chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV5
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; Overdose; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2725847-1. The original narrative from the sender is the following:  None stated.  The causal relationship between Vaxelis and the events " extra dose administered." was assessed as not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Injection site granuloma
Clinical narrative: presumed granuloma in left thigh, developed within 24 hours of administration, still present 1 month after administration; This non-serious case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2708652-1. The original narrative from the sender is the following:  Presumed granuloma in left thigh, developed within 24 hours of administration, still present 1 month after administration.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event, "Presumed granuloma in left thigh".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Agency called to report that the HCP stated she gave VAXELIS to a patient today and they noticed a ball sized welt with redness and swelling after administration; Agency called to report that the HCP stated she gave VAXELIS to a patient today and they noticed a ball sized welt with redness and swelling after administration; Agency called to report that the HCP stated she gave VAXELIS to a patient today and they noticed a ball sized welt with redness and swelling after administration; This non-serious spontaneous safety report, with case reference number 02549709 (interaction number: 02549708) was received by a partner on 08-FEB-2024 and forwarded to Company on 09-FEB-2024, from a healthcare professional.  Due to the nature of the event, the causality between the events; "Agency called to report that the HCP stated she gave VAXELIS to a patient today and they noticed a ball sized welt with redness and swelling after administration" and Vaxelis is Related.   Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine overdose; Extra dose Administered; No Adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  " nurse that administered VAXELIS and IPOL at the same day and at the same time (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA341553(CLUSTER).  This case involves a 2 months old and unknown gender patient who's nurse administered VAXELIS and IPV (VERO) [IPOL] at the same day and at the same time (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of both the suspect IPV (VERO) (Suspension for injection) (lot V1B902M and expiry date: 02-Jun-2024) and VAXELIS not produced by Sanofi Pasteur (lot number and expiry not reported) at the same day and at the same time (with no reported adverse event) (extra dose administered) (latency: same day) with an unknown route and unknown administration site for prophylactic vaccination (Immunization).    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " No Adverse event, Extra dose Administered, Vaccine overdose".   Due to the nature of the events, the causal relationship between Vaxelis and "No Adverse event, Extra dose Administered and Vaccine overdose" was not applicable.  No further information is expected.  Case correction performed on 08-MAR-2024: initial receipt date (IRD) and central receipt date (CRD) updated from 05-FEB-2023 to 05-FEB-2024.
Sex: F
Vaccine: DTPPVHBHPB, IPV, PNC13, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose Administered; Vaccine overdose; No adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  "During our count of vaccines after clinic it was noted that the patient received both a Vaxelis and polio vaccination. A call was placed to the parents to notify of the inadvertent error of giving Vaxelis and polio at the same time. The patient has not had any adverse reactions due to this event."  The reporter did not provide an assessment of causal relationship between Vaxelis and the events " No Adverse event, Extra dose Administered, Vaccine overdose".   Due to the nature of the events, the causal relationship between Vaxelis and "No Adverse event, Extra dose Administered and Vaccine overdose "was not applicable.  No further information is expected.  Case correction performed on 08-MAR-2024:  In the Initial version the Initial Receipt date and Central Receipt date was captured incorrectly as 05-Feb-2023 instead of 05-Feb-2024.   The significant correction is performed with a correct initial receipt date as 05-Feb-2024 and Central Receipt date as 08-Mar-2024, as communication was received by safety writing team.
Sex: F
Vaccine: DTPPVHBHPB, IPV, RV1
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient also received vaxelis which also contains IPV; IPV given instead of Prevnair13; Overdose; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID. The original narrative from the sender is the following:  IPV given instead of Prevnair13. Patient also received vaxelis which also contains IPV.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling, hard lump at injection site; Swelling, hard lump at injection site; Swelling, hard lump at injection site; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS Primary ID 2714332-1. The original narrative from the sender is the following:  Swelling, hard lump at injection site.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently administered the VARIVAX vaccine instead of Vaxelis vaccine; Nursing error; This spontaneous safety report, with reference number 02551350 (Interaction number: 02551349), was received by the partner on 13-Feb-2024 and forwarded to Company on 13-Feb-2024, from a health professional.  Due to nature of the event, the causality between Vaxelis and the events of "Patient was inadvertently administered the VARIVAX vaccine and the VARIVAX was administered due to nursing error" was assessed as not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Immunisation reaction
Clinical narrative: Patient had a reaction to pertussis component of a vaccine of VAXELIS; This non-serious spontaneous safety report with reference number # 2024SA052145, was received by partner on 13-FEB-2024 and forwarded on 14-FEB-2024 from a health care professional.  The reporter confirmed that patient had a reaction to pertussis component of the Vavelis vaccine, therefore the causal relationship between Vaxelis and the reported event was assessed as related.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Pre-assessed as a medication error; a 6-month-old male moved his arm during injection and did not get the full dose of VAXELIS. Patient got the majority of the dose but didn't get the very last bit of the dose/an inappropriate use due to administration of less than the recommended dos; This non-serious spontaneous safety report with reference number # 2024SA052452 (Inquiry) was received by a partner on 13-FEB-2024 and forwarded to agency on 14-FEB-2024 from a health care professional.  Due to the nature of the events, the causal relationship between Vaxelis and the events of "a 6-month-old male moved his arm during injection and did not get the full dose of VAXELIS. Patient got the majority of the dose but didn't get the very last bit of the dose/an inappropriate use due to administration of less than the recommended dose" was assessed as not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, PNC
Symptoms: Inappropriate schedule of product administration, Limb mass, Off label use
Clinical narrative: Child at 12 months of age received VAXELIS and PREVNAR 12 same day (exact date unknown). child had a lump on the leg (area of leg not known) after child received the 1st dose of VAXELIS; Inappropriate schedule of vaccine administered; This spontaneous non-serious safety report, with reference number 02551844, was received by a partner on 13-FEB-2024 and forwarded on 14-FEB-2024, from a HCP.  This case was considered as off label use.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event " Child at 12 months of age received VAXELIS and PREVNAR 12 same day (exact date unknown). child had a lump on the leg (area of leg not known) after child received the 1st dose of VAXELIS" and the causal relationship between Vaxelis and the reported event " Inappropriate schedule of vaccine administered" Inappropriate schedule of vaccine administered was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: Nurse made a vaccine error. She was supposed to inject a 15-month old patient a combination of the DTaP, IPV and Hib vaccine, PENTACEL, but instead she injected the patient the VAXELIS vaccine; This non-serious spontaneous safety report with reference number # 2024SA053632 (Inquiry # 01946395) was received by a partner on 14-FEB-2024 and forwarded to Company on 15-FEB-2024 from a nurse.   Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "Nurse made a vaccine error. She was supposed to inject a 15-month-old patient a combination of the DTaP, IPV and Hib vaccine, PENTACEL, but instead she injected the patient the VAXELIS vaccine" was not applicable.    Further information is expected.  Significant Follow-up information was received by the partner on 29-FEB-2024 and forwarded to Company on the same day, from a HCP. The case is maintained as non-serious.  Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "Nurse made a vaccine error. She was supposed to inject a 15-month-old patient a combination of the DTaP, IPV and Hib vaccine, PENTACEL, but instead she injected the patient the VAXELIS vaccine" was not applicable.   No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, PNC, RV5
Symptoms: Extra dose administered
Clinical narrative: Additional dose of VAXELIS, ROTATEQ, and Prevnar administered inadvertently; This non-serious spontaneous safety report, with MSD case number 02553678 (Interaction number 02553670), was received by partner on 16-FEB-2024 and forwarded to agency on 16-FEB-2024 from another health professional.   The reporter did not assess the causal relationship between vaccine and 'Additional dose of VAXELIS, ROTATEQ, and Prevnar administered inadvertently'.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, Medication error
Clinical narrative: Pre-assessed as a medication error/Inappropriate use; 2-month-old female was administered with an expired VAXELIS. Caller did confirm that patient did not have any adverse reaction; This non-serious spontaneous safety report with reference number # 2024SA056777, was received by partner on 16-FEB-2024 and forwarded to agency on 19-FEB-2024 from a health care professional.  Due to the nature of the event, the causality assessment between Vaxelis and the Expired product administered and Medication error is not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Pre-assessed as a medication error/an inappropriate use due to administration of expired VAXELIS; Patient received Vaxelis today (19Feb2024) and it was already expired; This non-serious spontaneous safety report, with Global PV Identification number: (inquiry number:) was received by a partner on 19-FEB-2024 and forwarded to RA on 20-FEB-2024, from a Consumer or other non-HCP in the (PRIVACY).  Due to the nature of the event, the causality between the event "Patient received Vaxelis today (19Feb2024) and it was already expired and pre-assessed as a medication error/an inappropriate use due to administration of expired VAXELIS" and Vaxelis was assessed as not applicable.   Further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: One dose of VAXELIS was administered following TE. No additional AE reported.; This spontaneous safety report, with  Case ID 02554017 (Interaction Number 02554003), was received by a partner on 20-FEB-2024 and forwarded to Company on same day, from an other health professional.  Due to the nature of the event, the causality between the event "One dose of VAXELIS was administered following TE. No additional AE reported." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by the partner on 07-MAR-2024 and forwarded to Company on the same day, from HCP. The case is maintained as non-serious.   Due to the nature of the event, the causality between the event "One dose of VAXELIS was administered following TE. No additional AE reported." and Vaxelis is assessed as not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HPV9
Symptoms: Wrong product administered
Clinical narrative: 13 year old female received dose of VAXELIS instead of GARDASIL 9; Patient received dose of VAXELIS instead of GARDASIL 9/ HCP grabbed the wrong box; This non-serious spontaneous safety report, with reference number 02556245 (Interaction# 02556244), was received by a partner on 22-FEB-2024 and forwarded to Agency on 22-FEB-2024 from an other healthcare professional in the Country.   The reporter did not assess the causal relationship between Vaxelis and the reported events of "13 year old female received dose of VAXELIS instead of GARDASIL 9. Patient received dose of VAXELIS instead of GARDASIL 9/ HCP grabbed the wrong box."   Due to the nature of the event, the causality between the events "13 year old female received dose of VAXELIS instead of GARDASIL 9. HCP grabbed the wrong box," and Vaxelis was not applicable.   Further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: HCP reported vaccines were administered after temperature excursion; This non-serious spontaneous safety report, received by agency through fax on 20-FEB-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " HCP reported vaccines were administered after temperature excursion" and Vaxelis was assessed as not applicable.   For reference purposes the case is linked to MCM-005843 (same reporter).  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Overdose, Wrong product administered
Clinical narrative: Patient was given Vaxelis and Quadracel was supposed to get Vaxelis and Vaxneuvance; Vaccine overdose; No Adverse event; This non-serious spontaneous safety report, with case number/ Interaction number, was received by partner, on 21FEB2024 and forwarded to RA on 29FEB2024 from a physician, in (PRIVACY).  Due to nature of the events, the causal relationship between Vaxelis and the reported events "Patient was given Vaxelis and Quadracel was supposed to get Vaxelis and Vaxneuvance, Vaccine overdose, and No AE" is assessed as not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, PNC15
Symptoms: Expired product administered
Clinical narrative: Accidently gave an expired Vaxelis vaccine to the pt.; This spontaneous safety report, with the following VAERS Primary ID, was received by the partner on 07-MAR-2024 and forwarded to RA on 08-MAR-2024, from other health professional in the (PRIVACY).    The causal relationship between Vaxelis and the reported event of "Accidently gave an expired Vaxelis vaccine to the pt." is assessed as not applicable due to nature of the event.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP calling to report AE for improperly stored vaccine administration of VAXELIS PFS. No side effects reported. Temperature 8.7 C; Time frame 30 MINUTES; This non-serious spontaneous safety report, with reference number: 02564857 was received by a partner on 08-MAR-2024 and forwarded on 08-MAR-2024 from a physician. Additional information was received on 08-MAR-2024 and forwarded on 11-MAR-2024.   Due to the nature of the event, the causal relationship between Vaxelis and the event, "HBP calling to report AE for improperly stored vaccine administration of VAXELIS PFS. No side effects reported. Temperature 8.7 C; Time frame 30 MINUTES" is not applicable.  Further information is not expected.  Significant Follow-up information was received by the partner on 20-MAR-2024 and forwarded on 21-MAR-2024, from a physician. 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 causal relationship between Vaxelis and the event, "HBP calling to report AE for improperly stored vaccine administration of VAXELIS PFS. No side effects reported. Temperature 8.7 C; Time frame 30 MINUTES" is not applicable.  No further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report that a dose of VAXELIS was administered after a TE; This non-serious spontaneous safety report, with MSD Case ID number:, was received by a partner on 13-MAR-2024 and forwarded to agency on 14-MAR-2024, from a HCP  Due to the nature of the event, the causality between the event "HCP called to report that a dose of VAXELIS was administered after 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 that a dose of VAXELIS was administered after a TE. No further AE details available; Temperature (9.5C); This non-serious spontaneous safety report, with reference number 02567237 was received by a partner on 13-MAR-2024 and forwarded on 13-MAR-2024 from a healthcare professional.   Due to the nature of the event, the causal relationship between Vaxelis and the event, "HCP called to report that a dose of VAXELIS was administered after a TE. No further AE details available; Temperature (9.5C)" is not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Nurse reports VAXELIS product that experienced temperature excursion was administered to a patient; This non-serious spontaneous safety report, with reference number 02568837 (Interaction # 02568805), was received by a partner on 15-MAR-2024 and forwarded to agency on 18-MAR-2024 from an other health professional.   Due to the nature of the event, the causality between the event "Nurse reports VAXELIS product that experienced temperature excursion was administered to a patient." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Syringe issue, Underdose
