chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Hypertension and Anxiety.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat). At the time of the report, COVID-19 (Test it positive for covid19 on a home test,she was very sick,cough,very bad sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 on a home test.         It was reported that patient received either first or second booster dose. Concomitant medications include blood pressure medication, anxiety medications. Patient didn't experience fever. No treatment details were reported. Company comment-This Spontaneous case concerns a 76-year-old, female patient with relevant medical history of immunocompromised status reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 7 days after receiving a dose of mRNA-1273 Vaccine.  It was reported that patient was very sick with cough and sore throat a week after vaccination. No further details on clinical course, other lab test results and treatment received were reported. No details provided regarding the initial vaccination schedule. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19, elderly age and relevant medical history could be confounding factors for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 76-year-old, female patient with relevant medical history of immunocompromised status reported, who experienced non serious unexpected AESI event of COVID 19 (with a positive SARS-CoV-2 test), 7 days after receiving a dose of mRNA-1273 Vaccine.  It was reported that patient was very sick with cough and sore throat a week after vaccination. No further details on clinical course, other lab test results and treatment received were reported. No details provided regarding the initial vaccination schedule. At the time of the reporting, outcome of the event was unknown. Current pandemic situation of COVID 19, elderly age and relevant medical history could be confounding factors for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-542606, MOD-2022-542616 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Grip strength decreased, Inappropriate schedule of product administration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: I can still barely move my right arm/I couldn't even hold my coffee cup this morning; She says that she thinks it has something to do with the muscle; started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning), GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle), VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Depression. Concomitant products included ESCITALOPRAM for Depression.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning) and VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck). 05-Oct-2021, the patient experienced GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning), GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle) and VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  It was reported that patient had never been diagnose with COVID.  Symptoms were stable, however some days it's really bad was reported.   This case was linked to MOD-2022-542592.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: I can still barely move my right arm/I couldn't even hold my coffee cup this morning; She says that she thinks it has something to do with the muscle; started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning), GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle), VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Depression. Concomitant products included ESCITALOPRAM for Depression.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning) and VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck). 05-Oct-2021, the patient experienced GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I can still barely move my right arm/I couldn't even hold my coffee cup this morning), GRIP STRENGTH DECREASED (She says that she thinks it has something to do with the muscle) and VACCINATION SITE PAIN (started aching straight after shot/this one didn't go away/today my arm is sore from injection site all the way up to my neck) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  It was reported that patient had never been diagnose with COVID.  Symptoms were stable, however some days it's really bad was reported.   This case was linked to MOD-2022-542592.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Retching, Weight decreased
Clinical narrative: dry heaves; lost 37 pounds; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), WEIGHT DECREASED (lost 37 pounds) and NAUSEA (nauseated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (diabetic for 4 or 5 years.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseated). On an unknown date, the patient experienced RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds). The patient was treated with ONDANSETRON for Dry heaves, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds) outcome was unknown and NAUSEA (nauseated) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported. Patient has never had Covid.   This case was linked to MOD-2022-542685, MOD-2022-542686 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Endoscopy, Gastrointestinal disorder
Clinical narrative: dry heaves; lost 37 pounds; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), WEIGHT DECREASED (lost 37 pounds) and NAUSEA (nauseated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (diabetic for 4 or 5 years.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseated). On an unknown date, the patient experienced RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds). The patient was treated with ONDANSETRON for Dry heaves, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves) and WEIGHT DECREASED (lost 37 pounds) outcome was unknown and NAUSEA (nauseated) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported. Patient has never had Covid.   This case was linked to MOD-2022-542685, MOD-2022-542686 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Retching, Weight decreased
