chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Flu like symptoms; Diarrhea; Headaches; Joint pains; Chills; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 10-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.   This case was linked to MOD-2021-317521 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Injection site rash, Palpitations, Pyrexia
Clinical narrative: "All he does is sleep"; Racing heart; Swallowing difficult; severe rash on his arms, chest, back and neck; low grade fever of 99.9; he noticed a rash under the band-aid after removing band-aid (on the injection arm).; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).) and RASH (severe rash on his arms, chest, back and neck) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).). On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHAGIA (Swallowing difficult), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9). On 12-Sep-2021, the patient experienced PALPITATIONS (Racing heart). On an unknown date, the patient experienced SOMNOLENCE ("All he does is sleep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 99.9 (High) low grade fever of 99.9.         Concomitant medication were not reported by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Somnolence
Clinical narrative: "All he does is sleep"; Racing heart; Swallowing difficult; severe rash on his arms, chest, back and neck; low grade fever of 99.9; he noticed a rash under the band-aid after removing band-aid (on the injection arm).; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).) and RASH (severe rash on his arms, chest, back and neck) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).). On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHAGIA (Swallowing difficult), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9). On 12-Sep-2021, the patient experienced PALPITATIONS (Racing heart). On an unknown date, the patient experienced SOMNOLENCE ("All he does is sleep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 99.9 (High) low grade fever of 99.9.         Concomitant medication were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Myalgia, Night sweats
Clinical narrative: felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) and MYALGIA (aching everywhere/We felt those were similar to the second shot reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown. Not Provided          no concomitant medications were reported.  no treatment medications were reported.   This case was linked to MOD-2021-317608 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) and MYALGIA (aching everywhere/We felt those were similar to the second shot reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown. Not Provided          no concomitant medications were reported.  no treatment medications were reported.   This case was linked to MOD-2021-317608 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Candida infection, SARS-CoV-2 test
Clinical narrative: Thrush infection; breakthrough COVID infection 18 days after second vaccine in March; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) and CANDIDA INFECTION (Thrush infection) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (breakthrough COVID infection 18 days after second vaccine in March). On an unknown date, the patient experienced CANDIDA INFECTION (Thrush infection). At the time of the report, COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) had resolved and CANDIDA INFECTION (Thrush infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication information were provided.  No treatment information provided.   This case was linked to MOD-2021-317852 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Musculoskeletal stiffness, Pain in extremity, Vaccination site pain
Clinical narrative: arm stiff; cold feeling on neck; arm sore; arm sore and radiating down my arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: sore arm; achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1989 and Diabetes since 2010. Concomitant products included ATENOLOL for Blood pressure high, GLIPIZIDE for Diabetes, METFORMIN for Prediabetes, HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication.   On 05-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 10:00 AM, 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 VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   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-2021-317919 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Patient Demographics Added. Medical History Added. Concomitant Medications Information Added.
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.   This case was linked to MOD-2021-317898, MOD-2021-317907 (Patient Link).   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: pain in left arm /very painful/ it is not going well; can't use the left arm; the pain is now going to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well), HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well), HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well) had not resolved and HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers) outcome was unknown. Not Provided          No relevant concomitant medications were reported. The patient had pain in the left arm after the second shot. can't use the left arm, it was very painful, and it was not going well. The pain was now going to her fingers. Friend got the first shot in June, and second shot days later (reporter said the expected interval for second shot). The patient had been taking medication to treat symptoms, and it alleviates for a time, but then the pain comes back.  Treatment medication included Tylenol (it is not helping), ibuprofen, it also doesn't help.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 50 days after I will take second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (50 days after I will take 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose) had resolved.            The patient was asking what happens if I take second dose of moderna vaccine 50 days after the first one and 50 days between doses was safe.  No concomitant medication listed.   No treatment information provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: A little swollen in the arm which lasted for an hour or two.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (Has severe psoriatic arthritis for 22 years). Concomitant products included IXEKIZUMAB (TALTZ) for Psoriatic arthritis, PREDNISONE and OXYCODONE for an unknown indication.    On 04-Mar-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 PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.). At the time of the report, PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.) had resolved.        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.   Patient stated that she has been on 9 different biologic medicines. Treatment information was not provided.   This case was linked to MOD-2021-318127, MOD-2021-318145, MOD21-142970 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received contains no new information On 15-Sep-2021: Follow up contains no new information please confirm as NNI.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Very sore at site of injection; extreame fatigue; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore at site of injection), FATIGUE (extreame fatigue) and HEADACHE (a little headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0 21B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Psoriatic arthritis (Psoratiac Arthritis) since 01-Jan-1999. Concomitant products included PREDNISONE from 01-Jan-1999 to an unknown date and OXYCODONE from 01-Jan-1999 to an unknown date for Psoriatic arthritis.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Very sore at site of injection), FATIGUE (extreame fatigue) and HEADACHE (a little headache). The patient was treated with IXEKIZUMAB (TALTZ) from 04-Jul-2021 to 07-Jul-2021 for Psoriatic arthritis, at a dose of 1 dosage form. On 13-Sep-2021, PAIN IN EXTREMITY (Very sore at site of injection) and FATIGUE (extreame fatigue) had resolved. On 14-Sep-2021, HEADACHE (a little headache) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: The follow-up document received contain ne Information (medical history, concomitant meds) On 17-Sep-2021: Follow- up document received contain significant information - New events added and dosage information updated.
