chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: he got shingles two weeks later and still has it and he; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: he got shingles two weeks later and still has it and he). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-MAY-2025 This case was reported by a reporter via interactive digital media.  Reporter stated that reporter's husband's uncle four years ago, got the shingles shot and he got shingles two weeks later and still had it and he got it bad.
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: mild rash going down my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced rash (Verbatim: mild rash going down my arm). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. The patient got both shots and he/she not sure but had a mild rash going down arm. it was mild he/she glad got the shots.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: accentuated fatigue; pain in injection arm; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue aggravated in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number LT533) for prophylaxis.   On 07-MAY-2018, the patient received the 1st dose of Shingrix. On 07-MAY-2018, less than a day after receiving Shingrix, the patient experienced fatigue aggravated (Verbatim: accentuated fatigue) and pain in arm (Verbatim: pain in injection arm). The outcome of the fatigue aggravated and pain in arm were unknown.   It was unknown if the reporter considered the fatigue aggravated and pain in arm to be related to Shingrix.     It was unknown if the company considered the fatigue aggravated and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2025 The patient experienced pain in arm, with an accentuated fatigue after the first dose of Shingrix.; Sender's Comments:  US-GSK-US2025068287:For 2nd dose shingrix
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: developed rashes on  body around the injection site; developed rashes on body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced injection site rash (Verbatim: developed rashes on  body around the injection site) and generalized rash (Verbatim: developed rashes on body). The outcome of the injection site rash and generalized rash were not reported.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingles vaccine.     It was unknown if the company considered the injection site rash and generalized rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that after 2 weeks of getting second dose of Shingles vaccine had developed rashes on body and around the injection site
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A 31 years old female patient received Priorix IM instead of subcutaneous.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 31-year-old female patient who received MMR (Priorix) (batch number 57DD5, expiry date 01-DEC-2026) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 31 years old female patient received Priorix IM instead of subcutaneous.). The outcome of the subcutaneous injection formulation administered by other route 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: 27-MAY-2025 The reporter reported on 27/MAY/2025 a pharmacist called to report that a 31 years old female patient received Priorix Intramuscular instead of subcutaneous, which led to subcutaneous injection formulation administered by other route.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received first dose of Engerix-B but it was the adult dose instead of the pediatric one; received first dose of Engerix-B but it was the adult dose instead of the pediatric one; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On 28-APR-2025, the patient received the 1st dose of Engerix B adult. On 28-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one) and adult product administered to child (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one). The outcome of the overdose and adult product administered to child were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAY-2025 Registered Nurse explained that 2 patients that were twins received their first dose of Engerix-B but it was the adult dose instead of the pediatric one, which led to overdose and adult product administered to child. On the day of reporting, the patients received their second dose and that one was the correct pediatric dose.  Both patients had the same demographics, even initials for their names.  Lot number and expiration date where the same for the first and second dose. The case was linked with case US2025066874, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2025066874:Same reporter US-GSK-US2025066874:Same reporter,Different patient
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bexsero - second dose before 6 months; 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 a patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero  (received 1st and 2nd dose in the October 2024 to February 2025 timeframe).   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Bexsero - second dose before 6 months). 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: 28-MAY-2025 Health care professional unsure what to do with patients who completed Bexsero series one month apart in the October 2024 to February 2025 timeframe.  Clinic was either made aware or realized dosing change in February 2025.  They want to know if those patients need three doses. The patient received 3rd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccine schedule.
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix and  possible diluent only administration; Priorix and  possible diluent only administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix and  possible diluent only administration) and inappropriate dose of vaccine administered (Verbatim: Priorix and  possible diluent only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine 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: 29-MAY-2025 Pharmacist calls to report suspects the diluent only of the Priorix vaccine was administered to a patient because has 1 vial of the lyophilized portion left with no diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. States has no further information or patient details at the moment of call. The Vaccine Administration Facility is the same as Primary Reporter. The adverse event details were asked and declined because were not available at the moment of call.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Menveo extra dose administration; Menveo extra dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Z9214, expiry date 21-JAN-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received first dose on 03-APR-2019).   On 19-MAR-2025, the patient received the 3rd dose of Menveo. On 27-SEP-2023, the patient received the 2nd dose of Menveo. On 27-SEP-2023, not applicable after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Menveo extra dose administration). On 19-MAR-2025, the patient experienced extra dose administered (Verbatim: Menveo extra dose administration). The outcome of the extra dose administered and extra dose administered were not applicable.   Additional Information: GSK receipt date: 29-MAY-2025 Clinic supervisor wanted to know how to proceed after a patient received an extra dose of Menveo (1 vial).  The patient received three doses in total and given that the patient was already within the 2 to 55 years-old range of age for 1 dose only administration, in reality received two extradoses (one given intentionally and the other inadvertently), which led to extra dose administered. The vaccine administration facility was the same as primary reporter. Only one lot number and expiration date provided (for the third dose).
