chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Monovalent instead Bivalent in the month of January; Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09Sep2022.).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-709060.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2023: Follow-up received which contains significant information: Patient information update, suspect product information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709060:Master case -Female
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Dizziness; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Dizziness) and CHILLS (Chills) in an elderly female patient 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 DIZZINESS (Dizziness) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness) and CHILLS (Chills) outcome was unknown.        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 product was reported. No treatment information was reported.   This case was linked to MOD-2023-708885 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023; No adverse event; expired doses were given to 7 patients/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 12Jan2023).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial was initially stored in the refrigerator on 06-Dec-2022 and patient received vaccine on 12-Jan-2023. Vial did not undergo any temperature excursions. Caller stated that they received the vaccines they were refrigerated so they put them in the refrigerator, they were not put it in the freezer. Treatment medication was not reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator; No adverse event; Patients received vaccine after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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.   This case included information of 3rd patient out of 7 patients. No concomitant product reported by reporter.  It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial initially stored in the refrigerator on 06-Dec-2022. Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator. Vial size was 2.5ml.  Dates of administration of vaccine were 12-Jan-2023 for 2 patients, 16-Jan-2023 for 2 patients, 20-Jan-2023 for 1 patient, 24-Jan-2023 for 1 patient and 01-Feb-2023 for 1 patient. Vial did not undergone any temperature excursion issue.  No concomitant product reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708306 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708306:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.     It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial initially stored in the refrigerator on 06-Dec-2022. Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator. Vial size was 2.5ml.  Dates of administration of vaccine were 12-Jan-2023 for 2 patients, 16-Jan-2023 for 2 patients, 20-Jan-2023 for 1 patient, 24-Jan-2023 for 1 patient and 01-Feb-2023 for 1 patient.  Vial did not undergone any temperature excursion issue.  No treatment information was provided.  This case contains information for the 3rd of 7 patients described by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Had a sore arm for several days; Fever 101F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm for several days) and PYREXIA (Fever 101F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A, 011F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Ovarian cyst (Had for many years prior to vaccination) and Menopause (Stopped menstruating 3 years ago, way before vaccination). Concomitant products included PROGESTERONE and ESTRADIOL for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Had a sore arm for several days). In 2021, the patient experienced PYREXIA (Fever 101F). At the time of the report, PAIN IN EXTREMITY (Had a sore arm for several days) and PYREXIA (Fever 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 After the second shot, had fever 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the first shot, patient had a sore arm for several days.  After the second shot, patient had a sore arm and fever 101F and took unknown over the counter medicine. Patient was fine after a few days.   After the first booster (dose 3), patient had a sore arm for several days.  After the 2nd booster (dose 4), patient had a sore arm for several days.   This case was linked to (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; Felt feverish; Chills; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold), PYREXIA (Felt feverish) and CHILLS (Chills) 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.     Concurrent medical conditions included Drug allergy (Allergic to aspirin).  On 10-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), PYREXIA (Felt feverish) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), PYREXIA (Felt feverish) and CHILLS (Chills) had 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2023-708449 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Head discomfort, Neck pain, Testis cancer
Clinical narrative: testicular cancer; My neck is starting to hurt; it's slowly just starting to get my whole head to stop; I feel paralyzed; This spontaneous case was reported by a consumer and describes the occurrence of TESTIS CANCER (testicular cancer) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTIS CANCER (testicular cancer) (seriousness criterion medically significant), NECK PAIN (My neck is starting to hurt), HEAD DISCOMFORT (it's slowly just starting to get my whole head to stop) and FEELING ABNORMAL (I feel paralyzed). At the time of the report, TESTIS CANCER (testicular cancer), NECK PAIN (My neck is starting to hurt), HEAD DISCOMFORT (it's slowly just starting to get my whole head to stop) and FEELING ABNORMAL (I feel paralyzed) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was reported that the patient's neck was starting to hurt, felt like Superman. The patient was tazed and it's slowly just starting to get whole head to stop and felt paralyzed. The patient also had testicular cancer. The patient woke up to, out of the surgery and wrist band was saying COVID DIEN.   Company comment: This is a spontaneous case regarding an adult male patient, with no reported medical history, who received  mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/BA.5) and experienced unexpected and medically significant event of testicular cancer. Vaccination date and onset date of the event were not provided,  latency cannot be assessed. Patient mentioned that, on an unknown date, a surgery was performed for an unknown indication.  At the time of the report, the outcome was unknown. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Chills, Dizziness, Headache
Clinical narrative: headache; dizziness/dizzy at work; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness/dizzy at work), CHILLS (chills) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Feb-2023, the patient experienced DIZZINESS (dizziness/dizzy at work) and CHILLS (chills). On 08-Feb-2023, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness/dizzy at work), CHILLS (chills) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2023, Blood pressure measurement: 145/90, increased.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The patient experienced Chills and Dizziness after her bivalent booster dose that was administered on 2Feb2023. On wednesday 8FEB2023 the patient became dizzy at work.  No treatment information was reported.   This case was linked to MOD-2023-709251 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received Monovalent instead Bivalent in the month of January; Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.).    No concomitant medications were reported.  It was reported that, the patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.   No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2023-709143 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-709143:Master case -Female
