chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Medical assistant called and reported VAXELIS and ROTATEQ were administered to a patient after being involved in a temperature excursion; This spontaneous safety report, with reference number 02629244, was received by a partner on 02-JUL-2024 and forwarded on the same day, from a HCP. Additional information was received by the partner on 02-JUL-2024 and forwarded  on same day, from HCP. The cases is maintained as non-serious.  Due to the nature of the event, the causality between the event "Medical assistant called and reported VAXELIS and ROTATEQ were administered to a patient after being involved in a temperature excursion" and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HPV4, MEN
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: As a medication error/an inappropriate use due to administration of VAXELIS to an 11 year old patient; This non-serious spontaneous safety report with reference number # 02134958, was received by a partner on 12-JUL-2024 and forwarded to agency on 15-JUL-2024 from a health care professional.  The causal relationship between Vaxelis and the reported event "As a medication error/an inappropriate use due to administration of VAXELIS to an 11-year-old patient" was assessed as not applicable due to the nature of the event.  Case is considered off-label use, since Vaxelis was administered to a patient of inappropriate age (11-years-old).  Further information is expected.
Age: 1.25
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: administered 15 month old patient VAXELIS and the patient was due to receive Dtap and HIB.; This non-serious spontaneous safety report was received by partner on 16-JUL-2024 and forwarded to agency on 17-JUL-2024 from an other HCP. Additional information was received on 16-JUL-2024 by the partner and forwarded to agency on 17-JUL-2024 from the other HCP.  Due to the nature of the event, the causality assessment between Vaxelis and the Administered 15 month old patient VAXELIS and the patient was due to receive Dtap and HIB is not applicable.  Further information is expected.  Follow up information was received by agency on 05-AUG-2024 from a other HCP.  Due to the nature of the event, the causality assessment between Vaxelis and the Administered 15 month old patient VAXELIS and the patient was due to receive Dtap and HIB is not applicable.   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number 02638292 (interaction number: 02638274), was received by the partner on 17-JUL-2024 and forwarded on 17-JUL-2024, from consumer/other non-health professional.   This case was considered non-valid due to no patient identifiers provided (temperature excursion only).  Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 31-JUL-2024 and forwarded on same day, from a consumer/other non-health professional. The case is maintained as non-serious.  This case is now considered valid due to patient identifiers being provided.  Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: HCP calling to report VAXELIS was inadvertently administered today, 7/25/2024. after its labeled expiry date of 7/17/2024; This non-serious spontaneous safety report, with reference number 02643083 (interaction number: 02643078), was received by a partner on 25-JUL-2024 and forwarded to agency on 25-JUL-2024, from a reporter.   Due to the nature of the event, the causality between the event "HCP calling to report VAXELIS was inadvertently administered today, 7/25/2024. after its labeled expiry date of 7/17/2024" and Vaxelis was assessed as not applicable.   Further information is expected  Significant Follow-up information was received by the partner on 12-AUG-2024 and forwarded to agency on same day, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "HCP calling to report VAXELIS was inadvertently administered today, 7/25/2024. after its labeled expiry date of 7/17/2024" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of VAXELIS; This non-serious spontaneous Safety Report, with reference number 2024SA225786, was received by partner on 30-JUL-2024 and forwarded on 31-JUL-2024 from a HCP  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient received an expired dose of VAXELIS".  Further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant reported that an expired VAXELIS was administered to a patient. No additional AEs were reported. No further information provided; This non-serious spontaneous safety report, with reference number 02646867 (interaction number: 02646855), was received by partner on 31-JUL-2024 and forwarded on 31-JUL-2024 from other health professional.   Due to the nature of the event, the causality between the event 'Expired product administered' and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 19-AUG-2024 and forwarded on same day, from a HCP. The case is maintained as non-serious.  This case is now considered valid due to patient identifiers being provided.  Due to the nature of the event, the causality between the event 'Expired product administered' and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Dehydration, Lethargy, Poor feeding infant, Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: Dehydration; Poor feeding; Lethargy; Went into the wrong patient and gave it to the wrong patient; I am an outside facility. I was advised that this baby as three days old, inadvertently receive a pneumococcal 20 (Clarified as Prevnar 20), in addition to the Vaxelis and RotaTeq."; I am an outside facility. I was advised that this baby as three days old, inadvertently receive a pneumococcal 20 (Clarified as Prevnar 20), in addition to the Vaxelis and RotaTeq."; This non-serious spontaneous safety report, with reference number 202400225226, was received by partner on 29-JUL-2024 and forwarded to agency on 01-AUG-2024 from physician.  