chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Thrombosis
Clinical narrative: blood clots; faint; fevers; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (blood clots) and SYNCOPE (faint) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart valve disorders.   In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criteria hospitalization prolonged and medically significant), SYNCOPE (faint) (seriousness criterion medically significant) and PYREXIA (fevers). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clots), SYNCOPE (faint) and PYREXIA (fevers) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient stayed 2 weeks in hospital and need to take Eliquis after discharge until now.  Company Comment: This spontaneous case concerning a male patient of an unknown age with medical history of heart valve disorders who experienced the serious (due to medically significant and hospitalization) unexpected AESI of thrombosis; the serious (due to medically significant) unexpected event of syncope and other non-serious expected event of Pyrexia. The events occurred on an unknown date, after a dose of SPIKEVAX NOS vaccine (date for vaccination, dose number and onset date of the events were not provided; hence, latency could not be estimated). It was reported that the patient had 2 shots and was found out to have blood clots. The patient stayed 2 weeks in hospital and need to take Eliquis after discharge till the time of this report. At the time of the report, the event  thrombosis had not resolved, and the outcome of the events syncope and Pyrexia was not reported . The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Adverse event NOS; HCP calling to report that unknown # of patients may have received VARIVAX, PROQUAD, VAXELIS and ROTATEQ during supported temp. excursion.; This non-serious spontaneous safety report, with ID number: 02568334, was received by a partner on 14-MAR-2024 and forwarded on 15-MAR-2024, from a HCP.   This case was considered non-valid as no patient identifiers were provided.   Due to the nature of the event, the causality between the event " HCP calling to report that unknown # of patients may have received VARIVAX, PROQUAD, VAXELIS and ROTATEQ during supported temp. excursion. Caller did not have any information to confirm administration at time of call so filing precautionary AE" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received on 02-APR-2024, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causality between the events " HCP calling to report that unknown # of patients may have received VARIVAX, PROQUAD, VAXELIS and ROTATEQ during supported temp. excursion. Caller did not have any information to confirm administration at time of call so filing precautionary AE and Adverse event NOS" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Mucous stools, Pyrexia
Clinical narrative: Mucousy stools; Developed a fever of 104° Fahrenheit; This non-serious spontaneous Safety Report, with reference number 2024SA100201, was received by partner on 02-APR-2024 and forwarded on 03-APR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Mucousy stools and Developed a fever of 104° Fahrenheit".  Further information is expected.  NON SIGNIFICANT FOLLOW UP INFORMATION, with reference number 2024SA100201, was received by partner on 01-APR-2024 and forwarded on 03-APR-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Mucousy stools and Developed a fever of 104° Fahrenheit".  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product use issue
Clinical narrative: Medical Assistants vaccinated a 5 year old patient with VAXELIS while it is nly approved for 6 weeks through 4 years of age (prior to the 5th birthday); This non-serious spontaneous safety report, with case number 2024SA108209 (Inquiry Number: 02008138), was received by partner, on 08APR2024 and forwarded to Agency on 09APR2024 from a consumer.  This case was considered off-label use as Vaxelis was administered to a 5-year-old patient.  Due to the nature of the event, the causality between the events "Medical Assistants vaccinated a 5 year old patient with VAXELIS while it is only approved for 6 weeks through 4 years of age (prior to the 5th birthday) and Product use in unapproved population" and Vaxelis was assessed as not applicable.   Further information is expected.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Office manager reported ROTATEQ and VAXELIS (PFS) were administered after a temperature excursion to five patients; This spontaneous safety report, with reference number 02585436, was received by a partner on 15-APR-2024 and forwarded to agency on the same day, from a Consumer or other non HCP.   This case was considered non-valid due to no patient identifiers were provided (temperature excursion only).  Due to the nature of the event, the causality between the event "Office manager reported ROTATEQ and VAXELIS (PFS) were administered after a temperature excursion to five patients" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 30-APR-2024 and forwarded to agency on same day, from HCP. The case is maintained as non-serious and is now a valid case.  Due to the nature of the event, the causality between the event "Office manager reported ROTATEQ and VAXELIS (PFS) were administered after a temperature excursion to five patients" and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HBP called regarding ROTATEQ and VAXELIS. Both vaccines were administered to an 8 day old infant today.; This spontaneous safety report, with reference number, was received by the partner on 15-APR-2024 and forwarded to Agency on 16-APR-2024, from a consumer in the country.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "HBP called regarding ROTATEQ and VAXELIS. Both vaccines were administered to an 8 day old infant today."  Due to the nature of the event, the causality between the event "HBP called regarding ROTATEQ and VAXELIS. Both vaccines were administered to an 8 day old infant today." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Device use issue
