chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm) and ERYTHEMA (redness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles between his ear and temple, down to the back of his neck,), PRURITUS (itchy), VISION BLURRED (blurred vision), PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported.   This case was linked to MOD-2021-315988 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Depression, Fatigue, Headache, Menstruation irregular
Clinical narrative: Menstruation change; Depression; ADHD; Chronic fatigue/Tired all the time; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergic to banana), Drug allergy (bioxin), Depression and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), ESCITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression) and ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) outcome was unknown, FATIGUE (Chronic fatigue/Tired all the time) was resolving and HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Menstruation change; Depression; ADHD; Chronic fatigue/Tired all the time; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergic to banana), Drug allergy (bioxin), Depression and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), ESCITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression) and ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) outcome was unknown, FATIGUE (Chronic fatigue/Tired all the time) was resolving and HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis
Clinical narrative: cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065D21A and 048F21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, TORASEMIDE (TORSEMIDE), POTASSIUM CHLORIDE (KLOR-CON M20), CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, METOPROLOL, APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-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 NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 88.2 (Low) 88.2 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter.   This case was linked to MOD-2021-318405 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 35 days for administration of second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for administration of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up information received contains Non significant information. Added patient Race White and Ethnicity non Hispanic or latino and Patient Pregnancy as NO.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at injection site looks like red burn mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site looks like red burn mark) 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 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (rash at injection site looks like red burn mark). At the time of the report, VACCINATION SITE RASH (rash at injection site looks like red burn mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included hot and cold treatment and she went to doctor and was given antibiotics.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off label use; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced OFF LABEL USE (Off label use). At the time of the report, OFF LABEL USE (Off label use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-318424 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report my symptoms; 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 VACCINATION COMPLICATION (Report my symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report my symptoms). At the time of the report, VACCINATION COMPLICATION (Report my symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days from 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from 1st vaccination) 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 17-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days from 1st vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from 1st vaccination) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient was scheduled to get second dose on 13-Aug-2021.  No concomitant medications were reported.  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Insomnia, Rash, Vaccination site reaction
Clinical narrative: insomnia; She is still sweating in her hands and feet, profusely.; rash on my face; really bad reaction; started sweating profusely, really bad, especially her hands; diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands), DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit), INSOMNIA (insomnia) and HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands) and DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit). On 01-Sep-2021, the patient experienced RASH (rash on my face). On an unknown date, the patient experienced INSOMNIA (insomnia) and HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.). At the time of the report, VACCINATION SITE REACTION (really bad reaction), HYPERHIDROSIS (started sweating profusely, really bad, especially her hands), INSOMNIA (insomnia), HYPERHIDROSIS (She is still sweating in her hands and feet, profusely.) and RASH (rash on my face) outcome was unknown and DIARRHOEA (diarrhea / I've had diarrhea ever since 31Aug2021;it has not quit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a possible side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a possible side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a possible side effect). At the time of the report, VACCINATION COMPLICATION (Report a possible side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: after their first and second dose, their injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Concomitant drug was not reported.  Treatment medication was not reported.  It was reported that patient is not immunocompromised and received dose 2 and dose 3.   This case was linked to MOD-2021-318414, MOD-2021-318415 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included chemotherapy (every two weeks) since an unknown date. On Aug 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side). At the time of the report, pain in extremity (left arm still hurts, six weeks after first dose), loss of personal independence in daily activities (can't hardly lift anything with his left arm) and insomnia (hurts to lay and sleep on his left-side) outcome unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-318419 (patient link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Myalgia
Clinical narrative: left arm was sore; felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, TORASEMIDE (TORSEMIDE), POTASSIUM CHLORIDE (KLOR-CON), CLOPIDOGREL BESYLATE (CLOPIDOGREL [CLOPIDOGREL BESYLATE]), LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), METOPROLOL, APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.    On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit). At the time of the report, MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 88.2 (Low) 88.2 degrees Fahrenheit.         No treatment medications were reported.   This case was linked to MOD-2021-318247 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection arm was warm) in a 71-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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (injection arm was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-318263 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: sore arm; fatigue; 13 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date,patient got second dose of the Moderna COVID-19 vaccine.   Concomitant product use was not provided by the reporter.    No treatment information was provided.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Vaccination site swelling
Clinical narrative: extreme weakness in my hands; hurts to grab things, or even to just close them; swell at the injection site; swell at my upper arm quite a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot) in a 43-year-old patient of an unknown 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot). At the time of the report, MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, Product dose omission issue
Clinical narrative: She was due to get the second dose on 07SEP2021 and she was out of town and missed it.; So far asymptomatic for COVID-19 Disease; Exposed to COVID-19 infected person; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person), PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person). On 13-Sep-2021, the patient experienced ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: injection in her fat; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (injection in her fat) in a 33-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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-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 PRODUCT ADMINISTRATION ERROR (injection in her fat). At the time of the report, PRODUCT ADMINISTRATION ERROR (injection in her fat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Myalgia, Pyrexia