Due to the nature of the event, the causality between the event 'went into the wrong patient and gave it to the wrong patient', 'I am an outside facility. I was advised that this baby as three days old, inadvertently receive a pneumococcal 20 (Clarified as Prevnar 20), in addition to the Vaxelis and RotaTeq."' and Vaxelis was not applicable.  Off-label classification was added due to Vaxelis being administered to a 3-day-old patient.  Further information is expected.  Significant Follow-up information was received by the partner on 21-AUG-2024 and forwarded to agency on 22-AUG-2024, from a physician. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event 'went into the wrong patient and gave it to the wrong patient', 'I am an outside facility. I was advised that this baby as three days old, inadvertently receive a pneumococcal 20 (Clarified as Prevnar 20), in addition to the Vaxelis and RotaTeq."' and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 03-SEP-2024 and forwarded to agency on same day, from a physician. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event 'went into the wrong patient and gave it to the wrong patient', 'I am an outside facility. I was advised that this baby as three days old, inadvertently receive a pneumococcal 20 (Clarified as Prevnar 20), in addition to the Vaxelis and RotaTeq."' and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006707, MCM-006709, MCM-006708, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number 02638292 (interaction number: 02638274), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number 02638292 (interaction number: 02638274), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No furtherr information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006712, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: This spontaneous safety report, with reference number 02638292 (interaction number: 02638274), was received by the partner on 31-JUL-2024 and forwarded on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006713, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006714, MCM-006715, MCM-006716.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006715, MCM-006716.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.   Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006716.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients; This spontaneous safety report, with reference number (interaction number), was received by the partner on 31-JUL-2024 and forwarded to agency on 31-JUL-2024, from consumer/other non-health professional.  Due to the nature of the event, the causality between the event "TE on VAXELIS/vaccines were administered from 07/08/2024-07/17/2024 to multiple patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006654, MCM-006705, MCM-006707, MCM-006708, MCM-006709, MCM-006710, MCM-006711, MCM-006712, MCM-006713, MCM-006714, MCM-006715.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE where products were administered to a patient; This non-serious spontaneous safety report, with reference number 02651449 (interaction number: 02651435), was received by partner on 07-AUG-2024 and forwarded to agency on 08-AUG-2024 from other non-health professional.   Due to the nature of the event, the causality between the event "TE where products were administered to a patient" and Vaxelis was not applicable.    Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report TE where products were administered to a patient; This non-serious spontaneous safety report, with reference number (interaction number), was received by partner on 07-AUG-2024 and forwarded to agency on 08-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event "HCP called to report TE where products were administered to a patient" and Vaxelis was not applicable.    Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE where products were administered to a patient; This non-serious spontaneous safety report, with reference number (interaction number), was received by partner on 07-AUG-2024 and forwarded to agency on 08-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event "TE where products were administered to a patient" and Vaxelis was not applicable.    Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, HEPA, HIBV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: HCP calling to find out the side effects for a 12-month-old patient who received extra dose of Hepatitis B in the form of RECOMBIVAX HB; This non-serious spontaneous safety report, with reference number (interaction number), was received by partner on 09-AUG-2024 and forwarded to agency on 09-AUG-2024 from other health professional.  Due to the nature of the event, the causality between the event 'HCP calling to find out the side effects for a 12-month-old patient who received extra dose of Hepatitis B in the form of RECOMBIVAX HB' and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by agency on 28-AUG-2024 from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event 'HCP calling to find out the side effects for a 12-month-old patient who received extra dose of Hepatitis B in the form of RECOMBIVAX HB' and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Caller reported expired VAXELIS was administered; This non-serious spontaneous safety report, with reference number 02653358 (interaction number: 02653356), was received by partner on 12-AUG-2024 and forwarded on 12-AUG-2024 from physician.   Due to the nature of the event, the causality between the event 'Caller reported expired VAXELIS was administered' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for improperly stored and administered VAXELIS and VAXNEUVANCE; This spontaneous safety report, with reference number (interaction number), was received by the partner on 12-AUG-2024 and forwarded to agency on 12-AUG-2024, from other health professional.   