chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Vomiting
Clinical narrative: Soreness, some body ache, some vomitting
Age: 54.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Site reaction, redness, warmth, tenderness, inflammation,
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Cancer surgery, Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site pruritus
Clinical narrative: within 24 hours the injection site on my left arm became red and began to itchy. a bump began to appear as if it was swollen, the spot got worse over time and formed a red scab, it continued to itch, After a few months I pealed the scab off and a small amount of blood appeared. The scab grew back and became larger.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Injection site scab, Injection site swelling, Laboratory test abnormal, Malignant melanoma
Clinical narrative: within 24 hours the injection site on my left arm became red and began to itchy. a bump began to appear as if it was swollen, the spot got worse over time and formed a red scab, it continued to itch, After a few months I pealed the scab off and a small amount of blood appeared. The scab grew back and became larger.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Complement analysis, Complement factor C3
Clinical narrative: Two days after administration large local swelling in arm.  Approximately 11 days after administration developed hives and joint pain and swelling in ankles, wrists and knees. These symptoms lasted approximately one week.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Complement factor C4, Full blood count normal, Joint swelling, Metabolic function test normal, Peripheral swelling
Clinical narrative: Two days after administration large local swelling in arm.  Approximately 11 days after administration developed hives and joint pain and swelling in ankles, wrists and knees. These symptoms lasted approximately one week.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Urticaria
Clinical narrative: Two days after administration large local swelling in arm.  Approximately 11 days after administration developed hives and joint pain and swelling in ankles, wrists and knees. These symptoms lasted approximately one week.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abnormal behaviour, Anxiety, Asthenia, Dyspnoea, Hyperventilation
Clinical narrative: Right after receiving vaccine my son became hyperventilating, shortness of breath and weak( he does have a history of asthma and anxiety ), shortly after he was still a bit weak but was allowed to leave the clinic nurse advised maybe he could use some fresh air, I agreed and proceeded to drive home ,shortly after arriving home I contacted the on call provider because my son was unable to stay awake ,was talking very faint just very unusual behavior. On call provider did recommended going to ER as symptoms were very concerning. Did end up going to ER were they ran lab panels , urine samples and did not find anything concerning. A few hours of being at the hospital he started to act more like himself and were able to leave the same day but they did recommended me following up with PCP ,Dr . On 2/17 was his ER follow up were I explained to his provider and she believes it was not an allergic reaction to vaccine but more of his Anxiety. Dr also recommended I report incident as a precaution.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Somnolence, Urine analysis normal
Clinical narrative: Right after receiving vaccine my son became hyperventilating, shortness of breath and weak( he does have a history of asthma and anxiety ), shortly after he was still a bit weak but was allowed to leave the clinic nurse advised maybe he could use some fresh air, I agreed and proceeded to drive home ,shortly after arriving home I contacted the on call provider because my son was unable to stay awake ,was talking very faint just very unusual behavior. On call provider did recommended going to ER as symptoms were very concerning. Did end up going to ER were they ran lab panels , urine samples and did not find anything concerning. A few hours of being at the hospital he started to act more like himself and were able to leave the same day but they did recommended me following up with PCP ,Dr . On 2/17 was his ER follow up were I explained to his provider and she believes it was not an allergic reaction to vaccine but more of his Anxiety. Dr also recommended I report incident as a precaution.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Upper are swollen hurt  per patient unable to move
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Itching, swelling, warm to the touch
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Celulitis in the left arm; This is a spontaneous report received from a Pharmacist from a sales representative.  An 82-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jan2025 as dose number unknown, single (Lot number: LJ5283) at the age of 82 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (hospitalization) with onset 26Jan2025, outcome "recovering", described as "Celulitis in the left arm". The patient was hospitalized for vaccination site cellulitis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of vaccination site cellulitis.  Causality for "celulitis in the left arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Based on the given information, the Company confirms that the event vaccination site cellulitis is unrelated to the suspected drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and most likely to the device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: HCP reports an unknown number of patients may have received improperly stored VARIVAX or PROQUAD anytime between 03-JAN-2025 and 04-FEB-2025; No adverse event; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: . The previous case ID: 2502USA001449. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report was received from a registered medical assistant referring to an unknown number of patients of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On unknown dates between 03-JAN-2025 and 04-FEB-2025, the patients were vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) that were improperly stored at 6.2 Fahrenheit degrees for 38 minutes and at 33 Fahrenheit degrees for 5 hours and 19 minutes (most recent). No adverse event was reported.  This case was considered to be non-valid due to unknown number of patients without patient identifiers. Follow-up information has been received from the medical assistant on 10-FEB-2025. It was confirmed that no patients have reported any side effects since receiving doses of varicella virus vaccine live (oka/merck) (VARIVAX) or measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) after the temperature excursion.
