chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: a female patient received Trumeba at age 17 and Bexsero at age 18; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Trumenba. On an unknown date, an unknown time after receiving Bexsero and Trumenba, the patient experienced interchange of vaccine products (Verbatim: a female patient received Trumeba at age 17 and Bexsero at age 18). The outcome of the interchange of vaccine products 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: 24-JUL-2025 The nurse reported that a female patient received Trumeba at age 17 and Bexsero at age 18 which led to interchange of vaccine products. Nowadays patient was 20 years.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Active ingredient not added to diluent; Administration over the recommended age; Inappropriate age at vaccine administration; Extra dose administered;  This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 31-year-old male patient who received MMR (Priorix) for prophylaxis.   Previously administered products included Priorix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Active ingredient not added to diluent), inappropriate dose of vaccine administered (Verbatim: Administration over the recommended age), inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration) and extra dose administered (Verbatim: Extra dose administered). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, inappropriate age at vaccine administration and extra dose administered 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: The pharmacist reported that the possible administration of Priorix vaccine with received only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received 3 doses of Priorix vaccine, which led to extra dose administered The patient received dose of Priorix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 7/11/2025 and Twinrix second dose was on 2nd 7/23/2025.; 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 female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 23-JUL-2025, the patient received the 2nd dose of Twinrix. On 23-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 7/11/2025 and Twinrix second dose was on 2nd 7/23/2025.). 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: 25-JUL-2025 The pharmacist had an adult female patient who wanted to finish Twinrix schedule in a month, however Twinrix first dose was on 11th July 2025 and Twinrix second dose was on 2nd 23rd July 2025 which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was diagnosed with Covid this morning; I was diagnosed with Covid this morning; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jul2025, outcome "unknown" and all described as "I was diagnosed with Covid this morning". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported, patient has a prescription for a Paxlovid at this time and patient reported had all his vaccines from Pfizer, all his Covid vaccines (Clarified as Covid-19 vaccine) from Pfizer. Clarified if patient had Covid now and prescribed with Paxlovid for that reported as yes. Patient reported was diagnosed with Covid this morning. The first time he got it to the stadium, when there was, people were going to get the vaccines here in withheld in the Stadium, here in withheld and he thought the second one, he thought it was in withheld, thought he got 2 in withheld and got another one or 2 in withheld. Did not have lot information, he was at the pharmacy and the card was at home.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient experienced local site reaction of erythema, extended warmth and redness; Patient experienced local site reaction of erythema, extended warmth and redness; This is a spontaneous report received from a Nurse from a sales representative.  A 58-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "Patient experienced local site reaction of erythema, extended warmth and redness". Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema.  Additional information: Patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting., the patient did not received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting, the patient not taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event with Ice and Recommended Ibuprofen and Zyrtec.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Neck pain, Ocular discomfort
Clinical narrative: eye pressure; humming in head; head and neck aches; feel like I have a fever but didn't; dizziness; head and neck aches; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 20Jan2024, outcome "not recovered"; OCULAR DISCOMFORT (non-serious) with onset 20Jan2024, outcome "not recovered", described as "eye pressure"; MALAISE (non-serious) with onset 20Jan2024, outcome "not recovered", described as "feel like I have a fever but didn't"; NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 20Jan2024, outcome "not recovered" and all described as "head and neck aches"; TINNITUS (non-serious) with onset 20Jan2024, outcome "not recovered", described as "humming in head". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Additional information: Patient began having symptoms on 20Jan2024 including dizziness, eye pressure, humming in head and felt like patient had a fever but didn't. Also head and neck aches. That never stopped, at times very severe. Had been to 14 doctors, had  numerous tests all with good results. Could that be Covid shots patient asked for help.
