chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; Soreness at the injection site; Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drugs).    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.). At the time of the report, VACCINATION SITE WARMTH (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE PRURITUS (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE SWELLING (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.), VACCINATION SITE ERYTHEMA (Yesterday at the injection site she noticed it was swollen, red, warm, and itchy.) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Influenza like illness, Myalgia
Clinical narrative: mild shortness of breath,; flu-like symptoms; cough; Fever; 2 episodes of vomiting; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever) and VOMITING (2 episodes of vomiting) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). On 16-Apr-2021, DYSPNEA (mild shortness of breath,) and COUGH (cough) outcome was unknown and INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: mild shortness of breath,; flu-like symptoms; cough; Fever; 2 episodes of vomiting; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever) and VOMITING (2 episodes of vomiting) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNEA (mild shortness of breath,), INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). On 16-Apr-2021, DYSPNEA (mild shortness of breath,) and COUGH (cough) outcome was unknown and INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (Fever), VOMITING (2 episodes of vomiting), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) had resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Hives all over the body; Fatigue; Headache; Chills; Muscle ache; Fever; Severe sore arm; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), URTICARIA (Hives all over the body), FATIGUE (Fatigue) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever). On 01-May-2021, the patient experienced URTICARIA (Hives all over the body). On 29-Apr-2021, PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever) had resolved. At the time of the report, URTICARIA (Hives all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl and Steroid No concomitant medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Hives all over the body; Fatigue; Headache; Chills; Muscle ache; Fever; Severe sore arm; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), URTICARIA (Hives all over the body), FATIGUE (Fatigue) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever). On 01-May-2021, the patient experienced URTICARIA (Hives all over the body). On 29-Apr-2021, PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever) had resolved. At the time of the report, URTICARIA (Hives all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl and Steroid No concomitant medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache/ headache never let up during the 25 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/ headache never let up during the 25 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 02-Feb-2010, Hypertension since 02-Feb-2010, Osteoporosis since 02-Feb-2010, Irritable bowel syndrome (IBS) since 02-Feb-2010, Chronic kidney disease since 19-Feb-2014, Latex allergy, Allergy to plants (Allergy to Mushrooms), Drug allergy (Allergy to Sulfa), Drug allergy (Allergy to Aspirin), Drug allergy (Allergy to Lisinopril), Drug allergy (Allergy to Amlodipine), Drug allergy (Allergy to Nsaids), Drug allergy (Allergy to Benadryl), Drug allergy (Allergy to Fenofibrate), Drug allergy (Allergy to Simvastatin), Allergy to antibiotic (Allergy to Erthromycin), Allergy to antibiotic (Allergy to Tetracycline) and Allergy to antibiotic (Allergy to Metronidazole). Concomitant products included VENLAFAXINE for Fibromyalgia, METOPROLOL TARTRATE and OLMESARTAN MEDOXOMIL for Hypertension, CHLORTHALIDONE for Kidney disorder, CYCLOBENZAPRINE HYDROCHLORIDE for Muscle spasm.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HEADACHE (Headache/ headache never let up during the 25 days). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Headache, at a dose of 1 dosage form every six hours. At the time of the report, HEADACHE (Headache/ headache never let up during the 25 days) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-106233 (E2B Linked Report). This case was linked to MOD-2021-106439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow-up information received on 06-JUN-2021 contains significant information: Added patient demographics, relevant medical history (allergies and current conditions), 1st dose and 2nd dose vaccine information, concomitant  medications and treatment medication. The outcome of the event (Headache) changed from unknown to resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106233:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Body was hurting; Temperature was little bit warm than normal; Little bit tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A.) 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 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On 05-May-2021, the patient experienced RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (Runny nose), MYALGIA (Body was hurting), PYREXIA (Temperature was little bit warm than normal), FATIGUE (Little bit tired) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence, Urticaria
Clinical narrative: Itchy hives which turned red,; Local reaction was 20cm longer in size; Headache; Tired and slept the whole day; slept the whole day; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the whole day), URTICARIA (Itchy hives which turned red,), URTICARIA (Local reaction was 20cm longer in size), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SOMNOLENCE (slept the whole day), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day). On 20-Apr-2021, the patient experienced URTICARIA (Itchy hives which turned red,) and URTICARIA (Local reaction was 20cm longer in size). On 16-Apr-2021, SOMNOLENCE (slept the whole day), HEADACHE (Headache) and FATIGUE (Tired and slept the whole day) had resolved. On 27-Apr-2021, URTICARIA (Itchy hives which turned red,) outcome was unknown and URTICARIA (Local reaction was 20cm longer in size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Took Levocetirizine and applied topical hydrocortisone
