chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pyrexia, Vaccination site mass, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time), AXILLARY PAIN (hurts even in her armpit), VACCINATION SITE PAIN (hurts when you touch it) and PYREXIA (low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 prophylaxis. The patient had no allergies.  Previously administered products included for Product used for unknown indication: flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Diabetes, Blood pressure high (high blood pressure), Aneurysm of heart (heart aneurysm (watching out)) and Blood cholesterol abnormal (cholesterol). Concomitant products included METFORMIN, LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE (LOPRESSOR), ROSUVASTATIN, LOSARTAN POTASSIUM (COZAR), COLECALCIFEROL (VIT D3) and CYANOCOBALAMIN (VIT B12) for an unknown indication. On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PYREXIA (low grade fever). On 04-Nov-2021, the patient experienced VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), AXILLARY PAIN (hurts even in her armpit) and VACCINATION SITE PAIN (hurts when you touch it). On 03-Nov-2021, PYREXIA (low grade fever) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time), AXILLARY PAIN (hurts even in her armpit) and VACCINATION SITE PAIN (hurts when you touch it) had not resolved. Patient never had COVID positive test or diagnosis. No X-rays were done. No treatment medication was reported. This case was linked to MOD-2022-613438 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The vial was initially stored in the refrigerator on 27 May 2022. The vial did not undergo any temperature excursions.  It was reported that Route and Body site was deltoid. Treatment medication was not provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Felt uncomfortable; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Felt uncomfortable) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 004M20A and 025C20A) for COVID-19 vaccination.     The patient had no allergies. The patient never had COVID positive test or diagnosis. The patient had no acute and chronic illnesses at the time of vaccination. The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced DISCOMFORT (Felt uncomfortable). On 29-Nov-2021, DISCOMFORT (Felt uncomfortable) had resolved.            No concomitant medications were reported. It was reported that after first, second and first booster shot, patient only felt uncomfortable for around 1 day. No treatment medications were reported.   This case was linked to MOD-2022-612796 (Patient Link).
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Cough, Decreased appetite, Nasal congestion, Nasopharyngitis
Clinical narrative: Nasal congestion; Loss of appetite; Fever; Cold; Constipation; Cough; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite), CONSTIPATION (Constipation) and COUGH (Cough) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient had no allergies to medications, food and other products. Patient never  had a COVID  test or diagnosis. Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. .     On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COUGH (Cough). On 16-Jul-2022, the patient experienced CONSTIPATION (Constipation). On 22-Jul-2022, the patient experienced NASOPHARYNGITIS (Cold). On 23-Jul-2022, the patient experienced NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (Cold) had not resolved and NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite), CONSTIPATION (Constipation), COUGH (Cough) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The father called on behalf of his 1-year-old son. He had questioned about the COVID-19 vaccine. He wanted to know since his son currently has a cold which started on Friday 22Jul2022 would he be able to receive the vaccine on Wednesday 28Jul2022. Father stated patient had no immediate side effects after receiving the vaccine. The first  dose location was unknown. Father stated all his other vaccine has been given in the thigh. The expiration date for the first dose was not provided. Patient was taking drops of vitamin that goes into milk.HCP was aware of the side effects. No treatment medications were reported.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Nasal congestion; Loss of appetite; Fever; Cold; Constipation; Cough; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite), CONSTIPATION (Constipation) and COUGH (Cough) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient had no allergies to medications, food and other products. Patient never  had a COVID  test or diagnosis. Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. .     On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COUGH (Cough). On 16-Jul-2022, the patient experienced CONSTIPATION (Constipation). On 22-Jul-2022, the patient experienced NASOPHARYNGITIS (Cold). On 23-Jul-2022, the patient experienced NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). At the time of the report, NASOPHARYNGITIS (Cold) had not resolved and NASAL CONGESTION (Nasal congestion), DECREASED APPETITE (Loss of appetite), CONSTIPATION (Constipation), COUGH (Cough) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The father called on behalf of his 1-year-old son. He had questioned about the COVID-19 vaccine. He wanted to know since his son currently has a cold which started on Friday 22Jul2022 would he be able to receive the vaccine on Wednesday 28Jul2022. Father stated patient had no immediate side effects after receiving the vaccine. The first  dose location was unknown. Father stated all his other vaccine has been given in the thigh. The expiration date for the first dose was not provided. Patient was taking drops of vitamin that goes into milk.HCP was aware of the side effects. No treatment medications were reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022; administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022; Administered with the vaccine that had been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that had been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (The vaccine was put in the refrigerator on 15-Jun-2022 for more than 30 days and administered on 20-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. The patient received second booster. Treatment information was not provided.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Expired product administered, Product storage error
