chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Unspecified vaccine, Dose 1), COVID-19 Vaccine (Unspecified vaccine, Dose 3 (First booster dose).), COVID-19 Vaccine (Unspecified vaccine and Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 23-Aug-2022 at 11:36 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Aug-2022 at 11:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) 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 (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment medication was reported.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) and NO ADVERSE EVENT (No adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2022 at 12:19 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022 at 12:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.) 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 (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 06-Sep-22.).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment drug details was reported.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Unspecified COVID-19 vaccine dose 2) and COVID-19 vaccine (Unspecified COVID-19 vaccine dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine.    On 23-Aug-2022 at 2:27 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Aug-2022 at 2:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) 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 (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration 23-Aug-2022, vial was removed from the freezer and placed into the refrigerator on 22-Aug-2022. The vial did not undergo any temperature excursion.    No treatment details were reported.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator; No adverse event; expired Moderna Covid-19 vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.    On 06-Sep-2022 at 10:30 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Sep-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine administered), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) 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 (expired Moderna Covid-19 vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). The vial did not undergo any temperature excursion.   No treatment details were reported.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was moved from the freezer to place in the refrigerator the day before it was used; No adverse event; Patient was administered with expired Moderna Covid-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Aug-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) 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 was administered with expired Moderna Covid-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used).    No concomitant medication were reported. The patient had received 2 covid doses plus one booster dose. Only one vial was removed from the freezer to place in the refrigerator the day before it was used i.e on 15-Aug-2022  the vial was removed from the freezer and placed in the refrigerator. The vial was initially stored in the freezer on 18-Apr-2022. The size of the vial was reported as 5.5ml. The vial had not undergone any temperature excursions. No treatment medication were reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022; No adverse event; Patient administerd expired Moderna Covid-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2022 at 11:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 11:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-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 administerd expired Moderna Covid-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022).    No concomitant medications were reported.  Patient received 2 doses of unknown manufacture and 1 booster dose.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022.  No treatment information was reported.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 1), COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 3) and COVID-19 vaccine (Unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 23-Aug-2022 at 3:46 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Aug-2022 at 3:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22) 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 (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 23-Aug-22).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered from March-2022 forward to the patient. For each vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment drug details was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt a little sick next day after receiving 2nd dose of Moderna Vaccine; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003AZIA and 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Allergic to unspecified past drug.). Concomitant products included CITALOPRAM and OMEPRAZOLE for an unknown indication.   On 19-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine). On 21-Mar-2021, ILLNESS (felt a little sick next day after receiving 2nd dose of Moderna Vaccine) had resolved.            Patient was not hospitalized for the event. It was reported that patient had taken other medication within 2 weeks of starting COVID-19 treatment. Patient received COVID-19 vaccine previously. It was reported that patient had received PAXLOVID for treatment of COVID-19 on 01-Sep-2022 and date of last administration was 06-Sep-2022. It was also reported that patient received dose 3 of Moderna vaccine on 06-Dec-2021, Batch/Lot No: 030H21B Location of injection: Arm Left. On 19-Jul-2022 patient received dose 4 of Pfizer/BioNTech vaccine, Batch/Lot No: FN2908 Location of injection: Arm Right.  No treatment medications given for the event.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Eexpired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (unspecified COVID-19 vaccine Dose 1), COVID-19 vaccine (unspecified COVID-19 vaccine Booster dose) and COVID-19 vaccine (unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 30-Aug-2022 at 3:16 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 3:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator) 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 (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Eexpired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: shoulder problems; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (shoulder problems) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (shoulder problems). At the time of the report, MUSCULOSKELETAL DISCOMFORT (shoulder problems) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient had shoulder problems after getting the Moderna vaccine.  No treatment information was provided.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored in refrigerator; No adverse event; gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 1), Covid-19 vaccine (1st booster dose), Covid-19 vaccine (Dose 3) and Covid-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Covid-19 vaccine, Covid-19 vaccine, Covid-19 vaccine and Covid-19 vaccine.    On 06-Sep-2022 at 2:33 PM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 2:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator) 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 (gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). The vial did not undergo any temperature excursion.   No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Ear infections; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infections) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. In 2022, the patient experienced EAR INFECTION (Ear infections). At the time of the report, EAR INFECTION (Ear infections) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       It was reported that patient was delivered without any congenital anomalies and achieved all the expected developmental milestones. Patient was not  hospitalized. No confirmed diagnosis of COVID-19 was reported. No new birth defects (congenital anomalies) been noted since the last study contact  Concomitant and Treatment medications were not reported.   This case was linked to MOD-2022-645983 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Patient engine was powered down; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2022, the patient experienced ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Patient engine was powered down), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient did not identified any PQC, no additional AEs and no additional information.  No treatment medication were provided.   Reporter did not allow further contact
