chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The child was given 1st dose of Rotateq at 20 months; he is aged out of the recommended time frame.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events noted, parent (mother) stated that he is doing well and denied any side effects.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness and swelling of the injection site the day after receiving the vaccination. Swelling and pain persisting x 2 weeks, slowly improving.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed a sterile abscess, redness, swelling, and hardness at the injection site.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: The incorrect vaccine was scanned and administered to patient on accident
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles the day after receiving the Shingles vaccine/ rash; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for prophylaxis.   Concomitant products included gabapentin.   On 21-JUN-2025, the patient received the 1st dose of Shingrix (unknown arm) and Prevnar. On 22-JUN-2025, 1 days after receiving Shingrix and Prevnar, the patient experienced shingles (Verbatim: Patient developed shingles the day after receiving the Shingles vaccine/ rash). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix and Prevnar.     It was unknown if the company considered the shingles to be related to Shingrix and Prevnar.   Additional Information: GSK Receipt Date: 23-JUN-2025 The patient received the first dose of Shingrix vaccine and developed shingles the day after receiving the Shingles vaccine (Shingrix) as well as the Prevnar vaccine. The Health Care Professional mentioned that patient received the Shingles vaccine and Prevnar vaccine in the same day. The doctor mentioned patient went to urgent care and received Gabapentin after rash presented.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: A 23 years old female patient received a pediatric dose of Engerix-B; A 23 years old female patient received a pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis.   On 23-JUN-2025, the patient received the 1st dose of Engerix B pediatric. On 23-JUN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B) and accidental underdose (Verbatim: A 23 years old female patient received a pediatric dose of Engerix-B). The outcome of the adult use of a child product and accidental underdose 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: 23-JUN-2025 On 23 June 2025 a practice manager called to report that they accidentally administered a pediatric dose of Engerix-B to a 23 years old female adult patient which led to adult use of a child product and Accidental underdose. This was the first dose of Engerix-B for the patient.
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: multiversal experiences of parallel universes; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), 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: THINKING ABNORMAL (non-serious), outcome "unknown", described as "multiversal experiences of parallel universes".  Additional information: That was clarified and confirmed with the caller. Stated he took vaccination back in 2019 he got it from pharmacy. Clarified he got the vaccination Pfizer for corona. Reported he was experiencing multiversal experiences of parallel universes. How long did report take. Declined to report, he was late to therapy at redacted clinic. He might had to call back later. When queried reporter type caller stated they called him Dr. Redacted. He was a quantum theorist. They could contact him on his handler with social media. Caller asked if call handler had got any pym particles.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: went through a round of Paxlovid; went through a round of Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "recovering" and all described as "went through a round of Paxlovid". The clinical course was reported as follows: The patient's wife mentioned herself, her husband and son, had all Pfizer vaccines and updates, last vaccination occurred on Oct2024. The patient got sick with COVID, and he went through a round of Paxlovid. The patient's prescription was filled on 16Jun2025. It was reported the patient felt better and was able to return to work. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue
Clinical narrative: Left arm bone pain; L shoulder pain; weakness; brain fog; fatigue; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jun2025 at 09:45 as dose 01, single at the age of 72 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "exercise intolerance associated with abnormal thyroid levels" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "exercise intolerance" (unspecified if ongoing); "Statins Allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HCTZ. The following information was reported: ARTHRALGIA (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "L shoulder pain"; BONE PAIN (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "Left arm bone pain"; BRAIN FOG (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered"; FATIGUE (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered"; ASTHENIA (non-serious) with onset 18Jun2025 at 08:00, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of bone pain, arthralgia, asthenia, brain fog, fatigue.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient taking other medications within 2 weeks of the event starting. The patient had history of exercise intolerance associated with abnormal thyroid levels, currently within normal limits.
