chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Post-traumatic stress disorder, Scan, Spinal disorder, Stress
Clinical narrative: Onset 1 hour post 2nd Injection caused burning and seering of nerves headed strait for my Central Nervous System, Lower Brain, Brain Stem, inner and upper neck area structures of C1 and C2, Disintergrating bone and support structures in its wake and leaving an inflammatory substance in its path. The issues I had prior were mild and normal for aging process. That Vaccine nearly took my life. I couldn't see, think, move, sit, stand, or walk for days after and months after I walked with a limp because of what it did to my hip. The Vaccine caused me harm and injury and I have lots of problems now that I did not have before. Autoimmunity, Fatigue, Parathesias, Nueropathy, Brain Fog, Memory Problems, Head Pain, Heart Issue, Excercise induced exhaustion, mental exhaustion, worsened anxiety and depression, stress, ptsd, Gastro issues, Limb weakness, muscle weakness, Muscle spasms, nerve spasm, mcas, inflammation, Absolute horrible and severe and extreme pain caused by the disintergration affect of vaccine which includes nerves and small nerves, Vision changes, Absolute temperature problems and cold spells almost hypothermic. I am still in process of determining the extent of damage and actively working with support groups and doctors for these issues. The Vaccine has caused me dibilitating and disabling issues. I have medical tests and such to support the vaccine injury to me.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment, X-ray
Clinical narrative: Onset 1 hour post 2nd Injection caused burning and seering of nerves headed strait for my Central Nervous System, Lower Brain, Brain Stem, inner and upper neck area structures of C1 and C2, Disintergrating bone and support structures in its wake and leaving an inflammatory substance in its path. The issues I had prior were mild and normal for aging process. That Vaccine nearly took my life. I couldn't see, think, move, sit, stand, or walk for days after and months after I walked with a limp because of what it did to my hip. The Vaccine caused me harm and injury and I have lots of problems now that I did not have before. Autoimmunity, Fatigue, Parathesias, Nueropathy, Brain Fog, Memory Problems, Head Pain, Heart Issue, Excercise induced exhaustion, mental exhaustion, worsened anxiety and depression, stress, ptsd, Gastro issues, Limb weakness, muscle weakness, Muscle spasms, nerve spasm, mcas, inflammation, Absolute horrible and severe and extreme pain caused by the disintergration affect of vaccine which includes nerves and small nerves, Vision changes, Absolute temperature problems and cold spells almost hypothermic. I am still in process of determining the extent of damage and actively working with support groups and doctors for these issues. The Vaccine has caused me dibilitating and disabling issues. I have medical tests and such to support the vaccine injury to me.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Injection site discomfort, Injection site hypoaesthesia, Injection site pain
Clinical narrative: My thumb and fingertips went completely numb sometime in December. Today I feel numbness in my arm in the shot area and up in my arm. It feels like I got stung by a wasp. I massage it and it feels really uncomfortable and slightly painful. It has a strange sensation.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Epistaxis, Mouth haemorrhage, Pain, Petechiae, Platelet count decreased
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Thrombocytopenia, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Acute kidney injury, Anaemia, Blood creatinine increased, Epistaxis, Eye pain
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Haemoglobin decreased, Headache, Immune thrombocytopenia, Immunoglobulin therapy, Injection site bruising
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Magnetic resonance imaging abnormal, Myalgia, Myofascitis
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Ocular hyperaemia, Oral disorder, Oral mucosal blistering, Peripheral swelling, Petechiae
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Platelet count decreased, Purpura, Rash, Retinal haemorrhage, Transfusion
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Ultrasound Doppler normal, Vitreous floaters, Vitreous haemorrhage
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Anaemia, Blindness unilateral, Compartment syndrome, Computerised tomogram, Fasciitis
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Headache, Imaging procedure, Immunoglobulin therapy, Injection site bruising, Injection site pain
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Injection site swelling, Magnetic resonance imaging head, Platelet count decreased, Product use in unapproved indication, Retinal haemorrhage
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Transfusion, Ultrasound scan, Vision blurred, X-ray
Clinical narrative: 3hr following vaccination developed pain, swelling, and bruising localized to surrounding vaccination site. Throughout the following 72 hr developed diffuse body aches and petechia with associated nose bleeds and mouth mucosal bleeding. Ultimately found to be severe thrombocytopenic with concern for ITP (Immune Thrombocytopenic Purpura).