Clinical narrative: 15 month-old patient who received VAXELIS as the fourth dose of their DTaP/ HIB series. Pentacel administered for previous doses; This non-serious spontaneous Safety Report, with reference number 2024SA118809, was received by partner on 17-APR-2024 and forwarded to Health Authority on 18-APR-2024 from a HCP.  Case considered non-valid dure to no adverse event, until further confirmed from reported of a potential off-label use scenario.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "15-month-old patient who received VAXELIS as the fourth dose of their DTaP/ HIB series.".  Further information is expected.  Significant Follow-up information was received by the partner on 29-APR-2024 and forwarded to Health Authority on same day, from a HCP. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "15-month-old patient who received VAXELIS as the fourth dose of their DTaP/ HIB series.".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Expired product administered
Clinical narrative: a female infant patient of their practice experienced a febrile seizure after they were administered VAXELIS, ROTATEQ, and PREVNAR 20 vaccinations.; This spontaneous safety report, with reference number 02587674, was received by a partner on 18-APR-2024 and forwarded to Agency on 19-APR-2024, from Consumer or other non-HCP in the Country.  Due to the nature of the event, the causality between the event "a female infant patient of their practice experienced a febrile seizure after they were administered VAXELIS, ROTATEQ, and PREVNAR 20 vaccinations." and Vaxelis was not applicable.  Further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 07-MAY-2024 and forwarded to Agency on same day by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "a female infant patient of their practice experienced a febrile seizure after they were administered VAXELIS, ROTATEQ, and PREVNAR 20 vaccinations." and Vaxelis was not applicable.  No further information is expected.
Age: 1.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: VAXELIS was administered subcutaneously to a patient instead of intramuscularly; This non-serious spontaneous Safety Report, with reference number 2024SA122992, was received by partner on 22-APR-2024 and forwarded on 23-APR-2024 from a HCP in (PRIVACY).  This case was considered non-valid due to no patient identifiers.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "VAXELIS was administered subcutaneously to a patient instead of intramuscularly".  Further information is expected.  FOLLOW-UP INFORMATION was received by the partner on 16-MAY-2024 and forwarded on same day, from a HCP in the (PRIVACY). The case is maintained as non-serious.  This case is now considered valid due to patient identifiers being provided.  Due to nature of the event the causal relationship between VAXELIS and the "VAXELIS was administered subcutaneously to a patient instead of intramuscularly" was assessed as not applicable.  No further information is expected.
Age: 1.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Incorrect route of product administration
Clinical narrative: Inadvertently administered a child with Vaxelis via Subcutaneous injection (SQ) in the left arm instead of Intramuscular (IM); This non-serious spontaneous Safety Report, with reference number 2024SA124059, was received by partner on 22-APR-2024 and forwarded on 23-APR-2024 from a HCP in (PRIVACY).  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Inadvertently administered a child with Vaxelis via Subcutaneous injection (SQ) in the left arm instead of Intramuscular (IM)".  Further information is expected.  Significant Follow-up information was received by the partner on 23-MAY-2024 and forwarded on same day, from a HCP in (PRIVACY). The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Inadvertently administered a child with Vaxelis via Subcutaneous injection (SQ) in the left arm instead of Intramuscular (IM)".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMRV, PNC
Symptoms: Incorrect route of product administration
Clinical narrative: Inadvertently administered VAXELIS into a patient subcutaneously instead of IM/ patient being administered with VAXELIS subcutaneously, instead of intramuscular; This non-serious spontaneous Safety Report, with reference number 2024SA125540, was received by partner on 24-APR-2024 and forwarded on 25-APR-2024 from a HCP. Additional information was received by the partner on 24-APR-2024 and forwarded on 25-APR-2024. The cases is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Inadvertently administered VAXELIS into a patient subcutaneously instead of IM/ patient being administered with VAXELIS subcutaneously, instead of intramuscular".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called for TE evaluation of VAXELIS.; This spontaneous safety report, with reference number 02593469, was received by a partner on 30-APR-20243 and forwarded on02-MAY-2024, from a HCP.  Due to the nature of the event, the causality between the event "HCP called for TE evaluation of VAXELIS. Caller stated that product was administered after a not supported excursion. No reported signs/symptoms of adverse effects. Limited information provided. Permission to contact HCP was given. No additional AE/n" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called for TE evaluation of VAXELIS. Caller stated that product was administered after a not supported excursion; This spontaneous safety report, with reference number 02593603, was received by a partner on 30-APR-2024 and forwarded on 02-MAY-2024, from a HCP.  Due to the nature of the event, the causality between the event "HCP called for TE evaluation of VAXELIS. Caller stated that product was administered after a not supported excursion" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 patients with fair skin both had injection site swelling and redness; 2 patients with fair skin both had injection site swelling and redness; This non-serious spontaneous safety report with reference # 02595465, was received by partner on 03-MAY-2024 and forwarded to Agency on 03-MAY-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported events.  No further information is expected.  For reference purposes case is linked to MCM-006285 (same reporter).
