chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Drug name was not mentioned.).    On 23-Dec-2021, 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). At the time of the report, COVID-19 (Covid-19) was resolving.            No concomitant medication was reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient received unspecified treatment of COVID-19 from 20 May 2022 to 25 May 2022, causing rebound infection of Covid-19 and symptoms on 29-May-2022.  This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The outcome of the event was reported as resolving. The initial date of COVID-19 diagnosis and the result of the SARS-CoV-2 test is not provided. Patient received unspecified treatment of COVID-19 for duration of 6 days, and reported rebound infection of COVID-19 and symptoms 4 days after the end of treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The ongoing COVID-19 pandemic could be a confounder for the event. The outcome of the event was reported as resolving. The initial date of COVID-19 diagnosis and the result of the SARS-CoV-2 test is not provided. Patient received unspecified treatment of COVID-19 for duration of 6 days, and reported rebound infection of COVID-19 and symptoms 4 days after the end of treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was moved in to fridge on 17-May-2022 and was admininstered on 17-May-2022/expired vaccine was stored and then administered; 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 (Vial was moved in to fridge on 17-May-2022 and was admininstered on 17-May-2022/expired vaccine was stored and then administered) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     It was reported that patient no allergies and symptoms.  Previously administered products included for Drug use for unknown indication: Janssen (Dose 1 and Lot no: 1805031) on 09-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 02-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 (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 (Vial was moved in to fridge on 17-May-2022 and was admininstered on 17-May-2022/expired vaccine was stored and then administered). 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 (Vial was moved in to fridge on 17-May-2022 and was admininstered on 17-May-2022/expired vaccine was stored and then administered) outcome was unknown.        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 vial did not undergo any temperature excursions. It was reported that patient had not tested positive for COVID-19. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID 19) 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 Penicillin allergy.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient took unknown  medicine for COVID-19 treatment from 31-May-2022 to 01-Jun-2022.  The patient reported Lower abdominal pain from 31-May-2022 to 01-Jun-2022 which was resolved .  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with lower abdominal pain and started an unspecified COVID-19 treatment for 2 days. No SARS-CoV-2 test result was provided. No information was provided on the previous 3 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with lower abdominal pain and started an unspecified COVID-19 treatment for 2 days. No SARS-CoV-2 test result was provided. No information was provided on the previous 3 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 25.0
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 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083J21A) for COVID-19 vaccination.     Patient had no known drug allergies.     On 17-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The health care professional (HCP) stated that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had expired for 2 weeks. The HCP explained that since the expiration date was not written on the vial, they did not notice that 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. Treatment information was not provided.
Age: 45.0
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; administered the Moderna COVID-19 vaccine 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 the Moderna COVID-19 vaccine 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 45-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 083J21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy to antibiotic (Sulfa).   On 19-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks). 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 (administered the Moderna COVID-19 vaccine 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: positive (Positive) Positive.  For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported.   The reporter reported that since the expiration date was not written on the vial they did not noticed that the vaccine had already expired. The vial did not undergo any temperature excursions. The patient did not report any side effects.  No treatment information was provided by the reporter.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received Moderna vaccine that had been expired for 2 weeks; 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) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 083J21A) for COVID-19 vaccination.     The patient had no known drug allergy (NKDA). The patient was not had positive for COVID-19.    On 17-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 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). 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) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was reported that since the expiration date was not written on the vial, thus it was 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 medications were reported.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, 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; Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022; 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), PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Patient do not have any allergies.    On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received on 17-May-2022). 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), PRODUCT STORAGE ERROR (vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received was on 22-Feb-2022 , while dose 2 received 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials: 26 doses some were primary doses and some boosters .  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.  Reporter stated that none of them had reported side effects.  