chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778130 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778151 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778108 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778169 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded  on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778115 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778158 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778172 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02778145 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number: 02778105 (Interaction number 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from a nurse.  Due to the nature of the event, the causality between the event "HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; HCP confirmed that there were no symptomatic events; This non-serious spontaneous safety report, with reference number 02777952 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778165 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778153 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds', 'HCP confirmed that there were no symptomatic events' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007771.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VAXELIS was administered after a temperature excursion. (54.19F for 2hours 45 min); This non-serious spontaneous safety report, with reference number 02779819 (interaction number: 02779738), was received by partner on 31-MAR-2025 and forwarded on 01-APR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'VAXELIS was administered after a temperature excursion' and Vaxelis was not applicable.  Further information is expected.  Follow-up information, with reference number 02779819 (interaction number: 02779738), was forwarded on 01-MAY-2025 from other health professional.   Due to the nature of the event, the causality between the event 'VAXELIS was administered after a temperature excursion', 'No adverse event' and Vaxelis was not applicable.  No further information is expected.
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine; 1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine; This non-serious spontaneous safety report, with reference number 02780823 (interaction number: 02780822), was received by partner on 02-APR-2025 and forwarded on 02-APR-2025 from other health professional.  Due to the nature of the event, the causality between the event '1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine' and Vaxelis was not applicable.  Further information is expected.  This non-significant follow-up report, with reference number 02780823 (interaction number: 02780822), was received on 30-APR-2025 from other health professional.  Due to the nature of the event, the causality between the event '1 month and 30-day old consumer inadvertently received the RECOMBIVAX HB concomitantly with the VAXELIS vaccine' and Vaxelis was not applicable.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, Paralysis
Clinical narrative: Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS; This non-serious spontaneous, safety report was received by partner on 08-APR-2025 and forwarded on 09-APR-2025 from a healthcare professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS", and overdose.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received on 24-APR-2025 from a healthcare professional (clinical manager).  The healthcare professional reported that both Vaxelis and ACTHIB were not administered together at the same time.   She further noted that the patient had reaction ("palsy-like" reaction) to Vaxelis, or Prevnar, or Rota according to the patient's mother.   The reported was not able to confirm the reaction nor provide any further information as the event occurred while under the care of a previous pediatrician and there was no documentation was received from previous pediatrician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "Patient had a "palsy-like" reaction at 6 months of age after receiving ACTHIB and VAXELIS", and overdose.  No further information is expected.
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Inbound call from HCP with questions regarding a patient who was co-administered VAXELIS and PEDVAXHIB; HCP reported that there were no symptomatic events from the patient.; This non-serious spontaneous safety report, with reference number 02791973 (Interaction Number 02791970), was received by partner on 21-APR-2025 and forwarded on 22-APR-2025 from other health professional.  Due to the nature of the event, the causality between the events Inbound call from HCP with questions regarding a patient who was co-administered VAXELIS and PEDVAXHIB' and 'HCP reported that there were no symptomatic events from the patient.' and Vaxelis was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796514 (interaction number: 02796419), was received by the partner on 29-APR-2025 and forwarded on 29-APR-2025, from other health professional.   Due to the nature of the event, the causality between the event "HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion" and Vaxelis was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796506 (interaction number: 02796419), was received by the partner on 29-APR-2025 and forwarded on 30-APR-2025, from other health professional    Due to the nature of the event, the causality between the event "HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion" and Vaxelis was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HBP reported patient was administered VAXELIS during a temperature excursion.; This non-serious spontaneous safety report, with reference number 02796524 (Interaction Number 02796419), was received by partner on 29-APR-2025 and forwarded on 29-APR-2025 from an other Health Professional.  Due to the nature of the event, the causality between the event HBP reported patient was administered VAXELIS during a temperature excursion.' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Eye swelling, Peripheral swelling, Rash
Clinical narrative: swollen lower legs; both legs are swollen; lower legs are swollen "like golf balls".; swollen eyes; About 4 hours after receiving the vaccine, the patient developed a fever; rash on her back and belly; This non-serious spontaneous safety report, with reference number 02796482 (interaction number: 02796481), was received by partner on 29-APR-2025 and forwarded on 29-APR-2025 from other non-health professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'swollen lower legs; both legs are swollen; lower legs are swollen "like golf balls"', 'swollen eyes', 'About 4 hours after receiving the vaccine, the patient developed a fever' and 'rash on her back and belly'.  Further information is expected.  CASE CORRECTION performed on 13-MAY-2025 following QPPV review on the same date: Tylenol was coded as treatment under product tab and treatment was added for the event of fever under event tab. Outcome for the event of "Eye swelling" was conservatively updated to "Unknown".
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Caller stated that 5-week baby was give the product 4 days early.; This non-serious spontaneous safety report, with reference number 2025SA134302 (Inquiry Number 02514653), was received by partner on 08-MAY-2025 and forwarded on 09-MAY-2025 from an other health professional.  Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 5 weeks.  Due to the nature of the event, the causality between the event Caller stated that 5-week baby was give the product 4 days early.' and Vaxelis was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: VAXELIS expired on 5/6/2025 and was administered to a patient on 5/12/2025; This Spontaneous Safety Report with reference number: 02804293/interaction number 02804291 was received by a partner on 13-MAY-2025 and forwarded on 13-MAY-2025 from a health professional.  Due to the nature of the event, the causality between the event "VAXELIS expired on 5/6/2025 and was administered to a patient on 5/12/2025" and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: patient was given two doses of HIB; Vaccine coordinator said that there were no adverse events reported; This non-serious, spontaneous safety report with reference number: 2025SA130977, 02506717, and 02506678 was received by a partner on 01-MAY-2025 and forwarded on 06-MAY-2025 from a health professional.  Due to the nature of the event, the causality between the event "patient was given two doses of HIB" and Vaxelis was not applicable.  Further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cold type haemolytic anaemia, Laboratory test
Clinical narrative: Cold agglutinin disease; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Oct2023 as dose number unknown, 0.5 ml single (Lot number: GT6700, Expiration Date: 31Oct2024) at the age of 65 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension. The following information was reported: COLD TYPE HAEMOLYTIC ANAEMIA (medically significant) with onset Feb2024, outcome "unknown", described as "Cold agglutinin disease". The event "cold agglutinin disease" required physician office visit. The patient underwent the following laboratory tests and procedures: lab test: (2023) unknown results. 5 days after she was given Prevnar 20 (NDC number 0005200010), she was donating blood and they would not accept her blood. In Feb2024 she was given a letter that stated the diagnosis. She was seeing a hematologist.
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging neck, Nerve conduction studies
Clinical narrative: Guillain-Barre syndrome; This is a literature report for the following literature source(s).  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), 60 days after the suspect product(s) administration, outcome "recovering" (reported as partial recovery). The clinical course was reported as follows: the patient experienced lower back pain, numbness and tingling of the bilateral lower extremities, urinary retention and constipation. The patient underwent the following investigations: a magnetic resonance imaging (MRI) of the spine, which demonstrated signs of osteoarthritis with the spinal cord intact and nerve conduction and electromyography studies, which revealed demyelination and dysfunctions in the engagement of distal muscles below the knee. Therapeutic measures were taken as a result of guillain-barre syndrome, which included intravenous immunoglobulin (IV IG).; Sender's Comments: Given the compatible time association, the reasonable possibility that the event Guillain-Barre syndrome is related to BNT162b2 administration cannot be completely excluded. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: recently scraped her leg; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious) with onset May2025, outcome "unknown", described as "recently scraped her leg".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: have my bones hurt so much that I felt nearly unable to walk; tired; sore arm; dry heaves; not be able to stay awake to eat for over 30 hours; have blood in my urine; fever; chills; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in May2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 3, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 4, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 5, single, manufacturer unknown), for Immunisation. The following information was reported: CHILLS (non-serious) with onset May2025, outcome "unknown"; RETCHING (non-serious) with onset May2025, outcome "unknown", described as "dry heaves"; PYREXIA (non-serious) with onset May2025, outcome "unknown", described as "fever"; BLOOD URINE PRESENT (non-serious) with onset May2025, outcome "unknown", described as "have blood in my urine"; BONE PAIN (medically significant) with onset May2025, outcome "unknown", described as "have my bones hurt so much that I felt nearly unable to walk"; HYPERSOMNIA (non-serious) with onset May2025, outcome "unknown", described as "not be able to stay awake to eat for over 30 hours"; PAIN IN EXTREMITY (non-serious) with onset May2025, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset May2025, outcome "unknown", described as "tired". The patient specified that he/she recently had 6th COVID vaccine. The patient had a mix of Pfizer and Moderna. This past Friday the patient had the Pfizer shot. The patient expected to be tired and had a sore arm. He/she did not expect to have dry heaves; the patient had bones hurt so much that he/she felt nearly unable to walk, not be able to stay awake to eat for over 30 hours, had blood in urine and of course had fever and chills.
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: have my bones hurt so much that I felt nearly unable to walk; tired; sore arm; dry heaves; not be able to stay awake to eat for over 30 hours; have blood in my urine; fever; chills; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in May2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 2, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 3, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 4, single, manufacturer unknown), for Immunisation; Covid-19 vaccine (dose 5, single, manufacturer unknown), for Immunisation. The following information was reported: CHILLS (non-serious) with onset May2025, outcome "unknown"; RETCHING (non-serious) with onset May2025, outcome "unknown", described as "dry heaves"; PYREXIA (non-serious) with onset May2025, outcome "unknown", described as "fever"; BLOOD URINE PRESENT (non-serious) with onset May2025, outcome "unknown", described as "have blood in my urine"; BONE PAIN (medically significant) with onset May2025, outcome "unknown", described as "have my bones hurt so much that I felt nearly unable to walk"; HYPERSOMNIA (non-serious) with onset May2025, outcome "unknown", described as "not be able to stay awake to eat for over 30 hours"; PAIN IN EXTREMITY (non-serious) with onset May2025, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset May2025, outcome "unknown", described as "tired". The patient specified that he/she recently had 6th COVID vaccine. The patient had a mix of Pfizer and Moderna. This past Friday the patient had the Pfizer shot. The patient expected to be tired and had a sore arm. He/she did not expect to have dry heaves; the patient had bones hurt so much that he/she felt nearly unable to walk, not be able to stay awake to eat for over 30 hours, had blood in urine and of course had fever and chills.
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: a little soreness in my arm/ a slight pain for a couple of hours; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little soreness in my arm/ a slight pain for a couple of hours".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pre-assessed as an off-label use as per local labelling due to mixing pentacel and not using acthib component with no reported ae; Initial information received on 15-May-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received only vial 1 (DTaP-IPV component) due to mixing Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and not using ACTHIB component with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination [immunization], and acthib component was not mixed t o vaccine with no reported ae (single component of a two-component product administered) (unknown latency).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, Patient was inadvertently given only vial 1 (DTaP-IPV component) in office for his 2 month vaccines.  Action taken was not applicable.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: The day after vaccine administered, patient develop axillary swelling, worsen next day and then gradually resolved.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash, Throat tightness, Urticaria
Clinical narrative: In the evening after receiving vaccine patient developed urticarial rash and pruritis of the neck. Rash spread to left arm and face the following day and patient began feeling "throat tightness".  Presented to emergency department. Denies any difficulty swallowing, change in her voice. Denies any nausea, vomiting, shortness of breath, wheezing, lightheadedness or syncopal episodes.  Pruritus resolved after over-the-counter treatment. Given sensation in her throat given intramuscular epinephrine, steroids along with antihistamines. After several hours of monitoring, patient was able to discharge home in stable condition.
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Electrocardiogram normal, Gait disturbance, Magnetic resonance imaging, Walking aid user
Clinical narrative: Wife called that patient felt very dizzy next day after getting second dose of shingles shot. His gait was changed and he had to use cane and then walker.  Patient's vital are stable.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Headache, Nausea, Pruritus, Vomiting
Clinical narrative: Patient reports approximately 8 hours after vaccine experiencing symptoms of fiery itch from top of head to knees, nausea, vomiting x1 and headache. Took Benadryl and did feel that it helped but developed diarrhea. No hives or rash appeared. Symptoms resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Palpitations
Clinical narrative: Patient called pharmacy on 05-21-2025 stating that after receiving the immunization she did not feel good, had chills, diarrhea, nauseous. Recently she had heart racing. She stated not having a COVID Immunization over a year.  Counsel patient to get medical attention
Age: 87.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports arm pain lasting over one week with no redness or swelling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Deep vein thrombosis, Fibrin D dimer increased, Full blood count, International normalised ratio
Clinical narrative: right lower leg dvt. elevated dimer, elevated crp. ended up with paralyzed vocal cord
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time, Red blood cell sedimentation rate, Vocal cord paralysis
Clinical narrative: right lower leg dvt. elevated dimer, elevated crp. ended up with paralyzed vocal cord
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Dry skin, Erythema, Fatigue, Hypersomnia
Clinical narrative: Twenty-four hours after vaccine, incredible fatigue, arm hot to the touch and really hurt.  Ran a low grade fever of 99.7 degrees.  Felt the worst I have in a very long time.  Slept most of the day another 12 hours.  The next day, I recovered but weak.  The arm  has not recovered from being hot to the touch.  As of today, 5/21/2025,  6 days later, it is incredibly itchy, red, swollen, white dry patches, and hot to the touch.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Pruritus, Skin discolouration, Skin warm, Swelling
Clinical narrative: Twenty-four hours after vaccine, incredible fatigue, arm hot to the touch and really hurt.  Ran a low grade fever of 99.7 degrees.  Felt the worst I have in a very long time.  Slept most of the day another 12 hours.  The next day, I recovered but weak.  The arm  has not recovered from being hot to the touch.  As of today, 5/21/2025,  6 days later, it is incredibly itchy, red, swollen, white dry patches, and hot to the touch.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine, Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: The vaccine was administered on 5/15/25. The patient called the clinic on 5/21 to report a large red area to arm and shoulder that was warm and tender to touch, that was very itchy. She reported the redness to be very large almost larger than the size of her hand.  Patient was scheduled to visit with a provider same day. The provider recommended use of OTC medications to help the symptoms. Added Pneumococcal vaccine to her allergy list.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Pt had classic urticaria and erythematous splotches consistent with hypersensitivity reaction  that started 10 hours after vaccine given. Has started to subside 24 hours after vaccination given, but still she is very itchy. She never had any throat swelling, shortness of breath, or fever.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: Pt had large local reaction in the area 2 days post injection
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Product preparation issue
Clinical narrative: HIB not reconstituted, only sterile diluent given.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Immediate post-injection reaction, Lethargy
Clinical narrative: Lethargy x/15 minutes, immediately after receiving vaccinations. Patient remained in doctor's office until stable.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: noticed 5/1/25 9 am, Redness, warm to touch and swelling to left deltoid. No treatment at home (motrin/tylenol/ice). Area of pink, warm, discoloration measuring 4.5 in x 2.5 in. Advised benadryl & cool compresses
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Rash papular
Clinical narrative: 14 mo came to clinic with concern about papulovesicular rash beginning on 5/19. Denise fever, had scattered papuloesicles on lower trunk groin and lesser number on upper trunk/distal extremities. Considering diagnosis of vaccine related rash from Varivax or also hand foot mouth/other viral exanthem. Child is well appearing.   Due to potential for vaccine adverse event this report is being filed.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Urticaria
Clinical narrative: Urticaria on feet and lower legs bilateral observed for 20 minutes & released / resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: My son was given the Dtap vaccine around 10:20 a.m. on Friday, May 2, 2025 at his vaccine appointment.  After the needle was inserted in his leg, he screamed out in so much pain and said, "I don't like that."  About 4 hours later, he was crying and screaming in pain that his leg hurt so bad and that it hurt to walk. He was limping around.  The leg around the vaccine site was red, swollen, and firm to the touch.  I was told that this was normal.  The next day (Saturday, May 3, 2025), the swollen, firm area around the vaccine site had spread.  I called the local hospital after hours nurse because the clinic was closed because it was a Saturday afternoon.  The RN called me back and told me that it is normal for there to be swelling and redness and for the site to be painful.  I know this, but I explained that the entire top half of his leg from just below his groin to below his knee was swollen and red and firm.  The nurse told me that everything was ok.  I went to work on Sunday and worked my 12.5 hour shift.  When I arrived home, that evening, his leg was even more swollen, red, and firm.  I took him Hospital where the MD diagnosed him with a bacterial infection of the leg from the vaccination site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Bacterial infection, Blood creatine phosphokinase, Blood culture, C-reactive protein, Crying
Clinical narrative: My son was given the Dtap vaccine around 10:20 a.m. on Friday, May 2, 2025 at his vaccine appointment.  After the needle was inserted in his leg, he screamed out in so much pain and said, "I don't like that."  About 4 hours later, he was crying and screaming in pain that his leg hurt so bad and that it hurt to walk. He was limping around.  The leg around the vaccine site was red, swollen, and firm to the touch.  I was told that this was normal.  The next day (Saturday, May 3, 2025), the swollen, firm area around the vaccine site had spread.  I called the local hospital after hours nurse because the clinic was closed because it was a Saturday afternoon.  The RN called me back and told me that it is normal for there to be swelling and redness and for the site to be painful.  I know this, but I explained that the entire top half of his leg from just below his groin to below his knee was swollen and red and firm.  The nurse told me that everything was ok.  I went to work on Sunday and worked my 12.5 hour shift.  When I arrived home, that evening, his leg was even more swollen, red, and firm.  I took him Hospital where the MD diagnosed him with a bacterial infection of the leg from the vaccination site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Differential white blood cell count, Full blood count, Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: My son was given the Dtap vaccine around 10:20 a.m. on Friday, May 2, 2025 at his vaccine appointment.  After the needle was inserted in his leg, he screamed out in so much pain and said, "I don't like that."  About 4 hours later, he was crying and screaming in pain that his leg hurt so bad and that it hurt to walk. He was limping around.  The leg around the vaccine site was red, swollen, and firm to the touch.  I was told that this was normal.  The next day (Saturday, May 3, 2025), the swollen, firm area around the vaccine site had spread.  I called the local hospital after hours nurse because the clinic was closed because it was a Saturday afternoon.  The RN called me back and told me that it is normal for there to be swelling and redness and for the site to be painful.  I know this, but I explained that the entire top half of his leg from just below his groin to below his knee was swollen and red and firm.  The nurse told me that everything was ok.  I went to work on Sunday and worked my 12.5 hour shift.  When I arrived home, that evening, his leg was even more swollen, red, and firm.  I took him Hospital where the MD diagnosed him with a bacterial infection of the leg from the vaccination site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain, Procalcitonin
Clinical narrative: My son was given the Dtap vaccine around 10:20 a.m. on Friday, May 2, 2025 at his vaccine appointment.  After the needle was inserted in his leg, he screamed out in so much pain and said, "I don't like that."  About 4 hours later, he was crying and screaming in pain that his leg hurt so bad and that it hurt to walk. He was limping around.  The leg around the vaccine site was red, swollen, and firm to the touch.  I was told that this was normal.  The next day (Saturday, May 3, 2025), the swollen, firm area around the vaccine site had spread.  I called the local hospital after hours nurse because the clinic was closed because it was a Saturday afternoon.  The RN called me back and told me that it is normal for there to be swelling and redness and for the site to be painful.  I know this, but I explained that the entire top half of his leg from just below his groin to below his knee was swollen and red and firm.  The nurse told me that everything was ok.  I went to work on Sunday and worked my 12.5 hour shift.  When I arrived home, that evening, his leg was even more swollen, red, and firm.  I took him Hospital where the MD diagnosed him with a bacterial infection of the leg from the vaccination site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Screaming, Ultrasound scan
Clinical narrative: My son was given the Dtap vaccine around 10:20 a.m. on Friday, May 2, 2025 at his vaccine appointment.  After the needle was inserted in his leg, he screamed out in so much pain and said, "I don't like that."  About 4 hours later, he was crying and screaming in pain that his leg hurt so bad and that it hurt to walk. He was limping around.  The leg around the vaccine site was red, swollen, and firm to the touch.  I was told that this was normal.  The next day (Saturday, May 3, 2025), the swollen, firm area around the vaccine site had spread.  I called the local hospital after hours nurse because the clinic was closed because it was a Saturday afternoon.  The RN called me back and told me that it is normal for there to be swelling and redness and for the site to be painful.  I know this, but I explained that the entire top half of his leg from just below his groin to below his knee was swollen and red and firm.  The nurse told me that everything was ok.  I went to work on Sunday and worked my 12.5 hour shift.  When I arrived home, that evening, his leg was even more swollen, red, and firm.  I took him Hospital where the MD diagnosed him with a bacterial infection of the leg from the vaccination site.
Vaccine: MMR
Symptoms: Cough, Influenza virus test negative, Laboratory test, Measles, Polymerase chain reaction positive
Clinical narrative: measles-like symptoms following vaccination; This spontaneous report was received from a consumer regarding a child patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 23-APR-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL administered intramuscularly as prophylaxis (lot number reported as 4015995, which is an invalid lot number for this product, expiration date reported as 24-SEP-2026) (vaccination scheme and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date were not reported).  On 01-MAY-2025, the patient started to experience unusually severe measles-like symptoms (Measles) following the vaccination, such as runny nose and cough. On 04-MAY-2025, the patient experienced maculopapular rash covering most of the body. On 05-MAY-2025, the patient experienced 102 Fahrenheit degree (F) fever. On an unknown date in 2025, the patient tested negative for COVID and flu, and polymerase chain reaction (PCR) showed +. MeVa test result was pending. The outcome of measles-like symptoms was unknown.   The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.