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 patients with fair skin both had injection site swelling and redness, redness and warmth at injection site; 2 patients with fair skin both had injection site swelling and redness, redness and warmth at injection site; This non-serious spontaneous safety report with reference # 02595465, was received by partner on 03-MAY-2024 and forwarded to agency on 03-MAY-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported events.  No further information is expected.  For reference purposes case is linked to MCM-006284 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received by partner on 29-MAY-2024 and forwarded to agency on 30-MAY-2024 from a nurse.  The reporter did not provide a causality assessment between Vaxelis and the reported events.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Nurse called to report TE where products have been administered to patients.; This spontaneous safety report, with reference number 02598206 (Inquiry# 02598191), was received by the partner on 08-MAY-2024 and forwarded on 08-MAY-2024, from a Nurse in the (PRIVACY).   Due to the nature of the event, the causality between the event "Nurse called to report TE where products have been administered to patients." and Vaxelis was not applicable.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, PNC20
Symptoms: Product use issue
Clinical narrative: MA reports that a patient was given the ACTHIB and VAXELIS at the same time.; This spontaneous safety report, with reference number, was received by the partner on 14-MAY-2024 and forwarded to Agency on15-MAY-2024, from a healthcare professional in the Country.  Due to the nature of the event, the causality between Vaxelis and the event of "a patient was given the ACTHIB and VAXELIS at the same time" was assessed as not applicable.  Further information is expected.
Age: 16.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nursing Consultant stated that one of their providers gave VAXELIS to an 18-year-old patient. The nurse corrects that the patient is 16 years old; This spontaneous safety report with reference number 2024SA150131 (Inquiry number: 02052758) was received by partner on 16-MAY-2024 and forwarded on 17-MAY-2024, from a healthcare professional in the (PRIVACY).  Due to nature of the events, the causality between Vaxelis and "one of their providers gave VAXELIS to an 16-year-old patient" was assessed as not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, FLUX, HEPA, PNC15
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: 4-year-old patient inadvertently received the following: an additional dose of VAQTA, an additional dose of VAXELIS, fourth dose of Vaxneuvance. infleunza vaccine. No side effects.; This non-serious spontaneous safety report, was received by a partner on 17-MAY-2024 and forwarded to Agency on 20-MAY-2024, from a healthcare professional in the Country.  Due to nature of the event, the causality between Vaxelis and the event of "4-year-old patient inadvertently received the following: an additional dose of VAQTA, an additional dose of VAXELIS, fourth dose of Vaxneuvance, infleunza vaccine. No side effects." was assessed as not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HCP who reported that a 5-year-old child received a dose of VAXELIS in 2023 due to patient having no immunization records; This non-serious spontaneous safety report, with the reference number: 02604348 was received by a partner on 20-MAY-2024 and forwarded on 20-MAY-2024 from a healthcare professional.  This case was considered off-label use due to Vaxelis administered to a 5-year-old.   Due to the nature of the event, the causality between the event "HCP who reported that a 5-year-old child received a dose of VAXELIS in 2023 due to patient having no immunization records" and Vaxelis was not applicable.  No further information is expected.  Significant Follow-up information was received by the partner on 04-JUN-2024 and forwarded 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 who reported that a 5-year-old child received a dose of VAXELIS in 2023 due to patient having no immunization records" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Rash macular, Skin discolouration
Clinical narrative: The patient had purplish discoloration; Blotchy skin from knee and toes; This non-serious spontaneous Safety Report, with reference number 2024SA166794, was received by partner on 03-JUN-2024 and forwarded on 04-JUN-2024 from a HCP in (PRIVACY).  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "The patient had purplish discoloration" and "Blotchy skin from knee and toes".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS and ROTATEQ were administered following a TE; This spontaneous safety report, with reference number 02614558, was received by a partner on 05-JUN-2024 and forwarded to Health Authority on 06-JUN-2024, from a Consumer.  Due to the nature of the event, the causality between the event "VAXELIS and ROTATEQ were administered following a TE" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report a T/E for VAXELIS pre-filled syringes (see T/E case 02615297) and reported vaccine was administered to patient after T/E occurred; This spontaneous safety report was received by the partner on 06-JUN-2024 and forwarded on 07-JUN-2024 from a other health care professional.  Due to nature of the event, the causality between Vaxelis and the events of "HCP called to report a T/E for VAXELIS pre-filled syringes (see T/E case 02615297) and reported vaccine was administered to patient after T/E occurred" was assessed as not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report a T/E for ROTATEQ and VAXELIS (vial) (see T/E case 02615297) and reported vaccines were administered to patient after T/E occurred; This spontaneous safety report was received by the partner on 06-JUN-2024 and forwarded on 07-JUN-2024 from a other health care professional in the (PRIVACY).  