chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No adverse event; Administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant product use was reported.  Patient received full  dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Accidently gave a 0.25 mL/25 mcg to a 3 year old from a vial labeled for the 6 year to 11 year old instead of 6 month old to 5 year old vial; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently gave a 0.25 mL/25 mcg to a 3 year old from a vial labeled for the 6 year to 11 year old instead of 6 month old to 5 year old vial) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently gave a 0.25 mL/25 mcg to a 3 year old from a vial labeled for the 6 year to 11 year old instead of 6 month old to 5 year old vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently gave a 0.25 mL/25 mcg to a 3 year old from a vial labeled for the 6 year to 11 year old instead of 6 month old to 5 year old vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Accidently gave a 0.25 mL/25 mcg to a 3 year old from a vial labeled for the 6 year to 11 year old instead of 6 month old to 5 year old vial).    No concomitant medications were reported. No treatment medications were reported.  The medical assistant accidentally administered that vaccine to the patient.  The reporter reported that vaccination errors would be higher with different presentations and it would be more tedious.  The reporter reported that the dose should not be a problem for the patient and asked why the two preparations could not be used interchangeably since they were still Moderna vaccines.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received dose 1 from Pfizer and dose 2 from Moderna; Patient received dose 1 from Pfizer and dose 2 from Moderna; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1. the maroon cap Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    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 INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna) and COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna).    No concomitant medication information was provided. No treatment medication were provided.
Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Dose 1 Pfizer and Dose 2 Moderna; Dose 1 Pfizer and Dose 2 Moderna; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event) in a 17-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COMIRNAT (Dose 1. the maroon cap Pfizer Covid-19 vaccine). Past adverse reactions to the above products included No adverse event with COMIRNAT.    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 INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna), COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Dose 1 Pfizer and Dose 2 Moderna) and COVID-19 IMMUNISATION (Dose 1 Pfizer and Dose 2 Moderna).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-623916 (E2B Linked Report).; Sender's Comments:  MOD-2022-623916:4 year old male case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; The patient explains that she is immunocompromised. and took she had a Moderna booster On 14Oct2021; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient explains that she is immunocompromised. and took she had a Moderna booster On 14Oct2021) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 031B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes mellitus (Patient has been a diabetic for past 50 years) and Immunocompromised.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (The patient explains that she is immunocompromised. and took she had a Moderna booster On 14Oct2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The patient explains that she is immunocompromised. and took she had a Moderna booster On 14Oct2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  No treatment information was provided.   This case was linked to MOD-2022-623976 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna dose administered to patients after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patients after expiration).    No concomitant medication reported. No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Moderna dose administered to patient after expiration; Patient received a 0.30 mL dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration), INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration), INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient after expiration) and INCORRECT DOSE ADMINISTERED (Patient received a 0.30 mL dose).    No concomitant information was reported. The patient received the second booster dose. No adverse reactions had been reported for the patient. No treatment information was provided.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: interchange of vaccine products; Revaccination with different covid-19 vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Drug allergy. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) from December 2017 to 12-Jun-2022, BUPROPION from December 2017 to 12-Jun-2022, TADALAFIL from October 2021 to 09-Jun-2022 and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from December 2017 to 12-Jun-2022 for an unknown indication.   On 13-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No treatment medication were provided.   This case was linked to MOD-2022-595341 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: CD4 lymphocytes, CD4 lymphocytes increased
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 021C21A and 016B21A) for COVID-19 prophylaxis. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time). At the time of the report, CD4 LYMPHOCYTES INCREASED (After the booster, T-Cells were a little higher than the last time) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, CD4 lymphocytes: Had elevated T-Cells. No concomitant medications were reported. The patient was not allergic to any medications, food and other products. The patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient did not experienced a similar event in the past and did not felt sick. Adverse event did not cause patient to seek medical care and symptoms got worsened. The patient did not tested or diagnosed for covid-19 but tested for antibodies on 2020: results not provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Patient demographic details, suspect drug details were updated.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Severe stomach cramps; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramps) and DIARRHOEA (Diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis and ADALIMUMAB (HUMIRA) for Panuveitis.    The patient had no known allergies and no reported medical history.  Concurrent medical conditions included Panuveitis (Non-infectious intermediate, posterior and Panuveitis).   On 23-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE NRVV AD26 (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2022, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramps) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not reported.   Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administer the vaccine after 12 hours after first puncturing.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine after 12 hours after first puncturing.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine after 12 hours after first puncturing.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine after 12 hours after first puncturing.) 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 (administer the vaccine after 12 hours after first puncturing.).    No concomitant medication was reported. Patient was administered with the vaccine after 12 hours after first puncturing. No treatment information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022 at 8:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) 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 (Dose administered >12 hours post puncture).    Number of doses/vials: 1 dose/1vial. Date the vial was initially stored in the refrigerator was unknown. Date and time vial was first punctured was 5-Aug-2022  2pm. It was unknown if the vial was stored in fridge post puncture. The vial undergo any temperature excursions was unknown. Total amount of time the vial was exposed to room temperature range was unknown.  No concomitant medications was reported. No treatment medications was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site irritation, Vaccination site pain
Clinical narrative: The injection site was irritable; Achy arm, pain was from her elbowto the shoulder; Injection site was still sore, spot was all tender; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 053E219 / 053E214 / 053E21A) for COVID-19 prophylaxis.     Patient did not have COVID + test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender). At the time of the report, VACCINATION SITE IRRITATION (The injection site was irritable), PAIN IN EXTREMITY (Achy arm, pain was from her elbowto the shoulder) and VACCINATION SITE PAIN (Injection site was still sore, spot was all tender) had not resolved.            Patient was taking other medication.   The patient experienced achy arm since vaccination. Patient noticed in the past year and arm was achy. Patient stated it happened about 3 times. When the arm hurt, patient massaged the area. Then patient would feel better when massaged it. The arm was still achy where the shot was given. Once massaged it kind helped.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Received second primary dose of the Moderna Covid 19 vaccine more than 35 days after the first one; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second primary dose of the Moderna Covid 19 vaccine more than 35 days after the first one) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Nickel sensitivity, Drug allergy (Ionamin.), Allergy to metals (White gold) and Allergy to antibiotic (Sulfa Drugs).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second primary dose of the Moderna Covid 19 vaccine more than 35 days after the first one). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second primary dose of the Moderna Covid 19 vaccine more than 35 days after the first one) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug was reported. No Treatment medications were reported   This case was linked to MOD-2022-625024 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product preparation issue
Clinical narrative: No adverse event; gave vaccine  from a vial that was diluted  to a pediatric patient.; gave vaccine  from a vial that was diluted  to a pediatric patient.; This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.), POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. as1414b) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy.    On 05-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2022, the patient experienced PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.) and POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.), POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT PREPARATION ISSUE (gave vaccine  from a vial that was diluted  to a pediatric patient.) and POOR QUALITY PRODUCT ADMINISTERED (gave vaccine  from a vial that was diluted  to a pediatric patient.).    No concomitant medications were reported. No treatment  medications were reported. The AE did not cause patient to seek medical care. The patient did not experience similar event in the past.  Patient never had COVID+ test or diagnosis. Patient did not have any acute or chronic illness at the time of vaccination. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She had a period after 2 yrs, after she got her booster of Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She had a period after 2 yrs, after she got her booster of Moderna) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site warmth
Clinical narrative: injection site is really hot; injection site is bruised; injection site is dark; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     It was reported that patient had no allergies.  Patient never had COVID positive test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No medical history reported by the patient.     On 12-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark). At the time of the report, VACCINATION SITE WARMTH (injection site is really hot), VACCINATION SITE BRUISING (injection site is bruised) and VACCINATION SITE DISCOLOURATION (injection site is dark) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications information was reported.  The patient never experienced similar event in the past. AE did not cause patient to seek medical care. There was no change in the symptoms.   No treatment medications were provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; gave them the 6 months to 5 years of age vaccine and the patient was an adult; gave them the 6 months to 5 years of age vaccine and the patient was an adult; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (gave them the 6 months to 5 years of age vaccine and the patient was an adult), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave them the 6 months to 5 years of age vaccine and the patient was an adult) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B, 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (gave them the 6 months to 5 years of age vaccine and the patient was an adult) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave them the 6 months to 5 years of age vaccine and the patient was an adult). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (gave them the 6 months to 5 years of age vaccine and the patient was an adult), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave them the 6 months to 5 years of age vaccine and the patient was an adult) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (gave them the 6 months to 5 years of age vaccine and the patient was an adult) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave them the 6 months to 5 years of age vaccine and the patient was an adult).    Patient height was reported as 63 inches. Patient had no Allergies. No Concomitant medications were provided. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care. It was unknown whether patient experienced a similar event in the past. It was unknown whether patient symptoms improved or worsened. Patient never had COVID positive test or diagnosis. No treatment medications were provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022; No adverse event; Patient received vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 30-Jun-2022/Vaccine administered on 01-Aug-2022).  No concomitant medications were reported. Number of doses or vials were unknown.  The vial was initially stored in the refrigerator on 30-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 6-Jul-2022 and administered on 8-Aug-2022; No adverse event; Vial that had spent more than 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial that had spent more than 30 days in the refrigerator), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Jul-2022 and administered on 8-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial that had spent more than 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Jul-2022 and administered on 8-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial that had spent more than 30 days in the refrigerator), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Jul-2022 and administered on 8-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial that had spent more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 6-Jul-2022 and administered on 8-Aug-2022).    No concomitant medication was reported. The dose was administered after 30-day use by date or after manufacturer date of expiry.  The vial was initially stored in the refrigerator on 6-Jul-2022. The vial did not undergo any temperature excursion. No treatment information was provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022; No adverse event; Patient administered vaccine beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vial was refrigerated on 30-Jun-2022 and was administered to the patient on 01-Aug-2022).    No concomitant medications information was reported. On 30-Jun-2022, the vial was initially stored in refrigerator and vial did not undergo any temperature excursions. No treatment medications information was reported.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022; No adverse reaction; Used Moderna Covid-19 vaccine last week beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No adverse reaction) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022).    Patient had 2nd booster dose. No concomitant medications were provided. The vial was initially stored in refrigerator on 30-Jun-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022; No Adverse reaction; used Moderna Covid-19 vaccine last week beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 01-Aug-2022). No concomitant medication was reported. Medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination reported as unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine reported as unknown.  Patient's COVID + test or diagnosis was reported as unknown. Patient was administered with second booster dose. Date the vial was initially stored in the refrigerator on 30-Jun-2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022; No Adverse reaction; Used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 30Jun2022, Date of administration of vaccine on 02Aug2022).    Patient had 2nd booster dose. No concomitant medications were provided. The vial did not undergo any temperature excursions. No treatment medications were reported.