chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Dupixent, start date: 08Apr2022, stop date: 06Nov2024, for atopic dermatitis unspecified, reaction(s): "walking issues", notes: solution for injection of strength 300mg/2ml at a dose of 300 mg QOW subcutaneous; Dupixent, start date: 08Apr2022, stop date: 06Nov2024, for atopic dermatitis unspecified, reaction(s): "gotten really sick", notes: solution for injection of strength 300mg/2ml at a dose of 300 mg QOW subcutaneous. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Patient reported she had held off on taking Dupixent about 2 weeks ago due to getting a Covid shot. Patient stated it had made her very sick.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She just got really sick from getting the Pfizer a couple of times; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00069 (Novavax).  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She just got really sick from getting the Pfizer a couple of times".  Additional Information: Caller was asked if she was immunocompromised or previously vaccinated against COVID-19 and if she was over 65 years old. Caller added she just got really sick from getting the Pfizer a couple of times so she did not know if this was a better alternative in the future to get this vaccine, like the hepatitis A, B, they have the same type of you know, the flu shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt given Arexvy a 2nd time, previously administered 8/23/2023
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Musculoskeletal disorder
Clinical narrative: unberabl;e pain shoulder . couldnt move my arm for month. sensetive to the lightest tpuch evoke sharp pain. my arm was as paraloized,stuck. couldnt move,couldnt use, couldnt dress, .  i went to my doctor to get help. i was reffered to the physical therapy,  3 times a week. supreme pai in the therapy. chiropracot, needle treatment.  till today my left arm is weak.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: unberabl;e pain shoulder . couldnt move my arm for month. sensetive to the lightest tpuch evoke sharp pain. my arm was as paraloized,stuck. couldnt move,couldnt use, couldnt dress, .  i went to my doctor to get help. i was reffered to the physical therapy,  3 times a week. supreme pai in the therapy. chiropracot, needle treatment.  till today my left arm is weak.
Age: 71.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Infection
Clinical narrative: a customer come in claiming she got an infection in her left arm after she received two vaccinations from our pharmacy on Wednesday, Feb 19 at approximately noon. On Saturday, Feb 22 she sought medical attention to an urgent care facility for the infection she claimed she had gotten. Today Feb 23rd at 2:50pm she came into the store and stated she wanted it to be reported and brought in the medical paperwork she received.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Aldolase increased, Aspartate aminotransferase increased, Biopsy muscle abnormal, Blood creatine phosphokinase increased
Clinical narrative: I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase increased, Blood test abnormal, Chest pain, Discomfort, Fatigue
Clinical narrative: I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Lactate pyruvate ratio abnormal, Magnetic resonance imaging abnormal, Migraine, Muscle fatigue
Clinical narrative: I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myoglobin blood increased, Neuralgia, Oedema, Pain, Palpitations
Clinical narrative: I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: I was an active and healthy prior to this vaccine with minimal doctor?s visits per year except for recurrent sinuses infections. Before this vaccine, I had less than 5 doctors appointments for the year. After this 4th bivalent shot, I have had over 200 visits to clinic and emergency medicine. I suffer from migraines, fatigue, gi bloating and pain, muscle fatigue and soreness, migraine, and nerve pain. I also get one-sided unilateral pain and pressure that will go from head to toe and switch side to side. I also experienced heart palpitations and chest pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came in for an influenza vaccine and had a caregiver that filled out the Vaccine Administration Record form.  In the Date of Birth section they wrote the correct DOB of 8/XX/60, but in the Age section they wrote 65. The high dose influenza vaccine was run through the system due to the error on the form.  Patient was then administered the high dose flu shot.  The DOB/age discrepancy was noted shortly after patient and caregiver left.  Caregiver was contacted and made aware of the situation and what to monitor concerning potential side effects.  Staff was educated on error prevention.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: At vaccination patient had said he had shingles history. Patient returned to pharmacy said he got shingles from the vaccine he received. Patient was presribed valacyclovir and gabapentin for treatment.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Allergy to metals, Blood test, Colonoscopy abnormal, Constipation
