chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) 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 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID after vaccination) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (COVID after vaccination). At the time of the report, COVID-19 (COVID after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Sender's Comments: This case concerns a 34-year-old male patient  with no relevant medical history who experienced non-serious unexpected event of COVID-19. Temporal relationship is unknown since exact date of vaccination was not provided per SD. The rechallenge was unknown as the event occurred after the first dose of the vaccine and no information about second dose was given. Very limited information regarding clinical course of the event has been provided at this time. Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: had to stay in bed for 2 days feeling not so good, but it wasn't so extreme (compared to the third shot).; fluy; felt achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had to stay in bed for 2 days feeling not so good, but it wasn't so extreme (compared to the third shot).), INFLUENZA LIKE ILLNESS (fluy) and MYALGIA (felt achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008E21A, 046A21A and 011F21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (had to stay in bed for 2 days feeling not so good, but it wasn't so extreme (compared to the third shot).), INFLUENZA LIKE ILLNESS (fluy) and MYALGIA (felt achy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (had to stay in bed for 2 days feeling not so good, but it wasn't so extreme (compared to the third shot).), INFLUENZA LIKE ILLNESS (fluy) and MYALGIA (felt achy) outcome was unknown.            This case was linked to MOD-2021-345908 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Illness
Clinical narrative: I was sick for a day or two; 24-48 hours of feeling a little uncomfortable; headache; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick for a day or two), DISCOMFORT (24-48 hours of feeling a little uncomfortable), HEADACHE (headache) and FATIGUE (general fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR], ACETYLSALICYLIC ACID (BABY ASPIRIN) and HYDRALAZINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 ILLNESS (I was sick for a day or two), DISCOMFORT (24-48 hours of feeling a little uncomfortable), HEADACHE (headache) and FATIGUE (general fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (I was sick for a day or two), DISCOMFORT (24-48 hours of feeling a little uncomfortable), HEADACHE (headache) and FATIGUE (general fatigue) outcome was unknown.            This case was linked to MOD-2021-345790 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis viral, Chest X-ray, Dizziness, Fatigue, Malaise
Clinical narrative: severe bronchitis, viral/x-ray: spots on the lower right lung; made her woozy; feels fatigued all the time; fell extremely ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Antibiotic resistant Staphylococcus aureus infection. Concurrent medical conditions included Bronchitis and Bronchial scarring.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced MALAISE (fell extremely ill). On an unknown date, the patient experienced BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time). The patient was treated with HYDROCODONE for Cough, at an unspecified dose and frequency and LEVOFLOXACIN at a dose of 500 mg. At the time of the report, MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Chest X-ray: abnormal (abnormal) reveled spots on the lower right lung. On 20-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (made her woozy) to be not related. No further causality assessments were provided for MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung) and FATIGUE (feels fatigued all the time).    treatment products were Z pack and cough pearls. no concomitsnt products were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe bronchitis, viral/x-ray: spots on the lower right lung; made her woozy; feels fatigued all the time; fell extremely ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Antibiotic resistant Staphylococcus aureus infection. Concurrent medical conditions included Bronchitis and Bronchial scarring.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced MALAISE (fell extremely ill). On an unknown date, the patient experienced BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time). The patient was treated with HYDROCODONE for Cough, at an unspecified dose and frequency and LEVOFLOXACIN at a dose of 500 mg. At the time of the report, MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung), DIZZINESS (made her woozy) and FATIGUE (feels fatigued all the time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2021, Chest X-ray: abnormal (abnormal) reveled spots on the lower right lung. On 20-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (made her woozy) to be not related. No further causality assessments were provided for MALAISE (fell extremely ill), BRONCHITIS VIRAL (severe bronchitis, viral/x-ray: spots on the lower right lung) and FATIGUE (feels fatigued all the time).    treatment products were Z pack and cough pearls. no concomitsnt products were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Swelling face
Clinical narrative: she had fillers in her face and they all just started swelling like crazy bad; Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021). On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna COVID-19 vaccine, on 09Aug2021 and the second on 14Sep2021) had resolved. At the time of the report, SWELLING FACE (she had fillers in her face and they all just started swelling like crazy bad) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm started 12 hours after the shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Covid arm started 12 hours after the shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm started 12 hours after the shot). At the time of the report, VACCINATION SITE REACTION (Covid arm started 12 hours after the shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Patient had experienced Covid arm in 12 hours after taking 3rd dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received on 08-OCT- 2021.it includes Patient date of birth, first, second and third doses start date with batch numbers.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingling in both hands; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in both hands) and PAIN IN EXTREMITY (arm pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for Blood pressure high.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On an unknown date, the patient experienced PARAESTHESIA (tingling in both hands). At the time of the report, PARAESTHESIA (tingling in both hands) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient took cholesterol pill as concomitant medication. patient took Tylenol for the arm pain as treatment medication.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Original expiration was 2Mar2021 states the expiration was changed to 2Oct2021. Nurse states she wrote expired on the box but the doses were accidentally administered.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-345445, MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Vaccination complication
