chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Social anxiety disorder
Clinical narrative: Suffer social phobia illness/Dare not meet outside people; This spontaneous case was reported by a consumer and describes the occurrence of SOCIAL ANXIETY DISORDER (Suffer social phobia illness/Dare not meet outside people) 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 SOCIAL ANXIETY DISORDER (Suffer social phobia illness/Dare not meet outside people). At the time of the report, SOCIAL ANXIETY DISORDER (Suffer social phobia illness/Dare not meet outside people) outcome was unknown. Not Provided          No concomitant medicines were reported No treatment medicines were reported Lower body serotonin level was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Significant Follow Up Appended
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            No treatment information were reported by the reporter   This case was linked to MOD-2021-402797, MOD-2021-402869 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Headache
Clinical narrative: Headache; Fatigue; patient received 3 doses and may not be immunocompromised; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and EXTRA DOSE ADMINISTERED (patient received 3 doses and may not be immunocompromised) 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 third 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 and 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), FATIGUE (Fatigue) and EXTRA DOSE ADMINISTERED (patient received 3 doses and may not be immunocompromised). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and EXTRA DOSE ADMINISTERED (patient received 3 doses and may not be immunocompromised) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.  Patient wanted to volunteer her  blood plasma to test against the omicron variant for effectiveness.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received and contains no new Information. On 03-Dec-2021: Events fatigue and headache added.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first dose on 25Jan2021 and noticed that the vaccine card stated their second dose had been on 16Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 25Jan2021 and noticed that the vaccine card stated their second dose had been on 16Jan2021) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 25Jan2021 and noticed that the vaccine card stated their second dose had been on 16Jan2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 25Jan2021 and noticed that the vaccine card stated their second dose had been on 16Jan2021) had resolved.            No concomitant medications were reported. No treatment medications were reported.                  Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Hypokinesia
Clinical narrative: Temperature was gone up to 102.2F; Slowbody movement; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F), HYPOKINESIA (Slowbody movement), HEADACHE (Headache) and CHILLS (Chills) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 01-Dec-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F) and HYPOKINESIA (Slowbody movement). At the time of the report, BODY TEMPERATURE INCREASED (Temperature was gone up to 102.2F), HYPOKINESIA (Slowbody movement), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 102.2 (High) temperature was gone up to 102.2F.         The reporter was calling on behalf of the patient. The patient had booster shot on 30-Nov-2021 and had headache and chills. On 01-Dec-2021, at the time of call, the patient showed slow movement of body and the temperature was gone up to 102.2F.  No Concomitant product use was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: His sister had blurry vision with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (His sister had blurry vision with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (His sister had blurry vision with the vaccine). At the time of the report, VISION BLURRED (His sister had blurry vision with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Experiencing neurological problems after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the 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 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 NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the vaccine). At the time of the report, NEUROLOGICAL SYMPTOM (Experiencing neurological problems after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient mentioned knowing other people experiencing neurological problems after the vaccine, specifically mentioned a friend of a coworker and other coworkers nice.   This case was linked to MOD-2021-403024 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: patients received the 0.5ml dose; symptoms of a sore throat; Cold Symptoms; mild fever; body aches; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (symptoms of a sore throat), NASOPHARYNGITIS (Cold Symptoms), ACCIDENTAL OVERDOSE (patients received the 0.5ml dose), PYREXIA (mild fever) and MYALGIA (body aches) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (mild fever) and MYALGIA (body aches). On 23-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (symptoms of a sore throat) and NASOPHARYNGITIS (Cold Symptoms). On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (patients received the 0.5ml dose). At the time of the report, OROPHARYNGEAL PAIN (symptoms of a sore throat), NASOPHARYNGITIS (Cold Symptoms), PYREXIA (mild fever) and MYALGIA (body aches) outcome was unknown and ACCIDENTAL OVERDOSE (patients received the 0.5ml dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396492, MOD-2021-403159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Secondary reporter added
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Thirst, Vaccination site pain
Clinical narrative: Drank a lot of water; Sore shoulder; Injection site was really sore until next morning; Tired; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus. Concomitant products included LISINOPRIL, OMEPRAZOLE, CALCITRIOL, BUDESONIDE and VITAMINS NOS for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired). At the time of the report, THIRST (Drank a lot of water), ARTHRALGIA (Sore shoulder), VACCINATION SITE PAIN (Injection site was really sore until next morning) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported.  Patient weight was 139.  She states after first shot she had sore shoulder, injection site was really sore until next morning, tired, drank a lot of water.   This case was linked to MOD-2021-403187 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received half dose booster instead of a full dose repeat; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant (Took after Moderna second dose.) on 01-Apr-2021.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat). On 17-Nov-2021, ACCIDENTAL UNDERDOSE (Received half dose booster instead of a full dose repeat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that patient was instructed by MD to repeat the doses after stem cell transplant but HCP gave her a half dose booster instead of repeating full dose.  Treatment information was not provided.   This case was linked to MOD-2021-403091 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Fatigue, Mobility decreased
Clinical narrative: more pain in their neck; more pain in their lower back; more pain in their abdominal area.; have to take naps a lot; Every day they wake up and are stiff; they suffer immobility; local pain/painful; so much pain in the joints; muscle pain, they cannot deal with it; very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot) and MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Penicillin).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), PAIN (local pain/painful), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired). At the time of the report, NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired) outcome was unknown and PAIN (local pain/painful) had resolved.      It was reported patient had physical therapy but that did not really help. No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-033559 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Pain, Somnolence
Clinical narrative: more pain in their neck; more pain in their lower back; more pain in their abdominal area.; have to take naps a lot; Every day they wake up and are stiff; they suffer immobility; local pain/painful; so much pain in the joints; muscle pain, they cannot deal with it; very tired; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot) and MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Penicillin).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), PAIN (local pain/painful), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired). At the time of the report, NECK PAIN (more pain in their neck), BACK PAIN (more pain in their lower back), ABDOMINAL PAIN (more pain in their abdominal area.), SOMNOLENCE (have to take naps a lot), MUSCULOSKELETAL STIFFNESS (Every day they wake up and are stiff), MOBILITY DECREASED (they suffer immobility), ARTHRALGIA (so much pain in the joints), MYALGIA (muscle pain, they cannot deal with it) and FATIGUE (very tired) outcome was unknown and PAIN (local pain/painful) had resolved.      It was reported patient had physical therapy but that did not really help. No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-033559 (Patient Link).