Clinical narrative: I am tired from not sleeping; Body hurt; 101 degrees fever; Started to feel bad; Could not sleep that night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) 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 12-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), MYALGIA (Body hurt) and PYREXIA (101 degrees fever). On 13-Sep-2021, the patient experienced FATIGUE (I am tired from not sleeping). At the time of the report, FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) outcome was unknown. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient started to feel somewhat better after lunch on 13 Sep 2021.   This case was linked to MOD-2021-311034 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: had a procedure done and had anesthetics and IV; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had a procedure done and had anesthetics and IV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Anesthesia on 09-Sep-2021 and IV flush on 09-Sep-2021.   On 03-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SURGERY (had a procedure done and had anesthetics and IV). The patient was treated with PREDNISONE at a dose of 50 mg. At the time of the report, SURGERY (had a procedure done and had anesthetics and IV) outcome was unknown.            No concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Constant pain after 3rd shot; Suffering with bad headache after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Constant pain after 3rd shot) and HEADACHE (Suffering with bad headache after 3rd shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Angioma. Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Angioma.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PAIN (Constant pain after 3rd shot) and HEADACHE (Suffering with bad headache after 3rd shot). At the time of the report, PAIN (Constant pain after 3rd shot) outcome was unknown and HEADACHE (Suffering with bad headache after 3rd shot) had resolved.            Patient experienced headache and constant pain it was so bad that she visited the emergency room on Sunday,12-SEP-2021. They gave her a Migraine cocktail by IV. She believes that there was Muscle relaxer and Benadryl in the cocktail. They released her to follow up with her doctor. re-challenge is positive   This case was linked to MOD-2021-318514, MOD-2021-318486 (Patient Link).; Sender's Comments: This case concerns a 73 year-old,  female subject with a history of Angioma for which she takes Acetaminophen, Tramadol, and Flexeril  who experienced the expected event of headache and unexpected event of pain. The events occurred occurred on the same day  after the third dose of Spikevax. The rechallenge was positive as the subject experienced headache after the first, second and reoccurred on third dose.  The event is consistent with the current understanding of the mechanism of action of the study medication. The medical history of Angioma for which she takes Acetaminophen, Tramadol, and Flexeril  remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Events were assesed as non-serious as emergency room visits that do not result in admission to the hospital would not qualify for hospitalazation and the events doesn´t  seem to be serious by medical judgement and from a clinical or regulatory standpoint.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Retching, Vaccination site erythema
Clinical narrative: Injection site of arm is warm, hot; Dry heaving; Nauseous and dry heaving; Fever; Chills; Injection site of arm is warm, hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 042C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported  by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-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 VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site of arm is warm, hot) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red) had not resolved and RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     The patient continued using ice and Tylenol for ongoing symptoms after taking guidance from HCP and pharmacist.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site of arm is warm, hot; Dry heaving; Nauseous and dry heaving; Fever; Chills; Injection site of arm is warm, hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 042C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported  by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-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 VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site of arm is warm, hot) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red) had not resolved and RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     The patient continued using ice and Tylenol for ongoing symptoms after taking guidance from HCP and pharmacist.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Migraine, Pruritus, Rash
Clinical narrative: Dizzy; All my body was itchy; Rash all over my body; A lot of cough; migraine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PRURITUS (All my body was itchy), COUGH (A lot of cough), MIGRAINE (migraine) and RASH (Rash all over my body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced DIZZINESS (Dizzy), PRURITUS (All my body was itchy) and RASH (Rash all over my body). In September 2021, the patient experienced COUGH (A lot of cough) and MIGRAINE (migraine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PRURITUS (All my body was itchy), COUGH (A lot of cough), MIGRAINE (migraine) and RASH (Rash all over my body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Tingling in the left side of her neck and shoulder; Redness; Scratchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy). At the time of the report, PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) 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.  The patient experienced redness and it was scratchy within a week.   This case was linked to MOD-2021-318618 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: diarrhea; swollen arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abdominal aortic aneurysm (triple A Abdominal aorta aneurysm), Gallbladder stones and Heart attack. Concurrent medical conditions included Memory loss, High cholesterol, Stiffness and Vitamin D deficiency. Concomitant products included BACLOFEN, METOPROLOL, TERAZOSIN HCL, OXYBUTYNIN CHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, PAROXETINE HCL and SALINE [SODIUM CHLORIDE] for an unknown indication.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: After the second dose, the tingling went up to her shoulder to the back of her neck; She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.). At the time of the report, PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-318602 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Epistaxis
Clinical narrative: Bruising; he started having bloody nose every day when eating; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091B21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating). At the time of the report, CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.; Left arm was hot; had to much swelling on their left arm, it was very hot, lasting 2-3 days; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK UNK, q4h. At the time of the report, DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) outcome was unknown.            Concomitant medications included medication to replace thyroid.  Treatment for the events included ice.   This case was linked to MOD-2021-318648, MOD-2021-318654, MOD-2021-318659 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Her arm feels sore after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm feels sore after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MYALGIA (Her arm feels sore after vaccination). At the time of the report, MYALGIA (Her arm feels sore after vaccination) outcome was unknown.            Concomitant medication was not provided. no treatment medication was provided. patients sated that she was wanted to know if she could take Tylenol or apply heat to the site of the injection.