocardiogram
Clinical narrative: diagnosis was near syncope; Sweats; Dizziness; He took his blood pressure and it was 85/49; Low potassium; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRESYNCOPE (diagnosis was near syncope), HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), HYPOTENSION (He took his blood pressure and it was 85/49) and BLOOD POTASSIUM DECREASED (Low potassium). On 11-Mar-2021, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness) and HYPOTENSION (He took his blood pressure and it was 85/49) had resolved. At the time of the report, PRESYNCOPE (diagnosis was near syncope) and BLOOD POTASSIUM DECREASED (Low potassium) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood potassium: low (Low) low. On 11-Mar-2021, Blood pressure measurement: 85/49 mmhg, after 30 minutes was normal (Low) 85/49 mmHg, after 30 minutes was normal. On 11-Mar-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient went to ER and was observed for 3 hours. No treatment information was provided.