chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling pretty poorly since receiving his second Covid vaccine on 20-Feb-2021, which was similar to how he felt after his first  dose; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feeling pretty poorly since receiving his second Covid vaccine on 20-Feb-2021, which was similar to how he felt after his first  dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Edema of lower extremities, Basal squamous cell carcinoma in 2017, Rash in August 2020, Nausea in August 2020, Fever (Pyrexia) in August 2020 and Barrett's esophagus. Concurrent medical conditions included Mesothelioma since 28-Sep-2017, Dyspnea since 2017, Paroxysmal atrial fibrillation since August 2020, Gastroesophageal reflux disease, Hypertension, Obesity, Hypokalemia since 04-Sep-2020, Vomiting since 2017, Obstructive sleep apnea syndrome since 2016, Fatigue since 2016, Anxiety, Constipation since 10-Aug-2020 and Oedema peripheral since 2019. Concomitant products included LORAZEPAM from 24-Oct-2017 to an unknown date, LOSARTAN from 29-Sep-2017 to an unknown date, ONDANSETRON from 28-Sep-2017 to an unknown date, POTASSIUM CHLORIDE, PROCHLORPERAZINE from 11-Jun-2019 to an unknown date, WARFARIN from 30-Jan-2016 to an unknown date, LIDOCAINE, PRILOCAINE (LIDOCAINE AND PRILOCAINE), VANCOMYCIN from 09-Dec-2020 to an unknown date, POTASSIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC, SODIUM PHOSPHATE MONOBASIC (ANHYDROUS) (K-PHOS NEUTRAL) from 09-Dec-2020 to an unknown date, OXYCODONE from 28-Jan-2021 to an unknown date, APIXABAN from 17-Feb-2021 to an unknown date, DILTIAZEM from 20-Feb-2016 to an unknown date and FLECAINIDE from 11-Mar-2016 to an unknown date for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling pretty poorly since receiving his second Covid vaccine on 20-Feb-2021, which was similar to how he felt after his first  dose). At the time of the report, FEELING ABNORMAL (Feeling pretty poorly since receiving his second Covid vaccine on 20-Feb-2021, which was similar to how he felt after his first  dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.  It was reported that  patient had feeling pretty poorly since receiving his second Covid vaccine on 20-Feb-2021, which was similar to how patient felt after first dose and after anticancer treatment.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Had a terrible headache; Muscle aches; This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch; unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had a terrible headache), MYALGIA (Muscle aches), VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Immunization: Pfizer vaccine (2 immunizations with the Pfizer vaccine) and Pfizer vaccine (2 immunizations with the Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced HEADACHE (Had a terrible headache), MYALGIA (Muscle aches), VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch). At the time of the report, HEADACHE (Had a terrible headache), MYALGIA (Muscle aches) and VACCINATION SITE PAIN (This mark was the size of a silver dollar, maybe a little larger. it lasted for around a week or so and was very painful to the touch) outcome was unknown and VACCINATION SITE ERYTHEMA (unusual symptom was a large, very distinct circular red spot on his arm at the injection site, size of a silver dollar, maybe a little larger/lasted around a week/ very painful to the touch) had resolved.            It was reported that reporter believes the  vaccination date was near the end of JAN 2022. No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mother died after her 3rd Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (My mother died after her 3rd Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Company comment: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pulmonary fibrosis, Vaccine associated enhanced disease
Clinical narrative: ADE illness due to her Moderna vaccines; Lung fibrosis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) and PULMONARY FIBROSIS (Lung fibrosis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) (seriousness criterion medically significant) and PULMONARY FIBROSIS (Lung fibrosis) (seriousness criterion medically significant). At the time of the report, VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) and PULMONARY FIBROSIS (Lung fibrosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Patient did not develop antibodies to the nucleocapsid and spike antibody was off the chart, more than 2400.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. No treatment details were reported.  The patient had lung fibrosis from antibody-dependent enhancement (ADE) illness due to Moderna vaccines.  Company comment: This spontaneous case concerns a female patient (age unspecified), with relevant medical history of pulmonary fibrosis, who experienced the unexpected serious (medically significant) events of Vaccine associated enhanced disease (AESI) and Pulmonary Fibrosis, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The outcome of the events was reported as unknown. Details of duration of pulmonary fibrosis, concomitant medications, clinical course, further investigation reports, and treatment were not provided. Medical history of Pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient (age unspecified), with relevant medical history of pulmonary fibrosis, who experienced the unexpected serious (medically significant) events of Vaccine associated enhanced disease (AESI) and Pulmonary Fibrosis, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The outcome of the events was reported as unknown. Details of duration of pulmonary fibrosis, concomitant medications, clinical course, further investigation reports, and treatment were not provided. Medical history of Pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: receiving doses from vials affected by a temperature excursion; received doses from vials affected by a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022 at 10:46 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-May-2022 at 10:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received doses from vials affected by a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses from vials affected by a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient had received full dose. Patient received dose from first vial. It was reported that 20 patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range. It was reported that no adverse event occurred at time of administration or were reported thereafter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2022: Follow-up received contains patient details added, product start date, new event added, event onset date added and narrative updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Somnolence
