chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Glomerulonephritis minimal lesion
Clinical narrative: Minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: glomerular disease Glomerular disease.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) to be related.    No concomitant and treatment mediations were reported.  This is a literature non-study case with reference concerning a 45-year-old female patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant and occurred  on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients Biopsy kidney: glomerular disease Glomerular disease. It was reported that the outcome of the event was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539885, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This is a literature non-study case with reference concerning a 45-year-old female patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant and occurred  on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients Biopsy kidney: glomerular disease Glomerular disease. It was reported that the outcome of the event was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Glomerulonephritis rapidly progressive
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Glomerular disease in temporal association with SARS-CoV-2 vaccination: a series of 29 cases. Kidney360;2(11):1770. 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 GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) outcome was unknown. Related. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: proven glomerular disease proven glomerular disease. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic GN) to be related. No concomitant and treatment medications were reported. 28 patients were reported of de novo GN within native kidney biopsies and one disease flare in an allograft. Company comment: This literature non-study case concerns a 76yearold, female patient with no medical history reported, who experienced the unexpected, serious medically significant event of glomerulonephritis rapidly progressive. The event occurred after the administration of the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination dates. The report stated that the patient experienced Crescentic glomerulonephritis. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539885, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link). Sender's Comments: This literature non-study case concerns a 76yearold, female patient with no medical history reported, who experienced the unexpected, serious medically significant event of glomerulonephritis rapidly progressive. The event occurred after the administration of the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination dates. The report stated that the patient experienced Crescentic glomerulonephritis. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis rapidly progressive
Clinical narrative: crescentic GN; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (crescentic GN) in a 71-year-old female patient 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 GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (crescentic GN) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (crescentic GN) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (crescentic GN) to be related. No concomitant and treatment medications were reported. This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539885, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Dose of Moderna vaccine inadvertently administered from a partially thawed vial.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Dose of Moderna vaccine inadvertently administered from a partially thawed vial.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  It was reported that a patient was inadvertently given a dose of Moderna vaccine from a partially thawed vial. There was a cylinder of frozen vaccine in the middle of the vial, and the dose was drawn from the small amount of liquid surrounding it. At the time of reporting the provider estimates that the vial was still 80-90% frozen.  No treatment medication was reported by the reporter.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients administered vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  On 28-Jan-2022 maximum or minimum temperatures reached range was positive 34.7F to positive 41.2F, on 30-Jan-2022 temperature range was positive 34.7F to positive 41.2F which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temperature range was positive 35.2F to positive 41.7F for 12 hours.  It was reported that the patient did not experience any adverse event. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she had popped a vial of Moderna Covid-19 yesterday on 13APR2022 and doses wereadministered from the vial greater than 12 hours later.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The dose was administered >12/24 hours post puncture. Date the vial was initially stored in the refrigerator was on 04 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8.53 AM and the vial was stored in refrigerated post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 15 minutes.  No treatment medications were reported.   This case was linked to MOD-2022-540270 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Hypertension, Pain, Pyrexia
Clinical narrative: Respiratory Congestion; Experience pain; Blood pressure went high; 104.2 Degrees Farenheit fever; Arthritic pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Farenheit fever) and ARTHRALGIA (Arthritic pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21H, 013120A. and 013C20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies to almost everything), Peanut allergy, Shellfish allergy (shrimp), Asthma and Swelling. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY), PREGABALIN (LYRICA), MONTELUKAST SODIUM (SINGULAIR) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, METOPROLOL and AMLODIPINE for Blood pressure, IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, HCTZ for Swelling.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Farenheit fever) and ARTHRALGIA (Arthritic pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Pain, at a dose of 500 milligram once a day. At the time of the report, RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Fahrenheit fever) and ARTHRALGIA (Arthritic pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.2 degrees fahrenheit. (High) 104.2 Degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient tried to consult with pulmonologist regarding the side effects and was told to continue taking Tylenol. Patient is taking Tylenol 500mg once a day for pain.  Patient has been taking Metoprolol for 5 years, amlodipine since February this year, HCTZ for 10 years.   