Age: 11.0
Sex: F
Vaccine: HPV9, IPV, IPV, MNQ, TDAP
Symptoms: Posture abnormal
Clinical narrative: PATIENT SLUMPED OVER ABOUT TWO MINUTES AFTER RECEIVING THE VACCIES,. WAS RESPONSIVE, ALERT AND ORIENTED X4. GAVE HER WATER TO DRIN NEURO ASSESSMENT COMPLETED ON PATIENT. ALERT AND ORIENTED X4 ,WAS ABLE TO WALK TO CHECK OUT AREA. PARENT IS EDUCATED ON TO LET THE PATIENT GET SOME REST AND IF ANYTHING  ELSE OCURR TO GO THW NEAREST ER.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV1
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given HPV mistakenly due to not double-checking vaccines and not scanning vaccine in our system before giving vaccine to patient to avoid a mistake. This even happened around 8:39 am, 3/11/24. Showed no signs of an adverse infection. Parents were notified.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Product prescribing error
Clinical narrative: Provider ordered the wrong vaccine. MD selected a prevnar 20 instead of a shingrix vaccine. PCV 20 was given per provider order
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient states right foot is tingling/painful.  Pain/tingling began day after immunization.
Age: 16.0
Sex: F
Vaccine: COVID19, MENB, MMR, MNQ, TDAP
Symptoms: Asthenia, Chills, Feeling cold, Haemoglobin decreased, Pregnancy test negative
Clinical narrative: Parent reported that patient has 4 episodes of syncope (fainting) several hours after their vaccines were given.  Per provider notes on 03/06/2024 when patient was seen in the office, patient had fever, chills and felt weak. Per patient on provider notes on 03/06/2024 when patient was seen on the office "She describes the feeling as "weak, shakiness, darkening vision, and feeling cold."  No seizure like movement . When she came to there was no confusion or lethargy.  No incontinence.  This has never occurred before. Denies chest pain/palpitations. Denies any ongoing symptoms. No dizziness or light headedness."
Age: 16.0
Sex: F
Vaccine: COVID19, MENB, MMR, MNQ, TDAP
Symptoms: Pyrexia, Syncope, Tremor, Visual impairment
Clinical narrative: Parent reported that patient has 4 episodes of syncope (fainting) several hours after their vaccines were given.  Per provider notes on 03/06/2024 when patient was seen in the office, patient had fever, chills and felt weak. Per patient on provider notes on 03/06/2024 when patient was seen on the office "She describes the feeling as "weak, shakiness, darkening vision, and feeling cold."  No seizure like movement . When she came to there was no confusion or lethargy.  No incontinence.  This has never occurred before. Denies chest pain/palpitations. Denies any ongoing symptoms. No dizziness or light headedness."
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The adult dose of Engerix-B was given to a 19 year old. No adverse effects were noted.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood glucose, Fall, Syncope
Clinical narrative: Patient came to pharmacy to get updated Tetanus (Adacel) and first Shingles (Shingrix) vaccines. Patient got both shots no problem and went to sit out on bench with significant other. About 10 minutes later patient was leaving to check out when she fainted falling to the ground. Patient remained on the ground alert and awake until EMS responded. Patient had blood sugar and pressure checked. Patient was cleared and chose to leave the facility without additional medical attention.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS 3 YEARS AND 6 MONTHS OLD AT TIME OF VACCINATION. VACCINATION IS UNAPPROVED FOR THAT AGE RANGE (ONLY APPROVED FOR AGES +4 YEARS OLD).
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Vasovagal episode within 5 minutes after giving vaccines
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: A few days after vaccine, patient experienced left arm pain, reduced range of motions. Still ongoing.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Myalgia, Ophthalmic migraine
Clinical narrative: 5 hours post vaccination the patient experienced an "ocular migraine". She also had an injection site reaction including pain, redness, warmth to the touch. This occurred for  24 to 48 hours and the patient did not take any medications. About 3 days post-vaccination she took Acetaminophen. Now, 1 week later, the patient is reporting consistent muscle pain in her arm at the site of injection. It is not alleviated with ice.
