chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Drug Exposure During Pregnancy; Administration in a pregnant patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of product use in unapproved population in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis.   On 10-FEB-2025, the patient received the 1st dose of Arexvy. On 10-FEB-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Administration in a pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the product use in unapproved population and vaccine exposure during pregnancy were not applicable.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 04-MAR-2025 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-FEB-2025 The patient who was 35 weeks pregnant, received a dose of Arexvy, which led to product use in unapproved population and vaccine exposure during pregnancy.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Drug Exposure During Pregnancy; Administration in a pregnant patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of product use in unapproved population in a 34-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AE435, expiry date 30-OCT-2025) for prophylaxis.   On 10-FEB-2025, the patient received the 1st dose of Arexvy. On 10-FEB-2025, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Administration in a pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the product use in unapproved population and vaccine exposure during pregnancy were not applicable.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 04-MAR-2025 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-FEB-2025 The patient who was 35 weeks pregnant, received a dose of Arexvy, which led to product use in unapproved population and vaccine exposure during pregnancy.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash on back and legs; This non-serious case was reported by a consumer and described the occurrence of rash in a 84-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   Concurrent medical conditions included sensitive skin.   On 04-NOV-2024, the patient received Fluarix Quadrivalent 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced rash (Verbatim: Rash on back and legs). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the rash to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 07-FEB-2025 This was the patient's second request for assistance on this matter. The patient need information on contents of this vaccine to know if the patient was allergic to some. The patient had sensitive skin and wanted to prevent further issues with any future injections for flu or any other conditions. The reporter consented to follow up.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Rash
Clinical narrative: Rash on back and legs; This non-serious case was reported by a consumer and described the occurrence of rash in a 84-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   Concurrent medical conditions included sensitive skin.   On 04-NOV-2024, the patient received Fluarix Quadrivalent 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced rash (Verbatim: Rash on back and legs). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the rash to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 07-FEB-2025 This was the patient's second request for assistance on this matter. The patient need information on contents of this vaccine to know if the patient was allergic to some. The patient had sensitive skin and wanted to prevent further issues with any future injections for flu or any other conditions. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: even hurts where the injection was made.; Pain and soreness in my shoulder; but also double injected my arm/ did not administered the vaccine properly; did not administered the vaccine properly/ worng spot; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-MAR-2024, the patient received the 1st dose of Shingles vaccine. On 27-MAR-2024, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: even hurts where the injection was made.), shoulder pain (Verbatim: Pain and soreness in my shoulder), wrong technique in product usage process (Verbatim: but also double injected my arm/ did not administered the vaccine properly) and vaccine administered at inappropriate site (Verbatim: did not administered the vaccine properly/ worng spot). Shingles vaccine was discontinued. The outcome of the injection site pain and shoulder pain were not resolved and the outcome of the wrong technique in product usage process and vaccine administered at inappropriate site were not applicable.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain and shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient 's shoulder constantly ached and was sometimes very sore or even hurts where the injection was made.  It sometimes radiated into joint.  The patient didn't have this type of ongoing ache, pain and soreness in my shoulder in that exact spot before the vaccination.  The nurse practitioner did not administered the vaccine properly and not only in the worng spot but also double injected her arm, which led to wrong technique in product usage process and vaccine administered at inappropriate site. The patient did not go back to get the second dose.  The patient didn't need additional injury for a second dose of vaccine.  The patient could not get in touch to report this medical event or get in touch with the actual location to report to them.  This needs to be corrected.  There would be no more vaccines for the patient.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product use in unapproved indication, Vaccination failure