Clinical narrative: booster shot kicked back at me harder than either first two dosages; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (booster shot kicked back at me harder than either first two dosages) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus from 2016 to 2017 and Weight loss (Lost 50 pounds).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (booster shot kicked back at me harder than either first two dosages). On 03-Sep-2021, VACCINATION COMPLICATION (booster shot kicked back at me harder than either first two dosages) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 115 (Low) never gone above 115 an hour after eating..         A1C had consistently tested below 5.0 since 2017. On 23-SEP-2021 Eyesight was 20/20.  Concomitant medications and Treatment information were not provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (they gave a patient their 2nd dose of the Moderna Covid-19 vaccine today, 7Oct2021, that had a manufacturer date of expiry of 6Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pneumonia, Thrombosis
Clinical narrative: pneumonia; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and THROMBOSIS (Blood clot) 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 PNEUMONIA (pneumonia) (seriousness criterion medically significant) and THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) and THROMBOSIS (Blood clot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: pneumonia and blood clot (abnormal) pneumonia and blood clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  The patient reported that he done with A computed tomography by which pneumonia and blood clot was documented.  Treatment information was not provided.  Company Comment: This case concerns an uknown age uknown gender patient with no medical history provided, who experienced the unexpected events of Pneumonia and Thrombosis. On an uknown date the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced Pneumonia and Thrombosis (Blood Clot).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an uknown age uknown gender patient with no medical history provided, who experienced the unexpected events of Pneumonia and Thrombosis. On an uknown date the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced Pneumonia and Thrombosis (Blood Clot).The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: two days after first dose she got her menstrual cycle; patient  never experienced cramps in her life, it was just weird.; heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle), DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.) and HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Overweight (overweight triggers her abnormal menstrual cycle), Anxiety and Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ETHINYLESTRADIOL, LEVONORGESTREL (LEVONORGESTREL + ETINILESTRADIOL) and VITAMIN D NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow). On an unknown date, the patient experienced MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle) and DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.). At the time of the report, MENSTRUAL DISORDER (two days after first dose she got her menstrual cycle), DYSMENORRHOEA (patient  never experienced cramps in her life, it was just weird.) and HEAVY MENSTRUAL BLEEDING (heavier blood clotting, the size of two quarters and like for two months of a continuous flow, increased the blood flow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was birth control pills for Continuous blood  flow.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site pain
Clinical narrative: Just a little pain at injection site that lasted a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day) 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 August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day). At the time of the report, VACCINATION SITE PAIN (Just a little pain at injection site that lasted a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) Negative for antibodies.         No concomitant products were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-287857 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Anger, Arthralgia, Bone pain, Musculoskeletal stiffness, Vaccination complication
Clinical narrative: Worst bone pain after second shot/Bones hurt after second shot; Does not feel good after second shot/, I am not happy; Can not bend fingers after second shot; I am angry; Worst joint pain after second shot; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot). At the time of the report, BONE PAIN (Worst bone pain after second shot/Bones hurt after second shot), VACCINATION COMPLICATION (Does not feel good after second shot/, I am not happy), MUSCULOSKELETAL STIFFNESS (Can not bend fingers after second shot), ANGER (I am angry) and ARTHRALGIA (Worst joint pain after second shot) outcome was unknown.            No Treatment informations were reported.   This case was linked to MOD-2021-345934 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dry mouth, Fatigue, Feeling abnormal
Clinical narrative: freezing cold; shaking so violently; burning up; very achy; ankles were stiff; hands were stiff; hands were achy; could hardly walk; dry mouth; felt like I was going to pass out/ body felt traumatized; hungry; thirsty; fever chills; ankles were achy; threw up 2 or 3 times; exhausted/wiped out; couldn't sleep at all; really nauseous; arm was very sore/whole body was sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up) and PAIN (very achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 046A21A and 008E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced INSOMNIA (couldn't sleep at all), MYALGIA (arm was very sore/whole body was sore) and NAUSEA (really nauseous). On 07-Oct-2021, the patient experienced FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), VOMITING (threw up 2 or 3 times) and FATIGUE (exhausted/wiped out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 07-Oct-2021, INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), MYALGIA (arm was very sore/whole body was sore), VOMITING (threw up 2 or 3 times), NAUSEA (really nauseous) and FATIGUE (exhausted/wiped out) had resolved.            Treatment medicine include Tylenol   This case was linked to MOD-2021-345821 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Gait disturbance, Hunger, Insomnia, Joint stiffness
