chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: dizzy spells; stiffness in face; tightness in face; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 03-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 DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face). At the time of the report, DIZZINESS (dizzy spells), MUSCULOSKELETAL STIFFNESS (stiffness in face) and MUSCLE TIGHTNESS (tightness in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient does not use insulin for diabetes. He just does exercise and takes a blood thinner.  Patient has tried to correct the events with exercise.  No concomitant medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood cholesterol abnormal.Concomitant products included VITAMINS NOS for Vitamin supplementation, ATENOLOL for an unknown indication.On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) and BODY TEMPERATURE INCREASED (I had temperature for one night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Pain in arm and Redness, at an unspecified dose and frequency. On 07-Aug-2021, BODY TEMPERATURE INCREASED (I had temperature for one night) had resolved. At the time of the report, VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) outcome was unknown and VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Aug-2021, Body temperature: high (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Concomitant products also includes Cholesterol medication. Patient says she also used pain release cream for treatmeant
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood cholesterol abnormal.Concomitant products included VITAMINS NOS for Vitamin supplementation, ATENOLOL for an unknown indication.On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) and BODY TEMPERATURE INCREASED (I had temperature for one night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Pain in arm and Redness, at an unspecified dose and frequency. On 07-Aug-2021, BODY TEMPERATURE INCREASED (I had temperature for one night) had resolved. At the time of the report, VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) outcome was unknown and VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Aug-2021, Body temperature: high (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Concomitant products also includes Cholesterol medication. Patient says she also used pain release cream for treatmeant
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patinent less than 12 years of age received the moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patinent less than 12 years of age received the moderna Covid-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        Concomitant medication were not reported. Treatment medication were not reported.   This case was linked to MOD-2021-294383, MOD-2021-294516 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Vaccination complication, Vaccination site erythema, Vaccination site lymphadenopathy
Clinical narrative: Bicep is swollen; Definitely a bad reaction; Lymph node of neck (left side) is swollen; Lymph node of injection arm is swollen; Injection site is red; Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen). On an unknown date, the patient experienced PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Unknown; CORTISONE ACETATE at a dose of Unknown; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of Unknown and NAPROXEN SODIUM (ALEVE) at a dose of unknown. At the time of the report, PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen) outcome was unknown.            Patient thought to be used arthritis cream as treatment medication. No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Bicep is swollen; Definitely a bad reaction; Lymph node of neck (left side) is swollen; Lymph node of injection arm is swollen; Injection site is red; Injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen). On an unknown date, the patient experienced PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Unknown; CORTISONE ACETATE at a dose of Unknown; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of Unknown and NAPROXEN SODIUM (ALEVE) at a dose of unknown. At the time of the report, PERIPHERAL SWELLING (Bicep is swollen), VACCINATION COMPLICATION (Definitely a bad reaction), LYMPHADENOPATHY (Lymph node of neck (left side) is swollen), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph node of injection arm is swollen) outcome was unknown.            Patient thought to be used arthritis cream as treatment medication. No concomitant medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal
Clinical narrative: After the 1st dose, she noticed a spike, like manifest, of her condition (OCD); After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Aug-2021 and was forwarded to Moderna on 23-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury. Concurrent medical conditions included Obsessive-compulsive disorder (Patient had OCD like germaphobia for the past 30+ years and it was manageable and under control).    On 25-Jun-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 CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.). At the time of the report, CONDITION AGGRAVATED (After the 1st dose, she noticed a spike, like manifest, of her condition (OCD)) and FEELING ABNORMAL (After the 1st dose, she described her symptom as she'd need to dump the pitcher 3 or 4 times as she thought it was contaminated.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking a lot of medication but declined providing the medication list.  Treatment information was not provided.   This case was linked to MOD-2021-294492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-Sep-2021 and contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: Dizziness; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness). At the time of the report, SOMNOLENCE (Sleepiness) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was reported by patient.