chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022; No adverse event; Received expired first primary dose beyond 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first primary dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received Thawed on 13OCT2022 with a note that it expires on 13OCT2022 and administration of vaccine on 16Nov2022).    No concomitant information was reported. Pediatric patient was of age 8-10 years. The unbroken carton vial size was 2.5ml. Received Thawed on 13OCT2022 with a note that it expired on 13OCT2022. The vial did not underwent any temperature excursions.   This case was linked to US-MODERNATX, INC.-MOD-2022-673530 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673530:same reporter
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired Moderna Covid-19 vaccine for his second Primary Series dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired Moderna Covid-19 vaccine for his second Primary Series dose.).    No concomitant medications was provided.  The vial size was 5.5ml. The vial did not undergo any temperature excursions. It was reported that, no other adverse reactions reported after the first dose and second dose. Reporter does not know the date the vial was initially stored in the refrigerator as it came from the County Jails supply. Expiration date of the second dose vaccine was on 07 Apr 2022.  No treatment medications was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia, Vaccination site discolouration, Vaccination site erythema, Vaccination site induration
Clinical narrative: Shingles; Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in; The veins in my arm up to my shoulder are blue; had Covid arm, It was hot; had Covid arm, It was hard; had Covid arm. It was red; slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles) and VACCINATION SITE INDURATION (had Covid arm, It was hard) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy in December 2016. Concurrent medical conditions included Immune disorder (NOS) (patient did not have any Immunoglobulin A), Brain tumor (Patient had last chemo in Dec-2016) and Artificial cardiac pacemaker user.    On 28-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 29-Sep-2022, the patient experienced VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever). In October 2022, the patient experienced VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in) and VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue). On 15-Nov-2022, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever) outcome was unknown.            No concomitant drug was reported. Patient received first dose on 18Mar2021, Lot: 03N20A. Patient received second dose on 13Apr2021, Lot: 003B21A. Patient received third dose on 01Nov2021, Lot: 014F21A. Patient received fourth dose on 22Apr2022, Lot: 00ZM21A. Patient read somewhere that Covid arm should go away in about 21 days. Approximately 15Oct2022, patient left arm had a blue spot around the area that patient got injection in. The veins in patient arm up to shoulder are blue. Patient went to physician on 15-Nov-2022 and they were going to do a sonogram on patient's arm. No treatment drug was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vein discolouration
Clinical narrative: Shingles; Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in; The veins in my arm up to my shoulder are blue; had Covid arm, It was hot; had Covid arm, It was hard; had Covid arm. It was red; slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles) and VACCINATION SITE INDURATION (had Covid arm, It was hard) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy in December 2016. Concurrent medical conditions included Immune disorder (NOS) (patient did not have any Immunoglobulin A), Brain tumor (Patient had last chemo in Dec-2016) and Artificial cardiac pacemaker user.    On 28-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 29-Sep-2022, the patient experienced VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever). In October 2022, the patient experienced VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in) and VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue). On 15-Nov-2022, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, VACCINATION SITE WARMTH (had Covid arm, It was hot), VACCINATION SITE DISCOLOURATION (Approximately 15-Oct-2022: left arm had a blue spot around the area that I got injection in), VEIN DISCOLOURATION (The veins in my arm up to my shoulder are blue), HERPES ZOSTER (Shingles), VACCINATION SITE INDURATION (had Covid arm, It was hard), VACCINATION SITE ERYTHEMA (had Covid arm. It was red) and PYREXIA (slight fever) outcome was unknown.            No concomitant drug was reported. Patient received first dose on 18Mar2021, Lot: 03N20A. Patient received second dose on 13Apr2021, Lot: 003B21A. Patient received third dose on 01Nov2021, Lot: 014F21A. Patient received fourth dose on 22Apr2022, Lot: 00ZM21A. Patient read somewhere that Covid arm should go away in about 21 days. Approximately 15Oct2022, patient left arm had a blue spot around the area that patient got injection in. The veins in patient arm up to shoulder are blue. Patient went to physician on 15-Nov-2022 and they were going to do a sonogram on patient's arm. No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave 0.25 mL to an older adults; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) 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. AS7146B) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults).    No concomitant medication was reported.  It was reported that they gave 0.5 but initially charted 0.25 and changed it afterwards to 0.5. There was over a milliliter left of vaccine still in the vial after supposedly 5 full doses might have been withdrawn. The vial prior to puncturing was not observed. The vial fill volume was possibly too high. The vial was punctured 5 times. 5 doses were extracted from the vial. The technique was used to load the syringe and puncture technique was used to withdraw the dose was unknown. No treatment medication was reported.  This case was for Adult patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-673577, US-MODERNATX, INC.-MOD-2022-673580, US-MODERNATX, INC.-MOD-2022-673578 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Additional follow-up received QE id was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673577: US-MODERNATX, INC.-MOD-2022-673580: US-MODERNATX, INC.-MOD-2022-673578:Case for Adult patient 1