Clinical narrative: freezing cold; shaking so violently; burning up; very achy; ankles were stiff; hands were stiff; hands were achy; could hardly walk; dry mouth; felt like I was going to pass out/ body felt traumatized; hungry; thirsty; fever chills; ankles were achy; threw up 2 or 3 times; exhausted/wiped out; couldn't sleep at all; really nauseous; arm was very sore/whole body was sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up) and PAIN (very achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 046A21A and 008E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced INSOMNIA (couldn't sleep at all), MYALGIA (arm was very sore/whole body was sore) and NAUSEA (really nauseous). On 07-Oct-2021, the patient experienced FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), VOMITING (threw up 2 or 3 times) and FATIGUE (exhausted/wiped out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 07-Oct-2021, INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), MYALGIA (arm was very sore/whole body was sore), VOMITING (threw up 2 or 3 times), NAUSEA (really nauseous) and FATIGUE (exhausted/wiped out) had resolved.            Treatment medicine include Tylenol   This case was linked to MOD-2021-345821 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: freezing cold; shaking so violently; burning up; very achy; ankles were stiff; hands were stiff; hands were achy; could hardly walk; dry mouth; felt like I was going to pass out/ body felt traumatized; hungry; thirsty; fever chills; ankles were achy; threw up 2 or 3 times; exhausted/wiped out; couldn't sleep at all; really nauseous; arm was very sore/whole body was sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up) and PAIN (very achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 046A21A and 008E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced INSOMNIA (couldn't sleep at all), MYALGIA (arm was very sore/whole body was sore) and NAUSEA (really nauseous). On 07-Oct-2021, the patient experienced FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), VOMITING (threw up 2 or 3 times) and FATIGUE (exhausted/wiped out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 07-Oct-2021, INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), MYALGIA (arm was very sore/whole body was sore), VOMITING (threw up 2 or 3 times), NAUSEA (really nauseous) and FATIGUE (exhausted/wiped out) had resolved.            Treatment medicine include Tylenol   This case was linked to MOD-2021-345821 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst, Tremor, Vomiting
Clinical narrative: freezing cold; shaking so violently; burning up; very achy; ankles were stiff; hands were stiff; hands were achy; could hardly walk; dry mouth; felt like I was going to pass out/ body felt traumatized; hungry; thirsty; fever chills; ankles were achy; threw up 2 or 3 times; exhausted/wiped out; couldn't sleep at all; really nauseous; arm was very sore/whole body was sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up) and PAIN (very achy) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 046A21A and 008E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced INSOMNIA (couldn't sleep at all), MYALGIA (arm was very sore/whole body was sore) and NAUSEA (really nauseous). On 07-Oct-2021, the patient experienced FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), VOMITING (threw up 2 or 3 times) and FATIGUE (exhausted/wiped out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 07-Oct-2021, INSOMNIA (couldn't sleep at all), FEELING COLD (freezing cold), TREMOR (shaking so violently), BURNING SENSATION (burning up), PAIN (very achy), JOINT STIFFNESS (ankles were stiff), MUSCULOSKELETAL STIFFNESS (hands were stiff), PAIN IN EXTREMITY (hands were achy), GAIT DISTURBANCE (could hardly walk), DRY MOUTH (dry mouth), FEELING ABNORMAL (felt like I was going to pass out/ body felt traumatized), HUNGER (hungry), THIRST (thirsty), PYREXIA (fever chills), ARTHRALGIA (ankles were achy), MYALGIA (arm was very sore/whole body was sore), VOMITING (threw up 2 or 3 times), NAUSEA (really nauseous) and FATIGUE (exhausted/wiped out) had resolved.            Treatment medicine include Tylenol   This case was linked to MOD-2021-345821 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-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) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Live significant follow up appended : reporter information, lot no, expiration date were updated .
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRALGIA (Joint pain after first shot). At the time of the report, ARTHRALGIA (Joint pain after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information were provided.   This case was linked to MOD-2021-345905 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Reported administering expired Moderna COVID-19 vaccine to two different individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-345957 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: reported administering expired Moderna COVID-19 vaccine to two different individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals). On 10-May-2021, EXPIRED PRODUCT ADMINISTERED (reported administering expired Moderna COVID-19 vaccine to two different individuals) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported.  No treatment were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: is menstruating and she has cramps and they're strong; she is menstruating; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (is menstruating and she has cramps and they're strong) and MENSTRUAL DISORDER (she is menstruating) 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 07-Oct-2021, the patient experienced DYSMENORRHOEA (is menstruating and she has cramps and they're strong) and MENSTRUAL DISORDER (she is menstruating). At the time of the report, DYSMENORRHOEA (is menstruating and she has cramps and they're strong) and MENSTRUAL DISORDER (she is menstruating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm injection site sore) and HEADACHE (Major headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced VACCINATION SITE PAIN (Left arm injection site sore). On an unknown date, the patient experienced HEADACHE (Major headache). At the time of the report, VACCINATION SITE PAIN (Left arm injection site sore) had not resolved and HEADACHE (Major headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment information provided.