Clinical narrative: Developed severe diarrhea that Imodium and prescription anti-diarrheal had no impact. I had multiple tests that could not determine what caused it. I reacted as if all food had gluten in it. Even the low fodmap diet didn't help. In July 2022 I had an endoscopy and colonoscopy. I had inflammation thru whole digestive system. Diarrhea ended in Dec 2022 after taking Rabeprazole and severe constipation started. I also started having light-headedness and dizzy spells in June 2021. In May 2022 I was diagnosed with POTS. Since my Vagus nerve damaged in 2016, I could not feel my heart rate issues. I bought a smartwatch and found out that my heart rate varied from 30 bpm to low 200s.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Endoscopy abnormal, Gastrointestinal inflammation, Heart rate abnormal
Clinical narrative: Developed severe diarrhea that Imodium and prescription anti-diarrheal had no impact. I had multiple tests that could not determine what caused it. I reacted as if all food had gluten in it. Even the low fodmap diet didn't help. In July 2022 I had an endoscopy and colonoscopy. I had inflammation thru whole digestive system. Diarrhea ended in Dec 2022 after taking Rabeprazole and severe constipation started. I also started having light-headedness and dizzy spells in June 2021. In May 2022 I was diagnosed with POTS. Since my Vagus nerve damaged in 2016, I could not feel my heart rate issues. I bought a smartwatch and found out that my heart rate varied from 30 bpm to low 200s.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abdominal abnormal, Nerve injury, Postural orthostatic tachycardia syndrome, Stool analysis
Clinical narrative: Developed severe diarrhea that Imodium and prescription anti-diarrheal had no impact. I had multiple tests that could not determine what caused it. I reacted as if all food had gluten in it. Even the low fodmap diet didn't help. In July 2022 I had an endoscopy and colonoscopy. I had inflammation thru whole digestive system. Diarrhea ended in Dec 2022 after taking Rabeprazole and severe constipation started. I also started having light-headedness and dizzy spells in June 2021. In May 2022 I was diagnosed with POTS. Since my Vagus nerve damaged in 2016, I could not feel my heart rate issues. I bought a smartwatch and found out that my heart rate varied from 30 bpm to low 200s.
Age: 61.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: Feeling tired after 2-3 hours of vaccine administration
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Feeling abnormal, Intervertebral disc space narrowing, Neck pain, Pain
Clinical narrative: Patient presented 02/21/2025 for office visit and described the event. No report of the event was reported to our clinic prior to this date. Patient reported:  - Experienced pain in the left shoulder after receiving a vaccine on November 27, 2023. - Pain began the same day as the vaccine administration. - Pain intensifies with arm movement, particularly when raising the arm or doing hair. Pain located in shoulder (deltoid region), and feelings a "weird feeling" radiate down arm over lateral arm and forearm with certain movements - She notes that the pain sometimes starts radiates from the mid left side of her neck and radiates neck down the left arm.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Spinal X-ray abnormal, Spinal osteoarthritis, X-ray limb
Clinical narrative: Patient presented 02/21/2025 for office visit and described the event. No report of the event was reported to our clinic prior to this date. Patient reported:  - Experienced pain in the left shoulder after receiving a vaccine on November 27, 2023. - Pain began the same day as the vaccine administration. - Pain intensifies with arm movement, particularly when raising the arm or doing hair. Pain located in shoulder (deltoid region), and feelings a "weird feeling" radiate down arm over lateral arm and forearm with certain movements - She notes that the pain sometimes starts radiates from the mid left side of her neck and radiates neck down the left arm.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None reported, but this dose of Fluzone HD was second dose of the season, he received first dose 08/24/2024.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: None reported, Fluzone HD dose given 10/05/2024 was second dose of 2024-25 version, first dose of Flublok was given 08/24/2024.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Acne, Pustule
Clinical narrative: patient state about a week after injection a pimple came up and popped and pus came out. just has not healed in the meantime. just reported to me on 2/26/25
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, Asthma, Condition aggravated, Confusional state
Clinical narrative: Shortness of breath, wheezing, dizziness, anxiety, shaky , tremors, confusion, memory loss, increased insulin resistance, inflammation, frequent asthma attacks.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Inflammation, Insulin resistance, Tremor
Clinical narrative: Shortness of breath, wheezing, dizziness, anxiety, shaky , tremors, confusion, memory loss, increased insulin resistance, inflammation, frequent asthma attacks.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Shortness of breath, wheezing, dizziness, anxiety, shaky , tremors, confusion, memory loss, increased insulin resistance, inflammation, frequent asthma attacks.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting 1 hour after 2x with no fever
