chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product monitoring error
Clinical narrative: vaccines administered without temperatures being monitored; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) 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 PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored) 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 PRODUCT MONITORING ERROR (vaccines administered without temperatures being monitored).    The Moderna COVID-19 vaccines stored in the freezer but did not have device to monitor and recorded the temperatures, so could not verify the highest or lowest temperatures. The vaccines were administered with no monitored temperature.  The storage condition at the time of the excursion was frozen. The vial in the box were of unknown size. The maximum temperature reached as 31 degree celcius and minimum temperature was zero degree celcius. The excursion duration was unknown. The vial were returned to the freezer. The vials were always frozen, thawed to administer the vaccines and then discarded. The concomitant and treatment medication was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Achy; Injection site began to swell; Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     The patient did not had any complex allergies nor had any flu shot last year.  Concurrent medical conditions included Immunocompromised (Put it as "legally disabled but these illnesses are not life threatening") and Disability NOS (Put it as "legally disabled but these illnesses are not life threatening").    On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site) outcome was unknown. No concomitant medications were reported.NPatient received first dose on 20-Apr-2021, second dose on 18-Jul-2021 and first booster dose on 18-Nov-2021. The patient received bivalent booster dose at around 4:30pm, EST and at around 10:30-11:00pm, patient's arm where she got the injection (left arm) began to swell and had a mark on it.  Initially, reporter described it as a "hard baseball" which was 2-3 inches in diameter but later changed the description as oblong shaped redness 2-2.5 inches in diameter. On and off cold compress on the area was placed and patient took Tylenol. Reporter asked if it was a normal reaction to the vaccine especially the patient being immunocompromised.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (Linked Report). This case was linked to MOD-2022-654324, MOD-2022-654320 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Live follow-up received contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-653965:MOD22-025207 (Husband 's case/ Same reporter).
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast mass, Breast pain
Clinical narrative: Pain in the breast on the same side where she received the vaccine; She has a breast lump; This spontaneous case was reported by a physician assistant and describes the occurrence of BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had no allergies reported. It was Unknown if the patient ever had COVID + test or diagnosis. It was Unknown if patient had received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Chronic disease (Chronic medical problem, nothing had change after vaccination).    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump). At the time of the report, BREAST PAIN (Pain in the breast on the same side where she received the vaccine) and BREAST MASS (She has a breast lump) had not resolved.        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.   It was reported that the patient takes 10 different regular medications (unspecified).  On an unknown date, the patient received first, second and booster dose of Moderna COVID-19 vaccine (route of administration was unknown).  The patient received the Moderna Bivalent Booster and started experiencing pain in the breast on the same side were she received the vaccine and had a breast lump.  Adverse event caused patient to seek medical care. HCP wanted to perform a Mammogram. It was unknown if the patient experienced a similar event in the past. The symptoms started the same day and they are still ongoing. Patient did nor receive any treatment.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; Only one dose of the vaccine in Jun 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021) 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 ADMINISTRATION INTERRUPTED (Only one dose of the vaccine in Jun 2021).    No concomitant medication was reported.    Pharmacist stated that they have a patient who received only one dose of the Moderna vaccine in Jun 2021 and their job now requiring them to repeat the entire series. HCP was asking what will be Moderna's recommendation in this situation. No treatment information was reported.   Reporter did not allow further contact
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse event; patients received doses from affected vials by a temperature excursion; doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion). In September 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion).    No concomitant medication were reported.  The duration of the excursion was 1 hour on 02-SEP-2022. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection.  No treatment information was provided by the reporter.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion; No Adverse event; 3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion).    Concomitant medication information was not provided by the reporter.  No vaccines in this lot have been administered since the temperature excursion.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took first dose on 20-Apr-2021 and second dose on 18-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medications were reported.  It was reported that the patient did not have any flu shot last year.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (Linked Report). This case was linked to MOD-2022-654324, MOD-2022-654236 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Follow up received contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-653965:Wife's case.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion; No Adverse event; 3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion/3 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (3 doses administered from vials that underwent a temperature excursion/5 doses administered from vials that underwent a temperature excursion). No concomitant medication information was provided.  No vaccines in this lot have been administered since the temperature excursion. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter. US-MODERNATX, INC.-MOD-2022-654336:same reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient was immunocompromised and received first booster dose after second dose/ No third dose; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient does not had any complex allergies.  Concurrent medical conditions included Immunocompromised (Legally disabled but these illnesses are not life threatening).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received first booster dose after second dose/ No third dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient did not had any flu shot last year. Caller stated that his wife was immunocompromised and when asked as to what the immunocompromised he stated that with due respect they did not want to violate HIPAA and would just put it as "legally disabled but these illnesses are not life threatening".  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (E2B Linked Report). This case was linked to MOD-2022-654320, MOD-2022-654236 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Live Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653965:husband case
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse event; dose administered from vial that underwent a temperature excursion; dose administered from vial that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion). On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion).    No concomitant medications were reported. It was reported that there was an temperature excursion on the 02-Sep-2022 for one hour and there were no remaining doses. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654336, US-MODERNATX, INC.-MOD-2022-654306 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter US-MODERNATX, INC.-MOD-2022-654336:same reporter US-MODERNATX, INC.-MOD-2022-654306:same reporter
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Before having COVID patient received doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine) 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 COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine). At the time of the report, COVID-19 (Before having COVID patient received doses of the Moderna COVID19 vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided.  Reporter wanted to know how long after a patient had COVID they should wait to receive the bivalent booster.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination complication, Wrong technique in product usage process
Clinical narrative: response to the vaccine only lasted few hours overnight; incorrectly administered/some may have been inserted into the subcutaneous space; some of the vaccine had dripped onto my skin when the needle was removed.so all of the vaccine did not enter the muscle; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle) 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 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. In 2022, the patient experienced VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle). In 2022, VACCINATION COMPLICATION (response to the vaccine only lasted few hours overnight) had resolved. At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (incorrectly administered/some may have been inserted into the subcutaneous space) and ACCIDENTAL UNDERDOSE (some of the vaccine had dripped onto my skin when the needle was removed. So all of the vaccine did not enter the muscle) 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.   It was reported that patient had bivalent booster this weekend. It was reported that patient had bivalent booster this weekend. It was incorrectly administered as some of the vaccine had dripped onto patient skin when the needle was removed. So, all of the vaccine did not enter the muscle, and some may have been inserted into the subcutaneous space. Patient usually had a strong 24 hr response to getting the vaccine and this time it only lasted few hours overnight.  No treatment information provided.