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave 0.25 mL to an older adults; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) 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. AS7146B) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults).    No concomitant medications were reported. It was reported that vial fill volume was possibly too high. The vial was punctured five times. The Five doses extracted from the vial. Five patients dosed from the vial. No treatment medications were reported. This Case for Adult patient 4.   This case was linked to US-MODERNATX, INC.-MOD-2022-673533, US-MODERNATX, INC.-MOD-2022-673577 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Live Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673533: US-MODERNATX, INC.-MOD-2022-673577:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission in error
Clinical narrative: No adverse event; Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, 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 DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Patient did not receive his 2nd dose of Moderna vaccine for more than 1 month after his 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported by the patient that he had only received 1 dose but states that he was fully vaccinated due to this "2 in 1" vaccine. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID Disease after Bivalent Booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID Disease after Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 26-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. In November 2022, the patient experienced COVID-19 (COVID Disease after Bivalent Booster). At the time of the report, COVID-19 (COVID Disease after Bivalent Booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-673505 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2022-673505:Wife case
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccine was administered past expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered past expiration date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered past expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered past expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administered past expiration date).    Concomitant drugs were not reported. It was reported that the monovalent opened vial of 5.5 ml size was initially stored in the refrigerator on 14-Nov-2022. The vial did not underwent any temperature excursion. No additional doses, medications, or treatments were reported.
Age: 71.0
Sex: M
Vaccine: FLUR4
Symptoms: Product storage error
Clinical narrative: flu vaccine may be ineffective due to temperature excursion; Initial information was received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 71 years old male patient who stated flu vaccine may be ineffective due to temperature excursion after receiving influenza quadrivalent recombinant vaccine [Flublok qiv].  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine (unknown formulation) (lot: QFAA2248) (expiry date, strength, frequency was unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 17-Oct-2022 the patient had a non-serious event flu vaccine may be ineffective due to temperature excursion (product storage error) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  There were no lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got flu shot Then got flu two weeks later; Initial information received on 13-Nov-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had got flu shot then got flu two weeks later while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious event of got flu shot then got flu two weeks later (influenza) (latency: 2 weeks) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Cheilitis, Lip blister, Stomatitis, Tongue blistering, Tongue erythema
Clinical narrative: Tip of the tongue erythematous with sores and blisters all over the tongue and inside part of lower lip
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at injection site and on buttocks
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Auditory disorder, Headache, Loss of personal independence in daily activities, Lymph node pain, Nausea
Clinical narrative: I started hearing an odd sound like something scratching at something in the distance. I got up to find the source and noticed that as I moved my eyes from side to side I could hear the sound. Everytime I quickly move my eyes from side to side I can hear them move. I have had a continuous headache since the day after I received my shot and today also started having immense pain in the lymph node of my left armpit. The sound coming from the movement of my eyes however is making it quite difficult to function. It makes my nauseous and my head continues to hurt.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Needle issue