Clinical narrative: She states that when they put in the needle into the muscle, they went to depress the plunger and some of the vaccine came out of the hub and they don't know how much went into the patient.; She states that when they put in the needle into the muscle, they went to depress the plunger and some of the vaccine came out of the hub and they don't know how much went into the patient.; This non-serious spontaneous Safety Report, with reference number DE20220900241, was received by partner on 19-MAR-2024 and forwarded on 20-MAR-2024 from a HCP. Additional information was received by the partner on 19-MAR-2024 and forwarded on 20-MAR-2024, from HCP. The cases is maintained as non-serious.   Due to the nature of the event, the causality between the event "She states that when they put in the needle into the muscle, they went to depress the plunger and some of the vaccine came out of the hub and they don't know how much went into the patient" and Vaxelis was not applicable.  Further information is expected.
Age: 0.58
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This spontaneous safety report, with reference number 02542172, was received by a partner on 20-MAR-2024 and forwarded on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This spontaneous safety report, with reference number 02542172, was received by a partner on 20-MAR-2024 and forwarded to agency on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded to agency on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.
Age: 0.58
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This spontaneous safety report, with reference number 02542172, was received by the partner on 20-MAR-2024 and forwarded to agency on the same day, from a HCP.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded to agency on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.
Age: 3.0
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.  For reference purposes, source case is MCM-005806.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received by agency through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded to agency on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was not applicable.  No further information is expected.  For reference purposes, source case is MCM-005806.
Age: 0.25
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by the partner on 12-MAR-2024 and forwarded on 21-MAR-2024, from a HCP.   Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.58
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received by agency through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NNON-SIGNIFICANT FOLLOW-UP INFORMATION received by the partner on 12-MAR-2024 and Forwarded to agency on 21-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event "Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received by agency through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NON SIGNIFICANT FOLLOW UP INFORMATION, received by partner on 12-MAR-2024 and forwarded to agency by 21-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.
Age: 0.58
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded on 21-MAR-2024 by a health care professional. The case is maintained as non-valid and non-serious.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  For reference purposes, source case is MCM-005806.
Age: 0.5
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported; This non-serious spontaneous safety report, received by agency through fax on 20-MAR-2024, from a Health care professional.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 12-MAR-2024 and forwarded to agency on 21-MAR-2024 by a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event " Vaccine products that experienced a temperature excursion (TE). some products were administered after experiencing TEs. No PQC/additional AE reported" and Vaxelis was assessed as not applicable.   No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mastectomy, Vaccination site pain, X-ray
Clinical narrative: she had tenderness in the injection site and nothing else. She has had that before; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fractured bone in wrist", start date: Oct2023 (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for cardiac failure congestive (ongoing); CRESTOR taken for blood cholesterol (ongoing); RAMIPRIL taken for hypertension (ongoing); MONOCOR (ongoing); FUROSEMIDE taken for diuretic therapy (ongoing); APO PENTOXIFYLLINE (ongoing). Vaccination history included: BNT162b2 (09-JUN-2021 00:00, EW0221, DOSE 2, SINGLE, COVID-19 immunisation), administration date: 09Jun2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; comirnaty (Dose 1, Lot Number: ER1742), administration date: 25Mar2021, for COVID-19 immunisation; comirnaty (Dose 3, Lot number: GJ3274), administration date: 15Dec2022, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she had tenderness in the injection site and nothing else. She has had that before". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: Patient was 78 years old and received the Covid vaccine recommended for people over 65. It was almost 4 months to the day after her last one. It is the seventh of the Pfizer vaccines and she has received every one when available. She is up to date. Never before in caller's life time has she ever had an adverse effect to medication or vaccination. On the first day and half or so she had tenderness in the injection site and nothing else. She has had that before and that is nothing to worry about.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400073882 same patient/product, different dose number, similar event;
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 72-year-old male patient received BNT162b2 (COMIRNATY), on 19May2022 as dose 4 (booster), single (Lot number: FL3198) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fibrillation" (ongoing); "Coronary Artery Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Mitral Valve Prolapse" (not ongoing), notes: (repaired). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Mar2024 to 27Mar2024.; 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.