Sex: U
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: significant pain in the arm where the vaccine was administered; limit mobility, making it difficult to lift the arm; This spontaneous report was received from a consumer of unknown age and gender referring to him/herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-FEB-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection (dose number, dose, strength, batch/lot #, expiration date, route and anatomical site were unknown) for prophylaxis.  On 06-FEB-2025 (also reported as on the day following vaccination), the patient experienced significant pain in the arm where the vaccine was administered (severe) (vaccination site pain). The pain was severe enough to limit mobility, making it difficult to lift the arm (injected limb mobility decreased). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was unknown.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No Side effects/No Additional AE; adult patient received a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a nurse and refers to a 60-year-old male patient. His medical history, concurrent conditions and concomitant therapies were not provided.  On 12-FEB-2025, the patient was vaccinated with pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 2.5/0.5 (unit not provided), 0.5 mL, administered for prophylaxis (anatomical location, route of administration, lot # and expiration date were not reported) (Vaccine underdose). No side effects/ no additional adverse events.   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC.  Related AE cases; No adverse event; Information has been received from Business Partner/CRO on 11-Feb-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 1, (lot # and expiration date were not reported).  On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 3, (lot # and expiration date were not reported).  On an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL),, dose number 2, (lot # and expiration date were not reported). The patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), for the treatment of Prophylaxis.  On an unknown date, the patient experienced Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC.  Related AE cases. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of Nurse calling to state that 3 doses of GARDASIL-9 were administered to a patient after a temperature excursion. No further information was available from the HCP. Consent to contact the physician was provided. No additional AE/PQC.  Related AE cases and No adverse event was unknown.   The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine was reported as not applicable.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: headache; nausea; chills; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache), nausea (Verbatim: nausea) and chills (Verbatim: chills). The outcome of the headache, nausea and chills were resolved.   The reporter considered the headache, nausea and chills to be related to Shingrix.     The company considered the headache, nausea and chills to be related to Shingrix.   Additional Information: GSK receipt date: 23-JAN-2025 The reporter reported that the patient had recived Shingrix vaccine and experienced headache, nausea and chills. The expiry date of 1st dose of Shingrix were unknown. The patient did not want to get second dose and the doctor wants to be advised of next steps. Physician wanted to be advised if the patient should get the second dose even though the patient had the adverse reactions reported.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth, Joint swelling
Clinical narrative: Injection site redness/local reaction of redness at injection site; local reaction of swelling at injection site; local reaction of heat at injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and Menveo (unknown arm). On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced injection site erythema (Verbatim: Injection site redness/local reaction of redness at injection site), injection site swelling (Verbatim: local reaction of swelling at injection site) and injection site warmth (Verbatim: local reaction of heat at injection site). The outcome of the injection site erythema was resolved and the outcome of the injection site swelling and injection site warmth were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the injection site erythema, injection site swelling and injection site warmth to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   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: 24-JAN-2025 The reporter reported that a patient received Bexsero and Menveo in same arm at different sites during same visit and experienced local reaction of redness, swelling, heat at injection site and returned to clinic to be evaluated by physician.  Physician did not think site was infected.  Physician advised patient to treat with cold compress.  Patient did not return for repeat evaluation.