Due to nature of the event, the causality between Vaxelis and the events of "HCP called to report a T/E for ROTATEQ and VAXELIS (vial) (see T/E case 02615297) and reported vaccines were administered to patient after T/E occurred" was assessed as not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Medication error/an inappropriate use due to the patient received VAXELIS and subsequently received an extra dose of HIB; Medication error/an inappropriate use due to the patient received VAXELIS and subsequently received an extra dose of HIB; This non-serious spontaneous Safety Report, with reference number 2024SA171297, was received by partner on 06-JUN-2024 and forwarded to Agency on 07-JUN-2024 from a HCP.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Medication error/an inappropriate use due to the patient received VAXELIS and subsequently received an extra dose of HIB".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse reported that a patient received the third dose of VAXELIS and ROTATEQ earlier than recommended; This non-serious spontaneous Safety Report, with reference number 02616123, was received by partner on 10-JUN-2024 and forwarded on 11-JUN-2024 from a HCP in (PRIVACY).  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "Nurse reported that a patient received the third dose of VAXELIS and ROTATEQ earlier than recommended".  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient who received their first dose at 27 days old; This non-serious spontaneous safety report with reference number # 02618157, was received by a partner on 12-JUN-2024 and forwarded on 12-JUN-2024 from a health care professional in (PRIVACY).  The causal relationship between Vaxelis and the reported event "Patient who received their first dose at 27 days old" 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 (27 days-old).  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccines were administered after temperature excursions. No additional AEs or PQC. Temperature 48.4F Time frame 58 minutes; This spontaneous safety report, with reference number 02618725, was received by a partner on 13-JUN-2024 and forwarded on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Vaccines were administered after temperature excursions. No additional AEs or PQC. Temperature 48.4F Time frame 58 minutes" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Vaccines were administered after temperature excursion; This spontaneous safety report, with reference number 02618705, was received by a partner on 13-JUN-2024 and forwarded on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Vaccines were administered after temperature excursion" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Caller reported vaccines were administered after temperature excursions.; This spontaneous safety report, with reference number 02618775, was received by a partner on 13-JUN-2024 and forwarded to agency on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Caller reported vaccines were administered after temperature excursions." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient who just passed her 5th birthday and she was inadvertently administered with VAXELIS.; This non-serious spontaneous safety report, with reference number 2024SA178476 (Inquiry number 02091929), was received by partner on 13-Jun-2024 and forwarded to Health Authority on 14-Jun-2024 from a nurse.  This case was considered off-label use as Vaxelis was administered to a 5-year-old patient.  Due to the nature of the event, the causality between the events "patient who just passed her 5th birthday, and she was inadvertently administered with VAXELIS", and Vaxelis was assessed as not applicable.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured, Irritability, Pyrexia
Clinical narrative: decreased drinking last night still with wet diapers looser stool, dark green liquid; increased respirations; Is wetting diapers 1 episode of loose stool through the night; has a decreased appetite; Last night very fussy; Continues with fussiness today; Received vaccines yesterday Through the night spiked a fever as high as 103.5; This morning fever around 100; This non-serious spontaneous Safety Report, with reference number 2761844-1, was received by partner on 13-JUN-2024 and forwarded on 14-JUN-2024 from a HCP in (PRIVACY).  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Received vaccines yesterday Through the night spiked a fever as high as 103.5 Last night very fussy and increased respirations This morning fever around 100 and respirations are normal Continues with fussiness today has a decreased appetite Is wetting diapers 1 episode of loose stool through the night decreased drinking last night still with wet diapers looser stool, dark green liquid".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Respiratory rate increased
Clinical narrative: decreased drinking last night still with wet diapers looser stool, dark green liquid; increased respirations; Is wetting diapers 1 episode of loose stool through the night; has a decreased appetite; Last night very fussy; Continues with fussiness today; Received vaccines yesterday Through the night spiked a fever as high as 103.5; This morning fever around 100; This non-serious spontaneous Safety Report, with reference number 2761844-1, was received by partner on 13-JUN-2024 and forwarded on 14-JUN-2024 from a HCP in (PRIVACY).  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported events "Received vaccines yesterday Through the night spiked a fever as high as 103.5 Last night very fussy and increased respirations This morning fever around 100 and respirations are normal Continues with fussiness today has a decreased appetite Is wetting diapers 1 episode of loose stool through the night decreased drinking last night still with wet diapers looser stool, dark green liquid".  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Screaming
