chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: Feel weak; Feel sick; it started to swell up below the injection site in a lemon sized lump; little red circles; Sarted itching like crazy; This area continued to stay swollen and itchy; Pain in patient's arm which worsened; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain in patient's arm which worsened), ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump) and INJECTION SITE ERYTHEMA (little red circles) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN (Pain in patient's arm which worsened). On 22-Sep-2021, the patient experienced ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump), INJECTION SITE ERYTHEMA (little red circles), INJECTION SITE PRURITUS (Sarted itching like crazy) and VACCINATION SITE SWELLING (This area continued to stay swollen and itchy). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain in patient's arm which worsened), ASTHENIA (Feel weak), MALAISE (Feel sick), VACCINATION SITE MASS (it started to swell up below the injection site in a lemon sized lump), INJECTION SITE ERYTHEMA (little red circles), INJECTION SITE PRURITUS (Sarted itching like crazy) and VACCINATION SITE SWELLING (This area continued to stay swollen and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: Lump; Covid arm reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     The patient's past medical history included unidentified flu (it was all symptoms (no taste, fever) of covid but at the time it was unidentified) in January 2020. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) for Birth control, THYROID (ARMOUR THYROID) for Thyroid disorder, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE and DOXAZOSIN MESILATE (CARDURA) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction). At the time of the report, VACCINATION SITE MASS (Lump) and VACCINATION SITE RASH (Covid arm reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatments medications was reported.   This case was linked to MOD-2021-331634.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: They were felling sick; Have a fever of 101°F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00f21a, 0030l20a and 025a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F). At the time of the report, MALAISE (They were felling sick) and PYREXIA (Have a fever of 101°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 101°f (High) fever of 101°F.         They explain that they are not immunocompromise, but they work with immunocompromise patients, and that way they got their third dose.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-331467 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: second dose they stated that they got it on  the 5March2021; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (soar arm). On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (soar arm) had resolved. On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose they stated that they got it on the 5March2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-331446, MOD-2021-331522 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ear,ringing specially in her left ear,ringing comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure) and Cholesterol.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes). At the time of the report, TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes) outcome was unknown.            Concomitant medications included are: blood pressure medication and cholesterol medicine. No treatment medications were reported. She has not had the ringing since about 2 weeks, it comes and goes
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Computerised tomogram, Headache, Lacrimation increased, Muscular weakness
Clinical narrative: Water in left eye; Legs are weak; Headache; Went blind for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Went blind for 6 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental prosthesis placement (Dental work done on top teeth in the past year- 4 teeth removed and plate put in.). Previously administered products included for an unreported indication: TYLENOL. Concurrent medical conditions included Cough (He's always coughed since last 40 years, stopped smoking. Cough has changed since last year.) and Poor vision (Patient already have poor vision.).    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 BLINDNESS (Went blind for 6 hours) (seriousness criterion medically significant), LACRIMATION INCREASED (Water in left eye), MUSCULAR WEAKNESS (Legs are weak) and HEADACHE (Headache). At the time of the report, BLINDNESS (Went blind for 6 hours) and HEADACHE (Headache) had resolved and LACRIMATION INCREASED (Water in left eye) and MUSCULAR WEAKNESS (Legs are weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal normal (normal) normal.         Patient has been using CPAP  machine for at least 5 years.  Cough was sound different than what he used to.  Treatment information is not provided.  Concomitant medication were not reported.  The patient took Tylenol extra strength because he had a headache last week. He cough's but he was always coughed for 40 years, stopped smoking. Ocrevus identified as suspect as patient was on routine therapy.  Company comment: This case concerns a male of unknown age with no relevant medical history who experienced serious unexpected event of  blindness on unknown date lasting six hours after the second dose of the Moderna Covid 19 vaccine..Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a male of unknown age with no relevant medical history who experienced serious unexpected event of  blindness on unknown date lasting six hours after the second dose of the Moderna Covid 19 vaccine..Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm after 1st dose). At the time of the report, PAIN IN EXTREMITY (sore arm after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided. Patient took 3rd dose on 20-aug-2021. no sore arm and no side effects after the 3rd dose.   This case was linked to MOD-2021-332081 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm for several days after, but the same as experienced after the first shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included flu shots for unknown indication. Past adverse reactions to the above products included pain in arm with flu shots. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm for several days after, but the same as experienced after the first shot). At the time of the report, pain in extremity (sore arm for several days after, but the same as experienced after the first shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-330801 (patient link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling
Clinical narrative: Leg started to swell; Burning sensation in the feet; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Leg started to swell), BURNING SENSATION (Burning sensation in the feet) and PAIN IN EXTREMITY (Pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced PERIPHERAL SWELLING (Leg started to swell), BURNING SENSATION (Burning sensation in the feet) and PAIN IN EXTREMITY (Pain). At the time of the report, PERIPHERAL SWELLING (Leg started to swell), BURNING SENSATION (Burning sensation in the feet) and PAIN IN EXTREMITY (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was under no medication. He was not under any prescription at the time of the symptoms started and never experienced this symptom before.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Influenza like illness, Pyrexia
Clinical narrative: inappropriate schedule of vaccine administered; fever; sick all day; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ). On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered ) had resolved. At the time of the report, ILLNESS (sick all day), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) outcome was unknown.            Patient did not specify if he was immunocompromised. He did not have his vaccination card nearby but he said the third dose was given last Thursday 23 SEP 2021.   At the facility they told him they were authorized to mix the doses  No concomitant medication was provided  Treatment medication was not provided by the reporter   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dosed outside recomended time frame, >12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Advil), Fruit allergy (Kiwi), Seafood allergy (Lobster) and Seafood allergy (Shrimp).   On 24-Aug-2021 at 9:15 AM, 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 24-Aug-2021 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture). On 24-Aug-2021 at 9:15 AM, EXPIRED PRODUCT ADMINISTERED (Dosed outside recomended time frame, >12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vial with lot number: 022C21A was punctured on 23-Sep-2021 at 9 am, after puncture at 9 pm vial was properly labeled and was kept at recommended temp of 2-8 Celsius.  No treatment information was provided by the reporter.  No adverse events noted since vaccine given.   This case was linked to MOD-2021-331573 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient got third vaccine a full dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient got third vaccine a full dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066021A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Osteoporosis, Arthritis (arthritis different types) and Blood pressure high (high blood pressure controlled). Concomitant products included LISINOPRIL, ATORVASTATIN, DESVENLAFAXINE, CLONAZEPAM and METOPROLOL for an unknown indication.    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, the patient experienced INCORRECT DOSE ADMINISTERED (Patient got third vaccine a full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient got third vaccine a full dose) had resolved.            Patient also uses Diuretic , Inhaler, Cortisone injections as needed .Patient received full dose of third vaccine than the half dose .  Patient received all three vaccines in upper left arm.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Medical history was not provided.     On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 06721A) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient experienced vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it). At the time of the report,  vaccination site pain (muscle pain in the vaccination site, but doesn't have problems with it, just wanted to report it) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. On Sept 24, 2021, the pain started. The patient reported the second dose was scheduled for Oct 20, 2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011521A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Concomitant medications included blood pressure medication and cholesterol medication not in high doses.  No treatment information was provided.   This case was linked to MOD-2021-331695 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection felt hot and swollen for 2 weeks; injection felt hot and swollen for 2 weeks; fatigue; chills/chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection felt hot and swollen for 2 weeks), VACCINATION SITE SWELLING (injection felt hot and swollen for 2 weeks), FATIGUE (fatigue) and CHILLS (chills/chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]), INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE WARMTH (injection felt hot and swollen for 2 weeks), VACCINATION SITE SWELLING (injection felt hot and swollen for 2 weeks), FATIGUE (fatigue) and CHILLS (chills/chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 800 milligram. On 26-Aug-2021, FATIGUE (fatigue) and CHILLS (chills/chills) had resolved. In September 2021, VACCINATION SITE WARMTH (injection felt hot and swollen for 2 weeks) and VACCINATION SITE SWELLING (injection felt hot and swollen for 2 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood glucose, Blood glucose fluctuation, Dizziness, Vaccination site pruritus
Clinical narrative: little lightheaded; his balance worsened after the vaccines; his blood sugars dropped below 150 after a week. At the end of the week, his blood sugars went back up a little and now continue to range from 50 (lowest) to 150; injection site was itchy but not red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little lightheaded), BALANCE DISORDER (his balance worsened after the vaccines), BLOOD GLUCOSE FLUCTUATION (his blood sugars dropped below 150 after a week. At the end of the week, his blood sugars went back up a little and now continue to range from 50 (lowest) to 150) and VACCINATION SITE PRURITUS (injection site was itchy but not red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Asperger's syndrome. Concomitant products included INSULIN for Diabetes.    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 DIZZINESS (little lightheaded), BALANCE DISORDER (his balance worsened after the vaccines), BLOOD GLUCOSE FLUCTUATION (his blood sugars dropped below 150 after a week. At the end of the week, his blood sugars went back up a little and now continue to range from 50 (lowest) to 150) and VACCINATION SITE PRURITUS (injection site was itchy but not red). At the time of the report, DIZZINESS (little lightheaded) and BALANCE DISORDER (his balance worsened after the vaccines) had resolved and BLOOD GLUCOSE FLUCTUATION (his blood sugars dropped below 150 after a week. At the end of the week, his blood sugars went back up a little and now continue to range from 50 (lowest) to 150) and VACCINATION SITE PRURITUS (injection site was itchy but not red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 350-450 (High) blood sugar high had been in 350-450, 200 (Low) low around 200, below 150 (abnormal) his blood sugars dropped below 150 after a week. and 50-150 (abnormal) blood sugars went back up a little and now continue to range from 50 (lowest) to 150.         Concomitant include patient stated he went from taking 4 shots of insulin (unspecified) a day. and he advised & takes 1 shot of insulin a day of long-lasting insulin Flex touch at 35 units daily and is no longer on the Novolin FlexPen.  No treatment information was provided.  Patient stated He started controlling is diet more and eating keto type foods especially snacks. Consumer stated his sugars were coming down some, "but it was still stubborn" And stated his blood sugars have stayed even.   This case was linked to MOD-2021-320975 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Joint stiffness, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry; Hands are ice cold; hip replacement and that area feels so bad; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders) and PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement and Ankle operation (Right ankle has two screws and a plate).   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders). At the time of the report, FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders) outcome was unknown.            No concomitant medication was given by reporter.  No treatment medication was given by reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry; Hands are ice cold; hip replacement and that area feels so bad; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders) and PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement and Ankle operation (Right ankle has two screws and a plate).   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders). At the time of the report, FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders) outcome was unknown.            No concomitant medication was given by reporter.  No treatment medication was given by reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: had an itchy red rash with the first dose; had an itchy red rash with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (had an itchy red rash with the first dose) and RASH ERYTHEMATOUS (had an itchy red rash with the first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Measles in January 1980. Past adverse reactions to the above products included Hives with Measles. Concurrent medical conditions included Hives, Iodine allergy (Hives), Allergy to chemicals (Eczema), Hypersensitivity, High cholesterol since 2010, Hypertension since 2002 and Depression since 2010. Concomitant products included DULOXETINE from 2010 to an unknown date for Depression, ATORVASTATIN from 2010 to an unknown date for High cholesterol, LOSARTAN from 2008 to an unknown date and HYDROCHLORIC ACID from 2002 to an unknown date for Hypertension.    On 12-Apr-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced RASH PRURITIC (had an itchy red rash with the first dose). April 2021, the patient experienced RASH ERYTHEMATOUS (had an itchy red rash with the first dose). At the time of the report, RASH PRURITIC (had an itchy red rash with the first dose) and RASH ERYTHEMATOUS (had an itchy red rash with the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was given by reporter.   This case was linked to MOD-2021-296722 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1-340321) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-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 INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were reported. No treatment medications were provided.  On 15-Apr-2021, the patient received first dose  (Sputnik COVID-19 Vaccine) (Batch No:- 1-340321) (unknown route) 1 dosage form.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC) (SPUTNIK V (GAM-COVID-VAC)) injection for COVID-19 vaccination.    No Medical History information was reported.   On 15-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (GAM-COVID-VAC) (SPUTNIK V (GAM-COVID-VAC)) (unknown route) 1 dosage form. On 13-Aug-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 INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (he 1st dose was Sputnik COVID 19, while the 2nd dose was the Moderna COVID 19 vaccine.) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Mobility decreased, Nausea
