chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hand-eye coordination impaired, Magnetic resonance imaging, Pain, Primary stabbing headache
Clinical narrative: Approximately an hour after receiving the vaccine, I experienced a stabbing (ice pick) headache and have experienced the same headache daily since the vaccine (aprox. 3 1/2 years). I have never experienced this type of headache in my life prior to the vaccine.  The intensity of the headache varies but has been consistent and persistent since receiving the vaccine on 10/21/2021. Other symptoms include, dizziness, brain fog, confusion, memory loss, feelings of derealization, fatigue, body aches, hand eye coordination difficulties and my reaction time and awareness of my surroundings have been impaired dramatically.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Slow response to stimuli
Clinical narrative: Approximately an hour after receiving the vaccine, I experienced a stabbing (ice pick) headache and have experienced the same headache daily since the vaccine (aprox. 3 1/2 years). I have never experienced this type of headache in my life prior to the vaccine.  The intensity of the headache varies but has been consistent and persistent since receiving the vaccine on 10/21/2021. Other symptoms include, dizziness, brain fog, confusion, memory loss, feelings of derealization, fatigue, body aches, hand eye coordination difficulties and my reaction time and awareness of my surroundings have been impaired dramatically.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient reported sore arm post vaccination. Patient was prescribed a Medrol Dosepak 11 days post vaccination but did not immediately take it. Patient was also told to take over the counter pain relieving medication, but refused to initially take these as well. Patient was told to be evaluated by a physician if soreness continued, and was seen on 4/28 at a local urgent care. Urgent care recommended patient follow up with orthopedic specialist to be evaluated for potential gabapentin therapy.  Urgent care also instructed patient to use Voltaren Gel and Salon Paas topically as well as heating pad to relieve pain. It is unknown if the patient has contacted an ortho.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: 6 x 6 inches of redness and inflammation in the injection site
Age: 27.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: huge red, hot circle around injection site lot of pain, bruising
Age: 78.0
Vaccine: FLU3
Symptoms: Diplopia, Dizziness, Vision blurred
Clinical narrative: pt left clinic after vaccine admin, went to local pharmacy to pick up meds. Had episode of dizziness and double vision, presented back to clinic. Vital signs stable. Neuro check by NP normal. Pt c/o continued dizziness & blurred vision. EMS called and pt transported to ER for further evaluation.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR, MMRV
Symptoms: Unevaluable event
Clinical narrative: No additional AE.; A HCP transferred from a Specialist agent called to report an AE for MMR II.  The HCP stated their facility was having issues accessing "M-tracks" on Friday, 04/11/2025 during and MMR II vaccination event and she was unable to view a patient's vacci; This spontaneous report was received from an Other health professional and refers to a 5-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.     On 03-Feb-2021, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported).  On 25-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported) reconstituted with  with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). On 11-Apr-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported)(extra dose administered). No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: MMR, MMR, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE.; A HCP transferred from a Specialist agent called to report an AE for MMR II.  The HCP stated their facility was having issues accessing "M-tracks" on Friday, 04/11/2025 during and MMR II vaccination event and she was unable to view a patient's vacci; This spontaneous report was received from an Other health professional and refers to a 5-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.     On 03-Feb-2021, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported).  On 25-Jan-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported) reconstituted with  with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). On 11-Apr-2025, the patient started therapy with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported)(extra dose administered). No additional adverse event was reported.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Cellulitis, Condition aggravated, Pruritus, Rash
Clinical narrative: Fatigue; lot of discomfort; Headache; pain in the arm; Pain injection site since vaccination date; she had not have a night sleep, the pain wake her up every night; Increased symptoms for asthma; Increased symptoms for Chronic obstructive airways disease exacerbated; Increased symptoms for cellulitis; Increased symptoms for tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthma aggravated in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis, asthma, tinnitus and chronic obstructive airways disease exacerbated.   On 11-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site since vaccination date). In APR-2025, the patient experienced asthma aggravated (Verbatim: Increased symptoms for asthma), chronic obstructive airways disease exacerbated (Verbatim: Increased symptoms for Chronic obstructive airways disease exacerbated), cellulitis aggravated (Verbatim: Increased symptoms for cellulitis), tinnitus aggravated (Verbatim: Increased symptoms for tinnitus) and difficulty sleeping (Verbatim: she had not have a night sleep, the pain wake her up every night). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), discomfort (Verbatim: lot of discomfort), headache (Verbatim: Headache) and pain in arm (Verbatim: pain in the arm). The outcome of the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, difficulty sleeping, fatigue and headache were unknown and the outcome of the injection site pain, discomfort and pain in arm were not resolved.   It was unknown if the reporter considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had vaccine on 11 Apr 2025, they said that the pain in the arm will disappear and was still experiencing a lot of things. The patient was still in a lot of discomfort. The patient mentioned that since the vaccination until today 01 May 2025, had a lot of pain in the injection site, and due to this, she had not had a night sleep, the pain wakes her up every night. She also mentioned that since the vaccination, all her illness (cellulitis, asthma, Chronic obstructive airways disease exacerbated and tinnitus) gets on and on and also mentioned that she would not get the 2nd dose.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Condition aggravated, Dyspnoea, Pain in extremity
Clinical narrative: Fatigue; lot of discomfort; Headache; pain in the arm; Pain injection site since vaccination date; she had not have a night sleep, the pain wake her up every night; Increased symptoms for asthma; Increased symptoms for Chronic obstructive airways disease exacerbated; Increased symptoms for cellulitis; Increased symptoms for tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthma aggravated in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis, asthma, tinnitus and chronic obstructive airways disease exacerbated.   On 11-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site since vaccination date). In APR-2025, the patient experienced asthma aggravated (Verbatim: Increased symptoms for asthma), chronic obstructive airways disease exacerbated (Verbatim: Increased symptoms for Chronic obstructive airways disease exacerbated), cellulitis aggravated (Verbatim: Increased symptoms for cellulitis), tinnitus aggravated (Verbatim: Increased symptoms for tinnitus) and difficulty sleeping (Verbatim: she had not have a night sleep, the pain wake her up every night). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), discomfort (Verbatim: lot of discomfort), headache (Verbatim: Headache) and pain in arm (Verbatim: pain in the arm). The outcome of the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, difficulty sleeping, fatigue and headache were unknown and the outcome of the injection site pain, discomfort and pain in arm were not resolved.   It was unknown if the reporter considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had vaccine on 11 Apr 2025, they said that the pain in the arm will disappear and was still experiencing a lot of things. The patient was still in a lot of discomfort. The patient mentioned that since the vaccination until today 01 May 2025, had a lot of pain in the injection site, and due to this, she had not had a night sleep, the pain wakes her up every night. She also mentioned that since the vaccination, all her illness (cellulitis, asthma, Chronic obstructive airways disease exacerbated and tinnitus) gets on and on and also mentioned that she would not get the 2nd dose.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Fatigue; lot of discomfort; Headache; pain in the arm; Pain injection site since vaccination date; she had not have a night sleep, the pain wake her up every night; Increased symptoms for asthma; Increased symptoms for Chronic obstructive airways disease exacerbated; Increased symptoms for cellulitis; Increased symptoms for tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthma aggravated in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis, asthma, tinnitus and chronic obstructive airways disease exacerbated.   On 11-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site since vaccination date). In APR-2025, the patient experienced asthma aggravated (Verbatim: Increased symptoms for asthma), chronic obstructive airways disease exacerbated (Verbatim: Increased symptoms for Chronic obstructive airways disease exacerbated), cellulitis aggravated (Verbatim: Increased symptoms for cellulitis), tinnitus aggravated (Verbatim: Increased symptoms for tinnitus) and difficulty sleeping (Verbatim: she had not have a night sleep, the pain wake her up every night). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), discomfort (Verbatim: lot of discomfort), headache (Verbatim: Headache) and pain in arm (Verbatim: pain in the arm). The outcome of the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, difficulty sleeping, fatigue and headache were unknown and the outcome of the injection site pain, discomfort and pain in arm were not resolved.   It was unknown if the reporter considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had vaccine on 11 Apr 2025, they said that the pain in the arm will disappear and was still experiencing a lot of things. The patient was still in a lot of discomfort. The patient mentioned that since the vaccination until today 01 May 2025, had a lot of pain in the injection site, and due to this, she had not had a night sleep, the pain wakes her up every night. She also mentioned that since the vaccination, all her illness (cellulitis, asthma, Chronic obstructive airways disease exacerbated and tinnitus) gets on and on and also mentioned that she would not get the 2nd dose.