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pediatric patient received second dose before the recommended time range after first dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose). No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; second dose was bivalent booster instead of monovalent; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent) 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 INCORRECT DOSE ADMINISTERED (second dose was bivalent booster instead of monovalent).    No concomitant medication was provided by reporter.  The nurse states that there is a nursing student who received her first dose of the Moderna on 02Sep2022. On 30-Sep-2022, instead of receiving the second dose, the patient got 0.5ml of the bivalent booster because the patient was in nursing school, the nursing director had said that need to be fixed by 31-Dec-2022 otherwise she would be kicked out of the program. The HCP would like information in writing what to do for this patient.  No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Gave 0.25 of the Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) 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 ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster).    Concomitant medication information was not provided by the reporter.  It was reported that on 29-Sep-2022, a technician gave 0.25 of the Bivalent booster to 5 patients.  Treatment information was not provided by the reporter.  This case was created for elderly patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654611 Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654610:Patient 4 US-MODERNATX, INC.-MOD-2022-654611:Patient 5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Gave 0.25mL of the Moderna Bivalent; gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19.     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) .25 milliliter. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) 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 ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks).    No concomitant medication was reported.  Reportedly, one pharmacist had been only giving 0.25 mL of the Moderna Bivalent Booster shot to approximately 30 patients including reporter and her husband. The pharmacist who only gave 0.25mL of the Moderna Bivalent Vaccine had the assumption that it was just the same as the first Moderna Vaccine. They gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654629, US-MODERNATX, INC.-MOD-2022-654591 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2022: Live non significant follow up information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654629:Husband case US-MODERNATX, INC.-MOD-2022-654591:Remaining patients case
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; A patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was with comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full 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 ACCIDENTAL UNDERDOSE (A patient was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant medication information provided. No treatment information provided.  Reporter asked for the recommendation as patient was given 0.25 of the Bivalent booster. The CDC website says to re-administer the dose.  This case was considered for elderly patient number 2 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654611, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654610 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654611:Patient 5 US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654610:Patient 4
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patient was administered a half dose of the Bivalent booster instead of the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had comorbid conditions.   On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full 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 ACCIDENTAL UNDERDOSE (patient was administered a half dose of the Bivalent booster instead of the full dose).    No concomitant drug was reported. It was reported that a technician gave 0.25 ml of the Bivalent booster to patient. The CDC website says to re-administer the dose. No treatment drug was reported. This case contains information for the 5th of 5 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654609 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654610:Patient 3 US-MODERNATX, INC.-MOD-2022-654609:Patient 4
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Patient tested positive to COVID-19; a little soreness in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a little soreness in the site of injection) and COVID-19 (Patient tested positive to COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included GERD (Intestinal reflux). Concurrent medical conditions included Seasonal allergy, Diabetes, Cholesterolosis NOS, Asthma (Acute asthma), Drug allergy (diabetic medications) and Drug allergy (cholesterol medications).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (a little soreness in the site of injection). On 14-Sep-2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with AZITHROMYCIN for COVID-19, at an unspecified dose and frequency. On 07-Nov-2021, VACCINATION SITE PAIN (a little soreness in the site of injection) had resolved. On 19-Sep-2022, COVID-19 (Patient tested positive to COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 19-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient did not take other vaccines within one month prior to Moderna COVID-19 vaccine. Patient stated she was under a lot of regular and concomitant medications which also included diabetic medications and cholesterol medications. It was reported that AE cause patient to seek medical care. Patient does not experienced a similar event in the past.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Patient tested positive to COVID-19; a little soreness in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a little soreness in the site of injection) and COVID-19 (Patient tested positive to COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included GERD (Intestinal reflux). Concurrent medical conditions included Seasonal allergy, Diabetes, Cholesterolosis NOS, Asthma (Acute asthma), Drug allergy (diabetic medications) and Drug allergy (cholesterol medications).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (a little soreness in the site of injection). On 14-Sep-2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with AZITHROMYCIN for COVID-19, at an unspecified dose and frequency. On 07-Nov-2021, VACCINATION SITE PAIN (a little soreness in the site of injection) had resolved. On 19-Sep-2022, COVID-19 (Patient tested positive to COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 19-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient did not take other vaccines within one month prior to Moderna COVID-19 vaccine. Patient stated she was under a lot of regular and concomitant medications which also included diabetic medications and cholesterol medications. It was reported that AE cause patient to seek medical care. Patient does not experienced a similar event in the past.