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around vaccination injection site. Patient was complaining that injection site hurts on 2/25/2025.  Per personnel, arm is getting better on 2/26/2025.  Ice was applied and arm was elevated.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: ER
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Areflexia, CSF protein increased, Immunoglobulin therapy, Muscular weakness, Paralysis
Clinical narrative: Patient experienced lower extremity weakness starting Tuesday 2/18/25 which progressed to full paralysis on Friday 2/21/25. Patient had no reflexes upon presentation at ER and underwent lumbar puncture.  She received IGG with improvement in symptoms and no worsening or further paralysis.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, tightness in chest came in shortly after the dose of Pfizer vaccine. Weakness and increased inflammation in joints, dizziness, wheezing are all symptoms I experienced since having the series of the Pfizer vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Shortness of breath, tightness in chest came in shortly after the dose of Pfizer vaccine. Weakness and increased inflammation in joints, dizziness, wheezing are all symptoms I experienced since having the series of the Pfizer vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood alkaline phosphatase increased, COVID-19, Computerised tomogram abdomen normal, Malaise
Clinical narrative: The following events are before any COVID19 infection: first 48H after the vaccine administration, developed malaise, 72H after vaccine administration started with severe abdominal pain, nausea and vomiting, that prompted ED visit.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Primary biliary cholangitis, Scan with contrast normal, Smooth muscle antibody positive, Transaminases increased
Clinical narrative: The following events are before any COVID19 infection: first 48H after the vaccine administration, developed malaise, 72H after vaccine administration started with severe abdominal pain, nausea and vomiting, that prompted ED visit.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The following events are before any COVID19 infection: first 48H after the vaccine administration, developed malaise, 72H after vaccine administration started with severe abdominal pain, nausea and vomiting, that prompted ED visit.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis perforated, Blood test, Computerised tomogram, Intra-abdominal fluid collection, Magnetic resonance imaging
Clinical narrative: 1. Pernicious Anemia onset 4 months after 1 Moderna dose mRNA Covid. Treatment has been B-12 injections 2x/month. Outcome is injections and monitoring for life.  2. Burst Appendix 2 years after Covid 19 Modern with mucin in abdomen. Treatment is HPEC surgery was recommended but refused; MRI, CT, blood tests for tumor markers, MRI again, monitoring for life.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pernicious anaemia, Tumour marker test
Clinical narrative: 1. Pernicious Anemia onset 4 months after 1 Moderna dose mRNA Covid. Treatment has been B-12 injections 2x/month. Outcome is injections and monitoring for life.  2. Burst Appendix 2 years after Covid 19 Modern with mucin in abdomen. Treatment is HPEC surgery was recommended but refused; MRI, CT, blood tests for tumor markers, MRI again, monitoring for life.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy, SARS-CoV-2 test negative
Clinical narrative: Enlarged/inflamed lymph nodes, persist today, years later. Never had a positive covid test even though I took them whenever me or someone in my family was symptomatic. My reason for including this is: it seems to me to be from the vaccine not ?long covid? or anything other than the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Exposure during pregnancy, Foetal hypokinesia, Foetal monitoring
Clinical narrative: Received first dose of moderna covid vaccine from pharmacy while 36 weeks pregnant. No side effects other than a sore arm.  Received the second dose of moderna covid vaccine from pharmacy at 38 weeks pregnant, after/at 5 pm on 10/21/21. That evening, I  Noticed the fetus/ infant stopped moving. Admitted to labor and delivery triage the next morning to monitor fetal vitals. Due to decreased fetal movement, the infant was delivered via emergency c-section on the same day, 10/xx/24. The original delivery date was 11/1/2021. Baby was considered full term at 38 weeks, weighing 6 lbs 2 oz.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: no adverse event; vaccine exposure during pregnancy; This prospective spontaneous report has been received from a health professional regarding a 31-year-old female patient. The patient's medical history included rash due to handling bleach. Information regarding concurrent conditions and concomitant therapies was not reported. On 08-JAN-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis , lot number Y007991 which has been verified to be valid, expiration date reported and validated as 18-JUN-2026. (strength, dose, scheme, route of administration, and anatomical site not reported) On 12-NOV-2024, the patient's pregnancy test resulted negative. On an unknown date, the caller stated during ultrasound, patient was about 6 weeks and 3 days pregnant when she received vaccine (conflicting information, the reporter stated the patient was "unknowingly pregnant" when she received the vaccine) (vaccination exposure during pregnancy). On 28-JAN-2025, the patient's pregnancy test was positive. No additional information provided, no adverse event. The pregnancy and fetal outcome was unknown.