chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact; Sender's Comments:  MOD-2021-086711:Case received in same source doc email  MOD-2021-086996:Case received in same source doc email  MOD-2021-087217:Case received in same source doc email  MOD-2021-087097:Case received in same source doc email  MOD-2021-085006:Case received in same source doc email
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: soreness in arm; exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 26-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 26-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-086800 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added pregnancy information LMP 13 Oct 2020, Due Date  21 Jul 2021.; Sender's Comments:  MODERNATX, INC.-MOD-2021-086800:Case for dose 1
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LORAZEPAM for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            On 17-APR-2021, patient stated that her fatigue improved, her energy level improved more, her sense of smell and taste slightly and both of those things were improved and returned at the time of this report.  Treatment details were not reported by the reporter.   This case was linked to MOD-2021-086772 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of syringe issue (broken syringe) and underdosage (insufficient dose administered) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2021, patient experienced syringe issue (broken syringe) and underdosage (insufficient dose administered). At the time of the report, syringe issue (broken syringe) and underdosage (insufficient dose administered) resolved. No concomitant medication or treatment information provided. The action taken for mRNA-1273: not applicable.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling hot, Headache, Pyrexia
Clinical narrative: warm face; cough; tired; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache). At the time of the report, FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: Sty; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Sty) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced HORDEOLUM (Sty). At the time of the report, HORDEOLUM (Sty) outcome was unknown.            No Concomitant list is provided. No treatment is provided. Action taken with mRNA-1273 in response to the events were Not Applicable.   This case was linked to MOD-2021-013240 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: On 24-May-2021, follow up document was attached which contains NNI
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Dizziness, Fatigue, Head discomfort, Hypersensitivity
Clinical narrative: Feels like fluids in one side of the head; Some parts of patient's body swelling up; Dizziness; Heaviness in patient's eyes; allergic reaction; throat swelling; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up) and DIZZINESS (Dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling) and FATIGUE (tired). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness) and ASTHENOPIA (Heaviness in patient's eyes). At the time of the report, HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness), ASTHENOPIA (Heaviness in patient's eyes) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication  details were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: Feels like fluids in one side of the head; Some parts of patient's body swelling up; Dizziness; Heaviness in patient's eyes; allergic reaction; throat swelling; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up) and DIZZINESS (Dizziness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling) and FATIGUE (tired). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness) and ASTHENOPIA (Heaviness in patient's eyes). At the time of the report, HYPERSENSITIVITY (allergic reaction), PHARYNGEAL SWELLING (throat swelling), HEAD DISCOMFORT (Feels like fluids in one side of the head), SWELLING (Some parts of patient's body swelling up), DIZZINESS (Dizziness), ASTHENOPIA (Heaviness in patient's eyes) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication  details were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain, Pyrexia
Clinical narrative: Felt unwell; Body aches; Chills; Fever of 103.5 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt unwell), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 103.5 Fahrenheit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Continuous positive airway pressure. Concurrent medical conditions included Pulmonary arterial hypertension, Peripheral swelling, Restless legs syndrome, Headache, Dyspnoea exertional and Oedema peripheral. Concomitant products included PARACETAMOL (TYLENOL) for Headache, TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension, BOSENTAN (TRACLEER [BOSENTAN]), WARFARIN SODIUM and SILDENAFIL CITRATE (REVATIO) for an unknown indication.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MALAISE (Felt unwell), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 103.5 Fahrenheit). In April 2021, MALAISE (Felt unwell) had resolved. At the time of the report, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever of 103.5 Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 103.5 fahrenheit (High) 103.5 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Treprostinil  1.5 mg tid
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Exposure via breast milk
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythema (red ring on the arm) and exposure via breast milk (breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027B21A) for COVID-19 immunization. No medical history reported. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 21, 2021, patient experienced erythema (red ring on the arm). Apr 21, 2021, patient experienced exposure via breast milk (breast feeding). At the time of the report, erythema (red ring on the arm) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Product administered to patient of inappropriate age