Age: 1.25
Sex: M
Vaccine: PNC20, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Hives; This is a spontaneous report received from a Physician.  A 15-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08May2025 as dose 4, single (Batch/Lot number: unknown) at the age of 15 months for immunisation; varicella zoster vaccine (VARICELLA VACCINE), on 08May2025 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Ear infection" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for ear infection, start date: 05May2025. Vaccination history included: Prevnar 20 (dose 1), for Immunization; Prevnar 20 (dose 2), for Immunization; Prevnar 20 (dose 3), for Immunization. The following information was reported: URTICARIA (medically significant) with onset 09May2025, outcome "recovered" (14May2025), described as "Hives"; RASH (medically significant) with onset 09May2025, outcome "recovered" (14May2025). Therapeutic measures were taken as a result of rash, urticaria. Clinical course: The reporter clarified, it was Pfizer varicella vaccine. It was the one usually given to 15 month olds. The reporter was not the person who gave vaccine to the patient, the pediatrician did. This Pediatrician sent patient to reporter, as allergist, to evaluate what have given this reaction. The reporter was later asked to evaluate if rash was related to the varicella vaccine. The reporter was asking Pfizer how to evaluate whether there was allergy to vaccine and, if the vaccine can be given. The patient was given Zyrtec by the pediatrician for events rash, hives, and, by 14May2025, everything was gone. The reporter clarified that the rash and hives were gone. The seriousness criteria was nothing critical, patient was not in respiratory distress.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: The events rash, and urticaria conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine: COVID19
Symptoms: Cardiac disorder, Discomfort, Heart rate irregular
Clinical narrative: I feel a little bit weird in my heart; feel like I have an issue with my heart; My heart is missing the beat, I did not have this issue before; I do not feel comfortable; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "I feel a little bit weird in my heart; feel like I have an issue with my heart"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "My heart is missing the beat, I did not have this issue before"; DISCOMFORT (non-serious), outcome "unknown", described as "I do not feel comfortable".  Additional information: Consumer stated, when patient had COVID back in the days in 2020. The patient had a very bad COVID and patient did their vaccine (clarified as Pfizer COVID-19 Vaccine) like everyone is supposed to do and patient did vaccine of Pfizer. After a while when the patient did the vaccine the patient felt a little bit weird in my heart. The patient felt like patient had an issue with my heart. The patient went check heart but everything okay back in the days but patient just want to report you again. The patient think patient had issue with heart. The patient heart is missing the beat and patient didn't know what is that really and patient felt it connected to what patient did back in the days when patient took the vaccine because patient did not have this issue before, after patient did the vaccine patient felt like patient had issue with my heart and patient know these are recorded and patient didn't feel comfortable."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.                                                                                                                                                                                                                 .
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: severe pain in hips, shoulder; severe pain in hands; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Jun2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunization; Covid-19 vaccine (dose 2), for COVID-19 immunization; Covid-19 vaccine (dose 3), for COVID-19 immunization; Covid-19 vaccine (dose 4), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Jun2025, outcome "recovering", described as "severe pain in hands"; ARTHRALGIA (non-serious) with onset 16Jun2025, outcome "recovering", described as "severe pain in hips, shoulder". Therapeutic measures were not taken as a result of arthralgia, pain in extremity. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 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: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022; passed away; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): GL-062425-24239.  A 64-year-old patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in 2022 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: DEATH (death) with onset 16May2023, outcome "fatal", described as "passed away"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022". The patient date of death was 16May2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: The consumer reported that her husband had a stroke a few weeks after receiving an unspecified COVID 19 vaccine in 2022. The consumer stated that she knows the vaccine was not Moderna brand.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
Age: 77.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: pink circle around injection site about 2.5 inches wide, itchy
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: likely injection site reaction -- red, warm to touch, patient states the red "circle" appears to have gotten bigger this morning.  Pt states the redness has improved.  Patient very concerned of reaction despite being told injection site reactions are common.  Agreed to submit VAERS report on pt's reaction.  Pt states soreness is no longer present but she did experience "normal" amount of soreness for the day or two following the vaccination.   Encouraged pt to continue monitoring and to try reaching out to doctor if still no improvement seen in the next 24 hours.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot, Syncope
Clinical narrative: Child felt hot, dizzy and fainted ~20 minutes after vaccines administered. Immediately woke up, but went to ER out of an abundance of caution.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Discomfort, Pain, Pain in extremity
Clinical narrative: Patient reports with concerns of lasting pain as a potential side effect of the vaccine in her arm, mentions radiating pain up to the shoulder, and discomfort chronically, but could not give me a lot of details. Urged to follow up with provider and follow up regarding the pain she is experiencing .
