chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort
Clinical narrative: Discomfort at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The patient was speaking with the healthcare professional regarding needle sizes for vaccines, she stated that she had discomfort with the flu shot. It was related to patient. It appeared that the healthcare professional was referring to discomfort at the injection site.  The reporter did not attempt to gather additional information as the healthcare professional wanted to opt out on providing additional information, therefore unable to verify what flu vaccine she was referring to. The reporter did not consent to follow-up. Additional Supportive Information: This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023031934:Same reporter US-GSK-US2023AMR032489:Same reporter US-GSK-US2023AMR032491:Same reporter US-GSK-US2023AMR032493:Same reporter US-GSK-US2023AMR032492:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix only adjuvant administration; Shingrix only adjuvant administration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 34EC5, expiry date 2nd July 2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the box of Shingrix vaccine had an extra antigen vial so they assumed that one patient might received only the adjuvant of the Shingrix vaccine. The reporter did consent to follow up. Additional supportive information: The reporter stated that only adjuvant of shingrix vaccine administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: A medical assistant called to report that, a pediatric dose of Engerix-B was administered to a adult patient. The reporter had consent to follow-up. Additional supportive information: The adult patient received the Engerix-B pediatric dose, which had led to adult use of a child product and underdose.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash, Rash papular
Clinical narrative: 1st and 2nd dose in 2021, shingles recently/ took shingle shot, got shingles/Suspected vaccination failure; shingles on back; left arm is still sore; 4-5 little bumps; it hurt/very painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (one outbreak when he was around 55 or 60 years old).   On 2nd June 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 2nd April 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm, papular rash and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, papular rash and pain were unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash and pain to be related to Shingrix and Shingrix. The reporter considered the pain in arm to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: The patient self-reported this case. The patient received two doses of Shingrix vaccine in left arm. The patient did not had the lot number of the administered vaccines but he provide the phone number of the pharmacy where the shots were administered. The pharmacy should have a record of the lot numbers used.  The patient stated the vaccine being be injected into the muscle, but he wonders if it was injected into a tendon because his left arm was still sore today and it was almost 2 years later. The patient reported that recently he experienced a case of shingles. He stated that he had just gotten over the shingles.  The patient was prescribed acyclovir pills as a treatment which was cleared shingles up in the past couple weeks.  The patient stated the shingles outbreak was on the left side of his back and it was only 4 to 5 little bumps, but it hurts very painful. The patient wanted to know the Shingrix vaccine did not work for him should he had to take it again. The reporter did not want to share his physician contact information. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: 1st and 2nd dose in 2021, shingles recently/ took shingle shot, got shingles/Suspected vaccination failure; shingles on back; left arm is still sore; 4-5 little bumps; it hurt/very painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (one outbreak when he was around 55 or 60 years old).   On 2nd June 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 2nd April 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm, papular rash and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, papular rash and pain were unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash and pain to be related to Shingrix and Shingrix. The reporter considered the pain in arm to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: The patient self-reported this case. The patient received two doses of Shingrix vaccine in left arm. The patient did not had the lot number of the administered vaccines but he provide the phone number of the pharmacy where the shots were administered. The pharmacy should have a record of the lot numbers used.  The patient stated the vaccine being be injected into the muscle, but he wonders if it was injected into a tendon because his left arm was still sore today and it was almost 2 years later. The patient reported that recently he experienced a case of shingles. He stated that he had just gotten over the shingles.  The patient was prescribed acyclovir pills as a treatment which was cleared shingles up in the past couple weeks.  The patient stated the shingles outbreak was on the left side of his back and it was only 4 to 5 little bumps, but it hurts very painful. The patient wanted to know the Shingrix vaccine did not work for him should he had to take it again. The reporter did not want to share his physician contact information. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Pyrexia
Clinical narrative: t 38C, 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (t 38C, 2 days) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 24-Jan-2023, the patient experienced PYREXIA (t 38C, 2 days). In January 2023, PYREXIA (t 38C, 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, Body temperature: 38 degree Celsius.     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 medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold) in an 87-year-old 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold). At the time of the report, COVID-19 (COVID-19 after receiving Moderna booster shot /  he got sick / Cough and cold) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2023: Live followup contains no new information.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days; Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) 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)) for COVID-19 prophylaxis.     No information about patient's vaccine history and historical conditions.     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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) 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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days).    No concomitant medications was reported.  Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days. No other information about the patient's was known.  No treatment medications were reported.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-714297 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714297:Patient 1 of 2 Patients
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jan-2023, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported. Chronic or long standing health conditions and acute illnesses at the time of vaccination and up to one month before was none. Prescription, over the counter medication, dietary supplements or herbal remedies being taken at time of vaccination and/or at the tine of the adverse event was none. No treatment medications details were reported.   This case was linked to MOD-2023-711261 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose was given 1MAR2023 after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 01-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) to be not related.    No treatment medications were reported No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Possible administration of expired vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Possible administration of expired vaccine).    No concomitant medications was reported. It was reported that may be possible administration of expired vaccine but want to check an expiration date for Moderna Monovalent vaccine. When asked if expired vaccine was administered HCP initially stated no, then answered that's what they were trying to find out.  No treatment drug details was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.; Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) 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)) 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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) and NO ADVERSE EVENT (No adverse event ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.), PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) 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 (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.) and PRODUCT STORAGE ERROR (Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days.).    No concomitant medications were reported. Two patients received Moderna Bivalent vaccine that had been in the refrigerator for more than 30 days. At this point in time the phone call was disconnected. The agent called HCP back and left a message with case number. No other information about the patient's or their vaccine history was known.  No treatment medications were reported. This case contains information for the 1st of 2 patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-714305 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714305:Patient 2 of 2 Patients
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Pharmacist reports that they inadvertently administered a dose of the monovalent vaccine to a patient today, 06Mar2023 which was past the published expiry date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they inadvertently administered a dose of the monovalent vaccine to a patient today, 06Mar2023 which was past the published expiry date.) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they inadvertently administered a dose of the monovalent vaccine to a patient today, 06Mar2023 which was past the published expiry date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they inadvertently administered a dose of the monovalent vaccine to a patient today, 06Mar2023 which was past the published expiry date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist reports that they inadvertently administered a dose of the monovalent vaccine to a patient today, 06Mar2023 which was past the published expiry date.).    No concomitant medication was reported.    Pharmacist reported that they inadvertently administered a dose of the monovalent vaccine to a patient on 06-Mar-2023 which was past the published expiry date.Expiration date: 26-Feb-2023. No treatment information was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; I administered two doses of Moderna Primary vaccine that were expired; Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Seizure. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Hyperlipidemia, Hypertension, Hypothyroidism and Type 2 diabetes mellitus.    On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (I administered two doses of Moderna Primary vaccine that were expired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 3-Jun-2022 and second dose on 27-Feb-2023).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714383 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2023: Live Follow up received contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714383:Same reporter
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023; No adverse event; Dose administered after 30 day BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.), PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.), PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day BUD.) and PRODUCT STORAGE ERROR (Dose was administered after 30 day BUD, after being stored in the refrigerated since 30-JAN-2023).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No symptoms were reported. No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vial was initially stored in the refrigerator; No adverse event; Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the monovalent Moderna COVID19 vaccine as a first dose) and PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator).    No concomitant medications were reported.  The patient did not report side effects.  The vial was initially stored in the refrigerator on 26-Feb- 2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine was administered on 23-FEB-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered on 23-FEB-2023) and NO ADVERSE EVENT (no adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered on 23-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered on 23-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 (expired vaccine was administered on 23-FEB-2023).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    No concomitant medications were reported.  HCP stated that they had 2 lots of the Moderna COVID-19 monovalent vaccine stored in the freezer. One of them with lot 015B22A, had an expiration date of 12-Feb-2023, which was confirmed using Moderna expiration checker website. This lot was potentially involved in an administration error. HCP stated that it was possible that a dose was administered to a patient on 22-Feb-2023 after the expiration date. They did have another Moderna COVID-19 monovalent lot number stored in the freezer which was not expired yet. Reporter stated that it was possible that the second lot was administered to the patient instead, he was not sure and was in the process of gathering details for this incident. Wanted to know if there had been any extensions for lot 015B22A and if not, then was there any additional stability information for expired Moderna vaccine administered to a patient. Vial size was unknown. The vial was initially stored in the refrigerator on 22-Feb-2023. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 52.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered Moderna Covid-19 bivalent dose) that later determined to be expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired) and NO ADVERSE EVENT (No adverse event) in a 52-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. 023H22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 06-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 bivalent dose) that later determined to be expired).    No concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7170B and AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-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) 1 dosage form. On 07-Mar-2023, 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 1 dosage form. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023).    Concomitant drugs were not reported. Dosage text was reported as additional booster. No adverse events were reported from patient. Treatment medications were not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Because the very 1st dose she received was a bi-valent,; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Because the very 1st dose she received was a bi-valent,).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male 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.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st bivalent vaccine) on 28-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high and Blood cholesterol abnormal.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 06-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .05 milliliter. On 06-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna COVID-19 Vaccine on 6MAR2023 but the vaccine expired on 26FEB2023).    No concomitant medication were reported. Patient has not advised of any adverse effects. No treatment information was provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (her friend had received a Pfizer bivalent booster on 23Sep2022 and he just received the Moderna Covid 19 Bivalent on 04Mar2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (bivalent booster) on 23-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.       No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.