This case was considered non-valid due to no patient identifiers provided (temperature excursion only).  Due to the nature of the event, the causality between the event "HCP calling to report AE for improperly stored and administered VAXELIS and VAXNEUVANCE" and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 31-AUG-2024 from a physician.  The case is maintained as non-serious and is now valid.   Due to the nature of the event, the causality between the event "HCP calling to report AE for improperly stored and administered VAXELIS and VAXNEUVANCE" and Vaxelis was not applicable.  No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: 2-month-old baby was accidently given Pentacel and Vaxelis; This non-serious spontaneous Safety Report, with reference number 2024SA249105, was received by partner on 21-AUG-2024 and forwarded to agency on 22-AUG-2024.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "2-month-old baby was accidently given Pentacel and Vaxelis".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reported that a patient received VAXELIS at 5 years and 2 months old; This non-serious spontaneous Safety Report, with reference number 02660342, was received by partner on 22-AUG-2024 and forwarded on 23-AUG-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Nurse reported that a patient received VAXELIS at 5 years and 2 months old".  Further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 10-SEP-2024 and forwarded on 11-SEP-2024 by a health care professional. The case is maintained as non-valid and non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Nurse reported that a patient received VAXELIS at 5 years and 2 months old".  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Extra dose administered, Product prescribing error
Clinical narrative: Nurse reported that a 2-month old patient has been prescribed with IPOL and VAXELIS and both vaccines were given on the same day; Nurse reported that a 2-month old patient has been prescribed with IPOL and VAXELIS and both vaccines were given on the same day, 23AUG2024; This non-serious spontaneous safety report, with reference number 2024SA252504, was received by partner on 29-AUG-2024 and forwarded to agency on 30-AUG-2024 from other health professional.  The reporter did not assess the causal relationship between Vaxelis and 'Nurse reported that a 2-month old patient has been prescribed with IPOL and VAXELIS and both vaccines were given on the same day, 23AUG2024'  Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received their first dose of VAXELIS at 12 weeks on 14AUG2024, instead of the recommended 2 month first dose schedule; This non-serious spontaneous Safety Report, with reference number 2024SA270374, was received by partner on 17-SEP-2024 and forwarded on 18-SEP-2024 from a nurse practitioner.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient received their first dose of VAXELIS at 12 weeks on 14AUG2024, instead of the recommended 2 month first dose schedule".    Non-significant follow-up information with reference number 2024SA270374 was received by partner on 18-SEP-2024 and forwarded on 19-SEP-2024 from the other health professional. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Patient received their first dose of VAXELIS at 12 weeks on 14AUG2024, instead of the recommended 2 month first dose schedule".   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: HCP called to report a 5-month-old child who may have been administered VAXELIS subcutaneously. The patient was given a first dose of VAXELIS at a 45-degree angle with 1-inch needle attached.; This non-serious spontaneous safety report with reference number # 02675489 (Interaction # 02675473) was received by a partner on 19-SEP-2024 and forwarded on 20-SEP-2024 from a health care professional.   The causal relationship between Vaxelis and the reported event of "HCP called to report a 5-month-old child who may have been administered VAXELIS subcutaneously. The patient was given a first dose of VAXELIS at a 45-degree angle with 1-inch needle attached." is not applicable due to the nature of the event.   No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Fever; chills; site injection soreness; fatigue; nausea; loss of appetite; diarrhea; dizziness; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "spondylitis" (unspecified if ongoing); "spondylolisthesis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "GERD" (unspecified if ongoing); "eczema" (unspecified if ongoing); "rhinitis" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing), notes: hit or miss. Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; FAMOTIDINE; FLUTICASONE. The patient did not receive any vaccines within 4 weeks prior to the vaccine(s). The following information was reported: PYREXIA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; DIARRHOEA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "diarrhea"; DIZZINESS (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; FATIGUE (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "loss of appetite"; NAUSEA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "site injection soreness". Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain, fatigue, nausea, decreased appetite, diarrhoea, dizziness.