chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Rash
Clinical narrative: Bilateral localized rash/ reaction noted on cheeks, arms, and feet twenty- minutes after vaccine administration. No distress noted.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2727029-1. The original narrative from the sender is the following:  Bilateral localized rash/ reaction noted on cheeks, arms, and feet twenty- minutes after vaccine administration. No distress noted.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "Bilateral localized rash/ reaction noted on cheeks, arms, and feet twenty- minutes after vaccine administration. No distress noted".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Influenza was given under recommended age.; Individual did not experience any adverse reactions; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2727563-1. The original narrative from the sender is the following:  Individual did not experience any adverse reactions. Influenza was given under recommended age.  Event of "product administered to patient of inappropriate age" referred to the Influenza vaccine and not to Vaxelis.  The reporter assessed the causal relationship between Vaxelis and the reported events "Influenza was given under recommended age and Individual did not experience any adverse reactions" as not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RVX
Symptoms: Pyrexia
Clinical narrative: Patient mother called today stating patient has fever of 103. Made appt to be seen in the afternoon. Patient mother called back few hours later with child having temp of 105.; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2728415-1. The original narrative from the sender is the following:  Pt came in to receive 4 month well child vaccines. Vaxelis (Dtap, IPV, Hib, Hep B)- RVL Pneumococcal 20-RVL RSV (Beyfortus 100mg/ml)- LVL rotavirus- orally Patient mother called today stating patient has fever of 103. Made appt to be seen in the afternoon. Patient mother called back few hours later with child having temp of 105. Now under instruction to take child to Hospital Emergency Department.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HIBV, PNC15, RSV, DTPPVHBHPB, FLU4, HIBV, PNC15, RSV
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: Child received extra dose of HIB also; Child received abryso adult RSV; Child received extra dose of HIB also; No Adverse event; This non-serious spontaneous Safety Report, with MSD case ID 2729859-1, was received by partner on 05-MAR-2024 and forwarded on 08-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Child received extra dose of HIB also, Child received abryso adult RSV and No adverse event".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HIBV, PNC15, RSV, DTPPVHBHPB, FLU4, HIBV, PNC15, RSV
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child received extra dose of HIB also; Child received abryso adult RSV; Child received extra dose of HIB also; No Adverse event; This non-serious spontaneous Safety Report, with MSD case ID 2729859-1, was received by partner on 05-MAR-2024 and forwarded on 08-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Child received extra dose of HIB also, Child received abryso adult RSV and No adverse event".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RSV, RV1, DTPPVHBHPB, PNC15, RSV, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Child received abrysvo; This non-serious spontaneous safety report, with the following VAERS Primary ID 2729864-1, was received by the partner on 05-MAR-2024 and forwarded on 07-MAR-2024, from other health professional.    The causal relationship between Vaxelis and the reported event of "Child received abrysvo- no adverse event" is assessed as not applicable due to nature of the event.  No further information is expected.  Regulatory Agency notes: Based on the available information, the events of Product administered to patient of inappropriate age and No adverse event were not related to Vaxelis but to Abrysvo vaccine. Vaxelis should have been considered a concomitant, however the case was from VAERS and information was kept as reported in the form.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, UNK, DTPPVHBHPB
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza virus test positive, Mobility decreased
