chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: having covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2022 and was forwarded to Moderna on 29-Jan-2022.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (having covid) 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 COVID-19 (having covid). At the time of the report, COVID-19 (having covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is enquiring how long should be waited to receive booster shot after contracting COVID-19. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.; Sender's Comments: This spontaneous case concerns a patient of unknown age/sex with no medical history, experience the unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the first dose of mRNA-1273. The patient was tested positive for SARS-Cov-2. The patient had only first dose and the dates of dose and events were not reported. The treatment details were not reported. At the time of reporting the outcome was not known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: booster shot side effect; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (booster shot side effect) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster shot side effect). At the time of the report, VACCINATION COMPLICATION (booster shot side effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     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. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and no treatment medications were reported.  About 2 weeks later, 06-Dec-2021, tested positive for COVID. Patient was asking about when could get the 2nd dose now or does have to start over.  Company comment: This spontaneous case concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected non serious event AESI of COVID-19, approximately 12 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient with no medical history reported, who experienced the unexpected non serious event AESI of COVID-19, approximately 12 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine) in a 64-year-old female patient 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Got COVID Disease 2 weeks after receiving  booster dose of Moderna COVID-19 vaccine) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.  Company comment: This spontaneous case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected non serious ADR of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-465333 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with no medical history reported, who experienced the unexpected non serious ADR of COVID-19, approximately 2 weeks after the booster dose of mRNA- 1273 vaccine. Information regarding the initial schedule of vaccination was not disclosed. Very limited information is available regarding clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Testicular pain
Clinical narrative: Muscle weakeness; Testicular pain; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakeness), TESTICULAR PAIN (Testicular pain), HEADACHE (Headache) and MYALGIA (Muscle pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included CABG (History of CABG blood pressure medication, and history of damaged vocal chord with CABG procedure.). Concurrent medical conditions included Blood pressure high, Anxiety and Acid reflux (esophageal). Concomitant products included HYDROCODONE for Back discomfort, METOPROLOL for Blood pressure management, OMEPRAZOLE for GERD, ALBUTEROL [SALBUTAMOL], ACETYLSALICYLIC ACID (ASPIRIN 81), BUMETANIDE (BUMEX), BUMETANIDE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), THYROID and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakeness), TESTICULAR PAIN (Testicular pain), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, MUSCULAR WEAKNESS (Muscle weakeness), TESTICULAR PAIN (Testicular pain), HEADACHE (Headache) and MYALGIA (Muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient after receiving the first dose of the vaccine experienced headache, muscle weakness, testicle pain, and muscle pain which has persisted up until today. The patient believed that the patient previously had Covid-19 in Nov-2019.   The patient's concomitant medications reported included Eye gel, 1 drop each eye 4 times a day, Isidolam, a low dose for anxiety, Cholesterol, (statin) 20mg tablet, Thyroid 15mg tablet. The patient also had Implant in their mouth.  No treatment information was provided.   This case was linked to MOD-2022-465664 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Erythema, Headache
Clinical narrative: sick to stomach; diarrhea; no energy; muscle ache; headache; face swell up; turn red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swell up), ERYTHEMA (turn red), ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea) and ASTHENIA (no energy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 039k20A and 004MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2022, the patient experienced SWELLING FACE (face swell up) and ERYTHEMA (turn red). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea), ASTHENIA (no energy), MYALGIA (muscle ache) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face swell up) had resolved, ERYTHEMA (turn red) outcome was unknown and ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea), ASTHENIA (no energy), MYALGIA (muscle ache) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient took steroid shot for treating symptoms. He takes daily medications but did not provided the names and screened Covid since and has come back negative. Concomitant medications was not reported.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test, Swelling face