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Chills, Feeling cold, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported a small lump on right arm only after getting vaccinate with the Capvaxive vaccine.  On friday 6/27/25, the following day after patient got the vaccine she has fever , chills, feeling cold, and had felt warmth and swelling and a small lump on deltoid area of right arm for one week.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient reported a small lump on right arm only after getting vaccinate with the Capvaxive vaccine.  On friday 6/27/25, the following day after patient got the vaccine she has fever , chills, feeling cold, and had felt warmth and swelling and a small lump on deltoid area of right arm for one week.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Balance disorder, Calcinosis, Cardiomyopathy, Chest pain
Clinical narrative: Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Connective tissue disorder, Dizziness, Dyspnoea, Imaging procedure
Clinical narrative: Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laboratory test, Left ventricular failure, Metabolic acidosis, Pain
Clinical narrative: Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Quality of life decreased, Reactive perforating collagenosis, Rhabdomyolysis, Temperature regulation disorder
Clinical narrative: Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Advanced systolic heart failure , Cardiomyopathy, connective tissue disorder, metabolic acidosis, rhabdomyolysis chronic, calcification of soft tissues, perforating fibrosis multiple systems., system wide inflammation, sob, chest pain, palpitations, neurological issues such as balance, dizziness., extreme pain, I have no quality of life, inability to regulate body temperature, vision issues, akf, clotting issues,
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine given outside of dosing interval. No adverse effects reported
Age: 67.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chills, Erythema, Hyperhidrosis, Peripheral swelling, Pyrexia
Clinical narrative: Pt HAD cellulitis in right arm so she received both vaccinations in the left arm on 06/28 around 1:15pm.  Starting the evening of 06/28, she experienced arm swelling and redness.  On 06/29, she experienced fever, chills, sweating, shaking which lasted about 1 day.  As of today 07/01, she is still experiencing arm soreness and redness.  She has taken advil (which did not help) and Tylenol.  She has also used ice packs and heat.  Referred patient to contact PCP tomorrow for follow up.
Age: 67.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Tremor
Clinical narrative: Pt HAD cellulitis in right arm so she received both vaccinations in the left arm on 06/28 around 1:15pm.  Starting the evening of 06/28, she experienced arm swelling and redness.  On 06/29, she experienced fever, chills, sweating, shaking which lasted about 1 day.  As of today 07/01, she is still experiencing arm soreness and redness.  She has taken advil (which did not help) and Tylenol.  She has also used ice packs and heat.  Referred patient to contact PCP tomorrow for follow up.
Age: 81.0
Sex: F
Vaccine: HEPAB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has left arm soreness in the muscle where the vaccine was given. Patient is having a hard time lifting her arm above her shoulder. There is no swelling, no bruising, and no redness.
Age: 0.75
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a dose of vaccine on 07/01/2025 at 3:00 PM. The patient was checked out at 3:21 PM. At the time of the visit, neither the patient nor the parent expressed any concerns. Following the visit, the physician contacted the parent on 07/01/2025 to discuss any current symptoms and to disclose an error related to the vaccine administered. The parent reported no symptoms or concerns during the call. The physician provided ER precautions and gave the parent specific instructions regarding signs and symptoms of intussusception to monitor for at home.
Age: 73.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt has not reported any adverse effects, however the dose of Arexvy was unnecessary. Patient previously received a single dose of Arexvy on03/24/2024, making this an extraneous dose
Age: 29.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye pain, Headache
Clinical narrative: On Sunday I started to get pain behind my eyes I felt dizzy and I have a headache this has occurred since June 29th at 8 am I received the vaccine on June 27th at 9:00 am
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Confusional state, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Fever, headache, fatigue nausea, vomiting and confusion
Age: 60.0
Sex: F
Vaccine: HEPAB, MMR, PNC21, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient presented to the pharmacy on 6/26/25 to report a suspected reaction following vaccinations received on 6/9/25. She stated that on the morning of 6/10/25, she began experiencing symptoms of itching on her shoulders, back and hips. She also noted the appearance of rash on her skin. The patient reported that she has been taking Pregabalin (Lyrica) which appeared to alleviate some of the itchiness. She indicated that the symptoms have significantly improved since onset but have not completely resolved. The patient no longer has visible rash on her skin when she reported to the pharmacy. She denies any new or worsening symptoms. She did report to her primary care doctor as well.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Crohn's disease, Cystitis, Diarrhoea, Gastrointestinal disorder
Clinical narrative: I got really sick which is not unusual after the vaccine, nauseous vomiting and diarrhea Days later i got a bladder infection that i could not get rid of and that was for 4 months and i was also having GI issues. I got a lot of bad pain in my abdomen. I went to my PCP and told him i had a sharp pain on my left side and my right side and wanted me to get a colonoscopy. While i was working on that a couple months and i ended up going to the hospital because i could not stop vomiting, they sent me home the first time and second time, and the third time they couldn't stopped the vomiting at all and they found out i had a bowl issues and they came back the Chrons, I am 100% positive that it was caused by the vaccine. They ended up doing a bowel obstruction. They removed part of my ilium. I still have stomach issues and they haven't gone away. I reported that i thought i was from the vaccine and i had inflammation and it was like symptoms of a UTI they put me on meds but i had a bad reaction to that. They put me on zofran because things would get stuff in there.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Intestinal obstruction, Malaise, Nausea, Small intestinal resection
Clinical narrative: I got really sick which is not unusual after the vaccine, nauseous vomiting and diarrhea Days later i got a bladder infection that i could not get rid of and that was for 4 months and i was also having GI issues. I got a lot of bad pain in my abdomen. I went to my PCP and told him i had a sharp pain on my left side and my right side and wanted me to get a colonoscopy. While i was working on that a couple months and i ended up going to the hospital because i could not stop vomiting, they sent me home the first time and second time, and the third time they couldn't stopped the vomiting at all and they found out i had a bowl issues and they came back the Chrons, I am 100% positive that it was caused by the vaccine. They ended up doing a bowel obstruction. They removed part of my ilium. I still have stomach issues and they haven't gone away. I reported that i thought i was from the vaccine and i had inflammation and it was like symptoms of a UTI they put me on meds but i had a bad reaction to that. They put me on zofran because things would get stuff in there.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I got really sick which is not unusual after the vaccine, nauseous vomiting and diarrhea Days later i got a bladder infection that i could not get rid of and that was for 4 months and i was also having GI issues. I got a lot of bad pain in my abdomen. I went to my PCP and told him i had a sharp pain on my left side and my right side and wanted me to get a colonoscopy. While i was working on that a couple months and i ended up going to the hospital because i could not stop vomiting, they sent me home the first time and second time, and the third time they couldn't stopped the vomiting at all and they found out i had a bowl issues and they came back the Chrons, I am 100% positive that it was caused by the vaccine. They ended up doing a bowel obstruction. They removed part of my ilium. I still have stomach issues and they haven't gone away. I reported that i thought i was from the vaccine and i had inflammation and it was like symptoms of a UTI they put me on meds but i had a bad reaction to that. They put me on zofran because things would get stuff in there.
Age: 0.75
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received extra dose of vaccine on 26-Jun-2025 with no reported adverse event; Initial information received on 27-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 9 months old male patient who was received extra dose of influenza usp trival a-b subvirion no preservative vaccine [fluzone] on 26-Jun-2025 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jun-2025, the patient received an extra dose of 0.5 ml (dose 3) of suspect influenza usp trival a-b subvirion no preservative vaccine, Suspension for injection (lot UT8496JA, frequency: once, strength: standard and expiry date 30-Jun-2025) via intramuscular route in the left thigh for immunisation with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, Nurse mentioned that patient had received his second dose on 25-Jun-2025 in a different facility, but on 26-Jun-2025, he was given another shot (extra dose).  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: VARZOS
Symptoms: Chills, Nausea, Renal pain
Clinical narrative: had chills and nausea afterwards; nausea; pain in kidney area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUN-2025, the patient received Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: had chills and nausea afterwards), nausea (Verbatim: nausea) and perirenal pain (Verbatim: pain in kidney area). In JUN-2025, the outcome of the chills was resolved. The outcome of the nausea and perirenal pain were not reported.   It was unknown if the reporter considered the chills, nausea and perirenal pain to be related to Shingrix.     It was unknown if the company considered the chills, nausea and perirenal pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a consumer via (shingrix GRC Chatbot) interactive digital media. The patient had the Shingrix vaccine the day before reporting, had chills and nausea afterwards.  Chills were gone, but he/she had sharp pain in kidney area.
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling; This non-serious case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 45-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 09-JUN-2025, the patient received Boostrix. In JUN-2025, less than 2 weeks after receiving Boostrix, the patient experienced swelling arm (Verbatim: Arm swelling). The outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm to be related to Boostrix and Boostrix 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: 17-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter The GlaxoSmithKline Account Manager called to report a Practice Manager mentioning the administration of Boostrix to a patient last week.  GlaxoSmithKline Account Manager did not provide any vaccination date and no patient demographics at all and only provided lot number (no other vaccine detail).  Account Manager requested a call back to the Practice Manager.  Once the call back was successful, the Practice Manager confirmed all the vaccination date, vaccine detail and patient demographics. No Medical Information question or concern arise in this call back.; Sender's Comments:  US-GSK-US2025075892:same reporter /different patient US-GSK-US2025075892:same reporter /different patient
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Patient Was Administered Heplisav-b in Three Doses on 08/22, Again on 06/2024, and Recently on 05/2025; Initial report received on 05-Jun-2025.  A pharmacist reported that a 48-year-old male received three doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  In Aug-2022, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided).  In Jun-2024, one year and ten months after receiving the first dose,  the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided).  In May-2025, 11 months after receiving the second dose , the patient received dose 3 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not provided). The patient was administered three doses of HEPLISAV-B. The patient reported no side effects or adverse reactions.  No additional information was reported.  Company Comment: The  company assessed the events as non-serious.; Sender's Comments: The  company assessed the events as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: What Do We Do With An Interrupted Dosing Schedule. Patient Received First Dose More Than 2 Months Ago ?; Initial report received on 17-Jun-2025.  A nurse reported that a 64-year-old if male (race, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose.  No medical history or concomitant medication were reported.    On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)].  At the time of the report, the patient had not received the second dose yet.  No additional information was reported.   Reporter declined to provide further information.   Company Comment: The  company assessed the event as non-serious.; Sender's Comments: The  company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: We Had A Patient Who Received First dose on 6/10/2024, And Did Not Receive The 2nd Dose; Initial report received on 17-Jun-2025.    A pharmacist reported that a 20-year-old male (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but had not yet received the second dose.   No medical history or concomitant medication were reported.       On 10-Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 943005, expiration date 30-Sep-2025, NDC #, site, and route not available).    At the time of this report, the patient had  not received the second dose yet. The first dose was said to have been administered at a different facility than the reporter's facility.   No additional information was reported.       Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Low platelets; This non-serious case was reported by a consumer via call center representative and described the occurrence of platelets decreased in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis.   On 07-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular use, left deltoid). On 11-JUN-2025, 35 days after receiving Shingrix, the patient experienced platelets decreased (Verbatim: Low platelets). The outcome of the platelets decreased was unknown.   It was unknown if the reporter considered the platelets decreased to be related to Shingrix.     It was unknown if the company considered the platelets decreased to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUN-2025 The reporter was a female patient that stated that she received the first dose of Shingrix on 7th May 2025, and she had blood work done on 11th June 2025 and her platelet count was 141, which was a little below what it should be according to the scale provided by the Lab.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles was reported as worsened/outbreak of shingles; Post herpetic neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (getting shingles since 1996 around once a year.) and post herpetic neuralgia. Previously administered products included Zostavax (in 2016).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was reported as worsened/outbreak of shingles) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the vaccination failure was not reported and the outcome of the shingles and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-JUN-2025 The patient self-reported this case. He stated he had been getting shingles since 1996 around once a year. He stated he received 2 doses Shingrix in 2022, 2 to 6 months apart.  He stated he was currently having an outbreak of shingles that started a few weeks ago. Shingles was reported as worsened. It was a red painful rash on left side of buttocks and outer thigh. He stated he had post herpetic neuralgia. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2)
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Shingrix in 2018 but never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. In 2018, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Shingrix in 2018 but never received the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 25-JUN-2025 The healthcare professional reported a patient received the first dose of Shingrix in 2018 but never received the second dose. Till the time of reporting, the patient did not receive 2nd dose Shingrix vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Vaccine positive rechallenge
Clinical narrative: After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   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 injection site swelling (Verbatim: After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter). Rechallenge with Shingrix was positive. The outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date:23-JUN-2025 Patient has had both doses of Shingrix. The area did swell after dose 2, but it nearly as much.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine (1 month apart); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in the unspecified the number of patients who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On an unknown date, the patients received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine (1 month apart)). The outcome of the drug dose administration interval too short 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: 17-JUN-2025 General Response Center (did not raise an adverse event report) transferred a Nurse Manager that asked that they were following the previous Prescribing Information administering doses one month apart to some of the patients, which led to drug dose administration interval too short. They want to know if the patients have to receive a third dose, a booster, or what should they do? No vaccination date, no vaccine detail and no patient demographics were obtained in this call. No further information was obtained in this call.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: A patient could have potentially received only the adjuvant of Shingrix; A patient could have potentially received only the adjuvant of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) 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 inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix) and inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 On 18th June 2025, an nurse called to report that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available.  It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient
Sex: F
Vaccine: MENB
Symptoms: Underdose
Clinical narrative: An 18 years old female patient received a half dose (0.25 mL) of Bexsero.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number PX7E2, expiry date 30-SEP-2026) for prophylaxis.   Previously administered products included Bexsero (received 1st dose in 2024) and Menactra.   On 23-JUN-2025, the patient received the 2nd dose of Bexsero. On 23-JUN-2025, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: An 18 years old female patient received a half dose (0.25 mL) of Bexsero.). The outcome of the incomplete dose administered was not applicable.   It was unknown if the reporter considered the incomplete dose administered to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the incomplete dose administered to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter reported that on 23rd June 2025 that an 18 year old female patient received a 0.25 mL dose of Bexsero because the patient moved the arm and some of it got wasted which led to incomplete dose administered. The patient received Menactra on 2018. The first dose of Bexsero was administered in 2024. On 23rd June 2025 the patient received the half dose of Bexsero as her second dose. The reporter asked what were the recommendations, should they had to give the full dose.