Clinical narrative: Vaccine was administered after being stored on the refrigerator for more than 30 days; expired dose administered; ear infection today; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (ear infection today), EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination. Patient do not have any allergies(medications, food and other products), patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination, Patient never had COVID positive test or diagnosis and no other vaccines given within one month prior to Moderna COVID-19 vaccine. On 25-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced EAR INFECTION (ear infection today). On 25-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days). The patient was treated with AMOXICILLIN for Ear infection, at a dose of 1 dosage form. At the time of the report, EAR INFECTION (ear infection today), EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days) outcome was unknown. 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. It was reported as one dose of the vaccine was administered after being stored on the refrigerator for more than 30 days. Patient did not experience any symptoms but today patient experienced ear infection and prescribed amoxicillin, after the administration of the vaccine. It was also reported that AE cause patient to seek ( medical care office visit, Urgent care, ER, hospitalized) and patient did not experienced a similar event in the past. No concomitant information were reported by the reporter.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administered Moderna vaccine on 19-Jul-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Cyst (cyst between toes on left foot, it disappeared without a trace and never came back) and Cough. Concurrent medical conditions included COPD (COPD symptoms returned after 5 to 7 days after the 1st shot) and Allergy NOS (Allergy issues returned after 5 to 7 days after the 1st shot).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  It was reported that patient had COPD and after the 1st vaccine the COPD symptoms disappeared, Patient could breath better, chronic allergy issues disappeared and patient had a cyst between two toes on left foot it disappeared without a trace and never came back, the coughing was gone but the COPD symptoms and allergy issues returned after 5 to 7 days after the 1st shot. Patient stated that the 1st vaccination was fantastic. Patient spoke with their HCPs and she was told that no patients reported the unattended benefits. Patient stated she didn't took any drugs. It was reported that patients condition of COPD symptoms and allergy issues disappeared initially after receiving 1st vaccine, However after 5 to 7 days of 1st vaccine it got reappeared. No treatment information was reported.   This case was linked to MOD-2022-613577, MOD-2022-613593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Lethargy, Nasopharyngitis
Clinical narrative: unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Cyst (cyst between toes on left foot, it disappeared without a trace and never came back) and Cough. Concurrent medical conditions included COPD (COPD symptoms returned after 5 to 7 days after the 1st shot) and Allergy NOS (Allergy issues returned after 5 to 7 days after the 1st shot).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unintended benefits/cyst between two toes on her left foot it disappeared without a trace and never came back, her coughing was gone) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  It was reported that patient had COPD and after the 1st vaccine the COPD symptoms disappeared, Patient could breath better, chronic allergy issues disappeared and patient had a cyst between two toes on left foot it disappeared without a trace and never came back, the coughing was gone but the COPD symptoms and allergy issues returned after 5 to 7 days after the 1st shot. Patient stated that the 1st vaccination was fantastic. Patient spoke with their HCPs and she was told that no patients reported the unattended benefits. Patient stated she didn't took any drugs. It was reported that patients condition of COPD symptoms and allergy issues disappeared initially after receiving 1st vaccine, However after 5 to 7 days of 1st vaccine it got reappeared. No treatment information was reported.   This case was linked to MOD-2022-613577, MOD-2022-613593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: With the 2nd vaccine she had the same side effects as other people; lethargy; feeling like she had a cold; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001b21a and 013m20a) for COVID-19 vaccination.     The patient's past medical history included Cyst (cyst between two toes on left foot). Concurrent medical conditions included COPD, Allergy (chronic allergy issues) and Knee injury (patient had pain from knee injury).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold). At the time of the report, IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had not taken any drugs and that was because of her experience as a retired personal trainer "people were not in touch with their bodies". Also patient encouraged Moderna to advertise the unintended benefits from the vaccine.   No treatment drug was reported.   This case was linked to MOD-2022-613555, MOD-2022-613593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Lethargy, Nasopharyngitis
Clinical narrative: With the 2nd vaccine she had the same side effects as other people; lethargy; feeling like she had a cold; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001b21a and 013m20a) for COVID-19 vaccination.     The patient's past medical history included Cyst (cyst between two toes on left foot). Concurrent medical conditions included COPD, Allergy (chronic allergy issues) and Knee injury (patient had pain from knee injury).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold). At the time of the report, IMMUNISATION REACTION (With the 2nd vaccine she had the same side effects as other people), LETHARGY (lethargy) and NASOPHARYNGITIS (feeling like she had a cold) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had not taken any drugs and that was because of her experience as a retired personal trainer "people were not in touch with their bodies". Also patient encouraged Moderna to advertise the unintended benefits from the vaccine.   No treatment drug was reported.   This case was linked to MOD-2022-613555, MOD-2022-613593 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: When the patient received the 2nd booster shot her pain from a knee injury went away; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056m1a, 939906, 001b21a and 013m20a) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Knee injury, Allergy and Knee pain (pain gradually returned to what it was before the booster). Concomitant products included PARACETAMOL (TYLENOL) for Knee injury and Knee pain.