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on face; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash on face). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK receipt date: 13-FEB-2025 The reporter reported that the patient had recived Shingrix vaccine and experienced rash. The reporter had a question about Shingrix vaccine could it cause a rash on face and how long to go away.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: 9-year-old male patient was accidentally given two doses of Flulaval; should have received Flulaval and Gardasil/9-year-old male patient was accidentally given two doses of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 9-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   Co-suspect products included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL).   On 30-JAN-2025 17:10, the patient received FluLaval 2024-2025 season (right deltoid). On an unknown date, the patient received GARDASIL. On 30-JAN-2025 17:10, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental overdose (Verbatim: 9-year-old male patient was accidentally given two doses of Flulaval) and wrong vaccine administered (Verbatim: should have received Flulaval and Gardasil/9-year-old male patient was accidentally given two doses of Flulaval). The outcome of the accidental overdose and wrong vaccine administered 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 : 30-JAN-2025 The patient was accidentally given two doses of Flulaval, one in the Left Deltoid, and one in the Right Deltoid.  The patient should have received Flulaval and Gardasil, and the patient's sibling was also going to get the flu shot, but she somehow put everything on one tray, and the 9-year-old got 2 doses of flu, which led to accidental overdose and wrong vaccine administered. No further details were provided.  The reporter consented to follow up.
Age: 25.0
Vaccine: UNK
Symptoms: Chills, Pyrexia
Clinical narrative: High fever, shivers
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour
Clinical narrative: Pre-term labor. Pregnancy was otherwise uncomplicated. Estimated date of delivery was 1/4/25. Birth weight was 5 lbs 5 oz
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal non-stress test normal, Uterine contractions during pregnancy
Clinical narrative: False labor contractions- due date 3/12/25
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Fainted; Dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-FEB-2025, the patient received the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant) and dizziness (Verbatim: Dizzy). The outcome of the fainting was resolved and the outcome of the dizziness was not resolved.   It was unknown if the reporter considered the fainting and dizziness to be related to Shingles vaccine.     The company considered the fainting and dizziness to be unrelated to Shingles vaccine.   Additional Information: GSK receipt Date: 15-FEB-2025 This case was reported by a patient via interactive digital media. The patient received shingles vaccine a day before reporting .  Now, the patient was extremely dizzy and fainted once.; Sender's Comments: Syncope and Dizziness are unlisted events which are considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   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: 12-FEB-2025 Patient received 2 doses of Shingrix and developed shingles. Patient was recovered. The symptoms were treated. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received his second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second ). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter reported that patient stated that he received his first dose of Shingrix in 2023 and never received his second because he moved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin reaction (Verbatim: Skin reaction). The outcome of the skin reaction was not reported.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.     It was unknown if the company considered the skin reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2025 The patient self reported this case for himself/herself  This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: selling in her neck; tender to touch; States there are no visual signs of bruising it just feels like bruising; she developed a headache; nausea; she had chills; fever; aches and pains; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 04-FEB-2025, 3 hrs after receiving Shingrix, the patient experienced chills (Verbatim: she had chills), fever (Verbatim: fever) and pain (Verbatim: aches and pains). On 05-FEB-2025, the patient experienced headache (Verbatim: she developed a headache) and nausea (Verbatim: nausea). On 06-FEB-2025, the patient experienced neck swelling (Verbatim: selling in her neck), tenderness (Verbatim: tender to touch) and contusion (Verbatim: States there are no visual signs of bruising it just feels like bruising). The outcome of the chills, fever, pain and headache were resolved and the outcome of the nausea and neck swelling were not resolved and the outcome of the tenderness and contusion were not reported.   It was unknown if the reporter considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix.     It was unknown if the company considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix.   Additional Information: GSK receipt date: 06-FEB-2025 The reporter was the patient who received the first dose of Shingrix vaccine series in her left deltoid.  The vaccine was administered at the pharmacy. The reporter stated she had experienced chills, fever, aches, and pains 3 hours after receiving vaccine and symptoms have resolved.  Also, stated she developed a headache and nausea 1 day after receiving the vaccine.  The headache had resolved but the nausea still remains. The reporter mentioned that 2 days after receiving the vaccine she noticed swelling in her left neck that was tender to touch and feels like bruising. The reporter stated there were no visual signs of bruising it just feels like bruising.  The selling in her neck still remains. The patient did not have a lot number or number of vaccine on the papers she received from the pharmacy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: selling in her neck; tender to touch; States there are no visual signs of bruising it just feels like bruising; she developed a headache; nausea; she had chills; fever; aches and pains; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 04-FEB-2025, 3 hrs after receiving Shingrix, the patient experienced chills (Verbatim: she had chills), fever (Verbatim: fever) and pain (Verbatim: aches and pains). On 05-FEB-2025, the patient experienced headache (Verbatim: she developed a headache) and nausea (Verbatim: nausea). On 06-FEB-2025, the patient experienced neck swelling (Verbatim: selling in her neck), tenderness (Verbatim: tender to touch) and contusion (Verbatim: States there are no visual signs of bruising it just feels like bruising). The outcome of the chills, fever, pain and headache were resolved and the outcome of the nausea and neck swelling were not resolved and the outcome of the tenderness and contusion were not reported.   It was unknown if the reporter considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix.     It was unknown if the company considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix.   Additional Information: GSK receipt date: 06-FEB-2025 The reporter was the patient who received the first dose of Shingrix vaccine series in her left deltoid.  The vaccine was administered at the pharmacy. The reporter stated she had experienced chills, fever, aches, and pains 3 hours after receiving vaccine and symptoms have resolved.  Also, stated she developed a headache and nausea 1 day after receiving the vaccine.  The headache had resolved but the nausea still remains. The reporter mentioned that 2 days after receiving the vaccine she noticed swelling in her left neck that was tender to touch and feels like bruising. The reporter stated there were no visual signs of bruising it just feels like bruising.  The selling in her neck still remains. The patient did not have a lot number or number of vaccine on the papers she received from the pharmacy.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 day old receiving a infanrix vaccine; Administered Infanrix instead of hepatitis B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-day-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 21-FEB-2025, the patient received Infanrix. On an unknown date, the patient received Engerix B. On 21-FEB-2025, an unknown time after receiving Infanrix and not applicable after receiving Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 day old receiving a infanrix vaccine) and wrong vaccine administered (Verbatim: Administered Infanrix instead of hepatitis B vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 21-FEB-2025 Other HCP started a 16 day old receiving a Infanrix vaccine. According to reporter, the dose was administered earlier that day. Reporter had a 16 days old baby that received Infanrix instead of the Hepatitis B, Engerix-B, which led to wrong vaccine administered. Reporter need to know what they need to do for this child. 16 day old receiving a Infanrix vaccine, which led to inappropriate age at vaccine administration.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Agitation, Aphasia, Arthritis, Blister
Clinical narrative: Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable BP, admitted in hospital under stroke alert. Depression.Unexplained fever. Often feel malaise. Severe inflammation in joints & muscles. Loss of muscle mass. Agitation, depression. Difficulty regulating body temperature.Trigeminal nerve flareup. Stomach & digestive issues, IBS. Worsening vision & sensitivity to light. Extreme fatigue, foggy brain & trouble concentrating. My handwriting has gotten worse. Please see additional symptoms below: At times, difficulty articulating sentences. Insomnia. Unregulated body temperature.  Uncontrollable sweating at night. Admitted to the hospital under stroke watch. Stomach pain with digestive issues. Red rash on lower arms & legs. Rash on the right side of the face, more so on the right side. Excruciating thigh pain. Extreme exhaustion after low exercise or daily activities. EBV flareups will start in my face, work their way down my body, through my digestive tract, down my leg, and come out through my toe, where the toe will blister, and eventually, the nail will fall off. I have all the documentation & dates of "episodes." With EBV since Moderna, I am constantly in a cold sore breakout throughout my body.   