Clinical narrative: Irritability upset stomach; Chills; Congestion; Unable to use leg; Body pain/ Aches; Shaking; Shaking; Fatigue; Fever 103; Influenza Virus Test Positive; This non-serious spontaneous Safety Report, with reference number 2730123-1, was received by partner on 05-MAR-2024 and forwarded to agency on 07-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Irritability upset stomach, Chills, Congestion, Unable to use leg, Body pain, Aches, Shaking, Fatigue, Fever 103, Influenza Virus Test Positive".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, UNK, DTPPVHBHPB
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Seizure, Tremor
Clinical narrative: Irritability upset stomach; Chills; Congestion; Unable to use leg; Body pain/ Aches; Shaking; Shaking; Fatigue; Fever 103; Influenza Virus Test Positive; This non-serious spontaneous Safety Report, with reference number 2730123-1, was received by partner on 05-MAR-2024 and forwarded to agency on 07-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Irritability upset stomach, Chills, Congestion, Unable to use leg, Body pain, Aches, Shaking, Fatigue, Fever 103, Influenza Virus Test Positive".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, UNK, DTPPVHBHPB
Symptoms: Abdominal discomfort, Chills, Epigastric discomfort, Fatigue, Influenza virus test positive
Clinical narrative: Irritability upset stomach; Chills; Congestion; Unable to use leg; Body pain/ Aches; Shaking; Shaking; Fatigue; Fever 103; Influenza Virus Test Positive; This non-serious spontaneous Safety Report, with reference number 2730123-1, was received by partner on 05-MAR-2024 and forwarded to agency on 07-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Irritability upset stomach, Chills, Congestion, Unable to use leg, Body pain, Aches, Shaking, Fatigue, Fever 103, Influenza Virus Test Positive".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, UNK, DTPPVHBHPB
Symptoms: Musculoskeletal disorder, Pain, Pyrexia, Respiratory tract congestion, Tremor
Clinical narrative: Irritability upset stomach; Chills; Congestion; Unable to use leg; Body pain/ Aches; Shaking; Shaking; Fatigue; Fever 103; Influenza Virus Test Positive; This non-serious spontaneous Safety Report, with reference number 2730123-1, was received by partner on 05-MAR-2024 and forwarded to agency on 07-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Irritability upset stomach, Chills, Congestion, Unable to use leg, Body pain, Aches, Shaking, Fatigue, Fever 103, Influenza Virus Test Positive".  No further information is expected.
Sex: F
Vaccine: COVID19, DTPPVHBHPB, FLUC3, PNC15, RV5, COVID19, DTPPVHBHPB, FLUC3, PNC15, RV5
Symptoms: Nausea, Overdose, Pyrexia
Clinical narrative: Nausea; Pyrexia; Was given 0.5 ml when it needed to be 0.25 ml; This spontaneous safety report, with the following VAERS Primary ID 2734490-1 (Imm Project # INC.MOD20247), was received by the partner on 07-MAR-2024 and forwarded on 08-MAR-2024, from other health professional.    The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "Fever and Nausea";   The causality between Vaxelis and the event " Overdose (Was given 0.5 ml when it needed to be 0.25 ml)" and Vaxelis was assessed as not applicable due to the nature of the event.  of note: The event of Overdose do not concern Vaxelis, but rather Moderna COVID-19 vaccine. The case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Injection site rash, Skin reaction
Clinical narrative: Patient went to the ER on 11/10/2023 for a rash on the right thigh.; The ER diagnosis as localized reaction at the injection site; This non-serious spontaneous safety report, with case number 2734865-1, was received by partner, on 07-MAR-2024 and forwarded on 08-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient went to the ER on 11/10/2023 for a rash on the right thigh, and The ER diagnosis as localized reaction at the injection site".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Injection site rash, Local reaction
Clinical narrative: Patient went to the ER on 11/10/2023 for a rash on the right thigh.; The ER diagnosis as localized reaction at the injection site; This non-serious spontaneous safety report, with case number 2734865-1, was received by partner, on 07-MAR-2024 and forwarded on 08-MAR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Patient went to the ER on 11/10/2023 for a rash on the right thigh, and The ER diagnosis as localized reaction at the injection site".  No further information is expected.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Genital herpes, Pain, Pyrexia, Vaccination failure
Clinical narrative: an outbreak of genital herpes; This non-serious case was reported by a consumer via call center representative and described the occurrence of genital herpes in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 6th September 2023, refer linked case US2024031090).   On 03-DEC-2023, the patient received the 2nd dose of Shingrix. On 26-DEC-2023, 23 days after receiving Shingrix, the patient experienced genital herpes (Verbatim: an outbreak of genital herpes). The outcome of the genital herpes was not resolved.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     It was unknown if the company considered the genital herpes to be related to Shingrix.   Linked case(s) involving the same patient:  US2024031090   Additional Information: GSK Receipt Date: 08-Mar-2024 The patient was self-reported this case. The patient received her 2nd dose and on 26th December 2023 she had an outbreak of genital herpes, which she stated that she never had before.  The patient had a total of two genital herpes outbreaks since receiving the 2nd Shingrix vaccine.  The patient was requesting compensation and a returned call. This US2024031090 case has been linked to the case reported by the same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024031090:Same patient/Dose 2
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Genital herpes
Clinical narrative: an outbreak of genital herpes; This non-serious case was reported by a consumer via call center representative and described the occurrence of genital herpes in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 6th September 2023, refer linked case US2024031090).   On 03-DEC-2023, the patient received the 2nd dose of Shingrix. On 26-DEC-2023, 23 days after receiving Shingrix, the patient experienced genital herpes (Verbatim: an outbreak of genital herpes). The outcome of the genital herpes was not resolved.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     It was unknown if the company considered the genital herpes to be related to Shingrix.   Linked case(s) involving the same patient:  US2024031090   Additional Information: GSK Receipt Date: 08-Mar-2024 The patient was self-reported this case. The patient received her 2nd dose and on 26th December 2023 she had an outbreak of genital herpes, which she stated that she never had before.  The patient had a total of two genital herpes outbreaks since receiving the 2nd Shingrix vaccine.  The patient was requesting compensation and a returned call. This US2024031090 case has been linked to the case reported by the same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024031090:Same patient/Dose 2
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: REBOUND OF SYMPTOMS; This spontaneous report received from a consumer by a other manufacturer (Pfizer Inc.) was received on 18-MAR-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, hypothyroidism, hypoparathyroidism, and penicillin allergy. The patient experienced drug allergy when treated with moxifloxacin hydrochloride, hydroxychloroquine phosphate, and ceftriaxone sodium. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on an unspecified date to Left Arm for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. Concomitant medications included bupropion, calcitriol, ergocalciferol, estradiol, levothyroxine, metoprolol, and tirzepatide. On 07-MAR-2024, treatment medications included: nirmatrelvir/ritonavir. On an unspecified date, the patient experienced  rebound of symptoms (dose series 1). Laboratory data (dates unspecified) included: COVID-19 virus test Negative, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rebound of symptoms. This report was non-serious. This report was associated with a product quality complaint: 90000318875.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE.No patient symptoms; This spontaneous non-serious safety report, with reference number 02533398, was received by a partner on 10-JAN-2024 and forwarded to Company on 11-JAN-2024, from a HCP.   Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms" and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by the partner with reference number 02533295 on 01-MAR-2024 and forwarded to Company on 05-MAR-2024, from HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms" and Vaxelis was not applicable.  Further information is expected.  Follow-up information was received by Company on 13-MAR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms" and Vaxelis was not applicable.  No further information is expected.  Significant Follow-up information was received by Company on 20-MAR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms" and Vaxelis was not applicable.  No further information is expected.
Age: 1.08
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE.No patient symptoms have been reported.; This spontaneous safety report, with reference number 02533429, was received by a partner on 10-JAN-2024 and forwarded to Company on 11-JAN-2024, from a HCP.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis is assessed as not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by the partner with reference number 02533429 on 01-MAR-2024 and forwarded to Company on 05-MAR-2024, from HCP. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported." and Vaxelis is assessed as not applicable.  No further information is expected.  Follow-up information was received by Company on 13-MAR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported." and Vaxelis is assessed as not applicable.  No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE were administered to a patient since the TE.No symptoms reported. TE:59.45F, Time:18hrs 30min,No additional AE.; This spontaneous safety report, with reference number 02533416 (interaction number 02533295), was received by a partner on 10-JAN-2024 and forwarded to agency on 11-JAN-2024, from a HCP.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis was not applicable.  Further information is expected.  Follow-up information with reference number 02533416 (interaction number 02533295) was received by the partner on 01-MAR-2024 and forwarded to agency on 05-MAR-2024, from a health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by fax and forwarded to agency on 13-MAR-2024, from HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis was not applicable.  No further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in (removed) administered to patient since (removed).No pt symptoms have been reported.Temp:59.45F, Time:18 Hrs 30min,No additional AE.; This spontaneous safety report, with reference number, was received by a partner on 10-JAN-2024 and forwarded to Angency on 11-JAN-2024, from a HCP in the Country.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in (removed) have been administered to a patient since the (removed). No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis is assessed as not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 01-MAR-2024 and forwarded to Agency on 05-MAR-2024, from HCP in the Country. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in (removed) have been administered to a patient since the (removed). No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis is assessed as not applicable.  Further information is expected.  Significant Follow-up information was received by via fax and forwarded to Agency on 13-MAR-2024, from HCP in the Country. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in (removed) have been administered to a patient since the (removed). No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis is assessed as not applicable.  No further information is expected.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE.; This non-serious spontaneous safety report was received by partner on 10-JAN-2024 and forwarded to agency on 11-JAN-2024 from a nurse.  Due to the nature of the event, the causality between the event "Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported. Temp:59.45F, Time frame:18 Hrs 30min,No additional AE." and Vaxelis is assessed as not applicable.  Further information is expected.  Follow-up information with the reference number: 02533304 (interaction number 02533295) was received by the partner on 01-MAR-2024 and forwarded to agency on 05-MAR-2024, from a nurse. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE." and Vaxelis is assessed as not applicable.  Further information is expected.  Significant Follow-up information was received by fax and forwarded to agency on 13-MAR-2024, from HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE." and Vaxelis is assessed as not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE administered to patient since the TE.No patient symptoms reported.Temp:59.45F, Time:18 Hrs 30min,No additional AE.; This non-serious spontaneous safety report was received by partner on 10-JAN-2024 and forwarded to agency on 11-JAN-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported event.  Further information is expected.  Follow-up information was received by agency on 13-MAR-2024, from a nurse. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE administered to patient since the TE.No patient symptoms reported.Temp:59.45F, Time:18 Hrs 30min,No additional AE." and Vaxelis was not applicable.  No further information is expected.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since TE.No patient symptoms have been reported.Temp:59.45F, Time:18 Hrs 30min,No additional AE.; This non-serious spontaneous safety report was received by partner on 10-JAN-2024 and forwarded on 11-JAN-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported event.  Further information is expected.  Significant Follow-up information was received by the partner on 13-MAR-2024 and forwarded on 13-MAR-2024, from a HCP. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event of "Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since TE.No patient symptoms have been reported.Temp:59.45F, Time:18 Hrs 30min,No additional AE."  No further information is expected.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE.; This non-serious spontaneous safety report was received by partner on 10-JAN-2024 and forwarded on 11-JAN-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported event.  Further information is expected.  Follow-up information was received on 01-MAR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event " Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE." and Vaxelis was assessed as not applicable.   No further information is expected.  Significant Follow-up information was received on 13-MAR-2024, from a HCP by fax. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event " Nurse reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE admin to patient since the TE.No pt symptoms have been reported.Temp:59.45F, Time frame:18 Hrs 30min,No additional AE." and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved and have been administered to a patient. No patient symptoms have been reported.; This non-serious spontaneous safety report with reference number #02533403, was received by partner on 10-JAN-2024 and forwarded on 11-JAN-2024 from a nurse.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes) and VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE" and Vaxelis is assessed as not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 01-MAR-2024 and forwarded on 05-MAR-2024, from HCP. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE." and Vaxelis was not applicable.  No further information is expected.  Follow-up information was received on 13-MAR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Nurse called and reported ROTATEQ, VAXELIS (prefilled syringes), VAXNEUVANCE involved in TE have been administered to a patient since the TE. No patient symptoms have been reported. Temperature:59.45F, Time frame:18 Hrs 30min, No additional AE." and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTAPIPV, DTPPVHBHPB
Symptoms: Overdose, Wrong product administered
Clinical narrative: Reports an AE for VAXELIS.States that a dose of QUADRACEL was given instead of VAXNEUVANCE.; ReportS an AE for VAXELIS.States that a dose of QUADRACEL was given instead of VAXNEUVANCE.; This non-serious spontaneous Safety Report was received by partner on 15-JAN-2024 and forwarded on 16-JAN-2024 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and 'Wrong product administered' and 'Vaccine overdose'.  Further information is expected.  FOLLOW UP INFORMATION was received by partner on 16-JAN-2024 and forwarded on 17-JAN-2024 from a physician.  No adverse event occurred after  'Wrong product administered' and 'Vaccine overdose'. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reported that expired dose of VAXELIS was inadvertently administered. Exp date was 1/16/2024 but administered on 1/17/2024.Post-expiry memo referenced. No adverse effects or AE reported.; This spontaneous safety report, with reference number, was received by a partner on 17-JAN-2024 and forwarded to RA on the same day, from a HCP in the (PRIVACY).  Due to the nature of the event, the causality between the event "HCP reported that expired dose of VAXELIS was inadvertently administered. Exp date was 1/16/2024 but administered on 1/17/2024.Post-expiry memo referenced. No adverse effects or AE reported" and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 05-FEB-2024 was forwarded to RA from a from a healthcare professional in the (PRIVACY). The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "HCP reported that expired dose of VAXELIS was inadvertently administered. Exp date was 1/16/2024 but administered on 1/17/2024.Post-expiry memo referenced. No adverse effects or AE reported" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: She was already given a Polio vaccine and since VAXELIS contains IPV, somehow she received an extra dose; VAXELIS was given incorrectly to a patient/ administered with Vaxelis at an earlier time; This non-serious spontaneous safety report was received by partner on 15-JAN-2024 and forwarded on 17-JAN-2024 from another health professional.   The reporter did not assess the causal relationship between vaccine and 'Extra dose administered' and 'Inappropriate schedule of product administration'.  Further information is expected.
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Office manager called on behalf of physician stated that they had a patient administered Vaxelis on 05Jan2024 by a different facility and was then administered Pentacel on 17Jan2024,wanted to know if there will be any Adverse effects because of this; Office manager called on behalf of physician stated that they had a patient administered Vaxelis on 05Jan2024 by a different facility and was then administered Pentacel on 17Jan2024,wanted to know if there will be any Adverse effects because of this; This spontaneous safety report, with reference number 2024SA018754, was received by the partner on 17-JAN-2024 and forwarded to agency on 18-JAN-2024, from a non-health professional.  Due to the nature of the event, the causality between the event "Office manager called on behalf of physician stated that they had a patient administered Vaxelis on 05Jan2024 by a different facility and was then administered Pentacel on 17Jan2024, wanted to know if there will be any Adverse effects because of this" and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product distribution issue, Product storage error
Clinical narrative: temperature excursion due to the 2 day shipment delay of VAXELIS and PENTACEL; This non-serious spontaneous safety report, with reference number 2024SA023514 (inquiry number: 01914598), was received by a partner on 19-JAN-2024 and forwarded to Health Authority on 22-JAN-2024, from a HCP.   The reporter did not assess the causal relationship between Vaxelis and the event of "temperature excursion due to the 2 day shipment delay of VAXELIS and PENTACEL".  Due to the nature of the event, the causality between the events; "temperature excursion due to the 2 day shipment delay of VAXELIS and PENTACEL" and Vaxelis was not applicable.   Further information is expected.    SIGNIFICANT FOLLOW-UP INFORMATION RECEIVED ON 08-FEB-2024 was forwarded from a Health Care professional.   The reporter did not assess the causal relationship between Vaxelis and the event of "temperature excursion due to the 2 day shipment delay of VAXELIS and PENTACEL".  Due to the nature of the event, the causality between the events; "temperature excursion due to the 2 day shipment delay of VAXELIS and PENTACEL" and Vaxelis was not applicable.   No further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP calling regarding Vaxelis stated that VAXELIS, with an expiration date of 01/14/2024, was administered on 01/23/2024. No signs/symptoms of adverse effects were reported. Limited information was provided.No additional AE/no PQC.; This spontaneous safety report, with reference number 02540228, was received by a partner on 23-JAN-2024 and forwarded to Health Authority on 25-JAN-2024, from a HCP.  This case was considered non-valid due to no patient identifiers were provided  Due to the nature of the event, the causality between the event "HCP calling regarding Vaxelis stated that VAXELIS, with an expiration date of 01/14/2024, was administered on 01/23/2024. No signs/symptoms of adverse effects were reported. Limited information was provided. No additional AE/no PQC." and Vaxelis was not applicable.  Further information is expected.  Significant follow up information received on 14-FEB-2024 by partner and forwarded to Health Authority on 15-FEB-2024 from a health professional.  The case is deemed valid as patient identifiers provided. No adverse event occurred following vaccination with expired vaccine.  Due to the nature of the event, the causality between the event "HCP calling regarding Vaxelis stated that VAXELIS, with an expiration date of 01/14/2024, was administered on 01/23/2024. No signs/symptoms of adverse effects were reported. Limited information was provided. No additional AE/no PQC." and Vaxelis was not applicable.  Further information is not expected.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This spontaneous safety report, with reference number 02542172, was received by a partner on 26-JAN-2024 and forwarded on 29-JAN-2024 and additional information was received by partner on 29-JAN-2024 and forwarded on 30-JAN-2024 from a HCP.  This case was considered non-valid due to no patient identifiers were provided   Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs" and Vaxelis was not applicable.  Further information is expected.  Follow-up information was received by the partner on 04-MAR-2024 and forwarded on 05-MAR-2024, from HCP. The cases is maintained as non-serious and non-valid.  Due to the nature of the event, the causality between the event Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs" and Vaxelis is assessed as not applicable.  Further information is expected.  Follow-up information was received by the partner on 12-MAR-2024 and forwarded on 13-MAR-2024, from HCP. The case is maintained as non-serious and non-valid.  Due to the nature of the event, the causality between the event Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs" and Vaxelis is assessed as not applicable.  Further information is expected.  Non-significant follow-up information was received by the partner on 18-MAR-2024 and forwarded on same day, from HCP. The case is maintained as non-serious and non-valid.  No further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 20-MAR-2024 and forwarded on same day by a health care professional. The case is maintained as valid and non-serious.  Due to the nature of the event, the causality between the event Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs" and Vaxelis is assessed as not applicable.  No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by the partner on 12-MAR-2024 and forwarded on 21-MAR-2024, from HCP.   Due to the nature of the event, the causality between the event Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs" and Vaxelis is assessed as not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Caller stated they gave Vaxelis to a patient that was 14 days expired and they are checking to see if the dose needs to be repeated/an inappropriate use due to administering an expired vaccine to a patient.; Caller stated they gave Vaxelis to a patient that was 14 days expired and they are checking to see if the dose needs to be repeated/Medication error; This non-serious spontaneous safety report with reference number 2024SA035048 (Inquiry number:) was received by partner on 31-JAN-2024 and forwarded to RA on 01-FEB-2024, from a healthcare professional in the (PRIVACY).  Due to the nature of the event, the causality between the events "Caller stated they gave Vaxelis to a patient that was 14 days expired and they are checking to see if the dose needs to be repeated/an inappropriate use due to administering an expired vaccine to a patient." and Vaxelis is assessed as Not Applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report T/E case that occurred on 12/7/2023. HCP stated VAXELIS (PFS) AND ROTATEQ were administered on 1/17/2024 to a twin patient during TE.No additional AE reported. No PQC reported; This spontaneous safety report, with reference number 02544485, was received by a partner on 31-JAN-2024 and forwarded to agency on 01-FEB-2024, from a HCP.  Due to the nature of the event, the causality between the event "HCP called to report T/E case that occurred on 12/7/2023. HCP stated VAXELIS (PFS) AND ROTATEQ were administered on 1/17/2024 to a twin patient during TE. No additional AE reported. No PQC reported" and Vaxelis was not applicable.  Further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: HCP stated VAXELIS (PFS) and ROTATEQ were administered on 1/17/2024 to a twin patient during a Temperature Excursion; This spontaneous safety report, with reference number, was received by a partner on 31-JAN-2024 and forwarded to RA on 01-FEB-2024, from a HCP in the (PRIVACY).  Due to the nature of the event, the causality between the event "HCP called to report T/E case that occurred on 12/7/2023. HCP stated VAXELIS (PFS) AND ROTATEQ were administered on 1/17/2024 to a twin patient during TE. No additional AE reported. No PQC reported" and Vaxelis was not applicable.  Further information is expected.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Product storage error
Clinical narrative: Caller reports products that experienced TE. TE for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023.; This non serious spontaneous safety report was received by Company on 05-FEB-2024, from a health care professional (HCP).  Due to nature of the event, the causality between the event "Caller reports products that experienced TE. TE for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023" and Vaxelis was assessed as not applicable.  No further information is expected.  For reference purposes, this case report is linked to companion case(s): MCM-005735, MCM-005840 and MCM-005842.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Product storage error
Clinical narrative: Caller reports products that experienced TE. TE for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023.; This non-serious spontaneous safety report was received by Company on 05-FEB-2024 via fax from a health care professional.  Due to nature of the event, the causality between Vaxelis and the event of "temperature excursion (TE) for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023" was assessed as not applicable.  No further information is expected.  For reference purposes, this case report is linked to companion case(s): MCM-005735, MCM-005839 and MCM-005842.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Caller reports products that experienced TE. TE for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023.; This non-serious spontaneous safety report was received on 05-FEB-2024 via fax from a health care professional.  Due to nature of the event, the causality between Vaxelis and the event "Temperature excursion (TE) for all products occurred 1/13/2024 and were administered to unknown number of patients between the TE date and today 1/19/2023" was assessed as not applicable.  No further information is expected.  For reference purposes, this case report is linked to companion case(s): MCM-005735, MCM-005839 and MCM-005840.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP reported vaccines were administered after temperature excursion; This spontaneous safety report, with the reference number: 02546781 (interaction number:02546714), was received by a partner on 05-FEB-2024 and forwarded to Health Authority on 05-FEB-2024, from a HCP.  This case was considered non-valid as no patient identifiers were provided.  Due to the nature of the event, the causality between the event: "vaccines were administered after temperature excursion, temperature 9.1 for time frame 2 hours 45 minutes 0 seconds. All products were administered to patients on 02-FEB-2024, however HCP did not have patient demographics" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received by Health Authority on 20-FEB-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event " The HCP reported that a 6month old patient inadvertently received a dose of VARIVAX" and Vaxelis was assessed as not applicable.   No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: Patient's arms were extremely cold the night after the vaccination/Mottling the evening of and the day after; Patient's arms were extremely cold the night after the vaccination/Mottling the evening of and the day after; Patient developed a 102 degree fever; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  Grandmother called stating the patient's arms were extremely cold the night after the vaccination. She states she noticed mottling the evening of and the day after. Patient also developed a 102 degree fever.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events of patient's arms were extremely cold the night after vaccination, mottling the evening of and day after and 102 degree fever.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS MEDICATION ERROR RSVNirsevimab( Beyfortus); Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml.; NO ADVERSE EVENTS MEDICATION ERROR RSVNirsevimab( Beyfortus); This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight  Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 8 oz = to 5.22 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs.  Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per RA and CDC guidelines.  The causal relationship between Vaxelis and the events " NO ADVERSE EVENTS MEDICATION ERROR RSV-Nirsevimab(Beyfortus) is based on weight  Administer only half dose of the vaccine, 0.5 ml instead of 1.0 ml. DOS - Patient weignt was 11 lbs 8 oz = to 5.22 kgs. Patient's correct dosage should of be 1.0 ml for > 5 kgs.  Will give additional dose of Beyfortus 0.5 ml at next OV (12/19/23) per RA and CDC guidelines." was assessed as not applicable due to the nature of the reported events.  No further information is expected.  RA notes: Based on the available information, the events were not related to Vaxelis but to Nirsevimab (beyfortus) vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.