chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Inappropriate schedule of product administration, Lymphadenopathy, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) in a 29-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. Previously administered products included for COVID-19 vaccination: Pfizer BIONtech COVID-19 Vaccine (1st dose of COVID-19 Vaccine) on 05-Apr-2021 and Pfizer BIONtech COVID-19 Vaccine (2nd dose of COVID-19 Vaccine) on 27-Apr-2021.On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 14-Nov-2021, the patient experienced BREAST PAIN (Left breast is a little sore in one spot.). In November 2021, the patient experienced VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) outcome was unknown. No concomitant medications were provided. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up received on 17-Nov-2021 contains non significant information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) in a 29-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. Previously administered products included for COVID-19 vaccination: Pfizer BIONtech COVID-19 Vaccine (1st dose of COVID-19 Vaccine) on 05-Apr-2021 and Pfizer BIONtech COVID-19 Vaccine (2nd dose of COVID-19 Vaccine) on 27-Apr-2021.On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 14-Nov-2021, the patient experienced BREAST PAIN (Left breast is a little sore in one spot.). In November 2021, the patient experienced VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect). On 13-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, BREAST PAIN (Left breast is a little sore in one spot.), VACCINATION COMPLICATION (Side effect), BREAST SWELLING (Left breast does feel a little more swollen), SWELLING (It may be swollen) and LYMPHADENOPATHY (Lymph node side effect) outcome was unknown. No concomitant medications were provided. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up received on 17-Nov-2021 contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. No Medical History information was reported.On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were reported.It was reported that the vials were administered to at least 12 patients but believes it could be more cause they immunized 80 patients.This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non serious event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The expired product administered (mRNA-1273 vaccine with batch/lot number 033c21a0) was administered 19 days past the expiration date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the unexpected non serious event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The expired product administered (mRNA-1273 vaccine with batch/lot number 033c21a0) was administered 19 days past the expiration date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Two patients may have gotten booster shots after the 20 punctures in the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 023C21A and 047B21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy.On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021 at 12:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial). On 15-Nov-2021, PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.It was reported that the patient received vaccine on Deltoid anatomical location. Pharmacist had reported that the vials were stored in normal refrigerator temperatures. No Concomitants and Treatment medication were reported.This case was linked to MOD-2021-390269 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant Follow Up Appended- patient initials, Start date of 1st and 2nd dose, batch no and medical history(allergy) updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 Patients received expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 Patients received expired dose). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (8 Patients received expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The Treatment history was not reported.  The Concomitant medication was not reported.Reporter was reported that 8 Patients not 10 Patients were administered an expired dose and No demographic information available for patients. Reporter stated that it had expired on 06NOV2021 but thought it expired 16NOV2021. According to Reporter, patients had no adverse reactions.Most recent FOLLOW-UP information incorporated above includes:On 16-Nov-2021: Follow up report contains 8 patient were administered an expired dose instead of 10 Patients and stop date of event were updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she has a cold) and MALAISE (she is not feeling very well) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form.On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (she has a cold) and MALAISE (she is not feeling very well). At the time of the report, NASOPHARYNGITIS (she has a cold) had not resolved and MALAISE (she is not feeling very well) outcome was unknown. No concomitant medications were reported.No treatment details were reported.Reporter did not allow further contact.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Feeling of body temperature change, Influenza like illness, Vertigo
Clinical narrative: vertigo; Lightheadedness; tried to stand and couldn't.; flu like symptoms; hot and cold off; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.), INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0161F21A, 013L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Pain. Concomitant products included PRAVASTATIN for Cholesterol, AMLODIPINE for Hypertension, MELOXICAM for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.), INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, VERTIGO (vertigo) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold off) had not resolved and DIZZINESS (Lightheadedness), DYSSTASIA (tried to stand and couldn't.) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported.   This case was linked to MOD-2021-388271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up document received on 17-NOV-2021 contains patient reported that events (vertigo, hot and cold off) are still ongoing. On 17-Nov-2021: The follow-up document received on 17-NOV-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: injected expired booster vaccine; 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 EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided.Treatment information was not provided.Patient was administered with booster vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills) and INJECTION SITE PAIN (injection site pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported.On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (chills) and INJECTION SITE PAIN (injection site pain). At the time of the report, CHILLS (chills) and INJECTION SITE PAIN (injection site pain) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication  was reported.No treatment information was provided. This case was linked to MOD-2021-388148 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular symptom