Age: 48.0
Sex: F
Vaccine: COVID19, 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 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 Mar2024, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 16Mar2024 to 21Mar2024. Clinical course: Symptoms improved while taking the medication.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "not recovered", described as "PMR". The event "pmr" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: Reporter's wife actually got it (PMR), had the Pfizer covid vaccine. Reporter's wife has had it over a year. She had gone to the doctor and has been taking treatments they were doing nothing for her. They were doing an infusion for his wife every 2 months. It started out they gave her a corticosteroid and weaned her off to a low dose steroid and then went to infusions and she was still deal with the pain all day long.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400074877 same reporter/event, different patient;US-PFIZER INC-202400075129 same reporter, different patient/event;US-PFIZER INC-202400075206 same reporter/patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient 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. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "PMR". The event "pmr" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical Course: Reporter stated COVID 19 vaccine is causing PMR in many people. Reporter stated that his neighbour down the street got it, they all had the Pfizer covid vaccine. The neighbour, doing treatments from doctor it was not doing anything for him either. Reporter just met the neighbour for the first time when he went to help him and it turns out he had the same thing and had the Pfizer covid-19 vaccine.  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: Linked Report(s) : US-PFIZER INC-202400074852 same reporter, different patient/event/dose;US-PFIZER INC-202400075129 same reporter, different patient/event/dose;
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: he knows someone who lost his taste and smell too; He knows someone who lost his taste and smell too; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknow, 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: ANOSMIA (non-serious), outcome "unknown", described as "he knows someone who lost his taste and smell too"; AGEUSIA (non-serious), outcome "unknown", described as "He knows someone who lost his taste and smell too". Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had all the Pfizer COVID shots and I actually had COVID between the last shot and the one prior to that.; had all the Pfizer COVID shots and I actually had COVID between the last shot and the one prior to that.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN5318), on 12Feb2021 as dose 2, single (Lot number: EL9266) and on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma Diagnosed as a child probably in 1957; "COPD" (ongoing), notes: COPD Diagnosed probably when got out. Probably 1970; "help control blood pressure" (ongoing); "cough" (unspecified if ongoing), notes: Historically, he coughs almost every morning of his life. Concomitant medication(s) included: LOSARTAN HCTZ taken for blood pressure abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for blood pressure abnormal (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "had all the Pfizer COVID shots and I actually had COVID between the last shot and the one prior to that.". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: He had all the Pfizer COVID shots and he actually had COVID between the last shot and the one prior to that. He took Paxlovid. Clarified had covid around Thanksgiving 2023. Received on either 18Sep2022 or 28Sep2022. It was written down and cannot make it out.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400074929 same patient, different vaccine doses and different AE.;US-PFIZER INC-202400075162 same patient, different vaccine doses and different AE.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller states he and his wife had all the Covid vaccines except for the last booster which was last year and still got Covid; Caller states he and his wife had all the Covid vaccines except for the last booster which was last year and still got Covid; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller states he and his wife had all the Covid vaccines except for the last booster which was last year and still got Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: wife had all the Covid vaccines except for the last booster which was last year and still got Covid; wife had all the Covid vaccines except for the last booster which was last year and still got Covid; This is a spontaneous report and received from Consumer or other non HCPs from medical information team and product quality group.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ED7534), on 07Apr2021 as dose 2, single (Lot number: ER8737, Expiration Date: Jul2021) and in Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history included: "Maybe a thyroid problem" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "wife had all the Covid vaccines except for the last booster which was last year and still got Covid". Clinical Course: Reporter stated that his wife had four doses and all the Covid vaccines except for the last booster which was last year and still got Covid. They were all Pfizer Covid Vaccines. Reporter did not knew the date his wife had Covid. Reporter (spouse) clarified he had no other expiration dates to provide for the Pfizer Covid vaccines his wife received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400074852 Same reporter/patient, different dose/events.;