chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1, DTPPVHBHPB, PNC20
Symptoms: Rash, Urticaria
Clinical narrative: Diffuse erythematous maculopapular rash began about two hours after injection, on face, back, chest / abdomen, upper arms and legs, sparing palms/soles. Annular erythematous macules over bilateral injection sites. No vomiting, diarrhea, fussiness, facial/oral swelling, difficulty breathing, fever, lethargy.  5/30/2025 Update information: Attempted to contact parents and no answer to obtain updates on health status. A voice mail was left in parent's phone to contact clinic for any updates and also instructed to go to Emergency Room if any shortness of breath, swelling, fever.
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Joint range of motion decreased, Muscle spasms
Clinical narrative: - Muscle Spasms - Decreased range of motion
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; Product was expired 3/14/2021, was  administered on 4/1/2021.; This spontaneous report was received from a Nurse and refers to an 1-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 01-APR-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #S007814, expiration date reported as 14-MAR-2021 (dose, strength, route of administration, anatomical location of vaccine were not reported) and diluted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) for prophylaxis. The patient did not experience adverse effects.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: reconstituted with sterile water instead of the MenCYW-135; Menveo - Reconstitution with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMABO56A, expiry date 31-AUG-2025) for prophylaxis.   On 28-MAY-2025, the patient received Menveo. On 28-MAY-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water instead of the MenCYW-135) and inappropriate dose of vaccine administered (Verbatim: Menveo - Reconstitution with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 28-MAY-2025 A nurse reported that a patient was given a dose of Menveo (2 vial) that was reconstituted with sterile water instead of the MenCYW-135 liquid component which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The nurse asked for the recommended interval to repeat the dose. Consented to follow up.
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Patient called and states she is having a reaction to the vaccine she received on Saturday. She states she started having flu-like symptoms (fever, chills, general malaise) on Sunday, followed by an injection site reaction starting Monday.  She called concerning her arm. She is experiencing swelling, pain, redness, warmth, itching and it?s ?hard?. The affected area starts at the shoulder and extends about 4 inches. I advised her to ice on and off for 20minutes, take Tylenol, and Benadryl before bed, if no relief in 24hrs or symptoms worsen to have it examined by provider. 48 hours late, patient reports arm is still symptomatic, but is improving.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain left wrist knee and ankle
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at injection site 2 days after vaccination.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Asthenia, Back pain, Burning sensation, Dizziness
Clinical narrative: Deep muscle or pain and burning in left arm down tips of fingers. Throat and ears hurt. Dizziness, nausea, feeling faint, eye sight change to tunnel vision and darkness, sweating, and weakness. Neck and shoulder pain. Weakness and lower back pain with left leg pain, and headache.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Ear pain, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Deep muscle or pain and burning in left arm down tips of fingers. Throat and ears hurt. Dizziness, nausea, feeling faint, eye sight change to tunnel vision and darkness, sweating, and weakness. Neck and shoulder pain. Weakness and lower back pain with left leg pain, and headache.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Tunnel vision
Clinical narrative: Deep muscle or pain and burning in left arm down tips of fingers. Throat and ears hurt. Dizziness, nausea, feeling faint, eye sight change to tunnel vision and darkness, sweating, and weakness. Neck and shoulder pain. Weakness and lower back pain with left leg pain, and headache.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acne, Arthropod bite, Laboratory test, Magnetic resonance imaging head, Staphylococcal infection
Clinical narrative: Developed MRSA four different times in a row in 2021, first infection developed from a minor bug bite and took over a month to treat, daily visits to the walk-in clinic.  This repeated itself with another MRSA infection from a pimple 3 other times.  Had to get an MRI to see if the infection had spread to my eyes and they had been swollen shut for 4 days I couldn't see.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Developed MRSA four different times in a row in 2021, first infection developed from a minor bug bite and took over a month to treat, daily visits to the walk-in clinic.  This repeated itself with another MRSA infection from a pimple 3 other times.  Had to get an MRI to see if the infection had spread to my eyes and they had been swollen shut for 4 days I couldn't see.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Deafness, Dizziness, Hearing aid user, Laboratory test
Clinical narrative: SEVERE VERTIGO, both times of the required 2 shot required, first 08/24/2021, second required was 9/14/2021
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Vertigo
Clinical narrative: SEVERE VERTIGO, both times of the required 2 shot required, first 08/24/2021, second required was 9/14/2021
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PATIENT COMPLAINED OF A RED VERY ITCHY  RASHES ON TORSO - UPPER BACK / THORAX / ARMPITS / BREASTS AND MOVING TO NECK  A SHORT WHILE AFTER  THE VACCINE WAS ADMINISTERED .