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain). At the time of the report, CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.It was reported that the patient felt so sick in December 2020 but had COVID test three times which all turned out to be negative and patient was treated with experimental flu drug.No concomitant medication was reported.No treatment information was reported.This case was linked to MOD-2021-388558, MOD-2021-388559 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 11J20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Blood pressure.Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at a dose of dose pack. At the time of the report, SECRETION DISCHARGE (Thick mucus draining on the back of their throat/it was terrible/never truly went away) had not resolved. Concomitant medications include arthritis medication and blood pressure medication.Treatment to the events given as common allergy medication.A day or 2 after the second dose of the Moderna vaccine noticed thick mucus draining on the back of their throats For patient one it became not quite as thick and not quite as much. For patient 2 it never got better, it was always thick. This case was linked to MOD-2021-388670 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (lower fever), CHILLS (chills), MYALGIA (body aches that come and go), VACCINATION SITE PAIN (sore arm since the injection) and HEADACHE (feel like maybe started getting a headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: covid 19 vaccine janssen on 06-Mar-2021.Past adverse reactions to the above products included No adverse event with covid 19 vaccine janssen. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PYREXIA (lower fever), CHILLS (chills), MYALGIA (body aches that come and go), VACCINATION SITE PAIN (sore arm since the injection) and HEADACHE (feel like maybe started getting a headache). At the time of the report, PYREXIA (lower fever), CHILLS (chills), VACCINATION SITE PAIN (sore arm since the injection) and HEADACHE (feel like maybe started getting a headache) had not resolved and MYALGIA (body aches that come and go) outcome was unknown. Patient experiencing some mild side effect.No concomitant medication details was reported.No treatment medication details was reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site reaction
Clinical narrative: famous Moderna arm; I am on 5 days now it's just red and itchy; I am on 5 days now it's just red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure abnormal.Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure abnormal.On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (famous Moderna arm), ERYTHEMA (I am on 5 days now it's just red and itchy) and PRURITUS (I am on 5 days now it's just red and itchy) outcome was unknown.    The patient was wondering if he can put a lotion on the reactions. The patient received the Moderna booster dose on left non dominant arm. The patient also put some cold cloth on the reactions.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023MZ0A and 092L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.  No other preexisting condition nor allergy is reported by reporter  Company's comment: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Rheumatoid arthritis, the unexpected non-serious event of Pain in extremity and the expected non-serious event of Fatigue . The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the previous dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Rheumatoid arthritis, the unexpected non-serious event of Pain in extremity and the expected non-serious event of Fatigue . The events occurred on an unknown date after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the previous dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on left arm coming back on and off), PAIN IN EXTREMITY (Left arm hurt after first vaccine), HYPOACUSIS (Difficulty hearing), INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.  The patient's past medical history included COVID-19 (Long hauler COVID-19) in July 2021. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt after first vaccine), INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine). On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain on left arm coming back on and off). On an unknown date, the patient experienced HYPOACUSIS (Difficulty hearing). On 26-Oct-2021, PAIN IN EXTREMITY (Left arm hurt after first vaccine) had resolved. On 02-Nov-2021, INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on left arm coming back on and off) had not resolved and HYPOACUSIS (Difficulty hearing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided.No treatment medications were provided.Patient has refused to see a doctor.Consent received for safety to follow up with daughter (Since patient can not hear well).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Similar side effects to those of reporter) and MALAISE (Down on bed for a day) in a 54-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Similar side effects to those of reporter) and MALAISE (Down on bed for a day). At the time of the report, VACCINATION COMPLICATION (Similar side effects to those of reporter) outcome was unknown and MALAISE (Down on bed for a day) had resolved. Not Provided. Concomitant products were not provided.Treatment medication were not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little bit sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported.On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was a little bit sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little bit sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.No concomitant medications were reported. No treatment medications were reported.This case was linked to MOD-2021-388704, MOD-2021-388705 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown. Not Provided. No concomitant medications were reported.No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Decreased appetite, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), HEADACHE (slight headache) and NAUSEA (felt nauseous the entire day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 038A21A and 014M20A) 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 ATORVASTATIN CALCIUM (LIPITOR), SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (ZYBAN) 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 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced HEADACHE (slight headache) and PYREXIA (I felt feverish). On 15-Nov-2021, the patient experienced CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Nov-2021, HEADACHE (slight headache) and PYREXIA (I felt feverish) had resolved. On 16-Nov-2021, CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted) had resolved. Patient had a chest pain in the upper center part on my chest around my clavicle. It felt like pins and needles and lasted less than 5 Minutes.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), HEADACHE (slight headache) and NAUSEA (felt nauseous the entire day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 038A21A and 014M20A) 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 ATORVASTATIN CALCIUM (LIPITOR), SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (ZYBAN) 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 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced HEADACHE (slight headache) and PYREXIA (I felt feverish). On 15-Nov-2021, the patient experienced CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Nov-2021, HEADACHE (slight headache) and PYREXIA (I felt feverish) had resolved. On 16-Nov-2021, CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted) had resolved. Patient had a chest pain in the upper center part on my chest around my clavicle. It felt like pins and needles and lasted less than 5 Minutes.