The scariest episode was when I showed one of my listings, and the seller was home by the grace of God. I got a head rush like I have never had in my life. It would not go away. My seller sat me down and gave me water & cold compress. Asked if she should call EMS. I said no, I don't need that bill.... I went to the ER the next morning, and my BP was at stroke levels, and that is when I was admitted. I can't imagine what my blood pressure was during the showing.   I have seen my:  A primary care provider on more than one occasion. She ran the EBV test and other bloodwork. That doctor left another doctor took her place and he said he won't run the EBV test again because once you have it, you always have it. I've paid out of pocket and have had myself tested, keeping an eye on my EBV load  Gastroenterologist twice in the past few years who has performed endoscopy & colonoscopy to try and figure out if something was going on inside  The podiatrist showing her blistered toes  Rheumatoid Arthritis doctor who could not understand why my PCP referred me to her   A Psychiatrist who tried to put me on antidepressant  Cardiologist for heart ultrasound & to wear a halter for 5 days (waiting to see if they call me to let me know results because they never scheduled a follow-up appointment with me.  Neurologist 1 to rule out MS  Neurologist 2 to rule out MS again & to go over mini stroke  Urologist 1 to go over incontinent issues with no resolve  Urologist 2 to go over incontinent issues again with no resolve  I have an appointment with an infectious disease doctor on March 3, 2025
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure fluctuation, Blood test, Brain fog, Chronic active Epstein-Barr virus infection, Chronic fatigue syndrome
Clinical narrative: Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable BP, admitted in hospital under stroke alert. Depression.Unexplained fever. Often feel malaise. Severe inflammation in joints & muscles. Loss of muscle mass. Agitation, depression. Difficulty regulating body temperature.Trigeminal nerve flareup. Stomach & digestive issues, IBS. Worsening vision & sensitivity to light. Extreme fatigue, foggy brain & trouble concentrating. My handwriting has gotten worse. Please see additional symptoms below: At times, difficulty articulating sentences. Insomnia. Unregulated body temperature.  Uncontrollable sweating at night. Admitted to the hospital under stroke watch. Stomach pain with digestive issues. Red rash on lower arms & legs. Rash on the right side of the face, more so on the right side. Excruciating thigh pain. Extreme exhaustion after low exercise or daily activities. EBV flareups will start in my face, work their way down my body, through my digestive tract, down my leg, and come out through my toe, where the toe will blister, and eventually, the nail will fall off. I have all the documentation & dates of "episodes." With EBV since Moderna, I am constantly in a cold sore breakout throughout my body.   The scariest episode was when I showed one of my listings, and the seller was home by the grace of God. I got a head rush like I have never had in my life. It would not go away. My seller sat me down and gave me water & cold compress. Asked if she should call EMS. I said no, I don't need that bill.... I went to the ER the next morning, and my BP was at stroke levels, and that is when I was admitted. I can't imagine what my blood pressure was during the showing.   I have seen my:  A primary care provider on more than one occasion. She ran the EBV test and other bloodwork. That doctor left another doctor took her place and he said he won't run the EBV test again because once you have it, you always have it. I've paid out of pocket and have had myself tested, keeping an eye on my EBV load  Gastroenterologist twice in the past few years who has performed endoscopy & colonoscopy to try and figure out if something was going on inside  The podiatrist showing her blistered toes  Rheumatoid Arthritis doctor who could not understand why my PCP referred me to her   A Psychiatrist who tried to put me on antidepressant  Cardiologist for heart ultrasound & to wear a halter for 5 days (waiting to see if they call me to let me know results because they never scheduled a follow-up appointment with me.  Neurologist 1 to rule out MS  Neurologist 2 to rule out MS again & to go over mini stroke  Urologist 1 to go over incontinent issues with no resolve  Urologist 2 to go over incontinent issues again with no resolve  I have an appointment with an infectious disease doctor on March 3, 2025
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Colonoscopy, Computerised tomogram head, Depression, Disturbance in attention, Dizziness
Clinical narrative: Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable BP, admitted in hospital under stroke alert. Depression.Unexplained fever. Often feel malaise. Severe inflammation in joints & muscles. Loss of muscle mass. Agitation, depression. Difficulty regulating body temperature.Trigeminal nerve flareup. Stomach & digestive issues, IBS. Worsening vision & sensitivity to light. Extreme fatigue, foggy brain & trouble concentrating. My handwriting has gotten worse. Please see additional symptoms below: At times, difficulty articulating sentences. Insomnia. Unregulated body temperature.  Uncontrollable sweating at night. Admitted to the hospital under stroke watch. Stomach pain with digestive issues. Red rash on lower arms & legs. Rash on the right side of the face, more so on the right side. Excruciating thigh pain. Extreme exhaustion after low exercise or daily activities. EBV flareups will start in my face, work their way down my body, through my digestive tract, down my leg, and come out through my toe, where the toe will blister, and eventually, the nail will fall off. I have all the documentation & dates of "episodes." With EBV since Moderna, I am constantly in a cold sore breakout throughout my body.   The scariest episode was when I showed one of my listings, and the seller was home by the grace of God. I got a head rush like I have never had in my life. It would not go away. My seller sat me down and gave me water & cold compress. Asked if she should call EMS. I said no, I don't need that bill.... I went to the ER the next morning, and my BP was at stroke levels, and that is when I was admitted. I can't imagine what my blood pressure was during the showing.   I have seen my:  A primary care provider on more than one occasion. She ran the EBV test and other bloodwork. That doctor left another doctor took her place and he said he won't run the EBV test again because once you have it, you always have it. I've paid out of pocket and have had myself tested, keeping an eye on my EBV load  Gastroenterologist twice in the past few years who has performed endoscopy & colonoscopy to try and figure out if something was going on inside  The podiatrist showing her blistered toes  Rheumatoid Arthritis doctor who could not understand why my PCP referred me to her   A Psychiatrist who tried to put me on antidepressant  Cardiologist for heart ultrasound & to wear a halter for 5 days (waiting to see if they call me to let me know results because they never scheduled a follow-up appointment with me.  Neurologist 1 to rule out MS  Neurologist 2 to rule out MS again & to go over mini stroke  Urologist 1 to go over incontinent issues with no resolve  Urologist 2 to go over incontinent issues again with no resolve  I have an appointment with an infectious disease doctor on March 3, 2025
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgraphia, Echocardiogram, Electrocardiogram ambulatory, Endoscopy, Epstein-Barr virus test
Clinical narrative: Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable BP, admitted in hospital under stroke alert. Depression.Unexplained fever. Often feel malaise. Severe inflammation in joints & muscles. Loss of muscle mass. Agitation, depression. Difficulty regulating body temperature.Trigeminal nerve flareup. Stomach & digestive issues, IBS. Worsening vision & sensitivity to light. Extreme fatigue, foggy brain & trouble concentrating. My handwriting has gotten worse. Please see additional symptoms below: At times, difficulty articulating sentences. Insomnia. Unregulated body temperature.  Uncontrollable sweating at night. Admitted to the hospital under stroke watch. Stomach pain with digestive issues. Red rash on lower arms & legs. Rash on the right side of the face, more so on the right side. Excruciating thigh pain. Extreme exhaustion after low exercise or daily activities. EBV flareups will start in my face, work their way down my body, through my digestive tract, down my leg, and come out through my toe, where the toe will blister, and eventually, the nail will fall off. I have all the documentation & dates of "episodes." With EBV since Moderna, I am constantly in a cold sore breakout throughout my body.   The scariest episode was when I showed one of my listings, and the seller was home by the grace of God. I got a head rush like I have never had in my life. It would not go away. My seller sat me down and gave me water & cold compress. Asked if she should call EMS. I said no, I don't need that bill.... I went to the ER the next morning, and my BP was at stroke levels, and that is when I was admitted. I can't imagine what my blood pressure was during the showing.   I have seen my:  A primary care provider on more than one occasion. She ran the EBV test and other bloodwork. That doctor left another doctor took her place and he said he won't run the EBV test again because once you have it, you always have it. I've paid out of pocket and have had myself tested, keeping an eye on my EBV load  Gastroenterologist twice in the past few years who has performed endoscopy & colonoscopy to try and figure out if something was going on inside  The podiatrist showing her blistered toes  Rheumatoid Arthritis doctor who could not understand why my PCP referred me to her   A Psychiatrist who tried to put me on antidepressant  Cardiologist for heart ultrasound & to wear a halter for 5 days (waiting to see if they call me to let me know results because they never scheduled a follow-up appointment with me.  Neurologist 1 to rule out MS  Neurologist 2 to rule out MS again & to go over mini stroke  Urologist 1 to go over incontinent issues with no resolve  Urologist 2 to go over incontinent issues again with no resolve  I have an appointment with an infectious disease doctor on March 3, 2025