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Rash
Clinical narrative: rash and hospitalized
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Arthralgia, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: Moderate redness/pain/swelling at injection site (4?x4?), headache, joint pain,  muscle aches, feverish, chills, fatigue, food tastes strange,
Age: 51.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Moderate redness/pain/swelling at injection site (4?x4?), headache, joint pain,  muscle aches, feverish, chills, fatigue, food tastes strange,
Age: 71.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Blood culture, Blood lactic acid, Blood test, Cardiac monitoring, Chest X-ray
Clinical narrative: Developed high fever  of 103 and could barely walk. Also urinating more than normal. Had to call 911 times take me to ER
Age: 71.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Computerised tomogram abdomen, Culture urine, Electrocardiogram, Full blood count, Gait disturbance
Clinical narrative: Developed high fever  of 103 and could barely walk. Also urinating more than normal. Had to call 911 times take me to ER
Age: 71.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Influenza virus test, Metabolic function test, Pollakiuria, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Developed high fever  of 103 and could barely walk. Also urinating more than normal. Had to call 911 times take me to ER
Age: 71.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: SARS-CoV-2 test, Scan with contrast, Troponin, Urine analysis
Clinical narrative: Developed high fever  of 103 and could barely walk. Also urinating more than normal. Had to call 911 times take me to ER
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Dysarthria, Fatigue, Gait disturbance
Clinical narrative: patient had fatigue, unsteady gait, slurred speech
Age: 1.25
Sex: F
Vaccine: HEPA, PNC20, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: patient attend 15month WCC at Primary Care Office on 5/29/25. Parents reported seeing the beginnings of a red pinpointed slightly raised rash on stomach that day while in the exam room PRIOR to receiving 3 of the scheduled vaccines she was due for, but it was minor. what was clear and what prompted a call to the same PCP office on 5/31/25 by both parents, is that the rash started spreading by late 5/29 and clearly morning of 5/30. rash also associated with low grade fever, no higher than 100.4 , but mostly 99. Patient is in  no apparent distress, change in behaviors or routines, appetite, rash has spread in 24-48 hrs of the visit , if not that night  to full stomach, back , bilateral arms and legs, tops of feet's and hands , some on fingers. some scattered around chin area and jaw. slightly raised, not fluid filled yet. does not appear to itch or be painful . fever controlled by Motrin.  rash is not deep purple  - red pink. not blotchy . various stages of size. has 1 spot on bottom of foot.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Lethargy, Pallor, Posture abnormal
Clinical narrative: patient reported feeling faint after exiting vaccine room-she was advised to take a seat to be observed-patient looked pale and lethargic- head tilted back but was responsive when called and sat up-patient reported she had not eaten-was observed till she looked stronger and was offered a drink-by 15 minutes, patient husband had arrived and she was talking and feeling better and went home.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Eye movement disorder, Muscle contractions involuntary, Pallor, Syncope
Clinical narrative: After I administered the yellow fever vaccine, patient expressed concerns about feeling sick since he had work that night and the next day. We were discussing about immune support supplements and what to expect if feeling unwell. After a couple minutes of talking, they were about to leave and I was going to direct them to sit outside for a while before heading out, but when patient got up to leave, he felt dizzy and his skin turned pale. Patient's girlfriend and I helped him to sit back down into the chair. Once in the chair, patient took deep slow breaths. I asked his girlfriend if this had ever happen before, but then patient fainted in the chair and his girlfriend held him upright. His body was contracting and eyes rolling to the back of his head. I left the room for help from other pharmacist. Someone helped to call 911, and I tried to call a manager through the phone, but no one picked up, so I went to the front of the warehouse to notify a supervisor to let a manager know 911 was called and to help direct them to the pharmacy. Another person went to the patient to check and make sure they were okay. He mentioned when the patient regained consciousness, he said he was "really thirsty". EMT arrived and they were directed to the vaccine room. We closed the door to give privacy and space. A supervisor came around a couple minutes later to let us know an ambulance was coming through the tire center to gurney the patient out. Once the ambulance arrived, they smoothly came through and helped the patient out.