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: arm pain; chills; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHILLS (chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 (arm pain) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had arm pain and slight chills after first and second dose.  Concomitant product use was not provided by reporter.  Patient took booster dose on 02-Nov-2021, lot number 014F21A and site was left arm.   This case was linked to MOD-2021-403254, MOD-2021-403028 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Product preparation error, Pyrexia
Clinical narrative: sweating; potential invalid Moderna COVID-19 doses given; body aches; a little bit of fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweating), PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given), MYALGIA (body aches) and PYREXIA (a little bit of fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A & 026C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given), MYALGIA (body aches) and PYREXIA (a little bit of fever). At the time of the report, HYPERHIDROSIS (sweating), MYALGIA (body aches) and PYREXIA (a little bit of fever) outcome was unknown and PRODUCT PREPARATION ERROR (potential invalid Moderna COVID-19 doses given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Moderna vaccine was transported from one clinic to the other in a trip that lasted 5 hours tops. vials were surrounded with icepacks. Temperature was not checked. Two of this conveyances took place. First one on 15Sep2021 (lot #044B21A) while second one on 15Sep2021 (lot #026C21A). HCP said that the conditions were the same for both transportations. Most of the vials were still frozen or starting to thaw (with only a small portion in liquid state). Frozen vials were placed in the freezer while partially thawed were put in the fridge. All doses from carton with lot #044B21A (expired on 21Oct2021) were given; but only 6 vials from carton with lot #026C21A (expires on 06Dec2021) were administered. The remaining 4 vials were confiscated in an audit. Both cartons contained 15-dose vials. Vaccines given included 1st doses, 2nd doses and booster doses.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Peripheral swelling, Vaccination site swelling
Clinical narrative: had Large swelling on the opposite armpit; large swelling underneath the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (had Large swelling on the opposite armpit) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Swollen lymph nodes.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (large swelling underneath the site of injection). On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (had Large swelling on the opposite armpit). At the time of the report, PERIPHERAL SWELLING (had Large swelling on the opposite armpit) and VACCINATION SITE SWELLING (large swelling underneath the site of injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Computerised tomogram: swollen lymph nodes (Positive) which revealed swollen lymph nodes on the same area but he mentioned that this is unrelated as he has other medical conditions..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medication were provided.   This case was linked to MOD-2021-396542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: The follow-up document contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: lasting nervous system issues; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (lasting nervous system issues) 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 NERVOUS SYSTEM DISORDER (lasting nervous system issues). At the time of the report, NERVOUS SYSTEM DISORDER (lasting nervous system issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Haematuria, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Patient notices blood in urine as Hematuria.; Fever of 100.9; Body aches; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of HAEMATURIA (Patient notices blood in urine as Hematuria.), PYREXIA (Fever of 100.9), MYALGIA (Body aches) and INJECTION SITE PAIN (Injection site pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones, Hypercalciuria and Carcinoma (was addressed 20 years ago by surgery).    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PYREXIA (Fever of 100.9), MYALGIA (Body aches) and INJECTION SITE PAIN (Injection site pain). On 19-Nov-2021, the patient experienced HAEMATURIA (Patient notices blood in urine as Hematuria.). At the time of the report, HAEMATURIA (Patient notices blood in urine as Hematuria.), PYREXIA (Fever of 100.9), MYALGIA (Body aches) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.9 (High) fever of 100.9.         No concomitant medication were reported. No treatment information was reported. HCP visited and several tests were conducted however cause was not detected. Caller reported his preexisting conditions: previous kidney stones, hypercalciuria and carcinoma which was addressed 20 years ago by surgery. No allergy was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Feeling hot, Headache, Mass
Clinical narrative: arm is very hot; they touch their arm  they feel like theirs a ball of meat or fat; arm is getting red and black; arm is getting red and black and is itching; headache; their arm got red and stated to bothering them; arm got red; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black) and ERYTHEMA (arm got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058h21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced DISCOMFORT (their arm got red and stated to bothering them) and ERYTHEMA (arm got red). On 01-Dec-2021, the patient experienced FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), ERYTHEMA (arm got red), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.  Few hours after the vaccination patient started experiencing the adverse events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration
Clinical narrative: arm is very hot; they touch their arm  they feel like theirs a ball of meat or fat; arm is getting red and black; arm is getting red and black and is itching; headache; their arm got red and stated to bothering them; arm got red; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black) and ERYTHEMA (arm got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058h21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced DISCOMFORT (their arm got red and stated to bothering them) and ERYTHEMA (arm got red). On 01-Dec-2021, the patient experienced FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), ERYTHEMA (arm got red), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.  Few hours after the vaccination patient started experiencing the adverse events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash, Urticaria
