chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. AR4504B and 056M21A) for COVID-19 vaccination. Patient had no known allergies. It was unknown if patient ever had COVID positive test or diagnosis.  On 06-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 05-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 05-Aug-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient inadvertently given dose from different age group.). No concomitant medications were reported. It was unknown if other vaccines given within 1 month prior to Moderna vaccine. It was reported that 18yr old patient was inadvertently given 0.5mL dose from a purple vial Lot number AR4504B, which was slated for 6-11 year old age group and 18 plus booster dose. No treatment medications were reported.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: little cranky after 1st dose; pain at the injection site after 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: IPV on 22-Jul-2022, HEPB on 22-Jul-2022 and PCV13 on 22-Jul-2022. Past adverse reactions to the above products included No adverse event with HEPB, IPV and PCV13.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose). At the time of the report, FEELING ABNORMAL (little cranky after 1st dose) and VACCINATION SITE PAIN (pain at the injection site after 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided. Patient height was reported as 3 feet. Patient had no history of Myocarditis/pericarditis No treatment medication was provided.   This case was linked to MOD-2022-623915 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (have no energy at all), FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 082B22A, 068H21A, 012M20A and 013L20A) for COVID-19 vaccination. It was unknown if the patient had any allergies to medications, food, and other products.  It was unknown if the patient ever had COVID positive test or diagnosis.  It was unknown if patient had medical history relating to mentioned Adverse event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2022, the patient experienced ASTHENIA (have no energy at all), FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever). At the time of the report, ASTHENIA (have no energy at all) outcome was unknown and FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever) had not resolved. No concomitant medications were reported. On 05-Aug-2022 morning, the patient felt out of it and had felt out of it all day. The patient had no energy at all and had nausea and a little fever. It was reported that the patient didn't experience any side effects after first, second and first booster dose. It was unknown if the patient had experienced similar adverse events in the past. The adverse events didn't cause the patient to seek medical care. Reportedly, the symptoms after the second booster dose worsened. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Temperature excursions duration 7 days/ the vial undergo temperature excursions; No adverse event; Dose administered after exposure to room temperature >24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions).    It was unknown that other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.   It was unknown that patient received any concomitant and treatment medication.  It was unknown that patient received a full dose for primary series or a booster dose. Number of doses/vials were 1 dose from 1 vial.  It was unknown when the vial was initially stored in the refrigerator. It was reported that vial undergone temperature excursion for 7 days. Storage condition at the time of the excursion was room temperature.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous case was reported by a dietician and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccine site look too low/Appears it is outside of the deltoid area). No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient experienced diarrhea after 3rd booster dose; Patient received 3 booster doses instead of 2 because she was immunocompromised; received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Wegeners granulomatosis (Wegener's vasculitis).   On 04-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series). At the time of the report, DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series) outcome was unknown.            Information about allergies was Unknown. It was reported that the patient was Immunocompromised and that was why she received 2 full doses of primary series and three booster doses after primary series to be protected. Patient received third dose of vaccine due to the condition of Wegener's vasculitis. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-624057 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient experienced diarrhea after 3rd booster dose; Patient received 3 booster doses instead of 2 because she was immunocompromised; received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Wegeners granulomatosis (Wegener's vasculitis).   On 04-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series). At the time of the report, DIARRHOEA (Patient experienced diarrhea after 3rd booster dose), EXTRA DOSE ADMINISTERED (Patient received 3 booster doses instead of 2 because she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series) outcome was unknown.            Information about allergies was Unknown. It was reported that the patient was Immunocompromised and that was why she received 2 full doses of primary series and three booster doses after primary series to be protected. Patient received third dose of vaccine due to the condition of Wegener's vasculitis. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-624057 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: immunocompromised patient received booster dose instead of Third dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Wegener's granulomatosis (patient was 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported that, the patient was immunocompromised and hence patient received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series, to be protected.  No treatment medications were reported.   This case was linked to MOD-2022-624050 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: immunocompromised patient received booster dose instead of Third dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Wegener's granulomatosis (patient was 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (immunocompromised patient received booster dose instead of Third dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported that, the patient was immunocompromised and hence patient received 2 full shots of Moderna COVID-19 Vaccine and 3 booster doses after the primary series, to be protected.  No treatment medications were reported.   This case was linked to MOD-2022-624050 (Patient Link).   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna dose administered to patient after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration).    It was reported that patient received second booster. Concomitant drugs were not reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). No concomitant medications were reported. Reporter declined to provide patient identifiers for the 4th patient, stating that she already had a follow up form for them. No treatment  medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic itching after booster vaccination; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (Systemic itching after booster vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Systemic itching after booster vaccination). At the time of the report, PRURITUS (Systemic itching after booster vaccination) outcome was unknown.     Concomitant product use was not provided by the reporter.  The patient experienced systemic itching after booster vaccination. The booster recipient was taking medication on a regular basis for treatment at the time of report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and UNDERDOSE (Patient recieved 0.25mL dose) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 08-Jul-2022, the patient experienced UNDERDOSE (Patient received 0.25mL dose). In July 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). In 2022, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, UNDERDOSE (Patient received 0.25mL dose) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product use was reported. The patient experienced a sore arm after this injection which has resolved after an unknown duration. Patient had not taken any additional doses, medications, or treatments at this time.