Clinical narrative: Screaming; Swelling and redness in the vaccination site; Swelling and redness in the vaccination site; Crying; This non-serious spontaneous safety report with reference number # 2024SA185661 (Inquiry #02098715) was received by a partner on 18-JUN-2024 and forwarded on 24-JUN-2024 from a physician in the (PRIVACY).  The reporter assessed the causal relationship between Vaxelis and the reported events of "Swelling and redness in the vaccination site, screaming and crying" as related.  Further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Pfizer / BioNTech and Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 (BNT162B2 NOS), on 08Sep2023 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2022 at 13:00 as dose number unknown, single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY, start date: 01Jan2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech and Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 which included Paxlovid from 14Jun2024 to 19Jun2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Feb2023, stop date: 15Jun2024; MELATONIN, start date: 01Sep2023. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch\lot number: EL3249, Anatomical location: Left arm), administration date: 09Feb2021, when the patient was 69-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch\lot number: EN6203, Anatomical location: Left arm), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch\lot number: FF2590, Anatomical location: Left arm), administration date: 15Oct2021, when the patient was 69-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Time: 12:00 PM, Anatomical location: Left arm), administration date: 06Oct2022, when the patient was 70-year-old, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 15Jun2024 to 19Jun2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Lot number: HH7595), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "recovered" (14Jun2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2024) negative; (15Jun2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 09Jun2024 to 13Jun2024.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: entire mouth was now toothless/did not have any teeth at all left in his mouth; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: TOOTH LOSS (non-serious), outcome "unknown", described as "entire mouth was now toothless/did not have any teeth at all left in his mouth".  Additional information: The reporter's friend entire mouth was now toothless, without prior dental issues.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 as dose 1, single (Lot number: HG7557), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sports Asthma" (unspecified if ongoing); "General Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: 019B21A, Location of injection: Arm Left), administration date: 12Apr2021, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: 026C21A, Location of injection: Arm Left), administration date: 10May2021, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 069F21A, Location of injection: Arm Left), administration date: 10Dec2021, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 056A22A, Location of injection: Arm Left), administration date: 03May2022, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: 010H22A, Location of injection: Arm Left), administration date: 28Oct2022, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 11Jun2024, outcome "recovered" (19Jun2024); VACCINATION FAILURE (medically significant) with onset 11Jun2024, outcome "recovered" (19Jun2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2024) Positive; (19Jun2024) Negative, notes: symptom-free through 22Jun2024. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 14Jun2024 to 18Jun2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Auto-immune issues" (unspecified if ongoing); "Known allergies: trees" (unspecified if ongoing); "Known allergies: strawberries" (unspecified if ongoing); "Known allergies: avocado" (unspecified if ongoing); "Known allergies: weeds" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 15Jun2024 to 19Jun2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: last pneumonia shot was almost 3 years ago/got very sick; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "last pneumonia shot was almost 3 years ago/got very sick".  Additional information: Doctor said patient's last pneumonia shot was almost 3 years ago. Doctor did not say what the product was, just came in with it. Caller got very sick that night and the whole weekend.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: COVID-19 (medically significant) with onset Jul2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jul2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 10Jul2023. Clinical course: Patient took Pfizer vaccines 6 times in the past, had covid and took Paxlovid which helped.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 06-JUN-2024, the patient received the 1st dose of Bexsero. On 06-JUN-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-JUN-2024 Medical Assistant reported she administered a dose of Bexsero to a patient on 06Jun2024 from , which had an expiration date of 31Mar2024.  She was not certain but believed that was the patients first dose in the series.  At the time of reporting, a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 64.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Biopsy skin abnormal, Eczema
