chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A patient received a dose from a vial that was transported outside of the recommended policy.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy.). On 29-Jan-2022, PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was removed from  the cooler (unpunctured), placed in a glove with two ice cubes and transported for 15 minutes to a different location. Upon new site, vaccine was then punctured and dose was administered.  No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up received contains no new information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: seven patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Seven patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Seven patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  Office manager stated that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment medications are provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: seven patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (seven patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        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 provided.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that seven patients received wrong doses of the Moderna COVID 19 vaccine. Five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: A case of autoimmune hemolytic anemia after the first dose of COVID-19 mRNA-1273 vaccine with undetected pernicious anemia. Case Rep. 2022;2036460. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune Hemolytic Anemia) to be related. No concomitant and treatment information were provided. Company Comment: This case refers to a 42-year-old female patient with no known medical history who experienced the unexpected event of Autoimmune Haemolytic Anaemia on an unspecified date after the first dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case refers to a 42-year-old female patient with no known medical history who experienced the unexpected event of Autoimmune Haemolytic Anaemia on an unspecified date after the first dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Under treatment for this illness.). Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days). On 02-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022.   Date of vaccination reported as 02 Mar 2021 and 30 Mar 2021.  Patient did not know if any of the patients experienced any symptoms after vaccination  No treatment medication were provided.   This case was linked to MOD-2022-476392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant Follow-up received. Patient demographic, medical history, administration date, event onset and end date were updated.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 doses of COVID-19 vaccines of moderna were administered past expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (first dose) on 11-Mar-2021 and COVID-19 Vaccine (second dose) on 20-Apr-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine. Concurrent medical conditions included HIV disease. Concomitant products included AZITHROMYCIN (ZITHROMAX), MOMETASONE FUROATE (NASONEX), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 07-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 doses of COVID-19 vaccines of moderna were administered past expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no known allergies. The patient had a clinical history of human immunodeficiency virus (HIV) and was under treatment for this illness.  It was reported by Health care professional that they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that were stored in the fridge for more than 30 days.  The vials had been moved to the fridge on 28-Dec-2021 and had the expiration date of 27-Jan-2022 (30 days at fridge temps). The expiration date was not caught in time and these doses were administered in error.  Reporter did not know if the patient had experienced any symptoms after vaccination. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up information received included significant information. The case was initially invalid and it was updated to a valid case. Patient Demographics, medical history and concomitant medications were added.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: 4 doses (patients) Got expiration doses past day 30; The expiration date was not caught in time, and these doses were administered in error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ceftriaxone), Drug allergy (idiodine), Drug allergy (morphine), Drug allergy (zoplidem) and HIV disease (under treatment for this illness). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), IRON, METFORMIN and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was moved to the fridge on 28-Dec-2021 and had the expiration date of 27-jan-2022. 30 days at fridge temperature. No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received contains, patient demographic, concomitant medication and new event added.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 doses (patients) Got expiration doses past day 30; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (all of them were under treatment for this illness). Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that clinic accidentally administered 26 doses of Moderna COVID-19 Vaccine past the expiration date. The vials had been moved to the fridge on 28-DEC-2021, and had the expiration date of 27-JAN-2022 (30 days at fridge temps). The expiration date was not caught in time, and these doses were administered in error. On 09-FEB-2022 case MOD-2022-475926 became invalid as it was confirmed there are no patient identifiers. Therefore, this case will be logically deleted from the safety database   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant follow up information contains Patient Demographic added, Patient Medical history added, Dosage regimen, Route of administration for 2 nd dose vaccine, concomitants were updated.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching here or there; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching here or there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching here or there). At the time of the report, PRURITUS (itching here or there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  Reporters daughter  just had a bit of itching here or there.   No treatment medication details was provided.   This case was linked to MOD-2022-476307 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: SLE flare (mild/moderate recurrent oral ulcers); This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (mild/moderate recurrent oral ulcers)) to be related.    Treatment and concomitant medications were not reported.  Company Comment: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Systemic Lupus Erythematosus on an unspecified date after the second dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-476138 (Patient Link).; Sender's Comments: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Systemic Lupus Erythematosus on an unspecified date after the second dose of mRNA-1273 vaccine. The reporter assessed the event as related to mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Your thing for the 3rd vaccine knocked me out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out) in a  patient of an unknown age and gender who received mRNA-1273 for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out). At the time of the report, VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out) outcome was unknown.            No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Headache, Somnolence, Vomiting
Clinical narrative: No energy at all; All  she want to do is sleep; No appetite at all; Bad headache; Had vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy at all), SOMNOLENCE (All  she want to do is sleep), DECREASED APPETITE (No appetite at all), HEADACHE (Bad headache) and VOMITING (Had vomiting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Started after the birth of her 3rd kid.), Drug allergy and Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy at all), SOMNOLENCE (All  she want to do is sleep), DECREASED APPETITE (No appetite at all), HEADACHE (Bad headache) and VOMITING (Had vomiting). The patient was treated with ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]) for Vomiting, at a dose of 8 milligram. At the time of the report, ASTHENIA (No energy at all), SOMNOLENCE (All  she want to do is sleep), DECREASED APPETITE (No appetite at all), HEADACHE (Bad headache) and VOMITING (Had vomiting) had not resolved.            Concomitant medication included blood pressure medication.   Patient not had COVID positive test or diagnosis.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Bronchospasm, Chest discomfort, Cough variant asthma, Dizziness, Dyspnoea