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: having palpitations; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of palpitation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced palpitation (Verbatim: having palpitations). The outcome of the palpitation was not reported.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     It was unknown if the company considered the palpitation to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JAN-2025 The reporter reported that recieved the shingrix shingles vaccine and had palpitations.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 3 year after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose 3 year after). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 29-JAN-2025 The reporter reported that the patient received Shingrix vaccine 1st dose 4 years ago and 2nd dose 3 years after the 1st dose, which led to drug dose administration interval too long.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 7LC49, expiry date 30-JAN-2027) for prophylaxis.   In JAN-2025, the patient received Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure) and inappropriate dose of vaccine administered (Verbatim: a patient who received Shingrix vaccine dose with an unapproved diluent maybe from a MMR but unsure). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-JAN-2025 The reporter requested data on how to proceed with a patient who received Shingrix vaccine dose with an unapproved diluent, maybe from a MMR but unsure which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter reported that Shingrix vaccine was administered between 6th January 2025 and 15th January 2025, exact date unknown. It was unknown which Shingrix vaccine in the series. The reporter stated that all the details will not be known regarding the exact patient until the clinic runs a report.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Menveo in 2022 and another dose of Menveo; Boostrix in 2022 and then received another dose of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number LN75D, expiry date 30-SEP-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2A755, expiry date 28-OCT-2025) for prophylaxis.   Previously administered products included Boostrix (in 2022) and Menveo (in 2022).   On 22-JAN-2025, the patient received Menveo and Boostrix. On 22-JAN-2025, an unknown time after receiving Menveo and not applicable after receiving Boostrix, the patient experienced drug dose administration interval too long (Verbatim: Menveo in 2022 and another dose of Menveo) and drug dose administration interval too short (Verbatim: Boostrix in 2022 and then received another dose of Boostrix). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JAN-2025 The patient received a dose of Menveo and Boostrix in 2022 and then received another dose of Menveo and Boostrix today (22-January-2025).  The patient received Menveo at longer time than the recommended which led lengthening of vaccination schedule. The patient received Boostrix at shorter time than the recommended which led shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: Havrix - Pediatric dose to an adult; underdose; Havrix - Pediatric dose to an adult; underdose; drug dose administrartion interval too short; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 43-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric and Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric and not applicable after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Havrix - Pediatric dose to an adult), underdose (Verbatim: underdose), adult use of a child product (Verbatim: Havrix - Pediatric dose to an adult), underdose (Verbatim: underdose) and drug dose administration interval too short (Verbatim: drug dose administrartion interval too short). The outcome of the adult use of a child product, underdose, adult use of a child product, underdose and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2025 A medical assistant reported that an adult patient received a Havrix pediatric dose and one month later the patient received another pediatric dose.  The medical assistant asked if they should re start the series.  The reporter did not provide any information about the 2 pediatric Havrix doses. The adult patient received Havrix pediatric dose, which led to adult use of a child product and underdose. The patient received another dose of Havrix pediatric, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as 2nd IPV dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap).   On 09-JAN-2025, the patient received Kinrix. On 09-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as a 2nd Dtap dose and as 2nd IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter reported 4 months old patient, received Kinrix as a 2nd Dtap dose and as 2nd IPV dose, which led inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up. This case was linked with case US2025009565 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025009565:Same reporter,Different patient
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age; Kinrix as a 2nd Dtap dose and as 2nd IPV dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Polio vaccine inact (Ipv).   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent Use of Kinrix in Children Younger than 4 Years of Age) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as a 2nd Dtap dose and as 2nd IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter reported 4 months old patient, received Kinrix as a 2nd Dtap dose and as 2nd IPV dose, which led inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter consented to follow up. This case was linked with case US2025009559 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025009559:Same reporter,Different patient