Sex: U
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Left eyelid is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Left eyelid is a little swollen) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING OF EYELID (Left eyelid is a little swollen). At the time of the report, SWELLING OF EYELID (Left eyelid is a little swollen) 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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed 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 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 DIZZINESS (Light headed dizzy). At the time of the report, DIZZINESS (Light headed dizzy) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Headache, Malaise, Pain
Clinical narrative: stress; headache; Vomiting; Pain; Feeling unwell; Diarrhea; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and STRESS (stress) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (due to dental issues). Concomitant products included vitamin B12, multivitamin and NICOTINAMIDE (VITAMIN B3) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). In April 2021, the patient experienced PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced STRESS (stress) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]) at an unspecified dose and frequency. On 05-Apr-2021, BURNING SENSATION (Burning sensation) had resolved. In August 2021, MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN (Pain), STRESS (stress) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Her left breast was larger than the other. She had thermography that indicated excess heat in the left underarm and left breast lymph nodes. treatment medication include cold packs. She was scheduled for her second dose on 13 Sep 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vomiting
Clinical narrative: stress; headache; Vomiting; Pain; Feeling unwell; Diarrhea; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and STRESS (stress) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (due to dental issues). Concomitant products included vitamin B12, multivitamin and NICOTINAMIDE (VITAMIN B3) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). In April 2021, the patient experienced PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced STRESS (stress) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]) at an unspecified dose and frequency. On 05-Apr-2021, BURNING SENSATION (Burning sensation) had resolved. In August 2021, MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN (Pain), STRESS (stress) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Her left breast was larger than the other. She had thermography that indicated excess heat in the left underarm and left breast lymph nodes. treatment medication include cold packs. She was scheduled for her second dose on 13 Sep 2021.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeding disorder, Headache, Pain in extremity
Clinical narrative: Slept all day and night; Couldn't see anything - "it shouldn't have been like that dark"; "Explosive diarrhea"; Had "absolutely no energy"; Little bit of fever; Headache "but not a big deal"; Arm got sore; Could not eat anything until Friday night; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") and DIARRHOEA ("Explosive diarrhea") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Breast cancer since 2008.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore) and FEEDING DISORDER (Could not eat anything until Friday night). On 10-Sep-2021, the patient experienced ASTHENIA (Had "absolutely no energy"), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark"), DIARRHOEA ("Explosive diarrhea"), PYREXIA (Little bit of fever) and HEADACHE (Headache "but not a big deal"). On 10-Sep-2021, VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") had resolved. On 11-Sep-2021, SOMNOLENCE (Slept all day and night) and HEADACHE (Headache "but not a big deal") had resolved. On 12-Sep-2021, DIARRHOEA ("Explosive diarrhea") had resolved. At the time of the report, ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore) and PYREXIA (Little bit of fever) outcome was unknown and FEEDING DISORDER (Could not eat anything until Friday night) was resolving.            Concomitant product use was not provided. Treatment information was not provided.  It was reported that patient was not sure whether she was immunocompromised.   This case was linked to MOD-2021-318772 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Visual impairment
Clinical narrative: Slept all day and night; Couldn't see anything - "it shouldn't have been like that dark"; "Explosive diarrhea"; Had "absolutely no energy"; Little bit of fever; Headache "but not a big deal"; Arm got sore; Could not eat anything until Friday night; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") and DIARRHOEA ("Explosive diarrhea") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Breast cancer since 2008.