Clinical narrative: Left arm tingling from the upper arm to the hands an fingers; Trouble breathing; Asthmatic Cough; bronchoconstriction; tightness in her chest; Arms, hands and fingers turned purple; Arms were useless; Flu-like symptoms; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction) and CHEST DISCOMFORT (tightness in her chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness). At the time of the report, PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Limb discomfort, Paraesthesia, Skin discolouration
Clinical narrative: Left arm tingling from the upper arm to the hands an fingers; Trouble breathing; Asthmatic Cough; bronchoconstriction; tightness in her chest; Arms, hands and fingers turned purple; Arms were useless; Flu-like symptoms; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction) and CHEST DISCOMFORT (tightness in her chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness). At the time of the report, PARAESTHESIA (Left arm tingling from the upper arm to the hands an fingers), DYSPNOEA (Trouble breathing), COUGH VARIANT ASTHMA (Asthmatic Cough), BRONCHOSPASM (bronchoconstriction), CHEST DISCOMFORT (tightness in her chest), SKIN DISCOLOURATION (Arms, hands and fingers turned purple), LIMB DISCOMFORT (Arms were useless), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine). On 04-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (her 16 year old son received 2 doses of the Moderna Covid-19 Vaccine) had resolved.      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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure before pregnancy
Clinical narrative: Inappropriate schedule of drug administration; Maternal exposure before pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 29-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. In April 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of drug administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   When tried to enter the doses in the system, the system did not accept the DEC2021 dose as the first dose, so ended up recording it as the second dose and  recorded the FEB2022 dose as a full dose booster.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-476097 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product information was not provided.  AEs were not medically treated.   This case was linked to MOD-2022-476104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received and contains No New Information
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: 3rd full dose booster received 41 days after the second dose; Received 3rd full booster dose by error; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd full dose booster received 41 days after the second dose) and INCORRECT DOSE ADMINISTERED (Received 3rd full booster dose by error) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd full dose booster received 41 days after the second dose). 02-Feb-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received 3rd full booster dose by error). On 02-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd full dose booster received 41 days after the second dose) and INCORRECT DOSE ADMINISTERED (Received 3rd full booster dose by error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that it was not sure if the patient was pregnant / breastfeeding while receiving the vaccine. When tried to enter the doses in the system, the system did not accept the DEC2021 dose as the first dose, so ended up recording it as the second dose and  recorded the FEB2022 dose as a full dose booster.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-476088 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received a dose from a vial that was transported outside of the recommended policy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy). On 29-Jan-2022, PRODUCT STORAGE ERROR (received a dose from a vial that was transported outside of the recommended policy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient received a dose from a vial that was transported outside of the recommended policy. Vial was removed from the cooler (unpunctured), placed in a glove with two ice cubes and transported for 15 minutes to a different location. Upon new site, vaccine was then punctured, and dose was administered.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Followup contains no newinformation.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Inflammation, Pyrexia
Clinical narrative: erythema; rubor; fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever) 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.   This case was linked to MOD-2022-476096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Non significant Follow-up received
Sex: M
Vaccine: COVID19
Symptoms: Pelvic pain
Clinical narrative: About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stone.   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 PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit). At the time of the report, PELVIC PAIN (About 25 days after the 3rd dose, he had pelvic pain in the same area, but it eased up a bit) was resolving.            No concomitant and treatment drug information was provided.   This case was linked to MOD-2022-475998 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Mixed series (Pfizer as 1st dose and Moderna as 2nd dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 59H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER. Past adverse reactions to the above products included No adverse event with PFIZER.    On 07-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)). On 07-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient given 0.25 as a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as 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) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient given 0.25 as 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.  Treatment information was not provided. Pharmacist called and indicated that they had a patient that they got the Moderna two dose primary series (0.5 milliliter) and then a Moderna booster dose (0.25 milliliter). The patient told the pharmacist that they were immunocompromised and wanted a fourth dose. The pharmacist also indicated that they needed an answer fast because the patient was there. The context and the details of why the 0.25 milliliter dose given were not described in details.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Throat irritation, Vaccination site pain
Clinical narrative: Minor throat irritation; Body aches; Headache; Left arm ache where she received injection; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension.    The patient's past medical history included Back pain and Dizziness (On 27 Jan 2022, the day after initiating IH Tyvaso, the patient had minor lightheadedness) on 27-Jan-2022. Concurrent medical conditions included Pulmonary arterial hypertension (secondary pulmonary arterial hypertension). Concomitant products included APIXABAN (ELIQUIS) and PIRFENIDONE (ESBRIET) for an unknown indication.   On 27-Jan-2022, the patient started TREPROSTINIL SODIUM (Nasal) 18 microgram four times per day. On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection). At the time of the report, THROAT IRRITATION (Minor throat irritation), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Left arm ache where she received injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on an unreported date in 2022, the patient experienced the event of minor throat irritation. On an unreported date in Feb 2022, the patient experienced the events of body aches pain, headache and left arm ache where she received injection.  Treatment medications were not provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 28-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter as it was unclear whether the patient experienced any events.