chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618090-1. The original narrative from the sender is as follows:  On 17-Apr-2023, after vaccination with Vaxelis on 14-Apr-2023, a four-month-old neonate experienced seizure like activity-full body shaking upon feeding afternoon bottle (had eaten half of the bottle, or (about 1.5-2 ounces). Afterward the neonate fell asleep for about twenty minutes. The neonate was reported to be in normal state of health upon waking up. He was brought in and had an evaluation in the ER (emergency room) about one hour after the event. At that time, he had a normal physical exam. Lab results were reported as CBC (complete blood count): wnl (within normal limits), Plt (Platelets): 550, MCV (mean corpuscle volume): 50, BMP (basic metabolic panel): wnl (within normal limits), and lactic acid: 2.2.  Due to the nature of the event the causal relationship between Vaxelis and the event, "Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.)" was assessed as related, whereas, the events, "blood lactic acid", "brain natriuretic peptide normal", "full blood count abnormal", "mean cell volume normal", "platelet count increased" were considered not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Blood lactic acid, Brain natriuretic peptide normal, Full blood count abnormal, Mean cell volume decreased, Metabolic function test normal
Clinical narrative: Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618090-1. The original narrative from the sender is as follows:  On 17-Apr-2023, after vaccination with Vaxelis on 14-Apr-2023, a four-month-old neonate experienced seizure like activity-full body shaking upon feeding afternoon bottle (had eaten half of the bottle, or (about 1.5-2 ounces). Afterward the neonate fell asleep for about twenty minutes. The neonate was reported to be in normal state of health upon waking up. He was brought in and had an evaluation in the ER (emergency room) about one hour after the event. At that time, he had a normal physical exam. Lab results were reported as CBC (complete blood count): wnl (within normal limits), Plt (Platelets): 550, MCV (mean corpuscle volume): 50, BMP (basic metabolic panel): wnl (within normal limits), and lactic acid: 2.2.  Due to the nature of the event the causal relationship between Vaxelis and the event, "Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.)" was assessed as related, whereas, the events, "blood lactic acid", "brain natriuretic peptide normal", "full blood count abnormal", "mean cell volume normal", "platelet count increased" were considered not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Platelet count increased, Seizure like phenomena, Sudden onset of sleep, Tremor
Clinical narrative: Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.); This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618090-1. The original narrative from the sender is as follows:  On 17-Apr-2023, after vaccination with Vaxelis on 14-Apr-2023, a four-month-old neonate experienced seizure like activity-full body shaking upon feeding afternoon bottle (had eaten half of the bottle, or (about 1.5-2 ounces). Afterward the neonate fell asleep for about twenty minutes. The neonate was reported to be in normal state of health upon waking up. He was brought in and had an evaluation in the ER (emergency room) about one hour after the event. At that time, he had a normal physical exam. Lab results were reported as CBC (complete blood count): wnl (within normal limits), Plt (Platelets): 550, MCV (mean corpuscle volume): 50, BMP (basic metabolic panel): wnl (within normal limits), and lactic acid: 2.2.  Due to the nature of the event the causal relationship between Vaxelis and the event, "Seizure like activity-full body shaking upon feeding afternoon bottle (had eaten 1/2 the bottle, or 1.5-2 oz.)" was assessed as related, whereas, the events, "blood lactic acid", "brain natriuretic peptide normal", "full blood count abnormal", "mean cell volume normal", "platelet count increased" were considered not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old pt was given vaxelis vaccine; product use in unapproved population; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618351-1. The original narrative from the sender is as follows:  A seventeen-year-old patient was given Vaxelis vaccine. PT has not had any reaction to this. Parent made aware.  Due to the nature of the event the causal relationship between Vaxelis and the events, "seventeen-year-old pt was given vaxelis vaccine and product use in unapproved population" was assessed as not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old pt was given vaxelis vaccine; product use in unapproved population; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2618351-1. The original narrative from the sender is as follows:  A seventeen-year-old patient was given Vaxelis vaccine. PT has not had any reaction to this. Parent made aware.  Due to the nature of the event the causal relationship between Vaxelis and the events, "seventeen-year-old pt was given vaxelis vaccine and product use in unapproved population" was assessed as not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, VARCEL, DTPPVHBHPB, PNC13, RV5, VARCEL
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2620134-1. The original narrative from the sender is the following:  " Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing".  The causal relationship between Vaxelis and the events, "Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made" and "Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well" was assessed as not applicable due to the nature of the reported events.  No further information is expected
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, VARCEL, DTPPVHBHPB, PNC13, RV5, VARCEL
Symptoms: Medication error, No adverse event, Product administration error