No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid-19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Melanoma and Anxiety. Concurrent medical conditions included Migraine with aura, Premature ventricular contractions (PVCs), Penicillin allergy and Drug allergy (Neosporin).    On 11-Nov-2021, 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 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  On 23-May-2022 patient experienced Horrible taste and rebound COVID. At the time of the report, Horrible taste and COVID-19 was resolving.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Company comment- This spontaneous case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected AESI COVID-19. A dose of mRNA-1273 vaccine, given as a third dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event. Patient was treated with Paxlovid for 5 days, it was reported patient had a horrible taste and rebound COVID. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected AESI COVID-19. A dose of mRNA-1273 vaccine, given as a third dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event. Patient was treated with Paxlovid for 5 days, it was reported patient had a horrible taste and rebound COVID. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received booster for third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose) outcome was unknown.            No concomitant medications details were reported.  The patient stated that his wife had two Moderna vaccines and first Moderna booster. He noticed that there was a third Moderna shot for immunocompromised. He was wondering that she should forego her second booster and get the Moderna immunocompromised shot.  No treatment medications details were reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, 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; Received the Moderna Covid 19 vaccine after manufacturer date of expiry; second dose was adminstered after 2 months 25 day; 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), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Azithromycin allergy), Drug allergy (Amoxicillin allergy), Drug allergy (Codeine allergy), Drug allergy (Promethazine allergy), Drug allergy (sulfa allergy), Iodine contrast media allergy (intravenous pyelogram (IVP) dye allergy), Drug allergy (Keflex allergy) and Allergy to NSAIDs.   On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day). 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), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 2 months 25 day) 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, Patient was not positive for covid-19.     For mRNA-1273 (Spikevax) (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.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error, SARS-CoV-2 test
Clinical narrative: Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses; Dose 1 was administered on 22-Feb-2022 and dose 2 was administered 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/Patient Administered Expired Doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022) and PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies (NKDA).    On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (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/Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid 19 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 (Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022) and PRODUCT STORAGE ERROR (Moderna Covid 19 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 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Number of doses/vials: 26 doses some were primary doses and some boosters  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: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error, SARS-CoV-2 test
Clinical narrative: Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022; Dose 1 administered on 22 Feb 2022 and Dose 2 administered 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), PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 22 Feb 2022 and Dose 2 administered on 17 May 2022) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Lidocaine), Drug allergy (Lamictal) and Drug allergy (Effexor).   On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 22 Feb 2022 and Dose 2 administered on 17 May 2022). On an unknown date, the patient experienced 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), PRODUCT STORAGE ERROR (Vaccine had been expired for 2 weeks and stored in fridge on 17 May 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 22 Feb 2022 and Dose 2 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: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was found out that the administered vaccine had been expired for 2 weeks. The HCP mentioned that since the expiration date was not written on the vial, they did not notice it had already expired. It was unknown when the vial was initially stored in the refrigerator. On 17-May-2022, the vial was stored in the refrigerator and the vial did not undergo any temperature excursions. The patient did not report any side effects. No treatment information was provided.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, 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; First dose on 22-Feb-2022 and second dose 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), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose on 17-May-2022) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (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) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose on 17-May-2022). 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), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-Feb-2022 and second dose 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 (Spikevax) (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: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: vaccine had been expired for 2 week and stored in refrigerator on 17-May-2022; Received first dose on 15-Mar-2022 and second dose 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), EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose on 17-May-2022) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Bactrim).   On 15-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Spikevax), 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) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose 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), EXPIRED PRODUCT ADMINISTERED (Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 15-Mar-2022 and second dose on 17-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   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 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Currently on Day 4 of confirmed covid.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Currently on Day 4 of confirmed covid.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 02-Dec-2021 at 3:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced COVID-19 (Currently on Day 4 of confirmed covid.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 30-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Currently on Day 4 of confirmed covid.) was resolving.        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 patient stomach bile taste in her mouth from the drug made her feel so gross she started to regurgitate. Couldn't get past it. Patient Did feel an improvement in covid symptoms and currently on Day 4 of confirmed covid. Company comment: This spontaneous case of concerns a 41-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the booster dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment approximately 4 months after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case of concerns a 41-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event was reported with no onset date; hence, latency to the booster dose of mRNA-1273 vaccine cannot be assessed. No details of previous doses were provided. As per source document, she received Paxlovid as COVID-19 treatment approximately 4 months after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Headache, Immunisation reaction, Pain
Clinical narrative: couple other things for a few days; she had felt some more achy; headache; non immunocompromised patient received full 3rd dose instead of half; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy), HEADACHE (headache) and ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 007M20A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concurrent medical conditions included Atrial fibrillation, Flutter atrial, Mitral regurgitation and Sleep apnea.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half). On an unknown date, the patient experienced IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy) and HEADACHE (headache). At the time of the report, IMMUNISATION REACTION (couple other things for a few days), PAIN (she had felt some more achy) and HEADACHE (headache) had resolved and ACCIDENTAL OVERDOSE (non immunocompromised patient received full 3rd dose instead of half) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wanted to know whether the patient was eligible for 2nd booster shot or not and was concerned  to get it since got the full dose as 1st booster shot.  The patient was not taking any medications or treatments.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Follow-up document received includes significant information; patient demographics, suspect vaccine details and additional events were added.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered; Expired Moderna doses given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) and PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) and PRODUCT STORAGE ERROR (Lot expired on April 2022 and vial was initially stored in the refrigerator on 02-Jun-2022 then administered) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. It was reported that HCP was unclear/unsure which doses these were only that they were boosters. On 02-Jun-2022, Vial was initially stored in the refrigerator. It was reported that vial did not undergo any temperature excursions.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna doses given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Dose number was reported as booster dose. It was reported that health care professional was unclear which doses these were only that they were boosters. Treatment details was not reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: Felt like fever but its normal 98.6F; Shoulder hurts; Gave her chills; headache; Arm hurt where she got the vaccine left arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Lot number ET7534, 1st dose, intramuscular route) on 22-Mar-2021, Pfizer Biontech Covid-19 vaccine (Lot number EW0151, 2nd dose) on 12-Apr-2021, Pfizer Biontech Covid-19 vaccine (Lot number 300308D and booster dose) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine, Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 05-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2022, the patient experienced FEELING ABNORMAL (Felt like fever but its normal 98.6F). 05-Jun-2022, the patient experienced ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm). At the time of the report, FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive (Positive) Positive. On 05-Jun-2022, Body temperature: 98.6 (normal) 98.6 F which was normal.         Patient had no allergy or acute or chronic condition at time of vaccination. Patient weight was 177.  No concomitant medication was reported by reporter.  Patient got 2nd booster.  Events did not cause patient to seek medical care. Patient had experienced similar event in past for one Pfizer.  No treatment medication was reported by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Felt like fever but its normal 98.6F; Shoulder hurts; Gave her chills; headache; Arm hurt where she got the vaccine left arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine (Lot number ET7534, 1st dose, intramuscular route) on 22-Mar-2021, Pfizer Biontech Covid-19 vaccine (Lot number EW0151, 2nd dose) on 12-Apr-2021, Pfizer Biontech Covid-19 vaccine (Lot number 300308D and booster dose) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine, Pfizer Biontech Covid-19 vaccine and Pfizer Biontech Covid-19 vaccine.    On 05-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2022, the patient experienced FEELING ABNORMAL (Felt like fever but its normal 98.6F). 05-Jun-2022, the patient experienced ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm). At the time of the report, FEELING ABNORMAL (Felt like fever but its normal 98.6F), ARTHRALGIA (Shoulder hurts), CHILLS (Gave her chills), HEADACHE (headache) and VACCINATION SITE PAIN (Arm hurt where she got the vaccine left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive (Positive) Positive. On 05-Jun-2022, Body temperature: 98.6 (normal) 98.6 F which was normal.         Patient had no allergy or acute or chronic condition at time of vaccination. Patient weight was 177.  No concomitant medication was reported by reporter.  Patient got 2nd booster.  Events did not cause patient to seek medical care. Patient had experienced similar event in past for one Pfizer.  No treatment medication was reported by reporter.