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20); This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 61-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2724L, expiry date 20-JUN-2025) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis.   Concomitant products included Influenza vaccine inact split 3v (Flulaval).   On 24-JAN-2025 14:30, the patient received the 2nd dose of FluLaval 2024-2025 season. On an unknown date, the patient received Prevnar 20. On 24-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20)). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-JAN-2025 The reporter reported that they recently had a gentlemen come in to receive a vaccination, and however he/she gave him the wrong vaccination, which was the Flu vaccination (Flulaval) instead of Pneumonia vaccination (Prevnar 20) which led to, wrong vaccine administered. However, he recently had a 1st Flu vaccination (Flulaval) in October 2024, but latter the health care professional mentioned that the vaccine was given in 11th November 2024. The reporter also mentioned that the 2nd dose was given at 02:30 pm of 24th  January 2025. Both Flulaval vaccines that the patient received were administer in the same place. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17-NOV-2023) for prophylaxis.   On 21-DEC-2023, the patient received the 1st dose of Pediarix (intramuscular, left thigh) .5 ml. On 21-DEC-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-JAN-2025 The reporter states that the patient received her first dose of Pediarix on 21-DEC-2023, and the reporter just found out from the patient's new clinic, that the patient received an expired dose, which led to expired vaccine used. The reporter stated that the nurse that administered the dose no longer works at the clinic. The patient also received her first two month dose on 21-DEC-2023, six days past 8 weeks of age, the second four month dose on 26-FEB-2024, one day past four months of age, and the third six month dose on 26-APR-2024, eleven days past six months of age.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: We mixed it with sterile solution instead of the compound; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 36-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis.   On 28-JAN-2025, the patient received Menveo. On 28-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: We mixed it with sterile solution instead of the compound). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 28-JAN-2025 The nurse reported the following for Menveo 2-vial presentation, mixed it with sterile solution instead of the Compound, which led wrong solution used in drug reconstitution. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: they did not receive a second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose of Twinrix in 26-JAN-2020).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: they did not receive a second dose.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JAN-2025 The pharmacist reported that a patient got a dose of Twinrix back in January 26th 2020 and patient did not remember but seemed that they did not receive a second dose.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a second dose of Boostrix too early; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 13-JAN-2020).   On 30-JAN-2025, the patient received the 2nd dose of Boostrix. On 30-JAN-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Patient received a second dose of Boostrix too early). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025 The patient had received a second dose of Boostrix too early, which led to an extra dose administered.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: approximately half of the volume of a Boostrix dose was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number L5229, expiry date 19-APR-2027) for prophylaxis.   On 04-FEB-2025, the patient received Boostrix. On 04-FEB-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: approximately half of the volume of a Boostrix dose was administered). The outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-FEB-2025 A Medical assistant reported that a patient received approximately half of the volume of a Boostrix dose which led to underdose. The reporter asked for recommendations on this situation.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: instead of Infanrix they administered Kinrix to a 15 month old patient; they administered Kinrix to a 15 month old patient on January 30th 2025; Inappropriate schedule of vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Pediarix (first dose on December 19th 2023 of batch number: 2227K and expiry date : January 17th 2026), Pediarix (second dose on February 20th 2024 of batch number: 2227K and expiry date: January 17th 2026) and Pediarix (third dose on April 24th 2024 of batch number: X9EP5 and expiry date: March 9th 2026).   On 30-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not received Infanrix. On 30-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: instead of Infanrix they administered Kinrix to a 15 month old patient), inappropriate age at vaccine administration (Verbatim: they administered Kinrix to a 15 month old patient on January 30th 2025) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administration). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-FEB-2025 Nurse explained that instead of Infanrix they administered Kinrix after 3 doses of Pediarix to a 15-month-old patient, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: antibodies are low; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: antibodies are low). The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-FEB-2025 A surgery manager reported to have one employee who was ready for dental school.  They gave her the series of Engerix-B vaccine two years ago in 2023 and the antibodies were low. The reporter enquired if she needs a booster.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usage process
Clinical narrative: needle stayed in the patient's leg; steps were not done correctly; patient received partial dose due to the needle coming off of syringe during administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 6-month-old male patient who received Hib (Hiberix) (batch number KF25B, expiry date 14-JUL-2026) for prophylaxis.   On 03-FEB-2025, the patient received the 3rd dose of Hiberix (injection, right thigh). On 03-FEB-2025, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patient received partial dose due to the needle coming off of syringe during administration). On an unknown date, the patient experienced accidental needle stick (Verbatim: needle stayed in the patient's leg) and wrong technique in device usage process (Verbatim: steps were not done correctly). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered and wrong technique in device usage process were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt Date: 07-FEB-2025 The nurse reported that the product quality complaint ruled out due to incorrect preparation.    While reviewing product instructions for use step by step, reporter states that the steps were not done correctly.  Instructions for vial and prefilled syringe presentation figure one was align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock, was not performed as per package inset.   Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock. Reporter states that patient received partial dose due to the needle coming off of syringe during administration, which led to incomplete dose administered. When nurse attempted to take needle out of patients right upper thigh the needle stayed in the patient's leg.   Reporter states that the child's health care professional provider evaluated the partial dose given and determined that enough of the dose was administered and the dose did not need to be repeated. This case is linked with US2025016605, reported by same reporter.; Sender's Comments:  US-GSK-US2025016605:Same reporter/Diffrent patient
