chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis (RA) flare up/RA was pretty intense; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20M) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Aug-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) (seriousness criterion medically significant). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis (RA) flare up/RA was pretty intense) outcome was unknown.            Concomitant medications includes medications for blood pressure and Cholesterol.  No treatment medications reported.  Patient experienced a Rheumatoid arthritis flare up that started on same arm. On 26 Aug 2021 and 27 Aug 2021, it was pretty intense. Patient had 2nd shot with batch number 0022MZ0A or 00ZZMZ0A.  Patient's medical history included blood pressure abnormal and cholesterol abnormal  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for  further assessment of this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of Rheumatoid Arthritis was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. Follow up information is expected for  further assessment of this event.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: myocardial infarction / heart attack; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction / heart attack) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction / heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 29-Aug-2021 to 30-Aug-2021 due to MYOCARDIAL INFARCTION. On 30-Aug-2021, MYOCARDIAL INFARCTION (myocardial infarction / heart attack) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided.  Treatment medication was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Endocrine ophthalmopathy, Feeling abnormal, Impaired driving ability, Impaired quality of life
Clinical narrative: Thyroid eye disease; Did not feel good; Can't work,Can't live,Can't see, her life is a living ,ruined her life; Can't live,Can't see, her life is a living ,ruined her life; Can´t see; can't drive; This spontaneous case was reported by a consumer and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) and BLINDNESS (Can´t see) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease) (seriousness criterion medically significant), FEELING ABNORMAL (Did not feel good) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), BLINDNESS (Can´t see) (seriousness criterion medically significant) and IMPAIRED DRIVING ABILITY (can't drive). At the time of the report, ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life), BLINDNESS (Can´t see) and IMPAIRED DRIVING ABILITY (can't drive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: +23 (High) Thyroid level sky rocket high at +23.         No concomitant medication information was mentioned by reporter  Synthroid 1mg used as a treatment medication then dose of Synthroid  was changed it to 0.88mg.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Thyroid function test
Clinical narrative: Thyroid eye disease; Did not feel good; Can't work,Can't live,Can't see, her life is a living ,ruined her life; Can't live,Can't see, her life is a living ,ruined her life; Can´t see; can't drive; This spontaneous case was reported by a consumer and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) and BLINDNESS (Can´t see) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease) (seriousness criterion medically significant), FEELING ABNORMAL (Did not feel good) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life) (seriousness criterion medically significant), BLINDNESS (Can´t see) (seriousness criterion medically significant) and IMPAIRED DRIVING ABILITY (can't drive). At the time of the report, ENDOCRINE OPHTHALMOPATHY (Thyroid eye disease), FEELING ABNORMAL (Did not feel good), IMPAIRED WORK ABILITY (Can't work,Can't live,Can't see, her life is a living ,ruined her life), IMPAIRED QUALITY OF LIFE (Can't live,Can't see, her life is a living ,ruined her life), BLINDNESS (Can´t see) and IMPAIRED DRIVING ABILITY (can't drive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: +23 (High) Thyroid level sky rocket high at +23.         No concomitant medication information was mentioned by reporter  Synthroid 1mg used as a treatment medication then dose of Synthroid  was changed it to 0.88mg.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Cholecystectomy, Gallbladder disorder, Hypertension
Clinical narrative: gallbladder issues which result in having it removed; diagnose of hypertension after vaccination; Gallbladder disorder; This spontaneous case was reported by a consumer and describes the occurrence of CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) 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.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder). At the time of the report, CHOLECYSTECTOMY (gallbladder issues which result in having it removed), HYPERTENSION (diagnose of hypertension after vaccination) and GALLBLADDER DISORDER (Gallbladder disorder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company Comment  This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.; Sender's Comments: This case concerns a patient who experienced gallbladder disorder and hypertension following administration of mRNA-1273 . Very limited information was provided. Further information has been requested. Based on current available information and plausible temporal relationship between product use and onset of the events, causal role cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, body aches, headache, vomiting all within of 4 hours of getting the vaccine. Taken Tylenol, zofran,  and dicyclomine
