chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm tenderness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The patient had blood pressure in the normal range (for the past two years). The patient had two syncope events in 2020 after heart surgery related to low blood pressure medication (as that medication caused her blood pressure to dip too low. Concurrent condition included cholesterol. The patient never been diagnosed with/ tested positive for COVID-19. The patient's past medical history included Pernicious anemia in 1970, Syncope in 2020, Blood pressure low and Cardiac operation. Concurrent medical conditions included Food allergy (poultry), Allergy to antibiotic (biaxin) and Thyroid disorder since 08-Oct-2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 10-Aug-2020 to an unknown date for Cholesterol, FOLIC ACID (FOLVITE [FOLIC ACID]) for RBC count abnormal, DOCUSATE SODIUM for Stools hard, LEVOTHYROXINE from 08-Oct-2020 to an unknown date for Thyroid disorder, CYANOCOBALAMIN, TILACTASE (LACTAID), LORATADINE (CLARITIN [LORATADINE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL (OMEGA-3 FISH OIL), VACCINIUM MACROCARPON (CRANBERRY JUICE EXTRACT), CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3 and GLUCOSAMINE & CHONDORITIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm tenderness). At the time of the report, VACCINATION SITE PAIN (Arm tenderness) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient blood type was reported as A positive. No treatment medication was provided.   This case was linked to MOD-2022-539717, MOD-2022-536098 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered
Clinical narrative: Expired dose administered; 0.25Ml/3rd Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25Ml/3rd Dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022; Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (14 patients were vaccinated on 06Apr2022,Expiration date: 02Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Date the vial was initially stored in the refrigerator was on 14-MAR-2022.  No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; 0.25ML/3rd dose; Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (0.25ML/3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14-Mar-2022. The vial did not undergo any temperature excursions. No concomitant medications was reported. No treatment medications was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Somnolence
Clinical narrative: got a bit of a fiber; and felt a bit sleepy; felt a little tired,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,). At the time of the report, VACCINATION COMPLICATION (got a bit of a fiber), SOMNOLENCE (and felt a bit sleepy) and FATIGUE (felt a little tired,) was resolving.            Concomitant medication was not reported. The patient was not tested positive or diagnosed with COVID. Patient hasn't taken other vaccine prior 1 month to Moderna COVID-19 vaccine. Patient hasn't experienced similar events in the past. It was reported that there was little improvement in the symptoms. Treatment medication was not reported.
Age: 61.0
Sex: M
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 (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No concomitant medication reported. No treatment medication details reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 13-Apr-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022; Expired dose administered to 5 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and PRODUCT STORAGE ERROR (5 patients were vaccinated on 13 Apr 2022,expiration date was on 02 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    The vial was initially stored in the refrigerator on 14-Mar-2022.  No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; Expired dose administered to 5 patients; 0.25ML/3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients), ACCIDENTAL UNDERDOSE (0.25ML/3rd dose) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) and ACCIDENTAL UNDERDOSE (0.25ML/3rd dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 06-Apr-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 5 patients) outcome was unknown. At the time of the report, ACCIDENTAL UNDERDOSE (0.25ML/3rd dose) and PRODUCT STORAGE ERROR (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.   Date the vial was initially stored in the refrigerator: 14-Mar-2022. The vial did not undergo any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022; Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 14 Mar 2022, manufacturer date of expiry was on 02 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The vial was initially stored in the refrigerator on 14 Mar 2022. Expiration date of the vial  was on 02 Apr 2022. The vial did not undergo any temperature excursions.  No treatment medication details reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received a half booster dose instead of taking a full third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received a half booster dose instead of taking a full third dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received a half booster dose instead of taking a full third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received a half booster dose instead of taking a full third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient had received 2 regular full doses of Moderna vaccine previously. The reporter found on online website that they can give a patient full dose after a booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Moderna as booster which threw me for a loop/Earlier stronger reaction seems it means it's doing more for my system; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna as booster which threw me for a loop/Earlier stronger reaction seems it means it's doing more for my system) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid Vaccine-BNT162b2 (2 Dose) and Pfizer Covid Vaccine-BNT162b2 (1 Dose). Past adverse reactions to the above products included No adverse event with Pfizer Covid Vaccine-BNT162b2 and Pfizer Covid Vaccine-BNT162b2.    