chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19, COVID19
Symptoms: Illness, Malaise
Clinical narrative: I am sick and suffering and haven't been well ever since I received your vaccine; I am sick and suffering and haven't been well ever since I received your vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer vaccine for covid (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I am sick and suffering and haven't been well ever since I received your vaccine".  Additional information: The reporter (patient reported for self) had Pfizer vaccine for covid. Two of them. And the reporter was sick and suffering and had not been well ever since the reporter received vaccine. The reporter stated "I have lost everything - my health, my quality of life, my job". The reporter was an ultrasound technologist. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500019917 Same patient/ product/AEs, different dose;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038076 same patient, different vaccine doses;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038076 same patient, different vaccine doses;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: developed folliculitis under her scalp; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOLLICULITIS (non-serious), outcome "not recovered", described as "developed folliculitis under her scalp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of folliculitis. Additional information: After taking the 5 Pfizer COVID-19 vaccines between 2021 and 2022 she experienced folliculitis. Caller states that first time the vaccine came out she got it and it started on her scalp. Ended up in clinic and they were not able to help her either and nothing happened because all of the prescription that was given to her did not work, she even had shots in her scalp but did not work, had special medications made in the special pharmacy but did not work. Folliculitis is very painful and nothing could have been done. It started on the scalp and it moved under the scalp now. Had 3 biopsies done by different clinics. Had some outside on her scalp but she used to have a lot on the beginning when it started. Was taking the medications, had shots and she had a lot of different things, it went inside her scalp now. It's no longer 100% on top of the scalp, patient some but not many but most of the spots right now are inside the scalp. When patient touches scalp, feels bumps with the size of a little rice. It started it was like little pimples with little 'pops' on top of it and a lot of them. The thing developed when patient started having this is that it hurts a lot and it itches a lot. Feels like has a rash and has to scratch her head because it bother her. Lost a lot of hair and whenever drives, have the window rolled down, just the air touching her hair, it hurts her. It's painful. It burns a lot. Was specifically diagnosed with 'Folliculitis'.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500038076 same patient, different vaccine doses;
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: It got into his eye too; two weeks later he had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: It got into his eye too) (serious criteria GSK medically significant) and shingles (Verbatim: two weeks later he had shingles). The outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-FEB-2025 This case was reported by the daughter/son of the patient via interactive digital media.  Th reporter stated that his/her father (patient) went and got his Shingles vaccine and about two weeks later he had shingles. Reporter stated that it got into his eye too.; Sender's Comments: Ophthalmic herpes zoster and Herpes zoster are unlisted events which are considered unrelated to GSK Shingles vaccine.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025; The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025; Extra dose administered; 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 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 9M2R7) for prophylaxis.   On 13-FEB-2025, the patient received the 2nd dose of Menveo. On 13-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025), inappropriate dose of vaccine administered (Verbatim: The sterile water diluent from a Merck MMR-Varicella vaccine was used to reconstitute the MENVEO Vaccine on 13 February 2025) and extra dose administered (Verbatim: Extra dose administered). The outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 18-FEB-2025 The reporter was a medical assistant for a medical office. The sterile water diluent from a Merck MMR Varicella vaccine was used to reconstitute the Menveo vaccine on 13th February 2025 which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The MMR Varicella antigen was not involved. The diluent was baxter sterile water. This was the second Menveo dose for the patient no other adverse event reported which led to extra dose administered.