Clinical narrative: Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made; Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2620134-1. The original narrative from the sender is the following:  " Client at clinic accompanied by mother and father for 2 month immunizations. Client properly identified by name and DOB. Client properly screened for allergies (food/medication) and medical conditions. Explained to mother and father what vaccines are to be received. Nurse began by first administering Rotavirus vaccine via oral administration. No adverse reaction. Patient tolerated Rotavirus vaccine well. Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well. Nurse then proceeded to administer PCV vaccine intramuscular to left vastus lateralis. No adverse reaction noted. Patient tolerated PCV vaccine well. Nurse then administered Varicella vaccine subcutaneously on left arm. No adverse reaction noted. Patient tolerated Varicella vaccine well. Nurse advised mother and father of possible side effects of vaccines and what precautions to take if necessary. Mother, father and patient were then escorted back to main lobby to await finalization of paperwork. Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made. LVN was notified, as was Nurse Supervisor. The mother and father were called back in to discuss the medication error and its possible side effects. Nurse and RN viewed all three injection sites and determined they were within normal limits. Patient was observed for 30 minutes with no adverse reaction noted. Mother and father were encouraged to inquire any questions they have before departing".  The causal relationship between Vaxelis and the events, "Nurse then acquired that the Varicella vaccine was not indicated for this patient and a medication error was made" and "Nurse then proceeded to administer Vaxelis combination vaccine intramuscular to right vastus lateralis. No adverse reaction noted. Patient tolerated Vaxelis vaccine well" was assessed as not applicable due to the nature of the reported events.  No further information is expected
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile convulsion; Parent reports fever 101.3 and staring episode the day after vaccine; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2620826-1. The original narrative from the sender is as follows:  Concomitant medication included Vitamin D for unknown indication.  Parent reports fever of 101.3 and staring episode the day after vaccine,? febrile seizure.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "patient reports fever of 101.3 and staring episode the day after vaccine,? febrile seizure.".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient recieved Vaxelis instead of pentacel due to mishearing the doctor 's order; There was no obvious adverse event after vaccine administration; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2621601-1. The original narrative from the sender is the following:  Concomitant medication included cholecalciferol 10mcg/mL - 1ml daily.  "Patient received Vaxelis instead of Pentacel due to mishearing the doctor's order. There was no obvious adverse event after vaccine administration. Physician notified immediately."  It was reported that Physician referenced the CDC to determine if the additional Hep B antigen vaccination would be harmful to baby and he concluded it would not.  The causal relationship between Vaxelis and the events " Patient received Vaxelis instead of Pentacel due to mishearing the doctor 's order " and " There was no obvious adverse event after vaccine administration" were assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Product communication issue, Wrong product administered
Clinical narrative: Patient recieved Vaxelis instead of pentacel due to mishearing the doctor 's order; There was no obvious adverse event after vaccine administration; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2621601-1. The original narrative from the sender is the following:  Concomitant medication included cholecalciferol 10mcg/mL - 1ml daily.  "Patient received Vaxelis instead of Pentacel due to mishearing the doctor's order. There was no obvious adverse event after vaccine administration. Physician notified immediately."  It was reported that Physician referenced the CDC to determine if the additional Hep B antigen vaccination would be harmful to baby and he concluded it would not.  The causal relationship between Vaxelis and the events " Patient received Vaxelis instead of Pentacel due to mishearing the doctor 's order " and " There was no obvious adverse event after vaccine administration" were assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site swelling, Keratosis pilaris
Clinical narrative: On 01/26/2023 patient followed at our office ,bump was gone by then only keratosis pilaris was documented by Dr.; Mom noticed a bump on injection site on right leg on 01/24/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2621698-1. The original narrative from the sender is as follows:  Medical history included eczema.  "Mom noticed a bump on injection site on Right leg on 01/24/2023, patient followed up in office on 01/26/2023 at our office, bump was gone by then only keratosis pilaris was documented by Dr."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " Mom noticed a bump on injection site on right leg on 01/24/2023" and "On 01/26/2023 patient followed at our office, bump was gone by then only keratosis pilaris was documented by Dr."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine; No known symptoms of adverse reaction; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2622372-1. The original narrative from the sender is as follows:  Medical history included Eczema on back since an unspecified date but was seen in ER in mid-March.  Concomitant medication included Hydrocortisone cream 1% white petroleum ointment for unknown indication.  "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine. PT should have received Dtap, Polio, and Hep B vaccines, not the HIB. At this time, no known symptoms of adverse reaction. Will continue to monitor."  The causal relationship between Vaxelis and the events "Received Vaxelis at 8 yrs old, which is not recommended due to it containing the HIB vaccine" and "No known symptoms of adverse reaction" was assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Dermatitis, Rash
Clinical narrative: Dr. assessed the patient and stated Dermatitis Vs reaction to vaccines; Patient received vaccines on 5/1/2023 returned on 5/2/2023 with rash on body for 1 day.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2627504-1. The original narrative from the sender is as follows:  "Patient received vaccines on 5/1/2023 returned on 5/2/2023 with rash on body for 1 day. Dr. assessed the patient and stated Dermatitis VS reaction to vaccines. He prescribed Hydrocortisone 1% to apply BID. On 5/5/2023 I called parent, and she stated that rash is less."  Treatment medication included Hydrocortisone 1% to apply BID (twice daily.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Dr. assessed the patient and stated Dermatitis Vs reaction to vaccines" and " Patient received vaccines on 5/1/2023 returned on 5/2/2023 with rash on body for 1 day".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Pyrexia; SARS-CoV-2 test negative; Streptococcus test negative; This spontaneous safety report, with reference number 2307USA002563 (VAERS Reference ID  2629827-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional.  Follow-up non-significant information was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2629827-1.   The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Pyrexia".  The causal relationship between Vaxelis and the events " Sars-COV-2 Test Negative" and " Streptococcus test negative" were assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Decreased appetite, Infant irritability, Pyrexia, Rash
Clinical narrative: More fussy; Fever of 103 within 24 hours; Fine rash that started on head and spread over torso over 24 hours; Decrease in appetite; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2630244-1. The original narrative from the sender is as follows:  "Fever of 103 within 24 hours, fine rash that started on head and spread over torso over 24 hours. More fussy. Decrease in appetite."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "More fussy", "Fever of 103 within 24 hours", Fine rash that started on head and spread over torso over 24 hours", "Decrease in appetite".   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Rash
Clinical narrative: More fussy; Fever of 103 within 24 hours; Fine rash that started on head and spread over torso over 24 hours; Decrease in appetite; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2630244-1. The original narrative from the sender is as follows:  "Fever of 103 within 24 hours, fine rash that started on head and spread over torso over 24 hours. More fussy. Decrease in appetite."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "More fussy", "Fever of 103 within 24 hours", Fine rash that started on head and spread over torso over 24 hours", "Decrease in appetite".   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Currently having diarrhea over ten times a day; Vomiting; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2630487-1. The original narrative from the sender is as follows:  Medical history included GI Issues in utero bowel perforation possible hernia.  "Currently having diarrhea over ten times a day, vomiting."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "Currently having diarrhea over ten times a day" and " Vomiting."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area is warm to the touch and didn't seem to be painful when palpated; Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2630745-1. The original narrative from the sender is the following:  "Dad brought pt into clinic and this nurse was summoned to lobby. Pt was asleep on dads chest. Pt breathing normally with ygen saturation (02 sat)was at 98% RA, afebrile and HR=89. Pt aroused with physical touch. Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered. Area is warm to the touch and didn't seem to be painful when palpated. Dad states he has given pt Tylenol for comfort but pt does not complain of pain to area. Dad is not familiar with vaccines so he felt the need to have a nurse visualize area. This RN recommended cold pack to area, Pediatric Benadryl 12.5mg per bottle instructions and Tylenol for pain. Alert placed in chart for future immunization administration. Dad and pt left clinic without s/sx's distress.".  The reporter did not provide the causal relationship between Vaxelis and the events, "Area is warm to the touch and didn't seem to be painful when palpated" and "Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area is warm to the touch and didn't seem to be painful when palpated; Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2630745-1. The original narrative from the sender is the following:  "Dad brought pt into clinic and this nurse was summoned to lobby. Pt was asleep on dads chest. Pt breathing normally with ygen saturation (02 sat)was at 98% RA, afebrile and HR=89. Pt aroused with physical touch. Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered. Area is warm to the touch and didn't seem to be painful when palpated. Dad states he has given pt Tylenol for comfort but pt does not complain of pain to area. Dad is not familiar with vaccines so he felt the need to have a nurse visualize area. This RN recommended cold pack to area, Pediatric Benadryl 12.5mg per bottle instructions and Tylenol for pain. Alert placed in chart for future immunization administration. Dad and pt left clinic without s/sx's distress.".  The reporter did not provide the causal relationship between Vaxelis and the events, "Area is warm to the touch and didn't seem to be painful when palpated" and "Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Subcutaneous haematoma
Clinical narrative: Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma; Initial redness and swelling at injection site; Initial redness and swelling at injection site; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2630747-1. The original narrative from the sender is the following:  "Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma".  The reporter did not provide the causal relationship between Vaxelis and the event, " Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma ".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC13, DTPPVHBHPB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma; Initial redness and swelling at injection site; Initial redness and swelling at injection site; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2630747-1. The original narrative from the sender is the following:  "Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma".  The reporter did not provide the causal relationship between Vaxelis and the event, " Initial redness and swelling at injection site, transitioned into 1.3cm subq hematoma ".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Electroencephalogram normal, Facial paralysis, Muscle twitching
Clinical narrative: With one day baby developed a drooping eye & twitching of  leg. The eye drooping lasted a week.; With one day baby developed a drooping eye & twitching of leg, the leg twitching was intermittent for 6 weeks; Electroencephalogram normal; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632804-1. The original narrative from the sender is the following:  With one day baby developed a drooping eye & twitching of leg. The eye drooping lasted a week & the leg twitching was intermittent for 6 weeks.  Lab data included EEG (electroencephalogram) nl (normal) 05/04/2023.  The causal relationship between Vaxelis and the events " With one day baby developed a drooping eye & twitching of  leg. The eye drooping lasted a week; the leg twitching was intermittent for 6 weeks" was not reported, and causality between Vaxelis and " Electroencephalogram normal " was assessed as not applicable due to the nature of the reported event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Infant irritability, Rash maculo-papular
Clinical narrative: Afebrile but fussy.; Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2633089-1. The original narrative from the sender is as follows:  Medical history included viral illness, 2 weeks prior.  Concomitant medication included topical clotrimazole  for unknown indication.  Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas. Afebrile but fussy. inconsistent with topical clotrimazole reaction that was put on neck. Not consistent with viral exanthem. Treatment of Benadryl PRN.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events, "afebrile but fussy" and "Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Irritability, Rash macular, Rash papular
Clinical narrative: Afebrile but fussy.; Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS primary ID 2633089-1. The original narrative from the sender is as follows:  Medical history included viral illness, 2 weeks prior.  Concomitant medication included topical clotrimazole  for unknown indication.  Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas. Afebrile but fussy. inconsistent with topical clotrimazole reaction that was put on neck. Not consistent with viral exanthem. Treatment of Benadryl PRN.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events, "afebrile but fussy" and "Patient received vaccines ~ 20 hours later developed diffuse, macular rash with some papular areas".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Hypophagia, Injection site pain, Pain, Rash
Clinical narrative: Hypophagia; Pain; Rash papular; Crying; Injection site pain; Rash; This spontaneous safety report, with reference number 2307USA002587 (VAERS Reference ID 2633096-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Hypophagia"," Pain", "Rash papular"," Crying"," Injection site pain"," Rash",".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Rash papular
Clinical narrative: Hypophagia; Pain; Rash papular; Crying; Injection site pain; Rash; This spontaneous safety report, with reference number 2307USA002587 (VAERS Reference ID 2633096-1), was received by the partner on 06-JUL-2023 and forwarded on 10-JUL-2023, from a health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Hypophagia"," Pain", "Rash papular"," Crying"," Injection site pain"," Rash",".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, MMRV, PNC13, DTPPVHBHPB, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction,; Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction,; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2634619-1. The original narrative from the sender is the following:  Checked the system for patient's record.  Put in patient's full name (four parts) and date of birth. System search returned with no matching records.  Continued on as if to create new record, then the system produced a record for the patient.  I checked what vaccines were due per the system and the following were due and available to be given: Vaxelis, ProQuad, and Prevnar-13.  When going to print updated record for parent, a second system record was found, and contained two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction, and instructed mom to return here immediately if she noticed and change in the child including rash, fever, change in activity level/lethargy.  The causal relationship between Vaxelis and the events " Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction." was assessed as not applicable due to the nature of the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, MMRV, PNC13, DTPPVHBHPB, MMRV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction,; Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction,; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2634619-1. The original narrative from the sender is the following:  Checked the system for patient's record.  Put in patient's full name (four parts) and date of birth. System search returned with no matching records.  Continued on as if to create new record, then the system produced a record for the patient.  I checked what vaccines were due per the system and the following were due and available to be given: Vaxelis, ProQuad, and Prevnar-13.  When going to print updated record for parent, a second system record was found, and contained two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction, and instructed mom to return here immediately if she noticed and change in the child including rash, fever, change in activity level/lethargy.  The causal relationship between Vaxelis and the events " Two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction." was assessed as not applicable due to the nature of the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Diarrhoea, Ear infection, Gastroenteritis adenovirus, Hypophagia, Vomiting
Clinical narrative: Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.; The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2636250-1. The original narrative from the sender is the following:  A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake. Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED. Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request. Was given Rocephin and was recommended to follow up with pediatritrician. The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.  The causal relationship between Vaxelis and the events " A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s. , Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request, The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms." was not assessed.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Adenovirus infection, Decreased appetite, Diarrhoea, Ear infection, Gastroenteritis
Clinical narrative: Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.; The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2636250-1. The original narrative from the sender is the following:  A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake. Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED. Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request. Was given Rocephin and was recommended to follow up with pediatritrician. The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.  The causal relationship between Vaxelis and the events " A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s. , Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request, The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms." was not assessed.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, PNC13, DTPPVHBHPB, FLU4, PNC13
Symptoms: Vomiting
Clinical narrative: Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request.; The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2636250-1. The original narrative from the sender is the following:  A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake. Was concerned that the immunizations may of caused the s/s.  He was a poor historian on the phone, was unsure of the discharge instructions from the ED, states had no MD to take the child to.  Reviewed needed to take the child to the nearest clinic for follow up after ED visit.  Obtained ED visit, Medical decision making:  Vital signs were reviewed and were acceptable.  Patient was seen in ED, had taken a few sips of Pedialtye while in the ED. Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request. Was given Rocephin and was recommended to follow up with pediatritrician. The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms.  Patient was discharged home in good stable condition.  Sent home with amoxicillin, Q 12 hrs.  The causal relationship between Vaxelis and the events " A man called and identified himself as the father on 5/23/23 and stated that had to take the child to the ER for vomiting / diarrhea and decreased PO intake.  Was concerned that the immunizations may of caused the s/s. , Child was treated for for an ear infection and given an IM injection of IM antibiotic per family request, The child was suspected to have adenoviral gastroenteritis and told to follow up in ED for significant worsening of symptoms." was not assessed.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pentacel ordered, but Vaxelis given by staff; Pentacel ordered, but Vaxelis given by staff. Patient without adverse reaction or issues.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2636258-1. The original narrative from the sender is the following:  Pentacel ordered, but Vaxelis given by staff. Patient without adverse reaction or issues.  The causal relationship between Vaxelis and the events " Pentacel ordered, but Vaxelis given by staff. Patient without adverse reaction or issues" was assessed as not applicable due to the nature of the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SQ instead of IM; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2637291-1. The original narrative from the sender is the following:  Vaccine given SQ instead of IM.  The case is considered as off label use.  The causal relationship between Vaxelis and the event "Vaccine given SQ instead of IM" was assessed as not applicable due to the nature of these reported event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: Vaccine given SQ instead of IM; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2637291-1. The original narrative from the sender is the following:  Vaccine given SQ instead of IM.  The case is considered as off label use.  The causal relationship between Vaxelis and the event "Vaccine given SQ instead of IM" was assessed as not applicable due to the nature of these reported event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given as SQ instead of IM; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2637292-1. The original narrative from the sender is the following:  Vaccine given as SQ instead of IM.  The case is considered as off label use.  The causal relationship between Vaxelis and the event "Vaccine given as SQ instead of IM." was assessed as not applicable due to the nature of the reported event.  No further information is expected.