chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Rash broke out on both Legs, Back, and  Left shoulder after the second dose; She broke out on both legs and  left shoulder  injection site 2 weeks after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash broke out on both Legs, Back, and  Left shoulder after the second dose) and VACCINATION SITE RASH (She broke out on both legs and  left shoulder  injection site 2 weeks after the second shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced RASH (Rash broke out on both Legs, Back, and  Left shoulder after the second dose) and VACCINATION SITE RASH (She broke out on both legs and  left shoulder  injection site 2 weeks after the second shot). The patient was treated with BETAMETHASONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash broke out on both Legs, Back, and  Left shoulder after the second dose) and VACCINATION SITE RASH (She broke out on both legs and  left shoulder  injection site 2 weeks after the second shot) outcome was unknown.            The patient was taking Celebrex and  stopped the use of  Celebrex to see if that improves the rash, but the rash  was not recovered.   This case was linked to MOD-2021-296638 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Vision blurred
Clinical narrative: Experienced anxiety while driving; Generally he does not feel good; A little bit of blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision) 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-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision). At the time of the report, ANXIETY (Experienced anxiety while driving), FEELING ABNORMAL (Generally he does not feel good) and VISION BLURRED (A little bit of blurred vision) outcome was unknown.            No concomitant and treatment information were reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: didn't feel well; broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Urticaria (Hives). Concurrent medical conditions included Blood pressure high since 2015, GERD since 2008, Asthma, Penicillin allergy and Drug allergy (Sulfa). Concomitant products included LISINOPRIL, DEXLANSOPRAZOLE (DEXILANT) from 06-Jan-2008 to an unknown date, LEVOTHYROXINE SODIUM (SYNTHROID) and LEVOTHYROXINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere). The patient was treated with HYDROCHLOROTHIAZIDE (oral) at a dose of 12.5 mg daily. At the time of the report, VACCINATION COMPLICATION (didn't feel well) and RASH (broke out in a rash entirely all over my body /Rash was like little bumps underneath the skin, everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Directions for first dose were not provided.   This case was linked to MOD-2021-296654, MOD-2021-296286 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Significant Follow up updated patient history.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Fatigue, Illness
Clinical narrative: Weak; Really sick; Arm did hurt like a fracture; Loosing  sensation for taste; Loosing  sensation for smell; Extremely tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste) and ANOSMIA (Loosing  sensation for smell) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-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 ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste), ANOSMIA (Loosing  sensation for smell), FATIGUE (Extremely tired) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste), ANOSMIA (Loosing  sensation for smell), FATIGUE (Extremely tired) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-296660 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Weak; Really sick; Arm did hurt like a fracture; Loosing  sensation for taste; Loosing  sensation for smell; Extremely tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste) and ANOSMIA (Loosing  sensation for smell) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-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 ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste), ANOSMIA (Loosing  sensation for smell), FATIGUE (Extremely tired) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm did hurt like a fracture), AGEUSIA (Loosing  sensation for taste), ANOSMIA (Loosing  sensation for smell), FATIGUE (Extremely tired) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-296660 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed his second Moderna vaccine due to cardiac surgery; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine due to cardiac surgery) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery.    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 PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine due to cardiac surgery). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine due to cardiac surgery) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: weakness; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ASTHENIA (weakness), HEADACHE (Headache) and PYREXIA (Fever). On 24-Jan-2021, ASTHENIA (weakness), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-297468 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: son didn't receive second shot / Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose). On 21-May-2021, PRODUCT DOSE OMISSION ISSUE (son didn't receive second shot / Beyond 35 days for 2nd dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received , Product lot number added.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Hypokinesia, Migraine, Swelling, Vomiting
Clinical narrative: swelling; Interfere with motion; Pain under arm pit; Migraine with  vomiting; Migraine with  vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine with  vomiting), SWELLING (swelling), HYPOKINESIA (Interfere with motion), VOMITING (Migraine with  vomiting) and AXILLARY PAIN (Pain under arm pit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 016B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced MIGRAINE (Migraine with  vomiting) and VOMITING (Migraine with  vomiting). On 25-Aug-2021, the patient experienced SWELLING (swelling), HYPOKINESIA (Interfere with motion) and AXILLARY PAIN (Pain under arm pit). At the time of the report, MIGRAINE (Migraine with  vomiting), SWELLING (swelling), HYPOKINESIA (Interfere with motion), VOMITING (Migraine with  vomiting) and AXILLARY PAIN (Pain under arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. Patient said that he would provide ultra sound data to Moderna, but Modena would have to follow-up with him.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Malaise, Myalgia, Pruritus, Swelling
Clinical narrative: There are big bumps.  They are swelling up; Itching; Looked as if she had shingles; Body is "not well"; Body began to ache/Felt like "when bees bite you, all over my body"; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body"). At the time of the report, SWELLING (There are big bumps.  They are swelling up), PRURITUS (Itching), HERPES ZOSTER (Looked as if she had shingles), MALAISE (Body is "not well") and MYALGIA (Body began to ache/Felt like "when bees bite you, all over my body") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Blood test, Chest discomfort, Electrocardiogram
Clinical narrative: anxiety; blood pressure was high; really tired; felt chest pressure; fast heartbeat; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety), CHEST DISCOMFORT (felt chest pressure), HEART RATE INCREASED (fast heartbeat), HYPERTENSION (blood pressure was high) and FATIGUE (really tired) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CHEST DISCOMFORT (felt chest pressure), HEART RATE INCREASED (fast heartbeat) and FATIGUE (really tired). On 03-Jun-2021, the patient experienced HYPERTENSION (blood pressure was high). On an unknown date, the patient experienced ANXIETY (anxiety). The patient was treated with DIAZEPAM (VALIUM) for Anxiety, at an unspecified dose and frequency. On 15-Jun-2021, CHEST DISCOMFORT (felt chest pressure) and HEART RATE INCREASED (fast heartbeat) had resolved. In July 2021, HYPERTENSION (blood pressure was high) had resolved. At the time of the report, ANXIETY (anxiety) and FATIGUE (really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Blood pressure measurement: 160/100 (High) High at 160/100 and remained so for a month. On 03-Jun-2021, Blood test: normal (normal) normal. On 03-Jun-2021, Electrocardiogram: normal (normal) Normal. On 11-Jun-2021, Blood pressure measurement: 180/116 (High) 180/116. On 11-Jun-2021, Electrocardiogram: normal (normal) normal.     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.   The concomitant medication was not reported. On 13/Aug/2021, Patient had a stress test, Holter Monitor, and echogram performed and did not yet receive the results. Patient had another cardiology appointment in Sep/2021. Patient did not consistently take treatment medication Valium for anxiety and stopped the medication as he did not like how it made him feel.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hypertension
Clinical narrative: anxiety; blood pressure was high; really tired; felt chest pressure; fast heartbeat; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety), CHEST DISCOMFORT (felt chest pressure), HEART RATE INCREASED (fast heartbeat), HYPERTENSION (blood pressure was high) and FATIGUE (really tired) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CHEST DISCOMFORT (felt chest pressure), HEART RATE INCREASED (fast heartbeat) and FATIGUE (really tired). On 03-Jun-2021, the patient experienced HYPERTENSION (blood pressure was high). On an unknown date, the patient experienced ANXIETY (anxiety). The patient was treated with DIAZEPAM (VALIUM) for Anxiety, at an unspecified dose and frequency. On 15-Jun-2021, CHEST DISCOMFORT (felt chest pressure) and HEART RATE INCREASED (fast heartbeat) had resolved. In July 2021, HYPERTENSION (blood pressure was high) had resolved. At the time of the report, ANXIETY (anxiety) and FATIGUE (really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Blood pressure measurement: 160/100 (High) High at 160/100 and remained so for a month. On 03-Jun-2021, Blood test: normal (normal) normal. On 03-Jun-2021, Electrocardiogram: normal (normal) Normal. On 11-Jun-2021, Blood pressure measurement: 180/116 (High) 180/116. On 11-Jun-2021, Electrocardiogram: normal (normal) normal.     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.   The concomitant medication was not reported. On 13/Aug/2021, Patient had a stress test, Holter Monitor, and echogram performed and did not yet receive the results. Patient had another cardiology appointment in Sep/2021. Patient did not consistently take treatment medication Valium for anxiety and stopped the medication as he did not like how it made him feel.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: very mild malaise type of feeling; Soreness at the injection site; feeling of tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (very mild malaise type of feeling), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (feeling of tiredness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A OR 02C120A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Hypertension (High Blood Pressuer), BPH, Sleep apnea and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness). an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness) outcome was unknown and VACCINATION SITE PAIN (Soreness at the injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Dose-3 on 25-AUG-2021 and he had experience Hot, typical covid arm,giving him a little bit of problem. On 26-AUG-2021 he felt much better than 25-AUG-2021 and later itchiness and soreness is much better but the swelling and redness is a little bit better or the same. Other Treatment medicine: CBD Cream.   This case was linked to MOD-2021-297029, MOD-2021-297099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease, Penicillin allergy, Sulfonamide allergy (Allergic to Sulfa drugs), Food allergy (Allergic to corn products and Mt Dew.), Drug allergy (Allergic to Ilosone), Drug allergy (Allergic to Cipro), Drug allergy (Allergic to Avelox), Drug allergy (Allergic to Valtrex), Drug allergy (Allergic to Flagyl) and Drug allergy (Allergic to Dacyclomins). Concomitant products included DIAZEPAM from 1977 to an unknown date and IMIPRAMINE HCL from 1977 to an unknown date for Agoraphobia, MESALAZINE (PENTASA) for Crohn's disease, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]) and ASCORBIC ACID (ESTER C [ASCORBIC ACID]) for an unknown indication.    On 20-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      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.   The consumer stated that she has been using pentasa drug, 3 or 2 times per day, for Crohn's disease, since 2 or 3 years.  Treatment information was not provided.   This case was linked to MOD-2021-114492 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid-19 around 3 weeks ago and became dealthly ill, lost their sense of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid-19 around 3 weeks ago and became dealthly ill, lost their sense of taste and smell) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    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 (got covid-19 around 3 weeks ago and became dealthly ill, lost their sense of taste and smell). At the time of the report, COVID-19 (got covid-19 around 3 weeks ago and became dealthly ill, lost their sense of taste and smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not reported.  Patient had COVID -19 around 3 weeks ago.   This case was linked to MOD-2021-297213 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Exposure to SARS-CoV-2, Fatigue, Illness, Product dose omission issue
Clinical narrative: no appetite; Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus; dog tired,too tired to do anything; did not receive second shot in allowed time; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included TAMSULOSIN, LORATADINE (LOMAX [LORATADINE]), VITAMINS NOS (DAILY VITAMINS) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 20 (Low) loss of 20lbs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included Cotaught and Blood pressure medication.  Treatment medication was not reported.  Patient was exposed to their grandson who tested positive for COVID-19 the day after seeing them. Patient's primary care doctor suggested that they had enough protection from the virus and did not need to continue the vaccination series. They have not received the second dose at but patient was considering at the time of this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: no appetite; Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus; dog tired,too tired to do anything; did not receive second shot in allowed time; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included TAMSULOSIN, LORATADINE (LOMAX [LORATADINE]), VITAMINS NOS (DAILY VITAMINS) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 20 (Low) loss of 20lbs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included Cotaught and Blood pressure medication.  Treatment medication was not reported.  Patient was exposed to their grandson who tested positive for COVID-19 the day after seeing them. Patient's primary care doctor suggested that they had enough protection from the virus and did not need to continue the vaccination series. They have not received the second dose at but patient was considering at the time of this report.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: The rash as big blotchy red areas that itch; The rash as big blotchy red areas that itch; They are huge masses of red spots all over her body; The rash continued to spread all over the body from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091O21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe) outcome was unknown.            No concomitant medications were reported. Treatment Includes Prednisone Taper Therapy.   This case was linked to MOD-2021-297311 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was very sore all night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore all night) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore all night). At the time of the report, PAIN IN EXTREMITY (arm was very sore all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-297345.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: some one tell me its create complication like elergic reation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (some one tell me its create complication like elergic reation) 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 HYPERSENSITIVITY (some one tell me its create complication like elergic reation). At the time of the report, HYPERSENSITIVITY (some one tell me its create complication like elergic reation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little fatigued after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little fatigued after first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis (On  hands, inside area of the elbow, lower back, inner upper thighs and backs of the knees. Significant improvement ~10-14 days after receiving the second dose of COVID-19 vaccine.) since March 2016, Eczema (mainly on the palms of their hands, on the inside of their elbows, on the back of knee, in the lower back and in the inguinal area, and inner thigh.) and Psoriasis.    On 01-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 FATIGUE (little fatigued after first dose). The patient was treated with IBUPROFEN at a dose of 200 milligram, one pill. At the time of the report, FATIGUE (little fatigued after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient experienced a positive side effect for atopic dermatitis, eczema and psoriasis, mainly on the palms of their hands, on the inside of their elbows, on the back of knee,  in the lower back and in the inguinal area, and inner thigh.   This case was linked to MOD-2021-297551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information included Patient demographic details and Current condition details.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-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 ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache). At the time of the report, ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was around a relative who might have exposed her to Covid-19 last weekend, she had herself done a home test which was negative.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Irregular breathing, Lethargy, Product dose omission issue, Pruritus
Clinical narrative: 20 minutes after I was vaccinated I went through an allergic reaction; itching; hives later in the day; very minor breathing  issues; semi lethargic state in functionality; safe to get a second vaccine as the response  was minor; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues) and LETHARGY (semi lethargic state in functionality) in a 27-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.    In January 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 HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues), LETHARGY (semi lethargic state in functionality) and PRODUCT DOSE OMISSION ISSUE (safe to get a second vaccine as the response  was minor). At the time of the report, HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues) and LETHARGY (semi lethargic state in functionality) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (safe to get a second vaccine as the response  was minor) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 20 minutes after I was vaccinated I went through an allergic reaction; itching; hives later in the day; very minor breathing  issues; semi lethargic state in functionality; safe to get a second vaccine as the response  was minor; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues) and LETHARGY (semi lethargic state in functionality) in a 27-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.    In January 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 HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues), LETHARGY (semi lethargic state in functionality) and PRODUCT DOSE OMISSION ISSUE (safe to get a second vaccine as the response  was minor). At the time of the report, HYPERSENSITIVITY (20 minutes after I was vaccinated I went through an allergic reaction), PRURITUS (itching), URTICARIA (hives later in the day), IRREGULAR BREATHING (very minor breathing  issues) and LETHARGY (semi lethargic state in functionality) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (safe to get a second vaccine as the response  was minor) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt a little tired after her first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt a little tired after her first vaccination) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced FATIGUE (felt a little tired after her first vaccination). At the time of the report, FATIGUE (felt a little tired after her first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: received an expired booster dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017621A, 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired booster dose). 24-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (received an expired booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Pain
Clinical narrative: Next day, she had really bad body aches.; She also had fatigue next day.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; She slept for 23.5 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040021A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), BUSPIRONE HYDROCHLORIDE (BUSPAR) and FLUOXETINE for an unknown indication.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HYPERSOMNIA (She slept for 23.5 hours). On 23-Aug-2021, the patient experienced PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.). On 24-Aug-2021, the patient experienced PAIN (Next day, she had really bad body aches.) and FATIGUE (She also had fatigue next day.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Blood pressure medicine.  Patient had body aches. She also had fatigue. She slept for 23.5 hours and at the day of reporting she felt better.