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore) and FEEDING DISORDER (Could not eat anything until Friday night). On 10-Sep-2021, the patient experienced ASTHENIA (Had "absolutely no energy"), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark"), DIARRHOEA ("Explosive diarrhea"), PYREXIA (Little bit of fever) and HEADACHE (Headache "but not a big deal"). On 10-Sep-2021, VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") had resolved. On 11-Sep-2021, SOMNOLENCE (Slept all day and night) and HEADACHE (Headache "but not a big deal") had resolved. On 12-Sep-2021, DIARRHOEA ("Explosive diarrhea") had resolved. At the time of the report, ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore) and PYREXIA (Little bit of fever) outcome was unknown and FEEDING DISORDER (Could not eat anything until Friday night) was resolving.            Concomitant product use was not provided. Treatment information was not provided.  It was reported that patient was not sure whether she was immunocompromised.   This case was linked to MOD-2021-318772 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: fever; Chills; Body ache; arm is really sore; fatigue; severe headache triple this time, much worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for No adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse) outcome was unknown.            Patient received first dose on 01-FEB-2021 intramuscularly (batch no: 004M20A) and second dose on 02-MAR-2021 (batch no: 025A21A) Patient's side effects from 3rd dose is much worse than from the 2nd dose.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Chills; Body ache; arm is really sore; fatigue; severe headache triple this time, much worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for No adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse) outcome was unknown.            Patient received first dose on 01-FEB-2021 intramuscularly (batch no: 004M20A) and second dose on 02-MAR-2021 (batch no: 025A21A) Patient's side effects from 3rd dose is much worse than from the 2nd dose.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: Did not sleep for 3 nights after first shot; Headache for 3 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep for 3 nights after first shot) and HEADACHE (Headache for 3 days after the first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Angioma (Patient suffers from Angioma takes Acetaminophen, Tramadol, and Flexeril.). Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    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 INSOMNIA (Did not sleep for 3 nights after first shot) and HEADACHE (Headache for 3 days after the first shot). At the time of the report, INSOMNIA (Did not sleep for 3 nights after first shot) outcome was unknown and HEADACHE (Headache for 3 days after the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-318514, MOD-2021-318515.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes after both shots in vaccinated (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 025L20A) for COVID-19 vaccination.     Medical history was not provided.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date, Patient had a biopsy with unknown results.  Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-132300 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Sharp Headache  for 3 days after the 2nd dose; Second shot about 3 months after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sharp Headache  for 3 days after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Angioma (Patient suffers from Angioma takes Acetaminophen, Tramadol, and Flexeril.). Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Sharp Headache  for 3 days after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot) had resolved. On 11-Mar-2021, HEADACHE (Sharp Headache  for 3 days after the 2nd dose) had resolved.            Treatment information was not  provided.   This case was linked to MOD-2021-318486, MOD-2021-318515 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045821A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included METFORMIN, MULTIVITAMINS [VITAMINS NOS] and VITAMIN B COMPLEX (B COMPLEX (B50)) for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Adverse event, at a dose of 2 tablets. At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            Concomitant medications also include Thyroid medications Patient had a suspect that the pharmacist injected a different vaccine. She was with her husband who was scheduled to get the vaccine for shingles on the same schedule of her second dose. As per patient, the pharmacist brought out three syringes at the same time, 1 for her husband which was a shingles vaccine and the other two which were Moderna vaccine, one for her and one for the other patient. She noticed that the pharmacist was kind of confused that time. She said she already informed the manager of the facility but they cannot prove yet if she got the Moderna vaccine or a different one.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: shivering at approximately 11PM that same day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering at approximately 11PM that same day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced CHILLS (shivering at approximately 11PM that same day). At the time of the report, CHILLS (shivering at approximately 11PM that same day) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Reporter reported that they received the shot at the same time of day during the middle of day, and reports that her patient began to experience the side effect of shivering at approximately 11 pm that same day. Reporter described her husband's reaction as being light and not so severe.