chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Costochondritis, Electrocardiogram, Feeling abnormal
Clinical narrative: Waking up at night around 4 AM; Stinging sensation; Costochondritis between her ribs; Chest discomfort; Feels like a burning sensation; Woke up a few times with her heart going fast; Feeling like it is vibrating; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast) and FEELING ABNORMAL (Feeling like it is vibrating) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F218, 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    No medical history information was not provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE, TOLTERODINE L-TARTRATE (DETROL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 04-Sep-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 started NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On 09-Sep-2021, the patient experienced MIDDLE INSOMNIA (Waking up at night around 4 AM) and PAIN (Stinging sensation). In September 2021, the patient experienced CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating) and COSTOCHONDRITIS (Costochondritis between her ribs). At the time of the report, MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating), PAIN (Stinging sensation) and COSTOCHONDRITIS (Costochondritis between her ribs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Electrocardiogram: perfectly fine with no changes (normal) perfectly fine with no changes.         Patient had been careful with her activities, and had been increasing her anti-inflammatory medications. She mentioned that had been going on for 19 days, and it has not gone away yet.   This case was linked to MOD-2021-329349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant FU appended, Event was added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Pain, Palpitations
Clinical narrative: Waking up at night around 4 AM; Stinging sensation; Costochondritis between her ribs; Chest discomfort; Feels like a burning sensation; Woke up a few times with her heart going fast; Feeling like it is vibrating; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast) and FEELING ABNORMAL (Feeling like it is vibrating) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F218, 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    No medical history information was not provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE, TOLTERODINE L-TARTRATE (DETROL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 04-Sep-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 started NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On 09-Sep-2021, the patient experienced MIDDLE INSOMNIA (Waking up at night around 4 AM) and PAIN (Stinging sensation). In September 2021, the patient experienced CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating) and COSTOCHONDRITIS (Costochondritis between her ribs). At the time of the report, MIDDLE INSOMNIA (Waking up at night around 4 AM), CHEST DISCOMFORT (Chest discomfort), BURNING SENSATION (Feels like a burning sensation), PALPITATIONS (Woke up a few times with her heart going fast), FEELING ABNORMAL (Feeling like it is vibrating), PAIN (Stinging sensation) and COSTOCHONDRITIS (Costochondritis between her ribs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Electrocardiogram: perfectly fine with no changes (normal) perfectly fine with no changes.         Patient had been careful with her activities, and had been increasing her anti-inflammatory medications. She mentioned that had been going on for 19 days, and it has not gone away yet.   This case was linked to MOD-2021-329349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant FU appended, Event was added
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that issue was on 7/22/21 involved 2 vials of lot 17C21A.On that date, upon review of his  notes, the unit alarmed at -14.9C and was above for 15 minutes when vials were removed to secondary unit for 24 hours and maintained at -17C to -22C. This issue was actually due to a freezer pack leak that froze the element in the primary unit. The vials were kept in the secondary unit while the primary unit defrosted and was reset. This was the date of the incident where a thawed freezer pack was placed against the sensor. It was reported that manual thermometer on that freezer unit showed -19C, so no action was taken.The two vials of lot 17C21A remained in the primary freezer unit and the digital reader was reset.  Had the secondary freezer unit on site. With previous excursion, primary freezer alarmed at -14.6C and vials were immediately moved to secondary unit (move took less than 30 seconds) and maintained at -18C. With this excursion, the primary freezer unit was left open and alarmed at -14.7C. The same procedure was followed and our one remaining vial was immediately moved to the secondary freezer and maintained at -18C.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received on 30-September-2021 contains ADR form
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Inappropriate schedule of product administration
Clinical narrative: today she is noticing that she is retaining alot of fluid; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (today she is noticing that she is retaining alot of fluid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Hypertension and Thyroid disorder NOS (Thyroid). Concomitant products included FLUOROURACIL, FOLINIC ACID, OXALIPLATIN (FOLFOX), LEVOTHYROXINE, ROSUVASTATIN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced FLUID RETENTION (today she is noticing that she is retaining alot of fluid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FLUID RETENTION (today she is noticing that she is retaining alot of fluid) outcome was unknown. No treatment medications were reported. Patient reported cholesterol as medical history. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up appended.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Musculoskeletal discomfort