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose to a pediatric PX; Overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 13-year-old female patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 15-DEC-2025) for prophylaxis.   Previously administered products included Havrix (1st dose received on 26th June 2023).   On 24-MAY-2025, the patient received the 1st dose of Havrix adult. On 24-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Adult dose to a pediatric PX) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 29-MAY-2025 On of our patients well not a patient from us, but we have a mobile unit event, and a young lady was given a Havrix vaccine, the Hep A, she was 13, but she was given the vaccine for 19 and up, which led to adult product administered to child and overdose.  HCP reported that the patient received the Havrix vaccine on 24-May-2025.  Also, they mentioned that the patient had a prior Hep A vaccine in 26-Jun-2023, but they are not sure if this was also Havrix. So, this is the 2nd Hep A dose that the patient receive Also, HCP mentioned that as this was a mobile event, the place where the patient get the dose was in (they didn't provide any specific.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has a patient that apparently had the first dose 5 years ago; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (apparently had the first dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has a patient that apparently had the first dose 5 years ago). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK receipt date: 29-MAY-2025 A physician wants to know the efficacy of Shingrix if the patient waits over a year for their second dose.  She also wants to know when it's recommend it to repeat the two doses.  She mentioned that she had a patient that apparently had the first dose 5 years ago.  She wants to know if she could give this patient the two doses so the patient could have the over the 90 percent efficacy. No further information was provided. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. .
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent; possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) (batch number 7hg2a, expiry date 01-JAN-2026) for prophylaxis.   On 29-MAY-2025, the patient received Priorix. On 29-MAY-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent) and inappropriate dose of vaccine administered (Verbatim: possible improper reconstitution/eceived Priorix reconstituted with Merck's MMR vaccine diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine 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: 30-MAY-2025 Nurse practitioner reported that there was a possibility that a patient might have received Priorix reconstituted with Merck's MMR vaccine diluent one day prior to the reporting date, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. She was still gathering information. No patient details or other information available at this time.
Age: 1.25
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Initial information received on 20-May-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (health care professional).  This case involves a 15 months old and unknown gender patient to whom nurse reconstituted the hib powder portion of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] with an unknown liquid and liquid dtap/ipvportion not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of hib powder portion of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization for patient 15 months old (Immunisation) as nurse reconstituted with an unknown liquid and liquid dtap/ipvportion not administered with no reported adverse event (product preparation error) (single component of a two-component product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA150688:
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of open ipol; temperature of 9.6 degrees C for 11 minutes with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves temperature excursion of open IPV (VERO) [IPOL]; temperature of 9.6 degrees C for 11 minutes with no reported adverse event. No patient's involved.  On an unknown date, the caller reported that an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) had temperature excursion with temperature of 9.6 degrees C for 11minutes with no reported adverse event (product storage error).  Reportedly- extended stability data covers the excursion, There was no previous excursion.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Pain in extremity, Skin warm
Clinical narrative: Area hurt when injected and was sore right then.  The sight was warm and red around the area. ARM WAS PAINFULL FOR 3 DAYS AND RED AT THE AREA WHERE SHOT WAS GIVEN.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Ear infection, Erythema, Pyrexia, Rash, Skin warm
Clinical narrative: On 5/5/25, my 1 year old daughter was administered 12 month shots including the MMR vaccine. She was also diagnosed with a double ear infection and prescribed amoxicillin. On the morning of 5/13/25, small bumps (roughly dime size) erupted on her face, back of the neck, arms and legs. I took her to the doctor; we were told she had a reaction to amoxicillin and to stop taking it. On 5/14/25, the rash had progressively gotten worse and the majority of her body was bright red and warm to the touch; a low grade fever was also observed now. I took her to the doctor; we were told with the progression of the rash and added fever, it was a reaction to the MMR vaccine that roughly 6% of children experience.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain, Swelling
Clinical narrative: I received the shingles vaccine two days ago. Besides pain at the injection site, left shoulder, which was expected, I now have developed swelling and pain just below my left clavicle. I had no trauma or other incident to explain this pain and swelling at this location.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram normal, Gait disturbance, Lymph node pain, Lymphadenopathy
Clinical narrative: I was due for a COVID booster and I didn't get it. All of my lymph nodes are swelling up very large and are painful. My doctor said it was from the COVID vaccine. It's been going on a month this week ?? I can't walk in the late afternoon because it hurts so much. All I can do is sit or lay down to get some relief from it.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I was due for a COVID booster and I didn't get it. All of my lymph nodes are swelling up very large and are painful. My doctor said it was from the COVID vaccine. It's been going on a month this week ?? I can't walk in the late afternoon because it hurts so much. All I can do is sit or lay down to get some relief from it.
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood test, Brain fog, COVID-19, Cough
Clinical narrative: I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Drainage, Dyspnoea, Eye infection, Fatigue
Clinical narrative: I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
Sex: M
Vaccine: COVID19
Symptoms: Ileus, Intensive care, Laboratory test, Limb discomfort, Neuropathy peripheral
Clinical narrative: I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
Sex: M
Vaccine: COVID19
Symptoms: Organ failure, Pancreatitis, Pancreatitis necrotising, Post procedural infection, Renal pain
Clinical narrative: I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I am experiencing long covid systems i believe were caused by the Pfizer Covid vaccine. I received the covid vaccine in fall of 2021 and also the booster shot. i got covid in February 2022. I got pancreatitis on May 2, 2022. All my organs shut down and i was in the ICU for 9 days and suffered multiple illeus and 40 days hospitalized. That lead to necrotizing pancreatitis. After going in for a second opinion, doctors got me into surgery to drain a liter and a half of fluid. a second follow up surgery lead to a infection and my organ attempted to shut down again. After multiple surgeries and infections, i got covid again. One infection penetrated my eye and nearly caused a detached retina. I can no longer see out of my right eye after 56 years. It took over a year to recover, but I continue to have a cough from covid. I have had multiple blood tests and body function tests since then. I am experiencing dizziness, cough, tinnitus, neuropathy, kidney pain, shortness of breath, brain fog and the most unexplained side effect of bouts where i randomly feal completely exhausted. My legs feel like they weigh a hundred pounds. No doctor has been able to explain it. My GI doctor says it is not from the pancreatitis or enzyme deficiency. My endocrinologist can't explain it. My family doctor has done several tests and they can't figure it out. I was relatively healthy before getting this vaccine. Now i have these side effect symptoms that can't be explained. More studies need to be done on these side effects and this vaccine reevaluated.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Abnormal dreams, Chills, Dizziness, Influenza like illness, Myalgia
Clinical narrative: I had a RSV vaccination yesterday, 5/31/2025. Last night I had a severe side effect, flu type syndrome, which I woke up in the middle of the night to find my body shivering and trembling badly, muscle aches also. Immediately I pulled a comforter to cover me and it took perhaps 10 minutes for my body to calm down. I could not sleep for a long time, even when I fell asleep eventually I had some king of dream over and over again, which had the same symptoms as I got flu or severe cold. This morning I felt light-headed and had to lie down most of time to ease the problems.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Sleep disorder, Tremor
Clinical narrative: I had a RSV vaccination yesterday, 5/31/2025. Last night I had a severe side effect, flu type syndrome, which I woke up in the middle of the night to find my body shivering and trembling badly, muscle aches also. Immediately I pulled a comforter to cover me and it took perhaps 10 minutes for my body to calm down. I could not sleep for a long time, even when I fell asleep eventually I had some king of dream over and over again, which had the same symptoms as I got flu or severe cold. This morning I felt light-headed and had to lie down most of time to ease the problems.
Age: 0.08
Vaccine: RVX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of ROTATEQ earlier than recommended schedule; a patient was administered their first dose of ROTATEQ today, 5/8/2025, at the age of 5 weeks and 3 days old; This spontaneous report was received from a medical assistant and refers to a 5-week-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 08-May-2025, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 mL (2 mL / three dose series) (lot # and expiration date were not reported) for prophylaxis, which was earlier than the recommended age of 6 weeks old as stated on the patient information (PI) leaflet (product administered to patient of inappropriate age). The Medical Assistant confirmed there have been no reports of the patient experiencing any medical concerns or symptoms after being administered the dose of the suspect vaccine earlier than recommended schedule (no adverse event). Consent granted for correspondence. No additional information provided. Lot # is being requested and will be submitted if received.
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist calling with a report of an adverse event regarding GARDASIL 9.  Pharmacist stated that a patient's schedule was interrupted after their first dose was administered in 2022 and did not complete the vaccination series as recommended.  Phar; the patient has not reported any medical concern regarding interruption in their series of Gardasil 9; 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 an unknown date in 2022, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), 0.5 mL (route of administration, lot # and expiration date were not reported) for prophylaxis, however, the patient did not continued the vaccination schedule (inappropriate schedule of product administration). No adverse event was reported.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No symptoms reported.; 47 year old male patient received an expired does of RECOMBIVAX HB 0.5ml, lot X026485; HCP called to report an AE for RECOMBIVAX HB.  Caller reported that a 47 year old male patient received an expired does of RECOMBIVAX HB today, 5/29/2025.    Caller reported that dose expired 5/11/2025.  Potency of the dose was supported by the Post; This spontaneous report was received from a Pharmacist and refers to a 47-year-old male patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 29-May-2025, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) Injection (lot #X026485, expiration date: 11-May-2025) 0.5 mL administered by Unknown route as prophylaxis.  Potency of the dose was supported by the Post Expiry Memo. No symptoms reported. No additional AE/PQC.
Sex: F
Vaccine: HEP
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swollen Joints; Swollen Feet; Swollen Fingers; Initial report received on 06-May-2025.    A consumer reported that she, a female (age, race, and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced swollen feet, fingers, and joints.    Medical history included psoriatic arthritis. No concomitant medications were reported at the time of vaccination.   On 26-Apr-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot # 945665, expiration date, NDC #, route, and site not available).  On an unknown date,  a few days after receiving HEPLISAV-B, she experienced swelling in the feet, fingers, and joints.    No additional information was reported.    Company Comment: he company assessed the events as non-serious.; Sender's Comments: he company assessed the events as non-serious.
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive
Clinical narrative: nowi have a positive ANA/serious reaction to their vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of antinuclear antibody positive in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced antinuclear antibody positive (Verbatim: nowi have a positive ANA/serious reaction to their vaccine) (serious criteria other: serious as per reporter). The outcome of the antinuclear antibody positive was not resolved.   It was unknown if the reporter considered the antinuclear antibody positive to be related to Shingles vaccine.     The company considered the antinuclear antibody positive to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient had a serious reaction to their vaccine and when the patient tried to report it their web site was so encrypted that the patient could report it and no one ever called him/her.  Now the patient had a positive ANA and won't ever take another vaccine and said but you can make your own decisions.; Sender's Comments: Antinuclear antibody positive is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 6months old patient; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5h95b, expiry date 16-FEB-2026) for prophylaxis.   On 05-MAY-2025, the patient received the 1st dose of Kinrix (right thigh). On 05-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 6months old patient). The outcome of the inappropriate age at vaccine administration 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: 05-MAY-2025 Other Health Professional reported that Kinrix was administered to a 6months old patient , which led to Inappropriate age at vaccine administration.
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Skin disorder, Vaccination failure
Clinical narrative: Suspected vaccination failure; Suspected shingles; Kinds of skin problems; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Suspected shingles) and skin disorder (Verbatim: Kinds of skin problems). The outcome of the vaccination failure was not reported and the outcome of the shingles and skin disorder were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and skin disorder to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and skin disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Patient reported that vaccine was as bad as the Covid vaccine, patient's  doctor made them get it before Covid and then when they got the Covid vaccines they thought they were going to die. Patient had all the symptoms of shingles? At the time of reporting patient had all kinds of skin problems. Also indicated that too many vaccines. It was unknown if reporter considered the COVID vaccine to be related to shingles and skin problems. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (Insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given 1 year later from the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given 1 year later from the first dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 28-MAY-2025 The reporter reported that someone had received only one dose of Shingrix and had forgotten to take the second dose within the recommended 2 to 6 month window, but instead received the second dose one year after the first. The reporter had a question if they need to restart the two-dose series. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Vaccine: VARZOS, VARZOS
Symptoms: Nerve injury
Clinical narrative: nerves are permanently damaged; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced nerve damage (Verbatim: nerves are permanently damaged). The outcome of the nerve damage was not reported.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the nerve damage to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The patient took both of those and no relief. He/she assuming nerves were permanently damaged and he/she would have to live with this the rest of life.  The patient even had steroid injections and no relief from that either.
Vaccine: VARZOS
Symptoms: Bone pain, Myalgia
Clinical narrative: For 3 days after my muscles and bone's ached; For 3 days after my muscles and bone's ached; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, 3 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: For 3 days after my muscles and bone's ached) and bone pain (Verbatim: For 3 days after my muscles and bone's ached). The outcome of the muscle pain and bone pain were not reported.   It was unknown if the reporter considered the muscle pain and bone pain to be related to Shingrix.     It was unknown if the company considered the muscle pain and bone pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. Three weeks ago patient received the 1st of two Shingrix shots with the second due in 6 months. The patient know a few friends that suffered for months after getting shingles, they encouraged to get the shots . For 3 days after my muscles and bone's ached but that was unusual and the patient understood . The patient was glad for started with the shots.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the shot in the last two years and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine