chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; injected the vaccine to a patient 2 days beyond expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected the vaccine to a patient 2 days beyond expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-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 14-Jun-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 (injected the vaccine to a patient 2 days beyond expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected the vaccine to a patient 2 days beyond expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (injected the vaccine to a patient 2 days beyond expiration date).    No concomitant medication was reported.  Date the vial initially stored in the refrigerator on 01-JUN-2023. Expiry date was reported as 12-JUN-2023. No treatment information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023; No adverse event; 1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, 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 21-Jun-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 (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-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 (1 Patient received as a fifth dose an expired dose of the Moderna COVID19 vaccine bivalent) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 22-May-2023 and admininstered on 21-Jun-2023).    No concomitant medication was reported. Dose administered after 30-day Use By Date or after manufacturer. Vial size was reported as  2.5ml . Vial did not undergo any temperature excursions. Treatment information was not provided.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: Injection site swelling, Rash
Clinical narrative: Patient went to the office on 1/26 with a bump at the Vaxelis injection site; Rashes on right and left thigh; This non-serious spontaneous Safety Report, with reference number 2023SA031837, was received by partner on 26-JAN-2023 and forwarded on 27-JAN-2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient went to the office on 1/26 with a bump at the Vaxelis injection site".  Further information is expected.  Significant Follow-up information was received by the partner on 24-MAR-2023 and forwarded on 27-MAR-2023, from other health professional. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient went to the office on 1/26 with a bump at the Vaxelis injection site and Rashes on right and left thigh".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA
Symptoms: Induration, Product storage error
Clinical narrative: Small induration; Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F (58.1F); This spontaneous safety report, with reference number 02365662 (Interaction # 02365635) was received by the partner on 04-APR-2023 and forwarded to agency on 05-APR-2023, from a health professional.    This case was considered non-valid due to no patient identifiers (Temperature excursion only).  Due to the nature of the event, the causality between the event "coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis was not applicable.   Further information is expected.  FOLLOW-UP INFORMATION was received on 18-APR-2023, from a HCP. The case is maintained as non-serious and non-valid.   Due to the nature of the event, the causality between the event "coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  FOLLOW-UP INFORMATION was received on 09-MAY-2023 from an HCP and additional information was received by the partner on 10-MAY2023 and forwarded to agency on 11-May-2023 from an HCP.  This case is now considered valid due to patient identifiers being provided.   The reporter did not provide an assessment of the causal relationship between VAXELIS and the event of "Small induration."   Due to the nature of the event, the causality between the event "Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 25-MAY-2023, from a HCP. The case is maintained as non-serious and upgraded to valid (patient identifiers were provided on the follow-up received on 09-MAY-2023, from the HCP).   The reporter did not provide an assessment of the causal relationship between VAXELIS and the event of "Small induration."   Due to the nature of the event, the causality between the event "Coordinator reports improperly stored vaccine products were administered to patients on unknown dates. Names of vaccines involved; VAXELIS. Temperature ABOVE 47F" and Vaxelis remained not applicable.  No further information is expected given that the reporter replied to all our queries.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Incorrect route of product administration, Injection site nodule, Off label use, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023; HCP reported that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/  nodule was still present at follow up 17/03/2023; This spontaneous safety report, with reference number 02366699 (Interaction# 02366693), was received by the partner on 05-APR-2023 and forwarded to agency on 06-APR-2023, from a non- health professional.  The case was considered off-label due to Incorrect route of product administration.  The reporter did not assess the causal relationship between Vaxelis and the reported events of "Agency calling on behalf of HCP to report AE for VAXELIS. Agency received information verbally from HCP during meeting on 4/5/23. HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose."  Due to the nature of the event, the causality between the event "Route of administration reported as IV for Vaxelis" and Vaxelis was not applicable.  Further information is expected.  For reference purposes the case is linked to MCM-004673 (same reporter).  SIGNIFICANT FOLLOW-UP INFORMATION was received on 19-APR-2023 by partner from the physician and forwarded to agency on 20-APR-2023.  