chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received 3 full doses of the Moderna COVID-19 vaccine; is immunocompromised. They got COVID in February 2022 after receiving Moderna vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient received 3 full doses of the Moderna COVID-19 vaccine; is immunocompromised. They got COVID in February 2022 after receiving Moderna vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (Patient received 3 full doses of the Moderna COVID-19 vaccine; is immunocompromised. They got COVID in February 2022 after receiving Moderna vaccines). At the time of the report, COVID-19 (Patient received 3 full doses of the Moderna COVID-19 vaccine; is immunocompromised. They got COVID in February 2022 after receiving Moderna vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. The patient also received monoclonal antibodies because they had COVID in February 2022.  Company comment: This case concerns a patient of unknown age and gender with medical history of immunodeficiency, who experienced the adverse event of special interest of COVID-19 an unknown time after the first, second and third dose of mRNA-1273. The medical history of immunodeficiency is a confounder. Because the report does not specify dates of vaccination, lack of effect cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a patient of unknown age and gender with medical history of immunodeficiency, who experienced the adverse event of special interest of COVID-19 an unknown time after the first, second and third dose of mRNA-1273. The medical history of immunodeficiency is a confounder. Because the report does not specify dates of vaccination, lack of effect cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. No Medical History information was reported. On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included Birth control patch. The patient never had COVID-19 positive test. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was reported that no symptoms were reported after any of the vaccines. The patient did not seek medical care and no treatment received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave two doses of an expired vaccine to two patients for their Booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059h21a, 048b21a and 039b21a) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy and Drug allergy (Allergy to Nesporin).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave two doses of an expired vaccine to two patients for their Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported.  Concomitant medication were reported as tyrod medication and asthma medication.  No treatment medications was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose administered to 2 patients; Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients) and PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 060H21A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.). On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 2 patients) and PRODUCT STORAGE ERROR (Lot expired on 28MAR2022 and was administered on 29MAR2022, prior to administration the vial was frozen and thawed.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Vial did not undergo any temperature excursions.The patients have not reported any adverse reactions to the dose at this time. No treatment medication was reported
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient tested positive on 30Dec2021) on 30-Dec-2021. Concurrent medical conditions included Blood pressure high since 2020. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No symptoms were reported after any of the vaccines.  No treatment has been given   This case was linked to MOD-2022-527381 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Imunocompromised patient that received a first, second and booster dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (barely sore arm) and FATIGUE (little tiredness/barely tired). At the time of the report, PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) outcome was unknown. No concomitant medication was reported by the reporter. The reporter informed that patient was over 70 years and not immunocompromised. Patient was scheduled for surgery. Patient talked with surgeon and doctor, and they told him to get the shot. No treatment medication was reported by the reporter. This case was linked to MOD-2022-527272 (Patient Link). Reporter did not allow further contact.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: 5 Patients received and dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 022c21A and 014c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Dec-2021. Concurrent medical conditions included Bee sting hypersensitivity, Pollen allergy and Drug allergy (Flonase).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator was on 9 March 2022 and the date of administration of vaccine was on 24 march 2022. The vial did not undergo any temperature excursions. It was reported unknown that if patient experienced a similar event in the past.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received and dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 036a21a and 019b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received and dose from an expired vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The date the vial was initially stored in the refrigerator was 9-Mar-2022. The vial did not undergo any temperature excursion. It was reported that patient had no allergies (medications, food and other products) It was unknown whether patient  had ever COVID positive test or diagnosis. It was reported that no other vaccines given within 1month prior to Moderna COVID-19 vaccine (type,brand, lot,route, dose #) It was unknown whether Adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) It was unknown whether patient  had experienced a similar event in the past. It was reported that death was not the cause and autopsy was not done. No treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Additional information about the Dose administered was; Date the vial was initially stored in the refrigerator as 9 March 2022 and the vial did not undergo any temperature excursions.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 5 Patients received and dose from an expired vial; The patient has more than 30 days between first and second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient has more than 30 days between first and second dose) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient has more than 30 days between first and second dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Patients received and dose from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient has more than 30 days between first and second dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The dose administered after 30-day Use by Date or after manufacturer date of expiry. The date the vial initially stored in the refrigerator was 9-Mar-2022. It was also reported that the vial didn't undergo any temperature excursions.  It was unknown if the patient had any allergic history, or the patient ever had COVID + test or diagnosis. It was unknown if the patient had any medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. Reportedly, it was unknown if the patient received any other vaccines within 1 month prior to Moderna COVID-19 vaccine and whether the AE caused patient to seek medical care. It was also reported that the patient had not experienced a similar event in the past.   The adverse event outcome and the patient's symptoms improved or worsened was unknown.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received a booster dose instead of a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  It was reported that the patient came to get the fourth shot, and the reporter reported that the patient was given the primary series and a booster dose of the vaccine because they did not know at that time that the patient was immunocompromised, or had became immunocompromised since then.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: sore arm; tiredness; not felling well for 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to bee sting, Allergy to antibiotic, Allergic reaction and Osteopenia. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown and MALAISE (not felling well for 24 hours) had resolved.        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.   The patient was a retired registered nurse.  The patient never had COVID positive test or diagnosis. The patient did not have any past medical history and both acute and chronic illnesses at the time of vaccination.   This case was linked to MOD-2022-527083, MOD-2022-527372 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, White blood cell count, White blood cell count decreased
Clinical narrative: felt aching; low white cell count; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Seasonal allergy, Drug allergy (Allergies to medicines for osteopenia and osteoporosis) and Adhesive tape allergy (allergic to tape). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever). At the time of the report, PAIN (felt aching) and WHITE BLOOD CELL COUNT DECREASED (low white cell count) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) low.         No treatment medications were reported.   The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. She received her Seasonal allergy shot last fall, the caller believes it was on Sep-2021. Height: 5´8.   This case was linked to MOD-2022-527664 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental underdose
Clinical narrative: felt aching; low white cell count; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Seasonal allergy, Drug allergy (Allergies to medicines for osteopenia and osteoporosis) and Adhesive tape allergy (allergic to tape). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 PAIN (felt aching), WHITE BLOOD CELL COUNT DECREASED (low white cell count) and PYREXIA (fever). At the time of the report, PAIN (felt aching) and WHITE BLOOD CELL COUNT DECREASED (low white cell count) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) low.         No treatment medications were reported.   The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. She received her Seasonal allergy shot last fall, the caller believes it was on Sep-2021. Height: 5´8.   This case was linked to MOD-2022-527664 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received booster dose first instead of 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Immunosuppressant drug therapy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received booster dose first instead of 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone increased, Menstruation irregular
Clinical narrative: Irregular Periods; High Testosterone Levels; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD TESTOSTERONE INCREASED (High Testosterone Levels) and MENSTRUATION IRREGULAR (Irregular Periods) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID 19 vaccine on 11-Apr-2021. Past adverse reactions to the above products included Irregular periods with Janssen COVID 19 vaccine.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced BLOOD TESTOSTERONE INCREASED (High Testosterone Levels). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular Periods). At the time of the report, BLOOD TESTOSTERONE INCREASED (High Testosterone Levels) and MENSTRUATION IRREGULAR (Irregular Periods) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Blood testosterone: high (High) High.         No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; Excessive tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (Severe anemia).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) outcome was unknown.            No concomitant medication was provided. Patient experienced headache, fever, chills, and excessive tiredness after each of first three Moderna Covid-19 vaccines. It was reported that patient did not provide permission for safety to contact. No treatment information was provided.   This case was linked to MOD-2022-528505, MOD-2022-528529 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: headache after each of the three Moderna Covid-19 vaccines; fever after each of the three Moderna Covid-19 vaccines; chills after each of the three Moderna Covid-19 vaccines; excessive tiredness after each of the three Moderna Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1C1B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (Severe anemia).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines). At the time of the report, HEADACHE (headache after each of the three Moderna Covid-19 vaccines), PYREXIA (fever after each of the three Moderna Covid-19 vaccines), CHILLS (chills after each of the three Moderna Covid-19 vaccines) and FATIGUE (excessive tiredness after each of the three Moderna Covid-19 vaccines) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.  The patient reported that the patient's husband had no immune system and asked whether the patient and the patient's husband should receive another booster shot. The patient was advised to consult with the physician.   This case was linked to MOD-2022-528505, MOD-2022-528526 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fever; Chills; Excessive tiredness; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1C1B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (severe anemia).    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was provided by the reporter.  Patient experienced headache, fever, chills, and excessive tiredness after each of first three Moderna Covid-19 vaccines.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-528526, MOD-2022-528529 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm; they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) and PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 1:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 1:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) and PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  On 29-Mar-2022, the vial was initially stored in the refrigerator. On same day at 01:48 pm vial was first punctured. On 30-Mar-2022 at 1:37 pm, dose administered more than 12 hours post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature was reported as for 6 minutes.  No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine was administered on 07-Jan-2021 and second on 15-Feb-2021(more than 35 days)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dosage of first and second dose of Moderna vaccine was reported as 0.5. Other vaccines given on the same day of Moderna COVID-19 vaccine included Influenza High Dose (SANOFI PASTE) with lot number of UJ772AA on right deltoid through intramuscular route. Treatment information was not provided.   This case was linked to MOD-2022-503787 (Patient Link).
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) 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.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-512521 (Patient Link).
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: The caller said that 1 patient received Rotateq and Vaxelis after a temperature excursion; This non-serious spontaneous safety report with reference number 02082971 and 02082963 was received by a partner on 04-JAN-2022 and forwarded to regulatory authority on 07-JAN-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event of a patient received Rotateq and Vaxelis after a temperature excursion was assessed as not applicable due to the nature of the event.  Further information is expected.  SIGNIFICANT follow-up information was received by Fax from a HCP on 24-Jan-2021. The case is maintained as non-serious. The reporter confirmed that the patient did not experience any Adverse Event following the administration of Vaxelis.  The temperature excursion occurred because a vaccine box did not allow the refrigerator to be closed completely. The vaccine box was moved and the door was closed completely.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Temperature excursion of 31.8 F during 10 min. Vaxelis was administered to a patient.; This non-serious spontaneous safety report with reference #02089387 was received by a partner on 12-Jan-2022 from a Medical Assistant, and forwarded on 13-Jan-2022.  Due to the nature of the event, the causality between Vaxelis and the reported event of "Temperature excursion for Vaxelis and administered to a patient" was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC
Symptoms: Off label use, Product use issue, Wrong product administered
Clinical narrative: Wrong product administered; Administered Vaxelis, Hep B, and PCV; Product use in unapproved population; No adverse event; This case was retrieved on 12-JAN-2022 with the following reference number: 1801803. The original narrative from the sender is as below:  Patient came in for a well child check today and the provider ordered the administration of Vaxelis, PCV-13, and Rotavirus vaccine. While I was taking these out of the fridge, I got distracted and pulled out Hep B by mistake instead of rotavirus. I administered Vaxelis, Hep B, and PCV. Within one minute of administration, I realized that I gave Hep B by mistake and forgot to administer the rotavirus vaccine. I immediately informed the provider, and she spoke with the patient's mother. Patient did not experience any symptoms or signs while in the office, and the provider advised mother to monitor for any concerning signs or symptoms.  The case was considered off-label use, since product was administer in unapproved population (patient 1 month old).
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth.; The baby missed his vaccinations at TWO months old; This non-serious spontaneous safety report with reference number #2022SA024585 was received by a partner on 25-JAN-2022 and forwarded to regulatory authority on 27-JAN-2022 from a health care professional.  The causal relationship between Vaxelis and the reported events "received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth" and "the baby missed his vaccinations at two months old" was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old female received a dose of Vaxelis and a dose of Pentacel; This non-serious spontaneous safety report was received by a partner on 08-MAR-2022 and forwarded to Agency on 09-MAR-2022 from a healthcare professional.  The causal relationship between Vaxelis and the reported event "6-month-old female received a dose of Vaxelis and a dose of Pentacel" is assessed as not applicable due to the nature of the event.  Further information is expected.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient did not receive his/her 4 month or 6 month dose of VAXELIS.; This non-serious spontaneous safety report with reference number 02126618 was received by a partner on 11-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event 'The patient did not receive his/her 4 month or 6 month dose of VAXELIS' was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This non-serious spontaneous safety report with reference number 02125895 was received by a partner on 10-MAR-2022 and forwarded to Agency on 14-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event of "On 10-Feb-2022, patient was administered both improperly stored ROTATEQ, and improperly stored VAXELIS (product temperature excursion happened on 05-Feb-2022)" is assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Patient was administered both improperly stored Vaxelis and Rotateq; This non-serious spontaneous safety report with reference number 02125894 was received by the partner on 10-Mar-2022 and forwarded to Agency on 15-Mar-2022 from another health care professional.  The causal relationship between Vaxelis and the reported event is not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored; This non-serious spontaneous safety report with reference number 02125902 was received by a partner on 10-MAR-2022 and forwarded to Agency on 15-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored is assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: Temperature: 0.8°C (Temperature Excursion had occurred on 02/05/2022. On 02/25/2022, patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS.; This non-serious spontaneous safety report, with reference number 02125903 (and interaction # 02125857), was received by the partner on 10-MAR-2022 and forwarded to Agency on 15-MAR-2022, from a Nurse.   Due to the nature of the event, the causality between the reported event "Temperature: 0.8°C (Temperature Excursion had occurred on 02/05/2022. On 02/25/2022, patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS." and Vaxelis was assessed as not applicable.   Further information is expected.