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; site injection soreness; fatigue; nausea; loss of appetite; diarrhea; dizziness; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 23Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "dry eyes" (unspecified if ongoing); "spondylitis" (unspecified if ongoing); "spondylolisthesis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "GERD" (unspecified if ongoing); "eczema" (unspecified if ongoing); "rhinitis" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing), notes: hit or miss. Concomitant medication(s) included: LISINOPRIL; MONTELUKAST; FAMOTIDINE; FLUTICASONE. The patient did not receive any vaccines within 4 weeks prior to the vaccine(s). The following information was reported: PYREXIA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; DIARRHOEA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "diarrhea"; DIZZINESS (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; FATIGUE (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "loss of appetite"; NAUSEA (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 23Sep2024 at 13:30, outcome "unknown", described as "site injection soreness". Therapeutic measures were not taken as a result of pyrexia, chills, vaccination site pain, fatigue, nausea, decreased appetite, diarrhoea, dizziness.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: the customer tested positive on 06Sep2024; the customer tested positive on 06Sep2024; the muscles in abdomen felt as if they were pulled from the hard coughing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774311 (Moderna).  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HD9835) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198), administration date: 25Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: ER2613), administration date: 17Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 30145BA), administration date: 25Sep2021, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE; Lot number: FK9896), administration date: 31Mar2022, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER),SINGLE; Lot number: GH9702), administration date: 13Sep2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Sep2024, outcome "unknown" and all described as "the customer tested positive on 06Sep2024"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Sep2024, outcome "unknown", described as "the muscles in abdomen felt as if they were pulled from the hard coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had not contacted Moderna before. The inquiry was from a patient who stated that he received the COVID-19 Spikevax NDC-80771-910-96 (possibly NDC-80777-910-96) Lot# 808047 on 17Sep2024. He stated that case was a bit different. The patient's last booster was Pfizer given on 26Sep2023. The reason for delay was waiting for the updated booster to be available. It didn't kill him but when he went to the ER after testing positive, the muscles in his abdomen felt as if they were pulled from the hard coughing and took several days to get better and had been a day or two. The patient was given Paxlovid 300mg; 100mg taken twice a day for 5 days on 06Sep2024 to 11Sep2024.  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400126532 same patient, different event and dose;
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Obstructive airways disorder
Clinical narrative: felt constriction of my airways; allergic reaction; This is a spontaneous report received from a Physician from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Moderna covid-19 vaccine (dose 1), for COVID-19 immunization; Moderna covid-19 vaccine (dose 2), for COVID-19 immunization; Moderna covid-19 vaccine (dose 3 (booster)), for COVID-19 immunization; Moderna covid-19 vaccine (dose 4 (booster)), for COVID-19 immunization; Moderna covid-19 vaccine (dose 5 (booster)), for COVID-19 immunization. The following information was reported: OBSTRUCTIVE AIRWAYS DISORDER (hospitalization), outcome "unknown", described as "felt constriction of my airways"; ALLERGY TO VACCINE (hospitalization), outcome "unknown", described as "allergic reaction".  Additional information: The patient stated, "I had an allergic reaction. I felt constriction of my airways and went to the hospital. I have to get the updated COVID-19 vaccine soon, would it be better if I don't get Pfizer?" The report was non-serious.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event allergy to vaccine and the suspect drug BNT162B2 OMI XBB.1.5. As there is limited information in the case provided, the causal association between the event obstructive airways disorder and the suspect drug cannot be excluded. The case will be reassessed once new information is 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 Positive; Covid-19 Positive; This is a spontaneous report received from an Other HCP.  A male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Lot number: EL9265), in Mar2021 as dose 2, single (Lot number: EN6200) and in Dec2021 as dose 3 (booster), single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Sep2024, outcome "unknown" and all described as "Covid-19 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2024) positive, notes: Covid-19 Positive.  Clinical course: The patient did not receive other vaccine in the same date or in 4 weeks. It was unknown if the patient received other medications in 2 weeks; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: His arm was equally as sore but subsided by next morning; This is a spontaneous report received from a Nurse.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), as dose number unknown, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "recovering", described as "His arm was equally as sore but subsided by next morning". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: they went to reconstitute and entire thing broke apart, the plastic adapter had a crack in it; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HN8090, Expiration Date: 31May2025) for immunisation, Device Lot Number: HN8090, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "they went to reconstitute and entire thing broke apart, the plastic adapter had a crack in it".  Additional information: The reporter informed that the NDC was 0069-0207-01. The concern was wanting to get a replacement for this. The reporter thinks 5 total but confirmed only 1 Abrysvo was with issue.  The reporter considered "they went to reconstitute and entire thing broke apart, the plastic adapter had a crack in it" not related to rsv vaccine prot.subunit pref 2v. Causality for "they went to reconstitute and entire thing broke apart, the plastic adapter had a crack in it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy, Biopsy bone marrow, Biopsy skin, Cancer screening