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: eye pressure; humming in head; head and neck aches; feel like I have a fever but didn't; dizziness; head and neck aches; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 20Jan2024, outcome "not recovered"; OCULAR DISCOMFORT (non-serious) with onset 20Jan2024, outcome "not recovered", described as "eye pressure"; MALAISE (non-serious) with onset 20Jan2024, outcome "not recovered", described as "feel like I have a fever but didn't"; NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 20Jan2024, outcome "not recovered" and all described as "head and neck aches"; TINNITUS (non-serious) with onset 20Jan2024, outcome "not recovered", described as "humming in head". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.  Additional information: Patient began having symptoms on 20Jan2024 including dizziness, eye pressure, humming in head and felt like patient had a fever but didn't. Also head and neck aches. That never stopped, at times very severe. Had been to 14 doctors, had  numerous tests all with good results. Could that be Covid shots patient asked for help.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid back in June of this year; covid back in June of this year; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 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 (Primary series completed), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "covid back in June of this year". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient called regarding a follow up questionnaire that she just got another one from Pfizer, both her husband and her (patient) contracted covid back in June of this year (2025) they've both have had all the Pfizer vaccines, the first initial and every update they had every single one and in spite of that she still wearing mask, nevertheless she got covid, and was treated with Paxlovid. It worked right away, by the second day and probably least the 3rd day she felt like she was well, she continued and finish the 5 days, after the 5 days and completed the whole course. 3 days after that she started feeling sick again, now have long covid which is the reason it is continuing the nasal junk that she have been dealing with as well as the other symptoms nevertheless she ended up sick again 3 days after she had finished that she got ill again.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500155436 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male 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), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "contracted covid". The patient has had all the Pfizer vaccines, including the first initial and every update; the patient received every single one. Despite this, the patient continued wearing a mask, yet still contracted COVID-19 and was treated with Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500155427 same reporter/drug/event, different patient;
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Activated partial thromboplastin time normal, Aplastic anaemia, Aspergillus test, Biopsy bone marrow abnormal, Blood beta-D-glucan positive
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Blood creatinine normal, Blood culture negative, Blood test abnormal, Bone marrow failure, Chest X-ray normal
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Computerised tomogram, Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Coxiella test
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Cryptococcus test, Culture urine negative, Cytomegalovirus test negative, Cytopenia, Epistaxis
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Epstein-Barr virus test negative, Febrile neutropenia, Fungal test positive, HIV test negative, Haemoglobin decreased
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex test negative, Human herpes virus 6 serology negative, Immune thrombocytopenia
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Immunoglobulin therapy, Incorrect route of product administration, International normalised ratio normal, Laboratory test normal, Leukopenia
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Liver function test normal, Lymphadenopathy, Lymphocyte count decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging pelvic
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Neutrophil count decreased, Oral contusion, Parvovirus B19 test negative, Pelvic fluid collection, Petechiae
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Platelet count decreased, Platelet transfusion, Prothrombin level normal, Pyrexia, Rash
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 18.0
Sex: M
Vaccine: ANTH, HEP, TYP, YF
Symptoms: Red blood cell transfusion, Thrombocytopenia, Typhus rickettsia test, Viral test negative, White blood cell count decreased
Clinical narrative: 18 y/o previously health male received AVA, Hep B, ViCPS, and YF-VAX on 05 May 2025. On 08 May 2025 he presented to the primary care clinic for a 2 day history of a "rash", brusing and blood in tissue when wiping his nose. Exam revealed generalized petechiae, and bruising to bilat legs, knees, and upper arms, back and trunk as well as dark/black spots of bruising in mouth. He was sent to the ER. At (withheld name) ER, his initial labs were notable for significant leukopenia/thrombocytopenia (WBC 3, Hgb 13.5, PLT 4, ANC 2000, ALC 600).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: My wife had her first dose of the vaccine on 9/8/2021 while in her third trimester and went into premature (5.5 weeks early) labor that night, giving birth the following morning (9/9/2021). I would have reported this sooner had I known this system existed. She got her vaccine from the pharmacy, and gave birth next day at the hospital.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electroencephalogram, Fall, Injury, Laboratory test
Clinical narrative: pt  says a few days after getting second dose she developed seizures.  Sometimes she has partial seizures and other times she has a regular seizure. She will go down and hit the ground and injures herself during these episodes. She now has a service dog.  She states they have found odd growths in her body and her memory is being affected as well. She has been ER and ER and hospital. Her initial medical records will be located at hospital.  She is being treated by a neurologist now. She has been diagnosed temporal lobe seizures/epilepsy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Partial seizures, Seizure, Temporal lobe epilepsy
Clinical narrative: pt  says a few days after getting second dose she developed seizures.  Sometimes she has partial seizures and other times she has a regular seizure. She will go down and hit the ground and injures herself during these episodes. She now has a service dog.  She states they have found odd growths in her body and her memory is being affected as well. She has been ER and ER and hospital. Her initial medical records will be located at hospital.  She is being treated by a neurologist now. She has been diagnosed temporal lobe seizures/epilepsy.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Diarrhoea, Intestinal barrier dysfunction, Malabsorption
Clinical narrative: My ears started ringing the following day and have not stopped ringing since the shot.  I have also suffered Leaky Gut issues including chronic diarrhea since the vaccination and have had difficulty absorbing nutrients since that time.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My ears started ringing the following day and have not stopped ringing since the shot.  I have also suffered Leaky Gut issues including chronic diarrhea since the vaccination and have had difficulty absorbing nutrients since that time.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal clotting factor, Arterial occlusive disease, Hypertension
Clinical narrative: Clotting factor sky high. High blood pressure. 99% blockage in artery
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Blood culture positive, Chills, Headache, Inflammation, Injection site erythema
Clinical narrative: Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER  for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on  7/31/25 for lump on left deltoid,  6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site induration, Injection site mass, Nausea, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER  for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on  7/31/25 for lump on left deltoid,  6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: White blood cell count increased
Clinical narrative: Patient developed redness at the injection site, fevers, chills, headache and nausea within 24 hours of vaccine. on 7/5/25 Patient was seen in the ER  for above symptoms was noted to have an elevated WBC and blood culture found to have 1 bottle positive for coagulase negative staph possible contamination. Patient was treated with IV Vancomycin. Symptoms improved and patient was discharged. Patient returned to Urgent Care on  7/31/25 for lump on left deltoid,  6cm x 3cm firm palpable mass. Ultrasound appeared to indicate an inflammatory response to the vaccination injection.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reactions noted before, during, nor after administration of vaccine. Minor kept for post vaccination observation for 15 minutes and then released.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Minor received 0.3 mL of Pfizer dose labeled for use to children ages 6 months to 4 years old. No adverse reactions noticed before, during, nor after receiving vaccine. Client kept for post vaccination observation for 15 minutes and then released from vaccine clinic.
Vaccine: RVX
Symptoms: Cardiac ablation, Respiratory syncytial virus infection, Supraventricular tachycardia, Traumatic lung injury, Vaccination failure
Clinical narrative: had it; Permanent lung damage; supraventricular tachycardia needing an ablation; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: had it) (serious criteria hospitalization), lung injury (Verbatim: Permanent lung damage) (serious criteria hospitalization) and supraventricular tachycardia (Verbatim: supraventricular tachycardia needing an ablation) (serious criteria hospitalization). The outcome of the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection, lung injury and supraventricular tachycardia to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. The patient had it and after that hospitalized for10 days.  The patient had permanent lung damage and supraventricular tachycardia needing an ablation and now on permanent nocturnal oxygen.  The patient had the vaccine too late. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 RSV vaccine. A case of Respiratory syncytial virus infection, Traumatic lung injury and Supraventricular tachycardia, unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: a patient had been given an Infanrix dose that expired on 13th July 2025; 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 3-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis.   On 31-JUL-2025, the patient received Infanrix. On 31-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: a patient had been given an Infanrix dose that expired on 13th July 2025 ). 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: 31-JUL-2025 Medical assistant called to request information about what to do after a patient had been given an Infanrix dose that expired on 13th July 2025 which led to expired vaccine used.  The dose was given to patient on 31st July 2025.
Age: 53.0
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: started a two-dose pre-exposure series but never received her second dose with no reported ae; Initial information received on 01-Aug-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53-year-old female patient who started a two-dose pre-exposure series of Rabies (HDC) vaccine [IMOVAX Rabies] but never received her second dose with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Jun-2025, the patient received a first dose of 0.5ml of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (lot Y1A8CP1, standard strength, frequency once, and expiry date-28-Feb-2025) via intramuscular route in unknown administration site for Immunization and was to receive  two-doses of pre-exposure series but never received her second dose with no reported ae (routine immunisation schedule not administered).  Reportedly-Patient missed the second dose they wanted to know if they can get the second dose or they need to restart.  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.