Off-label classification was removed as route of administration was reported as intra-muscular.  The reporter assessed the causal relationship between Vaxelis and the event, "HCP reported to agency that 2 pediatric patients were observed to have a nodule/bump still present at injection site after 2nd dose/ Subcutaneous nodule lasting 2 months on L thigh/  nodule was still present at follow up 17/03/2023" as related.  The reporter did not assess the relationship between Vaxelis and the event, "Redness and swelling at vaccination site inflammation resolved without intervention but nodule was still present at follow up 17/03/2023".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized site reaction with swelling and redness; a nodule present at 4 month well child (2 months later); Localized site reaction with swelling and redness; Localized site reaction with swelling and redness; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2598701-1. The original narrative from the sender is as follows:  Localized site reaction with swelling and redness, improved over time but still has a nodule present at 4 month well child (2 months later).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Localized site reaction with swelling and redness, and a nodule present at 4 months well child (2 months later)".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HPV9, MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Product administered to patient of inappropriate age (13 years old); This case was retrieved during the  monitoring on 12-APR-2023 with the following Primary ID 2602334-1. The original narrative from the sender is as follows:  No symptoms or adverse effects.  Due to the nature of the event, the causal relationship between Vaxelis and "no symptoms or adverse effects and Product administered to patient of inappropriate age (13 years old)" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Coronavirus infection, Coronavirus test positive, Pyrexia
Clinical narrative: Fever of 106 treated with Tylenol by mom, patient discharged home; Coronavirus infection; Coronavirus test positive; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2559597-1. The original narrative from the sender is the following:  Fever of 106 treated with Tylenol by mom, patient discharged home.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Fever of 106 treated with Tylenol by mom, patient discharged home, coronavirus infection, and coronavirus test positive".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: A MMRV WAS ADMINISTERED INSTEAD OF A MMR WHICH RESULTED IN THE PT RECEIVING TWO VARIVAX DOSES; A MMRV WAS ADMINISTERED INSTEAD OF A MMR WHICH RESULTED IN THE PT RECEIVING TWO VARIVAX DOSES; This case was retrieves during monitoring on 12-APR-2023 with the following Primary ID 2601724-1. The original narrative from the sender is as follows:  A MMRV was administered instead of a MMR which resulted in the PT receiving two VARIVAX doses.  Due to the nature of the events, the causal relationship between Vaxelis and the event "A MMRV was administered instead of a MMR which resulted in the PT receiving two VARIVAX doses" was not applicable.  No further information is expected. Notes: Based on the available information, the events were not related to Vaxelis but to Varivax and MMR vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.; Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2561510-1. The original narrative from the sender is the following:  Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given both Vaxelis and Hib vaccinations. No adverse reactions reported by parents.".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMR
Symptoms: Contusion, Urticaria
Clinical narrative: It was bruised badly and had welts; It was bruised badly and had welts; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2602428-1. The original narrative from the sender is as follows:  Notes per provider during follow-up office visit as follows: "Pt was seen by another provider one week ago & received shots (Vaxelis, MMR, Varicella). Dad reports that it was bruised badly and had welts. It had spread but now it is better according to dad.  She was given an allergy med. At home."  cephALEXin (Keflex) 250 MG/5ML suspension prescription sent to pharmacy with for patient to take 2.4 mLs (120 mg total) by mouth 3 (three) times daily for 10 days.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "It was bruised badly and had welts".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMR, PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient received Vaxelis instead of getting varicella; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2570580-1. The original narrative from the sender is the following:  Patient received Vaxelis instead of getting varicella. Patients mother was notified, manufacturer , and safety report from office was completed.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient received Vaxelis instead of getting varicella".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP, HIBV, PNC13, RV5
Symptoms: Brief resolved unexplained event, Chest X-ray normal, Crying, Electrocardiogram normal, Erythema
Clinical narrative: Went limp; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; She was still unresponsive; Retching; She had a fever of 100.3 at the time; Electrocardiogram normal; Turned grey; She was still unresponsive; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2555808-1. The original narrative from the sender is as follows:   At 8:45pm Pt started sounding like she was trying to vomit, turned grey and went limp. We rushed her to the ER at the medical center. When we got there, she was still unresponsive and she started to come to while we were being triaged. She had a fever of 100.3 at the time. We were sent to the waiting room; after an hour or two, she was fully alert and back to her normal color. We decided to go home and monitor her because there was a very long wait time at the ER and a lot of sick people and we were uncomfortable keeping her around that many sick people. Saturday morning, she had a fever of 103, we gave her Tylenol and it came down. She didn't have a fever the rest of the day. That afternoon, I went to change her diaper and noticed the bottoms of her feet were red, swollen and hot to the touch. She was then inconsolable for 4-5 hours and I spoke to the after hours nurse and the on call provider at pediatrics clinic and they said we needed to go back to the ER. We packed up and went to the hospital and they did a chest X-ray, labs, and EKG and all came back normal. They called it a brief resolved unexplained event.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Went limp", "Noticed the bottoms of her feet were red, swollen, and hot", "Retching, and "She was still unresponsive".  Due to the nature of the event, the causal relationship between Vaxelis and the events "She had a fever of 100.3 at the time", "Electrocardiogram normal", "Turned grey", and, "She was still unresponsive" is not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP, HIBV, PNC13, RV5
Symptoms: Hypotonia, Laboratory test normal, Peripheral swelling, Pyrexia, Retching
Clinical narrative: Went limp; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; She was still unresponsive; Retching; She had a fever of 100.3 at the time; Electrocardiogram normal; Turned grey; She was still unresponsive; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2555808-1. The original narrative from the sender is as follows:   At 8:45pm Pt started sounding like she was trying to vomit, turned grey and went limp. We rushed her to the ER at the medical center. When we got there, she was still unresponsive and she started to come to while we were being triaged. She had a fever of 100.3 at the time. We were sent to the waiting room; after an hour or two, she was fully alert and back to her normal color. We decided to go home and monitor her because there was a very long wait time at the ER and a lot of sick people and we were uncomfortable keeping her around that many sick people. Saturday morning, she had a fever of 103, we gave her Tylenol and it came down. She didn't have a fever the rest of the day. That afternoon, I went to change her diaper and noticed the bottoms of her feet were red, swollen and hot to the touch. She was then inconsolable for 4-5 hours and I spoke to the after hours nurse and the on call provider at pediatrics clinic and they said we needed to go back to the ER. We packed up and went to the hospital and they did a chest X-ray, labs, and EKG and all came back normal. They called it a brief resolved unexplained event.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Went limp", "Noticed the bottoms of her feet were red, swollen, and hot", "Retching, and "She was still unresponsive".  Due to the nature of the event, the causal relationship between Vaxelis and the events "She had a fever of 100.3 at the time", "Electrocardiogram normal", "Turned grey", and, "She was still unresponsive" is not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP, HIBV, PNC13, RV5
Symptoms: Skin discolouration, Skin warm, Unresponsive to stimuli
Clinical narrative: Went limp; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; Noticed the bottoms of her feet were red, swollen, and hot; She was still unresponsive; Retching; She had a fever of 100.3 at the time; Electrocardiogram normal; Turned grey; She was still unresponsive; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2555808-1. The original narrative from the sender is as follows:   At 8:45pm Pt started sounding like she was trying to vomit, turned grey and went limp. We rushed her to the ER at the medical center. When we got there, she was still unresponsive and she started to come to while we were being triaged. She had a fever of 100.3 at the time. We were sent to the waiting room; after an hour or two, she was fully alert and back to her normal color. We decided to go home and monitor her because there was a very long wait time at the ER and a lot of sick people and we were uncomfortable keeping her around that many sick people. Saturday morning, she had a fever of 103, we gave her Tylenol and it came down. She didn't have a fever the rest of the day. That afternoon, I went to change her diaper and noticed the bottoms of her feet were red, swollen and hot to the touch. She was then inconsolable for 4-5 hours and I spoke to the after hours nurse and the on call provider at pediatrics clinic and they said we needed to go back to the ER. We packed up and went to the hospital and they did a chest X-ray, labs, and EKG and all came back normal. They called it a brief resolved unexplained event.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Went limp", "Noticed the bottoms of her feet were red, swollen, and hot", "Retching, and "She was still unresponsive".  Due to the nature of the event, the causal relationship between Vaxelis and the events "She had a fever of 100.3 at the time", "Electrocardiogram normal", "Turned grey", and, "She was still unresponsive" is not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2573153-1. The original narrative from the sender is the following:  Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-APR-2023 with the following VAERS Primary ID 2573888-1. The original narrative from the sender is the following:  FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV was administered to a patient under 6 months old instead of vaxelis with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination. On 27-JAN-2023 the patient developed a non-serious event of fluzone qiv np (strength, formulation was unknown,dose:0.5ml, batch number: UT7689LA and expiry date:30-Jun-2023 via intramuscular route in Left thigh for prophylactic vaccination) was administered to a patient under 6 months old instead of vaxelis with no reported adverse event (product administered to patient of inappropriate age, wrong product administered) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and VAXELIS. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) was not applicable. Outcome: Unknown 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 guidelines. 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.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "FLUZONE QIV NP was administered to a patient under 6 months old instead of VAXELIS with no reported adverse event".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: extra dose of hep b; Patient ordered Pentacel and received Vaxelis; extra dose of hep b; No adverse reaction noted; This case was retrieves during monitoring on 12-APR-2023 with the following Primary ID 2593261-1. The original narrative from the sender is as follows:  Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, just extra dose of hep b.  Due to the nature of the events, the causal relationship between Vaxelis and the events "Patient ordered Pentacel and received Vaxelis. No adverse reaction noted, and extra dose of hep b" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given a Varivax in addition to a Pro Quad which contained Varicella; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2589271-1. The original narrative from the sender is as follows:  Patient was given a Varivax in addition to a Pro Quad which contained Varicella.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient was given a Varivax in addition to a Pro Quad which contained Varicella".  No further information is expected.  Based on the available information, the events were not related to Vaxelis but to other vaccines. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Discomfort, Muscle spasms
Clinical narrative: Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no c; This case was retrieved during monitoring on 12-APR-2023 with the following Primary 2591780-1. The original narrative from the sender is as follows:  Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no color change or weakness Could not breastfeed due to spasms Parents called on call Nurse and spoke with on Call Doctor, given option to  monitor at home or go to ER. Parents chose to monitor at home over night.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Off label use, Wrong product administered
Clinical narrative: Vaxelis was mistakenly administered instead at 11:45 AM; 5-year-old child; Patient currently not experiencing any adverse events; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2550238-1. The original narrative from the sender is as follows:   Patient was due for her Influenza vaccine at the appointment. Vaxelis was mistakenly administered instead at 11:45AM. Mother was made aware of error at 11:48. Patient currently not experiencing any adverse reaction and will return at a later date for her Influenza vaccine. Mother aware of potential reaction types and voiced understanding.   Due to the nature of the event, the causal relationship between Vaxelis and the events "Vaxelis was mistakenly administered instead at 11:45 AM" and "Patient currently not experiencing any adverse events" is not applicable.  Off-label use added to the case due to Vaxelis being administered to a 5-year-old child.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA, HIBV, MMRV, PNC13
Symptoms: Back pain, Extra dose administered, Pain
Clinical narrative: Seeming mild soreness; PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine; This case was retrieved during monitoring on 12-APR-2023 with the following Primary ID 2554760-1. The original narrative from the sender is as follows :  Patient came in to get caught up on routine vaccines. PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine. No reaction noted at time of vaccination. Child tolerated vaccines well. Mom was contacted on 04-JAN-2023 to notify of extra dose and to ask how child was doing. Mom stated patient was doing well with no fever and seeming mild soreness. No concerns from mom other than to ask if child received all the vaccines he needed.  The causal relationship between Vaxelis and the reported event Seeming mild soreness" was not provided.  Due to the nature of the event, the causal relationship between Vaxelis and "PedVaxHib was accidentally given in addition to Vaxelis, resulting in an extra dose of Hib vaccine" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB; This non-serious spontaneous Safety Report was received by partner on 19-APR-2023 and forwarded to agency on 21-APR-2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "A medical assistant called and wants to know if there is any side effects because the both administered ACTHIB & Vaxelis to a patient. They concern was it both contains HIB".  Further information is expected.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance; A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance; This non-serious spontaneous safety report, with reference number 2023SA130811/ Inquiry# 01590758 was received by a partner on 25-APR-2023 and forwarded to agency on 26-APR-2023 from a health professional.    Due to the nature of the event, the causality between the events "A patient inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance" and Vaxelis was not applicable.  Further information is expected.
Age: 13.0
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Off label use, Product use issue
Clinical narrative: Patient is supposed to have a diptheria, tetanus and polio vaccine. She administered Vaxelis and a polio injectable.; Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated.; Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated.; This non-serious spontaneous safety report with reference number # 2023SA134066 (Inquiry #01594542) was received by a partner on 27-APR-2023 and forwarded to agency on 01-MAY2023 from a health care professional.  The case was considered as off-label due to product being administered in unapproved population.  Due to the nature of the events, the causality between the events "Nurse called stating 13-year old male came in today. She administered Vaxelis and a polio injectable. Polio vaccine has been duplicated. and " and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Wrong product administered
Clinical narrative: HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered; This spontaneous safety report, with reference number 02385069 (Interaction # 02385061) was received by the partner on 08-MAY-2023 and forwarded to agency on 09-MAY-2023, from a health professional.    Due to the nature of the event, the causality between the event "HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 16-MAY-2023 and forwarded to agency on 17-MAY-2023, from a health care professional. This case is maintained as non-serious.  This case continues to be considered non-valid.   The causal relationship between VAXELIS and the reported event of "HCP called to report a TE with MMR II, PROQUAD, VARIVAX, GARDASIL 9, ROTATEQ, VAQTA, VAXELIS PFS. VAXELIS PFS and ROTATEQ were administered is not applicable."  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Vaccination error
Clinical narrative: Patient was given Vaxelis an ACTHIB on the same day; Patient was given Vaxelis an ACTHIB on the same day; This non-serious spontaneous safety report was received by partner on 10-MAY-2023 and forwarded to agency on 11-MAY-2023 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient was given Vaxelis an ACTHIB on the same day".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was accidentally administered another dose of Vaxelis and Rotateq; inappropriate schedule of drug administration; This non-serious spontaneous safety report, with Case ID: 02387773 (Interaction number 02387767), was received by partner, on 11-MAY-2023 and forwarded to agency on 12-MAY-2023 from other health professional.  The causal relationship between Vaxelis and the reported events "The patient was accidentally administered another dose of Vaxelis and Rotateq and Inappropriate schedule of drug administration" was assessed as not applicable due to the nature of the events.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Employee states that a 2 month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose.; This non-serious spontaneous safety report, with case ID 02389872 (Interaction Number 02389865), was received by partner, on 16MAY2023 and forwarded to agency on 17MAY2023 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Employee states that a 2-month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose.".  Further information is expected.  Significant Follow-up information was received by the partner on 02-JUN-2023 and forwarded to agency on 02-JUN-2022, from a physician. The case is maintained as non-serious.   The reporter confirmed that there were no adverse events following the accidental early administration of Vaxelis second dose.  The causal relationship between Vaxelis and the reported event  "Employee states that a 2-month-old patient received the first dose of VAXELIS on schedule on 18-APR-2023. Second dose of VAXELIS was given by accident earlier than the recommended schedule on 12- MAY-2023, only 23 days after the first dose" was assessed as not applicable due to the nature of the event.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received on 07-JUN-2023 by the partner and forwarded to agency on 07-JUN-2023.  The case is maintained as non-serious.  The causal relationship between the event and Vaxelis is not applicable due to the nature of the event.   No further information is expected.
