chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: 90 percent bed ridden; unable to walk; unable to function; balance issues; Guillain-Barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant and other: Serious as per reporter), bedridden (Verbatim: 90 percent bed ridden), unable to walk (Verbatim: unable to walk), performance status decreased (Verbatim: unable to function) and balance difficulty (Verbatim: balance issues). The outcome of the guillain barre syndrome was unknown (duration 2 days) and the outcome of the bedridden, unable to walk, performance status decreased and balance difficulty were not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the bedridden, unable to walk, performance status decreased and balance difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date : 09-MAR-2025 This case was reported by a patient via interactive digital media. Patient developed Guillain-Barre syndrome (GBS) after receiving the first shingles shot.  As a result, she was 90 percent bedridden, unable to walk or function.  She had to re-learn to walk, dealing with balance issues, and it was a long three year journey.  Her physician had recommended the vaccine after she recovered from shingles to prevent a recurrence, but the vaccination was worse and caused nerve damage. she should have never taken the shot.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Dementia, Extra dose administered
Clinical narrative: accidentally administered a third dose of Shingrix on March 4th 2025; suffered from dementia; This serious case was reported by a pharmacist via call center representative and described the occurrence of dementia in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 04-MAR-2025, the patient received the 3rd dose of Shingrix. On 04-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally administered a third dose of Shingrix on March 4th 2025). In MAR-2025, the patient experienced dementia (Verbatim: suffered from dementia) (serious criteria GSK medically significant). The outcome of the dementia was not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the dementia to be related to Shingrix.     The company considered the dementia to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2025 The patient was accidentally administered a third dose of Shingrix, which led to extra dose administered. The reporter mentioning that the patient suffered from dementia and that they were experiencing undisclosed adverse events.  The vaccine administration facility was the same as primary reporter.; Sender's Comments: Dementia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: PNC20
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: Felt kind of abnormal; Breaking out in hives; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt kind of abnormal "; URTICARIA (non-serious), outcome "unknown", described as "Breaking out in hives". Additional information: the patient stated, "I got a pneumonia shot on Friday and I am 62. So, I did not get the one for 65 and above and I felt kind of (redated) over the weekend which you know okay, but now I am breaking out in hives." The patient described the vaccine as "it's pneumonia, for pneumonia." The patient was 'under impression' it was the Pfizer vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: The patient tested positive for Flu A; Vaccination failure; This spontaneous case, initially received on 28-Feb-2025, was reported by a non health professional and concerns a female patient.  Medical History and concomitant medication were reported as unknown. There was no allergy information reported.  There was no product complaint associated with this case.  Administration of company suspect drug: On 02-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease., Dose Regimen: Not reported, Route of administration: Not reported, Anatomical location: Right Deltoid, Lot number: 946624.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Feb-2025, The patient tested positive for Flu A (Medically Significant, outcome: Unknown). On an unknown date in 2025, the patient had Vaccination failure (Outcome: Not reported)  On 22-Feb-2025, the patient went to urgent care where she tested positive for Flu. She was given the flu shot at work. Flu was not verified by nasal swab. Back to work by 25-Feb-2025. Didn't know how she got this, no one in the family had the flu.  Flucelvax (TIV) action taken: Not Applicable Treatment measures associated with event was reported as unknown.  Reporter's assessment:  The reporter assessed the seriousness as unknown and causality assessment was not reported for event The patient tested positive for Flu A. The reporter did not provide the seriousness and causality assessment of the event Vaccination failure.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the events are considered related for reporting purposes.  For influenza and vaccination failure, patient tested positive within 21 to 180 day time period. Furthermore, A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3, RSV, VARZOS
Symptoms: Expired product administered
Clinical narrative: This was a vaccine administration error. The patient did not report any adverse effects. The dose of Shingrix administered 11/8/2024 was the patient's 3rd dose of Shingrix. The series was completed by the facility, who did not report administered vaccines to the Immunization Electronic Registry System at the time of this error.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient had a rash and itching and was very painful and red and swollen patient apply Benadryl cream and took acetaminophen symptoms for about 10 days and has gotten better
Age: 0.58
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patient given adult Havrix 1440 Elisa units/dose (hepatitis A vaccine) by GSK for hepatitis A vaccine. Patient was to receive dose of pediatric Hepatitis A vaccine  (Havrix 720 Elisa units/dose by GSK).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Within 10 minutes of administration, patient experienced tingling in arm and on tongue, headache, and nausea.  Sensation on tongue diminished, but then lips started tingling .  Patient had a sip of water and walked around a bit, then staff was notified.  Slight headache persisted as did nausea and arm felt cold.  Patient was offered benadryl, but initially declined.  Stated odd sensation at back of throat subsiding, no difficulty breathing or throat closing down.  Legs felt weak .  When offered benadryl again, patient agreed and received 10 ml of the dye free childrens liquid (25 mg dose.)  Patient was told to check with her physician before receiving the next dose. Patient stayed in waiting room for a bit longer, then did some shopping in the store.  Patient checked back with the pharmacy to inform staff she felt well enough (not impaired) and was going to go home.  Patient was given the bottle of liquid Benadryl at no charge to have on hand.  A little after 1 pm, the pharmacist called the patient at  home and was informed patient arrived safely home and was feeling much more "like normal."  The patient did not feel strongly either way about a VAERS report, but decided that reporting her experience may benefit others.  Patient open to phone calls about her other supplements and any other pertinent information.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient administered Havrix 720 EL.U/0.5ml dose on 3/11/25 that had an expiration date of 3/2/25. Patient was given expired vaccine for dose and will be re-vaccinated as considering the dose void.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Rotator cuff repair, Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: Ended up with sirva. Torn cuff and had 2 surgeries to try and repair the torn cuff.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Redness from injection site extending down about eight inches sideways about six inches.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Dizziness, Dysphonia, Headache, Injection site pain
Clinical narrative: Dizziness, lightheaded, headache, sore throat, hoarseness, dry cough, injection site pain
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain
Clinical narrative: Dizziness, lightheaded, headache, sore throat, hoarseness, dry cough, injection site pain
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Musculoskeletal stiffness, Pain, Rash, Rash pruritic
Clinical narrative: Patient received vaccine in afternoon 3/11/25. Patient called on 3/12/25 9:30am stating she developed an itchy rash on vaccinated arm and neck. In pain and neck felt stiff. Instructed pt to contact medical professional to be seen as it sounded like a form of allergic reaction
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NONE. PATIENT IS FINE NO ADVERSE REACTION WAS ENCOUNTERED, PATIENT WAS GIVEN 3RD DOSE IN 52 DAYS, RECOMMENDED 5 MONTHS BETWEEN 2 ND AND 3RD DOSE.
Age: 9.0
Sex: F
Vaccine: HEPA, HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 2 doses of Hepatitis A vaccine. Patient asymptomatic. No treatment needed.
Age: 12.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMRV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of freezer.; This spontaneous report was received from a nurse and refers to a 12-year-old male patient.   The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9),  Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Polio vaccine inact 3v (Vero) (IPOL), Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid (BOOSTRIX), Meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO), Hepatitis a vaccine inact (HAVRIX) .  On 06-JAN-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (valid lot number Y013579, expiration date: 03-FEB-2026), administered by subcutaneous route in right arm, with sterile diluent (BAXTER STERILE DILUENT) for prophylaxis (dose and vaccination scheme were not provided), after a temperature excursion since it "was stored in the refrigerator for months" instead of freezer, with a total time in the range 15 degrees Fahrenheit (F) to 46 degrees F of 1296 (units not provided) since 13-NOV-2024 (reported as 2025, conflicting information) (product storage error). No additional adverse event (AE).
