chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was stored in the refrigerator the day before administration; expired doses administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  Patient received the first booster dose of Moderna vaccine on 04-Apr-2022 (Expiry date: 02-Apr-2022).   It was reported that, the vials was initially stored in refrigerator a day before the administration and vials did not undergo any temperature excursions. The patient had not reported any adverse reactions to the dose.   No information on treatment medications was reported.   This case was linked to MOD-2022-558954 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Live follow up received contain no new information
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration; expired dose administered on 06-APR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received first booster dose of Moderna vaccine on 06-Apr-2022.    Concomitant medication information was not provided.    The vial was initially stored in the refrigerator on 05-Apr-2022.    The healthcare provider had a lot number of the vial which they thought expired at a different time. However, when the healthcare provider entered the lot number on Moderna's online expiration tool look up, it was found that the lot had expired on 02-Apr-2022.    The healthcare provider reported that each patient was administered with the dose from a different vial and each of the vial was stored in the refrigerator on the day before administration.    The vial did not undergo any temperature excursions. It was reported that the patient had not reported of experiencing any adverse reactions to this expired dose.    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Live Follow up received contained non significant information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea
Clinical narrative: COVID-19; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and COVID-19 (COVID-19) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q16M20A) for COVID-19 vaccination.    Co-suspect product included non-company product (PAXLOVID) for COVID-19 treatment.    The patient did not have any allergy to drug.  Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (The patient had previously received a COVID-19 Vaccine.). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.   In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022, the patient started. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, DIARRHOEA (Diarrhea) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information was provided.  The administration time of Moderna vaccine was 12:15 P.M.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 03-May-2022.  No treatment information was provided.  company comment:  This case concerns an 89-year-old female patient, with no relevant medical history and concurrent conditions, who experienced, unexpected, non-serious, of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving an unknown dose of mRNA-1273 vaccine approximately 9 months before receiving the third dose of mRNA-1273 vaccine.  No information was provided regarding the second dose of mRNA-1273.  Approximately 6 months after vaccination, the patient was started with (Paxlovid) on an unknown dose and frequency.  The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This case concerns an 89-year-old female patient, with no relevant medical history and concurrent conditions, who experienced, unexpected, non-serious, of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a third dose.  The patient reported receiving an unknown dose of mRNA-1273 vaccine approximately 9 months before receiving the third dose of mRNA-1273 vaccine.  No information was provided regarding the second dose of mRNA-1273.  Approximately 6 months after vaccination, the patient was started with (Paxlovid) on an unknown dose and frequency.  The outcome of the event was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Had COVID) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced COVID-19 (Had COVID). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE in March 2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Had COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took three full doses of Moderna.  The name of the monoclonal antibodies was unknown company comment:This Spontaneous case concerns a 74-year-old, male patient underlying medical history of immunodeficiency and Crohn's disease, who experienced the unexpected, non serious  AESI event of COVID 19, approximately 6 months  after receiving a dose of mRNA-1273 as third dose of COVID-19 Vaccine. It was reported that patient received monoclonal antibodies granulocyte at the time of the event COVID-19. The clinical course  was not provided in the case. The patient's  advanced age and underling medical history of immunodeficiency and Crohn's disease may be considered as  risk factors for the event of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 74-year-old, male patient underlying medical history of immunodeficiency and Crohn's disease, who experienced the unexpected, non serious  AESI event of COVID 19, approximately 6 months  after receiving a dose of mRNA-1273 as third dose of COVID-19 Vaccine. It was reported that patient received monoclonal antibodies granulocyte at the time of the event COVID-19. The clinical course  was not provided in the case. The patient's  advanced age and underling medical history of immunodeficiency and Crohn's disease may be considered as  risk factors for the event of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.; Patients received expired Moderna Covid-19 vaccine for their booster doses; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, o32F21A, 017C212A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired Moderna Covid-19 vaccine for their booster doses) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 04-MAY-2022 and then administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No side effects or adverse events were known for 1st and 2nd (primarydose) and 1st booster dose. Vial did not undergo any temperature excursions. It was reported that 4 doses were given on 04-May-2022 and 1 dose was given on 05-May-2022 No treatment information was provided.   This case was linked to MOD-2022-560262, MOD-2022-561458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received updated No New Information
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: felt crappy; fatigued; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported no side effects after dose 1.  The next day after dose 2 the patient was fatigued, felt crappy and had a headache. It was stated that, events fatigued, and headache did not cause patient to seek medical care. Treatment medications were not provided.   This case was linked to MOD-2022-560438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: The follow up information received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Achiness; headache; felt wiped out for a week; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Achiness), HEADACHE (headache) and FATIGUE (felt wiped out for a week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 046B21A and 018B21A) for COVID-19 vaccination.     Allergies (medications, food and other products) information of the patient was unknown and it was also unknown if the patient ever had COVID positive test or diagnosis. Acute and Chronic illnesses at the time of vaccination was unknown.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PAIN (Achiness), HEADACHE (headache) and FATIGUE (felt wiped out for a week). At the time of the report, PAIN (Achiness) and FATIGUE (felt wiped out for a week) had resolved and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication of the patient was not reported.  The events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was reported that symptoms of headache was improved.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-560437 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Upon follow-up, MI source document was received. Reporter details (occupation and reporter type) and event onset dates for all the events were updated and reporter phone number was added.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: traditional fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     Patient other concurrent condition included Age related eye disease, No change in status reported. Patient has never been diagnosed or tested positive for COVID-19. Other vaccines given within one month or prior to Moderna COVID-19 vaccine was reported as unknown.  Concurrent medical conditions included Osteoarthritis (Started 10 to 12 years ago or longer. condition worsening), Coronary artery disease (No change in status reported .), Depression (No change in status reported .) and Immunosuppression NOS (Immunologically suppressed, No change in status reported .). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN D NOS and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021, the patient experienced FATIGUE (traditional fatigue) and MYALGIA (muscle soreness). At the time of the report, FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medications included Areds eye vatamins, Two fish oils, Vitamin B and folic acid. No treatment medication information provided.   This case was linked to MOD-2022-560464, MOD-2022-560462, MOD-2022-560457 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscular weakness, Myalgia
Clinical narrative: traditional fatigue; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     Patient other concurrent condition included Age related eye disease, No change in status reported. Patient has never been diagnosed or tested positive for COVID-19. Other vaccines given within one month or prior to Moderna COVID-19 vaccine was reported as unknown.  Concurrent medical conditions included Osteoarthritis (Started 10 to 12 years ago or longer. condition worsening), Coronary artery disease (No change in status reported .), Depression (No change in status reported .) and Immunosuppression NOS (Immunologically suppressed, No change in status reported .). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN D NOS and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021, the patient experienced FATIGUE (traditional fatigue) and MYALGIA (muscle soreness). At the time of the report, FATIGUE (traditional fatigue) and MYALGIA (muscle soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medications included Areds eye vatamins, Two fish oils, Vitamin B and folic acid. No treatment medication information provided.   This case was linked to MOD-2022-560464, MOD-2022-560462, MOD-2022-560457 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Myalgia
Clinical narrative: stayed in bed for a full day; whole-body aches; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (stayed in bed for a full day) and MYALGIA (whole-body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011821A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (10 to 12 years ago or longer, worsening), Coronary artery disease (Recent change in status such as improvement or worsening: No change reported), Depression (Recent change in status such as improvement or worsening: No change reported), Eye abnormality (Recent change in status such as improvement or worsening: No change reported) and Immunocompromised (Recent change in status such as improvement or worsening: No change reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), DULOXETINE HYDROCHLORIDE (CYMBALTA), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), VITAMIN D3, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL and CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 + FOLIC ACID) for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, the patient experienced BEDRIDDEN (stayed in bed for a full day) and MYALGIA (whole-body aches). At the time of the report, BEDRIDDEN (stayed in bed for a full day) and MYALGIA (whole-body aches) had not resolved.            It was reported that patient had taken all four shots and every shot had a reaction and the reactions were getting worse and worse after each dose. Patient symptoms had worsened. The patient was concerned saw her physician yesterday (05-May-2022). Patient never had Covid  positive  test or diagnosis. No treatment information provided.   This case was linked to MOD-2022-560464, MOD-2022-560462, MOD-2022-560454 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine moved from freezer to fridge on 6-May-2022 with expiration date of 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Vaccine moved from freezer to fridge on 06-May-2022. No adverse events were noted. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Worse side effects after first booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Worse side effects after first booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse side effects after first booster). At the time of the report, IMMUNISATION REACTION (Worse side effects after first booster) outcome was unknown.            No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 expired doses of moderna covid-19 vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP states that when they received the shipment a expiration date of 25 May 2022 was entered into the system.. The actual expiration date was 05 May 2022. Vial was stored in freezer and taken out of freezer on 06 May 2022. Vial did not undergo any temperature excursions. Patient was given 1st booster dose. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were stored in the freezer before administration; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Doses were stored in the freezer before administration) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Doses were stored in the freezer before administration. One dose was administered on 26-Nov-2021  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 05 May 2022 stored in freezer and taken out of freezer on 06May2022 and was administered on 06 May 2022; 2 expired doses of moderna covid-19 vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 05 May 2022 stored in freezer and taken out of freezer on 06May2022 and was administered on 06 May 2022) and EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 05 May 2022 stored in freezer and taken out of freezer on 06May2022 and was administered on 06 May 2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 05 May 2022 stored in freezer and taken out of freezer on 06May2022 and was administered on 06 May 2022) and EXPIRED PRODUCT ADMINISTERED (2 expired doses of moderna covid-19 vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported patient received 1st booster. Vials was stored in freezer and taken out of freezer on 06May2022. Vials did not undergone any temperature excursions. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  The vial were stored in the freezer before administration.  No treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The doses were administered past expiration. It was reported that the doses were stored in the freezer before administration. The vaccine was expired on 09-Nov-2021.  No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 09-Nov-2021 and was administered on 04-Jan-2022 past expiration, doses were stored in the freezer before administration; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 04-Jan-2022 past expiration, doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 04-Jan-2022 past expiration, doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 04-Jan-2022 past expiration, doses were stored in the freezer before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  On 04-Jan-2022, patient received a dose (lot no: 048C21A) of Moderna vaccine (Expiry date: 09-Nov-2021)  No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine expired on 09-Nov-2021 and stored in freezer before administration and administered on 19-Jan-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that the doses were stored in the freezer before administration. One dose was administered on 05-Mar-2022. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 29-Mar-2022 past expiration, doses were stored in the freezer before administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration; Received vaccine that expired on 10-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine that expired on 10-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 10-Mar-2022 and was administered on 23-Mar-2022 past expiration, doses were stored in the freezer before administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received a full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a full dose instead of a booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received a full dose instead of a booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Patient received a full dose instead of a booster dose) outcome was unknown.    No concomitant medication information was reported.  The patient was about to get the second booster dose. The patient was wondering if it would be appropriate to get the second booster dose or not.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Dose Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vaccine was continuously stored in stable freezer environment. It was only stored in fridge on date of administration for thaw period. No treatment medications were reported.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nine year old twin grand daughters. They have been vaccinated with the first two shots; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nine year old twin grand daughters. They have been vaccinated with the first two shots) in a 9-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nine year old twin grand daughters. They have been vaccinated with the first two shots). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Nine year old twin grand daughters. They have been vaccinated with the first two shots) outcome was unknown.     Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-561278 (Patient Link).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nine year old twin grand daughters. They have been vaccinated with the first two shots; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots) in a 9-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (nine year old twin grand daughters. They have been vaccinated with the first two shots) outcome was unknown.            No concomitant medication was provided.  Reporter stated that, nine year old twin grand daughters had been vaccinated with the first two shots but so far there is no booster for 5-11 year old's. It was very concerning as by now the protection from the first two shots was waning.  No treatment information was provided.   This case was linked to MOD-2022-561278, MOD-2022-561266 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a booster dose of the Moderna Covid-19 vaccine on 04-May-2022 lot number which was expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid-19 vaccine on 04-May-2022 lot number which was expired on 03-May-2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid-19 vaccine on 04-May-2022 lot number which was expired on 03-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid-19 vaccine on 04-May-2022 lot number which was expired on 03-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Information on first two doses was unknown. Patient received a booster dose of the expired Moderna Covid-19 vaccine. It was not known which booster dose the patient received and also not known which arm the injection was received in. No other side effects or adverse events were known. No treatment medications were reported.   This case was linked to MOD-2022-561462, MOD-2022-560262, MOD-2022-561464, MOD-2022-560259 (Patient Link).