Age: 93.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: Fatigue; lot of discomfort; Headache; pain in the arm; Pain injection site since vaccination date; she had not have a night sleep, the pain wake her up every night; Increased symptoms for asthma; Increased symptoms for Chronic obstructive airways disease exacerbated; Increased symptoms for cellulitis; Increased symptoms for tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthma aggravated in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cellulitis, asthma, tinnitus and chronic obstructive airways disease exacerbated.   On 11-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site since vaccination date). In APR-2025, the patient experienced asthma aggravated (Verbatim: Increased symptoms for asthma), chronic obstructive airways disease exacerbated (Verbatim: Increased symptoms for Chronic obstructive airways disease exacerbated), cellulitis aggravated (Verbatim: Increased symptoms for cellulitis), tinnitus aggravated (Verbatim: Increased symptoms for tinnitus) and difficulty sleeping (Verbatim: she had not have a night sleep, the pain wake her up every night). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), discomfort (Verbatim: lot of discomfort), headache (Verbatim: Headache) and pain in arm (Verbatim: pain in the arm). The outcome of the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, difficulty sleeping, fatigue and headache were unknown and the outcome of the injection site pain, discomfort and pain in arm were not resolved.   It was unknown if the reporter considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had vaccine on 11 Apr 2025, they said that the pain in the arm will disappear and was still experiencing a lot of things. The patient was still in a lot of discomfort. The patient mentioned that since the vaccination until today 01 May 2025, had a lot of pain in the injection site, and due to this, she had not had a night sleep, the pain wakes her up every night. She also mentioned that since the vaccination, all her illness (cellulitis, asthma, Chronic obstructive airways disease exacerbated and tinnitus) gets on and on and also mentioned that she would not get the 2nd dose.
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; patient received improperly stored vaccine; This spontaneous report was received from a certified medical assistant (CMA) on 28-APR-2025 and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported.   24-APR-2025, the patient was vaccinated with an improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y014868, expiration date: 03-SEP-2026), dose/frequency was reported as 1 dose, and sterile diluent (lot #, dose, route o administration not reported) for prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 5.5 Fahrenheit up to 14.4 Fahrenheit for 40 minutes and 14.5 Fahrenheit up to 46.4 Fahrenheit for 10 minutes, with no previous temperature excursion reported.  No adverse vent reported.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; patient was administered GARDASIL9 during a temperature excursion.; This spontaneous report was received from a health care business professional and refers to a patient of unknown age and gender.   The patient's medical, concurrent conditions were not reported, and concomitant therapies were not reported.   On 28-APR-2025, the patient was vaccinated with an improper storage dose of dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL9), prefilled syringe (lot #Y012508, expiration date: 01-JAN-2027) (dose and frequency reported as 1 dose), for prophylaxis. The administered doses of the vaccine experienced a temperature excursion 0 degree centigrade for 1 hour. No previous temperature excursion was reported. There was no adverse effect reported. No product quality complaint was involved.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Varicose vein
Clinical narrative: autoimmune likened pigmentosis; prominent varicose veins,; black spots all over her tongue; This spontaneous report has been received from a health professional regarding a 46-year-old female patient. Information regarding medical history included chickenpox, and shingles, concurrent conditions included allergy to tetracycline, hydro (+) acitamin (VICODIN) and griseofulvin. And concomitant therapies included enzymes, magnesium, fexofenadine (ALLEGRA), Vitamin D, levothyroxine (SYNTHROID) and valacyclovir.  On 24-MAY-2024, the patient was vaccinated with the first dose of  Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9), for prophylaxis, 0.5 milliliters, intramuscularly (strength, lot number, expiration date, anatomical location not provided)  On an unspecified date (reported as a few days after the vaccine was administered), the patient developed varicose veins that became very prominent.  The patient followed-up with a Rheumatologist and found she had also developed Autoimmune Likened Pigmentosis (autoimmune disorder). On an unknown date, (also reported as not sure of date but was "pretty soon after developing the symptoms) the rheumatologist prescribed hydroxychloroquine (PLAQUENIL). After starting hydroxychloroquine (PLAQUENIL) the patient then developed black spots all over her tongue (tongue discoloration). After discovering the black spots the Rheumatologist stopped the hydroxychloroquine (PLAQUENIL). At the time of the report, the patient was not recovered from the events. No further treatment is being administered.   The causality between the events and the suspect products was unknown.