Clinical narrative: Shingles; Shingles; Suspected vaccination failure; Shingles; had active shingles at the time of the vaccination; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypercholesterolemia, sinusitis, hypertension and shingles (had active shingles at the time of the 1st vaccination). Concomitant products included atorvastatin calcium (Lipitor), montelukast sodium (Singulair) and lisinopril.   In JUL-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, the patient received Shingrix (intramuscular). In MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: had active shingles at the time of the vaccination). In MAR-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In SEP-2024, the patient experienced shingles (Verbatim: Shingles). In DEC-2024, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure was not resolved and the outcome of the shingles, shingles and shingles were resolved and the outcome of the drug use for unapproved indication was not applicable.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles, shingles and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2025 The patient self-reported this case for himself. The patient stated that he received the two doses of Shingrix vaccine. The patient stated that he received his first Shingrix dose and had active shingles at the time of the vaccination which led to drug use in unapproved indication. The patient had experienced 4 shingles outbreaks. In March 2024, between 8 and 9 months after 2nd dose and between 1 and 2 years after 1st dose, the patient had shingles. In September 2024 and December 2024, between 1 and 2 years after 1st and 2nd dose, the patient had two more shingles. This case was considered as suspected vaccination failure laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; received only the liquid conjugate; This non-serious case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis.   On 20-FEB-2025, the patient received Menveo (intramuscular) .5 ml. On 20-FEB-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: received only the liquid conjugate). On 20-FEB-2025, the outcome of the inappropriate preparation of medication was not applicable. The outcome of the inappropriate dose of vaccine administered was not applicable.   Additional Information: GSK Receipt Date: 20-FEB-2025 The patient received only the liquid conjugate component of Menveo, and the liquid conjugate vial was not combined with the lyophilized conjugate component of Menveo, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The location of administration of the vaccine was unknown.
Vaccine: VARZOS
Symptoms: Chills, Erythema, Limb mass, Pain in extremity
Clinical narrative: red painful lump on their arm; red painful lump; painful lump; chilled; couldn't function for the rest of the day; This non-serious case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-FEB-2025, the patient received Shingrix. On 05-FEB-2025, 4 hrs after receiving Shingrix, the patient experienced activities of daily living impaired (Verbatim: couldn't function for the rest of the day). On 06-FEB-2025, the patient experienced erythema (Verbatim: red painful lump on their arm), local swelling (Verbatim: red painful lump), pain (Verbatim: painful lump) and chills (Verbatim: chilled). The outcome of the erythema, local swelling, pain and activities of daily living impaired were not resolved and the outcome of the chills was not reported.   It was unknown if the reporter considered the erythema, local swelling, pain, chills and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the erythema, local swelling, pain, chills and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient received the Shingrix vaccine and after 4 hours, could not function for the rest of the day. The patient had a chilled, red painful lump on their arm.
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: took arexvy and it gave Diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced diarrhea (Verbatim: took arexvy and it gave Diarrhea). The outcome of the diarrhea was not reported.   It was unknown if the reporter considered the diarrhea to be related to Arexvy.     It was unknown if the company considered the diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-FEB-2025 The patient received Arexvy and had diarrhea.
Vaccine: RVX
Symptoms: Choking, Cyanosis
Clinical narrative: Baby chocked; Turned blue; This serious case was reported by a nurse via sales rep and described the occurrence of choking in a patient who received Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced choking (Verbatim: Baby chocked) (serious criteria GSK medically significant) and cyanosis (Verbatim: Turned blue). The outcome of the choking and cyanosis were not reported.   It was unknown if the reporter considered the choking and cyanosis to be related to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device.     The company considered the choking and cyanosis to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device.   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: 21-FEB-2025 The nurse gave Rotatix to the patient  The patient chocked and turned blue.; Sender's Comments: Choking and Cyanosis are unlisted events which are considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE.
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I felt like I had the flu for 4 days after my 1st shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: I felt like I had the flu for 4 days after my 1st shingles vaccine). The outcome of the influenza was resolved (duration 4 days).   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-FEB-2025 This case was reported by a patient via (shingrix GSK chatbot) interactive digital media. The patient felt like had the flu for 4 days after 1st shingles vaccine.  The reporter ask should expect the same reaction from the 2nd shot.
