chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 4-FEB-2021 and second dose on 24-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 4-FEB-2021 and second dose on 24-MAR-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Penicillin allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 4-FEB-2021 and second dose on 24-MAR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 4-FEB-2021 and second dose on 24-MAR-2021) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.   This case was linked to MOD-2022-582887 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 18 years old/17 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old) in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Drug allergy. Concomitant products included TESTOSTERONE for an unknown indication.    On 02-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 years old/17 years old) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No other vaccines given within one month prior to Moderna COVID-19 vaccine. The patient was going through a gender change from female to male. An adult was considered 19 years old. Health care professional got parental consent from the patient's mom and administered the vaccine. Then health care professional found out that the patient was under 18 years old. Patient stayed for 30 minutes and had no reaction. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions; administration after 45 hours excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) and EXPIRED PRODUCT ADMINISTERED (administration after 45 hours excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration after 45 hours excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions). On 02-May-2022, EXPIRED PRODUCT ADMINISTERED (administration after 45 hours excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the product was administered after having been exposed to 45 hours of out-of-range temps reaching a max of 13.4 C. The date the vial was initially stored in the refrigerator was reported as unknown. It was reported that provider removed vials from freezer as needed, stored in the refrigerator and did not mark BUD date or keep vaccine tracking records. It was reported that freezer was exposed to excursions but the provider contacted and indicated the vaccine was considered viable.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-583493 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Follow-up received updated start date of Moderna Vaccine, event verbatim and event start date.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-583493:MOD-2022-583493 (same reporter case)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of Covid per antigen test after taking Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of Covid per antigen test after taking Paxlovid) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L214) for COVID-19 vaccination.     Concomitant products included DUTASTERIDE (AVODART) from 01-Jan-2018 to 01-Jun-2022 for an unknown indication.    On 16-Mar-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022 at 12:00 PM, the patient experienced COVID-19 (Rebound of Covid per antigen test after taking Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. On 02-Jun-2022, COVID-19 (Rebound of Covid per antigen test after taking Paxlovid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 Rebound of COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment and also received a COVID-19 Vaccine previously. It was reported as Rebound of COVID per antigen test after taking Paxlovid. Device Date was reported as 02 Jun 2022.  No treatment information was reported. COMPANY COMMENT: This is an spontaneous case concerning an 75-year-old male patient with  medical history of Concomitant products included DUTASTERIDE and PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 (AESI) 73 days after  4th dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 75-year-old male patient with  medical history of Concomitant products included DUTASTERIDE and PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 (AESI) 73 days after  4th dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain in the neck; Patient was not able to move her neck; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain in the neck) and MUSCULOSKELETAL STIFFNESS (Patient was not able to move her neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced NECK PAIN (Pain in the neck) and MUSCULOSKELETAL STIFFNESS (Patient was not able to move her neck). At the time of the report, NECK PAIN (Pain in the neck) and MUSCULOSKELETAL STIFFNESS (Patient was not able to move her neck) had not resolved.            No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 7008121001) for COVID-19 vaccination.     The patient's past medical history included Nephrolithiasis. Concurrent medical conditions included Hyperlipidemia, Osteoarthritis, Enlarged prostate and Drug allergy (Sulfa allergy).    On 29-Oct-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Reporter reported that on 1-JUN-2022 at 20:00, the patient had rebound of COVID-19 symptoms six days after the completion of Paxlovid treatment.  Device Date: 01Jun2022 Company comment: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, there was no information provided regarding the initial two doses. Patient was started on treatment regimen of Paxlovid on May 22-26, 2022, six days after completion of the treatment, patient experienced rebound symptoms of COVID-19. Details of concomitant medications, clinical course and outcome were not provided. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of onset of the event was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, there was no information provided regarding the initial two doses. Patient was started on treatment regimen of Paxlovid on May 22-26, 2022, six days after completion of the treatment, patient experienced rebound symptoms of COVID-19. Details of concomitant medications, clinical course and outcome were not provided. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID on 28-DEC-2021 and 15-FEB-2022.; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     The patient had no allergies.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Dec-2021, the patient experienced COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Positive for COVID on 28-DEC-2021 and 15-FEB-2022.) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 15-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was reported.  Company comment: This case concerns a 44-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 9 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-583164 (Patient Link).; Sender's Comments: This case concerns a 44-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 9 months after the second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 076C21A, 026L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Clonidine Hcl), Drug allergy (Diltiazem Hcl), Drug allergy (Tramadol), Drug allergy (Nitrofuran Derivatives), Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Cephalosporins).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial they had not noticed it had already expired. Date the vial was initially stored in the refrigerator: 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials: 26 doses. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: immunocompromised patient received half a dose for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received half a dose for third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-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. On 29-Oct-2021, the patient experienced UNDERDOSE (immunocompromised patient received half a dose for third dose). At the time of the report, UNDERDOSE (immunocompromised patient received half a dose for third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 083J21A) for COVID-19 vaccination.     Patient had No known drug allergies. Patient was not tested Positive for COVID-19.  Previously administered products included for Drug use for unknown indication: J & J (Patient received 1st dose of JNJ and Lot number is 1805031) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with J & J.   