chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: itching in the hip area; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching in the hip area) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 Vaccine.  Concurrent medical conditions included Schizoaffective disorder (unspecified medication). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In September 2022, the patient experienced PRURITUS (itching in the hip area). At the time of the report, PRURITUS (itching in the hip area) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Historical drug was reported as Fle. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (Issues with her mind come and go/Mind is not right, getting into arguments, and fighting/ Unable to hold down a job/ Anger is not controllable) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The patient was not well since after receiving the second shot of primary series.  Patients anger was not controllable and unable to hold down a job. The treatment medication was not reported.  Company comment: This spontaneous case concerns a female patient of unspecified age, with no medical history reported, who experienced the unexpected serious (Medically significant) event of Mental impairment that occurred in the context of second dose of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the exact date of vaccination and onset date of the event was not available. No further information regarding risk factors, clinical course, medical history, concurrent conditions, concomitant medication, additional vaccination details, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date).    No concomitant drug was reported. Pharmacist reported that they just found out last 18-Mar-2023 that they accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date. They were from 2 different vials but the same lot number.  HCP worried of providing patient's details because of HIPAA. This case contains information for the 1st of 2 patients. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716519 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716519:Patient 2
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered an expired dose of the Moderna COVID-19 monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Feb-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the Moderna COVID-19 monovalent vaccine).    No concomitant medications were reported.  Vial size was 5.5 mL  The vial was initially stored in the refrigerator 30-Jan-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: didn't feel that great/she felt like she needed to go to bed and didn't feel that great/She stayed in bed for a couple of days, and felt like she had a cold; covid 19; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel that great/she felt like she needed to go to bed and didn't feel that great/She stayed in bed for a couple of days, and felt like she had a cold) and COVID-19 (covid 19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039A21A and 021C21A) for COVID-19 prophylaxis.     No medical history information was reported by the reporter.  Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel that great/she felt like she needed to go to bed and didn't feel that great/She stayed in bed for a couple of days, and felt like she had a cold) and COVID-19 (covid 19). At the time of the report, FEELING ABNORMAL (didn't feel that great/she felt like she needed to go to bed and didn't feel that great/She stayed in bed for a couple of days, and felt like she had a cold) outcome was unknown and COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had COVID on 26-DEC. Treatment details was not reported by the reporter.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 3 doses to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     The patient medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses to children after the expiration date).    The patient was 7 months and 2 weeks old.  No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient did not experienced any adverse events .  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716538, US-MODERNATX, INC.-MOD-2023-716545 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716538:same reporter US-MODERNATX, INC.-MOD-2023-716545:same reporter
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No allergy or disease reported.   On 17-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they accidentally administered 3 doses to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (no adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient relevant medical history,conditions, allergy, concomitant diseases and risk factor reported as unknown.     On 13-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they accidentally administered 3 doses to children after the expiration date).    No concomitant medications was provided. The patient did not experienced any adverse events . No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716538, US-MODERNATX, INC.-MOD-2023-716441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716441:same reporter US-MODERNATX, INC.-MOD-2023-716538:same reporter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose).    No concomitant medication details was reported. The vial was initially stored in the refrigerator on 15-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     Patient had no allergy or disease listed. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medications were provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered dose to children after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered dose to children after the expiration date  ).    No concomitant information was reported. It was reported that patient number 3 did not experienced any adverse event and was 6 months and 2 weeks old . No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716545, US-MODERNATX, INC.-MOD-2023-716441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716545:same reporter US-MODERNATX, INC.-MOD-2023-716441:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023; No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 vaccine used) and PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023).    No concomitant medications were reported. It was unknown if Patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. Pharmacist would like to know if an expired dose is administered. HCP informed the vaccine was administered after the 30-day Use by Date of 08-Mar-2023 to 2 patients on 2 different dates. No concomitant medication information was provided. The product was reported as Bivalent 6 years and older and vial size was reported as 2.5 ml. It was reported that Lot 066H22A was stored to the refrigerator on 06-Feb-2023 Vaccine was administered on 19-Mar-2023 and 20-Mar-2023 It was reported that the vial did not undergo temperature excursions. No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-716565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716565:
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medications were reported. It was reported that reporter's Husband was immunocompromised and was wondering how often in between they should wait before having another booster for the 7th booster dose.  Caller's husband (patient) got the first Bivalent 6 months ago today until it's been a year. Patient was on an immunosuppressive medications and high risk. Agent asked for vaccination records, but patient only wanted to provide that their Bivalent booster dose was administered 6 months ago from today 21Mar2023. AE submitted in case doses were provided contrary to authorized vaccine schedule. Caller ended the call. Further AE information could not be collected.  No treatment medications were reported.   Reporter did not allow further contact
Age: 70.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No Adverse Event) in a 70-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 2 doses of Moderna Covid-19 bivalent 2 days after BUD.).    No concomitant medications was reported. Dosage text of suspect Spikevax Bivalent was reported as Additional booster. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716324:Same Reporter