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.; No Adverse reaction; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 02-Aug-2022.).    No concomitant medication was reported.  It was reported that the vial was initially stored in the refrigerator on 30-Jun-2022.  Patient had received Second booster.  Vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on 01AUG2022). No concomitant medications were provided by the reporter. The vial was initially stored in the refrigerator on 30-Jun-2022 and Dates of administration of vaccine was given as 01-Aug-2022, 02-Aug-2022, & 05-Aug-2022.The vial  did not undergo any temperature excursions. No treatment medications were provided by the reporter. It was unknown whether the patient experienced a similar event in the past. It was unknown whether patient seek medical care.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022; No adverse event; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered vaccine on 05-Aug-2022).    No concomitant product use was reported.  Patient had received Second booster.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired first dose after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry).    No concomitant medications were reported. No treatment details were reported. Number of doses from vial was 1 dose from 1 vial. The vial was initially stored in the refrigerator on 08-Aug-2022 The vial did not undergo any temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: Purpura, Rash
Clinical narrative: skin rashes similar to purpuric skin rash in the palm, in the hands, parts of stomach, thigh and in the legs; skin rash in the palm, in the hands; skin rashes...parts of stomach; skin rashes...thigh and in the legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 18:45 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN B12 [CYANOCOBALAMIN]; COD LIVER OIL [COD-LIVER OIL]; VITAMIN K2 MK7. Vaccination history included: BNT162b2 (DOSE 3, SINGLE; Lot No: FD0810; Injection site: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: 22Oct2021, when the patient was 58-year-old, for COVID-19 immunisation; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rash in the palm, in the hands"; PURPURA (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes similar to purpuric skin rash in the palm, in the hands, parts of stomach, thigh and in the legs"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes...parts of stomach"; RASH (non-serious) with onset 23Jul2022, outcome "not recovered", described as "skin rashes...thigh and in the legs". Therapeutic measures were taken as a result of purpura, rash, rash, rash.  Additional information: The patient did not receive any other vaccines within 4 weeks. No covid prior vaccination and no covid tested post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 rebound infection after Paxlovid treatment; COVID-19 rebound infection after Paxlovid treatment; COVID-19 rebound infection after Paxlovid treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 rebound infection after Paxlovid treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "COVID-19 rebound infection after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 rebound infection after Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of interchange of vaccine products.  Clinical course: It was reported that if vaccine received: Yes. Other medication in 2weeks: Yes. Other medication in 2weeks product=Novolog insulin. Known allergies: Sulfa. Other medical history: Type 1 diabetes, COVID treatment: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 15:30 as dose 1, single (Lot number: EP7534), in right arm and on 06Apr2021 as dose 2, single (Lot number: ER8737) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 939905), in right arm and on 16Jun2022 at 16:00 as dose 4 (booster), single (Lot number: 048L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "no smoking" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022, outcome "recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (04Aug2022) Negative, notes: I've tested Negative for covid today. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID-19 treatment with Antiviral Paxlovid (Lot: 1918528A) from 29Jul2022 to 03Aug2022. Patient had just turned 65 and was very healthy and active. No smoking, drinking or drugs. No known allergies. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201038139 Same patient, different product and event;
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: 1st dose Pfizer COVID-19 Vaccine: Her issue is she can't see; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: ER9331) at the age of 85 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN (E.C.) taken for cardiac disorder; METOPROLOL taken for cardiac disorder. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "1st dose Pfizer COVID-19 Vaccine: Her issue is she can't see". The action taken for BNT162b2 was dosage not changed.  Additional Context: Warm transfer from (name) with Agency. Consumer online states she got the Pfizer COVID-19 Vaccine 2nd booster. After the booster shot, she was completely paralyzed for 24 hours and was unable to walk for 3 weeks.  Caller clarifies details provided by transfer agent. She has been talking to the medical people. She had the 2nd virus shot and within the 24hours she was completely paralyzed and couldn't do anything, not crawl or go to the door. The facility she is living was taking her temperature and said go and get the nurse. She couldn't get to the door, and she got the ambulance and took her to the hospital where she was told she had rhabdomyolysis. This is where her body shoots poison into her body and muscles. She has no problem and in medical report. She was asking her doctor for a bed to put her feet up to get her blood and oxygen flowing to her heart and brain and wrote to the legal department and realized she doesn't know if she needs to report this. She doesn't know how long it's going to be and never sent this report to the legal department. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 09:00 as dose number unknown,single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Overweight" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive other medication in two weeks. Paxlovid (anti-viral) treatment started on 28Jul2022 and stopped on 01Aug2022. It's been two days after ending isolation. She have mild sore throat, nausea, vomiting and diarrhea. She did not receive treatment for AE and it was unknown if patient recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "DM2" (unspecified if ongoing), notes: Other medical history: DM2 (diabetes mellitus 2); "HTN" (unspecified if ongoing), notes: Other medical history: HTN (Hypertension); "HLD" (unspecified if ongoing), notes: Other medical history: HLD (hyperlipidemia); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE; OZEMPIC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) positive, notes: tested positive on 18Jul2022; (01Aug2022) positive, notes: She tested positive again on 01Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. She received Losartan, levothyroxine, Ozempic medication in 2weeks. Her Symptoms started 15Jul2022 and she tested positive on 18Jul2022. She took Paxlovid and she felt better for the time she was on it. Then her symptoms started coming back again. She tested positive again on 01Aug2022. She received Paxlovid as treatment for COVID 19 Treatment and Treatment started on 18Jul2022 and stopped on 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4390940-00 (Agency).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER8733), on 08Nov2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure and covid-19 (treatment with Paxlovid from 22Jul2022 to 27Jul2022).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19/tested positive after testing negative several times; COVID-19/tested positive after testing negative several times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER, start date: 04Jun2022, stop date: 16Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022 at 18:00, outcome "recovering" and all described as "COVID-19/tested positive after testing negative several times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Pfizer Paxlovid as treatment (Treatment start date: 25Jul2022, Treatment stop date: 30Jul2022, lot number: GC9452, as reported).