Clinical narrative: Very low platelets; Hard time walking; back problems; This spontaneous case was reported by a patient and describes the occurrence of PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20O) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Breast Cancer). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, PRAVASTATIN for Cholesterol, COLECALCIFEROL (VITAMIN D3), MENATETRENONE (VITAMIN K2 TOWA), COLECALCIFEROL, UBIDECARENONE (COQ10+D), MAGNESIUM, CLONAZEPAM, PARACETAMOL (TYLENOL) and HYDROCODONE for an unknown indication.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems). At the time of the report, PLATELET COUNT DECREASED (Very low platelets), GAIT DISTURBANCE (Hard time walking) and MUSCULOSKELETAL DISCOMFORT (back problems) outcome was unknown.            Treatment information include patient took 40 mg of prednisone for two weeks, then 20mg for 2 weeks, then alternate each day with 10mg one day and 5 mg the other day for 2 more weeks.; Sender's Comments: This case concerns a 87 year old female with relevant medical history of Breast Cancer who experienced the unexpected events of decreased platelet count, Gait disturbance and musculoskeletal discomfort which happened on an unknown date after vaccinaton with Moderna vaccine. The rechallenge for this case is unknown since there is no information re the first dose. The age and medical condition Breast carcinoma can be considered confounders for this case. The benefit -risk relationship of Moderna is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Got a little throbbing under my arm where the lymph nodes were removed; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer. Concomitant products included TAMOXIFEN for Breast cancer. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed). The patient was treated with CISAPRIDE (MOBID) for Adverse event, at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (Got a little throbbing under my arm where the lymph nodes were removed) outcome was unknown. Treatment details included heating pad for pain in ears and drinking a lot of liquids. This case was linked to MOD-2021-330647.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Intentional product use issue, Myalgia, Pain in extremity
Clinical narrative: He got a third shot prior to approval; Lousy; Arms hurt/sore arm; Couldn't lift his arm; felt tired; arms hurt/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm) and FATIGUE (felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 004M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transient ischemic attacks and Enlarged prostate. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Transient ischemic attacks.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval) had resolved. On 24-Sep-2021, FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients Medical History information reported possible prostate cancer issues, and several aneurysms. Treatment medication reported included arthritis strength Tylenol.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: He got a third shot prior to approval; Lousy; Arms hurt/sore arm; Couldn't lift his arm; felt tired; arms hurt/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm) and FATIGUE (felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 004M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transient ischemic attacks and Enlarged prostate. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN for High cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Transient ischemic attacks.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval), FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (He got a third shot prior to approval) had resolved. On 24-Sep-2021, FEELING ABNORMAL (Lousy), PAIN IN EXTREMITY (Arms hurt/sore arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift his arm), FATIGUE (felt tired) and MYALGIA (arms hurt/sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients Medical History information reported possible prostate cancer issues, and several aneurysms. Treatment medication reported included arthritis strength Tylenol.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: felt of balance and like they could fall over; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Mezotrace for an unknown indication.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy). At the time of the report, BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy) outcome was unknown.            No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia, Pain, Product storage error, Vaccination site pain
Clinical narrative: recurring ache/ soreness; extreme pain; burning sensation; told that May be the vaccine was still frozen; sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme pain), BURNING SENSATION (burning sensation), PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen), MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot) and VACCINATION SITE PAIN (recurring ache/ soreness) 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 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (extreme pain), BURNING SENSATION (burning sensation), PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen) and MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (recurring ache/ soreness). On 22-Mar-2021, PAIN (extreme pain), BURNING SENSATION (burning sensation) and PRODUCT STORAGE ERROR (told that May be the vaccine was still frozen) had resolved. At the time of the report, MYALGIA (sore arm for several days/sore arm for several days after, but the same as I experienced after the first shot) and VACCINATION SITE PAIN (recurring ache/ soreness) outcome was unknown.            Patient stated that he experienced sore arm when he had his first shot for flu Concomitant and Treatment was not specified.    This case was linked to MOD-2021-331581 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site swelling