Clinical narrative: Patient presented to the Vaccine Site Team at the Public Health Center on 11/20/2022, accompanied by his parents for Pfizer COVID-19 bivalent vaccine. At 1230, RN injected the patient with first injection of the Pfizer COVID-19 bivalent vaccine for 5 through 11 years of age but the patient moved his left arm and RN grazed his left arm with the vaccine needle only before she was about to inject the vaccine while the patient is sitting in the chair by himself. RN notified lead and showed lead the syringe with the Pfizer COVID-19 bivalent vaccine for 5 through 11 years of age 0.2 ml in the syringe. Lead called Clinical Project Coordinator who gave the guidance to revaccinate the patient with the same syringe with a new needle. The on-call physician is aware. Lead assessed his left arm which showed only a pink quarter of an inch mark with no blood visible and explained the situation to patient?s father who agreed to vaccinate the patient on the same left arm for his COVID-19 vaccine and to vaccinate the patient with the flu vaccine on his right arm. Today, the patient received the Pfizer COVID-19 bivalent vaccine of the same syringe with a needle attached for 5 through 11 years of age (Lot# GK1657 expired 01.02.23) on the left arm at 1240 with his father holding him by RN, and the patient received the Fluarix vaccine (Lot # 9PG4D expired 06/30/23) on his right arm at 1247 PM by RN. Lead provided education to the patient?s father on possible adverse reactions and when to seek medical care. The patient?s father denied any chronic conditions, current medications, or known allergies. Lead educated RN to have the parent hold every child before any vaccination to prevent any future injury. RN verbalized understanding. The patient did not report any symptoms during the 30-minute observation period. The client left the vaccination site at 1310 ambulating unassisted with a steady gait with his parents.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Received thawed vials on 13-OCT-2022 with a note that it expires on 13-OCT-2022 and administered vaccine on 16-Nov-2022; No adverse event; Patient received expired first primary dose beyond 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received thawed vials on 13-OCT-2022 with a note that it expires on 13-OCT-2022 and administered vaccine on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired first primary dose beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received thawed vials on 13-OCT-2022 with a note that it expires on 13-OCT-2022 and administered vaccine on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired first primary dose beyond 30-day Use By Date), PRODUCT STORAGE ERROR (Received thawed vials on 13-OCT-2022 with a note that it expires on 13-OCT-2022 and administered vaccine on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired first primary dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received thawed vials on 13-OCT-2022 with a note that it expires on 13-OCT-2022 and administered vaccine on 16-Nov-2022).    No concomitant information was reported. The pediatric patient was of age 8-10 years. The unbroken carton vial size was 2.5ml. The vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673516:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave 0.25 mL to an older adults; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) 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. AS7146B) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults).    No concomitant medication was reported.  It was reported that they gave 0.5 but initially charted 0.25 and changed it afterwards to 0.5. There was over a milliliter left of vaccine still in the vial after supposedly 5 full doses might have been withdrawn.  The vial fill volume was possibly too high. The vial was punctured 5 times. 5 doses were extracted from the vial.  The technique was unknown to used to load the syringe. No treatment medication was reported.  This case was for Adult patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-673577, US-MODERNATX, INC.-MOD-2022-673580, US-MODERNATX, INC.-MOD-2022-673533 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Additional follow-up received QE id was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673577:Case for Adult patient 2 US-MODERNATX, INC.-MOD-2022-673580:Case for Adult patient 4 US-MODERNATX, INC.-MOD-2022-673533:Case for Adult patient 1
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; No adverse event; Patient received moderna Covid-19 vaccine that had undergone several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received moderna Covid-19 vaccine that had undergone several temperature excursions).    Concomitant drugs were not reported. It was reported that between 24-May-2022 and 03-Oct-2022 several patients received monovalent and bivalent Moderna Covid-19 vaccine that had undergone several temperature excursions. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673878, US-MODERNATX, INC.-MOD-2022-673836, US-MODERNATX, INC.-MOD-2022-673644, US-MODERNATX, INC.-MOD-2022-673181 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673836:same reporter US-MODERNATX, INC.-MOD-2022-673878:same reporter US-MODERNATX, INC.-MOD-2022-673644:same reporter US-MODERNATX, INC.-MOD-2022-673181:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: No adverse event; possibly given the monovalent form as booster after bivalent authorization; possibly given the monovalent form as booster after bivalent authorization; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization) 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 (possibly given the monovalent form as booster after bivalent authorization) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization).    No concomitant medications were reported.  The reporter had called to ask if the lot number that was given to a patient was a bivalent or a monovalent vaccine. They state that they already called the vaccine provider and they were confused and they could not give them the information. It was reported that they already used the vial expiration checker and got the expiration date and they were wondering why if this were the bivalent vaccine it had an expiration date that was way too soon after the bivalent vaccine was authorized.  No treatment medications were reported.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event, Underdose
Clinical narrative: vaccine ended up on the patient's neck and shirt with no reported adverse event; did not receive the entire dose with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 73 years old male patient who did not receive the entire dose and vaccine ended up on the patient's neck and shirt with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 11-Nov-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ934AA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 11-Nov-2022, (latency: same day) the patient did not receive the entire dose with no reported adverse event (incorrect dose administered) and vaccine ended up on the patient's neck and shirt with no reported adverse event (accidental exposure to product) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, when administering FLUZONE HD QIV to a patient. When she administered the vaccine, there was almost no resistance when pushing on the plunger. A lot of the vaccine ended up on the patient's neck and shirt. The patient noted something cold on his neck and the pharmacist noticed a visible wet stain on the collar of the patient's shirt.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01365664:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Someone forgot to reconstitute the dose; Someone forgot to reconstitute the dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: 04 Nov 2022 Reporter's Comment: The reprort from field office manager stated that they just used the last Menveo dose in the box on Wednesday. There was one powder vial remaining.  Someone might have forgot to reconstitute one dose.  Since it was the last one I'm not sure which one of the previous four patients did not receive the correct reconstituted dose.  The reporter was asking what should we do. Information in parenthesis captured upon callback to office manager.  The customer had no details regarding patients or product lot and expiration date. The reporter consent for follow up. The healthcare professionals unsure which one of 4 patients did not received proper reconstituted dose. Additional Supportive Information: The someone forgot to reconstitute the dose and only liquid administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick only for 1.5 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick only for 1.5 days) in a male patient of an unknown age 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 ILLNESS (Sick only for 1.5 days). At the time of the report, ILLNESS (Sick only for 1.5 days) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient had Pfizer, Moderna and J and J vaccine (one of each and was only sick for 1.5 days.  Treatment information was not provided.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 93-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 vaccination.     No Medical History information was reported.    On 16-Nov-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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) 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 (administered with vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674354, US-MODERNATX, INC.-MOD-2022-674357 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674354:same reporter US-MODERNATX, INC.-MOD-2022-674357:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks; This spontaneous case was reported by a patient and describes the occurrence of RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis. Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN D3 and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks). At the time of the report, RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had been taking Vitamin pills (Vitamin D3, C, Zinc) before the Covid shots and psoriasis completely disappeared. Further it was reported that It was just started with just patches of bumps on patient's elbows. There was no itching.  Further in the follow up it was it was reported that the patient had a couple of patches on body before patient got the shot, approximately 3 years ago. When COVID came about patient started taking Vitamin D and other vitamins which helped get rid of psoriasis. However, after receiving shots of the Moderna COVID-19 patient started getting rashes again. Patient had rashes on back, elbow, ankles, private parts, and even buttocks.  No treatment medication was provided by the reporter.   This case was linked to MOD-2022-674385 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Follow up received included significant information, secondary reported, as reported event verbatim and narrative was updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Sleep disorder
Clinical narrative: Complete inability to sleep .  Edd 1/28/23.  Pregnancy uncomplicated .
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Low grade fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that received the 2nd dose of vaccine. The patient stated still having chills and low grade fever.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, needs his 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on April 2019 intramuscularly in an unknown deltoid).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 11 NOV 2022 Reporter's comment: The reporter was the patient. The reporter reported he needed to get his second Shingrix vaccine as the pharmacy never called to remind him. Reporter did not consent to follow up. The reporter does not give permission to contact HCP. Additional supportive information: Till the time of reporting the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.