Vaccine: MENB
Symptoms: Incorrect dose administered, Injection site pain, Product quality issue
Clinical narrative: Pain at injection site; several Bexsero syringes having too much air and administered one dose which included the air bubble; administer one dose which included the air bubble in the syringe; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain at injection site), syringe issue (Verbatim: several Bexsero syringes having too much air and administered one dose which included the air bubble), incomplete dose administered (Verbatim: administer one dose which included the air bubble in the syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was resolved and the outcome of the syringe issue, incomplete dose administered and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain and syringe issue to be related to Bexsero and Bexsero 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: 24-JAN-2025 The healthcare professional reported that they did inject one dose of Bexsero with the air bubble in the syringe and the patient complained of pain upon injection and for several hours after, which led to syringe issue and incomplete dose administered They have experienced problems with several Bexsero syringes having too much air and had tried to expel the air with and without the syringe attached and the suspect syringes had been discarded.  The HCP now knew to save the suspect syringes if it happens again. They stated that this had been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they may administer the vaccine with the air. The defect was discovered during preparation for administration and only one dose was administered. The vaccine syringe is included in the product complaint. This case is linked with US2025008843, reported by same reporter.; Sender's Comments:  US-GSK-US2025008843:same reporter
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Drug Exposure During Pregnancy; Extra dose to pregnant patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR 3-COMPONENT;TETANUS VACCINE TOXOID (BOOSTRIX).   On 28-JAN-2025, the patient received the 2nd dose of Boostrix. On 28-JAN-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose to pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the extra dose administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Estimated Delivery/Due date: 10-MAR-2025   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 medical assistant explained that they accidentally administered a second dose of Boostrix to a pregnant patient on 28th January 2025 which led to extra dose administered and vaccine exposure during pregnancy. First dose of Boostrix vaccine was administered on 19th December 2024.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component; somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 9C5T4, expiry date 26-OCT-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 14th November 2024).   On 17-JAN-2025, the patient received the 2nd dose of Shingrix. On 17-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component) and inappropriate dose of vaccine administered (Verbatim: somebody administer a Shingrix vaccine without reconstitute it, they just use the liquid, and not the lyophilized gE antigen component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JAN-2025 Reporter called from a clinic, and they provided a vaccine for a patient.  He/she was doing the inventory management for the month for vaccines, and it looked like someone administered a Shingrix vaccine without reconstituting it. They just used the liquid and not the lyophilized gE antigen component, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. He/she was told by his/her manager that he/she needed to call and find out from what they needed to do. Healthcare professional reported that the 1st complete Shingrix dose was administered on 14th November 2024, then this 2nd dose (only the liquid portion) was on 17th January 2025.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a twelve month old female patient was administered a Kinrix vaccine by mistake; a twelve month old female patient was administered a Kinrix vaccine by mistake; 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 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Previously administered products included Dtp ipv vaccine (Received 2 doses on an unknown date).   On 26-SEP-2024, the patient received Kinrix. On 26-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a twelve month old female patient was administered a Kinrix vaccine by mistake) and inappropriate schedule of vaccine administered (Verbatim: a twelve month old female patient was administered a Kinrix vaccine by mistake). 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: 30-JAN-2025 The reporter reported that a twelve month old female patient was administered a Kinrix vaccine by mistake which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Reporter confirms this was the third dose of Dtap/IPV vaccination.  No further information was obtained in this call.
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo one vial presentation administered to patients under 10 year of age; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo one vial presentation administered to patients under 10 year of age). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 10-FEB-2025 The doctor stated that several patients under 10 year old received Menveo one vial presentation which led to inappropriate age at vaccine administration. The doctor wanted to know if these children under 10 year old who had been administered with Menveo one vial presentation will be protected from MCV4 compared with Menveo 2 vials presentation. The vaccine administration facility is the same as primary reporter. Consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received Twinrix -1st dose in May 2024 and 2nd dose October 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in May 2024).   In OCT-2024, the patient received the 2nd dose of Twinrix. In OCT-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received Twinrix -1st dose in May 2024 and 2nd dose October 2024). The outcome of the drug dose administration interval too long 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: 11-FEB-2025 The reporter reported a patient received Twinrix 1st dose in May 2024 and 2nd dose October 2024.  The reporter declined to provide patient demographics, Lot and Expiration dates of vaccines were not available at time of call. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Lymphadenopathy, Oropharyngeal pain, Skin irritation, Throat irritation
Clinical narrative: swollen lymph nodes; throat itchy; jaw irritation; having swollen lips; throat itchy and painful,; This non-serious case was reported by a consumer via call center representative and described the occurrence of swollen lymph nodes in a 65-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included Typhoid vaccine for prophylaxis.   On 07-FEB-2025, the patient received Twinrix (intramuscular, right arm). On 05-FEB-2025, the patient received Typhoid vaccine (left arm). On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced swollen lymph nodes (Verbatim: swollen lymph nodes), itchy throat (Verbatim: throat itchy), mouth irritation (Verbatim: jaw irritation), lip swelling (Verbatim: having swollen lips) and sore throat (Verbatim: throat itchy and painful,). The outcome of the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat were not resolved.   It was unknown if the reporter considered the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the swollen lymph nodes, itchy throat, mouth irritation, lip swelling and sore throat to be related to Twinrix and Twinrix 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: 12-FEB-2025 The patient was the reporter who received the Twinrix vaccine on and started having symptoms.  The reporter stated he also received the Typhoid vaccine.  The reporter stated that after the Twinrix vaccine, he noticed within 48 hours that he had swollen lips, swollen lymph nodes, jaw irritation, and his throat was itchy and painful.  All these symptoms were ongoing.  The reporter stated he was going to see his health case professional on the day of reporting. The reporter consented to follow-up.  The Vaccine Administration Facility was the same as the Primary Reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Innapropiate Schedule for vaccine (2 previous doses 2 years apart); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient got a first dose of the Shingrix vaccine on 31st October, 2022).   On 25-SEP-2024, the patient received the 2nd dose of Shingrix. On 25-SEP-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Innapropiate Schedule for vaccine (2 previous doses 2 years apart)). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 12-FEB-2025 Other HCP reported that a female patient got a first dose of the Shingrix vaccine on October 31st, 2022 and also did get a second dose on September 25th, 2024. Physician advised to administer a third dose. HCP wanted to know which guidance GSK has on this topic. The patient received 2nd dose of Shingrix,?later than the recommended interval, which led to lengthening of vaccinations schedule (Drug dose administration interval too long).