Clinical narrative: little swelling in the arm; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) and VACCINATION SITE SWELLING (little swelling in the arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced VACCINATION SITE SWELLING (little swelling in the arm). In September 2021, the patient experienced TACHYCARDIA (tachycardia). In September 2021, VACCINATION SITE SWELLING (little swelling in the arm) had resolved. At the time of the report, TACHYCARDIA (tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided. Patient has never experienced something like that in his life, he's very healthy and doesn't have any medical condition nor takes any specific medication.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder pain, Chills, Dysuria, Fatigue, Headache
Clinical narrative: When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection; Headaches; Chills; severe muscle aches; Felt like she had the flu; Bladder hurt so bad; So sick; Sore Arm; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ILLNESS (So sick), INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad) and DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 706-042) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and FATIGUE (Fatigue). On 23-Sep-2021, the patient experienced ILLNESS (So sick). On 23-Sep-2021 at 1:00 PM, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches). On an unknown date, the patient experienced DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection). The patient was treated with PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) for Adverse event, at an unspecified dose and frequency; CRANBERRY [VACCINIUM MACROCARPON] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Sep-2021 at 1:00 PM, FATIGUE (Fatigue) had resolved. On 24-Sep-2021, PAIN IN EXTREMITY (Sore Arm) and ILLNESS (So sick) had resolved. On 24-Sep-2021 at 9:00 AM, INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she has no other underlying illnesses. Patient also used cold packs for treatment of adverse event.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection; Headaches; Chills; severe muscle aches; Felt like she had the flu; Bladder hurt so bad; So sick; Sore Arm; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ILLNESS (So sick), INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad) and DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 706-042) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and FATIGUE (Fatigue). On 23-Sep-2021, the patient experienced ILLNESS (So sick). On 23-Sep-2021 at 1:00 PM, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches). On an unknown date, the patient experienced DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection). The patient was treated with PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) for Adverse event, at an unspecified dose and frequency; CRANBERRY [VACCINIUM MACROCARPON] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Sep-2021 at 1:00 PM, FATIGUE (Fatigue) had resolved. On 24-Sep-2021, PAIN IN EXTREMITY (Sore Arm) and ILLNESS (So sick) had resolved. On 24-Sep-2021 at 9:00 AM, INFLUENZA LIKE ILLNESS (Felt like she had the flu), BLADDER PAIN (Bladder hurt so bad), DYSURIA (When she would urinate she would have chills running throughout her whole body. but she did not have a bladder infection), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (severe muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she has no other underlying illnesses. Patient also used cold packs for treatment of adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.) 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 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 VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.). At the time of the report, VACCINATION COMPLICATION (Patient left a voicemail stating that after receiving the Moderna covid19 vaccine she has have side effects that coincidences with it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Somnolence
Clinical narrative: she goes to sleep every time she sits out; her back is hurting; Felling tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she goes to sleep every time she sits out), BACK PAIN (her back is hurting) and FATIGUE (Felling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    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 SOMNOLENCE (she goes to sleep every time she sits out), BACK PAIN (her back is hurting) and FATIGUE (Felling tired). At the time of the report, SOMNOLENCE (she goes to sleep every time she sits out), BACK PAIN (her back is hurting) and FATIGUE (Felling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vertigo
Clinical narrative: covid arm after first dose; vertigo before the second dose, the same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm after first dose) and VERTIGO (vertigo before the second dose, the same day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VERTIGO (vertigo before the second dose, the same day). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm after first dose). At the time of the report, VACCINATION SITE REACTION (covid arm after first dose) outcome was unknown and VERTIGO (vertigo before the second dose, the same day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported. Caller said she has conditions that would make her fall into the immunocompromised category.   This case was linked to MOD-2021-331271 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptoms after getting her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms after getting her second dose) 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 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms after getting her second dose). At the time of the report, VACCINATION COMPLICATION (Symptoms after getting her second dose) outcome was unknown.            No concomitant medications were reported.  No treatment information were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she felt crappy for a full 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt bad for a full 24 hours) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (About 9 months ago). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (she felt bad for a full 24 hours). At the time of the report, MALAISE (she felt bad for a full 24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take Vyvanse during the shot.  