chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster administered to patient as Primary dose on 21Dec2022).    Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-691256 (E2B Linked Report).; Sender's Comments:  MOD-2022-691256:Original Case : MOD-2022-691256
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).      No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses was 51 doses from lot AS7140C and 60 doses from lot AS7148B. No treatment details were reported.
Age: 1.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received by a partner on 12-SEP-2022 and forwarded on 13-SEP-2022, from a Health Professional.   This case was considered non-valid since no patient identifiers were provided (temperature excursion only).   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 / 02244285 was received by partner on 21-SEP-2022 and forwarded to Regulatory Agency on 22-SEP-2022 from a Health Professional.  Twenty-nine (29) administration dates and temperature excursion durations were reported for Vaxelis with batch # U7151AA (expiration date: 17-JUL-2024):  255 HRS 02 MIN 9/7/2022 60 HRS 24 MINS 8/19/2022 60 HRS 24 MINS 8/16/2022 19 HRS 2 MINS 8/4/2022 193 HRS 42 MINS 9/1/2022 193 HRS 42 MINS 8/30/2022 255 HRS 02 MIN 9/1/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/17/2022 60 HRS 24 MINS 8/15/2022 60 HRS 24 MINS 8/22/2022 255 HRS 02 MIN 8/31/2022 62 HRS 20 MINS 8/23/2022 60 HRS 24 MINS 8/15/2022 26 HRS 47 MINS 8/12/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/8/2022 62 HRS 20 MINS 8/25/2024 22 HRS 3 MINS 8/8/2022 19 HRS 2 MINS 8/5/2022 22 HRS 3 MINS 8/8/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/9/2022 5 HRS 32 MINS 8/2/2022 22 HRS 3 MINS 8/9/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022  The case is maintained as non-valid.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 was received on 17-Oct-2022 from a Health Professional.  ID, DOB, Vaxelis administration date, gender, age, dose number, concomitant vaccines and confirmation of no adverse event were provided for 29 patients.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: Patient received Vaxelis and ACTHIB during the same visit; This non-serious spontaneous safety report, with case number 02251468/02251464, was received by a partner, on 21SEP2022 and forwarded on 22SEP2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient received Vaxelis and ACTHIB during the same visit".  Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 17-OCT-2022 from the other health professional.  The causal relationship between Vaxelis and the event, "Patient received Vaxelis and ACTHIB during the same visit" is not applicable, due to the nature of the event.  No adverse event was reported.  Further information is not expected.
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: A patient of 5 years old and 2 months received the vaccine VAXELIS; This non-serious spontaneous safety report, with reference number 2022SA404522, was received by the partner on 29-SEP-2022 and forwarded on 30-SEP-2022, from a physician.   Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine VAXELIS" was not applicable.    Further information is expected.  Non-significant follow-up information was received on 14-OCT-2022 from health care professional.  Due to the nature of the event the causal relationship between Vaxelis and the event "A patient of 5 years old and 2 months received the vaccine VAXELIS" was not applicable.   No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine was administered to a patient. Temperature: 46.5F.; This spontaneous safety report, with reference number 02260497, was received by a partner on 04-OCT-2022 and forwarded on the same day, from a Health Professional.   Due to the nature of the event, the causality between the event "Improperly stored vaccine was administered to a patient. Temperature: 46.5F." and Vaxelis was not applicable.   Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 06-OCT-2022 and forwarded on 07-OCT-2022. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "Improperly stored vaccine was administered to a patient. Temperature: 46.5F." and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: Received a dose of Vaxelis and a dose of Recombivax HB on the same day; This non-serious spontaneous safety report, with case number 02262554 (Interaction number 02262553), was received by a partner, on 06-OCT-2022 and forwarded on 06-OCT-2022 from an other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Received a dose of Vaxelis and a dose of Recombivax HB on the same day".  Further information is expected.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Infant had a seizure that lasted 10 minutes. Diagnosed with a complex febrile seizure (in the ER); This non-serious spontaneous safety report, with reference number 02262838, was received by a partner on 05-OCT-2022 and forwarded on 06-OCT-2022, from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Infant had a seizure that lasted 10 minutes. Diagnosed with a complex febrile seizure (in the ER).".   Further information is expected.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Inappropriate schedule of product administration, Laboratory test, No adverse event
Clinical narrative: they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days.; This non-serious spontaneous safety report, with reference number 2022SA410225 (and inquiry number 01308495), was received by a partner on 05-OCT-2022 and forwarded on 06-OCT-2022, from a health care professional.  Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable.    Further information is expected.  SIGNIFICANT FOLLOW UP INFORMATION was received on 19-OCT-2022 from a health care professional.  It was reported that there was no adverse reaction following vaccination.  Due to the nature of the event the causal relationship between Vaxelis and "they provided a patient with their 2nd dose of VAXELIS 26 days after the first dose instead of 28 days." was not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Wrong product administered
Clinical narrative: HCP states that this vaccine was given subcutaneously instead of IM; A 12 month old child who was supposed to receive a VARIVAX vaccine, was accidentally given a VAXELIS vaccine.; the patient's injection site was red and swollen; the patient's injection site was red and swollen; This non-serious spontaneous safety report with reference number 02263229 was received by a partner on 06-OCT-2022 and forwarded to agency on 07-OCT-2022 from a physician. Additional information was received from a partner on 06-OCT-2022 (reference number 02263129) and on 07-OCT-2022.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "the patient's injection site was red and swollen".  Due to the nature of the event, the causality between Vaxelis and the reported events of "A 12-month-old child who was supposed to receive a VARIVAX vaccine, was accidentally given a VAXELIS vaccine and HCP states that this vaccine was given subcutaneously instead of IM" was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Was given Vaxelis in error instead of the ordered TDAP; 11-year old patient; This non-serious spontaneous safety report, was received by partner, on 07OCT2022 and forwarded on 11OCT2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Was given Vaxelis in error instead of the ordered TDAP" and "11 year old patient".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: A rash on the right hip that was bruising, red and warm to touch; Had the normal adverse reaction of injection site pain and swelling; Had the normal adverse reaction of injection site pain and swelling; This non-serious spontaneous safety report, with reference number 02264111/ 02264110 was received by a partner on 07-OCT-2022 and forwarded on 10-OCT-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  Further information is expected.  Significant follow-up information was received on 28-OCT-2022 from a HCP.  The reporter assessed the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site warmth
Clinical narrative: A rash on the right hip that was bruising, red and warm to touch; Had the normal adverse reaction of injection site pain and swelling; Had the normal adverse reaction of injection site pain and swelling; This non-serious spontaneous safety report, with reference number 02264111/ 02264110 was received by a partner on 07-OCT-2022 and forwarded on 10-OCT-2022 from a physician.   The reporter did not assess the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  Further information is expected.  Significant follow-up information was received on 28-OCT-2022 from a HCP.  The reporter assessed the causal relationship between Vaxelis and the reported events of "A rash on the right hip that was bruising, red and warm to touch" and "Had the normal adverse reaction of injection site pain and swelling".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Had given Vaxelis and had also given a dose on HIB that did not need to be given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2359757-1. The original narrative from the sender is the following:  When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had given Vaxelis and had also given a dose on HIB that did not need to be given".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: Computerised tomogram head normal, Full blood count normal, Laboratory test normal, Metabolic function test, Muscular weakness
Clinical narrative: Weakness left leg and hand; Shaking left hand; Computerised Tomogram Head Normal; Full blood count normal; Metabolic Function Test; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2453697-1. The original narrative from the sender is the following:  Mom report baby shaking left hand , weakness left leg and hand on 9/20/22 in am. Went to Er all test negative. Ct negative, labs negative. Sent home for monitoring.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events " Weakness left leg and hand", "shaking left hand."  Due to the nature of events the causal relationship between Vaxelis and "Computerised Tomogram Head Normal, Full blood count normal, Metabolic Function Test" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: Tremor
Clinical narrative: Weakness left leg and hand; Shaking left hand; Computerised Tomogram Head Normal; Full blood count normal; Metabolic Function Test; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2453697-1. The original narrative from the sender is the following:  Mom report baby shaking left hand , weakness left leg and hand on 9/20/22 in am. Went to Er all test negative. Ct negative, labs negative. Sent home for monitoring.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events " Weakness left leg and hand", "shaking left hand."  Due to the nature of events the causal relationship between Vaxelis and "Computerised Tomogram Head Normal, Full blood count normal, Metabolic Function Test" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhoea; Vomiting; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2364654-1. The original narrative from the sender is the following:  I am not sure if I selected the correct brands for these vaccines. I can't see on the patient system which brands they were so I am going off of memory. Both rounds of his vaccines now (2 and 4 months), my son has gotten horrible vomiting and diarrhea following his vaccines. It is Monday, he got the immunizations Friday, and he is still vomiting and having diarrhea (he just threw up again as I was filling out this form). He has 6 bottles a day and has been throwing up 4-5 times in between every single one of them, and today alone he has had 4 diarrhea blowouts in his diaper.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Diarrhoea" and "Vomiting".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Fever 103.8 4-6 hours past shot fussiness; Fever 103.8 4-6 hours past shot fussiness; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2365961-1. The original narrative from the sender is the following:  Fever 103.8 4-6 hours past shot fussiness.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Fever 103.8 4-6 hours past shot fussiness".  No further information is expected.
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose administered; No Adverse Event; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2371879-1. The original narrative from the sender is the following:  PENTACEL and VAXELIS were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5- component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid [Vaxelis] were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, strength unknown (lot UJ621AAA and expiry date 20-Jan-2023) via intramuscular route in the right thigh and on same day the patient received a dose of suspect diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid not produced by Sanofi Pasteur (formulation, dose, strength ,lot number and expiry date not reported) via unknown route in unknown administration site both for immunization was administered at different sites on the same day, causing an extra dose to occur with no reported adverse event (extra dose administered). Action taken : not applicable. Outcome : Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTPPVHBHPB, IPV, MMRV
Symptoms: Extra dose administered, No adverse event, Vaccination error
Clinical narrative: 5-year-old child; Extra dose administered; Vaccination Error; No Adverse Event; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2456155-1. The original narrative from the sender is the following:  Patient presented with caregiver to school health clinic for vaccine update. Immunization record indicated child was due for DTaP, IPV, MMR, Varicella. Child received Vaxelis (DTaP, IPV, Hib, and Hep B), IPV, and ProQuad (MMR, varicella) at 0900 on 9/23/22. No signs or symptoms of local or systemic reaction immediately noted after immunization administration in office. Vaccine error was noted by provider at 1000. Medical director for school clinic was notified of event. Caregiver contacted by phone at 1053 and was notified with vaccine error, potential local/systemic reactions, instructed to monitor and report known adverse reactions, provider contact information, and plan to follow up by phone in 48 hours. No adverse reactions reported by caregiver at time of phone call.  Due to the nature of events the causal relationship between Vaxelis and "Extra dose administered, Vaccination error, and No adverse event" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, PNC13
Symptoms: Decreased appetite, Gait disturbance, Lethargy, Mood altered, Pyrexia
Clinical narrative: Monotone mood; not eating; No ambulation/ still ambulation altering; Lethargic; Patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2396334-1. The original narrative from the sender is as follows:  07/20/2022-mom stated patient had a fever but didn't check the degree 07/21/2022-vaccinations give that morning-that evening temp 104, lethargic, not eating and no ambulation 07/22/2022-monotone mood, 103 temp, still ambulation altering Ibuprofen and Tylenol 07/23/2022-playing, no walking till that evening, no fever 07/24/2022-fever free, acts normal per mom.  When asked if child felt okay, no fever-guardian said yes. When the family called back with reaction, the child had been fevering the day before.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Monotone mood, not eating, no ambulation/ still ambulation altering, lethargic and patient had a fever, but didn't check the degree/ 07/21/2022-that evening temp 104/ 07/22/2022-103 temp".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Allergy test, Urticaria
Clinical narrative: Hives; Hives,benedryl resolved over 3-4days; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2441061-1. The original narrative from the sender is the following:  Referred for allergy testing before next vaccine, no results yet.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events " urticaria and allergy test"  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: Syringe Use; Underdose; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2463118-1. The original narrative from the sender is the following:  Patient received half of the dose as about half of the dose squirted out the syringe around where the needle is screwed onto the syringe. Consulted with MD and patient did not receive additional dose.  Due to the nature of events the causal relationship between Vaxelis and "Syringe use and Underdose" was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: provider ordered DTAP-IPV but DTAP-IPV-Hib-HepB(Vaxelis) was given; Vaccine administered to a 5year old child; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2443227-1. The original narrative from the sender is the following:  Provider ordered DTAP-IPV, but  DTAP-IPV-Hib-HepB (Vaxelis)was given.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Wrong product administered".  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed heat from injection site; patient developed bruising from injection site; patient developed a softball size redness from injection site; patient developed swelling from injection site; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2444885-1. The original narrative from the sender is the following:  On 17-May-2022 patient developed a softball size redness, bruising, swelling and heat from injection site. On 18May2022 patient's redness continued and progressed to be a bit bigger in size, redness and bruising still present. On 19May2022 patient's parents took child to the hospital to be evaluated. Antibiotics was prescribed, but not taken. On 28May2022 redness, swelling, heat and bruising resolved.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient developed a softball size redness, bruising, swelling and heat from injection site".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Expired Product Administered; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2464512-1. The original narrative from the sender is the following:  Vaccine expired 09-04-2022.  Due to the nature of events the causal relationship between Vaxelis and "Expired product administered" was not applicable.  No further information is expected.  Notes: Based on the available information, the expired vaccine administered is not sure if Vaxelis, however the case was retrieved from information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Blood culture, Culture urine, Erythema multiforme, Full blood count normal, Influenza virus test negative
Clinical narrative: Pt became febrile on 9/5/2022; Rash diagnose as erythema multiforme; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; The patient developed a rash at the site of the injection; The patient developed a rash at the site of the injection. The rash continue to spread to all extremities and chest/back/abdomen.; Blood culture; Culture urine; Urine Analysis normal; Full blood count normal; Influenza virus test negative; Respiratory Syncytial virus test negative; SARS-COV-2 TEST NEGATIVE; winter viral studies; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2428990-1. The original narrative from the sender is the following:  Pt received standard 2-month immunizations on 9/2/2022. The next day, the patient developed a rash at the site of injection - the rash continued to spread to all extremities & chest/back/abdomen. Rash diagnosed as erythema multiforme vs urticaria multiforme vs vasculitis. Pt became febrile on 9/5/2022 and re-presented to the emergency department. Unknown if immunizations vs fever/viral illness are the cause of the rash; doubt immunizations are cause of fever  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "The patient developed a rash at the site of the injection", "The rash continue to spread to all extremities and chest/back/abdomen", "Rash diagnosed as erythema multiforme vs urticaria vs vasculitis", and "Pt became febrile on 9/5/2022".  Due to the nature of the event, the causality between the events "Blood culture", "Culture urine", "Urine Analysis normal", "Full blood count normal", "Influenza virus test negative", "Respiratory Syncytial virus test negative", "SARS-COV-2 TEST NEGATIVE", and "winter viral studies" and Vaxelis was not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Injection site rash, Pyrexia, Rash, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Pt became febrile on 9/5/2022; Rash diagnose as erythema multiforme; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; The patient developed a rash at the site of the injection; The patient developed a rash at the site of the injection. The rash continue to spread to all extremities and chest/back/abdomen.; Blood culture; Culture urine; Urine Analysis normal; Full blood count normal; Influenza virus test negative; Respiratory Syncytial virus test negative; SARS-COV-2 TEST NEGATIVE; winter viral studies; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2428990-1. The original narrative from the sender is the following:  Pt received standard 2-month immunizations on 9/2/2022. The next day, the patient developed a rash at the site of injection - the rash continued to spread to all extremities & chest/back/abdomen. Rash diagnosed as erythema multiforme vs urticaria multiforme vs vasculitis. Pt became febrile on 9/5/2022 and re-presented to the emergency department. Unknown if immunizations vs fever/viral illness are the cause of the rash; doubt immunizations are cause of fever  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "The patient developed a rash at the site of the injection", "The rash continue to spread to all extremities and chest/back/abdomen", "Rash diagnosed as erythema multiforme vs urticaria vs vasculitis", and "Pt became febrile on 9/5/2022".  Due to the nature of the event, the causality between the events "Blood culture", "Culture urine", "Urine Analysis normal", "Full blood count normal", "Influenza virus test negative", "Respiratory Syncytial virus test negative", "SARS-COV-2 TEST NEGATIVE", and "winter viral studies" and Vaxelis was not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Urine analysis normal, Urticaria, Vasculitis
Clinical narrative: Pt became febrile on 9/5/2022; Rash diagnose as erythema multiforme; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; Rash diagnosed as erythema multiforme vs urticaria vs vasculitis; The patient developed a rash at the site of the injection; The patient developed a rash at the site of the injection. The rash continue to spread to all extremities and chest/back/abdomen.; Blood culture; Culture urine; Urine Analysis normal; Full blood count normal; Influenza virus test negative; Respiratory Syncytial virus test negative; SARS-COV-2 TEST NEGATIVE; winter viral studies; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2428990-1. The original narrative from the sender is the following:  Pt received standard 2-month immunizations on 9/2/2022. The next day, the patient developed a rash at the site of injection - the rash continued to spread to all extremities & chest/back/abdomen. Rash diagnosed as erythema multiforme vs urticaria multiforme vs vasculitis. Pt became febrile on 9/5/2022 and re-presented to the emergency department. Unknown if immunizations vs fever/viral illness are the cause of the rash; doubt immunizations are cause of fever  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "The patient developed a rash at the site of the injection", "The rash continue to spread to all extremities and chest/back/abdomen", "Rash diagnosed as erythema multiforme vs urticaria vs vasculitis", and "Pt became febrile on 9/5/2022".  Due to the nature of the event, the causality between the events "Blood culture", "Culture urine", "Urine Analysis normal", "Full blood count normal", "Influenza virus test negative", "Respiratory Syncytial virus test negative", "SARS-COV-2 TEST NEGATIVE", and "winter viral studies" and Vaxelis was not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Patient developed a 102 fever. It has been able to keep it to 99/100 with Tylenol.; Nickel size reddened area over injection site on the right thigh; Increased fussiness; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2418377-1. The original narrative from the sender is the following:  Mom of the client, called the clinic and shared that patient developed a 102 fever last evening, and has been able to keep it to 99/100 F with Tylenol. She also has a nickel size reddened area over injection site on the right thigh (where the DTap/IPV/Hib/HebB was given). She has increased fussiness, but has been drinking fine, and continues to have wet diapers.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient developed a 102 fever. It has been able to keep it to 99/100 with Tylenol", "Nickel size reddened area over injection site on the right thigh",  and "Increased fussiness".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 103; First dose of Vaxelis scheduled at 1.5 years.; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2422612-1. The original narrative from the sender is the following:  Fever 103, given Tylenol & Advil at Hospital.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Fever 103". Due to the nature of the event the causal relationship between Vaxelis and First dose of Vaxelis scheduled at 1.5 years was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Depressed level of consciousness
Clinical narrative: After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping.; Cry and was easily aroused; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2425360-1. The original narrative from the sender is the following:  After giving immunizations instructed Mom to wait with both children for 15 mins in our vaccination room and when returning to give mother the visit summary at 11:40am , baby was sitting in infant seat sound asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping. Mother reported that baby's nap time is usually around this time of day and she had been up since 6 am and last feeding was at 10:30am . Asked RN to please hold baby and stay with mom , retrieved our NP and our volunteer to please help assess baby in vaccination room. Applied child size bp cuff on left thigh to obtain bp reading and then baby began to cry and was easily aroused. Baby was then placed in mother's arms and baby was smiling and awake. Informed with help from translating RN that should mother see any changes in baby's respirations or behavior to please go to er or call emergency services for evaluation . Let her know that usually in the first 15 mins post vaccination that is when a reaction is likely to occur. Baby Awake and alert and responding to her mother. Discharged in stable condition with mom.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping." and "cry and was easily aroused".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Swelling face
Clinical narrative: Woke this morning with swelling of the face; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374938-1. The original narrative from the sender is the following:  Patients mother called clinic and notified us that patient woke this morning, 7/20/2022, with swelling of the face, mother stated that she was acting fine and had no signs of dyspnea.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "woke this morning with swelling of the face".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known symptoms of adverse effect; Pt was given dose of Rotateq after the age of 8 months; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2427502-1. The original narrative from the sender is the following:  Pt was given dose of Rotateq after the age of 8 months, no known symptoms of adverse effect.  Due to the nature of the events, the causal relationship between Vaxelis and "Pt was given dose of Rotateq after the age of 8 months" and "No known symptoms of adverse effect" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Swelling face
Clinical narrative: Had swelling on the facial area; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374944-1. The original narrative from the sender is the following:  Patients mother called clinic this morning, 07/20/2022 and stated that patient had swelling on the facial area. Patients mother stated that it just began when she woke this morning. Mother stated that patient was acting normal and had no signs of dyspnea.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had swelling on the facial area".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: an extra dose was given of Hep B vaccine. Pt has no reactions to vaccines she tolerated well; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2388371-1. The original narrative from the sender is the following:  Pt came in for a well child (4 month )check today the chart was not matched with the system and a extra dose was given of the hep B vaccine. Pt has no reactions to the vaccines she tolerated well.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "a extra dose was given of Hep B vaccine. Pt has no reactions to vaccines she tolerated well".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, RV1
Symptoms: Wrong product administered
Clinical narrative: 2 month patient was given ProQuad instead of Prevnar; 2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. The baby had received the wrong vaccine; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2402870-1. The original narrative from the sender is as follows:  2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. On 8-03-2022 the physician called the mother of the patient and explained that the baby had received the wrong vaccine. Explained that side effects include fever, soreness at the injection site and rash.  Current illness included Congenital torticollis.  No known allergies.  The causal relationship between Vaxelis and the events, "2 month patient was given ProQuad instead of Prevnar" and "2 month patient was given ProQuad instead of Prevnar. The wrong vaccine was ordered. The baby had received the wrong vaccine" is not applicable due to the nature of the events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Pallor, Somnolence
Clinical narrative: Sudden onset of extreme pallor; Somnolent, went to sleep for several hours; Vaccine administered to 1 month child; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2393248-1. The original narrative from the sender is the following:  sudden onset of extreme pallor. Somnolent, went to sleep for several hours, awoke appearing normal and back to baseline.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "sudden onset of extreme pallor", "Somnolent, went to sleep for several hours" and "Vaccine administered to 1 month child".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site nodule
Clinical narrative: red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed.; red knot and inflamed area in the thigh where the vaccine was given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2402883. The original narrative from the sender is as follows:  Per mother the child woke up this morning 8/5 with an red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed. The child was examined by the Doctor and Mom was instructed on how to handle the inflammation and what to do if it worsened.  The reporter did not assess the causal relationship between Vaxelis and "red knot and inflamed area in the thigh where the vaccine was given. The knot is extremely hard and inflamed."  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Crying, Erythema, Irritability, Poor feeding infant, Pyrexia
Clinical narrative: She wouldn't breastfeed; Mother saw she was crying then turned red; Mother saw she was crying; Mother notices severe irritability; Tactile fever; She had 2 episodes of vomiting; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2407394-1. The original narrative from the sender is as follows:  Shortly after vaccines, mother noticed severe irritability. She wouldn't breastfeed. She had 2 episodes of vomiting approximately EMS hours after vaccines. Tactile fever. Mother saw she was crying then turned red, no cyanosis. Called ambulance, went to local ER, was evaluated and sent home, no testing done.  Current illness included Viral bronchiolitis.  The causal relationship between Vaxelis and the events, " "She wouldn't breastfeed", "Mother saw she was crying then turned red", "Mother saw she was crying", "Mother notices severe irritability", "Tactile fever" and "She had 2 episodes of vomiting" was not reported.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: She wouldn't breastfeed; Mother saw she was crying then turned red; Mother saw she was crying; Mother notices severe irritability; Tactile fever; She had 2 episodes of vomiting; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2407394-1. The original narrative from the sender is as follows:  Shortly after vaccines, mother noticed severe irritability. She wouldn't breastfeed. She had 2 episodes of vomiting approximately EMS hours after vaccines. Tactile fever. Mother saw she was crying then turned red, no cyanosis. Called ambulance, went to local ER, was evaluated and sent home, no testing done.  Current illness included Viral bronchiolitis.  The causal relationship between Vaxelis and the events, " "She wouldn't breastfeed", "Mother saw she was crying then turned red", "Mother saw she was crying", "Mother notices severe irritability", "Tactile fever" and "She had 2 episodes of vomiting" was not reported.  No further information is expected.