chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: inadvertently administer the vaccine 11 days after expiration date, to 16 patients; The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 030m20a and 026L20A) for COVID-19 prophylaxis.     It was unknown if patient ever had COVID positive test or diagnosis. There was no history related to adverse event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if other vaccines were given to patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Latex allergy and Drug allergy (Lisinopril allergy).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022). On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022. Dose administered after 30 days use by date or after manufacturer date of expiry.  The number of vial was reported as 1. The vial did not undergo any temperature excursions. It was unknown if patient seek medical care.  No treatment medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator after expiration date; inadvertently administer the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A and 033C21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  After expiration date and date 31-May-2022, patient took Moderna first booster.  The patient had no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  Dose administered after 30-day use by date or after manufacturer date of expiry. On 27-May-2022, the vial was initially stored in the refrigerator. Number of doses/vials administered were reported as one vial. The vial had not undergone any temperature excursions.  No treatment medication was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose as second booster; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 939909, 028L20A and 039K20-2A) for COVID-19 prophylaxis.     The patient had no allergies.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL for Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) outcome was unknown.            The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. He received the second booster dose of the Moderna COVID-19 vaccine on 02-Jun-2022 from an expired lot per the online lot lookup tool. The lot number per his vaccination card was 038A21A, which expired on 02-Sep-2021. He had no reaction to it. He did not seek medical care and had no similar event in the past. He did not had COVID positive test or diagnosis. No treatment information was provided.   This case was linked to MOD-2022-593404 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 048B21A and 018B21a) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown that the patient had COVID positive  test or diagnosis. Patient had no history  relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was unknown that other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. It was unknown that the AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown that the patient experienced a similar event in the past It was unknown that the symptoms improved or worsened  It was reported that HCP had inadvertently administered the vaccine eleven days after expiration date. Vial was initially stored in refrigerator on 27-May-2022 and the vial had not undergone any temperature excursion issue.  No treatment drug information was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; Patient was inadvertently administed with the vaccine 11 days after expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (primary series.) on 22-Feb-2021 and Pfizer (primary series.). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 31-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed with the vaccine 11 days after expiration date.) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient had no known allergies.It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  Number of doses/vials administered were reported as one vial and the vial had not undergone any temperature excursions.  No treatment medication were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date; nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A and 005C21A) for COVID-19 prophylaxis.     Patient had no medical history. Patient had no allergies to medications, food and other products. Patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Flu vaccine on 10-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022). On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (nadvertently administer  the vaccine 11 days after expiration date and initially stored in refrigerator on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Biomedical ID for the flu vaccine was reported as JX223. It was unknown whether the patient had COVID positive test or diagnosis. It was reported that HCP had inadvertently administered the vaccine eleven days after expiration date. Vial was initially stored in refrigerator on 27-May-2022 and did not undergo any temperature excursion. No treatment drug information was provided.   This case was linked to MOD-2022-593722 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose as second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose as second booster) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-593310 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A, 026L20A and 026L20A) for COVID-19 prophylaxis.     The patient had no known allergies. Patient had no acute and chronic illness at the time of vaccination and up to one month before was reported.  Previously administered products included for Product used for unknown indication: Flu shot (JX223) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, to 16 patients.) 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  The vial was initially stored in the refrigerator on 27-May-2022 The vial did not undergo any temperature excursions  It was unknown whether the patient had been diagnosed with or tested positive for COVID 19.   This case was linked to MOD-2022-593739 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; Patient was inadvertently administed the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 071F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Primary series.) and Pfizer (Primary series.). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Benadryl).   On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  On 03-Nov-2021, patient received first booster dose of Moderna vaccine. On 31-May-2022, patient received second booster dose of Moderna vaccine (batch no. 033K21-2A) after expiration date. Number of doses/vials administered were reported as one vial. It was reported that the vial was initially stored in the refrigerator on 27May2022 and vial  did not undergo any temperature excursions. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Unknown if patient experienced a similar event in the past.  No treatment medications were reported.