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: More than 6 months away from first shot and had not received the second shot; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm) and PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (COVID Arm). On 23-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot). In January 2021, VACCINATION COMPLICATION (COVID Arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back in 24Jan2020 through 15Feb2020) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia). In March 2021, PAIN (Pain moved to all of their long bones and muscles), BACK PAIN (Back pain) and MYALGIA (Severe Myalgia) had resolved. Treatment information was not  provided. The patient explained these symptoms lasted through the first night, was gone the next day, then the pain came back the following day, and finally the next day it all went away.This case was linked to MOD-2021-294577, MOD-2021-294571 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Little sore arm; Little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little sore arm) and HEADACHE (Little headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and MS.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MYALGIA (Little sore arm) and HEADACHE (Little headache). At the time of the report, MYALGIA (Little sore arm) and HEADACHE (Little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included infusions for MS.  Treatment information was not provided.   This case was linked to MOD-2021-294520 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair falling out after both shots; 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 ALOPECIA (Hair falling out after both shots) 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 ALOPECIA (Hair falling out after both shots). At the time of the report, ALOPECIA (Hair falling out after both shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.  No treatment details were provided by reporter.  Abundance of red blood cells  and abundance of red blood cells  were reported as events.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) 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 PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medication was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: contains non significant information: Reporter address updated.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea
Clinical narrative: Her menstrual period is inconsistent, her menstrual period is on and off; she has it once every other week; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week). At the time of the report, MENSTRUATION IRREGULAR (Her menstrual period is inconsistent, her menstrual period is on and off) and POLYMENORRHOEA (she has it once every other week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: My arm hurt a little bit for an hour; it hurt where the needle was after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.). In March 2021, PAIN IN EXTREMITY (My arm hurt a little bit for an hour) and VACCINATION SITE PAIN (it hurt where the needle was after the second shot.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: 0 antibodies after 5 months (abnormal) produced 0 antibodies after 5 months..         No concomitant medications are provided. Patient Regular med: Diabetes medication. Patient doctor recommended him to get an antibody test and it returned with 0 antibodies. Patient would like to know why he has produced 0 antibodies after 5 months.   This case was linked to MOD-2021-294841 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059D21A, 001B21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-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 experienced PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt). At the time of the report, PAIN IN EXTREMITY (Arm was killing him for two days/ arm hurt when he moved it for two days/that is how bad it hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Antibody test: 0 antibodies (Negative) 0 antibodies.         No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-294807 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Her insomnia got worse after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Her insomnia got worse after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-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 INSOMNIA (Her insomnia got worse after 2nd dose). The patient was treated with TRAZODONE ongoing since an unknown date for Chronic insomnia, at a dose of 50 mg. At the time of the report, INSOMNIA (Her insomnia got worse after 2nd dose) outcome was unknown.            This case was linked to MOD-2021-294902 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site dryness, Vaccination site scar, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-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 SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen). At the time of the report, VACCINATION SITE SCAR ("had a big scar" that keeps getting bigger at injection site of right arm), VACCINATION SITE DRYNESS (skin at injection site is still dry) and VACCINATION SITE SWELLING (skin at injection site is still dry and swollen) had not resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient takes other concomitant medicine but not specified Patient used oil for treating dried skin
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) 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 VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER). At the time of the report, VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant and treatment drugs were not provided  Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Followup Recived on 24-AUG-2021, dose no. of the suspect vaccine added.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose) 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 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 (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He received his first dose of the Moderna covid-19 vaccine by injection almost 3 months ago/ Haven't received a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided. Patient date of birth was deleted upon IRMS documentation crash. While month and day are lost, born in 1980.