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased, Product administered at inappropriate site
Clinical narrative: Mobility issues; Shoulder pain; Needle goes into the tendon instead of the muscle when administering Afluria PFS; This spontaneous case, initially received on 25-Jul-2025, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On an unknown date in 2025, the patient received Afluria (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: No batch number available would be requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date in 2025, the patient experienced Mobility issues (outcome: Not Reported), Shoulder pain (outcome: Not Reported), Needle goes into the tendon instead of the muscle when administering Afluria PFS (outcome: Not Reported).  Healthcare professional (HCP) inquired about any records of adverse events where needle went into the tendon instead of the muscle when administering Afluria Prefilled syringe (PFS). When asked if there was a patient involved in this question, Healthcare professional (HCP states that they are still investigating and event was not yet confirmed; therefore, they did not wish to report any details yet. She mentioned a situation involving a patient who received Afluria 6 months ago and has been experienced shoulder pain and mobility issues. Caller stated that patient was given the 2023-2024 season formula, but mentions that this occurred last winter, in Jan (Sic!). Healthcare professional (HCP stated not knowing the size of the needle and that they were trying to figure out if the needle was long enough to go that deep; also mentions not having that much of clinical knowledge about the situation to share any details  Afluria (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality assessment for the events Mobility issues, Shoulder pain and Needle goes into the tendon instead of the muscle when administering Afluria PFS.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. There is insufficient information regarding events for meaningful causal assessment (events onset dates, temporality, site of vaccination and shoulder pain, route of administration, etc.). Of note, wrong technique in product usage process might be considered as confounding factors for the events occurrence.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Dizziness, Migraine, Photophobia, Pyrexia
Clinical narrative: severe migraine >10, fever, dizziness, loss of depth perception for <10 hours, fever, light sensitivity.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 RNA undetectable
Clinical narrative: severe migraine >10, fever, dizziness, loss of depth perception for <10 hours, fever, light sensitivity.
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Bell's palsy, Facial paralysis, Guillain-Barre syndrome, Muscle spasms, Respiratory disorder
Clinical narrative: patient started having leg cramps, and vomiting about 1 week after vaccine pt went to emergency room first was diagnosed with bell's palsy with one side of his face dropping - patient was not getting better then went to primary care doctor that said go to University and they diagnosed him with Gillian barre syndrome (patient has issues with his face, legs, and breathing )
Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Vomiting
Clinical narrative: patient started having leg cramps, and vomiting about 1 week after vaccine pt went to emergency room first was diagnosed with bell's palsy with one side of his face dropping - patient was not getting better then went to primary care doctor that said go to University and they diagnosed him with Gillian barre syndrome (patient has issues with his face, legs, and breathing )
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Atrophy, Fatigue, Incorrect route of product administration
Clinical narrative: Patient think that administrator gave her with shorter needle with let to SQ.  So she had atrophy on her arm.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Sensitive skin, Swelling face, Tenderness
Clinical narrative: Patient describes spontaneous facial bruising below the right eye with swelling and tenderness.  Additionally, she reports scalp sensitivity.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Swollen tongue, Tongue oedema
Clinical narrative: Reported Symptoms: 10014257:EDEMA TONGUE; 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING; SWELLING OF TONGUE
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Viral infection
Clinical narrative: Reported Symptoms: 10016797:FLU-LIKE SYMPTOMS; Narrative: a 67yo male reported he can't get influenza vaccine due to experiencing severe flu-like symptoms previously. Other Relevant HX: Patient reported had a severe viral illness after flu vaccines. Other: severe flu-like symptom
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDROME; Narrative: A 39yo female reported to physician unable to get flu vaccines due to Guillain-Barre syndrome with prior vaccines. Patient reported had allergies to influenza vaccine back in March, 2017 with no sx listed, then August 22,2022 reported sx of dyspnea when received influenza vaccine. Other Relevant HX: 39yo female reported a severe sx of Guillain-Barre when received influenza vaccine. Looking back to patient history, had also reported allergies to flue vaccine with no specific symptom listed back in March 16, 2017, Then later reported with sx of dyspnea when received influenza vaccine back in August 22, 2022. Other: Guillain-Barre syndrome
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Reported Symptoms: 10016558:FEVER; Narrative: Other Relevant HX: Other: FEVER
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Nausea, Vomiting
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10013573:DIZZINESS; 10028813:NAUSEA; 10047700:VOMITING; Narrative: Other Relevant HX: Other: NAUSEA AND VOMITING; CHEST PAIN; DIZZINESS
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: Reported Symptoms: 10019211:HEADACHE; 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MUSCLE PAIN; HEADACHE; MALAISE
Sex: M
Vaccine: FLUX
Symptoms: Cough, Malaise
Clinical narrative: Reported Symptoms: 10011232:COUGHING; Narrative: a 52yr male with PMH of Allergic Rhinitis, GERD, Asthma, Migraine, Plantar Fascial Fibromatosis, Knee Pain, Shoulder Pain, low Back pain, ED and Exposure to potentially hazardous substance. On February 20, 2025, staff RN @ 17:43 reported the patient had a history of influenza vaccine induced ADR of sever cough. The report included, "he became very sick after taking the Flu vaccine and had not taken the vaccine since 2009." No other information was provided regarding the vaccine and where, when and by who it was administered. Other Relevant HX: Other: COUGH
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10023222:JOINT PAIN; Narrative: Other Relevant HX: Other: JOINT PAIN
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Wheezing
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: per provider note: 72-year-old female who states that at about 9:00 a.m. this morning she got a flu shot and shortly after started having difficulty swallowing. She denies tightness in the chest, shortness of breath or wheezing. She denies inability to handle her own secretions. She denies diffuse itch or rash. Patient presented to ED and was offered treatment with Benadryl IV, steroids but patient refused. Also offered epi, patient refused. Patient's sx improved without treatment while in ED. She had not no respiratory involvement at this time and I believe the difficulty swallowing is probably esophageal/GI. There was no signs of angioedema or airway inclusion. No stridor. The lungs are clear to auscultation all fields and she was moving air well. Other Relevant HX: Other: ANAPHYLAXIS
Sex: F
Vaccine: FLUX
Symptoms: Contraindication to vaccination
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: A 69yo female with PMH of Osteopenia, Environmental Allergies, Osteoarthritis, Breast Cancer, long term use of anticoagulant, Atrial Flutter, Cardiomyopathy, Colonic Polyp and Cerebrovascular Accident s/p Arrhythmia. On February 8, 2025, PCC/WHC attending physician reported the patient had a historical ADR of Influenza vaccine induced Anaphylaxis classified as severe and updated the patient's ADR/Allergy profile. PCC attending physician also added an addendum note regarding influenza vaccine contraindication as "severe reaction in previous dose/contraindicated" No other detailed information was provided regarding reaction treatment, the product, when and where it occurred, who administered the vaccine, vaccine manufacturer, Expiration date, lot number etc. Unable to find on patient immunization profile. Other Relevant HX: Other: ANAPHYLAXIS
Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Myalgia
Clinical narrative: Reported Symptoms: 10025482:MALAISE; 10028322:MUSCLE PAIN; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: MALAISE; MUSCLE PAIN
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: This pharmacist reported that a 40 year old male patient received his first dose of Gardasil on 23-Feb-2024. His next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist  wondered if he has to restart his series.; This spontaneous report was received from a Pharmacist and refers to a 40-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 23-Feb-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, units and route of administration were not reported) lot #W007026, which was confirmed to be valid and the expiration date was verified to be 12-Apr-2024, for prophylaxis.  It was reported that the patient's next doses were to be administered at 2 and 6 months but he did not get them. The pharmacist wondered if he had to restart his series (Inappropriate schedule of product administration).
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reported that a patient received first dose (w014513 exp  1/26/2025) of GARDASIL 9 on 7/18/2024 and the second dose (z018414  exp 12/11/2025) on 7/15/2025.  No additional AEs were reported, no further information provided. No PQC.; no additional adverse event; Information has been received from Business Partner/CRO on 15-Jul-2025.  This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 18-Jul-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #W014513, expiration date: 26-Jan-2025), dose number 1, for an unknown indication. On 15-Jul-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Unknown), dose number 2, (indication and expiration date were not reported) (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
Clinical narrative: two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable.   The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316283).; Reporter's Comments:
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling
Clinical narrative: two patients who received CAPVAXIVE and experienced "swelling at the injection site"; This spontaneous report was received from a field-based employee (FBE) and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) solution for injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date (reported as "recently"), the patient experienced swelling at the injection site. The FBE stated that the physician originally reported it as "cellulitis" but then corrected herself and said "swelling" shortly after. No additional clarification was known by FBE. No additional information was known at that time. At the reporting time, the outcome of swelling at the injection site was not provided. The action taken with the suspect vaccine was assessed as not applicable.   The causal relationship between swelling at the injection site and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) was not provided. Lot # is being requested and will be submitted if received. This is 1 of the 2 reports received from the same reporter (cross-reference with case #2316262).; Reporter's Comments: