chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Muscular weakness
Clinical narrative: Fever; Headache; Chills; cold; Muscle weakness; muscle weakness; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), MUSCULAR WEAKNESS (muscle weakness), the second episode of PYREXIA (Fever) and the second episode of HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), the first episode of PYREXIA (Fever), the first episode of CHILLS (Chills) and the first episode of HEADACHE (Headache). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the second episode of PYREXIA (Fever), the second episode of HEADACHE (Headache) and the second episode of CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Mar-2021, MUSCULAR WEAKNESS (muscle weakness) had resolved. On 09-Apr-2021, FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the last episode of PYREXIA (Fever), the last episode of HEADACHE (Headache) and the last episode of CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 103 (High) 103.         Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-MAY-2021. ADR form was received. Added patient details and medical history.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Chills; cold; Muscle weakness; muscle weakness; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), MUSCULAR WEAKNESS (muscle weakness), the second episode of PYREXIA (Fever) and the second episode of HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), the first episode of PYREXIA (Fever), the first episode of CHILLS (Chills) and the first episode of HEADACHE (Headache). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the second episode of PYREXIA (Fever), the second episode of HEADACHE (Headache) and the second episode of CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Mar-2021, MUSCULAR WEAKNESS (muscle weakness) had resolved. On 09-Apr-2021, FEELING COLD (cold), MUSCULAR WEAKNESS (Muscle weakness), the last episode of PYREXIA (Fever), the last episode of HEADACHE (Headache) and the last episode of CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 103 (High) 103.         Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-MAY-2021. ADR form was received. Added patient details and medical history.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Felt Weak; Felt dizzy; Felt Nauseas; Had Chills; Had Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy), NAUSEA (Felt Nauseas), CHILLS (Had Chills) and PYREXIA (Had Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Had Chills) and PYREXIA (Had Fever). On 02-Apr-2021, the patient experienced ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy) and NAUSEA (Felt Nauseas). On 03-Apr-2021, ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy), NAUSEA (Felt Nauseas), CHILLS (Had Chills) and PYREXIA (Had Fever) had resolved.            The patient called to report possible adverse events that they experienced post receiving their second dose. On the same day, 01-Apr-2021 the patient experienced chills and fever. On 02-Apr-2021, the patient felt dizzy, weak, and nauseas. On 03-Apr-2021, the patient reported all of these adverse events subsided.  No Concomitant product use was reported.  The patient didn't take any treatment medication but drank some ginger ale to help with nausea.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema
Clinical narrative: Facial edema on right side involving the back jaw,ear and cheek; This spontaneous case was reported by a health care professional and describes the occurrence of FACE OEDEMA (Facial edema on right side involving the back jaw,ear and cheek) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FACE OEDEMA (Facial edema on right side involving the back jaw,ear and cheek). At the time of the report, FACE OEDEMA (Facial edema on right side involving the back jaw,ear and cheek) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's caretaker reported the patient took blood thinner concomitant medications.  The patient's caretaker reported the patient received treatment of diphenhydramine (Benadryl) prior to going to the emergency room. At the emergency room the patient received treatment of a steroid injection for his adverse event.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included INSULIN HUMAN (NOVOLIN R) and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient's COVID-19 test results were negative.. On an unknown date, Streptococcus test: (Negative) Patient's Strep test results were negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information was reported. The patient said that the vaccine had nothing to do with the bronchitis and she reported her doctor also said the same. Patient was scheduled to have a Cortisone shot as treatment but her doctor canceled the appointment as it conflicted with her second vaccine shot which was on same day.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: whiteness on their tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (whiteness on their tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.   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 TONGUE DISCOLOURATION (whiteness on their tongue). At the time of the report, TONGUE DISCOLOURATION (whiteness on their tongue) outcome was unknown.            Concomitant drugs were not reported. Treatment information was not provided.   This case was linked to MOD-2021-075749 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (shortness of breath) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 02-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031B21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, INSULIN DETEMIR (LEVEMIR) and INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 10R) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence, Tremor
Clinical narrative: little shaky; drowsiness; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, INSULIN DETEMIR (LEVEMIR) and INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, TREMOR (little shaky), SOMNOLENCE (drowsiness), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: White tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (White tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 TONGUE DISCOLOURATION (White tongue). At the time of the report, TONGUE DISCOLOURATION (White tongue) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-075727 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Device connection issue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingly; fever; headache; good quantity of the vaccine ran down the patients arm on to the floor; syringe came loss from the needle; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle) and HEADACHE (headache). On 14-Apr-2021, the patient experienced PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness), PARAESTHESIA (tingly) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medication included Women multivitamins, frequency 1 tab daily via oral route. Birth control pill frequency 1 tab daily via oral route.  No treatment drugs were provided.  Patient was treated for bilateral hand and feet cramping fever and stiffness with antipyretic fluid.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR form received included Patient demographic information. Information on suspect drug received. Additional events are added. Concomitant medication information added
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: numbness; tingly; fever; headache; good quantity of the vaccine ran down the patients arm on to the floor; syringe came loss from the needle; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle) and HEADACHE (headache). On 14-Apr-2021, the patient experienced PYREXIA (fever), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingly). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (good quantity of the vaccine ran down the patients arm on to the floor), DEVICE CONNECTION ISSUE (syringe came loss from the needle), PYREXIA (fever), HYPOAESTHESIA (numbness), PARAESTHESIA (tingly) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medication included Women multivitamins, frequency 1 tab daily via oral route. Birth control pill frequency 1 tab daily via oral route.  No treatment drugs were provided.  Patient was treated for bilateral hand and feet cramping fever and stiffness with antipyretic fluid.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR form received included Patient demographic information. Information on suspect drug received. Additional events are added. Concomitant medication information added
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Thermal burn
Clinical narrative: burning sensation; burn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation) and THERMAL BURN (burn) 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 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation) and THERMAL BURN (burn). At the time of the report, BURNING SENSATION (burning sensation) and THERMAL BURN (burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Pain in extremity
Clinical narrative: a little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Lung cancer (Almost in her 11th year of lung cancer. She had chemo and some radiation and has been stable for some time now.), Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, METOPROLOL for Blood pressure abnormal, VITAMIN D NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little sore arm). At the time of the report, PAIN IN EXTREMITY (a little sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram thorax: normal (normal) CT scan for lung cancer a couple of weeks ago and it was okay.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided for this event.  Reportedly, the patient is due for a mammogram 6 weeks after the second dose.    This case was linked to US-MODERNATX, INC.-MOD-2021-075816 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Initial additional: non-significant updated appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075816:2nd dose case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11LZOA and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Bactrim, Clindamycin), Drug allergy (Levaquin), Contrast media allergy (Contrast dye) and Gluten intolerance. Concomitant products included DIAZEPAM for Anxiety, ESCITALOPRAM OXALATE (ESCITALOPRAM +PHARMA) for Depression, MULTIVITAMINS [VITAMINS NOS], CALCIUM and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 08-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu-like symptoms) to be probably related.    No treatment of events was reported.   This case was linked to MOD-2021-008632 (E2B Linked Report).; Sender's Comments:  MOD-2021-008632:Same patient, 1st dose
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose interval is 44 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval is 44 days) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: serious covid-like symptoms; 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 COVID-19 (serious covid-like symptoms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (serious covid-like symptoms). At the time of the report, COVID-19 (serious covid-like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine that had been refrigerated for 34 days.; Vaccine that had been refrigerated for 34 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days). On 29-Mar-2021 at 10:15 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document received on 26-May-2021 contains Non-Significant information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Vomiting, Weight decreased
Clinical narrative: "I lost 20 pounds in 3 weeks"; Reports he was vomiting every other day for 2 weeks straight after dose 1.; This spontaneous case was reported by a nurse and describes the occurrence of WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cervical spinal stenosis and Carcinoma (Carcinoma on face). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.). At the time of the report, WEIGHT DECREASED ("I lost 20 pounds in 3 weeks") and VOMITING (Reports he was vomiting every other day for 2 weeks straight after dose 1.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram: pulmonary embolism (Inconclusive) Mid right lobe Pulmonary embolism.     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.   The patient reported he was now on heavy thrombolytics for the rest of his life.   This case was linked to US-MODERNATX, INC.-MOD-2021-075796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075796:Case for second dose
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: Second dose 7 days post 1st dose; Excruciating muscle pain her left leg; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose) and MYALGIA (Excruciating muscle pain her left leg) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose). 13-Apr-2021, the patient experienced MYALGIA (Excruciating muscle pain her left leg). On 13-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 7 days post 1st dose) had resolved. At the time of the report, MYALGIA (Excruciating muscle pain her left leg) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: getting the vaccine being 10 weeks pregnant; local reaction had appeared very close to the vaccine spot; it also was itching as an allergic side-effect; Little tired; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant), VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little 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 Nausea in pregnancy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMIN B6 for Nausea in pregnancy.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant). In April 2021, the patient experienced VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little tired). On 05-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (getting the vaccine being 10 weeks pregnant) had resolved. In April 2021, VACCINATION SITE REACTION (local reaction had appeared very close to the vaccine spot), VACCINATION SITE PRURITUS (it also was itching as an allergic side-effect) and FATIGUE (Little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was 10 weeks pregnant. One week ago she was 10 weeks pregnant and decided to get vaccinated, it was a personal choice as doctors and CDC have recommended. After 4-5 days a local reaction had appeared very close to the vaccine spot, it also was itching as an allergic side-effect. She was not sure but she was taking anti-histaminic (Unissom) and vitamin B6 as part of my nausea healing, it may contribute to heal more quickly. Fortunately, It went away after 2 days. Patient said it was important to mention that I did not have any other symptoms, just a little tired the day after, no fever though. She might have allergy to some ingredient and as it is local and went away. She was looking forward to having her second dose in April 30th.  