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, Medication error
Clinical narrative: Patient inadvertently received a dose of Vaxelis and Hiberix; medication error due to administering VAXELIS and a HIB vaccine in the same day resulting in extra dose of HIB; This non-serious spontaneous safety report, with (Inquiry Number: 01625364), was received by partner on 23MAY2023 and forwarded to agency on 24MAY2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient inadvertently received a dose of Vaxelis and Hiberix and medication error due to administering VAXELIS and a HIB vaccine in the same day resulting in extra dose of HIB".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Rash, Swelling face
Clinical narrative: child had a facial swelling; Rash across the bridge of nose and under eyes; This non-serious spontaneous safety report, with Case ID: 02395447 (Interaction Number 02395443), was received by partner, on 23MAY2023 and forwarded to agency on 26MAY2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "child had a facial swelling and Rash across the bridge of nose and under eyes".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site haematoma
Clinical narrative: large hematoma at the injection site 1-2 days after receiving VAXELIS and VAXENEUVANCE at his 6 month visit; This non-serious spontaneous safety report with local event number 02395610, and interaction number 02395604, was received by a partner on 25-MAY-2023 and forwarded to agency on 26-MAY-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Injection site haematoma".   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 102.2 within 4 hours of medication; This spontaneous safety report, with reference number 2612749 (ID 2612749-1), was received by the partner on 24-MAY-2023 and forwarded on 26-MAY-2023, from a non-health professional.  The reporter did not assess the causal relationship between Vaxelis and the reported event of "Fever 102.2 within 4 hours of medication".  Further information is not expected.
Age: 1.25
Sex: U
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given both Vaxelis and ActHIB in the same injection site; Patient was given both Vaxelis and ActHIB; This non-serious spontaneous safety report, with MSD Case ID: 02397640 (Interaction Number 02397630), was received by partner on 30-MAY-2023 and forwarded on the same day from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient was given both Vaxelis and ActHIB in the same injection site and Patient was given both Vaxelis and ActHIB".  Further information is expected.
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: The patient received a dose of Vaxelis and a dose of Pentacel on 5/19/23; This non-serious spontaneous safety report, with Case ID: 02400302 (Interaction number 02400301), was received by partner on 05-JUN-2023 and forwarded to agency on 05-JUN-2023 from other health professional.  The causality assessment between Vaxelis and the reported event "The patient received a dose of Vaxelis and a dose of Pentacel on 5/19/23" was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Physician states that a 25 year old patient was given Vaxelis by accident; This non-serious spontaneous safety report, with Case Number: 2023SA184651 (Inquiry Number: 01655266), was received by partner, on 15Jun2023 and forwarded to agency on 16Jun2023 from a physician.  Due to the nature of the event, the causal relationship between Vaxelis and the reported event "Physician states that a 25 year old patient was given Vaxelis by accident" was assessed as not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient; Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient; This non-serious spontaneous safety report, with Identification Number 2023SA183716 (Inquiry Number: 01653898/Inquiry: 01653864), was received by partner, on 14-JUN-2023 and forwarded on 16-JUN-2023 from a health professional. Additional Information was received on 16-JUN-2023.  The causal relationship between Vaxelis and the reported events "Medical assistant thought that the Vaxelis did not contain the components of ACTHIB and gave an extra dose of ACTHIB to the patient" was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: HCP reported 2 month old male developed bloody diarrhea 1 week after receiving VAXELIS; This non-serious spontaneous safety report with reference number # 02409163 (# 02409160) was received by a partner on 16-JUN-2023 and forwarded on 16-JUN-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "HCP reported 2-month-old male developed bloody diarrhea 1 week after receiving VAXELIS".  Further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: headache; Queasy stomach; vomiting; diarrhea (loose, then changed to runny); severe chills; slight fever at 99.6 degrees F; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 11:00 as dose 1, single (Lot number: GK1337) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac sprue" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Gluten (celiac sprue)" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; GLUCOSAMINE; TYLENOL; VIT D [VITAMIN D NOS]; OMEGA 3 [FISH OIL]. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: NAUSEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "Queasy stomach"; DIARRHOEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "diarrhea (loose, then changed to runny)"; CHILLS (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "slight fever at 99.6 degrees F"; VOMITING (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered"; HEADACHE (non-serious) with onset 21Jun2023 at 01:30, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, chills, pyrexia, headache.  Additional information: No other vaccine administered in four weeks. Other medications in two weeks: Levothyroxine/glucosamine/Tylenol/Vit D/omega 3. No Covid prior to vaccination and Not tested for Covid post vaccination. At 7 pm: Queasy stomach, then vomiting and diarrhea (loose, then changed to runny) for approx 30-40 minutes; went to bed with severe chills & slight fever at 99.6 degrees F. Woke up at 1:30 am w/headache.