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A patient at the pharmacy received said vaccine after the expiration date of 06-Feb-2023 on the date of 08-Feb-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient at the pharmacy received said vaccine after the expiration date of 06-Feb-2023 on the date of 08-Feb-2023.) and NO ADVERSE EVENT (no adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient at the pharmacy received said vaccine after the expiration date of 06-Feb-2023 on the date of 08-Feb-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient at the pharmacy received said vaccine after the expiration date of 06-Feb-2023 on the date of 08-Feb-2023.) 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 (A patient at the pharmacy received said vaccine after the expiration date of 06-Feb-2023 on the date of 08-Feb-2023.).    No concomitant product reported by the reporter. No signs or symptoms were noticed after vaccination. No treatment medication reported by the reporter.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a Moderna COVID19 vaccine bivalent as a second dose,; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215k22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 09-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a Moderna COVID19 vaccine bivalent as a second dose,).    Concomitant products were not provided. Treatment medication were not reported.  Patient's 1st dose was Moderna COVID19 vaccine monovalent on 09 Dec 2022 with lot AS1412B.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in a  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)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). On 08-Feb-2023, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) outcome was unknown. At the time of the report, NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medications were reported.  Individual vials or unbroken cartons reported as not sure, at least 1 and Vial size was 2.5 milliliter.  It was reported date the vial was initially stored in the refrigerator was said 30 days from the beyond use date but do not had specific day.  It was reported beyond use date was 05-Feb-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product expiration date issue
Clinical narrative: lot number AS1412B expired today but website said May; lot number AS1412B expired today but website said May; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 EXPIRATION DATE ISSUE (lot number AS1412B expired today but website said May) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (lot number AS1412B expired today but website said May).    No concomitant product was reported. No treatment information was reported. Reporter enquired about expiration date of lot number AS1412B, said it expired today but website said May. She wanted clarification about the Moderna primary series blue top vial with magenta label/stripe.
Age: 61.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; Patients administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication information provided. Date moved to refrigeration was 06-Jan-2023. 1 vial of bivalent beyond use date was 05-Feb-2023. No treatment information provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Limb discomfort, Neck pain
Clinical narrative: his neck which is still in pain; he was experiencing with his legs; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs) in an adult male patient 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs). At the time of the report, NECK PAIN (his neck which is still in pain) and LIMB DISCOMFORT (he was experiencing with his legs) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient went to the pain doctor because of his neck which was in pain, he told the PA what he was experiencing with his legs after the Moderna vaccine. The PA then told him that a lot of her patients have complained about the exact same thing as him. He was told that there's nothing that can be done.   No treatment medication were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they had Covid-19 15 days ago.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (they had Covid-19 15 days ago.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1), Moderna COVID-19 Vaccine (Booster) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (they had Covid-19 15 days ago.). At the time of the report, COVID-19 (they had Covid-19 15 days ago.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Caller wanted to know when patient can get the bivalent booster dose since had Covid-19, 15 days ago. Patient was now feeling okay. They had the 2 initial doses of the Moderna Covid-19 vaccine and the 2 booster doses, the last one of which was administered around 9 months ago. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Shoulder injury related to vaccine administration
Clinical narrative: Doctor has made a diagnosis of SIRVA; patient has not been able to work; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Diabetes.   In June 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Doctor has made a diagnosis of SIRVA) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient has not been able to work) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that after the second dose the patient's arm was frozen. It was stated that patient had been going to physical therapy for the SIRVA. The patient was not home and does not had her information about previous vaccines with her. The patient did not reported any adverse reactions. The patient did not remembered any of the dates of when she received her vaccine. No treatment information provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023; No adverse event; expired doses were given to 7 patients/Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired doses were given to 7 patients/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 6Dec2022 Date of administration of vaccine: 24Jan2023).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial was initially stored in the refrigerator on 06-Dec-2022 and patient received vaccine on 24-Jan-2023. Vial did not undergo any temperature excursions. Caller stated that they received the vaccines they were refrigerated so they put them in the refrigerator, they were not put it in the freezer.   Treatment medication was not reported.  This case contains information for the 6th of 7 adult patients described by the reporter.
Age: 15.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was administer after the 30 day refrigerator beyond use date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event) in a 15-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administer after the 30 day refrigerator beyond use date).    No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Vaccine was administer 12 hours after it had been opened for 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours) and NO ADVERSE EVENT (no adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer 12 hours after it had been opened for 12 hours).    No concomitant product reported by the reporter. No treatment medication reported by the reporter.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: she needed to report 3 more Vaccine Administration errors; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors) 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 PRODUCT ADMINISTRATION ERROR (she needed to report 3 more Vaccine Administration errors).    No concomitant medications were reported. No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (02Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Product was COVID 19 treatment, brand was Paxlovid and treatment start date at 26Jan2023, treatment stop date at 31Jan2023, Indication was treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Underactive thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received Paxlovid from from 27Jan2023 to 01Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.