chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fibroadenoma of breast, Headache, Hyperacusis, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: developed fibroadenomas in both breasts; On 30-NOV-2020, the patient received her third dosage of Gardasil; Intermittent migraine headaches accompanied by nausea, vomiting, and light sensitivity / blurry vision and sound sensitivity; Information has been received from a lawyer regarding an adolescent between 16 to 17-year-old (currently adult) female patient regarding a case in litigation. Information about concurrent condition, history condition, and concomitant medication was not reported. On 03-JUN-2019, when the patient was 16-year-old, she was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided). The patient's mother agreed to her daughter receiving the vaccine injections after been exposed by marketing by the company, that the vaccine was very safe and that the vaccine prevented cancer. Also, the patient's health care provider recommended that she received the vaccine, which was stated as a safe and effective vaccine for preventing cervical cancer. On an unknown date in 2019, following the first vaccination, the patient began to suffer from intermittent migraine headaches, accompanied by nausea, vomiting, and light sensitivity (Migraine). On 01-NOV-2019 and 30-NOV-2020, the patient received the second and third doses, respectively, of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided) (Inappropriate schedule of product administration). On an unknown date (reported as "the months progressed"), the patient's intermittent migraine headaches progressed with accompanying symptoms of nausea, vomiting, blurry vision, and light, and sound sensitivity. As a result of those symptoms, the patient had difficulty attending her college classes and completing her schoolwork when in the grips of a migraine or severe headache. On an unspecified date, the patient developed fibroadenomas in both breasts, and every six months, the patient had to check with her doctor to make sure there was no new growth. The outcome of the events was not recovered. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was considered as related by the reporter.  The event of migraine was considered to be disabling by the lawyer.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Nausea, Photophobia, Vision blurred, Vomiting
Clinical narrative: developed fibroadenomas in both breasts; On 30-NOV-2020, the patient received her third dosage of Gardasil; Intermittent migraine headaches accompanied by nausea, vomiting, and light sensitivity / blurry vision and sound sensitivity; Information has been received from a lawyer regarding an adolescent between 16 to 17-year-old (currently adult) female patient regarding a case in litigation. Information about concurrent condition, history condition, and concomitant medication was not reported. On 03-JUN-2019, when the patient was 16-year-old, she was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided). The patient's mother agreed to her daughter receiving the vaccine injections after been exposed by marketing by the company, that the vaccine was very safe and that the vaccine prevented cancer. Also, the patient's health care provider recommended that she received the vaccine, which was stated as a safe and effective vaccine for preventing cervical cancer. On an unknown date in 2019, following the first vaccination, the patient began to suffer from intermittent migraine headaches, accompanied by nausea, vomiting, and light sensitivity (Migraine). On 01-NOV-2019 and 30-NOV-2020, the patient received the second and third doses, respectively, of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided) (Inappropriate schedule of product administration). On an unknown date (reported as "the months progressed"), the patient's intermittent migraine headaches progressed with accompanying symptoms of nausea, vomiting, blurry vision, and light, and sound sensitivity. As a result of those symptoms, the patient had difficulty attending her college classes and completing her schoolwork when in the grips of a migraine or severe headache. On an unspecified date, the patient developed fibroadenomas in both breasts, and every six months, the patient had to check with her doctor to make sure there was no new growth. The outcome of the events was not recovered. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was considered as related by the reporter.  The event of migraine was considered to be disabling by the lawyer.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Product storage error
Clinical narrative: No symptoms reported. No further AE details; Temperature: 70F Date of excursion: 3/2/2023; Lot Number: W0252273, Expiration Date: 6/2/2023.; This spontaneous report was received from a pharmacist, referring to a 10-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number was reported as W0252273, but upon internal validation was updated to W025273, expiration date reported as 02-JUN-2023, but upon internal validation was established as 10-AUG-2024) as prophylaxis, which also experienced a temperature excursion (expired product administered and product storage error).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 9 minutes on 02-MAR-2023.