Clinical narrative: Vaccination on patient under 18 y/o; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ONDANSETRON HYDROCHLORIDE (ONDANSETRON ODT) from 23-Dec-2020 to an unknown date for Nausea and Vomiting, PRENATAL MULTIVITAMIN + DHA from 23-Dec-2020 to an unknown date for Pregnancy.    On 11-Feb-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 11-Feb-2021 at 2:15 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 11-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) had resolved. On 11-Feb-2021 at 2:15 PM, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was provided.  It was reported that the patient is doing well and did not experience an adverse reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Pregnancy Report received that included significant information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia, Somnolence
Clinical narrative: sleeping all day; feeling very cold; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever). At the time of the report, SOMNOLENCE (sleeping all day), FEELING COLD (feeling very cold) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Some soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some soreness in the arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PREDNISONE for Inflammation, CYCLOBENZAPRINE for Muscle relaxation, TRAMADOL for Pain.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Some soreness in the arm). On 16-Mar-2021, PAIN IN EXTREMITY (Some soreness in the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-086936 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lipoma, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: small lump under the skin at the first injection site; Itchiness at injection; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20Al) for COVID-19 vaccination.     Concomitant products included HCTZ and CARVEDILOL (COREG) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, LIPOMA (small lump under the skin at the first injection site), VACCINATION SITE PRURITUS (Itchiness at injection) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment history was not provided. patient experienced rashes, pain at the injection site and a small developed in his hand symptoms come and go every two weeks, the patient not received treatment for symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: FU Received on 23-july-21,New events and event Outcome provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective; inadequate dose; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hyperlipidemia on 17-Dec-2018. Concomitant products included SIMVASTATIN and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked , less dose given, Vaccine came in contact with skin/needle must be loose or defective) and UNDERDOSE (inadequate dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Vaccine Adverse event reporting form appended. Concomitants added. patient information updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Illness, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for Inflammation, CYCLOBENZAPRINE for Muscle relaxation, TRAMADOL for Pain.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache), MYALGIA (Whole bodyache almost all the times) and CHILLS (chills). On 15-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), ILLNESS (felt sick an hour after the dose was given) and CHILLS (chills) outcome was unknown.            Treatment medications include Ibuprofen 800mg one time only as soon patient felt sick. Ibuprofen 200 mg (4 tablets) 3 times.   This case was linked to MOD-2021-086907 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for Inflammation, CYCLOBENZAPRINE for Muscle relaxation, TRAMADOL for Pain.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), ILLNESS (felt sick an hour after the dose was given), HEADACHE (headache), MYALGIA (Whole bodyache almost all the times) and CHILLS (chills). On 15-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (One time it was really hot for short period then back to chills), HEADACHE (headache) and MYALGIA (Whole bodyache almost all the times) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), ILLNESS (felt sick an hour after the dose was given) and CHILLS (chills) outcome was unknown.            Treatment medications include Ibuprofen 800mg one time only as soon patient felt sick. Ibuprofen 200 mg (4 tablets) 3 times.   This case was linked to MOD-2021-086907 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site swelling
Clinical narrative: Swelling around shot area; Ill for a few days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Avascular necrosis (The severity changes due to weather, use (heavy activity) causes swelling in hips and knees.. The Moderna vaccine alleviated swelling and pain.) on 15-Mar-2006. Concurrent medical conditions included Pollen allergy, Dust allergy and Allergy (Mold). Concomitant products included CHLORAZEPATE for Anxiety, LISINOPRIL for Blood pressure, BUPROPION for Depression, OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) for Pain, PROPRANOLOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days). At the time of the report, INJECTION SITE SWELLING (Swelling around shot area) and ILLNESS (Ill for a few days) outcome was unknown. Not Provided          Past medical history include Patient had 6 surgeries: both hips replaced, both knees replaced, and both shoulders repaired via surgery for tearing and repair.  Treatment information was not reported.   This case was linked to MOD-2021-024754 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Headache, Malaise, Peripheral swelling
Clinical narrative: tiene calentura con 98.9°F/ has a fever, at 98.9 ° F; se siente mal/ feels unwel; escalofríos/ chills; dolor de cabeza/ headache; tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen; está en la cama/ is in bed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache) and PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY.  Concomitant products included MONTELUKAST, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CITALOPRAM, ALPRAZOLAM and TRAZODONE.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed). At the time of the report, PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included energy go stick,trazadone Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tiene calentura con 98.9°F/ has a fever, at 98.9 ° F; se siente mal/ feels unwel; escalofríos/ chills; dolor de cabeza/ headache; tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen; está en la cama/ is in bed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache) and PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     NO MEDICAL HISTORY.  Concomitant products included MONTELUKAST, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CITALOPRAM, ALPRAZOLAM and TRAZODONE.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed). At the time of the report, PYREXIA (tiene calentura con 98.9°F/ has a fever, at 98.9 ° F), MALAISE (se siente mal/ feels unwel), CHILLS (escalofríos/ chills), HEADACHE (dolor de cabeza/ headache), PERIPHERAL SWELLING (tiene hinchada la parte del brazo de la inyección/ the part of the arm from the injection is swollen) and BED REST (está en la cama/ is in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included energy go stick,trazadone Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue
Clinical narrative: pharmacist not sure if there was liquid or air in the needle; This spontaneous case was reported by a consumer and describes the occurrence of NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle). At the time of the report, NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was administered the vaccine subcutaneously; 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 21-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient was administered the vaccine subcutaneously) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Age: 36.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Generalized aching; Diarrhea; Intermittent Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Generalized aching), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized aching), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent Fever). At the time of the report, PAIN (Generalized aching), DIARRHOEA (Diarrhea) and PYREXIA (Intermittent Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-087217, MOD-2021-087097, MOD-2021-085006 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up Received on 06-MAY-2021 New Events Pyrexia, Diarrhea, added. Updated outcome of the event Body Ache from unknown to Recovered. updated action taken for the drug from Unknown to Discontinued. updated verbatim of Aches to Generalized aches; Sender's Comments: 21K-163-3881504-00 was considered a duplicate of AER 21K-163-3836205-00. All the information from cases was  merged into AER 21K-163-3836205-00 and AER 21K-163-3881504-00 was invalidated. MOD-2021-086818:Case received in same source doc email  MOD-2021-086711:Case received in same source doc email  MOD-2021-087217:Case received in same source doc email  MOD-2021-087097:Case received in same source doc email MOD-2021-085006:Case received in same source doc email
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chills, Dizziness, Dysgeusia
Clinical narrative: Tingling sensation; Light headedness; Papular rash; Burning sensation; Feeling hot and cold; Chest tightness; Throat tightness; Chills; rapid heart rate; difficulty in breathing; metallic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing), DYSGEUSIA (metallic taste in her mouth), PARAESTHESIA (Tingling sensation) and DIZZINESS (Light headedness) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LIOTHYRONINE SODIUM, LEVOTHYROXINE and TAFLUPROST (ZIOPTAN) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills). On 02-Jan-2021, HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Immediate- Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg. Ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-087081 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087081:case for dose 2
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling of body temperature change, Heart rate increased, Paraesthesia, Rash papular
Clinical narrative: Tingling sensation; Light headedness; Papular rash; Burning sensation; Feeling hot and cold; Chest tightness; Throat tightness; Chills; rapid heart rate; difficulty in breathing; metallic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing), DYSGEUSIA (metallic taste in her mouth), PARAESTHESIA (Tingling sensation) and DIZZINESS (Light headedness) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LIOTHYRONINE SODIUM, LEVOTHYROXINE and TAFLUPROST (ZIOPTAN) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills). On 02-Jan-2021, HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Immediate- Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg. Ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-087081 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087081:case for dose 2
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Tingling sensation; Light headedness; Papular rash; Burning sensation; Feeling hot and cold; Chest tightness; Throat tightness; Chills; rapid heart rate; difficulty in breathing; metallic taste in her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing), DYSGEUSIA (metallic taste in her mouth), PARAESTHESIA (Tingling sensation) and DIZZINESS (Light headedness) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LIOTHYRONINE SODIUM, LEVOTHYROXINE and TAFLUPROST (ZIOPTAN) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills). On 02-Jan-2021, HEART RATE INCREASED (rapid heart rate), DYSPNOEA (difficulty in breathing) and DYSGEUSIA (metallic taste in her mouth) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation), DIZZINESS (Light headedness), RASH PAPULAR (Papular rash), BURNING SENSATION (Burning sensation), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHEST DISCOMFORT (Chest tightness), THROAT TIGHTNESS (Throat tightness) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Immediate- Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg. Ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-087081 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087081:case for dose 2
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Intentional product use issue
Clinical narrative: Intentional deviation from dosage regimen; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: positive (Positive) Positive and negative (Negative) Negative. On an unknown date, Blood immunoglobulin M: negative (Negative) Negative and negative (Negative) Negative.         Concomitant medications were not provided. Treatment details were not provided.   Reporter did not allow further contact