chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Endotracheal intubation, Facial paralysis, Fatigue, Feeling abnormal
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Gait inability, Headache, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Magnetic resonance imaging head normal, Pain in extremity, Pneumonia aspiration, Respiratory disorder
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Unresponsive to stimuli, Visual impairment, Walking aid user
Clinical narrative: After her second injection she immediately stated that the arm she received the injection in started with unbearable pain, then terrible headache later that night. The next day was having breathing issues, had to call the rescue squad, told her to go to the hospital, became unresponsive, had to intubate her, stayed for several nights, then discharged her with adverse reaction to the vaccine, one doctor admitted it, after discharge fatigued, respiratory , vision started changed, got pneumonia in the hospital but they said was aspiration pneumonia, took a long time to see specialists like pulmonologist, 3 weeks Dec 4 visiting the mom, looked like having a stroke, went to the hospital, was stuttering really badly, started left face drooping, was fine that morning, out with her kids, went to put something in the garbage, lost her balance and realized she was not ok, felt dizzy, her grandma helped her then mouth started going numb, then couldn't talk or write, looked spacy, failed the test for a stroke, by the time she got to the hospital, couldn't recognize objects, they gave her TPA to flush out a blood clot, transferred to another hospital. Later that morning starting talking a little better, did an MRI and that was normal, says didn't have a stroke, they tried to discharge her before they even tried to get her to walk, realized she couldn't walk, Tuesday they brought her a walker and discharged her to home, dx'd with conversion disorder, Mom had to fight for her to get better care, due to lack of insurance coverage in spite of working for the federal government.  once they realized things changed completely, they assumed she didn't have any coverage.  Then got her PT, then stayed two more weeks, no PT though only when the requesting facility were asking for the PT notes but there were none, psychiatry came and talked to her.  She says her speech was worse so hard to advocate for herself.   After discharge saw two psychiatric doctors outside the hospital, they said she had depression and anxiety but only developed this due to the treatment, she says they never requested her previous records from when she was intubated, wasn't depressed then but now is depressed. Says then was still hopeful because she didn't understand the magnitude of what happened. The whole left side is in pain, the stuttering comes and goes but worse when anxious, angry,  or tired, doing speech therapy, learning to slow down,  Since then went to neurology who is calling it conversion disorder, has found now there are cases like hers with the same side effects. They are new to the area, found a new PCP but they never touched her after 3 visits. mom kept having to ask for help but no referrals made, the doctor only gave a few weeks off with no restrictions, doing PT, OT, ST, went to ortho who says she looks like a stroke but he felt like he couldn't go over the Neuro or PCP, needs to do EMG test prior to her next MRI.
Age: 36.0
Sex: F
Vaccine: PNC21
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; A HCP called to report a TE for CAPVAXIVE. The HCP stated that sometime during 06/27/2025 through 07/09/2025 the CAPVAXIVE was exposed to a minimum temperature of 0C and a maximum of 9C, but the HCP was unable to confirm when the excursions occurred; Information has been received from Business Partner/CRO on 09-Jul-2025.  This spontaneous report was received from an Other health professional and refers to a 36-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 30-Jun-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Z002626, expiration date: 04-Sep-2026) 0.5 mL for an unknown indication. This vaccine was exposed to a minimum temperature of 0 degree Celsius and a maximum of 9 degree Celsius (Improper storage of product in use). No additional adverse event was reported.; Reporter's Comments:
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Aspiration joint, Blood test, Cardiac failure, Computerised tomogram, Condition aggravated
Clinical narrative: heart failure exacerbation; This spontaneous report was received from a physician and refers to a 56-year-old male patient. The reporter stated that the patient was a Clinical Study participant enrolled in clinical trial for "GARDASIL 9" (however, no information regarding the study was reported). The patient's medical history was not reported. As concurrent conditions was reported "history" of heart failure. Concomitant therapies were not reported (discrepant information also reported that the patient "running out of medication" an unspecified medication).   On 21-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y019459, expiration date: 16-Feb-2027), dose number 1, (First Dose) (anatomical location and administration route were not reported) as prophylaxis.  