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Needle issue, Soft tissue foreign body, Underdose, Wrong technique in device usage process
Clinical narrative: needle stayed in the patient's leg; Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock; patient received partial dose due to the needle coming off of syringe; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 6-month-old male patient who received Hib (Hiberix) (batch number 3BP72, expiry date 13-JUL-2026) for prophylaxis.   On 04-FEB-2025, the patient received the 3rd dose of Hiberix (injection, right thigh). On 04-FEB-2025, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patient received partial dose due to the needle coming off of syringe). On an unknown date, the patient experienced accidental needle stick (Verbatim: needle stayed in the patient's leg) and wrong technique in device usage process (Verbatim: Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock). The outcome of the accidental needle stick was not reported and the outcome of the wrong technique in device usage process and incomplete dose administered were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt Date: 07-FEB-2025 The nurse reported that the product quality complaint ruled out due to incorrect preparation.    While reviewing product instructions for use step by step, reporter states that the steps were not done correctly.  Instructions for vial and prefilled syringe presentation figure one was align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock, was not performed as per package inset.   Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock. Reporter states that patient received partial dose due to the needle coming off of syringe during administration, which led to incomplete dose administered. When nurse attempted to take needle out of patients right upper thigh the needle stayed in the patient's leg.   Reporter states that the child's health care professional provider evaluated the partial dose given and determined that enough of the dose was administered and the dose did not need to be repeated. This case is linked with US2025016608, reported by same reporter.; Sender's Comments:  US-GSK-US2025016608:Same reporter/Diffrent patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Feeling cold, Injection site pain
Clinical narrative: she had trouble sleeping; she had pain at injection site; chills; stomach pain; she was cold; body aches; no appetite; been sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2025, the patient received the 1st dose of Shingrix (left arm). On 08-FEB-2025, several minutes after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had pain at injection site). On 10-FEB-2025, the patient experienced difficulty sleeping (Verbatim: she had trouble sleeping). In FEB-2025, the patient experienced chills (Verbatim: chills), stomach pain (Verbatim: stomach pain), cold (Verbatim: she was cold), general body pain (Verbatim: body aches), appetite absent (Verbatim: no appetite) and sleepiness (Verbatim: been sleepy). The outcome of the injection site pain, difficulty sleeping, chills, stomach pain, cold and appetite absent were resolved and the outcome of the general body pain was not resolved and the outcome of the sleepiness was resolving.   It was unknown if the reporter considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-FEB-2025 The patient self-reported this case. The patient received 1st dose of Shingrix dose and within minutes she had pain at injection site that had resolved.  On Monday she stated she had trouble sleeping because she had chills, stomach pain and she was cold and had body aches.  The patient had been sleepy but stated she was feeling better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Somnolence
Clinical narrative: she had trouble sleeping; she had pain at injection site; chills; stomach pain; she was cold; body aches; no appetite; been sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2025, the patient received the 1st dose of Shingrix (left arm). On 08-FEB-2025, several minutes after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had pain at injection site). On 10-FEB-2025, the patient experienced difficulty sleeping (Verbatim: she had trouble sleeping). In FEB-2025, the patient experienced chills (Verbatim: chills), stomach pain (Verbatim: stomach pain), cold (Verbatim: she was cold), general body pain (Verbatim: body aches), appetite absent (Verbatim: no appetite) and sleepiness (Verbatim: been sleepy). The outcome of the injection site pain, difficulty sleeping, chills, stomach pain, cold and appetite absent were resolved and the outcome of the general body pain was not resolved and the outcome of the sleepiness was resolving.   It was unknown if the reporter considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-FEB-2025 The patient self-reported this case. The patient received 1st dose of Shingrix dose and within minutes she had pain at injection site that had resolved.  On Monday she stated she had trouble sleeping because she had chills, stomach pain and she was cold and had body aches.  The patient had been sleepy but stated she was feeling better.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis
Clinical narrative: Rash above lip; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received first dose was on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced rash (Verbatim: Rash above lip). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2025 The patient had developing a rash above her lip two months after receiving the second dose of Shingrix.