This case was linked to MOD-2022-540053 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Respiratory Congestion; Experience pain; Blood pressure went high; 104.2 Degrees Farenheit fever; Arthritic pain; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Farenheit fever) and ARTHRALGIA (Arthritic pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21H, 013120A. and 013C20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergies to almost everything), Peanut allergy, Shellfish allergy (shrimp), Asthma and Swelling. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY), PREGABALIN (LYRICA), MONTELUKAST SODIUM (SINGULAIR) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, METOPROLOL and AMLODIPINE for Blood pressure, IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, HCTZ for Swelling.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Farenheit fever) and ARTHRALGIA (Arthritic pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Pain, at a dose of 500 milligram once a day. At the time of the report, RESPIRATORY TRACT CONGESTION (Respiratory Congestion), PAIN (Experience pain), HYPERTENSION (Blood pressure went high), PYREXIA (104.2 Degrees Fahrenheit fever) and ARTHRALGIA (Arthritic pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.2 degrees fahrenheit. (High) 104.2 Degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient tried to consult with pulmonologist regarding the side effects and was told to continue taking Tylenol. Patient is taking Tylenol 500mg once a day for pain.  Patient has been taking Metoprolol for 5 years, amlodipine since February this year, HCTZ for 10 years.   This case was linked to MOD-2022-540053 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Only lot number 059H21A, thawed on 28-Jan-2022 was affected with expiration date 27-Mar-2022. On 28-Jan-2022 Maximum or minimum temperatures reached range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit, on 30-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit for 12 hours and on 04-Feb-2022 temperature range was positive 35.2 degree Fahrenheit to positive 41.7 degree Fahrenheit for 12 hours.  No patient reported any adverse event. No treatment medication was provided by the reporter.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered vaccines that have undergone temperature excursion; First dose administered on 31-Jan-22 and second dose administered on 21-Mar-22; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 31-Jan-22 and second dose administered on 21-Mar-22) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 31-Jan-22 and second dose administered on 21-Mar-22). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 31-Jan-22 and second dose administered on 21-Mar-22) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported.  Maximum or minimum temperatures reached inside the refrigerator:- on 28-Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range: positive 35.2F to positive 41.7F for 12 hours. Vials Thawed on 28-JAN-2022. Patient have reported any adverse events to date  No Treatment information was reported.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccines that had undergone temperature excursion; Patient was administered with vaccines that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  The vial was thawed on 28-Jan-2022. The vials had Maximum or minimum temperatures reached, as applicable (specify temp is in C or F). On 28-Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range: positive 35.2F to positive 41.7F for 12 hours.   This case was linked to MOD-2022-539812 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Illness, Urticaria chronic
Clinical narrative: hives/chronic urticaria; sick; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA CHRONIC (hives/chronic urticaria) and ILLNESS (sick) 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 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ILLNESS (sick). In December 2021, the patient experienced URTICARIA CHRONIC (hives/chronic urticaria). In November 2021, ILLNESS (sick) had resolved. At the time of the report, URTICARIA CHRONIC (hives/chronic urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: no allergies no allergies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient started getting hives and patches on patients body and woke up in the morning and a couple hour they were gone. Patient mainly got them in areas in which there was pressure like where socks were on or her knees when they were on a table.   No treatment information was reported.   This case was linked to MOD-2021-067651, MOD-2021-067676 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after the first 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the first 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nephrectomy (one of his kidneys removed before getting any of the vaccines). Concurrent medical conditions included Renal cell carcinoma and Immunocompromised.   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 PAIN IN EXTREMITY (Sore arm after the first 2nd dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after the first 2nd dose) outcome was unknown.   No concomitant drug was reported. No Treatment medications were reported.   This case was linked to MOD-2022-541251, MOD-2022-541259 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: got kind of red around the shot area after getting the second booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (got kind of red around the shot area after getting the second booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE ERYTHEMA (got kind of red around the shot area after getting the second booster). At the time of the report, VACCINATION SITE ERYTHEMA (got kind of red around the shot area after getting the second booster) outcome was unknown.  Concomitant medication information was not provided.  On 14-Apr-2022, the patient received the second booster dose of the vaccine. The patient had not taken any treatment medication for the side effects. The patient was on other daily medications but declined to provide information. The patient did not have any other problems. The patient would like to know if it was normal for the patient to experience the event or not. Reporter did not allow further contact.  Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: Live follow-up document received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Thrombosis
Clinical narrative: Blood clots; Still in horrible conditoiin; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 THROMBOSIS (Blood clots) (seriousness criteria medically significant and life threatening) and FEELING ABNORMAL (Still in horrible conditoiin). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown and FEELING ABNORMAL (Still in horrible conditoiin) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient got blood clots and almost died. The patient was still in horrible condition and also had spent multiple thousands of dollars on tests.  No concomitant medication was provided by the reporter.  No treatment medication was provided.  Company comment: This spontaneous case concerns a patient with limited information, who experienced the unexpected serious (life-threatening, medically significant) AESI Thrombosis, on an unknown date after a dose of mRNA-1273 vaccine (dose unspecified). The patient experienced blood clots and felt like almost died and was feeling abnormal. At the time of reporting, the event had not resolved. No further details were reported. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with limited information, who experienced the unexpected serious (life-threatening, medically significant) AESI Thrombosis, on an unknown date after a dose of mRNA-1273 vaccine (dose unspecified). The patient experienced blood clots and felt like almost died and was feeling abnormal. At the time of reporting, the event had not resolved. No further details were reported. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Pruritus
Clinical narrative: he received an extra booster of COVID-19 vaccine on 01Apr2022; intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching) and EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st booster) on 27-Sep-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022). In April 2022, the patient experienced PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching). At the time of the report, PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching) and EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022) outcome was unknown.            Patient reported he was on no concomitant medication.  Patient took 2nd booster on 07 DEC 2021 and 3rd booster on 01 APR 2022 of Moderna.  He reported he received an extra booster of COVID-19 vaccine on 01Apr2022. A few days later, he started to experience intermittent itching that came for 10-30 minutes at a time. It migrated from different parts of the body. He woke up 3 times itching in the middle of the night, he itched for 10- 20 minutes. He was having an appointment with a dermatologist in a few days. He reported in total he has received 5 total doses of COVID-19 vaccines.  He mentioned he googled itching, he found a bunch of people who reported itching with the vaccine and read dozens of people who received Moderna, and Pfizer COVID-19 vaccines reported the same symptoms of itching he had. He mentioned as he thought Moderna should factor in all the data of people reporting these problems, and Moderna should be responsible.   No treatment medication was reported.   This case was linked to MOD-2022-541364 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he received an extra booster of COVID-19 vaccine on 01Apr2022; intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching) and EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st booster) on 27-Sep-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022). In April 2022, the patient experienced PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching). At the time of the report, PRURITUS (intermittent itching that comes and goes/migrates from different parts of body/woke up in the night itching) and EXTRA DOSE ADMINISTERED (he received an extra booster of COVID-19 vaccine on 01Apr2022) outcome was unknown.            Patient reported he was on no concomitant medication.  Patient took 2nd booster on 07 DEC 2021 and 3rd booster on 01 APR 2022 of Moderna.  He reported he received an extra booster of COVID-19 vaccine on 01Apr2022. A few days later, he started to experience intermittent itching that came for 10-30 minutes at a time. It migrated from different parts of the body. He woke up 3 times itching in the middle of the night, he itched for 10- 20 minutes. He was having an appointment with a dermatologist in a few days. He reported in total he has received 5 total doses of COVID-19 vaccines.  He mentioned he googled itching, he found a bunch of people who reported itching with the vaccine and read dozens of people who received Moderna, and Pfizer COVID-19 vaccines reported the same symptoms of itching he had. He mentioned as he thought Moderna should factor in all the data of people reporting these problems, and Moderna should be responsible.   No treatment medication was reported.   This case was linked to MOD-2022-541364 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Pruritus
Clinical narrative: 1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (1st booster) on 27-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021) outcome was unknown.            Patient reporter not having any concomitant drugs at that time.  Patient took 2nd booster as Moderna.  No treatment medication was reported by reporter.  Patient searched on the internet and found a bunch of people reported itching with Moderna and Pfizer COVID-19 vaccines.   This case was linked to MOD-2022-541322 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (1st booster) on 27-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster was on 27-Sep-2021 and 2nd booster on 07-Dec-2021) outcome was unknown.            Patient reporter not having any concomitant drugs at that time.  Patient took 2nd booster as Moderna.  No treatment medication was reported by reporter.  Patient searched on the internet and found a bunch of people reported itching with Moderna and Pfizer COVID-19 vaccines.   This case was linked to MOD-2022-541322 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: little bit of the needle left out/ didn't go all the way into the arm; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm) in a male 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm) outcome was unknown.     Reporter reported that needle went into fat (into muscle). No concomitant drug reported. No treatment information was provided by the reporter. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up appended, contains no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 008C21A and 030B21A) for COVID-19 vaccination. The patient had no allergies and the patient had not tested or diagnosed to Covid-19 ever. No acute and chronic illness at the time of vaccination and no the other vaccine was given within the month prior to Moderna Covid-19 vaccine. Concomitant products included LISINOPRIL, METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID), METHOTREXATE, PROPRANOLOL HYDROCHLORIDE (INDERAL) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was not experiencing any symptoms after receiving the vaccine. The vial did not undergo any temperature excursions. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received contains no new information.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. It was reported that patient was administered 1/2 dose of 2nd booster. The vial was initially stored in the refrigerator on 13-Apr-2022. It was stated that the vial did not undergo any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received and contains no new information