Clinical narrative: sick to stomach; diarrhea; no energy; muscle ache; headache; face swell up; turn red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swell up), ERYTHEMA (turn red), ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea) and ASTHENIA (no energy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 039k20A and 004MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2022, the patient experienced SWELLING FACE (face swell up) and ERYTHEMA (turn red). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea), ASTHENIA (no energy), MYALGIA (muscle ache) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face swell up) had resolved, ERYTHEMA (turn red) outcome was unknown and ABDOMINAL DISCOMFORT (sick to stomach), DIARRHOEA (diarrhea), ASTHENIA (no energy), MYALGIA (muscle ache) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient took steroid shot for treating symptoms. He takes daily medications but did not provided the names and screened Covid since and has come back negative. Concomitant medications was not reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Fatigue
Clinical narrative: Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together; Tired; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced FATIGUE (Tired). On 04-Dec-2021, the patient experienced APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together). At the time of the report, APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together) outcome was unknown and FATIGUE (Tired) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, SARS-CoV-2 test
Clinical narrative: Received full booster dose instead of half dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose). In August 2021, ACCIDENTAL OVERDOSE (Received full booster dose instead of half dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient had taken several PCR tests, and all results have been negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster received 4 Months and 5 days earlier; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier) 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 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier) had resolved.            No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.  It was reported that pharmacist administered the booster dose to patient only in three months.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Limb discomfort, Movement disorder, Nausea
Clinical narrative: pain at the back of her neck; blurry vision; legs are very heavy and uncontrollable; took her 1.5 hours to get up from bed (9:30- 10:45am).; to use her walker which she normally does not.; She has to pick them up and put them them  they did not go where they were supposed to.; dizziness; Injection site was burning, burning; Nausea; Pain at the base of her skull across her shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).) and WALKING AID USER (to use her walker which she normally does not.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 005C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinsonism and Bladder disorder NOS (has to get up whole night a lot because she has weak bladder).   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).), WALKING AID USER (to use her walker which she normally does not.), MOVEMENT DISORDER (She has to pick them up and put them them  they did not go where they were supposed to.), DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site was burning, burning), NAUSEA (Nausea) and ARTHRALGIA (Pain at the base of her skull across her shoulders). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination site burning, at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).), WALKING AID USER (to use her walker which she normally does not.), MOVEMENT DISORDER (She has to pick them up and put them them  they did not go where they were supposed to.), DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site was burning, burning), NAUSEA (Nausea) and ARTHRALGIA (Pain at the base of her skull across her shoulders) outcome was unknown.            Concomitant medications were not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Somnolence, Vaccination site pain, Vision blurred, Walking aid user
Clinical narrative: pain at the back of her neck; blurry vision; legs are very heavy and uncontrollable; took her 1.5 hours to get up from bed (9:30- 10:45am).; to use her walker which she normally does not.; She has to pick them up and put them them  they did not go where they were supposed to.; dizziness; Injection site was burning, burning; Nausea; Pain at the base of her skull across her shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).) and WALKING AID USER (to use her walker which she normally does not.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 005C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinsonism and Bladder disorder NOS (has to get up whole night a lot because she has weak bladder).   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).), WALKING AID USER (to use her walker which she normally does not.), MOVEMENT DISORDER (She has to pick them up and put them them  they did not go where they were supposed to.), DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site was burning, burning), NAUSEA (Nausea) and ARTHRALGIA (Pain at the base of her skull across her shoulders). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination site burning, at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain at the back of her neck), VISION BLURRED (blurry vision), LIMB DISCOMFORT (legs are very heavy and uncontrollable), SOMNOLENCE (took her 1.5 hours to get up from bed (9:30- 10:45am).), WALKING AID USER (to use her walker which she normally does not.), MOVEMENT DISORDER (She has to pick them up and put them them  they did not go where they were supposed to.), DIZZINESS (dizziness), VACCINATION SITE PAIN (Injection site was burning, burning), NAUSEA (Nausea) and ARTHRALGIA (Pain at the base of her skull across her shoulders) outcome was unknown.            Concomitant medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: It is hot and hurts; Like a welt about 2 inches from injection site; It is hot and hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts) 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 VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts). At the time of the report, VACCINATION SITE WARMTH (It is hot and hurts), VACCINATION SITE URTICARIA (Like a welt about 2 inches from injection site) and VACCINATION SITE PAIN (It is hot and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm was a bit stiff; Allergy reaction to the bandage; Left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff), PAIN IN EXTREMITY (Left arm hurt) and HYPERSENSITIVITY (Allergy reaction to the bandage) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff), PAIN IN EXTREMITY (Left arm hurt) and HYPERSENSITIVITY (Allergy reaction to the bandage). At the time of the report, MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff) and HYPERSENSITIVITY (Allergy reaction to the bandage) outcome was unknown and PAIN IN EXTREMITY (Left arm hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was not on any concomitant medication. No treatment was given to the patient.   This case was linked to MOD-2022-465764 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Mass, Neck pain
Clinical narrative: Left side of my neck hurts; Feel a bump; This spontaneous case was reported by an other health care professional and describes the occurrence of NECK PAIN (Left side of my neck hurts) and MASS (Feel a bump) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Left side of my neck hurts) and MASS (Feel a bump). At the time of the report, NECK PAIN (Left side of my neck hurts) and MASS (Feel a bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Moderna booster shot Thursday afternoon. On friday evening patient experienced events.   No concomitant medications were reported.  No Treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Pyrexia
Clinical narrative: 99.2 temp; Experiencing joint pain; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (99.2 temp), ARTHRALGIA (Experiencing joint pain) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JJ vaccine in June 2021. Past adverse reactions to the above products included No adverse event with JJ vaccine.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced PYREXIA (99.2 temp), ARTHRALGIA (Experiencing joint pain) and FATIGUE (Fatigue). At the time of the report, PYREXIA (99.2 temp), ARTHRALGIA (Experiencing joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2022, Body temperature: 99.2 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: they got an allergy / a possible allergy to a patient getting  the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna 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 ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna vaccine). At the time of the report, ALLERGY TO VACCINE (they got an allergy / a possible allergy to a patient getting  the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.  The reporter asked whether the vaccine was made of any yeast or the whole product was made of yeast or not as the patient had an allergy to the vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired driving ability
Clinical narrative: Cannot drive; Can hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Cannot drive) and GAIT DISTURBANCE (Can hardly walk) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21B and 032B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2021 and CABG. Concurrent medical conditions included Blood pressure, Acid reflux (esophageal) (Stomach acid reflux) and Anxiety. Concomitant products included METOPROLOL for Blood pressure, HYDROCODONE, ALBUTEROL [SALBUTAMOL], ACETYLSALICYLIC ACID (ASPIRINE), BUMETANIDE (BUMEX), BUMETANIDE, OMEPRAZOLE, CHOLESTEROL, THYROID and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication, VITAMINS NOS (MULTIVITAMINUM) for an unknown indication and an unknown indication.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced IMPAIRED DRIVING ABILITY (Cannot drive). 16-Jun-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk). At the time of the report, IMPAIRED DRIVING ABILITY (Cannot drive) and GAIT DISTURBANCE (Can hardly walk) outcome was unknown.            Isidolam - low dose for anxiety,Eye gel, 1 drop each eye 4x day and CABG blood pressure medication  No treatment medication was reported.   This case was linked to MOD-2022-465584 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in left arm injection site.1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left arm injection site.1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029o20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in left arm injection site.1st dose). At the time of the report, VACCINATION SITE PAIN (soreness in left arm injection site.1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient received vaccine in his shoulder deltoid muscle.   This case was linked to MOD-2022-465769, MOD-2022-465795, MOD-2022-465812 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia, Vaccination complication
Clinical narrative: adverse reaction to the booster shot; blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction to the booster shot) and HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    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 VACCINATION COMPLICATION (adverse reaction to the booster shot) and HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500). On 30-Jan-2022, HYPERGLYCAEMIA (blood sugar level went into more than 400 range and mostly stayed high, next day mostly stayed above 500) had resolved. At the time of the report, VACCINATION COMPLICATION (adverse reaction to the booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2022, Blood glucose: 110 (normal) normal range of 110. On an unknown date, Blood glucose: above 400 (High) Went into more than 400 range and mostly stayed high and above 500 (High) mostly stayed high above 500.         The patient was diabetic. The blood sugar level of the patient went into more than 400 range and mostly stayed high, next day mostly stayed above 500. The levels were dangerously high levels.  On the day of reporting, when patient got out of bed it was normal range of 110 and patient hope it came back to normal.  No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: been sick for 3 days; throwing up part of it.; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.). At the time of the report, ILLNESS (been sick for 3 days) and VOMITING (throwing up part of it.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Lymph node pain, Pruritus, Rash
Clinical narrative: bad irritation all day long; her arm was very, very itchy / very itchy all night long; red bandage mark / arm was all red; arm with a rash; hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched; can feel something in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 047B21A and 016E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash), AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) and LYMPH NODE PAIN (can feel something in the lymph nodes). At the time of the report, SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and LYMPH NODE PAIN (can feel something in the lymph nodes) outcome was unknown and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) was resolving.            It was reported patient date of birth.   The patient is not on any concomitant medication. No treatment was given.  On 29Jan2022, patient stated that arm pain was not too bad, but while touching her armpit it hurts, and when she was moving the arm she could feel something in the lymph nodes.   This case was linked to MOD-2022-465645 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: bad irritation all day long; her arm was very, very itchy / very itchy all night long; red bandage mark / arm was all red; arm with a rash; hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched; can feel something in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 047B21A and 016E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash), AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) and LYMPH NODE PAIN (can feel something in the lymph nodes). At the time of the report, SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and LYMPH NODE PAIN (can feel something in the lymph nodes) outcome was unknown and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) was resolving.            It was reported patient date of birth.   The patient is not on any concomitant medication. No treatment was given.  On 29Jan2022, patient stated that arm pain was not too bad, but while touching her armpit it hurts, and when she was moving the arm she could feel something in the lymph nodes.   This case was linked to MOD-2022-465645 (Patient Link).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unauthorized age received vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Listless, Pain in extremity, Vaccination site pain
Clinical narrative: listlissness; run down feeling; joint pain; pain at the site of the injection; soreness in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (listlissness), FEELING ABNORMAL (run down feeling), PAIN IN EXTREMITY (soreness in his left arm), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029o20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left arm) and VACCINATION SITE PAIN (pain at the site of the injection). On 13-Feb-2021, the patient experienced LISTLESS (listlissness), FEELING ABNORMAL (run down feeling) and ARTHRALGIA (joint pain). At the time of the report, LISTLESS (listlissness), FEELING ABNORMAL (run down feeling), PAIN IN EXTREMITY (soreness in his left arm), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the site of the injection) outcome 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-2022-465694, MOD-2022-465795, MOD-2022-465812 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to metals, Dermatitis, Hypersensitivity, Rash
Clinical narrative: Dermatitis on my face; Allergic to Cobalt chloride Hexahydrate; Suffered from rashes; Allergic to 2-Hydroxyethyl methacrylate; This spontaneous case was reported by an other health care professional and describes the occurrence of DERMATITIS (Dermatitis on my face), ALLERGY TO METALS (Allergic to Cobalt chloride Hexahydrate), RASH (Suffered from rashes) and HYPERSENSITIVITY (Allergic to 2-Hydroxyethyl methacrylate) 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 DERMATITIS (Dermatitis on my face), ALLERGY TO METALS (Allergic to Cobalt chloride Hexahydrate), RASH (Suffered from rashes) and HYPERSENSITIVITY (Allergic to 2-Hydroxyethyl methacrylate). At the time of the report, DERMATITIS (Dermatitis on my face), ALLERGY TO METALS (Allergic to Cobalt chloride Hexahydrate), RASH (Suffered from rashes) and HYPERSENSITIVITY (Allergic to 2-Hydroxyethyl methacrylate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was triple vaccinated and experienced adverse events after 5 days of initial shot.  No concomitant product information was provided. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Vaccination site pain
Clinical narrative: run down feeling; listlissness; joint pain; pain at the site of the injection 3rd dose, soreness in his  left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness), VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm) and ARTHRALGIA (joint pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 016M20A and 029o20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm). On 28-Aug-2021, the patient experienced FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness) and ARTHRALGIA (joint pain). At the time of the report, FEELING ABNORMAL (run down feeling), ASTHENIA (listlissness), VACCINATION SITE PAIN (pain at the site of the injection 3rd dose, soreness in his  left arm) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications details were reported. No treatment information details were reported.   This case was linked to MOD-2022-465694, MOD-2022-465812, MOD-2022-465769 (Patient Link).