Clinical narrative: One month after second dose she started with Idiopathic hives, and urticaria all over body; Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030L20A) 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) (unknown route) 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 04-Apr-2021, the patient experienced URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine). The patient was treated with PREDNISONE from April 2021 to May 2021 for Adverse event, at a dose of 2 courses; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date for Adverse event, at a dose of 10 mg once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 10 mg twice a day and MONTELUKAST SODIUM (SINGULAIR) ongoing since an unknown date for Adverse event, at a dose of 10 mg once a day. At the time of the report, URTICARIA (One month after second dose she started with Idiopathic hives, and urticaria all over body) and RASH (Rash comes and goes after 2nd dose, Rash comes randomly in random places on the body after 2nd dose, Not sure if the rash is related to the vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Patient was referred to an allergist whom did blood works, tested for allergies. All tests were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   At the time of report, patient has a follow up appointment to see the allergist again next week.  No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403355, MOD-2021-403373 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 23-Apr-2021, the patient experienced FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1). On 23-Apr-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1) had resolved. On 24-Apr-2021, FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-403397 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow Up received and contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 23-Apr-2021, the patient experienced FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1). On 23-Apr-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1) had resolved. On 24-Apr-2021, FEELING ABNORMAL (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-403397 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow Up received and contains no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at injection site). At the time of the report, INJECTION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Cholesterol medication  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-403387, MOD-2021-403392 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 029K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Cholesterol medication( unspecified). No treatment medication reported.   This case was linked to MOD-2021-403387, MOD-2021-403391 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Redness all over my body; itches; Looks like allergic reaction; rash; This spontaneous case was reported by another health care professional and describes the occurrence of ERYTHEMA (Redness all over my body), PRURITUS (itches), RASH (rash) and HYPERSENSITIVITY (Looks like allergic reaction) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced ERYTHEMA (Redness all over my body), PRURITUS (itches) and HYPERSENSITIVITY (Looks like allergic reaction). In November 2021, the patient experienced RASH (rash). At the time of the report, ERYTHEMA (Redness all over my body), PRURITUS (itches) and HYPERSENSITIVITY (Looks like allergic reaction) had not resolved and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  The doctor prescribed antihistamine and steroids but they did not help.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: New event rash was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Inappropriate schedule of product administration, Tachycardia, Vaccination complication
Clinical narrative: Not severe problem with her heart; Heart beating faster; Normal side effects; 2nd dose 20 March 2021 which is 24 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster), VACCINATION COMPLICATION (Normal side effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 661azia) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEFLUNOMIDE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days). On an unknown date, the patient experienced CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster) and VACCINATION COMPLICATION (Normal side effects). The patient was treated with CARVEDILOL for Adverse event, at a dose of UNK, bid and HYDROCHLOROTHIAZIDE for Adverse event, at a dose of 25 milligram. On 20-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 20 March 2021 which is 24 days) had resolved. At the time of the report, CARDIAC DISCOMFORT (Not severe problem with her heart), TACHYCARDIA (Heart beating faster) and VACCINATION COMPLICATION (Normal side effects) was resolving.            Following vaccination briefly after the 2nd dose patient experienced the events. Patient received diagnosis but everything was coming OK. Concomitant medication reported included hypertensive medication. Treatment medication includes medication to slow down her heart.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Chills, Fatigue, Headache
Clinical narrative: General unwell feeling; fever of 102 F; Body chills; Headache; Tired; 1 mL for dose 1 and dose 2; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 21-May-2021, the patient experienced MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache), FATIGUE (Tired) and ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2). On 21-May-2021, ACCIDENTAL OVERDOSE (1 mL for dose 1 and dose 2) had resolved. On 22-May-2021, MALAISE (General unwell feeling), PYREXIA (fever of 102 F), CHILLS (Body chills), HEADACHE (Headache) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Body temperature: 102 (High) 102 F.         No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-403390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up information included no new information