No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer received 1st dose on 30Jan2021 and wants second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer received 1st dose on 30Jan2021 and wants second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer received 1st dose on 30Jan2021 and wants second dose). On 30-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Consumer received 1st dose on 30Jan2021 and wants second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after both shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after both shots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick after both shots). At the time of the report, ILLNESS (got sick after both shots) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-075858, US-MODERNATX, INC.-MOD-2021-075230, US-MODERNATX, INC.-MOD-2021-075415 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075858:case created for second dose for unknown male patient US-MODERNATX, INC.-MOD-2021-075230:Cross linked case US-MODERNATX, INC.-MOD-2021-075415:Cross linked case
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness; Fever of 102.9; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9). At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Fever of 102.9) outcome was unknown.            No concomitant and treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075839, US-MODERNATX, INC.-MOD-2021-075230, US-MODERNATX, INC.-MOD-2021-075415 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075839:case created for first dose for unknown male patient US-MODERNATX, INC.-MOD-2021-075230:Cross linked case US-MODERNATX, INC.-MOD-2021-075415:Cross linked case
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and arthralgia (sore shoulder) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024M20A) for COVID-19 immunization. No medical history reported. On Apr 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient experienced  pain in extremity (sore arm) and arthralgia (sore shoulder). The patient treated with Tylenol (paracetamol) for pain in arm and shoulder pain, at an unspecified dose and frequency. At the time of the report, pain in extremity (sore arm) and arthralgia (sore shoulder) outcome: unknown. Concomitant medications not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 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 PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness; lightheaded; Fatigue; Sore Left Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Left Arm), DIZZINESS (Dizziness), DIZZINESS (lightheaded) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetic and Heart rate irregular.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MYALGIA (Sore Left Arm). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness), DIZZINESS (lightheaded) and FATIGUE (Fatigue). On 08-Apr-2021, MYALGIA (Sore Left Arm) had resolved. On 11-Apr-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, DIZZINESS (lightheaded) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Rash, Vaccination site erythema
Clinical narrative: allergic reaction; redness came back; (left leg) with a light rash over the whole leg; redness; legs turned pink/red from her knee down to the top of the socks area on both legs/redness came back; rash like bumps, "hundreds of them" under the skin/ (left leg) with a light rash over the whole leg; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (legs turned pink/red from her knee down to the top of the socks area on both legs/redness came back), RASH (rash like bumps, "hundreds of them" under the skin/ (left leg) with a light rash over the whole leg), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE ERYTHEMA (redness) and ERYTHEMA (redness came back) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0481AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (legs turned pink/red from her knee down to the top of the socks area on both legs/redness came back), RASH (rash like bumps, "hundreds of them" under the skin/ (left leg) with a light rash over the whole leg), VACCINATION SITE ERYTHEMA (redness) and RASH ((left leg) with a light rash over the whole leg). On 10-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction) and ERYTHEMA (redness came back). At the time of the report, ERYTHEMA (legs turned pink/red from her knee down to the top of the socks area on both legs/redness came back), RASH (rash like bumps, "hundreds of them" under the skin/ (left leg) with a light rash over the whole leg), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE ERYTHEMA (redness), ERYTHEMA (redness came back) and RASH ((left leg) with a light rash over the whole leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Injection site warmth; injection site itching; Injection site rash; Injection site tender; raised red oval rash at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash), INJECTION SITE PAIN (Injection site tender) and INJECTION SITE ERYTHEMA (raised red oval rash at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010H20A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (Since age 20).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash), INJECTION SITE PAIN (Injection site tender) and INJECTION SITE ERYTHEMA (raised red oval rash at injection site). In January 2021, INJECTION SITE ERYTHEMA (raised red oval rash at injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and INJECTION SITE PAIN (Injection site tender) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: chills; several side effects; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION COMPLICATION (several side effects) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VACCINATION COMPLICATION (several side effects). At the time of the report, CHILLS (chills) and VACCINATION COMPLICATION (several side effects) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint swelling, Lethargy
Clinical narrative: Swelling of knees; pain in knees; Headache; lethargy; This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (lethargy), JOINT SWELLING (Swelling of knees), ARTHRALGIA (pain in knees) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergic reaction to drug, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, VALACICLOVIR HYDROCHLORIDE (VALTREX), ESTRADIOL (ESTRACE VAGINAL), VITAMIN D NOS, ZINC, ELDERBERRY [SAMBUCUS NIGRA], BROMELAINS, QUERCETIN (QUERCETAIN) and BROMELAINE for an unknown indication.   On 06-Feb-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 07-Feb-2021, the patient experienced LETHARGY (lethargy) and HEADACHE (Headache). On an unknown date, the patient experienced JOINT SWELLING (Swelling of knees) and ARTHRALGIA (pain in knees). At the time of the report, LETHARGY (lethargy), JOINT SWELLING (Swelling of knees), ARTHRALGIA (pain in knees) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported   This case was linked to MOD-2021-075916 (Patient Link).