Age: 12.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMRV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP reports multiple patients may have received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of freezer.; This spontaneous report was received from a nurse and refers to a 12-year-old male patient.   The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9),  Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B), Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), Polio vaccine inact 3v (Vero) (IPOL), Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid (BOOSTRIX), Meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO), Hepatitis a vaccine inact (HAVRIX) .  On 06-JAN-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (valid lot number Y013579, expiration date: 03-FEB-2026), administered by subcutaneous route in right arm, with sterile diluent (BAXTER STERILE DILUENT) for prophylaxis (dose and vaccination scheme were not provided), after a temperature excursion since it "was stored in the refrigerator for months" instead of freezer, with a total time in the range 15 degrees Fahrenheit (F) to 46 degrees F of 1296 (units not provided) since 13-NOV-2024 (reported as 2025, conflicting information) (product storage error). No additional adverse event (AE).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No AE; was stored in the refrigerator for months instead of the freezer.; This spontaneous report was received from the Nurse and refers to a 5-year-old male patient. His medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero); Tetanus vaccine toxoid (KINRIX).  On 30-OCT-2024, the patient was vaccinated with 1st dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection, lot #X026598, expiration date: 11-MAY-2025, administered by subcutaneous route in left thigh for prophylaxis; used with the sterile diluent (MERCK STERILE DILUENT) (no details provided). The suspect vaccine was refrigerated since 01-OCT-2024 until the day of administration (Product storage error). No adverse events. This is one of the 39 reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; was stored in the refrigerator for months instead of the freezer.; This spontaneous report was received from the Nurse and refers to a 5-year-old male patient. His medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component; Polio vaccine inact 3v (Vero); Tetanus vaccine toxoid (KINRIX).  On 30-OCT-2024, the patient was vaccinated with 1st dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), solution for injection, lot #X026598, expiration date: 11-MAY-2025, administered by subcutaneous route in left thigh for prophylaxis; used with the sterile diluent (MERCK STERILE DILUENT) (no details provided). The suspect vaccine was refrigerated since 01-OCT-2024 until the day of administration (Product storage error). No adverse events. This is one of the 39 reports received from the same reporter.
Age: 82.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: Received the shot 11:07 AM on 2/18/25; On 2/21/25 (6:30 AM) Awoke to have numbness in hands and feet. Most pronounced on the right side (hand and foot)
Age: 82.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Hypoaesthesia
Clinical narrative: Received the shot 11:07 AM on 2/18/25; On 2/21/25 (6:30 AM) Awoke to have numbness in hands and feet. Most pronounced on the right side (hand and foot)
Vaccine: COVID19
Symptoms: Adverse event, Injury
Clinical narrative: side effects for 4 years; injury; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects for 4 years and injury. (dose series 1) The patient took C19 Vaccine and have had all sorts of side effects for 4 years and was looking for help.   The action taken with janssen covid-19 vaccine was not applicable.  The outcome of side effects for 4 years and injury was not reported.    This report was serious (disability/permanent damage).; Sender's Comments: V0-Adverse event, Injury. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures; This serious case was reported by a pharmacist via sales rep and described the occurrence of febrile seizure in a 1-year-old patient who received MMR (Priorix) (batch number 43G92) for prophylaxis.   On 06-MAR-2025, the patient received the 1st dose of Priorix. In MAR-2025, an unknown time after receiving Priorix, the patient experienced febrile seizure (Verbatim: Febrile seizures) (serious criteria hospitalization and GSK medically significant). The outcome of the febrile seizure was resolving.   The reporter considered the febrile seizure to be related to Priorix and Priorix Pre-Filled Syringe Device.     The company considered the febrile seizure to be unrelated to Priorix and Priorix 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: 07-MAR-2025 The patient received a first dose of Priorix and experienced febrile seizure after vaccination. The patient required hospitalization and rapid response.; Sender's Comments: Febrile convulsion is a listed event which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications, time to onset, confirmation of disease) is considered unrelated to GSK  vaccine Priorix and Priorix PRE-FILLED SYRINGE DEVICE.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Irritability, Pain, Pruritus, 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 elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUL-2024, 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2025 This case was reported by a patient via interactive digital media. They had the shingle vaccination 2 years ago, just got shingles 80 in July 2024 hurt, itch and irritable. 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: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.  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 Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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: had shingles 3 times). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2025 The case was received from the patient via (Instagram) interactive digital media. The reporter reported that you were the best person to encourage anyone, he/she had shingles 3 times unfortunately the vaccine did not work but he/she would not want anyone to suffer it's undescribable pain. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.  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: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; had the shot and still got them they were on back and under skin very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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: had the shot and still got them they were on back and under skin very painful). 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 and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2025 This case was reported by a patient via interactive digital media. The patient had Shingrix shot and still got shingles on back and under skin, it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.  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: 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 was not reported and the outcome of the shingles was not resolved.   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: 07-MAR-2025 This case was reported by a patient via interactive digital media. Patient had the vaccine and got shingles and stated that they were excruciating.  The patient stated that one in three would get shingles. Also stated that it was day 10 they were long way from recovery. 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 Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Ending Up Getting It; 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 hospitalization and GSK medically significant) and shingles (Verbatim: Ending Up Getting It) (serious criteria hospitalization). 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2025 The case was received from the patient via interactive digital media. The patient got the shingle shot and ending up getting it.  The patient was in the hospital. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: maladministration of Kinrix instead of Pediarix dose; Maladministration of Kinrix on a pediatric patient-underage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Kinrix and Pediarix. On an unknown date, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: maladministration of Kinrix instead of Pediarix dose) and inappropriate age at vaccine administration (Verbatim: Maladministration of Kinrix on a pediatric patient-underage). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 03-MAR-2025 Medical Assistant called to reported that the maladministration of Kinrix instead of Pediarix (pediatric patient, underage), which led to wrong vaccine administered and inappropriate age at vaccine administration.  Vaccine detail and patient demographics were obtained from the reporter´s end.  The vaccine administration facility was the same as primary reporter. No further information was obtained in this call.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: hib component was not reconstituted with the Dtap-IPV component of PENTACEL, with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 2 months old male patient and reporter reported that the HIB component was not reconstituted with the DTAP-IVP component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included Rotavirus Vaccine; Pneumococcal Vaccine Conj 15v (Crm197) And Hepatitis B vaccine for Immunisation.   On 07-Mar-2025, the patient received a HIB component was not reconstituted with the DTAP-IVP  component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (lot UK110AA) (expiry date-31-Aug-2025) via intramuscular route in the left thigh as prophylactic vaccination (immunization) (latency-same day) and  the HIB component was not reconstituted with the DTAP-IVP component  with no reported adverse event (single component of a two-component product administered)   Action taken: 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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to the administration of the dtap-ipv liquid portion of pentacel with sterile water. acthib was not administered to the patient with no reported ae; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 2 months old female patient who had inappropriate use due to the administration of the DTAP-IPV liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with sterile water and ACTHIB was not administered to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine, pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) and hepatitis B vaccine, all for Immunisation.  On 14-Feb-2025 the patient developed a non-serious inappropriate use due to the administration of the DTAP-IPV liquid portion of standard dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection once (Unknown strength) with lot UK149AB and expiry date 31-Aug-205 via intramuscular route in the right thigh for Immunization with sterile water. ACTHIB was not administered to the patient with no reported adverse event (single component of a two-component product administered) (Latency same day).   Reportedly, This situation is pre-assessed as a medication error/an inappropriate use due to the administration of the DTAP-IPV liquid portion of pentacel with sterile water. ACTHIB was not administered to the patient. Medical Assistant reported that pentacel was diluted incorrectly and administered to a patient. The liquid portion (DTAP-IPV component) was mixed with another diluent (sterile water) and administered to a patient. The powder (ACTHIB) portion was not administered.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACT-HIB was given to a patient with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a patient of unknown gender and age who was inappropriately administered with an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Mar-2025, the patient received an expired unknown dose of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UJ995AA, expiry date 28-Feb-2025; strength standard, Frequency = Once) via unknown route in unknown administration site for immunization, with no reported adverse event (expired product administered) (latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: According to the patient she has been experiencing swollen lymph nodes in neck, behind the ear and under arm on the left side. All tender to touch. Swelling lasting up to one week.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Was given a shingles shot, Shingrix This med hurt immediately while giving My left arm hurt so bad I couldn't sleep it hurt down to the muscle.. it was swollen about a quarter inch high and it was the size of a baseball around. This is March 6 and my muscle is still sore. I applied cold compresses and heat, the cold worked better. I was feverish and felt like someone had branded me
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Was given a shingles shot, Shingrix This med hurt immediately while giving My left arm hurt so bad I couldn't sleep it hurt down to the muscle.. it was swollen about a quarter inch high and it was the size of a baseball around. This is March 6 and my muscle is still sore. I applied cold compresses and heat, the cold worked better. I was feverish and felt like someone had branded me
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Pruritus
Clinical narrative: Rash at site of Shingrex vaccination (first shot). Started day after shot, slightly larger the following day and slightly itchy, mild pain at injection site. Using ice and 1% hydrocortisone.