Clinical narrative: could barely walk home; went to bed and stay at home I could hardly move; dizziness (for three days); nausea (for three days); Chills (for three days); This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could barely walk home), MOBILITY DECREASED (went to bed and stay at home I could hardly move), DIZZINESS (dizziness (for three days)), NAUSEA (nausea (for three days)) and CHILLS (Chills (for three days)) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced GAIT DISTURBANCE (could barely walk home), MOBILITY DECREASED (went to bed and stay at home I could hardly move), DIZZINESS (dizziness (for three days)), NAUSEA (nausea (for three days)) and CHILLS (Chills (for three days)). On 28-Feb-2021, DIZZINESS (dizziness (for three days)), NAUSEA (nausea (for three days)) and CHILLS (Chills (for three days)) had resolved. At the time of the report, GAIT DISTURBANCE (could barely walk home) and MOBILITY DECREASED (went to bed and stay at home I could hardly move) outcome was unknown.            Treatment medication was not reported. Concomitant medication was not reported.  Patient was not immunocompromised. Patient stated that  having a good health, has unregular blood pressure and sometimes need medication and other times not (which was not related to the vaccine).   This case was linked to US-irms-MOD21-147416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2021: follow up received on 26-sep-21, date of birth and new events were added.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Felt fatigued) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced FATIGUE (Felt fatigued). At the time of the report, FATIGUE (Felt fatigued) outcome was unknown.            Patient reported that she did not test positive for Covid. Concomitant information was not reported.  Treatment information was not reported.  The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: having pain in the injection side  for a  week after both doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (having pain in the injection side  for a  week after both doses) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history reported.  Concomitant products included PREGABALIN (LYRICA), LORATADINE and ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.    On 08-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 VACCINATION SITE PAIN (having pain in the injection side  for a  week after both doses). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (having pain in the injection side  for a  week after both doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported by patient were powder for stomach pain and was taking blood pressure medication   This case was linked to MOD-2021-332051 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: having pain in the injection side  for a  week after both doses; felling a bit tired after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PREGABALIN (LYRICA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), PARACETAMOL (TYLENOL) and LORATADINE for an unknown indication.    On 10-Mar-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 INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (having pain in the injection side  for a  week after both doses) and FATIGUE (felling a bit tired after the second dose) outcome was unknown.            Other concomitant medications include powder for stomach pain, Blood pressure medications.   This case was linked to MOD-2021-332031 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Oropharyngeal pain, Swollen tongue
Clinical narrative: feels like her tongue is swelling up; sore throat; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (feels like her tongue is swelling up), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). On 25-Sep-2021, the patient experienced SWOLLEN TONGUE (feels like her tongue is swelling up) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, SWOLLEN TONGUE (feels like her tongue is swelling up) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown and CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: bit of sore arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (bit of sore arm after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (bit of sore arm after 2nd dose). At the time of the report, PAIN IN EXTREMITY (bit of sore arm after 2nd dose) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-331574 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Treatment information was not reported.   The patients had gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation for the 2nd dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Arm sore; fever (102,3 °F); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-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 VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102,3 °f (abnormal) fever (102,3 °F).         No concomitant product was provided Medcial History of appendicitis after 1 dose of spikevax   This case was linked to MOD-2021-332163 (Patient Link).; Sender's Comments: This case concerns a 52 years old female patient, with no reported relevant medical history, who experienced the non-serious expected events of Pyrexia and vaccination site pain. The events occurred after receiving second dose of Spikevax vaccine. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.