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away) outcome was unknown.            It was reported that following vaccination patient stated it was fabulous and could not wait for the 5th dose as she had unintended benefits from the first vaccine and the second booster. When the patient received the 2nd booster shot her pain from a knee injury went away and had 2 infusions for that injury and Tylenol, and with Moderna drug within 24hours it was the first time in a year that she did not experienced any pain, after 7 days pain gradually returned to what it was before the booster.Patient stated that the first vaccination was fantastic and the second booster.Patient stated she does not take any drugs She spoke with their HCPs and she was told that no patients reported the unattended benefits Treatment medications were not reported.   This case was linked to MOD-2022-613555, MOD-2022-613577 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Lethargy, Nasopharyngitis
Clinical narrative: When the patient received the 2nd booster shot her pain from a knee injury went away; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056m1a, 939906, 001b21a and 013m20a) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Knee injury, Allergy and Knee pain (pain gradually returned to what it was before the booster). Concomitant products included PARACETAMOL (TYLENOL) for Knee injury and Knee pain.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (When the patient received the 2nd booster shot her pain from a knee injury went away) outcome was unknown.            It was reported that following vaccination patient stated it was fabulous and could not wait for the 5th dose as she had unintended benefits from the first vaccine and the second booster. When the patient received the 2nd booster shot her pain from a knee injury went away and had 2 infusions for that injury and Tylenol, and with Moderna drug within 24hours it was the first time in a year that she did not experienced any pain, after 7 days pain gradually returned to what it was before the booster.Patient stated that the first vaccination was fantastic and the second booster.Patient stated she does not take any drugs She spoke with their HCPs and she was told that no patients reported the unattended benefits Treatment medications were not reported.   This case was linked to MOD-2022-613555, MOD-2022-613577 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe). At the time of the report, syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was reported while one of technicians was administering a vaccine, liquid squirted in her eye due to a faulty syringe.
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (vial was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: we gave 3 doses from a vial that was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (we gave 3 doses from a vial that was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was Initially stored in the refrigerator .The vial had not undergone any temperature excursions.  There were no other vaccines given within one month prior to Moderna COVID-19 vaccine. The AE had not caused patient to seek medical care. It was unknown whether patient experienced a similar event in the past. No treatment medication was provided.
Age: 1.92
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 3 doses from a vial that was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days) in a 23-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Patient had no allergies and no history of acute or chronic illnesses at the time of vaccination.     On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was Initially stored in the refrigerator .The vial did not undergo any temperature excursions.  No treatment medication was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine stored beyond the 30 use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received the vaccine in deltoid.  No concomitant product reported by reporter. Vaccine was stored in fridge longer than 30 days prior to administration. The vial was stored in refrigerator on 27-May-2022. Vial did not undergone any temperature excursion. No treatment medication reported by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Deltoid was reported as anatomical location of vaccine administered.  It was reported that the vial was initially stored in the refrigerator on 27-May-2022. The vials did not undergo any temperature excursions. Patient did not have allergies to medications, food and other products. Patient had never been diagnosed with or tested positive for COVID-19. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  No treatment details was provided.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever about 1 month after receiving first dose; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever about 1 month after receiving first dose) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced PYREXIA (Fever about 1 month after receiving first dose). At the time of the report, PYREXIA (Fever about 1 month after receiving first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient received 1 dose of vaccine 1 month ago, she was due for 2nd dose on 27-jul-2022. No treatment drug details was reported.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Deltoid was reported as anatomical Location The vial was initially stored in the refrigerator on 27May2022. The vial did not undergo any temperature excursions. Treatment medication was not provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master Case
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored and administered beyond 30 days use by date; Vaccine was stored and administered beyond 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was initially stored in the refrigerator on 27May2022. The vial did not undergo any temperature excursions.  No treatment information were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. The vial was initially stored in the refrigerator on 27 May 2022. The vial did not undergo any temperature excursions. Manufacturer expiration date was reported as 10-Sep-2022. Body site of vaccination was reported as deltoid. Treatment medication was not provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master case.