Vaccine: HIBV
Symptoms: Device connection issue, Underdose
Clinical narrative: The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered; The needle and Luer Lok Adaptor broke off during administration; Product Complaint; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete dose administered in a patient who received Hib (Hiberix) (batch number 395JH, expiry date 11-DEC-2028) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: The needle and Luer Lok Adaptor broke off during administration but unknown how much vaccine administered), device connection issue (Verbatim: The needle and Luer Lok Adaptor broke off during administration) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, device connection issue and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent.     It was unknown if the company considered the device connection issue to be related to Hiberix and Haemophilus Influenzae Type B Vaccine And Diluent.   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: 10-FEB-2025 The reporter reported that Hiberix prefilled syringe luer lok adaptor broke off 3 to 5 times. The reporter believed up to five prefilled syringes were involved but one prefilled syringe discarded, so he was not sure of the total quantity affected. The box discarded so the batch number was not available. The batch number with expiry date  from the prefilled syringe picture of the defect has emailed. The reporter asked to confirm that all operations performed appropriately as defect discovered during administration in one instance, the needle and luer lok adaptor broke off during administration and was unknown how much vaccine the patient received. The reporter does not know if the product  not administered or partially administered with the other 2 to 4 suspect prefilled syringes. During injection detaching of the luer lok adaptor but previously discarded needles were not available for return to GlaxoSmithKline. One of the suspect prefilled syringes was available for return to GlaxoSmithKline and box, up to four additional suspect prefilled syringes and the needles discarded.  The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: administered boostrix during pregnancy; Boostrix second dose 2weeks apart form; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Boostrix and the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix and Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: administered boostrix during pregnancy) and drug dose administration interval too short (Verbatim: Boostrix second dose 2weeks apart form). The outcome of the vaccine exposure during pregnancy and drug dose administration interval too short were not applicable.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 13-FEB-2025 Reporter stated that a 30 week pregnant women received Boostrix second dose 2 weeks apart from Boostrix first dose.  Boostrix first dose was approximately at 28 weeks pregnancy.  There was no patient information available at the moment of the call. Patient received Boostrix during pregnancy, which led to vaccine exposure during pregnancy. The patient received 2nd dose of Boostrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: the administration of Infanrix instead of Tdap to a 47 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 47-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 19-FEB-2025, the patient received Infanrix. On 19-FEB-2025, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: the administration of Infanrix instead of Tdap to a 47 year old patient). The outcome of the adult use of a child product was not applicable.   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-FEB-2025 A nurse called to report the administration of Infanrix instead of Tdap to a 47 year old patient which led to Adult use of a child product. The health care professional was concerned about expected adverse reactions.
Vaccine: MNQ
Symptoms: Off label use, Underdose
Clinical narrative: adult patients but receiving all their pediatric vaccines; Pediatric vaccine to an adult patient/ using vaccine off label; Pediatric vaccine to an adult patient/ using vaccine off label; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   The patient's past medical history included stem cell transplant.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced underdose (Verbatim: adult patients but receiving all their pediatric vaccines), adult use of a child product (Verbatim: Pediatric vaccine to an adult patient/ using vaccine off label) and off label use (Verbatim: Pediatric vaccine to an adult patient/ using vaccine off label). The outcome of the underdose, adult use of a child product and off label use were not applicable.   Additional Information: GSK Receipt Date: 20-FEB-2025 The reporter reported the post stem cell transplant patients receive all their childhood vaccines again after transplant. They were vaccinated like a pediatric patient. And were unsure if they require the 2 vial presentation or 1 vial presentation. These were adult patients but receiving all their pediatric vaccines which led to underdose, adult use of a child product and off label use. All of adult patients were receiving the 2 vial presentation. Health care professional did not mentioned how many patients nor any patient information. Even that health care professional mentioned that they administer the Menveo 2 vial.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix + after recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 20-FEB-2025, the patient received Kinrix. On 20-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix + after recommended age). The outcome of the inappropriate age at vaccine administration was not applicable.   