chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Sleep disorder, Somnolence, Weight decreased
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Crying, Decreased appetite, Diarrhoea, Discomfort, Erythema
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Feeling hot, Hyperhidrosis, Pyrexia, Screaming, Somnolence
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB
Symptoms: Weight decreased
Clinical narrative: difficulty with balance and corrdenation; weight loss (1.5 pounds),; continued severe diarrhea; Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in; redness in face, neck; 100.3 temp, 103 temp; screaming in tears, unable to be consoled late into the next morning; screaming in tears, unable to be consoled late into the next morning; difficulty with balance and corrdenation; discomfort; sweating; sleepiness; loss of appetite; drowsy; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2667026-1. The original narrative from the sender is as follows.  "8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"  The reporter assessed the casual relationship between Vaxelis and the events " 8/1/23 loss of appetite, drowsy, sleepiness. 8/2/23 16:00 felt warm, sleepiness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to be consoled late into the next morning. 100.3 temp, 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain).103 temp produced 13+ liquids BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night.8/4/23 weight loss (1.5 pounds), continued discomfort, unable to sleep, difficulty with balance and coordination. Similar events with 2nd series with same vaccine(lot#U7536AA)"as related.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender; Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender, hot to the touch; patient would not crawl; wailed in pain; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667704-1. The original narrative from the sender is the following:  "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain" Message was sent to the provider Dr. and they were advised to get seen in urgent care, support care suggested (ibuprofen)"  The causal relationship between Vaxelis and the reported events "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain"" was assessed as Related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Pain
Clinical narrative: Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender; Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender, hot to the touch; patient would not crawl; wailed in pain; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667704-1. The original narrative from the sender is the following:  "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain" Message was sent to the provider Dr. and they were advised to get seen in urgent care, support care suggested (ibuprofen)"  The causal relationship between Vaxelis and the reported events "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain"" was assessed as Related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender; Parent reported redness and swelling that grew quickly and wrapped around her left thigh; It was tender, hot to the touch; patient would not crawl; wailed in pain; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2667704-1. The original narrative from the sender is the following:  "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain" Message was sent to the provider Dr. and they were advised to get seen in urgent care, support care suggested (ibuprofen)"  The causal relationship between Vaxelis and the reported events "Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain"" was assessed as Related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO A PATIENT OF INAPPROPRIATE AGE; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID number 2669308-1.The original narrative from the sender is the following:  "Patient presented for 6 month WCC check, Patient is 8 months old. Provider reported only reflux issues. Was given provided vaccinations, Vaxelis was administered for the first time and Rotateq was not age appropriate at this time"  Due to the nature of the event, the causal relationship between Vaxelis and "Product administered to patient of inappropriate age" was Not Applicable.  Of note, these events do not concern Vaxelis, but rather the RotaTeq vaccine which was administered to the patient on the same date as Vaxelis (as a co-suspect drug). However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Electroencephalogram, Illness, Musculoskeletal stiffness, Tremor
Clinical narrative: Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Electroencephalogram; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2669628-1. The original narrative from the sender is the following:  Upper body tremors and stiffening of legs began 1 week post vaccination. Tremors did not stop when arms were held down. Tremors occur when falling asleep, when going through developmental growth spurts, or when becoming ill. Tremors occur 2 or more times a week and have continued to current date.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Illness, Musculoskeletal stiffness, Tremor". Due to the nature of the event, the causal relationship between Vaxelis and "Electroencephalogram" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Electroencephalogram, Musculoskeletal stiffness, Tremor
Clinical narrative: Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Upper body tremors and stiffening of legs began 1 week post vaccination.  Tremors occur when falling asleep, when going through developmental growth spurts, or when  becoming ill. Tremors occur 2 or more times a week.; Electroencephalogram; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2669628-1. The original narrative from the sender is the following:  Upper body tremors and stiffening of legs began 1 week post vaccination. Tremors did not stop when arms were held down. Tremors occur when falling asleep, when going through developmental growth spurts, or when becoming ill. Tremors occur 2 or more times a week and have continued to current date.