Age: 6.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash, Rash pruritic, Tongue pruritus
Clinical narrative: c/o itchy rash  on chest and tongue felt itchy about 5-10 minutes after vaccination.  Treated w/ Zyrtec . After 20 minutes rash had dissipated  and did not have sensation of tongue itching.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was too young to be administered a Kinrix, patient did not suffer adverse reactions.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Office manager confirmed that the patient had not reported any other AEs.; Office manager reported a VARIVAX AE. Office manager reported that a patient at their practice received a dose of VARIVAX on 26FEB2024 after the product had experienced a temperature excursion on 24FEB2024. Office manager confirmed that the patient h; This spontaneous report was received from an other (office manager) refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-FEB-2024, the patient was vaccinated with 1 improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # X007373, expiration date: 12-MAR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On 24-FEB-2024, administered dose of vaccine was exposed to the temperature excursion of 6 degrees Fahrenheit (F) to 14 F (10 F) for 1 hours (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given on 01-SEP-2004; This spontaneous report has been received via Immunization Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA002295), concerning a currently 23-year-old male patient. Information regarding the patient's concurrent conditions, concomitant therapies or medical history provided were captured in 2311USA002295.  On 01-SEP-2004, the patient was vaccinated with the first dose of Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (reported as Measles, Mumps, Rubella) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  On 06-SEP-2005, he was vaccinated with the second dose of Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (reported as Measles, Mumps, Rubella) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2403USA000584: US-009507513-2403USA000583: US-009507513-2403USA000586: US-009507513-2403USA000582:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of vaccine given on 18-JUN-2008; This spontaneous report has been received via Immunization Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA002295), concerning a currently 23-year-old male patient. Information regarding the patient's concurrent conditions, concomitant therapies or medical history provided were captured in 2311USA002295.  On 23-JUL-2001, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as Varicella) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  On 06-SEP-2005, he was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as Varicella) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2403USA000582: US-009507513-2403USA000583: US-009507513-2403USA000584: US-009507513-2403USA000585:
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: cellulitis and her arm blew up; Allergy Pneumovax; This spontaneous report has been received from a currently might be 58 years old female patient via a company employee via other company referring to herself.   The patient's medical history included clostridioides difficile infection, and cellulitis. The patient's concurrent conditions included multiple sclerosis, numbness, tingling, pain, problems with memory, cluster headache, swelling, allergy to sulfa drugs, allergy to erythromycin, allergy to intravenous metronidazole (FLAGYL), allergy to intravenous vancomycin, tiredness, and inflammation. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced allergy to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).   On an unknown date, the patient was vaccinated with another dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date (reported as within hours of receiving vaccine), the patient experienced cellulitis and her arm blew up.   At the time of reporting, the outcome of all the events was not known.   The reporter considered allergy to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23). The causal relationship between cellulitis and her arm blew up and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events; Inbound call from office manager who reports adult dose of RECOMBIVAX HB was administered to a pediatric patient. Date of administration was 2/26/2024. Office manager places nurse practitioner on the line during the call for the purpose of receiving; This spontaneous report was received from office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-FEB-2024, the patient was vaccinated with adult dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 milliliter, lot #X021830, expiration date: 03-FEB-2026, administered for prophylaxis (strength, and route of administration were not provided) to pediatric patient (Product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or side effects reported.; Nurse practitioner calling with an inquiry on an expired dose of ROTATEQ. Caller stated that the 3rd dose of ROTATEQ was inadvertently administered 3 days after expiration to a 6 month old patient on 03/01/2023.; This spontaneous report has been received from a nurse practitioner, regarding a 6-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 04-MAR-2024, the patient was inadvertently vaccinated with an expired third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: 1918234, which was determined to be valid, with an expiration date on 01-MAR-2024) (strength, dose, anatomical location of administration and lot number were not reported).   No symptoms or side effects reported. No temperature excursions through date of administration.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP called to report ROTATEQ was given after possibly experiencing a temperature excursion.; This spontaneous report was received from the customer and refers to a 6-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 08-FEB-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (dose, indication, lot # and expiration date were not provided), after possibly experiencing a temperature excursion (product storage error).  No additional adverse event (AE) (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: experienced pain and swelling in the arm; experienced pain and swelling in the arm; This spontaneous report was received from a physician and refers to an adult (reported as in her 40's) female patient. The patient was allergic to penicillin and moldy cheese. There was no information regarding her medical history, concurrent conditions and concomitant medications provided.  On an unknown date (reported as within the last couple of years), the patient was vaccinated the first dose of the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. The vaccine was administered by a health professional.  On an unspecified date, the patient experienced pain and swelling in the arm. She sought medical attention, but there was no emergency room (ER) or physician visits for the events. On an unknown date, the patient recovered from pain and swelling in the arm.  The causal relationship between pain and swelling in the arm and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 3.0
Sex: U
Vaccine: FLUN4, MMRV
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; PROQUAD was not considered valid due shorter than recommended interval; This spontaneous report has been received from a nurse and refers to a 3-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.  On 01-JAN-2024, the patient was vaccinated with an expired dose of influenza vaccine live reassort 4V (FLUMIST), lot # TH2108, expiration date: 19-DEC-023, considered not valid by manufacturer Astrazeneca (exact dose, dose number, route of administration, and anatomical location were not reported), and on 16-JAN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, expiration date: 05-JAN-2025 (exact dose, dose number, lot #, route of administration, and anatomical location were not reported), both for prophylaxis (indication reported as "vaccination") (Inappropriate schedule of product administration). No additional adverse event was reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HBP calling to report an adverse event for PROQUAD.  Caller states a  PROQUAD dose was inadvertently administered to an adult patient in their 60's at one of their facilities.  No additional details provided.  No other AE and no PQC; No adverse event; This spontaneous report was received from registered nurse, concerning an adult patient in their 60's of unknown gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On an unknown date, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, was inadvertently administered to the patient (Inappropriate age at vaccine administration) for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). The operator of the device was a healthcare professional. No adverse event reported.   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles broken out on left side; Pain; 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), shingles (Verbatim: Shingles broken out on left side) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-FEB-2024 This case was reported by a patient via interactive digital media. The patient took the vaccine a few years ago. The patient was suffering with shingles at time of reporting which broken out on patient's left side and pain. 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 follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; have had 4 shot; had a shot in November; 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, Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 5th dose of Shingles vaccine, the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), extra dose administered (Verbatim: have had 4 shot) and extra dose administered (Verbatim: had a shot in November). The outcome of the vaccination failure, extra dose administered and extra dose administered were 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, Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2024 This case was reported by the patient via  interactive digital media. The patient stated that he/she had four shingles shots, and had the shingles probably 7 times since. The patient sated that he/she had a shot in November and he/she had the shingles as he/she wrote this. The patient received 5 shots of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them twice; 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: had them twice). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had them twice since having the vaccine. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ I had shot but still got it; I had shot but still got 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/ I had shot but still got it) (serious criteria hospitalization and GSK medically significant) and shingles (Verbatim: I had shot but still got it) (serious criteria hospitalization). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 04-Mar-2024 This case was reported by a patient via interactive digital media. Patient had it (Shingles) several years ago and it was awful. It was so bad it put patient in hospital. Patient had shot but still got it. Patient had another shot and hoped to never get it again.  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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Psoriasis, Vaccination failure
Clinical narrative: Suspected vaccination failure; it's shingles; Psoriasis; 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), shingles (Verbatim: it's shingles) and psoriasis (Verbatim: Psoriasis). The outcome of the vaccination failure was unknown and the outcome of the shingles and psoriasis were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and psoriasis to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and psoriasis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she was still suffering. The patient stated that he/she got the vaccine in 2022. The patient further stated that no doctor would help cream, but he/she sure that it was shingles or psoriasis. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
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 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 04-Mar-2024 This case was reported by a patient via interactive digital media. Patient had vaccine and you could still got them, the patient did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: shingles / Suspected vaccination failure; shingles; burning; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), burning sensation (Verbatim: burning) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.   Additional Information: GSK received date: 04-Mar-2024 This case was reported by a patient' wife via interactive digital media. Reporter stated that, her husband (patient) was also vaccinated a long time ago, it was ugly that shingles it's like your part was burning and pain. 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. This case had been linked with US2024AMR030115, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR030115:Same reporter, daughter-in-lawcase
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: had a friend go blind; This serious case was reported by consumer via market programs. This adult female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis was enrolled in study.   The patient received Hz/su + AS01B on an unknown date, for prophylaxis. On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced blind (Verbatim: had a friend go blind) (serious criteria GSK medically significant). The outcome of the blind was resolved.   The reporter considered the blind to be related to Hz/su + AS01B.   The company considered the blind to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 04-MAR-2024 The patient received the 1st dose of Hz/su + AS01B as Shingrix. The reporter had a friend who went blind from shingles vaccine. Follow-up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Sensitive skin, Vaccination failure
Clinical narrative: patient got the vaccine and still got shingles/Suspected vaccination failure; Shingles; Skin is sensitive; 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: patient got the vaccine and still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and sensitive skin (Verbatim: Skin is sensitive). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the sensitive skin was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sensitive skin to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sensitive skin to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she received the Shingles vaccine and still experienced shingles and now his or her skin was sensitive. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shot. 3 months later I got shingles/ Suspected vaccination failure; Shingles; Still feel pain; 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot. 3 months later I got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Still feel pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine and 3 months later got shingles. At the time of reporting the patient still felt pain. The patient stated no fun. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: chronic shingle outbreaks / Suspected vaccination failure; chronic shingle outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: chronic shingle outbreaks / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: chronic shingle outbreaks). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 04-Mar-2024 This case was reported via interactive digital media. Reporter knew someone (patient) with chronic shingle outbreaks. The shot did help her. She had a flare up but did not last as long. She got them on back of her neck. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot 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.   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: Got the shot 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 04-Mar-2024 This case was reported by a patient via interactive digital media. The reporter reported that he or she knew someone who got the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; burning; pain; daughter-in-law had just been given and she is 39 years old; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 39-year-old female 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), shingles (Verbatim: shingles), burning sensation (Verbatim: burning), pain (Verbatim: pain) and inappropriate age at vaccine administration (Verbatim: daughter-in-law had just been given and she is 39 years old). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles, burning sensation and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2024 This case was reported by a patient via interactive digital media. The reporter stated that if you get on antivirals within 3 days the shingles were very mild. Vaccination did not stop the patient from getting them and had them twice. The patient received Shingles vaccine at the age of 39 year, which led to inappropriate age at vaccine administration. 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 follow-up could not be possible as no contact details were available. This case has been linked to the case US2024AMR029352 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR029352:Same reporter, husband case