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given 01/14/2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 19-MAY-2031) for prophylaxis.   Previously administered products included Shingrix (The first dose was given 07-SEP-2019).   On 14-JAN-2025, the patient received the 2nd dose of Shingrix. On 14-JAN-2025, 1956 days after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given 01/14/2025). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-FEB-2025 A pharmacy student contacted to request information about the validity of a second dose of Shingrix that was administered years after the initial dose. The first dose was given 07-SEP-2019, no other information was given and second dose was given 14-JAN-2025 which led to drug dose administration interval too long. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administration of Pediatric dose of Engerix B to adult patient.; administering a pediatric dose of Engerix B to an adult patient; 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 37-year-old male patient who received HBV (Engerix B pediatric) (batch number 47XE4, expiry date 16-JUL-2026) for prophylaxis.   On 19-FEB-2025, the patient received Engerix B pediatric. On 19-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of Pediatric dose of Engerix B to adult patient.) and underdose (Verbatim: administering a pediatric dose of Engerix B to an adult patient). The outcome of the adult use of a child product and underdose 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 :19-FEB-2025 Medical assistant called to request information on how to proceed after administering a pediatric dose of Engerix B to an adult patient that is still in the office.  Then reporter reported administered to a pediatric dose of Engerix B to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient recived first dose but not recived second dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 05 January 2024 with lot number 797F9 and expiry date 30th December 2025).   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: The patient recived first dose but not recived second dose of Twinrix). 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: 19-FEB-2025 The reporter was aware that patient should receive the second dose of Twinrix as soon as possible and asked when this patient should receive the third dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Type A flu only; Initial information received on 12-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient.  This case involves Adult female patient who experienced type a flu only after receiving Influenza Vaccine.  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 Influenza vaccine solution for injection produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength and expiration date: not provided) for Immunisation.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date the patient developed type a flu only (influenza) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.33
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone mistaken for a 4 month vaccination with no reported adverse event; Initial information received on 12-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old and unknown gender patient who had received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] mistaken for a 4 month vaccination with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 12-Feb-2025, the patient received a  dose of 1 mg of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Suspension for injection) strength, expiry date, lot number not reported via intramuscular route in unknown administration site for Prophylactic vaccination (Immunization) and fluzone mistaken for a 4 month vaccination with no reported adverse event (product administered to patient of inappropriate age)(latency : same day).  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: 38.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured IPOL was administered to 1 patient post temperature excursion with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 38 years old male patient who was administered with punctured IPV (VERO) [IPOL] - post temperature excursion with no reported adverse event.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix; Varicella zoster vaccine (Varicella vaccine); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) and Influenza vaccine (Flu), all for Immunisation.  On an unknown date, the patient had administered 0.5mL standard dose of suspect IPV (Vero), Suspension for injection (lot X15141M, expiry date 31-Oct-2026 and frequency: once) via subcutaneous route in the right arm for Immunisation and the patient was administered with punctured poliomyelitis vaccine (inactivated)  - post temperature excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  Reportedly, temperature excursion that occurred on the night of 04-Feb-2025. Reason: Power outage, Max/low temperature reached: MAX = 8.1 C LOW = 4.6C, Duration: 18 minutes. Human error was no. All products except punctured IPOL was covered and it was administered to a patient.  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: 0.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: received a dose of act-hib that had been reconstituted with sterile water instead of the intended act-hib specific diluent with no reported adverse event; Initial information received on 10-Feb-2025 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5-month-old female patient who experienced received a dose of HIB (PRP/T) vaccine [ACT-HIB that had been reconstituted with sterile water instead of the intended specific diluent 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus Vaccine toxoid (DTAP) for Immunisation.  On 06-Feb-2025, a patient received a (0.5ml) dose 2 of suspect HIB (PRP/T) Vaccine powder and solvent for solution for injection (strength-unknown) (Frequency = once) (lot UK210AA) (Expiry date- 28-Feb-2026)  via intramuscular route in right leg for Immunization, that had been reconstituted with sterile water instead of the intended specific diluent with no reported adverse event (product preparation error) (latency- same day).  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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the administration of expired daptacel to a patient with no reported adverse event; Initial information received on 10-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered with expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]with no reported adverse event.  List of concomitant vaccines: No other vaccines.  On 07-Feb-2025, the patient had administration of expired 0.5mL standard dose of suspect diph-theria-15/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 2CA28C1, expiry date 04-Nov-2024) (Frequency: Once) via intramuscular route in the right arm for Immunization, with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  Reportedly, Administrative nursing manager said that the patient was okay and that no adverse events were noted.  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: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: flu vaccine hurt her arm more than any flu shot she received in the past; Initial information received on 10-Feb-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (health care professional).  Several cases were created from this master case.  This case involves 66 years old female patient who experienced flu vaccine hurt her arm more than any flu shot she received in the past after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past vaccination(s) included flu shot (influenza vaccine) for prophylactic vaccination (immnisation). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Nov-2024, the patient received a dose of 0.5 ml of suspect influenza USP  trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot number, strength and expiry date not reported) via unknown route in left arm for immunization. Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date the patient developed this flu shot hurt (vaccination site pain) (unknown latency).   Reportedly, The caller said with Covid shots, she expects that her arm hurts for 3 to 4 days. She never had her arm hurt much after a flu shot until this year. She was told that her second shingles shot would hurt more than the first, which it did. The caller's niece is a nurse. She said people at her niece's workplace are saying this year's flu shot is making their arms hurt this year more than other years.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was not recovered/not resolved for the event.; Sender's Comments:  US-SA-2025SA043293:Caller's Mom US-SA-2025SA044188:hairstylist's male US-SA-2025SA043499:Caller's niece
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Pain in extremity
Clinical narrative: flu shot hurt; flu shot will make inflammation worse. It has affected her whole body, the left side more than other; Initial information received on 10-Feb-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional .  This case is linked to this reference US-SA-2025SA043286 (master case)  This case involves a 91 years old female patient who experienced flu shot hurt and inflammation. It has affected her whole body, the left side more than other after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Arthritis and Musculoskeletal discomfort..  On 27-Nov-2024, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, strength, expiry date and  lot number not reported via unknown route in left arm for Immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence  On an unknown date the patient developed flu shot hurt (vaccination site pain) and flu shot will make inflammation worse. it has affected her whole body, the left side more than other (inflammation) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Reportedely, She took a survey of some of her clients who are 70 or older.  Two clients, both men, told her the high-dose vaccine bothered their arms as well.  They said it made their arms sore for longer than normal.  The caller and/or her mom had blood work drawn this morning.  The phlebotomist told them to call and complain.  The phlebotomist once received a chicken pox vaccine in order to work at her lab.  She said it took a year for her arm to feel better.  She said people in their state are not taught how to give shots, that they don't squeeze the top of your arm like they should and that this can make a difference.  The caller said with Covid shots, she expects that her arm hurts for 3 to 4 days.  She never had her arm hurt much after a flu shot until this year.  She was told that her second shingles shot would hurt more than the first, which it did.  The caller's niece is a nurse.  She said people at her niece's workplace are saying this year's flu shot is making their arms hurt this year more than other years  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events   At time of reporting, the outcome was Recovering / Resolving for both the events.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: high-dose vaccine bothered their arms as well. they said it made their arms sore for longer than normal; Initial information received on 10-Feb-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (health-care professional).  This case is linked to US-SA-2025SA043286 (master case).  This case involves 2 elderly patients with unknown age who received high-dose vaccine which bothered their arms as well and they also mentioned their arms sore for longer than normal after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone Hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization.  On an unknown date, the patients received  high-dose vaccine which bothered their arms as well and they also mentioned their arms sore for longer than normal(pain in extremity) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2025SA043286:Master case
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel vaccine was administered without first reconstituting the hib portion of the vaccine with no reported ae; Initial information received on 10-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received Diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and that was administered without first reconstituting the HIB portion of the vaccine with no reported AE (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 was administered an unknown dose of suspect Diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK043AA and expiry date- 31-AUG-2025) (strength - unknown) via unknown route in unknown administration site for immunization, without first reconstituting the HIB portion of the vaccine with no reported AE (single component of a two-component product administered) (latency- same day).  Reportedly, HCP (healthcare professional) knows that it counts as a valid DTaP-IPV vaccination, but they would like to administer the HIB portion as well and are requesting 0.4% NaCl solution for dilution of the HIB.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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.