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little bit sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported.On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore). At the time of the report, PAIN IN EXTREMITY (arm was a little bit sore) outcome was unknown. Concomitant and treatment medication details were not reported by the reporter.This case was linked to MOD-2021-388689, MOD-2021-388705 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.  Previously administered products included for Product used for unknown indication: pfizer (Lot number-EN6199) on 04-Mar-2021 and pfizer (Lot number-EP7533) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture). On 11-Nov-2021, PRODUCT STORAGE ERROR (Given after being punctured 25 hours before) and EXPIRED PRODUCT ADMINISTERED (Adult received a vaccine from a Moderna vial that had been stored in the refrigerator for 25 hours after the initial puncture) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medication details was reported.No treatment medication details was reported.Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up document was received and contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash macular, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very mild symptoms), RASH MACULAR (Very red and blotchy), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is reported. Concomitant products included VITAMINS NOS for an unknown indication. On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (very mild symptoms), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees) and CHILLS (Chills). On 16-Nov-2021, the patient experienced RASH MACULAR (Very red and blotchy), VACCINATION SITE RASH (Rash circle all around the injection site) and VACCINATION SITE ERYTHEMA (Today when woke up they have a red rash going from the injection site on her left arm.). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very mild symptoms), RASH MACULAR (Very red and blotchy), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees), CHILLS (Chills), VACCINATION SITE RASH (Rash circle all around the injection site) and VACCINATION SITE ERYTHEMA (Today when woke up they have a red rash going from the injection site on her left arm.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, Body temperature: high (High) around 100 degrees.This case was linked to MOD-2021-388764 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very mild symptoms), RASH MACULAR (Very red and blotchy), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is reported. Concomitant products included VITAMINS NOS for an unknown indication. On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (very mild symptoms), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees) and CHILLS (Chills). On 16-Nov-2021, the patient experienced RASH MACULAR (Very red and blotchy), VACCINATION SITE RASH (Rash circle all around the injection site) and VACCINATION SITE ERYTHEMA (Today when woke up they have a red rash going from the injection site on her left arm.). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very mild symptoms), RASH MACULAR (Very red and blotchy), TENDERNESS (Arm is tender), PYREXIA (Mild fever around 100 degrees), CHILLS (Chills), VACCINATION SITE RASH (Rash circle all around the injection site) and VACCINATION SITE ERYTHEMA (Today when woke up they have a red rash going from the injection site on her left arm.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, Body temperature: high (High) around 100 degrees.This case was linked to MOD-2021-388764 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got breakthrough COVID-19; 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 COVID-19 (got breakthrough COVID-19) 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 COVID-19 (got breakthrough COVID-19). At the time of the report, COVID-19 (got breakthrough COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.; Sender's Comments: This case concerns patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: 1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 048A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. Concurrent medical conditions included Breast cancer since 01-Nov-2014.On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 08 MAR 2021, 2nd dose on 04MAY 2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) COVID-19 PCR TEST POSITIVE.No concomitant medication information was provided by the reporter. This case concerns a 65 year old female with no relevant medical history reported, who experienced Non-serious event of Inappropriate Schedule of Product  Administration after vaccination  with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). The interval  perioid   between the 1st and the 2nd dose was  1 month and 27 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report. This case was linked to MOD-2021-386734 (Patient Link).; Sender's Comments: This case concerns a 65 year old female with no relevant medical history reported, who experienced Non-serious event of Inappropriate Schedule of Product  Administration after vaccination  with the 1st and 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). The interval  perioid   between the 1st and the 2nd dose was  1 month and 27 days. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Migraine, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong) and HEADACHE (I experience severe headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine since 09-Jan-1987 and Palpitations (Heart palpatations) since 01-Jan-2000.On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever). At the time of the report, THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) low grade fever. No Concomitant medications were providedNo treatment medications were provided.This case was linked to MOD-2021-386718 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up information received on  contains Significant information; patient demographics added, patient medical history added, vaccination dose information added, events added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong) and HEADACHE (I experience severe headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine since 09-Jan-1987 and Palpitations (Heart palpatations) since 01-Jan-2000.On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever). At the time of the report, THIRST (thirst), PALPITATIONS (severe heart pounding which continues for hours during the nigh), MALAISE (felt sick), MIGRAINE (migraine/had a bad migraine with very strong), HEADACHE (I experience severe headache) and PYREXIA (low grade fever) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) low grade fever. No Concomitant medications were providedNo treatment medications were provided.This case was linked to MOD-2021-386718 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up information received on  contains Significant information; patient demographics added, patient medical history added, vaccination dose information added, events added.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt like she was going to die) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She felt like she was going to die). At the time of the report, FEELING ABNORMAL (She felt like she was going to die) outcome was unknown. No concomitant products were reported. No treatment information was reported by the reporter.