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Cough, Headache, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache and nausea in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A and 031B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache, nausea and pyrexia (fever 103.2ºF). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; Advil (ibuprofen) at an unspecified dose and frequency; and Motrin (ibuprofen) at an unspecified dose and frequency. At the time of the report, burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache, nausea and pyrexia (fever 103.2ºF) outcome: unknown. No concomitant medications provided. This case linked to MOD-2021-068272 (patient link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache and nausea in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A and 031B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache, nausea and pyrexia (fever 103.2ºF). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; Advil (ibuprofen) at an unspecified dose and frequency; and Motrin (ibuprofen) at an unspecified dose and frequency. At the time of the report, burning sensation (extreme burning), cough, abdominal discomfort (severe pain in abdomen burning pain), exploding headache, nausea and pyrexia (fever 103.2ºF) outcome: unknown. No concomitant medications provided. This case linked to MOD-2021-068272 (patient link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: He was feeling worse since the last report; using a walker again; He has lost 22 lbs; Hard time getting out of bed; Dizzy/dizziness; Ability to walk has been reduced; fatigue (he barely gets out of bed); Chills; Fever 102F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/dizziness), WALKING DISABILITY (Ability to walk has been reduced), FEELING ABNORMAL (He was feeling worse since the last report), WALKING AID USER (using a walker again) and WEIGHT DECREASED (He has lost 22 lbs) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (Fever 102F) and CHILLS (Chills). On 02-May-2021, the patient experienced DIZZINESS (Dizzy/dizziness), WALKING DISABILITY (Ability to walk has been reduced), WEIGHT DECREASED (He has lost 22 lbs) and FATIGUE (Hard time getting out of bed). 02-May-2021, the patient experienced FATIGUE (fatigue (he barely gets out of bed)). On 07-May-2021, the patient experienced FEELING ABNORMAL (He was feeling worse since the last report) and WALKING AID USER (using a walker again). The patient was treated with PARACETAMOL (TYLENOL) on 30-Apr-2021 for Fever and Chills, at a dose of 1 dosage form and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) on 02-May-2021 for Dizziness, at a dose of 1 dosage form. On 02-May-2021, PYREXIA (Fever 102F) had resolved. On 05-May-2021, WALKING DISABILITY (Ability to walk has been reduced) and FATIGUE (Hard time getting out of bed) had resolved. At the time of the report, DIZZINESS (Dizzy/dizziness), FEELING ABNORMAL (He was feeling worse since the last report), WALKING AID USER (using a walker again), WEIGHT DECREASED (He has lost 22 lbs), FATIGUE (fatigue (he barely gets out of bed)) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided Treatment included  fluids   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added four additional events Feeling abnormal, Walking aid user, Fatigue and Weight decreased On 07-May-2021: Follow-up document does not contain any new information On 10-Jun-2021: Follow-up document does not contain any new information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Walking aid user, Walking disability, Weight decreased
Clinical narrative: He was feeling worse since the last report; using a walker again; He has lost 22 lbs; Hard time getting out of bed; Dizzy/dizziness; Ability to walk has been reduced; fatigue (he barely gets out of bed); Chills; Fever 102F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/dizziness), WALKING DISABILITY (Ability to walk has been reduced), FEELING ABNORMAL (He was feeling worse since the last report), WALKING AID USER (using a walker again) and WEIGHT DECREASED (He has lost 22 lbs) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (Fever 102F) and CHILLS (Chills). On 02-May-2021, the patient experienced DIZZINESS (Dizzy/dizziness), WALKING DISABILITY (Ability to walk has been reduced), WEIGHT DECREASED (He has lost 22 lbs) and FATIGUE (Hard time getting out of bed). 02-May-2021, the patient experienced FATIGUE (fatigue (he barely gets out of bed)). On 07-May-2021, the patient experienced FEELING ABNORMAL (He was feeling worse since the last report) and WALKING AID USER (using a walker again). The patient was treated with PARACETAMOL (TYLENOL) on 30-Apr-2021 for Fever and Chills, at a dose of 1 dosage form and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) on 02-May-2021 for Dizziness, at a dose of 1 dosage form. On 02-May-2021, PYREXIA (Fever 102F) had resolved. On 05-May-2021, WALKING DISABILITY (Ability to walk has been reduced) and FATIGUE (Hard time getting out of bed) had resolved. At the time of the report, DIZZINESS (Dizzy/dizziness), FEELING ABNORMAL (He was feeling worse since the last report), WALKING AID USER (using a walker again), WEIGHT DECREASED (He has lost 22 lbs), FATIGUE (fatigue (he barely gets out of bed)) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided Treatment included  fluids   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added four additional events Feeling abnormal, Walking aid user, Fatigue and Weight decreased On 07-May-2021: Follow-up document does not contain any new information On 10-Jun-2021: Follow-up document does not contain any new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Erythema, Fatigue, Vaccination site pain
Clinical narrative: loss stool; tired; not much energy; injection site was a little more sore; redness; injection site got full blow; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore) and ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow). At the time of the report, DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: loss stool; tired; not much energy; injection site was a little more sore; redness; injection site got full blow; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore) and ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow). At the time of the report, DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Myalgia, Pyrexia
Clinical narrative: Bone pain; Body pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), MYALGIA (Body pain), FATIGUE (Fatigue) and PYREXIA (Fever) 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 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 BONE PAIN (Bone pain), MYALGIA (Body pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BONE PAIN (Bone pain), MYALGIA (Body pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Feeling hot, Headache
Clinical narrative: bunch of different symptoms; hot; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bunch of different symptoms), FEELING HOT (hot), HEADACHE (headache) and CHILLS (Chills) 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 ADVERSE REACTION (bunch of different symptoms), FEELING HOT (hot), HEADACHE (headache) and CHILLS (Chills). At the time of the report, ADVERSE REACTION (bunch of different symptoms), FEELING HOT (hot), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-106167, MOD21-086829, US-MODERNATX, INC.-MOD-2021-106439 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106167: MOD21-086829: US-MODERNATX, INC.-MOD-2021-106439:sibiling case
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (FEVER) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided    No concomitant details were provided No treatment details were provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Fatigue, Pyrexia
Clinical narrative: a lot more tired; no energy; redness spread all the way under her right arm; At the injection on her right arm; there was a knot that was hard; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            treatment given included Sama-HC .
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a lot more tired; no energy; redness spread all the way under her right arm; At the injection on her right arm; there was a knot that was hard; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            treatment given included Sama-HC .
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site it is swollen; injection site it is hot; injection site it is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red). At the time of the report, VACCINATION SITE SWELLING (injection site it is swollen), VACCINATION SITE WARMTH (injection site it is hot) and VACCINATION SITE ERYTHEMA (injection site it is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Vertigo
Clinical narrative: Really dizzy; Can barely stand; Feels room is spinning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALLOPURINOL for Product used for unknown indication, DILTIAZEM HCL, FINASTERIDE, ROSUVASTATIN, TAMSULOSIN and IRBESARTAN for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning) outcome was unknown. Not Provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection Site Itching very much; Injection Site Hard to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch) in a 60-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 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch). At the time of the report, VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19 after receiving the first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID-19 after receiving the first dose of 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced COVID-19 (diagnosed with COVID-19 after receiving the first dose of vaccine). At the time of the report, COVID-19 (diagnosed with COVID-19 after receiving the first dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: Leg pain; Back pain; dizziness; warm; redness; pain at injection site right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm). At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Leg pain; Back pain; dizziness; warm; redness; pain at injection site right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-May-2021 and was forwarded to Moderna on 05-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), BACK PAIN (Back pain), DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm). At the time of the report, DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at injection site right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Virus test positive) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue
Clinical narrative: Chills; fatigue; stomach upset; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset). At the time of the report, CHILLS (Chills), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (stomach upset) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Gout, Lymphatic disorder
Clinical narrative: Chronic gout sever flareup; pain in joints; Difficulty walking; Swollen left arm; arm was still red and hot to touch; problem with lymphatics, fluid were not moving; hot to touch; Patient was not able to move left arm; Rash on left arm; Second shot postponed for 67days; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Patient was not able to move left arm), RASH (Rash on left arm), PERIPHERAL SWELLING (Swollen left arm), ERYTHEMA (arm was still red and hot to touch) and GOUT (Chronic gout sever flareup) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Gout. Concomitant products included Diltiazem                                                      Hypertension, carafate                                                       Acid reflux and Atenolol                                                       Hypertension for an unknown indication.    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 MOBILITY DECREASED (Patient was not able to move left arm), RASH (Rash on left arm) and PRODUCT DOSE OMISSION ISSUE (Second shot postponed for 67days). On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen left arm), ERYTHEMA (arm was still red and hot to touch), LYMPHATIC DISORDER (problem with lymphatics, fluid were not moving) and SKIN WARM (hot to touch). On 03-Apr-2021, the patient experienced GOUT (Chronic gout sever flareup), ARTHRALGIA (pain in joints) and GAIT DISTURBANCE (Difficulty walking). At the time of the report, MOBILITY DECREASED (Patient was not able to move left arm), RASH (Rash on left arm), PERIPHERAL SWELLING (Swollen left arm), ERYTHEMA (arm was still red and hot to touch), GOUT (Chronic gout sever flareup), ARTHRALGIA (pain in joints), GAIT DISTURBANCE (Difficulty walking), PRODUCT DOSE OMISSION ISSUE (Second shot postponed for 67days), LYMPHATIC DISORDER (problem with lymphatics, fluid were not moving) and SKIN WARM (hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.