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed that no symptomatic adverse events were reported; Caller states that product was administered to patient following the temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 09-MAY-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (formulation pre-filled syringe, 0.5 mL, lot #W004648, expiration date 06-OCT-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  The suspect vaccine experienced a temperature excursion of 34.4 degrees Fahrenheit (F) for 15 hours on unknown day. Confirmed that no symptomatic adverse events were reported. No additional information at this time. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No previous temperature excursion. ; Sender's Comments:  US-009507513-2306USA010783:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Inbound call from office manager calling to report administration of VARIVAX that experienced a temperature excursion.  Confirmed no symptomatic adverse events were reported.  VARIVAX was evaluated and found to have a supported temperature excursion.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 21-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous Injection, lot number W039689 that had been verified to be a valid lot number with expiration date 13-DEC-2024 (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) (product storage error).  The vaccina had a temperature excursion of -13.3 C for a time frame of 0 hours 52 minutes 0 seconds (total). A previous temperature excursion occurred, not data logger. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA011379:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose was Given to a Patient; Initial Report Received on 04-APR-2023.  A pharmacist reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #937233, expiration date 11-MAR-2023 and NDC #43528-003-05) from a pharmacist (route and injection site not provided).  On an unspecified date, the patient was vaccinated with HEPLISAV-B which was noted to have been an expired dose.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Recieved Engerix -B 1st and 2nd Dose, 3rd Dose Received was Heplisav-B and Expired; Received Expired Dose; Initial Report Received on 20-Apr-2023  A pharmacist reported that a 65-year-old female patient (race and ethnicity unknown) received Engerix-B for the first and second dose and was given an expired dose of HEPLISAV-B (hepatitis B vaccine) as the third dose for hepatitis B immunization.    Medical history, allergies, and concomitant medications at the time of vaccination were not reported.    On an unknown date in Oct-2022, the patient received Engerix-B as the first dose (no details provided).   On 18-Nov-2022, the patient received the second dose of Engerix-B (no details provided).   On 20-Apr-2023, the patient received an expired dose of HEPLISAV-B vaccine as the third dose (Lot # 935844, expiration date 04-Nov-2022, and NDC # 43528-003-05) intramuscularly in the left deltoid. No adverse reactions were witnessed. No concomitant medications were given to the patient.   No additional information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: First Dose Heplisav-B, Second Dose Engerix; Initial Report Received on 28-Apr-2023  A nurse reported that a male patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 4 weeks prior to receiving a dose of "Energix-B".   Medical history and concomitant medications at the time of vaccination were reported as unknown.  The patient had no known drug allergies.  On 24-Mar-2023, the patient received a dose of HEPLISAV-B vaccine (Lot #941054, expiration date, and NDC # unknown) intramuscularly in the left deltoid. No side effects were reported.  On an unknown date, the patient received a dose of "Energix-B" (no details reported).   No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Herpes zoster, Myalgia, Vaccination failure
Clinical narrative: experienced another case of shingles/Suspected Vaccination Failure; experienced another case of shingles; pharmacy administered a first shot dose; Tiredness; Muscle pain; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On 19-JUN-2023, more than 2 years after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: Tiredness) and muscle pain (Verbatim: Muscle pain). On an unknown date, the patient experienced vaccination failure (Verbatim: experienced another case of shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: experienced another case of shingles) and extra dose administered (Verbatim: pharmacy administered a first shot dose). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported and the outcome of the tiredness and muscle pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tiredness and muscle pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, tiredness and muscle pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-JUN-2023 The patient self-reported this case. The patient had the 2 Shingles shots in 2018. In 2022, he experienced another case of shingles. The patient asked if he could get another round of vaccines at that time, but he was told by my pharmacy and by you that a second round had not been authorized. One day before reporting, pharmacy told me him was now eligible for another round of vaccines. Pharmacy administered a first shot dose. The reporter asked was pharmacy correct ? The symptoms were not treated. 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. The reporter did not consent to follow up. The patient received 3rd dose of Shingles vaccine (first shot from second round), which led to extra dose administered.