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injected limb mobility decreased, Malaise, Pain, Pain in extremity
Clinical narrative: Received Prevnar21 on 3/06/2025. That night my arm where I received the injection really started to hurt. To the point that I could not move arm without significant pain. The next morning I started with body aches, headache and chills and over all not feeling well. Work up 3/8/3025 feeling a little better. Don't feel as chilled or feverish but still have headache and arm remains very tender, difficult to use arm where I received the injection.
Sex: F
Vaccine: PNC20
Symptoms: Tenderness
Clinical narrative: Received Prevnar21 on 3/06/2025. That night my arm where I received the injection really started to hurt. To the point that I could not move arm without significant pain. The next morning I started with body aches, headache and chills and over all not feeling well. Work up 3/8/3025 feeling a little better. Don't feel as chilled or feverish but still have headache and arm remains very tender, difficult to use arm where I received the injection.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Gastrooesophageal reflux disease, Influenza like illness, Malaise
Clinical narrative: Patient to ED by ambulance x 2 sick days with N/V, diarrhea, H/O diabetic gastroparesis(on Reglan), GERD, weakness, chills, thought it was a gallbladder attack. Spouse sick. Allergy to Flu Vaccine: rash. For flu like symptoms initiated Tamiflu 75mg however shortly afterwards the patient did break out in a pruritic rash, no throat closing sensation or angioedema. Administered Benadryl IV which resolved the rash. Product: Tamiflu 75mg capsule Event: Rash Patient also has allergy to flu vaccine.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Rash pruritic, Vomiting
Clinical narrative: Patient to ED by ambulance x 2 sick days with N/V, diarrhea, H/O diabetic gastroparesis(on Reglan), GERD, weakness, chills, thought it was a gallbladder attack. Spouse sick. Allergy to Flu Vaccine: rash. For flu like symptoms initiated Tamiflu 75mg however shortly afterwards the patient did break out in a pruritic rash, no throat closing sensation or angioedema. Administered Benadryl IV which resolved the rash. Product: Tamiflu 75mg capsule Event: Rash Patient also has allergy to flu vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Brain fog, Disturbance in attention, Fatigue, Gait disturbance
Clinical narrative: EXCESSIVE FATIQUE,WEAKNESS IN LEGS.COULD BARELY WALK .NEUROLOGICAL DISORDER.MUSCLE ACHES,TINGLING AND NUMBNESS,,,BRAIN FOG,, LOSS OF MEMORY ,DIFFICULTY CONCENTRATING AND FOCUSING, I COULD BARELY WALK FOR 3 YEARS,UNTIL I STARTED TAKING SPIKE PROTEIN DETOXIFICATION MED. DAILY SAUNAS , DOING A 3 DAY FAST ONCE A MONTH TO GET RID OF IGG4 ANTIBODIES  I HAD TO INVESTIGATE WHAT DOCTORS IN (REDACTED) WERE DOING FOR THEIR PATIENTS.TO DETOXIFY SPIKE PROTEIN AND IGG4 ANTIBODIES
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Myalgia, Nervous system disorder, Paraesthesia
Clinical narrative: EXCESSIVE FATIQUE,WEAKNESS IN LEGS.COULD BARELY WALK .NEUROLOGICAL DISORDER.MUSCLE ACHES,TINGLING AND NUMBNESS,,,BRAIN FOG,, LOSS OF MEMORY ,DIFFICULTY CONCENTRATING AND FOCUSING, I COULD BARELY WALK FOR 3 YEARS,UNTIL I STARTED TAKING SPIKE PROTEIN DETOXIFICATION MED. DAILY SAUNAS , DOING A 3 DAY FAST ONCE A MONTH TO GET RID OF IGG4 ANTIBODIES  I HAD TO INVESTIGATE WHAT DOCTORS IN (REDACTED) WERE DOING FOR THEIR PATIENTS.TO DETOXIFY SPIKE PROTEIN AND IGG4 ANTIBODIES
Age: 57.0
Sex: M
Vaccine: RSV
Symptoms: Device connection issue, Product preparation issue, Syringe issue
Clinical narrative: 5-6 faulty RSV vaccines since we started administering them in the clinic. The lurelock on the kit falls off when attempting to attach to the vial adapter and does not attach to the syringe/diluent porting of the vaccine in order to mix the solution resulting in inadequate mixing of the RSV vaccine and leaking
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Syringe issue
Clinical narrative: While I was trying to remove air from syringe of Men B vaccine Bexsero, the liquid kept seeping out of the syringe. It was not able to remove the air and was left with only half a dose of the vaccine. This vaccine was not given to this pt. and was report as wasted.
Vaccine: VARZOS
Symptoms: Liquid product physical issue
Clinical narrative: When Shingrix Lyophilized component was being reconstituted, a black particulate was noticed in the vial. Vial was not used or administered on a patient, but segregated from inventory and a new vial was used.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Nerve conduction studies, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: pain in left arm , sharp shooting pain down arm.  unable to use arm like before.  being continually getting worse.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: pain in left arm , sharp shooting pain down arm.  unable to use arm like before.  being continually getting worse.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Extra dose administered
Clinical narrative: Patient had 2 vaccine records in our IIS, they each had different last names and different spelling of first name.  Patient then received a second dose of RSV Beyfortus in error.  First dose given on 01/31/2025 and second dose given on 03/11/2025.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: NO ADVERSE EVENT OCCURRED. DUE TO THE PATIENT'S HEALTH HISTORY, IT WAS MEDICALLY CONTRAINDICATED THAT THE PATIENT RECEIVE THE ROTAVIRUS VACCINE.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: patient developed redness around the injection site one day after the injection was given.  MD examined the patient and prescribed Prednisolone.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No noted or reported adverse events thus far
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Fibromyalgia, Joint swelling
Clinical narrative: Side effects: Fever lasting 5 days, peaking at 101.3, chills, very bad body aches, joint pain/swelling(Fingers so swollen I could not make a fist.) Nausea, Headache causing a series of migraines. All triggering a new fibromyalgia flare.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Side effects: Fever lasting 5 days, peaking at 101.3, chills, very bad body aches, joint pain/swelling(Fingers so swollen I could not make a fist.) Nausea, Headache causing a series of migraines. All triggering a new fibromyalgia flare.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Extra dose  given. Patient get Influenza vaccine on 10-16-2024, did not need second dose for this season.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Blood thyroid stimulating hormone increased
Clinical narrative: Lab results of TSH 8.4c and Thyroid Peroxidase Antibodies 462.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Cough, Dyspnoea
Clinical narrative: Re-exacerbation of her chronic cough and shortness of breath
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chemotherapy, Endometrial cancer, Hysterectomy
Clinical narrative: Patient was diagnosed with endometrial cancer on 8/11/21.  She had a complete hysterectomy and 6 rounds of chemotherapy.  She is currently cancer free.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: pt says after getting the vaccines she came home and within an hour her heart started thumping and she began having chest pains. She felt as if she couldn't breath.  She thought she was having a heart attack so she used her inhaler. This helped her breath and calmed her down. She was scared and thought she was going to die.  She went to bed and stayed there that night and the next day.  She feels as is if it is an allergic reaction from the vaccine so will not be taking any more. She contacted her pharmacy and was told it maybe the norovirus that caused her to feel this way.  She went to her physicians office and was told it was from the covid vaccine. She was given steroids and refilled albuterol. She continues to have breathing issues.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased, Muscle spasms
Clinical narrative: Member reports pain in shoulder since last vaccine. Member reports pain has been constant since that appt. ROM is limited at times. And at random times he has spasms and pain. Some times he cannot lift his groceries or rise his hand above his head
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left arm sore, red, swollen, painful, itchy
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Dysstasia, Nausea
Clinical narrative: Extreme dizziness - couldn't stand up w/o feeling like I was going to pass out.  Nausea, diarrhea, stomach cramps.  Dizziness and diarrhea continued the next day.  Shot was on Tuesday and symptoms continued thru Wednesday.