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Pain
Clinical narrative: less range of motion due to discomfort; radiating pain of R shoulder; radiating pain of R shoulder; numbness from shoulder to fingers; less range of motion due to discomfort; Information has been received from the agency Food and Drug Administration (FDA) on 21-APR-2025 and refers to a(n) 51-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included chronic hip pain. Concomitant medications included gabapentin, paracetamol (TYLENOL) and ibuprofen.  On 13-Dec-2024, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (valid lot #Y013009, expiration date: 17-Nov-2025), administered by Intramuscular route in Right Arm for Prophylaxis.  On 03-Jan-2025, the patient adiating pain of R shoulder with numbness from shoulder to fingers. Patient also experiencing less range of motion due to discomfort. Per patient has not seeked medical attention for shoulder pain. referred patientto PCP for follow up. At the reporting time, the patient had not recovered from the events  The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable.   The causal relationship between the events and the suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-21 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2825370-1 , Central date : 2025-04-21 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (y014436   02/22/2026) Temperature and Ti; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-APR-2025, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, lot# Y014436, expiration date: 22-FEB-2026 (exact dose, dose number, route of administration and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not provided). On an unknown date before administration, the vaccine underwent a temperature excursion of 5.5 up to 14.4 Fahrenheit degree for 40 minutes and 14.5 up to 46.4 Fahrenheit degree/15.8 Fahrenheit degree for 10 minutes. There was no previous temperature excursion. No additional adverse event was reported.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD that experienced temperature excursion was administered to one patient; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 10-Apr-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y011215, expiration date: 18-Dec-2025, administered for prophylaxis (strength, dose and route of administration were not reported) following temperature excursion occurred in February 2025 (Temperature 6°F to 14°F (7.2F) for 0 hours 20 minutes 0 seconds) (Improper storage of product in use). The vaccine was reconstituted with sterile diluent. No previous temperature excursion. No additional details provided. No additional AE reported (No adverse event).
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: No adverse event; HBP reported patient was administered ROTATEQ & VAXELIS during a temperature excursion. Date of administration was 04/28/2025. No additional details reported. No additional AE reported. No PQC reported.   ?    Names of vaccines involved (including; This spontaneous report was received from a Health business professional and refers to a identified patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-APR-2025, the patient received a dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), Injection (lot #U7947AA, expiration date: 31-Oct-2026) 0.5 mL (1 dose), and a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (lot #2088619, expiration date: 09-Mar-2026) both for prophylaxis, during a temperature excursion of 0°C during 1hour. There were no previous temperature excursions. No additional details reported. No additional AE reported. No PQC reported.; Reporter's Comments:
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms were reported by patient; HCP calling to reporting an administered VARIVAX with TE.; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported.   On 29-APR-2025, the patient started therapy with an improper storage of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE),(dose , route of administration were not reported) (lot #Y014868, expiration date: 03-SEP-2026) with  sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis )( Product storage error).  The administered doses of the vaccine experienced a temperature excursion -10 degree Celsius to 0 degree Celsius for 2 hours 43 minutes and 14 degrees Celsius to -10 degree Celsius (-14 degree Celsius) for 15 hours 6 minutes. It was unspecified if the data was recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. It was reported that the vaccine did not experience previous temperature excursion.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: RVX
Symptoms: Myocardial infarction
Clinical narrative: my daughter had a heart attack; This serious case was reported by a consumer via interactive digital media and described the occurrence of heart attack in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced heart attack (Verbatim: my daughter had a heart attack) (serious criteria GSK medically significant). The outcome of the heart attack was not reported.   It was unknown if the reporter considered the heart attack to be related to RSV vaccine.     The company considered the heart attack to be unrelated to RSV vaccine.   Additional Information: GSK receipt date: 01-MAY-2025 This case was reported by a patient's parent via interactive digital media.  The reporter had a mini stroke after the vaccine and the patient had a heart attack. Patient would not get another one. This case is linked with US2025AMR055150, reported by same reporter.; Sender's Comments: Myocardial infarction  is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dermatitis, Erythema, Rash macular
Clinical narrative: skin inflammation; burning sensation; red; Bumpy; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin inflammation in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included skin cancer.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin inflammation (Verbatim: skin inflammation), burning sensation (Verbatim: burning sensation), erythema (Verbatim: red) and swelling (Verbatim: Bumpy). The outcome of the skin inflammation, burning sensation, erythema and swelling were not resolved.   It was unknown if the reporter considered the skin inflammation, burning sensation, erythema and swelling to be related to Shingrix.     It was unknown if the company considered the skin inflammation, burning sensation, erythema and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2025 The patient reports on April 25th, 2025, that she got her 1st dose of Shingrix Vaccine about 3 weeks ago. The patient reported that broke out with a skin inflammation on the arms and legs, but it was not like a rash. She reports it was like a burning sensation, and states, it was like a bad sunburn, like blotchy it was red and bumpy. The patient reports it's been 3 weeks and has not resolved.  The patient reports some medical history information.  No additional event was reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza A virus test positive, Respiratory syncytial virus infection, Sinusitis, Viral diarrhoea
Clinical narrative: HPV infection; Influenza A virus subtype H1N1 test positive; Sinusitis; Viral diarrhea; This non-serious case was reported by a consumer and described the occurrence of viral diarrhea in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included human papilloma virus infection (HPV reappeared after being cleared for 2 years on most recent pap. (Viral diarrhea)). Previously administered products included Flu vaccine (patient was vaccinated for both flu and covid in the autumn.) and COVID (patient was vaccinated for both flu and covid in the autumn.).   On 01-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15-OCT-2024, 14 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced viral diarrhea (Verbatim: Viral diarrhea). On 03-DEC-2024, the patient experienced sinusitis (Verbatim: Sinusitis). On 30-JAN-2025, the patient experienced influenza a virus subtype h1n1 test positive (Verbatim: Influenza A virus subtype H1N1 test positive). On 14-FEB-2025, the patient experienced hpv infection (Verbatim: HPV infection). On 30-NOV-2024, the outcome of the viral diarrhea was resolved with sequelae (duration 1 month 15 days).  On 08-FEB-2025, the outcome of the influenza a virus subtype h1n1 test positive was resolved (duration 9 days).  On 29-MAR-2025, the outcome of the sinusitis was resolved with sequelae (duration 3 months 26 days). The outcome of the hpv infection was not resolved.   It was unknown if the reporter considered the viral diarrhea, sinusitis, hpv infection and influenza a virus subtype h1n1 test positive to be related to Shingrix and Shingrix.     It was unknown if the company considered the viral diarrhea, sinusitis, hpv infection and influenza a virus subtype h1n1 test positive to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 28-APR-2025 Patient was vaccinated for both Flu and Covid in the autumn.  Patient have never had the flu before but was sick in January. Patient shared a room or bed with an immunocompromised person and they did not get sick. Sinusitis had to be treated by ENT and was ongoing after repeated antibiotics and steroids (systemic and local).  At the time of reporting patient was on steroid nasal rinse. HPV reappeared after being cleared for 2 years on most recent pap. (Viral diarrhea).
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Skin burning sensation
Clinical narrative: Skin burning sensation; Flu like symptoms; intermittent sharp pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2025, the patient received the 1st dose of Shingrix. On 04-APR-2025, 5 hrs after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). On 05-APR-2025, the patient experienced burning sensation skin (Verbatim: Skin burning sensation). In APR-2025, the patient experienced pain (Verbatim: intermittent sharp pain). The outcome of the influenza-like symptoms was unknown and the outcome of the burning sensation skin and pain were not resolved.   It was unknown if the reporter considered the influenza-like symptoms, burning sensation skin and pain to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, burning sensation skin and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2025 The reporter reported that patient received a Shingrix vaccine over 3 weeks ago.  He experienced flu like symptoms starting about 5 hours after the injection.  By the 2nd day, noticed feeling a skin burn like sunburn under his forearms, biceps, armpits and back. There were no visible signs of change in the appearance of the skin. The skin burn had persisted since that time.  It was annoying but not a substantial pain.  However, in the last 24 hours patient had experienced a higher level of skin burn, and in one spot a localized, intermittent sharp pain.
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Herpes zoster
Clinical narrative: broke out; stomach rolls; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Patient had chronic shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 27-APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: broke out) and stomach discomfort (Verbatim: stomach rolls). The outcome of the shingles and stomach discomfort were not resolved.   It was unknown if the reporter considered the shingles and stomach discomfort to be related to Shingles vaccine.     It was unknown if the company considered the shingles and stomach discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. Patient had chronic shingles since 2001.  Patient had received the first shot and broke out on the morning of reporting day. Also stated that the pain was horrible, and stomach rolled. This case is linked with case US2025AMR054754, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR054754:friend case
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Mobility decreased, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; the last one I get it/ The pain still there; now badly can move; have 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 80-year-old 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 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 and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: the last one I get it/ The pain still there), mobility decreased (Verbatim: now badly can move) and extra dose administered (Verbatim: have 3 shots). The outcome of the vaccination failure was not reported and the outcome of the shingles and mobility decreased were not resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure, shingles and mobility decreased to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and mobility decreased to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. The patient had 3 shots of Shingles vaccine and after the last one he/she got it (shingles). The patient reported that the pain was still there and now he/she badly could move. The patient received the three 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 regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and Dose 3).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received old vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 This case was reported by a patient via interactive digital media. The patient had the old vaccine then the two shots of the new Shingrix vaccine and after that he/she got shingles.  It was milder because of having the vaccine but patient still got it at 71. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Muscle disorder
Clinical narrative: lost all muscle control; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle disorder 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 muscle disorder (Verbatim: lost all muscle control). The outcome of the muscle disorder was not reported.   It was unknown if the reporter considered the muscle disorder to be related to Shingles vaccine.     It was unknown if the company considered the muscle disorder to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his/her friend who got second shot and experienced lost all muscle control. The reporter mentioned that so what's a person to did. This case had been link with US2025AMR052000, reported by the same reporter.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a patient via interactive digital media. The reporter said that they did not always work and he/she thought may sometimes trigger the disease, 2 out of 3 friends that took the vaccine got shingles shortly after. One friend (patient) had a light case and the other friend had more severe on her head and forehead. This case is linked with US2025AMR054251, reported by same reporter; Sender's Comments:  US-GSK-US2025AMR054251:friend case
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 unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a consumer via interactive digital media. Reporter reported that big pharmaceutical companies pushing poison (vaccine) and everyone the reporter knew who got their poison (vaccine) got shingles anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 17-year-old patient received an adult dose of Havrix; 17-year-old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 17-year-old female patient who received HAV (Havrix) (batch number Z27PB, expiry date 27-AUG-2026) for prophylaxis.   On 02-MAR-2025, the patient received the 1st dose of Havrix. On 02-MAR-2025, an unknown time after receiving Havrix, the patient experienced adult product administered to child (Verbatim: 17-year-old patient received an adult dose of Havrix) and overdose (Verbatim: 17-year-old patient received an adult dose of Havrix). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-APR-2025 Other HCP reported that on 02nd May 2025, a 17-year-old patient received an adult dose of Havrix, which led to Adult product administered to child and overdose. It was the first dose of the series.
Age: 61.0
Sex: F
Vaccine: CHIK
Symptoms: Bone pain, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Fever, severe bone pain, muscle aches, severe headache (described as the worst she's had, skeletal in nature. Teeth throbbing, skull pain, etc), lethargy, chills. Symptoms started on day 7, still continuing on day 10 . Patient reported today that she is starting to feel better, but still has nausea, low grade fever, fatigue. OTC medications not helpful in managing symptoms.