Age: 1.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2) in a 12-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2022 at 8:30 PM, the patient experienced PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, Body temperature: 100.6 100.6. On 22-Jun-2022, Body temperature: 104.2 104.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  It was reported that patient had experienced at 8.30 pm had a fever of 100.6 on 21 Jun 2022 and at 8 am 104.2 on 22 Jun 2022.  The patient had not received any medical care yet.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Nasopharyngitis
Clinical narrative: Common cold; Knee to ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain). At the time of the report, NASOPHARYNGITIS (Common cold) and ARTHRALGIA (Knee to ankle pain) had not resolved.            No Concomitant medication was reported  It was unknown if patient was enrolled in COVID-19 Vaccine trial. The reporter causality for events common cold and arthralgia with respect to Humira was not reported. No Treatment medication was reported
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if the patient was enrolled in COVID-19 vaccine trial.  No treatment medications were reported.  Company Comment: This spontaneous case reported by consumer concerns a 55-year-old female patient, who had concomitant use of Adalimumab for psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19 after receiving a dose of mRNA-1273 on an unknown date.  Clinical course, labs, and treatment details not reported.  The outcome was not resolved.  The concomitant use Adalimumab could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by consumer concerns a 55-year-old female patient, who had concomitant use of Adalimumab for psoriatic arthritis, who experienced unexpected, non-serious AESI Covid19 after receiving a dose of mRNA-1273 on an unknown date.  Clinical course, labs, and treatment details not reported.  The outcome was not resolved.  The concomitant use Adalimumab could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease aggravated.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medications were provided by the reporter.  Patient had taken HUMIRA drug as solution for injection in pre-filled pen.  No treatment information was provided. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event and administration of first dose of mRNA-1273 was not specified, hence latency could not be assessed. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The event was unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event and administration of first dose of mRNA-1273 was not specified, hence latency could not be assessed. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The event was unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient had severe shaking after her first booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of TREMOR (Patient had severe shaking after her first booster dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013A21A and 013A21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Concurrent medical conditions included Asthma (Mild asthma).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Patient had severe shaking after her first booster dose). At the time of the report, TREMOR (Patient had severe shaking after her first booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter was unaware if the patient was taking medications.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Bone pain, Chills, Illness, Influenza like illness
Clinical narrative: sick; full-blown like flu; bones ached; bedridden; chills; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), INFLUENZA LIKE ILLNESS (full-blown like flu), BONE PAIN (bones ached), BEDRIDDEN (bedridden) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058421A, 011M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder (patient had an anxiety attack while getting the booster).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021 at 1:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 22-Nov-2021, the patient experienced ILLNESS (sick), INFLUENZA LIKE ILLNESS (full-blown like flu), BONE PAIN (bones ached) and BEDRIDDEN (bedridden). On 23-Nov-2021, ILLNESS (sick), INFLUENZA LIKE ILLNESS (full-blown like flu), BONE PAIN (bones ached), BEDRIDDEN (bedridden) and CHILLS (chills) had resolved.            No concomitant medication information was provided.  The patient received her booster in November about 1:30 pm and then at 8 or 9 o'clock at night, she had chills. The next day patient was sick and experienced full-blown like flu, bones ache and was bedridden. She drank a lot of fluid and the following day was fine. The patient stated that she was due now for another booster. She was not understanding why she got so sick from a booster shot. Her PCP and allergist said get it in September and that there was supposed to be a common flu shot wondering why she got so sick. She was not sure what to do.  Treatment included Unspecified Vitamins and drank beverage.   This case was linked to MOD-2022-593731, MOD-2022-593732 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after second booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive for COVID-19 after second booster) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19 after second booster). At the time of the report, COVID-19 (tested positive for COVID-19 after second booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive continues to test positive for COVID (unknown length of time)..         No concomitant medication was reported. Reported reported that her sister caught Covid-19 after her 2nd booster. Reported could not confirm if her sister received the Moderna COVID-19 vaccine for any of her doses including the second booster.   No treatment medication was reported.  Company Comment: This is a spontaneous case concerning 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 (reported as tested positive for COVID-19 after second booster) which occurred on an unknown date after receiving a dose of mRNA-1273 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 has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning 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 (reported as tested positive for COVID-19 after second booster) which occurred on an unknown date after receiving a dose of mRNA-1273 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 has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 29-Jul-2021 and second dose was administered on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient had no known allergies. It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination was reported as none.  No treatment medication were reported.   This case was linked to MOD-2022-593388 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of nausea (after the first dose she was queasy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. The patient's past medical history included anxiety disorder (had an anxiety attack while getting the booster). On Feb 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nausea (after the first dose she was queasy). At the time of the report, nausea (after the first dose she was queasy) outcome unknown. No concomitant medication or treatment information provided. This case linked to MOD-2022-593718, MOD-2022-593732, MOD-2022-593068 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety disorder.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-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 IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) had resolved.            No concomitant medication was provided by the reporter.  It was reported that after 2nd dose patient arm hurt for a week, like someone punched in the arm. It was also reported that patient drank Gatorade and vitamins as a treatment.   This case was linked to MOD-2022-593718, MOD-2022-593731 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 prophylaxis.     Allergies (medications, food and other products) were none It was unknown if the patient ever had COVID positive test or diagnosis. Had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 05-Jan-2021 and second dose on 16-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2022-593416 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia
Clinical narrative: I'm feeling pretty punk today; I have body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Unknown information related to patient allergies (medications, food and other products), Covid positive test or diagnosis and medical history relating to mentioned AE and acute/chronic illnesses at the time of vaccination.    On 21-Jun-2022, the patient received fourth 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 22-Jun-2022, the patient experienced ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache). At the time of the report, ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache) had not resolved.            No Concomitant medication were reported. Medical care was not reported for events I'm feeling pretty punk today, headache and body aches and unknown whether similar events experienced in past. Symptoms were worsened for events I'm feeling pretty punk today, headache and body aches. No treatment drug were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: long term side effects from Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (long term side effects from Moderna) in a male 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 IMMUNISATION REACTION (long term side effects from Moderna) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (long term side effects from Moderna) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. The patient never tested positive or diagnosed COVID. No Concomitant medications were reported. No treatment medications were reported.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. A caller inquired on behalf of her husband inquiring what is needed to report long term side effects from vaccination with mRNA-1273, including hospitalization and emergency room visits. No further information was provided. The outcome of the events was reported as unknown. 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 male patient of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. A caller inquired on behalf of her husband inquiring what is needed to report long term side effects from vaccination with mRNA-1273, including hospitalization and emergency room visits. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received half dose as a 3rd dose instead of a full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A27B, 076C21A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Drug allergy (patient had Medications allergy, didn't want to specify which ones.).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received half dose as a 3rd dose instead of a full dose.) outcome was unknown. No concomitant medication were reported.   No treatment drug were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Discomfort
Clinical narrative: Patient was kind of anxious when patient had first booster; Patient was uncomfortable when patient had first booster; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Patient was kind of anxious when patient had first booster) and DISCOMFORT (Patient was uncomfortable when patient had first booster) in a patient of an unknown age and gender 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. On an unknown date, the patient experienced ANXIETY (Patient was kind of anxious when patient had first booster) and DISCOMFORT (Patient was uncomfortable when patient had first booster). At the time of the report, ANXIETY (Patient was kind of anxious when patient had first booster) and DISCOMFORT (Patient was uncomfortable when patient had first booster) outcome was unknown.            No concomitant information was reported. Patient had first booster of Moderna Vaccine. It was reported that in about 3 hours patient will take second Moderna booster and was debating about taking Tylenol before get home. No treatment information was provided.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: He had a mild fever/sweat; He had a mild fever/sweat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat) in a 3-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Ear infection (Fighting an ear infection and on antibiotics).    On 21-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Jun-2022, the patient experienced HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat). On 23-Jun-2022, HYPERHIDROSIS (He had a mild fever/sweat) and PYREXIA (He had a mild fever/sweat) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications included unspecified antibiotics.  It was reported that, in the middle of night of 22-Jun-2022 (early hours of 23-Jun-2022), patient had mild fever and sweat. The fever and sweat did not last that long and patient woke up fine.  Patient was not sure if it was related to the vaccine or not.  Patient was simultaneously fighting an ear infection and on antibiotic, though there was no fever associated with the ear infection over the prior week.  No treatment medications were reported.