Treatment information was not provided.   This case was linked to MOD-2021-331669 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin rush all over their body; This spontaneous case was reported by a patient and describes the occurrence of SKIN REACTION (skin rush all over their body) 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 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 SKIN REACTION (skin rush all over their body). At the time of the report, SKIN REACTION (skin rush all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: swelling on her eyes; Broke out  to a rush all over; Face swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swell up), EYE SWELLING (swelling on her eyes) and RASH (Broke out  to a rush all over) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051e21a and 038b21a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included GABAPENTIN, ALPRAZOLAM (XANAX), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and OXYCODONE for an unknown indication.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced SWELLING FACE (Face swell up) and RASH (Broke out  to a rush all over). On an unknown date, the patient experienced EYE SWELLING (swelling on her eyes). At the time of the report, SWELLING FACE (Face swell up), EYE SWELLING (swelling on her eyes) and RASH (Broke out  to a rush all over) outcome was unknown.            Concomitant medications includes ProAir and Med for arthritis. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Reporter details, Patient age and gender , Concomitant medications, dose 1 and dose 2 details were updated. Event start dates were updated and events added.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Inappropriate schedule of product administration, Rash, Urticaria
Clinical narrative: rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body; breaking out on hives; Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs; second dose on day 39 after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out on hives), ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs), RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose). On 24-Sep-2021, the patient experienced URTICARIA (breaking out on hives) and ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs). On 25-Sep-2021, the patient experienced RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose) had resolved. At the time of the report, URTICARIA (breaking out on hives), ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs) and RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body) outcome was unknown.            No Concomitant medications were reported. Other Treatment medications include Anti-itch cream. Patient reported that after taking second dose he started breaking out on hives, a rash. It started on his forearm and back and this morning spread to the rest of his body. He has raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) 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 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 VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Increasingly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Increasingly nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced NAUSEA (Increasingly nauseous). At the time of the report, NAUSEA (Increasingly nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient got a full dose as a booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient got a full dose as a booster) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient got a full dose as a booster). At the time of the report, ACCIDENTAL OVERDOSE (Patient got a full dose as a booster) outcome was unknown.            Concomitant medications were not reported. Treatment details were not provided. A patient's has an underlying condition.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Dyspnoea, Myalgia
Clinical narrative: having shortens of breath; cold  sweat; low temperature of 96.4°F; chills; felling  nauseas; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F) and NAUSEA (felling  nauseas) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F), NAUSEA (felling  nauseas) and MYALGIA (body aches). At the time of the report, DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F), NAUSEA (felling  nauseas) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.4 (Low) 96.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2021: Significant follow-up received on 27-Sep: Reporter last name corrected. Event (body ache, cold sweat) added.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: having shortens of breath; cold  sweat; low temperature of 96.4°F; chills; felling  nauseas; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F) and NAUSEA (felling  nauseas) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F), NAUSEA (felling  nauseas) and MYALGIA (body aches). At the time of the report, DYSPNOEA (having shortens of breath), COLD SWEAT (cold  sweat), CHILLS (chills), HYPOTHERMIA (low temperature of 96.4°F), NAUSEA (felling  nauseas) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.4 (Low) 96.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2021: Significant follow-up received on 27-Sep: Reporter last name corrected. Event (body ache, cold sweat) added.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered on 15-Jun-2021, 4 days from first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered on 15-Jun-2021, 4 days from first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided; Sender's Comments: This is a case of expired vaccine used for this 68-year-old subject of unknown gender with unknown medical history, who experienced no adverse events after the expired vaccine was administered. The medication error occurred during the administration of a dose of Spikevax. The rechallenge was not applicable, as this is a case of medication error. The benefit-risk relationship of Spikevax in not affected by this report.