Sex: F
Vaccine: MENB, MENB
Symptoms: Incomplete course of vaccination, Syncope
Clinical narrative: Fainted; Did not receive second dose; This serious case was reported by a physician and described the occurrence of fainting in a 12-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown arm) and did not receive the 2nd dose of Bexsero. On an unknown date, 1 day after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant) and incomplete course of vaccination (Verbatim: Did not receive second dose). The outcome of the fainting was resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-jun-2023 This report was submitted via the online direct entry reporting system. The patient received first dose of Bexsero prior to going to sleep away camp due to outbreak.  She did not receive second dose.  She fainted the following day after getting vaccine. That happened about 4 to 5 years prior to the reporting. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Bexsero, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: convulsions; This serious case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles before).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced convulsion (Verbatim: convulsions) (serious criteria hospitalization and GSK medically significant). The outcome of the convulsion was not reported.   It was unknown if the reporter considered the convulsion to be related to Shingles vaccine.     It was unknown if the company considered the convulsion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023. This case was reported by a patient via interactive digital media. After the second shot patient went into convulsions.  The patient went by ambulance to the hospital spent 2 weeks in the hospital 1 week in rehab and another 2 weeks with a home nurse.  The patient stated he/she had shingles before far less than what patient went through with the vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had two shingles shots and still got shingles/ 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had two shingles shots and still got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by a patient via interactive digital media. The patient had two shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: UNK
Symptoms: Cough, Headache, Influenza, Musculoskeletal stiffness, Pain
Clinical narrative: Headaches; Neck stiffness; Coughing; Pain; Flu; This non-serious case was reported by a consumer and described the occurrence of cough in a 64-year-old male patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On 29-MAY-2023, the patient received Meningitis ACWY vaccine (potential Menveo). On 31-MAY-2023, 2 days after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced cough (Verbatim: Coughing), pain (Verbatim: Pain) and influenza (Verbatim: Flu). On an unknown date, the patient experienced headache (Verbatim: Headaches) and stiff neck (Verbatim: Neck stiffness). The patient was treated with amoxicillin and benzonatate. The outcome of the cough, pain and influenza were not resolved and the outcome of the headache and stiff neck were not reported.   It was unknown if the reporter considered the cough, pain, influenza, headache and stiff neck to be related to Meningitis ACWY vaccine (potential Menveo).     It was unknown if the company considered the cough, pain, influenza, headache and stiff neck to be related to Meningitis ACWY vaccine (potential Menveo).   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter reported that the patient received meningitis combo shot vaccine and 2 days after received vaccine experienced coughing, pain and flu. On unknown date, patient experienced headache and neck stiffness and stated that the pain was worse in extreme at night from 8 pm to 1. The patient received Amoxicillin 875 mg tablet and Benzonatate 200 mg as a treatment. The reporter did consent to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Feeling hot, Pain in extremity, Swelling
Clinical narrative: hot feeling; bruising/ still brushied; Swollen; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12-JUN-2023, the patient received the 2nd dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). On 15-JUN-2023, the patient experienced feeling hot (Verbatim: hot feeling), contusion (Verbatim: bruising/ still brushied) and swelling (Verbatim: Swollen). The outcome of the pain in arm and contusion were not resolved and the outcome of the feeling hot and swelling were not reported.   It was unknown if the reporter considered the pain in arm, feeling hot, contusion and swelling to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling hot, contusion and swelling to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Jun-2023 and 19-Jun-2023 This case was reported the patient via interactive digital media. The patient just got shingles shot on Monday evening, and on June 15 2023, was feeling hot, swollen, bruised and still bruised. The patient arm was sore arm. The patient was glad to got the 2nd one and then no more, but it was over and arm would be better soon. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: miserable flu-like side effects after 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: miserable flu-like side effects after 2nd shot). The outcome of the influenza-like symptoms was not resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023 This case was reported by a patient via interactive digital media. The patient stated that currently going on day 3 of miserable flu-like side effects after 2nd dose.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/27/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 4/26/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Respiratory failure, Tracheal stenosis
Clinical narrative: J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 SEVERE PERSISTENT ASTHMA W ACUTE EXACERBATION J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 ASTHMA, UNSPECIFIED J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/30/2023 TRACHEAL STENOSIS
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Limb asymmetry, Neuropathy peripheral, Pregnancy
Clinical narrative: D68.9 COAGULATION DEFECT, UNSPECIFIED TYPE, IN PREGNANCY, UNSPECIFIED TRIMESTER 1/11/2023 ACQUIRED INEQUALITY OF LEG LENGTH G62.9 NEUROPATHY 10/14/2022 ACQUIRED INEQUALITY OF LEG LENGTH
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid arterial embolus, Embolic stroke, Embolism arterial, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/10/2023 ACUTE STROKE DUE TO EMBOLISM OF LEFT CAROTID ARTERY I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 4/12/2023 ACUTE STROKE DUE TO EMBOLISM OF LEFT CAROTID ARTERY
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult hep A vaccine administered instead of pediatric.