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Laboratory test, Pain in extremity, Palpitations
Clinical narrative: Sore arm, tingling all over. Fatigue, palpitations, tachycardia, weight loss
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tachycardia, Weight decreased
Clinical narrative: Sore arm, tingling all over. Fatigue, palpitations, tachycardia, weight loss
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 103, headache, body aches, vomiting, tiredness lasting for 5 days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: I was hospitalized for myocarditis. It started Sunday 8/1 with chest tightness and then pain under my jaw. I went in Monday morning to the ER and was hospitalized for 3 days. I was diagnosed with myocarditis related to the COVID vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging thoracic abnormal, Myocarditis, Pain in jaw, Red blood cell sedimentation rate increased, Troponin
Clinical narrative: I was hospitalized for myocarditis. It started Sunday 8/1 with chest tightness and then pain under my jaw. I went in Monday morning to the ER and was hospitalized for 3 days. I was diagnosed with myocarditis related to the COVID vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Cough; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) 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 LENVATINIB MESILATE (LENVIMA) for Liver carcinoma.    No Medical History information was reported.   On 30-Jul-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 8 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (shivering), PYREXIA (fever) and COUGH (Cough). At the time of the report, CHILLS (shivering), PYREXIA (fever) and COUGH (Cough) had resolved. Unknown          Patient started drug therapy of Lenvima for lung cancer due to which patient experienced adverse events stated as increase in blood pressure- improved; constipation/stomach bloating - on and off since last report.  In follow-up New report stated occasional "knot in the middle of chest/6 out of 10 pain level/at times, after a meal", stomatitis, on and off lower back pain, abdominal pain (affecting night sleep)- MD aware and it was advised patient to miss one dose and take Lenvima in the morning (night sleep- improved).  Patient recently also had Flu Vaccine.  Patient was prescribed with magic mouthwash for relief of stomatitis.  Treatment product information was not provided. Concomitant product use was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Myalgia
Clinical narrative: Headaches severe; tiredness; body aches; dizziness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), LETHARGY (lethargy), HEADACHE (Headaches severe), FATIGUE (tiredness) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear, Arthritis and Knee replacement. Concurrent medical conditions included Osteoporosis, COPD, Hypertension, Drug allergy (Melaxicom) and Drug allergy (tramadol). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), IRON and PANTOPRAZOLE for an unknown indication.    On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches). On 18-Aug-2021, the patient experienced HEADACHE (Headaches severe) and FATIGUE (tiredness). On 21-Aug-2021, DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (Headaches severe) and FATIGUE (tiredness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product also included Vitamin D4. No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up was received and patient details, relevant medical history, concomitant products and events were updated.
Age: 33.0
Sex: F
Vaccine: MMRV
Symptoms: Occupational exposure to product
Clinical narrative: no additional adverse events; nurse's eye was exposed to a partial of amount of PROQUAD vaccine due to the vaccine splashing into her eye during vaccination; nurse's eye was exposed to a partial of amount of PROQUAD vaccine due to the vaccine splashing into her eye during vaccination; This spontaneous report was received from a nurse and refers to a 33-year-old non-pregnant, female patient. Her pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 25-AUG-2021, the patient's eye was exposed to a partial amount of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dose once, for prevention of measles, mumps, rubella and varicella, lot # U22253, expiration date 24-JUL-2022) due to the vaccine splashing into her eye during vaccination. The eye was rinsed with a sterile eye wash. There were no additional adverse events.   Lot Number U222538 is not valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live and does not match any Company product.
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This spontaneous report was received from a pharmacist via Pfizer and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced anaphylactic reaction to vaccine. The outcome of anaphylactic reaction was unknown. The event of anaphylactic reaction was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  Upon internal review, the event of anaphylactic reaction was determined to be medically significant.