Clinical narrative: memory loss/doesn't remember grocery shopping after getting the booster dose; endoscopy finding of black fluid & garbage floating in her stomach; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (since 4 or 5 years.) and Nauseated (She is still nauseated to this day.) since 03-Mar-2021.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach). The patient was treated with ERYTHROMYCIN at a dose of for a month to 6 weeks. At the time of the report, AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: abnormal black fluid & garbage floating in her stomach.         She never had Covid. The treatment with erythromycin started due to endoscopy findings which were black fluid & garbage floating in her stomach. No concomitant medication reported.   This case was linked to MOD-2022-542581, MOD-2022-542685 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Endoscopy, Gastrointestinal disorder
Clinical narrative: memory loss/doesn't remember grocery shopping after getting the booster dose; endoscopy finding of black fluid & garbage floating in her stomach; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (since 4 or 5 years.) and Nauseated (She is still nauseated to this day.) since 03-Mar-2021.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach). The patient was treated with ERYTHROMYCIN at a dose of for a month to 6 weeks. At the time of the report, AMNESIA (memory loss/doesn't remember grocery shopping after getting the booster dose) and GASTROINTESTINAL DISORDER (endoscopy finding of black fluid & garbage floating in her stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: abnormal black fluid & garbage floating in her stomach.         She never had Covid. The treatment with erythromycin started due to endoscopy findings which were black fluid & garbage floating in her stomach. No concomitant medication reported.   This case was linked to MOD-2022-542581, MOD-2022-542685 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 1st shot hurt for a couple of days/some soreness with the 1st dose of the Moderna vaccine which lasted for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (1st shot hurt for a couple of days/some soreness with the 1st dose of the Moderna vaccine which lasted for a couple of days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient neither had COVID positive test nor COVID diagnosis. The patient did not receive other vaccines which were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (most narcotic medications) and Depression. Concomitant products included ESCITALOPRAM for Depression.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Aug-2021, the patient experienced PAIN (1st shot hurt for a couple of days/some soreness with the 1st dose of the Moderna vaccine which lasted for a couple of days). On 28-Aug-2021, PAIN (1st shot hurt for a couple of days/some soreness with the 1st dose of the Moderna vaccine which lasted for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2022-542579 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema
Clinical narrative: Red spot lower than injection site/good sized red spot; Injection was at a lower site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot lower than injection site/good sized red spot) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection was at a lower site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced VACCINATION SITE ERYTHEMA (Red spot lower than injection site/good sized red spot) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection was at a lower site). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot lower than injection site/good sized red spot) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection was at a lower site) outcome was unknown.      Suspect product dose number was 2nd booster dose of Moderna COVID-19 vaccine.  No concomitant medication reported.  It was reported that patient did not bleed and was not feeling well from other doses and did not have a problem with the first dose.  No treatment information was provided.   This case was linked to MOD-2022-542716 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast mass, Chemotherapy, HER2 positive breast cancer
Clinical narrative: 3 months after receiving the Johnson and Johnson vaccine in my right arm, I noticed a lump in my right breast. After scheduling an appointment with my OBGYN, he was unable to determine the type of lump and suggested I get a mammogram. The mammogram showed a mass that was examined closer on ultra-sound; these images presented a need for a biopsy and that result proved I had invasive lobular breast cancer. I was diagnosed on 6/21 and I have been receiving treatments for HER2+ since August 10, 2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Invasive lobular breast carcinoma, Mammogram abnormal, Mastectomy, Radiotherapy, Ultrasound breast abnormal
Clinical narrative: 3 months after receiving the Johnson and Johnson vaccine in my right arm, I noticed a lump in my right breast. After scheduling an appointment with my OBGYN, he was unable to determine the type of lump and suggested I get a mammogram. The mammogram showed a mass that was examined closer on ultra-sound; these images presented a need for a biopsy and that result proved I had invasive lobular breast cancer. I was diagnosed on 6/21 and I have been receiving treatments for HER2+ since August 10, 2021.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder for 3-5 days after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder for 3-5 days after previous doses) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN from 10-Apr-2022 to an unknown date for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder for 3-5 days after previous doses). At the time of the report, ARTHRALGIA (sore shoulder for 3-5 days after previous doses) outcome was unknown.            Patient's height was reported as 5 foot 11 inches  No treatment details were reported. Patient started Rivaroxaban 15 mg twice daily for 30 days and will take 20 mg for another 30 days and re-evaluated. It was reported that patient had Sore shoulders for 3-5 days, after Moderna shots .   This case was linked to MOD-2022-542545 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: sore shoulder for 3-5 days after previous doses; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder for 3-5 days after previous doses) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN from 10-Apr-2022 to an unknown date for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder for 3-5 days after previous doses). At the time of the report, ARTHRALGIA (sore shoulder for 3-5 days after previous doses) outcome was unknown.            