chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: passed out on the floor; sweat; discomfort; Head is in discomfort; neck is in discomfort; very nauseous; sore at the site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) in a 63-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.  Concomitant products included MAGNESIUM and COLECALCIFEROL, MENAQUINONE (D3 +K2) for an unknown indication.   On 26-May-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 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort). On an unknown date, the patient experienced NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site). On 02-Jun-2021, HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out on the floor), NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site) had resolved.            The patient reported that neck and head discomfort could be due to the way of lying in the bed. The patient mentioned that there was no  problems with the first dose. Patient had no treatment, just drinking water and been lying on the floor because it was cold.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23/7/21: events outcome added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sore Arms and legs; Fever Low grade; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade). At the time of the report, MYALGIA (Sore Arms and legs) and PYREXIA (Fever Low grade) had not resolved.            No concomitant medications reported. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported. Patient wants to know treatment for the side effects
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema
Clinical narrative: One large red welt continuing to grow; two red spots below injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (One large red welt continuing to grow) and VACCINATION SITE ERYTHEMA (two red spots below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement
Clinical narrative: boobs to grow bigger (breast grow); This spontaneous case was reported by a consumer and describes the occurrence of BREAST ENLARGEMENT (boobs to grow bigger (breast grow)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 BREAST ENLARGEMENT (boobs to grow bigger (breast grow)). At the time of the report, BREAST ENLARGEMENT (boobs to grow bigger (breast grow)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications and treatment reported.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Headache, Myalgia, Nasopharyngitis
Clinical narrative: cold head; cold sweats; light headed; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.  Action taken with the product in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Muscle spasms
Clinical narrative: Severe intestinal issues; Daily cramping that makes it hard to function; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function). At the time of the report, GASTROINTESTINAL DISORDER (Severe intestinal issues) and MUSCLE SPASMS (Daily cramping that makes it hard to function) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication were provided  No concomitant medication were provided   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Joint swelling, Malaise, Myalgia
Clinical narrative: Swollen left ankle/another swollen ankle; Ankle pain/Joint hurting really bad/Joint ache; feeling generally sick; Fever; Chills; Aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 PRAVASTATIN, HYDROCHLOROTHIAZIDE, Cartia, Aspirin, COLECALCIFEROL (VITAMIN D3) and METFORMIN.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MALAISE (feeling generally sick), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 01-Apr-2021, the patient experienced JOINT SWELLING (Swollen left ankle/another swollen ankle) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache). At the time of the report, MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swollen left ankle/another swollen ankle; Ankle pain/Joint hurting really bad/Joint ache; feeling generally sick; Fever; Chills; Aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 PRAVASTATIN, HYDROCHLOROTHIAZIDE, Cartia, Aspirin, COLECALCIFEROL (VITAMIN D3) and METFORMIN.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MALAISE (feeling generally sick), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 01-Apr-2021, the patient experienced JOINT SWELLING (Swollen left ankle/another swollen ankle) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache). At the time of the report, MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Tongue discolouration
Clinical narrative: Loss of taste; Some white spots on hid tongue; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and TONGUE DISCOLOURATION (Some white spots on hid tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste) and TONGUE DISCOLOURATION (Some white spots on hid tongue). At the time of the report, AGEUSIA (Loss of taste) and TONGUE DISCOLOURATION (Some white spots on hid tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: delayed period; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (delayed period) 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 27-May-2021, the patient experienced MENSTRUATION DELAYED (delayed period). At the time of the report, MENSTRUATION DELAYED (delayed period) outcome was unknown.            No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Platelets really dropped; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelets really dropped) 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 PLATELET COUNT DECREASED (Platelets really dropped). At the time of the report, PLATELET COUNT DECREASED (Platelets really dropped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for a day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for a day). At the time of the report, PAIN IN EXTREMITY (Arm was sore for a day) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contained updated patient's address
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) and PAIN IN EXTREMITY (Pain in my left foot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in my left foot). On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) and PAIN IN EXTREMITY (Pain in my left foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitants medication for diabetes.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Has a bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Has a bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Has a bad headache). At the time of the report, HEADACHE (Has a bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising on my legs; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on my legs) 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 CONTUSION (bruising on my legs). At the time of the report, CONTUSION (bruising on my legs) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy
Clinical narrative: I feel lethargic; have diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea) 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 LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea). At the time of the report, LETHARGY (I feel lethargic) and DIARRHOEA (have diarrhea) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: my arm of the ejection sight is red; my arm of the ejection alittle itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE ERYTHEMA (my arm of the ejection sight is red) and VACCINATION SITE PRURITUS (my arm of the ejection alittle itchy) 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 25-May-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (my arm of the ejection sight is red) and VACCINATION SITE PRURITUS (my arm of the ejection alittle itchy). At the time of the report, VACCINATION SITE ERYTHEMA (my arm of the ejection sight is red) and VACCINATION SITE PRURITUS (my arm of the ejection alittle itchy) outcome was unknown.            Med Info Agent: Are submitted via Chatbox I got the second dose 5/25/2021 No fever but my arm of the ejection sight is red alittle itchy   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.  Patient does not have Tylenol and asking if she can take Aleve.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am feeling feverish now; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I am feeling feverish now) 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 PYREXIA (I am feeling feverish now). At the time of the report, PYREXIA (I am feeling feverish now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Hypersomnia, Vaccination site pain