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-SeBC p-2022/Expired vaccine stored in refrigerator; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (First dose), COVID-19 vaccine (First booster dose), COVID-19 vaccine (Third dose) and COVID-19 vaccine (Second dose). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 13-Sep-2022 at 9:24 AM, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Sep-2022 at 9:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator) 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 (Vial was expired on 13-Aug-2022, and administered to the patient on 13-Sep-2022) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 12-Sep-2022 and administered to the patient on 13-Sep-2022/Expired vaccine stored in refrigerator).    No concomitant medications were reported.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration; No adverse event; Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (unspecified COVID-19 vaccine Dose 1), COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 3, 1st Booster) and COVID-19 Vaccine (unspecified COVID-19 vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 Vaccine and COVID-19 Vaccine.    On 06-Sep-2022 at 2:34 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 2:34 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration), EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-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 PRODUCT STORAGE ERROR (Vaccine was expired on 13-Aug-2022 and was stored in refrigerator after expiration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-Aug-2022 and was administered on 06-Sep-2022).    No concomitant medications were reported.   The vaccine was delivered and placed into the freezer on 18-Apr-2022. The vial size was reported as 5.5 ml. Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022. The vial did not undergo any temperature excursion.   No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: mild reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (mild reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1 (Mild reaction)), JANSSEN COVID-19 VACCINE (First booster (Mild reaction)) and JANSSEN COVID-19 VACCINE (Dose 2 (Mild reaction)). Past adverse reactions to the above products included Vaccination adverse reaction with JANSSEN COVID-19 VACCINE, JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE.    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 IMMUNISATION REACTION (mild reaction). At the time of the report, IMMUNISATION REACTION (mild reaction) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that patient received fifth vaccine from Pfizer COVID-19 Vaccine Bivalent as booster with batch number as CJ2524. It was reported that patient had two regular Johnson and Johnson, one booster Johnson and Johnson, one booster Moderna and then 6 months later or post to 6 months later he had  yesterday the Pfizer booster.   Patient had very little reaction to the other four, hardly any but was having a very much stronger reaction with Pfizer. Patient was having a hard time standing up, pale, weak, feeling dizzy and was all sweaty as back was all sweaty.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-646090 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: very intense reactions; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (very intense reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (First dose), Johnson and Johnson vaccine (first booster dose) and Johnson and Johnson vaccine (second dose). Past adverse reactions to the above products included Vaccination adverse reaction with Johnson and Johnson vaccine, Johnson and Johnson vaccine and Johnson and Johnson vaccine.    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 IMMUNISATION REACTION (very intense reactions). At the time of the report, IMMUNISATION REACTION (very intense reactions) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that patient received fifth vaccine from Pfizer COVID-19 Vaccine Bivalent as booster with batch number as CJ2524. It was reported that patient had two regular Johnson and Johnson, one booster Johnson and Johnson, one booster Moderna and then yesterday the Pfizer booster.   No treatment medications were provided by the reporter.   This case was linked to MOD-2022-646083 (Patient Link).
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick after each dose; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick after each dose) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after each dose). At the time of the report, ILLNESS (Sick after each dose) outcome was unknown.            No concomitant medication information was provided.  The patient was sick after each dose of vaccine for at least 3 or 4 days, especially the first dose.   All the doctors told the patient that too many antibodies were present in the body and they explained it more technically but all said that the patient had too many antibodies when took the shots.  One physician said that the patient should report this to the department that deals with side effects of the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-646124 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: fever; sore injection site arm; red spot at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020, Back surgery and Knee surgery NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection). In 2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE ERYTHEMA (red spot at the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 degrees Fahrenheit and 103 degrees Fahrenheit.   The patient received the first vaccine in left arm deltoid muscle. The patient did have fevers of 102 degrees Fahrenheit and 103 degrees Fahrenheit and she cannot remember which Fever occurred after each of the first two doses. Patient did not remember which arm that patient received the second vaccine in. Patient was on several medications and did not wish to discuss patient medications.   This case was linked to MOD-2022-646131, MOD-2022-646134 (Patient Link).
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022; No adverse event; Patient administered expired Moderna COVID-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Unspecified COVID-19 Vaccine Dose 1), COVID-19 Vaccine (Unspecified COVID-19 Vaccine, First Booster Dose) and COVID-19 Vaccine (Unspecified COVID-19 Vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 06-Sep-2022 at 3:17 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 3:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-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 expired Moderna COVID-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 06-Sep-2022 vial was placed into refrigerator on 05-Sep-2022.  NDC of vial was 8077727310.  No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: patient had a large hard reddening on her right arm./area was big 5 inches; patient had a large hard reddening on her right arm./area was big 5 inches; fever for 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in March 2020, Knee operation and Back surgery.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days). At the time of the report, VACCINATION SITE INDURATION (patient had a large hard reddening on her right arm./area was big 5 inches), VACCINATION SITE ERYTHEMA (patient had a large hard reddening on her right arm./area was big 5 inches) and PYREXIA (fever for 3 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 102 102 degrees Farenheight..         Concomitant medications were not reported.  The patient received her first booster dose on 29-Oct-2021 lot number 012F21A expiration date is 19-Jan-2022 The patient received this booster in her right arm. The patient reports a fever of 102 degrees Farenheight. The patient had a large hard reddening on her right arm. The area was big 5 inches .Fever lasted for 3 days.  Patient is on several and did not wish to discuss her medications.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-646120, MOD-2022-646134 (Patient Link).