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:25-FEB-2025 Medical assistant called to report that the Kinrix was administered to a 7-years and 3-months old patient, which led to inappropriate age at vaccine administration. Patient had previously 4 Dtap doses and 3 IPV doses. The reporter consented to follow up via email.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HBV (Engerix B) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis.   On 25-FEB-2025, the patient received Engerix B. On 25-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   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: 25-FEB-2025 Other HCP reported that they had a Hep B vaccine with a case of, that they had arrived at clinic on December 15th, 2024 and they did had a vaccine, a Hep B vaccine that was given but expired on February 17th, 2025. Reporter did gave it on the day of reporting and so, Nurse Manager wanted us to report to see  if it was like definitely expired, reporter did not knew if there was a window past the expiration date if it might still be good? and also they just wanted to clarify too, because they did receive this vaccine like just over two months ago, reporter stated that it was kind of unusual that expired that soon, and that was another thing that they wanted to check because they had another vaccines that expires on August of 2026, they usually get them with the same time. Patient received the expired vaccine which led to expired vaccine used.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Off label use
Clinical narrative: Intentional Off Label Prescription by HCP with no reported AE; Initial information received on 24-Feb-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 27 years old female patient who received intentional off label prescription of rabies (HDC) vaccine [Imovax Rabies] by Healthcare professional 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 intentional off label prescription by HCP of 1 ml of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for Open bite, right thigh, initial encounter (Bite) with no reported adverse event (off label use).   Information on the batch number cannot be requested corresponding to the one at time of event occurrence.  Action taken was not applicable.
Vaccine: DTAP, FLU3, FLU3, HIBV, MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were administered post excursion with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK], INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] vaccines post excursion 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 a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, solution for injection, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection, lHIB (PRP/T) VACCINE, Powder and solvent for solution for injection, INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, Suspension for injection and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation: unknown) post excursion with no adverse event (poor quality product administered) (latency same day) (dose, formulation, strength, route, lot and expiry: unknown) in unknown administration site for prophylactic vaccination.  Reportedly, there were no previous excursion, human error not involved.  not covered by extended stability   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA054065: US-SA-2025SA054013: US-SA-2025SA054381: US-SA-2025SA054097: US-SA-2025SA054040: US-SA-2025SA053939:
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HD given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case linked to other case US-SA-2025SA053939  This case involves 67 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 14-Feb-2025, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot U8515CA and expiry date 30-JUN-2025 via intramuscular route in right Arm for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day)  Reportedly, there were no previous excursion, human error not involved.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA053939:FLUZONE HD Patient #1: US-SA-2025SA054381: US-SA-2025SA054097:Fluzone
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: fluzone hd given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case linked to other case US-SA-2025SA053939  This case involves a 70 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 17-Feb-2025, the patient received influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot U8515CA and expiry date 30-JUN-2025 via intramuscular route in right Arm for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day)  Reportedly, there were no previous excursion, human error not involved.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA053939:FLUZONE HD Patient 2
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: an inappropriate use due to dose of ADACEL given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2025SA054065 (Master case).  This case involves a 34 years old female patient to whom had inappropriate use of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] given post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Feb-2025, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 31-Mar-2026 and lot: U8115AA) via intramuscular route in the right arm as immunization and inappropriate use of suspect given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly: "Max/low temperature reached: Negative 0.3 degrees C,  Duration: 1 hour, Previous Excursion: no Human error: NO, Administered post-excursion: Yes, 2-Fluzone HD doses, 1-ADACEL dose, and 3-PENTACEL. doses. the extended stability data cover the excursion for BEYFORTUS but no for all other products."  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA054065:
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to dose of PENTACEL given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2025SA054065 (Master case).  This case involves a 7 months old male patient to whom had inappropriate use of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and given post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine; Rotavirus Vaccine Live Reassort Oral 5v (Rotateq); And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Immunisation.  On 17-Feb-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: Mar-2026 and lot UK174AB via intramuscular route in the left leg as immunization and inappropriate use of suspect given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly: "Max/low temperature reached: Negative 0.3 degrees C,  Duration: 1 hour, Previous Excursion: no Human error: NO, Administered post-excursion: Yes, 2-Fluzone HD doses, 1-ADACEL dose, and 3-PENTACEL doses. the extended stability data cover the excursion for BEYFORTUS but no for all other products."  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA054065:Fluzone
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to US-SA-2025SA054097 (Master case).  This case involves a 5 months old female patient who had an inappropriate use due to dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] given post temperature excursion not covered by extended stability with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Immunisation; and Pneumococcal Vaccine Conj 20V (CRM197) (PREVNAR 20) for Immunisation.  On 14-Feb-2025, the patient received a  dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine  (Suspension for injection) lot UK112AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the right leg for Immunization and an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.3 degrees c Duration: 1 hour. Previous Excursion? no. Human error? NO. Administered post excursion? YES."  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA053939:PENTACEL Patient 3 US-SA-2025SA054097:Master case
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received IPOL after the excursion (with no reported adverse event); Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] after the excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry Date) via unknown route in unknown administration site for Immunization after the excursion (with no reported adverse event) (poor quality product administered) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, reporter stated that, Power Outage. Max/low temperature reached: 59.9F for 5 hours product was Opened. Human error not involved. extended stability data did not cover the excursion. Nurse manager also clarified based on the stability calculator that if unpunctured, it's still stable and MIS confirmed. Nurse manager also asked if the vaccine should be repeated since the opened IPOL was given to patient  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site induration, Injection site warmth, Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient looked like they were punched on their left arm because there was bruising and under it; tight spot that seems like a lump; Patient initially felt heat and the bruising got more pronounced; swelling; tight spot that seems like a lump; This situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65; Initial information received on 20-Feb-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old female patient who looked like they were punched on their left arm because there was bruising and under it, tight spot that seems like a lump,  patient initially felt heat and the bruising got more pronounced, this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 and swelling after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Autoimmune disorder.  Concomitant medications included Acetylsalicylic acid (Baby aspirin).  On 14-Feb-2025, the patient received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 1x(once) dose 0.5 ml Suspension for injection (strength-standard) lot U8264A expiry-31-Aug-2026 via intramuscular route in the left deltoid for Immunization,  this situation is pre-assessed as an off-label use as per local labelling due to use in patient older than 65 (off label use) (latency same day).  On 15-FEB-2025 the patient looked like they were punched on their left arm because there was bruising and under it (contusion), tight spot that seems like a lump (rash) (mass), patient initially felt heat and the bruising got more pronounced (feeling hot) and swelling (latency 1 day).  Reportedly, the patient told them about getting ADACEL every 10 years. Pharmacist asked the patient if they were on blood thinners and patient declined but said that they were taking baby aspirin.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Not Recovered / Not Resolved for all the events except off label use.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Burning sensation, Chest pain, Chills, Hypersomnia
Clinical narrative: sick; pain radiates to the chest when sleeping; pain in the joint of the arm; sleeping a lot; pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire; fever; chills; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient.  This case involves a 24 years old female patient who experienced sick, pain radiates to the chest when sleeping, pain in the joint of the arm, sleeping a lot, pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, fever and chills after receiving Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination (immunization).  On an unknown date the patient developed sick (illness), pain radiates to the chest when sleeping (chest pain), pain in the joint of the arm (pain in extremity), sleeping a lot (hypersomnia), pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire (vaccination site pain), fever (pyrexia)  and chills (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, pain radiates to the chest when sleeping, sleeping a lot, pain in the joint of the arm was Unknown for the event fever, sick, chills.