On 07-Jul-2025 (reported as "after a couple of weeks"), the patient experienced heart failure exacerbation. The reporting physician stated that patient was then admitted to the hospital on the same date 07-Jul-2025 for heart failure exacerbation due to "running out of medication". The reporter did not provide name of medication. During the hospitalization, some laboratory tests were performed (Aspiration of joint, blood work, X-Ray and computerized (CT) scan) but results were not provided. The patient recovered from the event on 11-Jul-2025 and was discharged from hospital on the same date. The physician stated that the event did not seem to be linked to vaccine with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and categorized the heart failure exacerbation as serious, however reiterated the hospitalization appears to be due to running out of medication and not linked to vaccine.; Sender's Comments: Based on the clinically relevant information currently available for this individual case, the reported event of cardiac failure is considered unlikely related to the GARDASIL 9 vaccine. The evidence is not sufficient to suggest a relationship between the vaccine and the reported serious adverse event. The causality assessment is impacted by the confounding factors of the patient's concurrent condition of heart failure and the mentioned etiology of exacerbation as being out of medication. No changes to the product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: X-ray
Clinical narrative: heart failure exacerbation; This spontaneous report was received from a physician and refers to a 56-year-old male patient. The reporter stated that the patient was a Clinical Study participant enrolled in clinical trial for "GARDASIL 9" (however, no information regarding the study was reported). The patient's medical history was not reported. As concurrent conditions was reported "history" of heart failure. Concomitant therapies were not reported (discrepant information also reported that the patient "running out of medication" an unspecified medication).   On 21-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y019459, expiration date: 16-Feb-2027), dose number 1, (First Dose) (anatomical location and administration route were not reported) as prophylaxis.  On 07-Jul-2025 (reported as "after a couple of weeks"), the patient experienced heart failure exacerbation. The reporting physician stated that patient was then admitted to the hospital on the same date 07-Jul-2025 for heart failure exacerbation due to "running out of medication". The reporter did not provide name of medication. During the hospitalization, some laboratory tests were performed (Aspiration of joint, blood work, X-Ray and computerized (CT) scan) but results were not provided. The patient recovered from the event on 11-Jul-2025 and was discharged from hospital on the same date. The physician stated that the event did not seem to be linked to vaccine with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and categorized the heart failure exacerbation as serious, however reiterated the hospitalization appears to be due to running out of medication and not linked to vaccine.; Sender's Comments: Based on the clinically relevant information currently available for this individual case, the reported event of cardiac failure is considered unlikely related to the GARDASIL 9 vaccine. The evidence is not sufficient to suggest a relationship between the vaccine and the reported serious adverse event. The causality assessment is impacted by the confounding factors of the patient's concurrent condition of heart failure and the mentioned etiology of exacerbation as being out of medication. No changes to the product safety information are warranted at this time. Merck Sharp & Dohme LLC continues to monitor the safety profile of the product
Age: 77.0
Sex: M
Vaccine: FLU3, PNC21, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: passed out at home next day per daughter
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Pruritus, Urticaria
Clinical narrative: I received a COVID-19 booster shot on July 8, 2022, in preparation for international work travel. Approximately two weeks later, on July 22, 2022, I began experiencing a severe allergic reaction characterized by hives and intense itching. The hives would appear in random locations?such as my forearms, neck, back, legs, and palms?and move unpredictably across different areas of my body.  The itching was severe enough to cause skin damage from scratching and rubbing. I initially tried over-the-counter Benadryl, which provided symptom relief, but the drowsiness made it unsuitable for use during work hours. I then began using Allerease (OTC fexofenadine), which I purchased on the military base. This medication effectively controlled the symptoms; however, missing a single dose caused the hives and itching to return immediately.  This condition has persisted for approximately three years. Since August 2022, I have taken fexofenadine daily, rarely missing a dose, due to the recurrence of symptoms upon interruption. The reaction has significantly impacted my daily comfort and quality of life.  Two coworkers also received the booster shot. One received the same vaccine batch on the same day, at the same location, by the same nurse, and developed similar symptoms. The other coworker, vaccinated on a different day, did not experience any adverse effects.  Upon returning from travel, I consulted my primary care physician, who:  Prescribed a 90-day supply of fexofenadine with multiple refills which I have renewed multiple times  Provided a VAERS form and instructed me to fill it out and return it  Ordered allergy testing I was told I would be contacted regarding my VAERS submission, but I have not received any follow-up. I was also informed the reaction could be either a vaccine-related adverse event or a dust allergy, though no definitive diagnosis has been made.  To this day, I remain dependent on daily antihistamines to control the ongoing symptoms.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: MA inadvertently gave a dose of 0.25 ml of the covid 19 vaccine (6m-11y) instead of 0.5 ml of the covid vaccine 12y and older (Spikevax)
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy administered to pregnant women; healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women; This non-serious prospective pregnancy case was reported by a other health professional via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to pregnant women) and product use in unapproved population (Verbatim: healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 16-JUL-2025 The health care professional reported that the Arexvy vaccine administered to pregnant women, which led to vaccine exposure during pregnancy and contraindicated product administered. The healthcare system decided to switch from Arexvy to Abrysvo due to some instances where Arexvy was administered to pregnant women.   She had no other details about these administrations.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient received Bexsero inadvertently, the patient was supposed to receive Menveo; This non-serious case was reported by a nurse and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 55N34, expiry date 30-SEP-2027) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-JUL-2025, the patient received Bexsero. The patient did not receive Menveo. On 17-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient received Bexsero inadvertently, the patient was supposed to receive Menveo). The outcome of the wrong vaccine administered 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-JUL-2025 The reporter stated that a patient received Bexsero inadvertently, the patient was supposed to receive Menveo, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient got shingles after receiving immunization; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got shingles after receiving immunization). 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUL-2025 Patient got shingles after receiving immunization. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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.
Sex: F
Vaccine: HEP, HIBV, HIBV, PNC13, TDAP
Symptoms: Paralysis
Clinical narrative: had like a type of palsy after vaccinations; This serious case was reported by a consumer via other manufacturer and described the occurrence of paralysis in a 15-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis, Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for prophylaxis and HIB vaccine conj (tet tox) (Act hib) for prophylaxis.   On an unknown date, the patient received DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib. On an unknown date, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib, the patient experienced paralysis (Verbatim: had like a type of palsy after vaccinations) (serious criteria GSK medically significant and other: Medically Significant). The outcome of the paralysis was unknown.   The reporter considered the paralysis to be related to DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib.     The company considered the paralysis to be unrelated to DTPa vaccine, Hepatitis B vaccine and Hib vaccine. The company considered the paralysis to be related to Prevnar 13 and Act hib.   Additional Information: GSK receipt date: 15-JUL-2025 The reporter reported that the patient who experienced a reaction that resembled a type of palsy after receiving the pneumococcal vaccine CONJ 13V (CR M 197) Prevnar 13, hepatitis B vaccine, HIB (PRP/T) Vaccine (ACT-HIB), and Diphtheria toxoid, Pertussis acellular, Tetanus toxoid vaccine (DTaP). The patient's past medical history, medical treatments, vaccinations, and family history were not provided. The patient received an unknown dose of the suspect HIB (PRP/T) vaccine (powder and solvent for solution for injection), an unknown dose of hepatitis B vaccine produced by an unknown manufacturer via an unknown route and administration site, an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via an unknown route and administration site, and an unknown dose of DTaP not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date, and lot number not reported for all) via an unknown route and administration site, all for immunization. The reporter reported that on an unknown date, the patient developed a reaction that resembled a type of palsy (paralysis) with unknown latency. The patient was followed by an allergist, who suspected that an egg or animal component might have caused the episode. The caller was unable to clarify the palsy further, including its location on the body. It was not reported whether the patient received corrective treatment for the event. At the time of reporting, the outcome was unknown for the event.; Sender's Comments: A case of Paralysis, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine and Hib vaccine, in a 15-month-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUL-2025 This case was reported by a consumer via interactive digital media. The patient took Shingrix and 2 months later got Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule,and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix .
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Erythema, Pain
Clinical narrative: localized reaction of redness; localized reaction of pain; gave a patient a Kinrix and a Pediarix at the same time; were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 06-NOV-2024, the patient received the 4th dose of Pediarix and the 3rd dose of Kinrix. On 06-NOV-2024, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: gave a patient a Kinrix and a Pediarix at the same time) and inappropriate schedule of drug administration (Verbatim: were the 3rd dose of Kinrix and 4th dose of Pediarix of the patient in the DTap series). On an unknown date, the patient experienced localized erythema (Verbatim: localized reaction of redness) and pain localized (Verbatim: localized reaction of pain). The outcome of the localized erythema and pain localized were resolved and the outcome of the overdose and inappropriate schedule of drug administration were unknown.   It was unknown if the reporter considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device.     It was unknown if the company considered the localized erythema and pain localized to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix 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: 06-NOV-2024 and 23-DEC-2024 The medical assistant reported that they gave a patient a Kinrix and a Pediarix at the same time and according to reporter, the doses were the 3rd and 4th doses of the patient in the DTap series, which led to overdose and inappropriate schedule of drug administration. The patient may had more localized reaction of redness or pain but that patient would be fine and no follow-up was needed. The Vaccine Administration Facility was the same as Primary Reporter
Age: 66.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect route of product administration
Clinical narrative: Twinrix subcutaneous administration;  This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old male patient who received HAB (Twinrix) (batch number P2334, expiry date 18-SEP-2027) for prophylaxis.   On 10-JUL-2025, the patient received Twinrix (unknown arm). On 10-JUL-2025, an unknown time after receiving Twinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Twinrix subcutaneous administration). The outcome of the intramuscular 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: 10-JUL-2025 The health care provider wanted to know how to proceed after a patient had received Twinrix administered subcutaneously, instead of intramuscularly, with a rather long needle in the arm, which led to Intramuscular formulation administered by other route.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received a 1st dose of Engerix-B 2 months ago, she is late for her second dose/missed 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 55-year-old female patient who did not receive HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 7th May 2025, Batch number: 4BX39 and Expiry date: 29-JUL-2027).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. The patient experienced incomplete course of vaccination (Verbatim: received a 1st dose of Engerix-B 2 months ago, she is late for her second dose/missed dose). The outcome of the incomplete course of vaccination 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-JUL-2025 The reporter called to know how to proceed for a second late dose of Engerix-B. Patient was coming on 17th July 2025 to receive her second dose. The reporter wanted to know when they could administer the third dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Foaming at mouth, Head injury
Clinical narrative: 8 hours later, patient was on the floor in his bedroom/and he fell; hit his head; foaming at the mouth; This spontaneous case was reported by a consumer and describes the occurrence of FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth). At the time of the report, FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) outcome was unknown.            No concomitant medication was reported. The patient had taken their second Moderna shots. 8 hours later, he was on the floor in his bedroom, foaming at the mouth, and he fell and hit his head. Then rushed to the hospital. Battery test was performed, and they saw nothing. He never went back for another shot. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 24-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:Master case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza like illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had extreme fatigue; Flu like run down mild, very mild symptoms; Got Covid in 21SEP2024; Got Covid in 21SEP2024; This serious initial Spontaneous report was received by Novavax on 16-May-2025 from a Consumer or other non-health professional via Novavax Medical Information (MI number NOV25- 00329).   A 65-year-old Female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (LOT: 5683_MF012) on 26-Oct-2023.  The following medical history was reported: COVID (on 04-Apr-2022 and 10-Feb-2023).   No concomitant medications were reported.  On 26-Oct-2024, the same day after vaccination the patient "Got Covid in 21SEP2024" (Vaccination failure) (Serious: Other Medically Important Condition) (COVID-19). On 21-Sep-2024, 332 days after vaccination, the patient "Got Covid in 21SEP2024" (COVID-19).  On an unspecified date after vaccination the patient experienced extreme fatigue (Fatigue), and Flu like run down mild, very mild symptoms (Influenza like illness). On an unspecified date after vaccination the patient experienced I had extreme fatigue(Fatigue), and Flu like run down mild, very mild symptoms(Influenza like illness).  Treatment included Paxlovid (nirmatrelvir/ritonavir).   Relevant lab tests included: COVID-19 TEST (Result: Positive, Test Date: 04-Apr-2022), COVID-19 TEST (Result: Positive, Test Date: 10-Feb-2023) and COVID-19 TEST (Result: Positive, Test Date: 21-Sep-2024).  At the time of reporting, the event outcome of Vaccination failure was Recovered/Resolved while the event outcome of Fatigue, Influenza like illness, and COVID-19 was Unknown.; Sender's Comments: This 65-year-old Female experienced Fatigue, Influenza like illness, Vaccination failure and COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Vaccination failure was reported as serious.  The events COVID-19, Fatigue, and Influenza like illness were reported as non-serious.  Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Vaccination failure, COVID-19, Fatigue and Influenza like illness is considered Possible.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal". It was unknown if therapeutic measures were taken as a result of myocarditis. The patient date of death was unknown. Reported cause of death: "myocarditis". It was not reported if an autopsy was performed.  Additional information: It is Unknown if other vaccine same date, if other vaccine in four weeks,  if other medications in two weeks. Covid vaccine caused myocarditis and death. AE resulted in: Patient died. if autopsy performed: Unknown. If treatment received: Unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: myocarditis
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (unspecified if ongoing); "kidney" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient had just expressed that they did take the vaccine, the Pfizer shots (Clarified as Pfizer Covid-19 Vaccine) and have taken the medication (clarified as Paxlovid) before. When probed to clarify if patient had covid again after getting the medication and vaccine, transferring agent stated, "Yes." Age adverse event(s) started: Consumer stated, "I am 69. When I had it before it was last year, I was 67. I am 69 now, 67."(Age at the time of AE was not clarified appropriately. Hence, not captured in tab). Consumer is being prescribed to Paxlovid again. Consumer stated, "I did not take the vaccine earlier, I took the vaccine after I completed the pack and went back to work. I took the vaccine during the Covid. During the covid, I did take the Pfizer vaccine." Consumer stated, "The only other thing that they gave is cough syrup, that's it." Other medical conditions and concomitant medication: patient took take a cholesterol and kidney pill. Indication: patient tested positive. One of the kids at her daycare took the test on Thursday and they call me back on Friday and told her tested positive and that they were sending a prescription for the cough syrup and the Pfizer pack. When probed to clarify if consumer had not taken the Covid-19 shot before, consumer stated, "Yes, I have. I had it in my right arm. I take it when they first start giving the shot. I have had it one time at the 'first of' year at the pharmacy where I am going to pick my medication. The other vaccine that I took was the Flu Vaccine (Unspecified Flu Vaccine).(pending clarification).
Sex: M
Vaccine: HIBV
Symptoms: Epilepsy
Clinical narrative: epilepsy; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional.  This case linked to US-SA-2025SA209519, US-SA-2025SA209950 and US-SA-2025SA209519  This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel), Polio vaccine inact 3v (Vero) (Ipol)  and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) all for prophylactic vaccination (Immunisation).  On an unknown date in 2017, the patient received an unknown dose (dose 1) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   On an unknown date, the patient received an unknown dose (dose 2) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   On 18-Sep-2018, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot U1915AA, strength: standard and frequency: once) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation).  On an unknown date in Nov-2017, the patient developed epilepsy (Latency: few days to few months approxmately) following the administration of (dose 1) of suspect HIB (PRP/T) vaccine [ACT-HIB].  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.  Seriousness criteria: This event was assessed as medically significant; Sender's Comments: Sanofi company comment dated 23-Jul-2025: This case involves a 5 months old male patient who had epilepsy after receiving HIB (PRP/T) vaccine [ACT-HIB]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed US-SA-2025SA209519:pentacel US-SA-2025SA209950:ipol US-SA-2025SA209519:daptacel
Age: 23.0
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule with no reported adverse evenf; Initial information received on 21-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 23 years old and unknown gender patient who had second dose of  Rabies (Hdc) Vaccine [Imovax Rabies] was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule 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 suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule with no reported adverse event (inappropriate schedule of product administration) (latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence  Reportedly, a patient was supposed to receive a 3-dose series of IMOVAX. Their second dose was supposed to be given on the 7th day, but there was a delay, and the patient was administered of their second dose 2 weeks after their supposed schedule.  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.