chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Presyncope
Clinical narrative: chest pain; dizziness; "feel like I am going to stop breathing"/short of breath/I can't breath; "I can't walk"; feel like I'm going to faint; I can't stand up; excruciating pain,intolerable pain; body pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN, DIZZINESS, DYSPNOEA, GAIT INABILITY, and PRESYNCOPE in an 84-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 Head injury in October 2021 and COVID-19 in November 2020. Concurrent medical conditions included Atrial fibrillation, Heart murmur, Blood pressure high and Chest pain.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced CHEST PAIN, DIZZINESS, DYSPNOEA, GAIT INABILITY, PRESYNCOPE, MOBILITY DECREASED, PAIN, and MYALGIA. At the time of the report, CHEST PAIN, DIZZINESS, DYSPNOEA, and GAIT INABILITY had not resolved and PRESYNCOPE, MOBILITY DECREASED, PAIN, and MYALGIA outcome was unknown.            Treatment medications included Pain pill. Concomitant medications included Blood pressure medication, Water pill, and Something to go to the bathroom. Patient does not have history of myocarditis and pericarditis. Patient said that had chest pain normally but now has 3 times the usual chest pain. The symptoms started 1.5 hours after booster dose was given.   This case was linked to MOD-2021-048169 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 08-Nov-2021 the Follow up received on 08-Nov-2021 included addition of new events extreme side effects, body pain, I can't stand up, feel like I'm going to faint, excruciating pain, and intolerable pain.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: achiness; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and CHILLS (lots of 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PAIN (achiness) and CHILLS (lots of chills). At the time of the report, PAIN (achiness) and CHILLS (lots of chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up includes; Reporter information, Patient details, event verbatim and outcome updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia, Pyrexia
Clinical narrative: low grade fever; diarrhea; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), DIARRHOEA (diarrhea) and MYALGIA (aches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 016M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever), DIARRHOEA (diarrhea) and MYALGIA (aches). At the time of the report, PYREXIA (low grade fever), DIARRHOEA (diarrhea) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Mobility decreased
Clinical narrative: difficult to move/difficult to walk; sweating, wrenched in sweat; low grade fever; body aches; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches) and CHILLS (chills, could not get warm, bone chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21 and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood transfusion (blood transfusion as an infant.) and Lumpectomy (breast cancer) (breast lumpectomy.). Concurrent medical conditions included Immunocompromised (complications her whole life for being immunocompromised), Obesity (Over weight), Smoker (Smoker) and Dermatitis (skin issues (dermatitis)).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and VACCINATION SITE PAIN (sore arm). At the time of the report, MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            Cholesterol pills, fish oil supplement, she gets once or twice a year a shot for osteoporosis, ointments for dermatitis issues- were used as concomitant medications.  No treatment medication was provided.   This case was linked to MOD-2021-377795, MOD-2021-377778, MOD-2021-377785 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: difficult to move/difficult to walk; sweating, wrenched in sweat; low grade fever; body aches; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches) and CHILLS (chills, could not get warm, bone chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21 and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood transfusion (blood transfusion as an infant.) and Lumpectomy (breast cancer) (breast lumpectomy.). Concurrent medical conditions included Immunocompromised (complications her whole life for being immunocompromised), Obesity (Over weight), Smoker (Smoker) and Dermatitis (skin issues (dermatitis)).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and VACCINATION SITE PAIN (sore arm). At the time of the report, MOBILITY DECREASED (difficult to move/difficult to walk), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), MYALGIA (body aches), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            Cholesterol pills, fish oil supplement, she gets once or twice a year a shot for osteoporosis, ointments for dermatitis issues- were used as concomitant medications.  No treatment medication was provided.   This case was linked to MOD-2021-377795, MOD-2021-377778, MOD-2021-377785 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move and walk; difficult to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills) and HEADACHE (headache, hit like a ton of bricks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast lump (breast limpectomy). Concurrent medical conditions included Blood transfusion (Blood transfusion as an infant), Immunocompromised, Overweight, Smoker and Dermatitis.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk). At the time of the report, VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk) was resolving.            cholesterol pills, fish oil supplement, she gets once or twice a year a shot for osteoporosis, ointments for dermatitis issues are concomitant drugs and no treatment are provided.   This case was linked to MOD-2021-377322 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Vaccination site pain
Clinical narrative: sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move and walk; difficult to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills) and HEADACHE (headache, hit like a ton of bricks) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast lump (breast limpectomy). Concurrent medical conditions included Blood transfusion (Blood transfusion as an infant), Immunocompromised, Overweight, Smoker and Dermatitis.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk). At the time of the report, VACCINATION SITE PAIN (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move and walk) and GAIT DISTURBANCE (difficult to walk) was resolving.            cholesterol pills, fish oil supplement, she gets once or twice a year a shot for osteoporosis, ointments for dermatitis issues are concomitant drugs and no treatment are provided.   This case was linked to MOD-2021-377322 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication
Clinical narrative: Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021; Vaccine side affects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccine side affects) and EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021). In November 2021, the patient experienced VACCINATION COMPLICATION (Vaccine side affects). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna booster shot 08-Nov-2021, which expired on 06-Nov-2021) had resolved. At the time of the report, VACCINATION COMPLICATION (Vaccine side affects) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported  Vaccine was kept in refrigerator on 07-Nov-2021 at 39.0 of temperature.  Patient was doing well and was having the normal vaccine side effects, feels like it felt the last two times.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received: Patient demographic details (ethnicity and race), product anatomical location and new event with outcome was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Headache, Insomnia, Pain in extremity, Speech disorder
Clinical narrative: arm continues to be sore; headache; delirious; talking nonsense/speech did not make sense; unable to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 022L20A and 602A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (unable to fall asleep). On 07-Nov-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant) and SPEECH DISORDER (talking nonsense/speech did not make sense). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm continues to be sore) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 06-Nov-2021, INSOMNIA (unable to fall asleep) had resolved. At the time of the report, DELIRIUM (delirious) outcome was unknown, SPEECH DISORDER (talking nonsense/speech did not make sense) was resolving and PAIN IN EXTREMITY (arm continues to be sore) and HEADACHE (headache) had not resolved.            Patient reported that she decided to not take her Celebrex the night she received the booster dose of the vaccine.  Company Comment This case concerns a 59-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of delirium. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378066, MOD-2021-378105 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of delirium. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Loss of consciousness, Pain in extremity
Clinical narrative: Passed out for 1 minute after booster shot; Both her arms hurt bad after booster shot; Lower back pain after booster shot; Felt bad after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Blood pressure high and High cholesterol.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FEELING ABNORMAL (Felt bad after booster shot). On 06-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot) (seriousness criterion medically significant), PAIN IN EXTREMITY (Both her arms hurt bad after booster shot) and BACK PAIN (Lower back pain after booster shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot), FEELING ABNORMAL (Felt bad after booster shot), PAIN IN EXTREMITY (Both her arms hurt bad after booster shot) and BACK PAIN (Lower back pain after booster shot) outcome was unknown.            No concurrent and treatment medication was reported by patient. Patient had not seen a doctor.  Company's comment: This case concerns a 64 year-old female patient with a history of hypertension and hypothyroidism who experienced the unexpected serious event of loss of consciousness. The event occurred approximately 2 days after the third dose of mRNA-1273.   The rechallenge was not applicable as no additional dosing will be administered. The medical history of hypertension and hypothyroidism remain confounders for loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378085 (Patient Link).; Sender's Comments: This case concerns a 64 year-old female patient with a history of hypertension and hypothyroidism who experienced the unexpected serious event of loss of consciousness. The event occurred approximately 2 days after the third dose of mRNA-1273.   The rechallenge was not applicable as no additional dosing will be administered. The medical history of hypertension and hypothyroidism remain confounders for loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Cefdinir). Concomitant products included LISINOPRIL from 2017 to an unknown date for Blood pressure high, VITAMINS NOS for Vitamin supplementation, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 2002 to an unknown date and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) from 2015 to an unknown date for an unknown indication.    On 14-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021 at 3:00 PM, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Pain in arm and Headache, at an unspecified dose and frequency. On 15-Jan-2021, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) to be possibly related.    Patient had taken bed rest and the headache (normal) and a sore arm (that resolved) went away within a day or two.   This case was linked to MOD-2021-378089, MOD-2021-378123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received and it contains significant information. Patient Age, Height, weight, Race, Ethnicity was updated. Patient medical history was added. Indication, Dose, Route for concomitant medication was updated. Treatment drug was captured. Events onset date and stop date, Outcome was updated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received on Nov 8th 2021 a dose expired on Nov 6th 2021; Patient was 17 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received on Nov 8th 2021 a dose expired on Nov 6th 2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 doses of a Moderna Covid19 Vaccine that expired on 6Nov2021 were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vial was initially stored in the refrigerator on 5 Nov 2021.   This case was linked to MOD-2021-381146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received and it contains information about patient and vaccine were updated. On 11-Nov-2021: Non significant follow up appended
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain
Clinical narrative: Afib; chest pains which kept him tossing and turning.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and CHEST PAIN (chest pains which kept him tossing and turning.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003AUA and 029L2CA) for COVID-19 vaccination.     The patient's past medical history included AFib.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization, medically significant and life threatening) and CHEST PAIN (chest pains which kept him tossing and turning.) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized from 25-Oct-2021 to 26-Oct-2021 due to ATRIAL FIBRILLATION and CHEST PAIN. On 26-Oct-2021, ATRIAL FIBRILLATION (Afib) and CHEST PAIN (chest pains which kept him tossing and turning.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication included IVs and patient cannot recall the names of any medications used in hospital.  Lab data include complete panel blood test and stress test with inconclusive result. Patient did not had any reactions to first and second dose. Also, patient has no previous diagnosis of covid.  Company comment; This case concerns a 73-year old, male subject with a medical history of atrial fibrillation, who experienced the serious unexpected events of Chest pain and Atrial fibrillation(AESI). The events, which resulted in hospitalization, occurred 2 days after the administration of a booster dose of mRNA-1273 vaccine. At the time of the report, outcome of the events was Recovered/Resolved. The rechallenge is not applicable as no additional dose is expected. The patient's age and medical history of atrial fibrillation remain as confounders. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 73-year old, male subject with a medical history of atrial fibrillation, who experienced the serious unexpected events of Chest pain and Atrial fibrillation(AESI). The events, which resulted in hospitalization, occurred 2 days after the administration of a booster dose of mRNA-1273 vaccine. At the time of the report, outcome of the events was Recovered/Resolved. The rechallenge is not applicable as no additional dose is expected. The patient's age and medical history of atrial fibrillation remain as confounders. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        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 provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-378221 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non Significant Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-378221:MOD21-162338 (Crosslinked)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided.  Treatment information was not provided.   This case was linked to MOD-2021-378310 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: awful chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (awful chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 026a21a and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (awful chills). At the time of the report, CHILLS (awful chills) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-378388 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side; arm is still little sore; swollen pretty much in the side that got the shot; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side), VACCINATION SITE PAIN (arm is still little sore) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPCID), MELOXICAM, ALPRAZOLAM (XANAX), LORATADINE (CLARITIN [LORATADINE]), VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side), VACCINATION SITE PAIN (arm is still little sore) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot). At the time of the report, SWELLING (swollen in the left side of the neck, from where bra stripe goes to the neck is really swollen/swollen but little bit on the other side) and VACCINATION SITE SWELLING (swollen pretty much in the side that got the shot) outcome was unknown and VACCINATION SITE PAIN (arm is still little sore) had not resolved.            Concomitant medication include Pepcid. No treatment information was reported Patient has got her vaccine on non dominant, upper arm.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant woman received vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant woman received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.  Company comment: This spontaneous case of maternal exposure during pregnancy concerns a female patient with no relevant medical history reported.  There were no associated adverse events. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case of maternal exposure during pregnancy concerns a female patient with no relevant medical history reported.  There were no associated adverse events. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Dizzy/ Could not stand up; Had to crawl from apartment to another to get help; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ Could not stand up) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) 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 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced DIZZINESS (Dizzy/ Could not stand up) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) (seriousness criterion hospitalization). The patient was hospitalized on 04-Nov-2021 due to DIZZINESS and GAIT DISTURBANCE. At the time of the report, DIZZINESS (Dizzy/ Could not stand up) and GAIT DISTURBANCE (Had to crawl from apartment to another to get help) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.  Since 04-Nov-2021, the patient was hospitalized. Patient was dizzy, could not stand up and had to crawl from apartment to another to get help.  Company comment: This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Dizziness and Gait disturbance. The events occurred the same day after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. It was reported that patient received a dose on 4Nov2021, and has been in the hospital since then. Patient was dizzy and couldn't stand up. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Dizziness and Gait disturbance. The events occurred the same day after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. It was reported that patient received a dose on 4Nov2021, and has been in the hospital since then. Patient was dizzy and couldn't stand up. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site rash
Clinical narrative: Blotches of rash; A mild case of Moderna arm defined as a rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotches of rash) and VACCINATION SITE RASH (A mild case of Moderna arm defined as a rash on the injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Blotches of rash) and VACCINATION SITE RASH (A mild case of Moderna arm defined as a rash on the injection arm). At the time of the report, RASH MACULAR (Blotches of rash) and VACCINATION SITE RASH (A mild case of Moderna arm defined as a rash on the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain, Vaccination site pain
Clinical narrative: Pain in the back of my neck; chills; Pain in the arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 046B21A and D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in the back of my neck), CHILLS (chills), VACCINATION SITE PAIN (Pain in the arm) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant products included diabetes medication, asthma medication,cholesterol medication,blood pressure medication   This case was linked to MOD-2021-379422, MOD-2021-379421 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D21A, 046B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Cholesterol and Blood pressure high.   On 19-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 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Blood glucose: high (High) blood sugar was over 600.         Concomitant medications included diabetes medication, asthma medication, cholesterol medication and blood pressure medication. No treatment information were provided.  The patient got vaccine shot at around 11 A.M and by dinner time, the patient's blood sugar was over 600, and it stayed that way for about a day and a half, until it went back down on its own. Patient reported that the patient never got that sugar level high up even considering when the patient was sick.   This case was linked to MOD-2021-379419, MOD-2021-379421 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021 at 4:01 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021 at 4:01 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days). On 10-Sep-2021 at 4:01 PM, EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days) to have an unknown relationship.    No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Non significant follow up
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021 at 2:49 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021 at 2:49 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days). On 15-Sep-2021 at 2:49 PM, PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2021-322337, MOD-2021-322483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received contains added patient DOB and initials.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received first dose from vial refrigerated more than 30 days; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05ZEZ1A and 011FZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021 at 2:59 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 4:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (received first dose from vial refrigerated more than 30 days) to have an unknown relationship.    No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Reporter and patient initials updated. Batch number and expiry date of the suspect updated.