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Bivalent administered as Third Dose (Immunocompromised Individuals); No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Concurrent medical conditions included COPD, Obesity and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent administered as Third Dose (Immunocompromised Individuals)).    No concomitant medications were reported.  Patient was recommended by pulmonologist to have fourth vaccine.   No treatment information was provided.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023) and NO ADVERSE EVENT (no adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Monovalent that expired on 12Mar2023 . Administered on 20Mar2023).    The concomitant medication was not reported.  The patient was administered 1 dose of Moderna Monovalent that expired on 12-Mar-2023. The treatment medication was not reported.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Bivalent given as second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent given as second dose) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history or conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Batch/lot number - EW0185) on 19-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 17-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent given as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent given as second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent given as second dose).    No concomitant medication were reported.  Nurse stated that they had a patient last who lied about the vaccination status, patient stated that she was already fully immunized, so they gave patient the Moderna bivalent booster dose. When they checked the vaccination record, they found out that patient had only 1 primary dose which was Pfizer. No adverse event was reported by the patient after the administration. No treatment information was provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Patient started experiencing a pressured headache; Patient started experiencing a painful headache; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 048B21A, 045J21A and 010H22A) for COVID-19 prophylaxis.     It was reported that patient had received other vaccine in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu vaccine fall 2021 (Flu vaccine fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine fall 2021.   On 02-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 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache). The patient was treated with GABAPENTIN at a dose of up to 2700 mg; AMITRIPTYLINE at an unspecified dose and frequency and LAMOTRIGINE at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (Patient started experiencing a pressured headache) and HEADACHE (Patient started experiencing a painful headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient started experiencing a pressured and painful headache, 8 days after the dose 1 which had not gone away. The pain initially started over left eye and later in summer f 2021, it started to move a little bit to the crown of head from front to back. The base pain and pressure had not gone away, but pain flared up at times. Patient had spoken to a neurologist and had taken Gabapentin.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter. Patient relevant medical history conditions, allergy, concomitant diseases and risk factor were not reported. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: new employ had too much time between vaccines primary series- approx 10 months inbetween; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event) in an adult 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (new employ had too much time between vaccines primary series- approx 10 months inbetween).    No concomitant medication was reported.    New employ had too much time between vaccines primary series- Approx 10 months in between. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 1 dose of the Moderna vaccine was administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna vaccine was administered past the expiration date.).    No concomitant medication was reported.    The vial was pulled from the freezer on 09-Mar-2023. Expiration date was 12-Mar-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     Patient reported that she would be having a medical surgery in the next two week.  No treatment medications were reported.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Overdose, Pain, Product preparation error
Clinical narrative: chills; body aches; headache; The nurse administered the Bivalent dose without diluting the vaccine first.; The nurse administered the Bivalent dose without diluting the vaccine first.; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician).  An 8-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 08:30 as dose 4 (booster), single (Lot number: GK1657) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular, Batch/ Lot number: Not available/ Provided at the time of report completion, Got at another facility), administration date: 04Nov2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Route of administration: Intramuscular, Batch/ Lot number: Not available/ Provided at the time of report completion, Got at another facility), administration date: 26Nov2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3, Route of administration: Intramuscular, Lot: FL8094), administration date: 24May2022, when the patient was 8-year-old, for COVID-19 immunization.  The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Jan2023 at 08:30, outcome "unknown" and all described as "The nurse administered the Bivalent dose without diluting the vaccine first."; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body aches"; HEADACHE (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of product preparation error, overdose. Therapeutic measures were taken as a result of chills, pain, headache.  Additional information: The patient had no other vaccine in four weeks. The patient had no known other medications in two weeks. The patient had no known allergies and no known other medical history.  Follow-up (04Mar2023): Follow-up attempts are completed. No further information is expected.  Follow up (20Mar2023): This is a spontaneous report from a contactable Physician. This Physician reported in response to HCP letter sent which includes that:  Updated information included: Reporter information (2nd reporter updated to true reporter, middle name added, suffix, email address added, and occupation updated to Physician from Other HCP) and event details (added AE: Chills, Generalized aching, and Headache)
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Stress cardiomyopathy
Clinical narrative: Takotsubo cardiomyopathy; This is a literature report for the following literature source(s). A 65-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STRESS CARDIOMYOPATHY (medically significant), 1 day after the suspect vaccine administration, outcome "unknown", described as "Takotsubo cardiomyopathy". Patient had chest pain, myalgia, nausea, and headache as symptoms. The patient underwent the following laboratory tests and procedures: Electrocardiogram: abnormal. Therapeutic measures were taken as a result of stress cardiomyopathy and included aspirin, atorvastatin, lisinopril, and metoprolol succinate as treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported event (Stress Cardiomyopathy) cannot be excluded. No alternative causes were identified as per the available information. Case will be reassessed upon receipt of additional information
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Paraesthesia
Clinical narrative: Tingling; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 15Mar2023 as dose number unknown, 0.5 ml single (Lot number: FN5548, Expiration Date: 31Jul2025) at the age of 18 years intramuscular for immunisation, Device Lot Number: FN5548, Device Expiration Date: 31Jul2025. The patient's relevant medical history included: "Anxiety", start date: Jun2022 (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 15Mar2023, outcome "unknown"; PARAESTHESIA (medically significant) with onset 15Mar2023, outcome "not recovered", described as "Tingling". The patient had vaccine on 15Mar2023 and 3 hours later, had tingling down his left leg and chills. On 16Mar2023, it is in his right leg and also feels like it is in different parts of his body, but patient can't pinpoint or explain. It was also reported that the tingling has worsened and spread to different areas of body. Patient also has chills and doesn't feel right, feels funny. The reporter considered tingling as serious for medically significant event. The vaccine was available to be returned.; Sender's Comments: Based on the close temporal relationship, the association between the event paraesthesia with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.