Clinical narrative: body aches; sleepy; nausea; Felt ill like flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt ill like flu), PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 prophylaxis.     The patient had not COVID + test or diagnosis. Concurrent condition included High cholesterol.  Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline), Allergy to antibiotic (Allergy to Erythromycin), Sulfonamide allergy, Penicillin allergy, Blood pressure high (Start Date: 10 years ago), Rheumatoid arthritis (Start Date: 3 years ago), Egg allergy and Environmental allergy. Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure high, ROSUVASTATIN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-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 INFLUENZA LIKE ILLNESS (Felt ill like flu), PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Felt ill like flu) had resolved and PAIN (body aches), SOMNOLENCE (sleepy) and NAUSEA (nausea) outcome was unknown.            The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  After 1st and 2nd dose, the patient experienced the same symptoms felt ill like flu for 24 hours, felt nausea, body aches and sleepy.  No treatment medications were reported.   This case was linked to MOD-2022-608554 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Patient had COVID arm, it got really swollen and hot to the touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Patient had COVID arm, it got really swollen and hot to the touch) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE REACTION (Patient had COVID arm, it got really swollen and hot to the touch). At the time of the report, VACCINATION SITE REACTION (Patient had COVID arm, it got really swollen and hot to the touch) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided.  It was reported that after first dose of the Moderna COVID-19 vaccine patient had COVID arm, it got really swollen and hot to the touch. This happened for 2 weeks after the first dose.  No treatment details were provided   This case was linked to MOD-2022-608571 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine administered beyond 30 day use by date; The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022) and PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date) in an 82-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator from the freezer on 31-may-2022 and the doses were administered on 01-jul-2022) and PRODUCT STORAGE ERROR (vaccine administered beyond 30 day use by date) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The occupation of the reporter was reported as clinic manager.  No concomitant medications was provided by the reporter. The vial was initially stored in the refrigerator 31-May-2022 4PM, 30 day BUD out of the freezer and was administration of vaccine on 01-jul-2022 between  9am and 12noon.  The vial did not undergo any temperature excursions.  No treatment medications was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022; HCP reported dose of Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The occupation of the reporter was reported as clinic manager. No concomitant medications was reported. The healthcare professional (HCP) stated the total number of doses was actually 8 doses. On 31-May-2022 4 PM, the vial went from freezer to refrigerator. The vial was administered on 01-Jul-2022 between 9 AM and 12 noon. It was reported that, the days were miscalculated. The vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2022 and was forwarded to Moderna on 14-Jul-2022.     This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack /After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a/After the first dose of the Moderna Covid-19 vaccine the relative experienced a heart attack) (seriousness criteria death and medically significant). The reported cause of death was after the second dose of the moderna covid-19 vaccine the person's relative suffered a fatal heart attack.. It is unknown if an autopsy was performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the unexpected and serious AESI (seriousness criteria death and medically significant) event of myocardial infarction, unknown days after a second dose of mRNA-1273 vaccine. The patient was also reported to have a myocardial infarction after the first dose. It is unknown if an autopsy was performed. No concomitant or treatment medication was reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: After the second dose of the Moderna Covid-19 vaccine the person's relative suffered a fatal heart attack.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022; Booster dose administered to patients after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. On 11-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered to patients after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patients had received their 1st booster dose of the Moderna COVID-19 vaccine after the use by date. The vial was initially stored in the refrigerator on 10-JUN-2022. The vial did not undergo any temperature excursions. BUD in refrigerator was on 10-Jul-2022 at 10am. Patients had not reported any adverse  reactions post vaccination. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Caller got a 3rd booster today 14Jul2022 of Moderna.; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0171322A and 016J212A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (1st booster dose) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised.   On 13-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, the patient experienced EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.). At the time of the report, EXTRA DOSE ADMINISTERED (Caller got a 3rd booster today 14Jul2022 of Moderna.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2022 and was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in the refrigerator on 02-Jun-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: (Moderna) Vaccine was given beyond the refrigeration use; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. On 02-Jun-2022 vial was initially stored in the refrigerator and vaccine was administered on 07-Jul-2022. It was reported that patient received first booster dose. The vial does not undergo any temperature excursions. Treatment details were not reported by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose administered after date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Hydrocodone) and Lupus syndrome.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry). On 13-Jul-2022, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No symptoms were reported to the HCP by patient after getting the vaccine.  No vaccines given within 1 month prior to Moderna COVID-19 vaccine. It is unknown that  patient ever had COVID + test or diagnosis. It is unknown if any treatment was given for any symptom after getting the vaccine, and if patient is taking any concomitant or regular medication.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Extra booster administered; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra booster administered) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Venous insufficiency, Type 2 diabetes mellitus, Hypothyroidism and Drug allergy.    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 EXTRA DOSE ADMINISTERED (Extra booster administered). At the time of the report, EXTRA DOSE ADMINISTERED (Extra booster administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that pharmacy did not have patient vaccination history on file. Patient had no side effects or prior vaccine allergy. No treatment medications were reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid 19) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Chronic respiratory disease (Patient had life long respiratory issues). On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication information was provided. Patient had horrible cough 33 day before so received prolovid which changed cough in 2 days. The patient underwent PCR and quick tests, results not reported. It was reported that patient would take a quick test in the afternoon on day of this report. Company comment: This spontaneous case concerns a 69-year-old patient (gender unspecified) with relevant medical history Chronic respiratory disease, who experienced the unexpected non-serious  of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had severe cough. SARS-CoV-2 test was done but report was not provided. The patient was reportedly treated with Prolovid (Paxlovid) which gave relief in two days. Further details of clinical course, investigation reports were not provided. Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 remains a confounder. The patient's medical condition of Chronic respiratory disease may be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 69-year-old patient (gender unspecified) with relevant medical history Chronic respiratory disease, who experienced the unexpected non-serious of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had severe cough. SARS-CoV-2 test was done but report was not provided. The patient was reportedly treated with Prolovid (Paxlovid) which gave relief in two days. Further details of clinical course, investigation reports were not provided. Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 remains a confounder. The patient's medical condition of Chronic respiratory disease may be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: testing positive for covid after getting 4 shots of Moderna vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.). At the time of the report, COVID-19 (testing positive for covid after getting 4 shots of Moderna vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient was not a clinical trial participant.  Treatment information was not provided by the reporter.  Company Comment: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth an unspecified dose of mRNA-1273 Vaccine. As reported, the patient tested positive for COVID-19 after getting 4 doses of the Moderna Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth an unspecified dose of mRNA-1273 Vaccine. As reported, the patient tested positive for COVID-19 after getting 4 doses of the Moderna Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Otitis media, Tinnitus, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site). At the time of the report, EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening) had not resolved, OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear) and VACCINATION SITE PAIN (had pain to injection site) outcome was unknown and EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) had resolved.    No concomitant medications were reported. The patient reported that after having the second Moderna booster, their left ear was clogged, followed by his right ear. The patient stated that his left ear cleared but his right ear was completely shut down which the patient found frightening. Reportedly, the patient was hearing "rice crispiest" in his right ear and the health care professional diagnosed him with Otitis Media. No treatment information was provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram, Balance disorder, Deafness, Deafness bilateral
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site). At the time of the report, EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening) had not resolved, OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear) and VACCINATION SITE PAIN (had pain to injection site) outcome was unknown and EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) had resolved.    No concomitant medications were reported. The patient reported that after having the second Moderna booster, their left ear was clogged, followed by his right ear. The patient stated that his left ear cleared but his right ear was completely shut down which the patient found frightening. Reportedly, the patient was hearing "rice crispiest" in his right ear and the health care professional diagnosed him with Otitis Media. No treatment information was provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Ear procedural complication, Middle ear effusion, Sneezing
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site). At the time of the report, EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening) had not resolved, OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear) and VACCINATION SITE PAIN (had pain to injection site) outcome was unknown and EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) had resolved.    No concomitant medications were reported. The patient reported that after having the second Moderna booster, their left ear was clogged, followed by his right ear. The patient stated that his left ear cleared but his right ear was completely shut down which the patient found frightening. Reportedly, the patient was hearing "rice crispiest" in his right ear and the health care professional diagnosed him with Otitis Media. No treatment information was provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Tympanic membrane perforation, Vertigo
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening), OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear), EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared) and VACCINATION SITE PAIN (had pain to injection site). At the time of the report, EAR DISCOMFORT (Left ear was clogged, followed by his right ear, Left ear was cleared, but his right ear completely shut down which he found frightening) had not resolved, OTITIS MEDIA (Ottitis Media), TINNITUS (hearing rice crispiest in his right ear) and VACCINATION SITE PAIN (had pain to injection site) outcome was unknown and EAR DISCOMFORT (Left ear was clogged, followed by his right ear,Left ear was cleared) had resolved.    No concomitant medications were reported. The patient reported that after having the second Moderna booster, their left ear was clogged, followed by his right ear. The patient stated that his left ear cleared but his right ear was completely shut down which the patient found frightening. Reportedly, the patient was hearing "rice crispiest" in his right ear and the health care professional diagnosed him with Otitis Media. No treatment information was provided by the reporter.