Clinical narrative: report of SS presenting 72 after the administration of the Pfizer/BioNTech COVID vaccine.; This is a literature report for the following literature source(s).  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "myelodysplastic syndrome" (unspecified if ongoing), notes: diagnosed in the past two years.; "type-2 diabetes mellitus" (unspecified if ongoing), notes: diagnosed in the past two years.; "bullous pemphigoid" (unspecified if ongoing), notes: diagnosed in the past two years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation.  The following information was reported: ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (hospitalization, medically significant, life threatening), 72 hrs after the suspect product(s) administration, outcome "recovering", described as "report of SS presenting 72 after the administration of the Pfizer/BioNTech COVID vaccine.". The patient underwent the following laboratory tests and procedures: Biopsy: showing only dense neutrophilic infiltrate; Biopsy bone marrow: non-diagnostic; Biopsy skin: found to meet the criteria for the SS; Cancer screening: Unknown results, notes: up to date on his age-appropriate; Computerised tomogram: cellulitis with significant leukocytosis; Culture: persistently negative; Further workup: significant for persistently negative cultures, notes: a non-diagnostic bone marrow biopsy, and multiple LUE tissue biopsies showing only dense neutrophilic infiltrate; White blood cell count: 95. Therapeutic measures were taken as a result of acute febrile neutrophilic dermatosis.; Sender's Comments: A possibly contributory role of BNT162b2 omi xbb.1.5 in triggering the onset of Sweet's syndrome might not be fully ruled out, considering the temporal relationship. More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Culture, Investigation, White blood cell count
Clinical narrative: report of SS presenting 72 after the administration of the Pfizer/BioNTech COVID vaccine.; This is a literature report for the following literature source(s).  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "myelodysplastic syndrome" (unspecified if ongoing), notes: diagnosed in the past two years.; "type-2 diabetes mellitus" (unspecified if ongoing), notes: diagnosed in the past two years.; "bullous pemphigoid" (unspecified if ongoing), notes: diagnosed in the past two years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation.  The following information was reported: ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (hospitalization, medically significant, life threatening), 72 hrs after the suspect product(s) administration, outcome "recovering", described as "report of SS presenting 72 after the administration of the Pfizer/BioNTech COVID vaccine.". The patient underwent the following laboratory tests and procedures: Biopsy: showing only dense neutrophilic infiltrate; Biopsy bone marrow: non-diagnostic; Biopsy skin: found to meet the criteria for the SS; Cancer screening: Unknown results, notes: up to date on his age-appropriate; Computerised tomogram: cellulitis with significant leukocytosis; Culture: persistently negative; Further workup: significant for persistently negative cultures, notes: a non-diagnostic bone marrow biopsy, and multiple LUE tissue biopsies showing only dense neutrophilic infiltrate; White blood cell count: 95. Therapeutic measures were taken as a result of acute febrile neutrophilic dermatosis.; Sender's Comments: A possibly contributory role of BNT162b2 omi xbb.1.5 in triggering the onset of Sweet's syndrome might not be fully ruled out, considering the temporal relationship. More epidemiologic and accumulative clinical data, together with immunological and biomolecular workups would be needed to determine the causal link and explore the plausible physiopathologic mechanism between the vaccination and the event occurrence. 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received the new covid shot and still got sick soon after; tested positive; received the new covid shot and still got sick soon after; tested positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 as dose 1, 0.3 ml single (Lot number: LM2215) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Sep2024, outcome "unknown" and all described as "received the new covid shot and still got sick soon after; tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2024) Positive, notes: I tested positive 25Sep. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was now taking Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: lost her hearing; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00569 (Novavax).  A female patient 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: DEAFNESS (medically significant), outcome "unknown", described as "lost her hearing". Reporter's sister had the Pfizer vaccine and lost her hearing after taking it.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: fatigue; orsl soreness; mild headaches; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "orsl soreness"; HEADACHE (non-serious), outcome "unknown", described as "mild headaches".