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 VACCINATION COMPLICATION (Moderna as booster which threw me for a loop/Earlier stronger reaction seems it means it's doing more for my system). At the time of the report, VACCINATION COMPLICATION (Moderna as booster which threw me for a loop/Earlier stronger reaction seems it means it's doing more for my system) outcome was unknown.            No concomitant product use was reported.  The patient reported had 2 Pfizer dose then Moderna as booster which threw patient for a loop. The patient was thinking to take Moderna as second booster as patient earlier had stronger reaction seems its doing more for patient system.  No treatment information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Sore left injection site arm; Greater than 35 days between primary doses of the Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A, 007B21A and 066K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between primary doses of the Moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received his second dose in his left arm shoulder muscle. The patient received his first Moderna Covid-19 vaccine booster dose on 13Apr2022.  Treatment information was unknown.   This case was linked to MOD-2022-539737 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Joint swelling, Malaise, Pain, Peripheral swelling
Clinical narrative: Arm swelling; swelling to elbow; Radiating pain to her collar bone; Low-grade fever (100F); Felt sick; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    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 PERIPHERAL SWELLING (Arm swelling), JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)). At the time of the report, PERIPHERAL SWELLING (Arm swelling) was resolving and JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 f (Low) Lowgrade fever (100F).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. No information on treatment medications was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm swelling; swelling to elbow; Radiating pain to her collar bone; Low-grade fever (100F); Felt sick; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    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 PERIPHERAL SWELLING (Arm swelling), JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)). At the time of the report, PERIPHERAL SWELLING (Arm swelling) was resolving and JOINT SWELLING (swelling to elbow), PAIN (Radiating pain to her collar bone), MALAISE (Felt sick) and PYREXIA (Low-grade fever (100F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 f (Low) Lowgrade fever (100F).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. No information on treatment medications was reported.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) in a 68-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (40 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.   Concomitant medications were not reported.  No patients have reported any adverse events to date.  Vaccines were thawed on 28-Jan-2022.  It was reported 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 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.  Treatment information was not reported.   This case was linked to MOD-2022-539815 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up information received: Added patient Information and dosage information.
Age: 38.0
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 39-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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  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.  No adverse event was reported.  No treatment medications was provided by the reporter.   This case was linked to MOD-2022-539812, MOD-2022-540812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up received contain significant information Patient Information, Dosage Information, Reporter details were updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Therapeutic response unexpected
Clinical narrative: seasonal sinus symptoms have completely resolved/typically has sinus attacks annually in April/reports that this year in 2022 the patient has not had a sinus attack.; patient was a non smoker and says he sometimes smells a cigarette ash since receiving his booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (patient was a non smoker and says he sometimes smells a cigarette ash since receiving his booster dose.) and THERAPEUTIC RESPONSE UNEXPECTED (seasonal sinus symptoms have completely resolved/typically has sinus attacks annually in April/reports that this year in 2022 the patient has not had a sinus attack.) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 025A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker. Concomitant products included CYCLOBENZAPRINE and PREDNISONE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PAROSMIA (patient was a non smoker and says he sometimes smells a cigarette ash since receiving his booster dose.). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (seasonal sinus symptoms have completely resolved/typically has sinus attacks annually in April/reports that this year in 2022 the patient has not had a sinus attack.). At the time of the report, PAROSMIA (patient was a non smoker and says he sometimes smells a cigarette ash since receiving his booster dose.) and THERAPEUTIC RESPONSE UNEXPECTED (seasonal sinus symptoms have completely resolved/typically has sinus attacks annually in April/reports that this year in 2022 the patient has not had a sinus attack.) outcome was unknown.            The patient received his booster dose in his right arm shoulder deltoid muscle.  The patient typically had sinus attacks annually in April. These attacks were so bad that the patient had a sinus surgery in 1989. About 7 years ago the patient started getting sinus attacks again each April. The patient reported that this year in 2022 the patient did not have sinus attack.  No treatment medications was reported.   This case was linked to MOD-2022-539788.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, IgA nephropathy
Clinical narrative: IgA Nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA Nephropathy) in a 57-year-old male 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 IGA NEPHROPATHY (IgA Nephropathy) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (IgA Nephropathy) 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 in patients recently vaccinated against SARS-CoV-2..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA Nephropathy) to be related.    No concomitant medication reported. No treatment medication 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 57-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected event of IgA Nephropathy, which occurred on an unknown date after the 2nd dose of mRNA-1273 vaccine. Biopsy: proven glomerular disease in patients recently vaccinated against SARS-CoV-2. No further information regarding the clinical course and treatment of the events were provided. The benefit-risk relationship of mRNA-1273 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-2022-539885, 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 literature-non-study case concerns a 57-year-old male patient with no medical history reported, who experienced the serious, due to medically significant, unexpected event of IgA Nephropathy, which occurred on an unknown date after the 2nd dose of mRNA-1273 vaccine. Biopsy: proven glomerular disease in patients recently vaccinated against SARS-CoV-2. No further information regarding the clinical course and treatment of the events were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: IgA nephropathy
Clinical narrative: IgA Nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA Nephropathy) in a 40-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 IGA NEPHROPATHY (IgA Nephropathy) (seriousness criterion medically significant). At the time of the report, IGA NEPHROPATHY (IgA Nephropathy) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA Nephropathy) to be related.    Company comment: This is a literature-non-study case concerning a 40-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event IgA nephropathy, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant and treatment medications were reported.  Glomerular disease to vaccination is rare, although it should be monitored as a potential adverse event.   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-2022-539885, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903.; Sender's Comments: Company comment: This is a literature-non-study case concerning a 40-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event IgA nephropathy, on an unknown date after receiving the second dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis rapidly progressive
Clinical narrative: Recurrence of crescentic GN; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) in a 79-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 (Recurrence of crescentic GN) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) to be related.    No concomitant and treatment medications were reported. Company comment: This literature-non-study case concerns a 79-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (reported as Recurrence of crescentic GLOMERULONEPHRITIS). No dates about the first and the second dose of mRNA-1273 vaccine, and no onset date of the event were reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 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-2022-539899, MOD-2022-539900, MOD-2022-539885, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This literature-non-study case concerns a 79-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (reported as Recurrence of crescentic GLOMERULONEPHRITIS). No dates about the first and the second dose of mRNA-1273 vaccine, and no onset date of the event were reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerulonephritis membranous
Clinical narrative: Membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:     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 MEMBRANOUS (Membranous nephropathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) to be related.    Treatment and concomitant medications were not reported.  This is a literature non-study case with reference to concerning a 54-year-old male patient with no reported medical history, who experienced the unexpected serious event of Glomerulonephritis membranous. The events was medically significant, which occurred on an unknown  date after receiving the second dose of mRNA-1273 COVID 19 Vaccine. No treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   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-2022-539900, MOD-2022-539901, MOD-2022-539885, MOD-2022-539903 (Patient Link).; Sender's Comments: This is a literature non-study case with reference to concerning a 54-year-old male patient with no reported medical history, who experienced the unexpected serious event of Glomerulonephritis membranous. The events was medically significant, which occurred on an unknown  date after receiving the second dose of mRNA-1273 COVID 19 Vaccine. No treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Glomerulonephritis membranous
Clinical narrative: Membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) in a 47-year-old male 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, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: glomerular disease (abnormal) glomerular disease.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) to be related.    No concomitant and treatment medication were reported. COMPANY COMMENT: This is a literature-non-study case concerning a 47 -years-old male patient with no clinical history reported  who experienced the unexpected  event  of GLOMERULONEPHRITIS MEMBRANOUS unknown  days after the 2nd  dose of mRNA-1273 vaccine. On an unknown date, Biopsy kidney was performed with diagnosis of abnormal glomerular disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME   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-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539885 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a literature-non-study case concerning a 47 -years-old male patient with no clinical history reported  who experienced the unexpected  event  of GLOMERULONEPHRITIS MEMBRANOUS unknown  days after the 2nd  dose of mRNA-1273 vaccine. On an unknown date, Biopsy kidney was performed with diagnosis of abnormal glomerular disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME