chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022; Administered dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The vial did not undergone any temperature excursions.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; Expired Moderna Covid-19 vaccine adminsitered on 13May2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine adminsitered on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Number of doses reported were 9 doses, (3 of 0.5mL and 6 doses of 0.25mL booster).  Date of refrigeration was reported as 12-May-2022.  No temperature excursions were reported.No treatment medication was reported.   This case was linked to MOD-2022-568784 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in refrigerator on 12-May-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Moderna Covid-19 Vaccine Administered; The vaccine was moved from freezer to refrigerator the day before administration.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccine was moved from freezer to refrigerator the day before administration.) and EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 Vaccine Administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (The vaccine was moved from freezer to refrigerator the day before administration.). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 Vaccine Administered). On 29-Oct-2021, PRODUCT STORAGE ERROR (The vaccine was moved from freezer to refrigerator the day before administration.) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 Vaccine Administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022; We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. The vial did not undergone any temperature excursions.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vial was initially stored in the refrigerator 12-May-2022. The vial did not undergo any temperature excursions. Reporter asked whether patients needs to be revaccinated. No treatment were reported.   This case was linked to MOD-2022-568784 (Patient Link).
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022; Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reporter asked whether patients needs to be revaccinated. The vial did not undergone any temperature excursions. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Crying, Fatigue, Headache
Clinical narrative: weakness in legs, a little energy to shuffle around, lack of energy, weakness; extreme anxiety; crying of despair; Feeling shaky; headache; fatigue, intense fatigue; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (First dose.), Pfizer (First Booster Dose) and Pfizer (Second dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.   On 09-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In May 2022, the patient started VILAZODONE HYDROCHLORIDE (VIIBRYD) (unknown route) Viibryd thirty. On 10-May-2022, the patient experienced HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea). On 12-May-2022, the patient experienced ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair) and NERVOUSNESS (Feeling shaky). At the time of the report, ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky), HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea) had not resolved.            No concomitant product was provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness
Clinical narrative: weakness in legs, a little energy to shuffle around, lack of energy, weakness; extreme anxiety; crying of despair; Feeling shaky; headache; fatigue, intense fatigue; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (First dose.), Pfizer (First Booster Dose) and Pfizer (Second dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.   On 09-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In May 2022, the patient started VILAZODONE HYDROCHLORIDE (VIIBRYD) (unknown route) Viibryd thirty. On 10-May-2022, the patient experienced HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea). On 12-May-2022, the patient experienced ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair) and NERVOUSNESS (Feeling shaky). At the time of the report, ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky), HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea) had not resolved.            No concomitant product was provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site discolouration, Vaccination site mass
Clinical narrative: grey red mark, hard lump below deltoid; grey red mark, hard lump below deltoid; injected into interstitial tissue and not IM; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (grey red mark, hard lump below deltoid), VACCINATION SITE MASS (grey red mark, hard lump below deltoid) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected into interstitial tissue and not IM) 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 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 VACCINATION SITE DISCOLOURATION (grey red mark, hard lump below deltoid), VACCINATION SITE MASS (grey red mark, hard lump below deltoid) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected into interstitial tissue and not IM). At the time of the report, VACCINATION SITE DISCOLOURATION (grey red mark, hard lump below deltoid), VACCINATION SITE MASS (grey red mark, hard lump below deltoid) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected into interstitial tissue and not IM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypokinesia, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: feel like he had the flu; He was achy; couldn't really move much; felt like everything was heavy; had to get up out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (feel like he had the flu), PAIN (He was achy), HYPOKINESIA (couldn't really move much), DISCOMFORT (felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to get up out of bed) outcome was unknown.            The reporter declined date of birth of the patient.  No concomitant drug was reported.  Dates of administration and lot numbers were unknown.  After 12 hours of the second dose the patient experienced adverse event.  Next morning on an unknown date of events occurred, patient took Ibuprofen.   This case was linked to MOD-2022-568876 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-Apr-2022 to 02-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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) positive antigen test. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative after Paxlovid tx. Started mild symptoms at day 14 on 11-May-2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that on unknown date patient experienced COVID with symptoms SOB, congestion, coughing, fatigue after receiving dose 3 of moderna vaccine.  The device date was reported as 15-May-2022.  Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider.  Company comment:This spontaneous case concerns a 30 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient developed shortness of breath, congestion, cough and fatigue. She was treated with Paxlovid and tested negative for COVID-19. Then she started having mild symptoms and subsequently tested positive for COVID-19 antigen test. The event was resolving. No information on the details pertaining to primary doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient developed shortness of breath, congestion, cough and fatigue. She was treated with Paxlovid and tested negative for COVID-19. Then she started having mild symptoms and subsequently tested positive for COVID-19 antigen test. The event was resolving. No information on the details pertaining to primary doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ATORVASTATIN for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Apr-2022 to 02-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Developed symptoms again and tested positive. The patient race was reported as Caucasian. No medical history information for patient was reported. It was reported that the patient was taking any other medication or product within two weeks of starting COVID-19 treatment. It was further reported that the patient started Paxlovid (treatment medication) three days after the first positive test. The patient felt better soon after taking it. The patient was fully recovered from the first round of COVID within a week. Five days later the patient developed symptoms again and tested positive. The patient had tested positive for four days now. Company comment: This spontaneous case concerns a 43-year-old female with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) 5 months and 6 days after vaccination with a third dose of mRNA-1273. 3 days after testing positive for Covid-19, the patient started taking Paxlovid and recovered within a week. 5 days later, she again developed symptoms tested positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 43-year-old female with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) 5 months and 6 days after vaccination with a third dose of mRNA-1273. 3 days after testing positive for Covid-19, the patient started taking Paxlovid and recovered within a week. 5 days later, she again developed symptoms tested positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  Concurrent medical conditions included Sulfonamide allergy and Lyme disease.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-Dec-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series). At the time of the report, BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  Concurrent medical conditions included Sulfonamide allergy and Lyme disease.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-Dec-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In May 2022, the patient experienced BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series). At the time of the report, BALANCE DISORDER (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) and DIZZINESS (lightheadedness affecting balance. Began on day 3 of Paxloivd series, continuing now 2 days after completion of series) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial did not undergo any temperature excursions. Concomitant drugs were not reported.  Treatment details were not given.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was exposed to room temperature for 73-74 hours; The vial was first punctured on 13-May-2022 and administered on 16-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022 at 9:28 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 9:28 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that a vial of Moderna vaccine was punctured on 13-May-2022 and it was pulled out on 16-May-2022 and punctured to administer a few doses. On 13-May-2022, the vial was initially stored in the refrigerator. On 13-May-2022 at 08:00 AM time, the vial was first punctured. The vaccine was administered on 16-May-2022 at 9:28 AM Pacific time to the patient. The vial was stored in the room temperature post puncture. Reportedly, the vial didn't undergo any temperature excursions and the total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was 73-74 hours.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Fibrin D dimer, Gait inability, Laboratory test, Pain
Clinical narrative: Clots are being made and destroyed at a faster rate; Couldn't walk; Severe pain; This spontaneous case was reported by a nurse and describes the occurrence of COAGULOPATHY (Clots are being made and destroyed at a faster rate), GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    Concurrent medical conditions included Blood pressure high (1.5 years ago) and Coronary artery disease (1.5 years ago). Concomitant products included METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. and ATORVASTATIN CALCIUM (LIPITOR) (unknown route) Stopped the Lipitor for one month and restarted. In October 2021, the patient experienced GAIT INABILITY (Couldn't walk) and PAIN (Severe pain). On an unknown date, the patient experienced COAGULOPATHY (Clots are being made and destroyed at a faster rate). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 1 dosage form. At the time of the report, COAGULOPATHY (Clots are being made and destroyed at a faster rate) outcome was unknown and GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Fibrin D dimer: 1.31 (High) D-Dimer lab value was elevated. Hematologist stated there may be a connection to the elevated D-Dimer lab value and the Moderna vaccine.. In October 2021, Laboratory test: used to identify dvt's used to identify a clotting Disorder (DVT's).. In October 2021, Ultrasound scan: to rule out blood clots To rule out blood clots.. In November 2021, Fibrin D dimer: 1.06 (High) 1.06.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COAGULOPATHY (Clots are being made and destroyed at a faster rate) to be related. No further causality assessments were provided for GAIT INABILITY (Couldn't walk) and PAIN (Severe pain).    This case was linked to MOD-2022-568930 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Clots are being made and destroyed at a faster rate; Couldn't walk; Severe pain; This spontaneous case was reported by a nurse and describes the occurrence of COAGULOPATHY (Clots are being made and destroyed at a faster rate), GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    Concurrent medical conditions included Blood pressure high (1.5 years ago) and Coronary artery disease (1.5 years ago). Concomitant products included METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. and ATORVASTATIN CALCIUM (LIPITOR) (unknown route) Stopped the Lipitor for one month and restarted. In October 2021, the patient experienced GAIT INABILITY (Couldn't walk) and PAIN (Severe pain). On an unknown date, the patient experienced COAGULOPATHY (Clots are being made and destroyed at a faster rate). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at a dose of 1 dosage form. At the time of the report, COAGULOPATHY (Clots are being made and destroyed at a faster rate) outcome was unknown and GAIT INABILITY (Couldn't walk) and PAIN (Severe pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Fibrin D dimer: 1.31 (High) D-Dimer lab value was elevated. Hematologist stated there may be a connection to the elevated D-Dimer lab value and the Moderna vaccine.. In October 2021, Laboratory test: used to identify dvt's used to identify a clotting Disorder (DVT's).. In October 2021, Ultrasound scan: to rule out blood clots To rule out blood clots.. In November 2021, Fibrin D dimer: 1.06 (High) 1.06.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COAGULOPATHY (Clots are being made and destroyed at a faster rate) to be related. No further causality assessments were provided for GAIT INABILITY (Couldn't walk) and PAIN (Severe pain).    This case was linked to MOD-2022-568930 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrinolysis increased
Clinical narrative: increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).; This spontaneous case was reported by a nurse and describes the occurrence of FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 022M20A and 042L20A) for COVID-19 vaccination.     Patient allergies included: None; nothing severe. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient not had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high (1.5 years ago (No change)) and Coronary artery disease (1.5 years ago (No change)). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.   On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).). At the time of the report, FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Fibrin D dimer: 1.69 (High) 1.69. In February 2022, Fibrin D dimer: 1.35 (High) 1.35. In March 2022, Fibrin D dimer: 1.38 (High) 1.38. In April 2022, Fibrin D dimer: 0.88 (High) 0.88.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FIBRINOLYSIS INCREASED (increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).) to be related.    On 01-Dec-2021, the patient received a first booster dose (Lot: 027H21B) of Moderna vaccine.  Reporter stated that her hematologist stated there may be a connection to the elevated D-Dimer lab value and the Moderna vaccine. She reported the Moderna vaccine may have increased the fibrin activity where clots are being made and destroyed at a faster rate (abnormal activity).  No treatment medication was reported.   This case was linked to MOD-2022-568897 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid symptoms reappeared and I retested positive for; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid symptoms reappeared and I retested positive for) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Type 2 diabetes mellitus.   On 22-Apr-2022 at 3:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 04-May-2022 at 7:00 PM, the patient experienced COVID-19 (Covid symptoms reappeared and I retested positive for). At the time of the report, COVID-19 (Covid symptoms reappeared and I retested positive for) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment drug were reported.  COMPANY COMMENT: This is a spontaneous case concerning a 47 -years-old male patient, with no relevant medical history, who experienced unexpected non serious EVENT OF covid-19, which occurred 12 days after fourth dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 4- may-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47 -years-old male patient, with no relevant medical history, who experienced unexpected non serious EVENT OF covid-19, which occurred 12 days after fourth dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 4- may-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses of the Moderna COVID-19 vaccine was administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Additional information stated by the HCP was that that their facility had an error where 5 doses of the Moderna. COVID-19 vaccine was administered after the expiration date of 25-MAR-2022.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022; 5 doses administered to patients after Moderna vaccine expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the vial was initially stored in the refrigerator on 02-May-2022. The vial did not undergo any temperature excursions.  The patient did not had any adverse reactions.  No treatment information was provided.