Clinical narrative: After the Shingrex  shot my doctor confirmed that I have  Eczema
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: We gave a patient a Covid Vaccination per provider discretion.  I had staff verify patients vaccines. Scanned into chart and gave vaccination. Dad was in waiting room waiting for records and asked if he had given patient a COVID vaccination and I stated yes and he stated that he had just received one today in another clinic. He did not give us this information prior to administration and was telling reception staff that he was upset and wanted to know if anything would happen to patient. We brought patients dad back into room to talk to Dr. In review the vial to prepare for a VARES the vial stated that the expiration date was 6/15/24. My computer did glitch but I did not see error message until after I went in to change eligibility. Advised attending of all information. She called the on-call infectious disease provider to verify if we should do anything further. Dr. advised that we did not do anything wrong as the documentation was not provided and there was a language barrier as well.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: I had the typical post injection arm soreness. I noticed that 3 weeks later the soreness and pain was still present daily in my left arm (deltoid). Over time it evolved into a strange pain localized in the left arm (deltoid). Touching the arm and moving the arm is fine, but I can feel the pain come on at random times of the day. It's nearly 5 months after the vaccine injection and I am still experiencing this minor pain in the arm. It's not severe enough that I need to take any pain medications or affecting my daily functions. It's just there and has not cease.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatinine increased, Brain fog
Clinical narrative: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation.  At baseline, patient is very active, plays golf, mobile.  Several days after receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed.  On 6-20-24, patient reported to the Emergency Department at Sequoia Hospital, and workup was completed (included MRI and labs).  Labs showed mild dehydration, elevated LFTs, and dehydration.  Covid, flu, and RSV swab negative.  He was discharged from the ED, but returned on 6-24-24 with ongoing symptoms of weakness.  Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults.  Patient discharged on 6-26-24 with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: C-reactive protein increased, Chills, Dehydration, Encephalopathy, Fall
Clinical narrative: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation.  At baseline, patient is very active, plays golf, mobile.  Several days after receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed.  On 6-20-24, patient reported to the Emergency Department at Sequoia Hospital, and workup was completed (included MRI and labs).  Labs showed mild dehydration, elevated LFTs, and dehydration.  Covid, flu, and RSV swab negative.  He was discharged from the ED, but returned on 6-24-24 with ongoing symptoms of weakness.  Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults.  Patient discharged on 6-26-24 with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Immunisation reaction, Influenza virus test negative, Liver function test increased, Magnetic resonance imaging, Malaise
Clinical narrative: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation.  At baseline, patient is very active, plays golf, mobile.  Several days after receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed.  On 6-20-24, patient reported to the Emergency Department at Sequoia Hospital, and workup was completed (included MRI and labs).  Labs showed mild dehydration, elevated LFTs, and dehydration.  Covid, flu, and RSV swab negative.  He was discharged from the ED, but returned on 6-24-24 with ongoing symptoms of weakness.  Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults.  Patient discharged on 6-26-24 with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Muscular weakness, Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation.  At baseline, patient is very active, plays golf, mobile.  Several days after receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed.  On 6-20-24, patient reported to the Emergency Department at Sequoia Hospital, and workup was completed (included MRI and labs).  Labs showed mild dehydration, elevated LFTs, and dehydration.  Covid, flu, and RSV swab negative.  He was discharged from the ED, but returned on 6-24-24 with ongoing symptoms of weakness.  Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults.  Patient discharged on 6-26-24 with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.
Age: 83.0
Sex: M
Vaccine: CHIK, CHIK, CHIK
Symptoms: Arthralgia, Blood test, Brain fog, Chest X-ray, Chills
Clinical narrative: Patient reported to have received Chikungunya vaccine on 6-13-24, in preparation for vacation.  At baseline, patient is very active, plays golf, mobile.  Several days after receiving the vaccine, patient started to feel ill, body aches, chills, generalized weakness, and brain fog, and reported minor fall out of bed.  On 6-20-24, patient reported to the Emergency Department at Sequoia Hospital, and workup was completed (included MRI and labs).  Labs showed mild dehydration, elevated LFTs, and dehydration.  Covid, flu, and RSV swab negative.  He was discharged from the ED, but returned on 6-24-24 with ongoing symptoms of weakness.  Pt was admitted and workup done for left lower extremity weakness, neurology and ID consults.  Patient discharged on 6-26-24 with diagnosis of encephalopathy, generalized weakness, reaction suspected to Chikungunya vaccine.