Clinical narrative: Sleeping a lot; No energy; Not feeling hungry; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy), DECREASED APPETITE (Not feeling hungry) and VACCINATION SITE PAIN (Right arm sore) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MELOXICAM, TRAMADOL, PROPRANOLOL HYDROCHLORIDE (CARDENOL), ATORVASTATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy), DECREASED APPETITE (Not feeling hungry) and VACCINATION SITE PAIN (Right arm sore). On 24-Apr-2021, HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy) and DECREASED APPETITE (Not feeling hungry) had resolved. At the time of the report, VACCINATION SITE PAIN (Right arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was taking water tablet.  The treatment information was not provided.   This case was linked to MOD-2021-181954 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: arm was sore for a day; fatigue; chills; slight headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache). At the time of the report, MYALGIA (arm was sore for a day), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (slight headache) outcome was unknown.            No concomitant and treatment information provided   Med Info Agent:  Moderna customer care warm transfer case # 169956.  Caller received her first dose of the Moderna COVID-19 vaccine on 28Apr2021 (lot # 036B21A).  She got her second dose on 26May2021 (lot # 039B21A).  After both shots, her arm got sore for a day or so.  This morning she reports that she felt fatigue, chills, and a slight headache.  Ok for the safety team to contact the patient later if needed       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains non-significant information. - Contact Info Updated
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Frequent bowel movements
Clinical narrative: softer bowel movements; gas; This spontaneous case was reported by a patient and describes the occurrence of FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder (at least once a year prior to receiving Moderna COVID-19 vaccine.) and Hemorrhoids (Chronic). No concomitant medication was reported.  On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas). At the time of the report, FREQUENT BOWEL MOVEMENTS (softer bowel movements) and FLATULENCE (gas) outcome was unknown.     Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Patient states that he has had similar symptoms before and has gastrointestinal issues at least once a year prior to receiving Moderna COVID-19 vaccine. Patient also suffers from chronic hemorrhoids which have not resolved since onset of symptoms.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy; tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and FATIGUE (tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 027821A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy) and FATIGUE (tired). At the time of the report, PAIN (achy) and FATIGUE (tired) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.    This case was linked to MOD21-099585 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tonsillitis
Clinical narrative: Throbbing sore throat; Felt like extreme tonsillitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis) 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 OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis). At the time of the report, OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Slight Arm pain; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B20A and 037K2QA) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever). At the time of the report, PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tooth loss
Clinical narrative: loss of teeth; pain; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (loss of teeth) and PAIN (pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTH LOSS (loss of teeth) and PAIN (pain). At the time of the report, TOOTH LOSS (loss of teeth) and PAIN (pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fall, Severe acute respiratory syndrome
Clinical narrative: Fell and hit her head; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell and hit her head) and DIZZINESS (Felt dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced FALL (Fell and hit her head) and DIZZINESS (Felt dizzy). At the time of the report, FALL (Fell and hit her head) and DIZZINESS (Felt dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Inconclusive) negative. On an unknown date, Severe acute respiratory syndrome: positive (Inconclusive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.   This case was linked to MOD-2021-182338 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tiredness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy) and FATIGUE (Tiredness). At the time of the report, PAIN (Achy) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD21-099585 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Patient is experiencing every side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Patient is experiencing every side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Patient is experiencing every side effect). At the time of the report, ADVERSE EVENT (Patient is experiencing every side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Extra dose administered, Underdose
Clinical narrative: Pharmacist went to give patient dose, but some leaked out/ didn't feel like anything went in; Pharmacist went to give patient dose, but some leaked out/didn't feel like anything went in; going to readminister/readministered dose; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Pharmacist went to give patient dose, but some leaked out/ didn't feel like anything went in), DEVICE CONNECTION ISSUE (Pharmacist went to give patient dose, but some leaked out/didn't feel like anything went in) and EXTRA DOSE ADMINISTERED (going to readminister/readministered dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 049C21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE for Thyroid disorder NOS.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 ml. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced UNDERDOSE (Pharmacist went to give patient dose, but some leaked out/ didn't feel like anything went in), DEVICE CONNECTION ISSUE (Pharmacist went to give patient dose, but some leaked out/didn't feel like anything went in) and EXTRA DOSE ADMINISTERED (going to readminister/readministered dose). On 27-May-2021, UNDERDOSE (Pharmacist went to give patient dose, but some leaked out/ didn't feel like anything went in), DEVICE CONNECTION ISSUE (Pharmacist went to give patient dose, but some leaked out/didn't feel like anything went in) and EXTRA DOSE ADMINISTERED (going to readminister/readministered dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The technician stated that it was approximately 0.2 ml that leaked out, but later said that they could not determine the amount.   The patient stated that they didn't feel like anything went in and they can usually feel it.  Therefore, the pharmacy decided that they were going to readminister the dose
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: severe swelling of the arm the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given) 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 VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given). At the time of the report, VACCINATION SITE SWELLING (severe swelling of the arm the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Flatulence, Haemorrhoids, Rash
Clinical narrative: itchy burning rash on leg and arm; hemorrhoids; Burning rash; softer bowel movements; gas/smelly gas an bowel movements; rash on left arm and right leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements) and FLATULENCE (gas/smelly gas an bowel movements) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastro-intestinal disorder NOS.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg). The patient was treated with SIMETICONE (GAS X) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTOBISMOL) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 23-Jul-2021: follow up received on 23 JUL 2021 contains no new information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy burning rash on leg and arm; hemorrhoids; Burning rash; softer bowel movements; gas/smelly gas an bowel movements; rash on left arm and right leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements) and FLATULENCE (gas/smelly gas an bowel movements) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastro-intestinal disorder NOS.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg). The patient was treated with SIMETICONE (GAS X) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTOBISMOL) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 23-Jul-2021: follow up received on 23 JUL 2021 contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Temporary soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Temporary soreness around the injection site) 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 VACCINATION SITE PAIN (Temporary soreness around the injection site). At the time of the report, VACCINATION SITE PAIN (Temporary soreness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants are included. No Treatment included.