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Illness, Musculoskeletal stiffness, Tremor". Due to the nature of the event, the causal relationship between Vaxelis and "Electroencephalogram" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP, DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: a patient inadvertently received Engerix-B right after receiving PCV-15 and Vaxelis (Which had a hep b component); Accidental overdose; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2670241-1. The original narrative from the sender is the following:  Inadvertently received Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 2-year-old female patient who received HBV (Engerix B) (batch number Zp72s) for prophylaxis. Co-suspect products included VAXELIS for prophylaxis. On 07-AUG-2023, the patient received Engerix B. On an unknown date, the patient received VAXELIS. On 07-AUG-2023, an unknown time after receiving Engerix B, the patient experienced accidental overdose (Verbatim: inadvertently received Engerix-B). The outcome of the accidental overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt date: 07-AUG 2023 The reporter stated that on the reporting day a patient inadvertently received Engerix-B right after receiving PCV-15 and Vaxelis (Which had a hep b component). The reporter did consent to follow up. On the reporting day a patient inadvertently received Engerix-B right after receiving PCV-15 and Vaxelis (Which had a hep b component), which lead to accidental overdose.  Due to the nature of the event, the causal relationship between Vaxelis and "Extra dose administered" and " Accidental overdose" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2670324-1. The original narrative from the sender is the following:  Blood in stool - speck. 1 day after vaccine and 1 week after vaccines. recurred with 1 episode of blood in stool after 4mo vaccines as well.  The reporter assessed the causal relationship between Vaxelis and the event, "Haematochezia" as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC15, DTPPVHBHPB, HEPA, MMR, PNC15
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Vaxelis vaccination was given to a child (age 10), but is only approved for children under S. The child needed all the components of the vaccination and was the correct time interval.; product use in unapproved population; This spontaneous safety report, with reference number 2670904 (VAERS ID # 2670904-1) was received by a partner on 21-SEP-2023 and forwarded on 25-SEP-2023, from a HCP.  This case was considered as Off label use due to product use in unapproved population.  The causal relationship between Vaxelis and the reported events "A Vaxelis vaccination was given to a child (age 10) but is only approved for children under 5. The child needed all the components of the vaccination and was the correct time interval "and " product use in unapproved population" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, PNC15, DTPPVHBHPB, HEPA, MMR, PNC15
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: A Vaxelis vaccination was given to a child (age 10), but is only approved for children under S. The child needed all the components of the vaccination and was the correct time interval.; product use in unapproved population; This spontaneous safety report, with reference number 2670904 (VAERS ID # 2670904-1) was received by a partner on 21-SEP-2023 and forwarded on 25-SEP-2023, from a HCP.  This case was considered as Off label use due to product use in unapproved population.  The causal relationship between Vaxelis and the reported events "A Vaxelis vaccination was given to a child (age 10) but is only approved for children under 5. The child needed all the components of the vaccination and was the correct time interval "and " product use in unapproved population" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was behind on vaccines. The HIB in the Vaxelis was given too early. The HIB needed to be an 8wk interval; Patient did not have any issues with the injection per Mom; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2671543-1. The original narrative from the sender is the following:  "Patient was in office for vaccines,RN  gave Vaxelis to patient. Patient was behind on vaccines. The HIB in the Vaxelis was given too early. The HIB needed to be an 8wk interval. Patient mother was contacted and informed of error. Mother V/U. Patient did not have any issues with the injection per Mom. PCP was notified. Message left with Nurse. Mother notified to contact RN if issues accord.  Due to the nature of the event, the casual relationship between Vaxelis and the events " Patient was behind on vaccines,the HIB in the Vaxelis was given too early, the HIB needed to be an 8wk interval ", and " Patient did not have any issues with the injection per Mom " was assessed as not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, RV5, UNK, DTPPVHBHPB, RVX, UNK
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient develop red color rash over trunk and chest wall; rPatient develop red color rash over trunk and chest wall; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2672513-1. The original narrative from the sender is the following:  "Patient develop red color rash over trunk and chest wall.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Patient develop red color rash over trunk and chest wall.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site induration, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: hard; Rash; It's warm; red; Spreading down my puffy swollen; Underneath the shot i got a fire burning sensation that doesn't go away it's warm red rash that keeps spreading down my arm puffy swollen hard.; Product administered to patient of 55years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674209-1. The original narrative from the sender is the following:  "Underneath the shot I got a fire burning sensation that doesn't go away its warm red rash that's spreading down my arm puffy swollen hard.   The case is considered as off label use due to Product use issue (product use in unapproved population).  The reporter assessed the casual relationship between Vaxelis and the events " "underneath the shot I got a fire burning sensation that doesn't go away "it's warm and "red rash that's spreading down my arm "puffy swollen hard "as related. The causal relationship between Vaxelis and the event " Product administered to patient of 55years" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Rash erythematous
Clinical narrative: hard; Rash; It's warm; red; Spreading down my puffy swollen; Underneath the shot i got a fire burning sensation that doesn't go away it's warm red rash that keeps spreading down my arm puffy swollen hard.; Product administered to patient of 55years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674209-1. The original narrative from the sender is the following:  "Underneath the shot I got a fire burning sensation that doesn't go away its warm red rash that's spreading down my arm puffy swollen hard.   The case is considered as off label use due to Product use issue (product use in unapproved population).  The reporter assessed the casual relationship between Vaxelis and the events " "underneath the shot I got a fire burning sensation that doesn't go away "it's warm and "red rash that's spreading down my arm "puffy swollen hard "as related. The causal relationship between Vaxelis and the event " Product administered to patient of 55years" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Product use issue, Rash erythematous
Clinical narrative: hard; Rash; It's warm; red; Spreading down my puffy swollen; Underneath the shot i got a fire burning sensation that doesn't go away it's warm red rash that keeps spreading down my arm puffy swollen hard.; Product administered to patient of 55years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674209-1. The original narrative from the sender is the following:  "Underneath the shot I got a fire burning sensation that doesn't go away its warm red rash that's spreading down my arm puffy swollen hard.   The case is considered as off label use due to Product use issue (product use in unapproved population).  The reporter assessed the casual relationship between Vaxelis and the events " "underneath the shot I got a fire burning sensation that doesn't go away "it's warm and "red rash that's spreading down my arm "puffy swollen hard "as related. The causal relationship between Vaxelis and the event " Product administered to patient of 55years" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Disorientation, Irritability, Musculoskeletal stiffness, Pyrexia, Unresponsive to stimuli
Clinical narrative: The next day he was fussy and somewhat disorented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; The next day he was fussy and somewhat disoriented; Patient's mom went to check on him at 0100 and found he was "stiff as a board and was not responding; That evening ,around 8pm,patient developed a fever of 101.9F; The next day he was fussy and somewhat disoriented; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2674304-1. The original narrative from the sender is the following:  patient's mother reported that patient had received second dose of Vaxelis on 08/11/2023. That evening, around 8pm, patient developed a fever of 101.9F. His parents put him to bed and co-slept with him to monitor him. Patient's mom went to check on him at 0100 and found he was "stiff as a board" and was not responding. She started screaming for help and had her phone ready to call 911 when he finally came to Per father, patient was not responding for about 1-2 minutes, and they were unsure if he was breathing or not. They did not call 911 or bring him to the hospital. The next day he was fussy and somewhat disoriented. Patient's mom spoke with an MD online provider who thought he may have been in REM sleep during the episode. The patient's mother disagrees with that assessment and states after the first dose of Vaxelis he has been very lethargic. Patient's primary care provider is unsure this event was related to the vaccination."  The reporter assessed the casual relationship between Vaxelis and the events "That evening, around 8pm, patient developed a fever of 101.9F, the next day he was fussy and somewhat disoriented, Patient's mom went to check on him at 0100 and found he was "stiff as a board, not responding, the next day he was fussy and somewhat disoriented" as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, TDAP, DTPPVHBHPB, MMRV, TDAP
Symptoms: Unevaluable event
Clinical narrative: Attempt to reach arent with assistance of interpreter to check on patient.Left message to call the office; product use in unapproved population; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2674478-1. The original narrative from the sender is as follows.  "Attempt to reach parent with assistance of interpreter to check on patient. Left a message to call the office."  The case was classified as non-valid given that the reported event was "Unevaluable event".  Due to the nature of the event, the causal relationship between Vaxelis and "Unevaluable event" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, TDAP, DTPPVHBHPB, MMRV, TDAP
Symptoms: Product use issue
Clinical narrative: Attempt to reach arent with assistance of interpreter to check on patient.Left message to call the office; product use in unapproved population; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2674478-1. The original narrative from the sender is as follows.  "Attempt to reach parent with assistance of interpreter to check on patient. Left a message to call the office."  The case was classified as non-valid given that the reported event was "Unevaluable event".  Due to the nature of the event, the causal relationship between Vaxelis and "Unevaluable event" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC15, DTPPVHBHPB, HEPA, MMRV, PNC15
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: child refused to walk complaining of pain In leg. Given Ibuprophen and no relief and continued to refuse to walk. Slept through night and woke up and continues to refuse to walk complaining of pain in Left thigh.; Mother brought child back to clinic on 8/22, observed her difficulty walking..; This serious spontaneous safety report, with case ID number:2674913 (VAERS ID# ), was received by a partner on 22-SEP-2023 and forwarded on 26-SEP-2023, from a HCP.  Due to the nature of the event, the causality between the events "child refused to walk complaining of pain In leg. Given Ibuprophen and no relief and continued to refuse to walk. Slept through night and woke up and continues to refuse to walk complaining of pain in Left thigh." , and "Mother brought child back to clinic on 8/22, observed her difficulty walking", and Vaxelis is Related.   No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site mass
Clinical narrative: Noticed a lump at pt vaccine site; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2675119-1. The original narrative from the sender is the following:  "Noticed a lump at pt vaccine site".  The reporter assessed the causal relationship between Vaxelis and the events "Injection site mass" as related.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Developed fever higher than expected - 103.9 without other symptoms; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2675644-1. The original narrative from the sender is the following:  "Developed fever higher than expected - 103.9 without other symptoms."  The causal relationship between Vaxelis and the event "Pyrexia", was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, DTPPVHBHPB, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2677158-1. The original narrative from the sender is the following:  "Incorrect dose administered (Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit)".  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and the event "Incorrect dose administered" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, DTPPVHBHPB, HEPA
Symptoms: Extra dose administered
Clinical narrative: Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2677158-1. The original narrative from the sender is the following:  "Incorrect dose administered (Provider inadvertently ordered an additional hepatitis B vacccine during the 6month visit. A combo vaccine was ordered containing hep b, however the smartset for 6month visit still contained a checked box for hep b. Offering 2 orders of hep b/visit)".  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and the event "Incorrect dose administered" was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Gaze palsy, Tremor
Clinical narrative: Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self resolved; Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self resolved; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2678698-1. The original narrative from the sender is the following:  "Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self-resolved."  The reporter did not provide an assessment of casual relationship between Vaxelis and the events "Gaze palsy" and "Tremor".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Dyskinesia, Gaze palsy
Clinical narrative: Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self resolved; Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self resolved; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2678698-1. The original narrative from the sender is the following:  "Brief 10-15 second upward eye deviation, bilateral arm jerking and bilateral leg jerking. self-resolved."  The reporter did not provide an assessment of casual relationship between Vaxelis and the events "Gaze palsy" and "Tremor".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2679159-1. The original narrative from the sender is the following:  "PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx. 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023."  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.   NON-SIGNIFICANT FOLLOW UP INFORMATION  with the case reference number 2679159-1 (VAERS ID#:2679159-1) was received by partner on 07-NOV-2023 and forwarded to UBC on 10-NOV-2023 from a from a healthcare professional. The case is maintained as non-serious.  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2679159-1. The original narrative from the sender is the following:  "PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx. 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023."  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.   NON-SIGNIFICANT FOLLOW UP INFORMATION  with the case reference number 2679159-1 (VAERS ID#:2679159-1) was received by partner on 07-NOV-2023 and forwarded to UBC on 10-NOV-2023 from a from a healthcare professional. The case is maintained as non-serious.  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Product administered at inappropriate site
Clinical narrative: PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; PCV15 vaccine administered R thigh; above R knee; pt inability to move R leg for 12hrs; 2 days of crying in pain and swelling above R knee; red area 2+months later on 8/28/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2679159-1. The original narrative from the sender is the following:  "PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx. 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023."  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.   NON-SIGNIFICANT FOLLOW UP INFORMATION  with the case reference number 2679159-1 (VAERS ID#:2679159-1) was received by partner on 07-NOV-2023 and forwarded to UBC on 10-NOV-2023 from a from a healthcare professional. The case is maintained as non-serious.  Due to the nature of the event and co-suspect product involved, the causal relationship between Vaxelis and "Product administered at inappropriate site", "Injected limb mobility decreased", "Crying", "Injection site pain", "Injection site swelling", was assessed as Not applicable.  No further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC15, RV5, COVID19, DTPPVHBHPB, FLU4, PNC15, RV5
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; product storage error; Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2681331-1. The original narrative from the sender is as follows:  "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions".  Due to the nature of the events, the causal relationship between Vaxelis and "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions" was not applicable.  No further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC15, RV5, COVID19, DTPPVHBHPB, FLU4, PNC15, RV5
Symptoms: Product administered to patient of inappropriate age, Product storage error, Product use issue
Clinical narrative: Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; product storage error; Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage.; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS Primary ID 2681331-1. The original narrative from the sender is as follows:  "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions".  Due to the nature of the events, the causal relationship between Vaxelis and "Patient was administered a 5-11yr old bivalent vaccination. Patient should have been given the 6mo-4yr dosage. Nursing states that the vial of 5-11 vaccine was in the incorrect bin and was then drawn up and labeled as 6mo-4yr. Nursing then administered this dose and it was not caught through medication scanning as it was labeled incorrectly. Patient family to be notified to monitor for any reactions" was not applicable.  No further information is expected.