On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) 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. Number of doses/vials were 26 doses.  The reporter reported that, found out that the vaccine had been expired for 2 weeks and the expiration date was not written on the vial and did not noticed it had already expired. The vaccine stored in fridge on 17-May-2022. The vials did not undergo any temperature excursion.  No treatment medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: lingering muscle weakness; pain in her arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm) 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 MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm). At the time of the report, MUSCULAR WEAKNESS (lingering muscle weakness) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient was experiencing the events since receiving the COVID vaccine (many month ago, the patient did not report whether it was from Pfizer or Moderna). The negative experience had prevented the patient from getting her child vaccinated, Patient reported symptoms to primary care physician, but was dismissed.  No treatment medication was provided.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Expired vaccine was stored in refrigerator on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Primary dose and lot number; 1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Latex allergy, Penicillin allergy (Allergy to PCN) and Drug allergy (Allergy to IBU and Zoloft).   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired.  On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  The patient did not report any side effects.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Penicillin allergy.    On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) rebound infection indicated by symptom return and home antigen testing.         No concomitant medication was reported.  It was reported that patient had not taking any other medications within 2 weeks of starting COVID-19 treatment. Hospitalization prolonged reported as no  Treatment received reported as no.  Company Comment:  This is a spontaneous case concerning a 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately one month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient took a five-day-course of COVID-19 treatment for the initial COVID-19 infection. However, six days after the completion of COVID-19 treatment, patient reported returned of symptoms and rebound infection, which was supported by a positive COVID-19 antigen test. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately one month after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient took a five-day-course of COVID-19 treatment for the initial COVID-19 infection. However, six days after the completion of COVID-19 treatment, patient reported returned of symptoms and rebound infection, which was supported by a positive COVID-19 antigen test. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022; Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 083J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary dose (Dose 1) and lot number; 1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired. On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Received the Moderna COVID 19 vaccine after manufacturer date of expiry; Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: J&J. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Drug allergy (Hydrocodone), Drug allergy (Morphine) and Drug allergy (codeine).   On 14-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired.  On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  The patient did not report any side effects.  No treatment medications were reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Not known drug allergies.  Previously administered products included for COVID-19 vaccination: J&J (Dose one Lot number: 1805031) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was found out that the vaccine had been expired for 2 weeks  It was reported that since the expiration date was not written on the vial they did not noticed it had already expired.  On an unknown date the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  The vaccine stored in fridge on 17-May-2022.  No treatment drugs were reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, RA and Drug allergy (Unknown drug). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-May-2022 to 01-Jun-2022 for an unknown indication.    On 29-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive after testing negative 5 days after stopping treatment.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. Device Date: 01-Jun-2022  Company comment: This case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. Patient received NIRMATRELVIR, RITONAVIR as treatment which resulted in a positive COVID-19 test 5 days after testing negative with new onset of COVID-19 symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. Patient received NIRMATRELVIR, RITONAVIR as treatment which resulted in a positive COVID-19 test 5 days after testing negative with new onset of COVID-19 symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Expired vaccine was stored in refrigerator on 17-May-2022; Patient received an expired vaccine on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 076C21A, 006D21A and 025B21A) for COVID-19 vaccination.     No known drug allergies were reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states that, they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The reporter explains that since the expiration date was not written on the vial, they did not notice it had already expired. Date the vaccine was stored in fridge on 17-May-2022 and the vial did not undergo any temperature excursions. The patient did not report any side effects. No treatment medications were reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Patient received vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     No known allergies were reported.  Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 Vaccine (Lot no-1805031 and First dose.) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID-19 Vaccine.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that Moderna Covid 19 vaccine was administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The reporter explains that since the expiration date was not written on the vial, they did not notice it had already expired. On 17-May-2022, the vial was stored in fridge.  The vial did not undergo any temperature excursions.  Reporter stated that none of them had reported side effects.  No treatment information was reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, SARS-CoV-2 test
Clinical narrative: Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose and Lot no. 1805031) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Latex allergy.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials were 26 doses. The reporter reported that, the expiration date was not written on the vial and did not noticed it had already expired.  The vaccine stored in fridge on 17-May-2022. The vials did not undergo any temperature excursion.  No treatment medications were reported.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022; Patient Administered Expired Doses; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 006D21A and 939906) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prozac).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022). At the time of the report, PRODUCT STORAGE ERROR (vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022) and EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patent's date of birth was reported as 3/85/1999. No concomitant medication information was provided.  The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial, they had not noticed it had already expired. The vaccine was stored in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials are 26 doses No treatment medication information was given.