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: entire body start burning after the injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (entire body start burning after the injection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (entire body start burning after the injection). At the time of the report, BURNING SENSATION (entire body start burning after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: The caller states she is almost well except she does still have a little pain in her arm where she received the injection.; Hard (at injection site); Itchy (at injection site); Real, Real Red (at injection site); Hot (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included PROBIOTICS NOS for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)). On an unknown date, the patient experienced VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.). The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot (at injection site)), VACCINATION SITE INDURATION (Hard (at injection site)), VACCINATION SITE PRURITUS (Itchy (at injection site)) and VACCINATION SITE ERYTHEMA (Real, Real Red (at injection site)) was resolving and VACCINATION SITE PAIN (The caller states she is almost well except she does still have a little pain in her arm where she received the injection.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included pills for blood pressure and cholesterol. Treatment also included  ice bags which have helped to take away the redness and an ointment that isn't Benadryl, but similar. Patient  is scheduled to receive the second dose on 28AUG2021.   Patient went to the pharmacy and the pharmacist said she may have cellulitis. Then she  went to the doctor and did not have cellulitis because she didn't have a fever. The caller's physician has told her not to receive the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: 6 moths after 2 shot, skin is painful when exposed to bright sun; 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 PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) 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 second 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 PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun). At the time of the report, PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain, aches and headache in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. The patient's past medical history included splenectomy. Concurrent medical conditions included immunocompromised (she is immunocompromised since she had her spleen removed). Concomitant product: clonazepam taken half of a 2.5 mg at night for sleep problem. On Mar 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 10, 2021, patient experienced pain, aches and headache. Patient treated with Tylenol (paracetamol) for adverse event, at an unspecified dose and frequency. On Mar 12, 2021, pain, aches and headache resolved. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-295323 (patient link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Magnetic resonance imaging, Nerve block, Ocular discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing), NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) and NERVE BLOCK (On 04Aug2021, she got another block) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache,never went away, nonstop,headaches haven't gone away). On 29-Apr-2021, the patient experienced EAR DISCOMFORT (pounding in my ear,feels like a pulsing). On 02-Jun-2021, the patient experienced NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.). On 04-Aug-2021, the patient experienced NERVE BLOCK (On 04Aug2021, she got another block). On an unknown date, the patient experienced OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out) and PAIN (pain ranges between 2-10). The patient was treated with DOXYCYCLINE from 22-Apr-2021 to 04-May-2021 at a dose of 40 milligram. At the time of the report, OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing) and NERVE BLOCK (On 04Aug2021, she got another block) outcome was unknown, NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) had resolved and HEADACHE (headache,never went away, nonstop,headaches haven't gone away) had not resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Magnetic resonance imaging: normal (Inconclusive) completely normal.Patient had close to 10 doctor visits between specialists and her primary care but they can't figure out what's wrong.Patient stopped taking it because her doctor told her it could cause headache. Patient stated that the pain ranges between 2-10 on any given day.This case was linked to MOD-2021-295321 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing), NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) and NERVE BLOCK (On 04Aug2021, she got another block) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache,never went away, nonstop,headaches haven't gone away). On 29-Apr-2021, the patient experienced EAR DISCOMFORT (pounding in my ear,feels like a pulsing). On 02-Jun-2021, the patient experienced NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.). On 04-Aug-2021, the patient experienced NERVE BLOCK (On 04Aug2021, she got another block). On an unknown date, the patient experienced OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out) and PAIN (pain ranges between 2-10). The patient was treated with DOXYCYCLINE from 22-Apr-2021 to 04-May-2021 at a dose of 40 milligram. At the time of the report, OCULAR DISCOMFORT (mostly above my left eye,feels like my eye will pop out), PAIN (pain ranges between 2-10), EAR DISCOMFORT (pounding in my ear,feels like a pulsing) and NERVE BLOCK (On 04Aug2021, she got another block) outcome was unknown, NERVE BLOCK (On 02Jun2021, she had an occipital nerve block, which lasted 7 weeks.) had resolved and HEADACHE (headache,never went away, nonstop,headaches haven't gone away) had not resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Magnetic resonance imaging: normal (Inconclusive) completely normal.Patient had close to 10 doctor visits between specialists and her primary care but they can't figure out what's wrong.Patient stopped taking it because her doctor told her it could cause headache. Patient stated that the pain ranges between 2-10 on any given day.This case was linked to MOD-2021-295321 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/first dose 30Apr2021 and he missed the 2nd) had resolved.        Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only received the first dose,several months later are coming for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) 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 PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.