Age: 18.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; accidently administered PROQUAD and VARlVAX; 18 year old patient was accidently administered PROQUAD and VARlVAX; This spontaneous report was received from a medical assistant referring to a 18 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-AUG-2021, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route were not reported, 0.5 ml, lot # T012548, expiration date: 10-APR-2022) for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin (rHA)) (strength and route were not reported, 0.5 ml, lot# T021640, expiration date: 21-DEC-2021) for prophylaxis (accidental overdose and product administered to patient of inappropriate age).      The reporter verified the patient had not experienced any side effects from the administration. No additional information and adverse event were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My friend got the shot in April,/ In November she got the Shingles really bad/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 6 and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shot in April and in November she got the Shingles really bad for about four months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR187284 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187284:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling hot, Gait inability, Heart rate
Clinical narrative: Two huge lymph nodes in lungs (both); Both her knees down to her feet are swollen; Hot to the touch; Six spots that are really really red; Can not walk; One huge lymph protruding from the side of her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red) and GAIT INABILITY (Can not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck). On an unknown date, the patient experienced PULMONARY MASS (Two huge lymph nodes in lungs (both)). At the time of the report, PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 186 (High) 186 over 108, sent to the hospital because of her blood pressure and heart rate. On an unknown date, Heart rate: 117 (High) Sent to the hospital because of her blood pressure and heart rate.         Concomitant medication use information was  provided by reporter that includes Blood pressure medicine. Treatment medication use information was not provided by reporter.  Patient was healthy up until the shot. Patient reported that side effects were not improving even though was seen by physicians.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received on 29- Aug-2021, added reporter contact details, event outcome updated from unknown to not recovered , added information in I narrative.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Pulmonary mass
Clinical narrative: Two huge lymph nodes in lungs (both); Both her knees down to her feet are swollen; Hot to the touch; Six spots that are really really red; Can not walk; One huge lymph protruding from the side of her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red) and GAIT INABILITY (Can not walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck). On an unknown date, the patient experienced PULMONARY MASS (Two huge lymph nodes in lungs (both)). At the time of the report, PULMONARY MASS (Two huge lymph nodes in lungs (both)), JOINT SWELLING (Both her knees down to her feet are swollen), FEELING HOT (Hot to the touch), ERYTHEMA (Six spots that are really really red), GAIT INABILITY (Can not walk) and LYMPHADENOPATHY (One huge lymph protruding from the side of her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 186 (High) 186 over 108, sent to the hospital because of her blood pressure and heart rate. On an unknown date, Heart rate: 117 (High) Sent to the hospital because of her blood pressure and heart rate.         Concomitant medication use information was  provided by reporter that includes Blood pressure medicine. Treatment medication use information was not provided by reporter.  Patient was healthy up until the shot. Patient reported that side effects were not improving even though was seen by physicians.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received on 29- Aug-2021, added reporter contact details, event outcome updated from unknown to not recovered , added information in I narrative.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: ANGIO EDEMA; SEVERE URTICARIA; This spontaneous report received from a physician concerned a 64 year old patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, rosacea, and shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 15-APR-2021, one month post vaccination, patient experienced severe urticaria. On 02-SEP-2021, patient experienced angio-edema and was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe urticaria and angio-edema was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210908058-covid-19 vaccine ad26.cov2.s- Angio-edema. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908058-covid-19 vaccine ad26.cov2.s- Severe urticaria. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood test normal, Drug hypersensitivity, Food allergy, Urticaria
Clinical narrative: ANGIO EDEMA; SEVERE URTICARIA; This spontaneous report received from a physician concerned a 64 year old patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, rosacea, and shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 15-APR-2021, one month post vaccination, patient experienced severe urticaria. On 02-SEP-2021, patient experienced angio-edema and was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe urticaria and angio-edema was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210908058-covid-19 vaccine ad26.cov2.s- Angio-edema. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908058-covid-19 vaccine ad26.cov2.s- Severe urticaria. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Dyspnoea, Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH / HARD TO BREATH; COLD; CANT KEEP EYES OPEN; SORE ARM; FEVER; SEVER HEADACHE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath / hard to breath, cold, cant keep eyes open, sore arm, fever, and sever headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sever headache, shortness of breath / hard to breath, fever, cold, sore arm and cant keep eyes open was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SHORTNESS OF BREATH / HARD TO BREATH; COLD; CANT KEEP EYES OPEN; SORE ARM; FEVER; SEVER HEADACHE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath / hard to breath, cold, cant keep eyes open, sore arm, fever, and sever headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sever headache, shortness of breath / hard to breath, fever, cold, sore arm and cant keep eyes open was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced asymptomatic covid-19. The action taken with covid-19 vaccine was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Acne; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Acne) in a 30-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Acne). The patient was treated with DOXYCYCLINE ongoing since an unknown date for Acne, at an unspecified dose and frequency. At the time of the report, ACNE (Acne) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported .  Caller stated that she, Knows a lot of people on antibiotics who get the vaccine
