chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received their first dose of KINRIX when they were 7 years old; another nurse accidentally administered KINRIX today to a patient instead of BOOSTRIX.; Extra dose administerd; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: another nurse accidentally administered KINRIX today to a patient instead of BOOSTRIX.) and extra dose administered (Verbatim: Extra dose administerd). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: patient received their first dose of KINRIX when they were 7 years old). The outcome of the wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration were 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:28-FEB-2025 The another nurse accidentally administered Kinrix at the time of reporting to a patient instead of Boostrix , which led to wrong vaccine administered and extra dose administered.  The patient received their first dose of Kinrix when they were 7 years old,which led to inappropriate age at vaccine administration This case was two of the three cases reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2025025487:same reporter US-GSK-US2025025495:same reporter
Age: 11.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received their first dose of KINRIX when they were 7 years old; nurse accidentally administered KINRIX today to a patient instead of Boostrix; Extra dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis.   On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: nurse accidentally administered KINRIX today to a patient instead of Boostrix) and extra dose administered (Verbatim: Extra dose administered). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: received their first dose of KINRIX when they were 7 years old). The outcome of the wrong vaccine administered, extra dose administered and inappropriate age at vaccine administration were 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:28-FEB-2025 The another nurse accidentally administered Kinrix at the time of reporting to a patient instead of Boostrix , which led to wrong vaccine administered and extra dose administered.  The patient received their first dose of Kinrix when they were 7 years old, which led to inappropriate age at vaccine administration This case was two of the three cases reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2025025491:same reporter US-GSK-US2025025487:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Pain, Pruritus
Clinical narrative: sore shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced shoulder soreness (Verbatim: sore shoulder). The outcome of the shoulder soreness was not reported.   The reporter considered the shoulder soreness to be related to Shingles vaccine and Shingles vaccine.     The company considered the shoulder soreness to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 02-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he was 50 plus, had it for a month or so in his hair, on his head.  He reported that he found a medicine that would work, for pain and itch it was dried up.  The reporter reported that he got the two shots no side effects, except very sore shoulder,  no fever, nothing else. But very minor compared to the Shingles. The reporter mentioned that if you were 50 plus, old dudes, ask your doctor, if okay for you to get the two shot series.
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: with the wrong dosage schedule; vaccine with the wrong dosage schedule; Mydaughter was born; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On 11-AUG-2023, the patient received the 3rd dose of Bexsero. On 24-MAY-2023, the patient received the 2nd dose of Bexsero. On 12-AUG-2022, the patient received the 1st dose of Bexsero. On 12-AUG-2022, an unknown time after receiving Bexsero, Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Mydaughter was born). On 24-MAY-2023, the patient experienced drug dose administration interval too long (Verbatim: vaccine with the wrong dosage schedule). On 11-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: with the wrong dosage schedule). The outcome of the drug dose administration interval too short, drug dose administration interval too long and inappropriate age at vaccine administration were 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: 28-FEB-2025 The reporter reported that the patient was given Bexsero vaccine with wrong dosage schedule. The patient was born. She administered 1st dose on August 12, 22, the 2nd dose on May 24, 2023 and the third dose on August 11, 2023, which led to inappropriate age at vaccine administration, drug dose administration interval too long and drug dose administration interval too short. The reporter asked that had she developed enough immunity.
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: currently going through the virus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of viral infection in a 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 viral infection (Verbatim: currently going through the virus). The outcome of the viral infection was not resolved.   It was unknown if the reporter considered the viral infection to be related to Shingles vaccine.     It was unknown if the company considered the viral infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2025 This case was reported by a patient via interactive digital media. The patient had gotten the shingles shot years ago and was currently going thru the virus.  It was extremely painful.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got a shingles shot and10 days later got shingles.  Patient was over 80 years old.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 The case was received from the patient via interactive digital media. The patient had shingles after the vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: having an outbreak; Well she's 19 years old; This non-serious case was reported by a consumer and described the occurrence of herpes zoster in a 19-year-old 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 herpes zoster (Verbatim: having an outbreak) and inappropriate age at vaccine administration (Verbatim: Well she's 19 years old). The outcome of the herpes zoster was not reported and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.     It was unknown if the company considered the herpes zoster to be related to Shingrix.   Linked case(s) involving the same patient: US2025024809   Additional Information: GSK Receipt Date: 27-FEB-2025  The patient was 19 years old. The other health professional reported that some idiot at a drugstore administered the second shot while the patient was having an outbreak. The patient received first dose of Shingrix outside the recommended age which led to inappropriate age at vaccine administration. For tolerance to 2nd dose, refer case US2025024809.; Sender's Comments:  US-GSK-US2025024809:Same patient ,2nd dose
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patients were administered with expired doses of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HAV (Havrix pediatric) (batch number Y3ME2, expiry date 23-FEB-2025) for an unknown indication.   On 27-FEB-2025, the patient received the 1st dose of Havrix pediatric. On 23-FEB-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: patients were administered with expired doses of Havrix). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2025 The patient was administered with expired dose which led expired vaccine used. This was the first Hepatitis A vaccine for the patient.  The reporter consented to follow up. This case was linked with case US2025025535 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025025535:Same reporter/Different patient
Sex: M
Vaccine: HEPAB
Symptoms: Angioedema, Discomfort, Feeling hot, Irritability, Lip dry
Clinical narrative: Angioedema; Irritation; Sore throat; This serious case was reported by a nurse via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis.   Additional patient notes included no allergies.   On 07-FEB-2025, the patient received Twinrix. On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced angioedema (Verbatim: Angioedema) (serious criteria GSK medically significant). In FEB-2025, the patient experienced irritability (Verbatim: Irritation) and sore throat (Verbatim: Sore throat). The patient was treated with prednisone. The outcome of the angioedema was not resolved and the outcome of the irritability and sore throat were resolving.   It was unknown if the reporter considered the angioedema, irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     The company considered the angioedema to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability 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: 28-FEB-2025 Nurse called to report that patient received the Twinrix vaccine on 07 February 2025. The symptoms started on 10 February 2025 presented angioedema and he was seen in the office on 12 February 2025 with swollen mouth, Irritation, sore throat, dry lips, no fever but feeling warm. Patient was treated with prednisone 40mg for 5 days and symptoms went away for the most part but on 28 February 2025 at 3am it reoccurs, and patient presented lip and tongue swelling, jaw line was white and feels a pressure from the inside of his mouth. Nurse comments patient had no allergies at all that he knows of. Did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No route for prednisone reported.; Sender's Comments: Angioedema is a listed event which is considered related to GSK vaccine Twinrix and Twinrix Pre-Filled Syringe Device.
Sex: M
Vaccine: HEPAB
Symptoms: Lip swelling, Mouth swelling, Oropharyngeal pain, Skin discolouration, Swollen tongue
Clinical narrative: Angioedema; Irritation; Sore throat; This serious case was reported by a nurse via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis.   Additional patient notes included no allergies.   On 07-FEB-2025, the patient received Twinrix. On 10-FEB-2025, 3 days after receiving Twinrix, the patient experienced angioedema (Verbatim: Angioedema) (serious criteria GSK medically significant). In FEB-2025, the patient experienced irritability (Verbatim: Irritation) and sore throat (Verbatim: Sore throat). The patient was treated with prednisone. The outcome of the angioedema was not resolved and the outcome of the irritability and sore throat were resolving.   It was unknown if the reporter considered the angioedema, irritability and sore throat to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     The company considered the angioedema to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability 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: 28-FEB-2025 Nurse called to report that patient received the Twinrix vaccine on 07 February 2025. The symptoms started on 10 February 2025 presented angioedema and he was seen in the office on 12 February 2025 with swollen mouth, Irritation, sore throat, dry lips, no fever but feeling warm. Patient was treated with prednisone 40mg for 5 days and symptoms went away for the most part but on 28 February 2025 at 3am it reoccurs, and patient presented lip and tongue swelling, jaw line was white and feels a pressure from the inside of his mouth. Nurse comments patient had no allergies at all that he knows of. Did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No route for prednisone reported.; Sender's Comments: Angioedema is a listed event which is considered related to GSK vaccine Twinrix and Twinrix Pre-Filled Syringe Device.
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Laboratory test normal, Vaccination failure, Zoster sine herpete
Clinical narrative: suspected vaccination failure; suspected Zoster Sine Herpete (ZSH); flank pain /the patient had this severe pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JAN-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: suspected Zoster Sine Herpete (ZSH)) and flank pain (Verbatim: flank pain /the patient had this severe pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown.   It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine.     The company considered the vaccination failure, zoster sine herpete and flank pain to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 The reporter called to speak with someone regarding Shingrix and Zoster sine herpete (ZSH) and was asking whether there was an increased reaction of Zoster Sine Herpete (ZSH) in patient who were vaccinated (not acutely/recently) with Shingrix.  The reporter stated two months ago a patient probably 50 s in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint.   She had no proof of Zoster Sine Herpete (ZSH), just a clinical suspicion because all the workup was negative but the patient had this severe pain that she could not account for. Now, in retrospect she thought it was Zoster Sine Herpete (ZSH). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for Zoster Sine Herpete (shingles) and laboratory confirmation regarding Zoster Sine Herpete (shingles) were unknown at the time of reporting. This case was one of the three case reported by the same reporter for different patient; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Zoster sine herpete and Flank pain are unlisted events which are considered unrelated to GSK Shingles vaccine. US-GSK-US2025026200:same reporter/Different patient US-GSK-US2025026208:Same reporter/Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test positive, Flank pain, Vaccination failure, Zoster sine herpete
Clinical narrative: suspected vaccination failure; potential zoster sine herpete (ZSH); flank pain; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a elderly female 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: potential zoster sine herpete (ZSH)) and flank pain (Verbatim: flank pain). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete and flank pain were unknown.   It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete and flank pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2025 Reporter called to speak with someone regarding Shingrix and zoster sine herpete (ZSH) and was asking whether there was an increased reaction of zoster sine herpete (ZSH) in patients who were vaccinated (not acutely/recently) with Shingrix.  In February 2025, 1 month ago, a female patient (also a doctor) probably 70ish in age who was vaccinated with a shingles vaccine (unknown if it was Shingrix) presented with flank pain as an initial complaint.  This was the only one of the 3 patients the caller had potential confirmation of zoster sine herpete (ZSH) for.  The patient said zoster sine herpete (ZSH) was evidently more common in vaccinated patients and the patient's zoster antibody levels were high. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is one of the three linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025026210:Same reporter/Different patient US-GSK-US2025026200:Same reporter/Different patient
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Llss than recommended interval/patient received the second dose a month later; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   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 short (Verbatim: Llss than recommended interval/patient received the second dose a month later). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK receipt date: 04-MAR-2025 The physician asked if the patient received the second dose of Shingrix a month later which led to, drug dose administration interval too short. The reporter reported that the patient was not immunocompromised. The reporter had a questioned did they need to get a third dose. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: looked like they were leaking; The initial case was missing the following minimum criteria: Invalid due to other - info not qualifying for AE reporting - Product complaint. Upon receipt of follow-up information on 05Mar2025, this case now contains all required information to be considered valid.   This is a spontaneous report and received from Other HCPs from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: HN8090, Expiration Date: 31May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "looked like they were leaking".  Additional information: The Medical Assistant/office supervisor informed that they have two defective vials. The reporter clarified that there was no patient involvement with these defective vials. They were going to be given to patients, once they were defective, they were not able to be give to patients, looked like they were leaking. It seemed like 1 was fine, had 1 defective one, the other one seemed to have a little crack inside of case, could see the fluid. The reporter clarified, specific presentation of Abrysvo involved has, part supposed to be screwed on, with plastic adapter piece, with powder in vial and syringe with liquid. Only has 1 of the syringes, has both vials. The reporter clarified, second vial and all components for second vial, including, carton, diluent syringe and carton, all have same NDC, LOT, EXP, Manufacturer, as provided for first kit.  Causality for "looked like they were leaking" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Vaccine: RSV
Symptoms: Device breakage, Device leakage
Clinical narrative: 2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; 2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid; This is a spontaneous report and received from Other HCPs from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HN8090, Expiration Date: Aug2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: 31May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid".  Causality for "2 defective vials, looked like they were leaking; the other one seemed to have a little crack in side of case, could see the fluid" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache, Loss of consciousness, Nausea
Clinical narrative: passed out; Light headed/Dizzy; headache; fatigue; nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 05Mar2025 at 14:45 as dose 2, single (Batch/Lot number: unknown) at the age of 17 years, in left arm for immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: PROZAC, start date: 01Nov2024. No other vaccine was received on the same day. No other vaccine was received on in four weeks. Vaccination history included: Meningococcal vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Immunization. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering", described as "Light headed/Dizzy"; FATIGUE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; HEADACHE (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 05Mar2025 at 19:00, outcome "recovering"; LOSS OF CONSCIOUSNESS (medically significant) with onset 05Mar2025 at 19:00, outcome "recovering", described as "passed out". Therapeutic measures were not taken as a result of loss of consciousness, dizziness, headache, fatigue, nausea.  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes were swollen; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Feb2025 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Mar2025, outcome "not recovered", described as "lymph nodes were swollen". Therapeutic measures were not taken as a result of lymphadenopathy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: she had it while she was pregnant; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient (pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "she had it while she was pregnant". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: This is the fourth time I've had COVID; This is the fourth time I've had COVID; This is the fourth time I've had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 64-year-old female patient 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "This is the fourth time I've had COVID". She did not remember it was the 4th or 5th time (as reported). She had all of the Pfizer vaccines. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence, included Pfizer medication for COVID. On another occasion, they gave the patient Pfizer medication for COVID. The patient said that she did not remember the name of medication for COVID, but on one of those occasions, she got sick with COVID, and they gave her COVID medication. The patient stated that this would be the second time she took COVID medicine.  The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired product to a patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 2 years,8 months old female patient to whom  administered  expired Hib (PRP/T) Vaccine [Act-Hib]with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Mar-2025, the patient received a 0.5 ml  dose of suspect Hib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot UK016AC , unknown strength, expiry date:28-feb-2025, via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (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: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered a dose of PENTACEL yesterday, but did not realize that it had expired on 12Feb2025 with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid  non-serious case received from a Other Health Care Professional.  This case involves a 1 years old male patient who  administered a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)].yesterday, but did not realize that it had expired on 12feb2025 with no reported ae [adverse event].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine and Pneumococcal vaccine conj 15v (CRM197) for Immunisation.  On 04-Mar-2025, the patient received a 0.5 ml  dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(PRP/T) Vaccine,Suspension for injection, lot UJ983AA, expiry date: 12-feb-2025, via intramuscular route in the left thigh for Immunization with no adverse event expired product administered) (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.  Sender's Comments:Reporter can be contacted by Sanofi.
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: reconstituted product with a sterile diluent live virus instead of what comes with product with no reported AE; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case (live processed together on 05-Mar-2025) received from a Pharmacist.  This case involves, the patient received the Yellow Fever Vaccine- [YF-VAX] as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Feb-2025, the patient received Yellow Fever Vaccine- Solution for injection (unknown strength, expiry date, batch number) for Immunization as reconstituted product with a sterile diluent live virus instead of what comes with product with no reported adverse event (product preparation error) (latency-same day).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   Reportedly, Temperature excursion: negative disposition, no human error and product not used. Caller previously reported that a dose of YF-VAX was administered to a patient after it had been reconstituted with an alternate diluent (not the intended YF-VAX diluent). The alternate diluent used for reconstitution was sterile diluent live virus vaccines. Caller noted that the invalid dose was administered on 28-Feb-2025. The patient is traveling on 15-Mar-2025.   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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 1-year-old patient received an expired act-hib vaccine with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received an expired HIB (PRP/T) vaccine [ACT-HIB] 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) and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Immunisation.  On 05-Mar-2025, the patient received a dose of (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot UJ995AA with unknown strength and expiry date) via intramuscular route in the right vastus lateralis for Immunization.  On 05-Mar-2025 the patient received an expired act-hib vaccine with no reported adverse event (expired product administered).  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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case, initially received on 21-Feb-2025, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had Osteoarthritis. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug:  On an unknown date, the patient received Flucelvax (TIV) for Influenza vaccination, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Not reported, Lot number: Not reported and would be requested upon follow up.  Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunization.  Adverse reactions/events and outcomes: On 02-Jan-2025, the patient experienced COVID-19 (outcome: Not recovered / Not resolved). experienced COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted.  Lab test: SARS-COV-2 TEST on an unknown date.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide a seriousness or causality assessment; Reporter's Comments: The causality of events was related to the administration of Flucelvax (TIV)
Age: 82.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Ear pain, Headache, Neck pain
Clinical narrative: Ear pain; Neck pain; Head pain; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug: On 20-Sep-2023, the patient received Fluad Quadrivalent for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine, Dose regimen: .5 ml, route of administration and anatomical location: not reported. Lot number: No batch number available and will be requested upon followup.   Non-company suspect drugs: Shingrix (Varicella zoster vaccine rgE (CHO), Indication not reported, Dose, route of administration and anatomical location were not reported. Lot number: No batch number available and will be requested upon follow-up.  Adverse reactions/events and outcomes: On Sep-2023, the patient experienced Ear pain (outcome: Recovered / Resolved, stop date: 2023), Neck pain (outcome: Recovered / Resolved, stop date: 2023), Head pain (outcome: Recovered / Resolved, stop date: 2023).  Because patient had a severe reaction from both the flu shot and a Shingrix shot, she was interested in obtaining a list of ingredients in the flu shot. She received the Fluad Quadrivalent (Influenza Vaccine, Adjuvanted) on 20-Sep-2023. She was interested in the components of Fluad 2023. She did not have the batch number. Her reaction was the same for the flu shot and the Shingles vaccine- ear, head, neck pain that lasted 2 weeks after the shingles shot but only a few days after the flu shot. She was trying to determine what ingredient was in both medications. She did not take medication for the symptoms and until the second shot, she didn't realize the cause of the problem. She was not hospitalized. She had never previously had reactions to any shots. She was happy to discuss the event if someone wants to reach out to her. The patient had event a few days after the flu shot.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and causality was not reported.; Reporter's Comments: All events were considered related.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Induration, Peripheral swelling, Swelling
Clinical narrative: Child had an extensive local reaction with induration swelling entire upper arm and upper chest across the clavicle which persisted over 24 hours, seen in office with still significant swelling  3/10/25
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: After vaccine administration patient felt excessive dizziness and expressed she was about to faint, but she did not. She was remained in sitting position with elevated legs. She was provided with cold compresses around the neck area. She was provided water and salt crackers as per her request. She started to feel better and was fully recuperated. She was advised to remain in the Pharmacy area for around 15 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV1
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Gardasil 9 instead of Prevnar 15.  Patient was closely monitored in the clinic for 20 minutes after injection given. NO sie reaction and NO physical reaction. Patient parents where notified and given instructions as to what they should watch for and advised to take to ER if any concerns.  Provider and clinic manager wehre notified.
Age: 21.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The morning after the shot, the patient had pain, swelling, redness, and the appearance of lots of tiny itchy bumps within a 2-3 inch diameter around the injection site. No systemic side effects. I am a pharmacist, and i told her to use hydrocortisone 1% cream OTC on the affected area 4 times daily for about a week. She as an OB appointment on 3/11/25, and i told her to ask the dr if it could be an allergic reaction (itchy red bumps) and ask if it would be safe or not to get the vaccine again in the future.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Blood test, Computerised tomogram, Gastritis, Inflammation
Clinical narrative: The vaccine caused inflammation in my body which aggravated my gastritis. That led to significant abdominal bloating which has lasted for months. All other causes of the bloating have been ruled out through lab work and imaging.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Oropharyngeal pain, Pain, Streptococcus test positive
Clinical narrative: Flu-like symptoms with injection site redness beginning late 03/06/25. Had tachycardia, sore throat, and persistent body aches from 3/6-3/10 with some improvement. Injection site redness evolved with spread distally in an annular pattern. No swelling or tenderness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Flu-like symptoms with injection site redness beginning late 03/06/25. Had tachycardia, sore throat, and persistent body aches from 3/6-3/10 with some improvement. Injection site redness evolved with spread distally in an annular pattern. No swelling or tenderness.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at the injection site that radiates down arm and to back and neck. Has improved after a 10 day taper course of prednisone, but pain still comes and goes.
Age: 68.0
Sex: F
Vaccine: HEPAB, PNC21, RSV, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient complains of having  sore arms on 3/9/25 due to vaccines administered on 3/8/25. She states use of cold compress and also an over the counter NSAID. She states she is feeling better today (3/10/25).
Age: 38.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt had red circle on arm where vaccine was given, shown to pharmacy on 3/10/25. Pt stated it was warm, firm, itchy and sore.