Age: 14.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult hep A vaccine given instead of pediatric.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased, Swelling
Clinical narrative: Pain and swelling in shoulder and subsequent mobility issues. Patient followed up 06/26/23 stating that pain and swelling went down but limited range of motion due to pain when shoulder is moved.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Patient administered additional HPV dose.  Tolerated well.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Didn't feel good next day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received the 2nd dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: Didn't feel good next day). The outcome of the feeling unwell was resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023. This case was reported by a patient via interactive digital media. The patient got 2nd shingles vaccine 2 days ago. Did not felt good next day.  The patient feeling much better today on the day of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: patient who had pain for almost 2 weeks; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in a 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 pain (Verbatim: patient who had pain for almost 2 weeks). The outcome of the pain was resolved (duration 2 weeks).   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023. The reporter mentioned there was a patient who had pain for almost 2 weeks. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: feel like you got the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: feel like you got the flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023. This case was reported by a patient via interactive digital media. The first shot make you felt like patient got the flu so better to get on a Friday. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: unbearable pain; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: unbearable pain) and fever (Verbatim: Fever). The outcome of the pain and fever were not reported.   It was unknown if the reporter considered the pain and fever to be related to Shingles vaccine.     It was unknown if the company considered the pain and fever to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUN-2023 This case was received by a consumer via interactive digital media. Yesterday (day before reporting) he/she got vaccinated which was an unbearable pain due to which got fever, but it does not compare to what suffer with shingles, he/she would not prefer to go all through this again and as there were people who would repeat it.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: lil sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 21-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: lil sore). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 1st dose of Shingles vaccine and experienced lil sore, nothing major.  The patient states that he/she had his/her 2nd shot in a few months. Follow up was not possible, as no contact details were available.
Age: 33.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received an unreconstituted (diluent only) dose of Menveo; patient received an unreconstituted (diluent only) dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 33-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA977A, expiry date 31-MAY-2024) for prophylaxis.   On 15-JUN-2023, the patient received Menveo. On 15-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received an unreconstituted (diluent only) dose of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received an unreconstituted (diluent only) dose of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 It was reported that patient received an unreconstituted (diluent only) dose of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in August 2021, second dose in January 2023; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2021).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in August 2021, second dose in January 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-JUN-2023 The reporter enquired that what was the efficacy of a patient who had Shingrix August 2021 and then a second dose in January 2023. The reporter also enquired that should they receive another dose third dose. The vaccine administration facility is the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received liquid portion of Menveo; received liquid portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA768A, expiry date 31-OCT-2024) for prophylaxis.   On 19-JUN-2023, the patient received Menveo (unknown arm). On 19-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: received liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that a patient received liquid portion of Menveo and after this error, patient was revaccinated with a full dose of Menveo on the same arm and on the same day (lot number: 2AMAA768A; expiration date: 31st December 2023). The reporter consented to follow up by email. The patient received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired Infanrix vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 19-JUN-2023, the patient received Infanrix. On 19-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired Infanrix vaccination). The outcome of the expired vaccine used was unknown.   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: 20-JUN-2023 The nurse reported that the patient received an expired Infanrix vaccination. The reporter did not consent to follow-up. The patient received Infanrix beyond the expiration date, which led to expired vaccine used.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 8/26/2020 and then the second dose was administered early on 9/27/2020; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 22N2D, expiry date 16-SEP-2022) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 27-SEP-2020, the patient received the 2nd dose of Shingrix. On 27-SEP-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on 8/26/2020 and then the second dose was administered early on 9/27/2020). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Jun-2023 The pharmacy manager called to inform that the patient received 1st dose and 2nd dose was administered early. The reporter asked if the patient needed with another dose. The patient received 2nd dose within one month from 1st dose, which lead to shortening of vaccinations schedule. The health care professional did not consent to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received a dose of Boostrix that had expired on 1 April 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 01-APR-2023) for prophylaxis.   On 06-MAY-2023, the patient received Boostrix. On 06-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: received a dose of Boostrix that had expired on 1 April 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023. On 20 June 2023, a pharmacist called to inform that on 6 May 2023, a patient received a dose of Boostrix that had expired on 1 April 2023 which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine with an expiration date of 6/17/2023 was administered to a patient after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date 17-JUN-2023) for prophylaxis.   In JUN-2023, the patient received Havrix. In JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Vaccine with an expiration date of 6/17/2023 was administered to a patient after the expiration date). The outcome of the expired vaccine used was unknown.   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: 20-JUN-2023 The reporter from healthcare professional office stated that a havrix vaccine with an expiration date of 17-Jun-2023 was administered to a patient after the expiration date.  The reporter did not consented to follow-up. The patient received expired vaccine, which led to expired vaccine used.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Inappropriate schedule of product administration, Malaise, Myalgia
Clinical narrative: first dose of SHINGRIX about two years ago; Headache; Muscle Pain; her arm is very hot; she does not feel well; most everything hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix about two years ago).   On 19-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), muscle pain (Verbatim: Muscle Pain), extremities hot feeling of (Verbatim: her arm is very hot), feeling unwell (Verbatim: she does not feel well) and general body pain (Verbatim: most everything hurts). On 19-JUN-2023, the patient experienced drug dose administration interval too long (Verbatim: first dose of SHINGRIX about two years ago). The outcome of the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.     It was unknown if the company considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received the second dose of Shingrix on Monday and was experiencing muscle pain, headache, and her arm is very hot, not feel well and most everything hurts. The reporter consented to follow up with the health care professionals (pharmacy). The patient received 2nd dose after 2 years of 1st dose, which led to lengthening of vaccination schedule.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first dose of SHINGRIX about two years ago; Headache; Muscle Pain; her arm is very hot; she does not feel well; most everything hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix about two years ago).   On 19-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), muscle pain (Verbatim: Muscle Pain), extremities hot feeling of (Verbatim: her arm is very hot), feeling unwell (Verbatim: she does not feel well) and general body pain (Verbatim: most everything hurts). On 19-JUN-2023, the patient experienced drug dose administration interval too long (Verbatim: first dose of SHINGRIX about two years ago). The outcome of the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.     It was unknown if the company considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received the second dose of Shingrix on Monday and was experiencing muscle pain, headache, and her arm is very hot, not feel well and most everything hurts. The reporter consented to follow up with the health care professionals (pharmacy). The patient received 2nd dose after 2 years of 1st dose, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than Recommended Interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The pharmacist inquired if the patient needs to restart the series. The reporter consented to follow-up. Till the time of reporting, the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix went down to 29.67 F and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-JUN-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix went down to 29.67 F and was administered to a patient). The outcome of the incorrect storage of drug was unknown.   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: 21-JUN-2023 The reporter stated that Boostrix went down to 29.67-degree Fahrenheit and was administered to a patient this morning (on the day of reporting). The vaccine administration facility was the same as primary reporter. The healthcare professional declined to provide patient details and did not have the vaccine details (lot, expiration date) at the time of the call.  The reporter consented to follow up via postal.  The patient received a dose of Boostrix went down to temperature 29.67-degree Fahrenheit, which led to incorrect storage of drug.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Systemic itching all over the body; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, 2 days after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: Systemic itching all over the body). The outcome of the generalized pruritus was not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     It was unknown if the company considered the generalized pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 21-JUN-2023 The reporter was the patient who stated that he received dose of Shingrix and then 2-3 days later developed what he called a systemic inching all over the body, with no rash. No other symptoms reported. Doctor was not aware of this event yet.  Consented to follow up.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Dyskinesia, Febrile convulsion, Pyrexia
Clinical narrative: jerking movements of arms and legs lasting less than 1 min; Patient developed febrile seizure at 12 midnight on 2/7/23.; Dad reports tactile fever/ He continues to have fever at this time; SARS-COV-2 test negative; Respiratory syncytial virus test negative; Influenza virus test negative; This case was retrieved during monitoring on 12-APR-2023. The original narrative from the sender is as follows:  Patient developed febrile seizure at 12 midnight on 2/7/23. Dad reports tactile fever at that time and jerking movements of arms and legs lasting less than 1 min. He was evaluated in the Emergency Dept and no focal source of infection was identified. Dx home with dx of febrile seizure. He continues to have fever at this time.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "dyskinesia, febrile convulsion and pyrexia". Due to the nature of the event the causal relationship between Vaxelis and the events, "Influenza virus test negative, Respiratory syncytial virus test negative and SARS-COV-2 test negative" is not applicable.  No further information is expected.  Duplicate follow-up information was received by the partner from the Reporting System monitoring on 18-APR-2023 and forwarded on 24-APR-2023.   No further information is expected as product was not administered.