Patient's height was reported as 5 foot 11 inches  No treatment details were reported. Patient started Rivaroxaban 15 mg twice daily for 30 days and will take 20 mg for another 30 days and re-evaluated. It was reported that patient had Sore shoulders for 3-5 days, after Moderna shots .   This case was linked to MOD-2022-542545 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the second booster dose of the Moderna Covid 19 vaccine 4 days after its expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 vaccine 4 days after its expiration date) in a 69-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 vaccine 4 days after its expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the second booster dose of the Moderna Covid 19 vaccine 4 days after its expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on concomitant medication but does not specified in which medication. Patient had not reported any side effects after receiving the vaccine. No treatment information was provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19, TTOX
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Received vaccine with expired BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product TETANUS VACCINE for an unknown indication.    It was reported that patient had not been diagnosed with/tested positive for COVID-19. It was reported that patient had no acute illnesses at the time of vaccination and upto one month before.  Concurrent medical conditions included Drug allergy (Cefdinir), Drug allergy (Codeine), Drug allergy (Doxycycline Hyclate), Drug allergy (Erythromycin), Drug allergy (Lamictal), Drug allergy (Lisinopril), Drug allergy (Lithium Carbonate), Drug allergy (Peniillin drugs), Drug allergy (Tramadol), Drug allergy (Wellbutrin), Drug allergy (Amitriptyline), Type 2 diabetes mellitus (No recent change), Bipolar disorder (No recent change), Major depression (No recent change), Hyperlipidemia (No recent change) and Asthma (No recent change.). Concomitant products included ATORVASTATIN, CELECOXIB (CELEBREX), GABAPENTIN and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 05-Apr-2022, the patient received dose of TETANUS VACCINE (Intramuscular) 1 dosage form. On 05-Apr-2022 at 10:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Apr-2022 at 10:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication included Ability 30 mg/daily by oral route of administration. It was reported that vial was initially stored in refrigerator between 2-8 degree Celsius on 18-Feb-2022. It was reported that vial did not undergo any temperature excursions. It was reported that patients did not have any symptoms or side effects. It was reported that this was patient's first moderna booster dose. No treatment medications were reported.   This case was linked to MOD-2022-536509.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Administered after the 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. Patient had no known drug allergy and also the patient did not have any acute illness at the time of vaccination and up to one month before. Patient had never been diagnosed with/tested positive for COVID-19.  Concurrent medical conditions included Paroxysmal atrial fibrillation (No recent change), Depression (No recent change) and Monoclonal B-cell lymphocytosis (No recent change). Concomitant products included FLECAINIDE ACETATE, PAROXETINE, LISINOPRIL, METOPROLOL SUCCINATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 08-Apr-2022 at 8:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Apr-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered after the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) and PRODUCT STORAGE ERROR (Administered after the 30 day use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine with expired BUD) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Administered after the 30 day use by date). The by use date of vaccine was labelled as 18-Mar-2022. On 18-Feb-2022, the vial was initially stored in refrigerator. The vaccine was stored in refrigerator between 2-8 degree Celsius and there was no temperature excursion. No symptoms or side effects were reported by the patient. The event did not cause patient to seek medical care. The reporter did not report any other potential causes. It was unknown if patient experience similar events in the past. No additional doses treatments or medications have been administered in response. This case was linked to MOD-2022-536509 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, TD
Symptoms: Expired product administered
Clinical narrative: Vaccine given past the use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given past the use by date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TETANUS DIPHTHERIA) for an unknown indication.    It was unknown patient had ever being diagnosed with/ tested positive for COVID-19. Patient had no allergies to medications, food, and other products. Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Type 2 diabetes mellitus, Hypothyroidism and Asthma. Concomitant products included SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, LEVOTHYROXINE for Hypothyroidism, ALPRAZOLAM, ESCITALOPRAM, RIZATRIPTAN BENZOATE (MAXALT), VALACICLOVIR HYDROCHLORIDE (VALTREX) and ATORVASTATIN CALCIUM for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022 at 9:53 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TETANUS DIPHTHERIA) (Intramuscular) 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given past the use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given past the use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Anatomical location for the booster dose was reported as right deltoid.  The use by date listed was on 18-Mar-2022.  Vial was initially stored in the refrigerator on 18-Feb-2022 and it was reported that the vial did not undergo ay temperature excursion.  No treatment medication were provided.   This case was linked to MOD-2022-536509 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel well from other doses; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well from other doses) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel well from other doses). At the time of the report, MALAISE (did not feel well from other doses) outcome was unknown. Concomitant medication information was not provided by the reporter. She did not had any problem with the first dose. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-542593 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 6-Aug-2021 , second dose 31-oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There were none acute illness at the time of vaccination and up to one month before. There were none chronic or long lasting health conditions.  Concurrent medical conditions included Allergy (Allergy to E-cigs). Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX) for an unknown indication.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 6-Aug-2021 , second dose 31-oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: 22 weeks pregnant; Expired dose administered; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) had resolved and EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. It was reported, the vial was initially stored in the refrigerator on 14-Apr-2022 and the vial underwent no temperature excursions  Company comment: This is a spontaneous case concerning a 22 year-old, female patient with no reported medical history. Maternal exposure during pregnancy and Expired product administered (the second dose expired two days prior to administration) were reported in the case. The patient received the second dose of mRNA-1273 vaccine at 22 weeks gestation. No adverse events were reported. No information regarding first dose was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 22 year-old, female patient with no reported medical history. Maternal exposure during pregnancy and Expired product administered (the second dose expired two days prior to administration) were reported in the case. The patient received the second dose of mRNA-1273 vaccine at 22 weeks gestation. No adverse events were reported. No information regarding first dose was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a second shot earlier than normal; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     Patient had no past medical history.    On 22-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second shot earlier than normal) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient had no side effects. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Conversion disorder, Expired product administered, Product storage error
Clinical narrative: Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022; administered with expired vaccine; Hysterical; This spontaneous case was reported by a nurse and describes the occurrence of CONVERSION DISORDER (Hysterical), EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. In April 2022, the patient experienced CONVERSION DISORDER (Hysterical). On 18-Apr-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022). At the time of the report, CONVERSION DISORDER (Hysterical), EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Initial date the vial was stored in the refrigerator is 20Jan2022, vaccine expired on 16Apr2022 and expired on 18Apr2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. The reporter reported that the vial did not undergo any temperature excursions. No treatment medication reported.   This case was linked to MOD-2022-543460 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the Moderna Covid 19 vaccine from a vial that had already expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) in a female patient of an unknown age 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 EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.     Vaccine expiration date: 02-Apr-2022.   This case was linked to MOD-2022-543435 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vomiting
Clinical narrative: after the first dose she had body aches; fatigue; fever; through up for two day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21a) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any acute illnesses or chronic conditions at time of vaccination.  Previously administered products included for Product used for unknown indication: Flu shot (bit more dramatic). Past adverse reactions to the above products included Vaccination adverse reaction with Flu shot. Concurrent medical conditions included Penicillin allergy.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day). In 2021, VOMITING (through up for two day) had resolved. At the time of the report, PAIN (after the first dose she had body aches), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. Patient did not receive medical care. No treatment medication were provided. The patient stated that she did not got covid, because of the Moderna covid19 vaccine, and everything that happened with her was all broadly publicated online.   This case was linked to MOD-2022-543456, MOD-2022-543457 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: after the first dose she had body aches; fatigue; fever; through up for two day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21a) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any acute illnesses or chronic conditions at time of vaccination.  Previously administered products included for Product used for unknown indication: Flu shot (bit more dramatic). Past adverse reactions to the above products included Vaccination adverse reaction with Flu shot. Concurrent medical conditions included Penicillin allergy.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (after the first dose she had body aches), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (through up for two day). In 2021, VOMITING (through up for two day) had resolved. At the time of the report, PAIN (after the first dose she had body aches), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. Patient did not receive medical care. No treatment medication were provided. The patient stated that she did not got covid, because of the Moderna covid19 vaccine, and everything that happened with her was all broadly publicated online.   This case was linked to MOD-2022-543456, MOD-2022-543457 (Patient Link).