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window). On 21-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist called to report that they gave a vaccine to two patients that was past the 12hr window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received and contains No New Information. On 25-Aug-2021: Follow up received added patient demographics (patient race), Second dose details(Route and site of administration).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 23-Jul-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 COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19). At the time of the report, COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, their doctor told they should wait 90 days after their symptoms gone, and pharmacist referred them to Moderna. They haven't received the 2nd dose yet. No concomitant medication was reported. The treatment information was unknown. This case was linked to MOD-2021-294322 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Illness, Paraesthesia, Sensory disturbance
Clinical narrative: he was very anxious, his anxiety level went through the roof; Tightness in his chest; He had pins and needles/He had pins and needles in his hair; it felt like he put charcoal on his skin a few times; he had to call in sick; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 036A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick). At the time of the report, ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) outcome was unknown.            Patient reported that he took multivitamins every third day.   This case was linked to MOD-2021-295014 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: She started with chronic insomnia 1 week after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose). At the time of the report, INSOMNIA (She started with chronic insomnia 1 week after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported   This case was linked to MOD-2021-294919 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphagia, Dyspnoea, Headache, Myalgia
Clinical narrative: throat was swollen; hard time trying to swallow; hard time trying  to breath; headache; nausea; fever, close to 104°F after the third dose; had pain in their muscles/body aches/body pain still,; pain in their  joints; developed a very strong reaction with a wide range of symptoms; everything was painful, painful to lay down, painful to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying  to breath) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), MYALGIA (had pain in their muscles/body aches/body pain still,) and ARTHRALGIA (pain in their  joints). On 20-Aug-2021 at 7:30 PM, the patient experienced PYREXIA (fever, close to 104°F after the third dose). On 21-Aug-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Aug-2021, the patient experienced PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying  to breath). The patient was treated with PARACETAMOL (TYLENOL) on 21-Aug-2021 for Pain, at a dose of 1 dosage form. On 24-Aug-2021, VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow), DYSPNOEA (hard time trying  to breath), PYREXIA (fever, close to 104°F after the third dose), MYALGIA (had pain in their muscles/body aches/body pain still,), ARTHRALGIA (pain in their  joints), HEADACHE (headache) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-294965 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pharyngeal swelling, Pyrexia, Vaccination complication
Clinical narrative: throat was swollen; hard time trying to swallow; hard time trying  to breath; headache; nausea; fever, close to 104°F after the third dose; had pain in their muscles/body aches/body pain still,; pain in their  joints; developed a very strong reaction with a wide range of symptoms; everything was painful, painful to lay down, painful to walk; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying  to breath) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), MYALGIA (had pain in their muscles/body aches/body pain still,) and ARTHRALGIA (pain in their  joints). On 20-Aug-2021 at 7:30 PM, the patient experienced PYREXIA (fever, close to 104°F after the third dose). On 21-Aug-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Aug-2021, the patient experienced PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow) and DYSPNOEA (hard time trying  to breath). The patient was treated with PARACETAMOL (TYLENOL) on 21-Aug-2021 for Pain, at a dose of 1 dosage form. On 24-Aug-2021, VACCINATION COMPLICATION (developed a very strong reaction with a wide range of symptoms), PAIN (everything was painful, painful to lay down, painful to walk), PHARYNGEAL SWELLING (throat was swollen), DYSPHAGIA (hard time trying to swallow), DYSPNOEA (hard time trying  to breath), PYREXIA (fever, close to 104°F after the third dose), MYALGIA (had pain in their muscles/body aches/body pain still,), ARTHRALGIA (pain in their  joints), HEADACHE (headache) and NAUSEA (nausea) had resolved.            This case was linked to MOD-2021-294965 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: foggy brained after second dose; sore arm after second dose; 104°F pretty high fever for a a day and a half,; They were also tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104°F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose) and PYREXIA (104°F pretty high fever for a a day and a half,). 2021, the patient experienced FATIGUE (They were also tired). At the time of the report, FEELING ABNORMAL (foggy brained after second dose), MYALGIA (sore arm after second dose), PYREXIA (104°F pretty high fever for a a day and a half,) and FATIGUE (They were also tired) outcome was unknown.            No treatment details were provided by reporter.   This case was linked to MOD-2021-294926, MOD-2021-294974 (Patient Link).