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Thirst
Clinical narrative: After I administered the yellow fever vaccine, patient expressed concerns about feeling sick since he had work that night and the next day. We were discussing about immune support supplements and what to expect if feeling unwell. After a couple minutes of talking, they were about to leave and I was going to direct them to sit outside for a while before heading out, but when patient got up to leave, he felt dizzy and his skin turned pale. Patient's girlfriend and I helped him to sit back down into the chair. Once in the chair, patient took deep slow breaths. I asked his girlfriend if this had ever happen before, but then patient fainted in the chair and his girlfriend held him upright. His body was contracting and eyes rolling to the back of his head. I left the room for help from other pharmacist. Someone helped to call 911, and I tried to call a manager through the phone, but no one picked up, so I went to the front of the warehouse to notify a supervisor to let a manager know 911 was called and to help direct them to the pharmacy. Another person went to the patient to check and make sure they were okay. He mentioned when the patient regained consciousness, he said he was "really thirsty". EMT arrived and they were directed to the vaccine room. We closed the door to give privacy and space. A supervisor came around a couple minutes later to let us know an ambulance was coming through the tire center to gurney the patient out. Once the ambulance arrived, they smoothly came through and helped the patient out.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Back pain, Condition aggravated, Dyspnoea exertional, Essential hypertension
Clinical narrative: Primary hypertensionPTSD (post-traumatic stress disorderUrinary frequency Short of breath on exertionPersistent depressive disorderBMI 22.0-22.9, adultPrimary insomniaVitamin D deficiencyModerate persistent asthma without complicationChronic bilateral low back pain with left-sided sciaticaPrimary hypertension
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Persistent depressive disorder, Pollakiuria, Post-traumatic stress disorder, Sciatica
Clinical narrative: Primary hypertensionPTSD (post-traumatic stress disorderUrinary frequency Short of breath on exertionPersistent depressive disorderBMI 22.0-22.9, adultPrimary insomniaVitamin D deficiencyModerate persistent asthma without complicationChronic bilateral low back pain with left-sided sciaticaPrimary hypertension
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: Primary hypertensionPTSD (post-traumatic stress disorderUrinary frequency Short of breath on exertionPersistent depressive disorderBMI 22.0-22.9, adultPrimary insomniaVitamin D deficiencyModerate persistent asthma without complicationChronic bilateral low back pain with left-sided sciaticaPrimary hypertension
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Patient called stating she has had a fever (unknown what temperature as she did not have a thermometer), knot at the injection site, and red splotches on her left arm. She stated the redness was not itchy and was in more that one spot on her arm.  The redness had not gotten worse over the past 48 hours. Patient has been treating with acetaminophen.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Rash macular, Skin discolouration
Clinical narrative: Heart pain necessitating emergency room visit; rashes and red blotches on and off over the next years. Small  Black and  blue marks all over arms and legs after vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Asthenia, Dizziness, Fatigue, Haematocrit decreased
Clinical narrative: The patient's menstrual cycle began two days after the vaccine and has not stopped. So from April 15 to at least June 1st she has been menstrating and has had severe symptoms such as pain in the ovaries and kidneys. She was given birth control progesterone for one month which did not stop the bleeding entirely. The patient reported mostly heavy days with a few days of light bleeding. In May, the patient had an ultrasound done which showed several hemorrhagic cysts had formed on both ovaries. The patient asked to be removed from the birth control as she felt it was making her even sicker, with more kidney pain, nausea, and moodiness. The patient had significant difficulty doing  her normal work, and quit her full time job because she could not function mentally because of the pain of her menstration. She claims her mind is constantly in anguish from the bleeding and her ovaries feel as if they are experiencing twisting and burning. She has tried to get out of the house and walk but complains she feels very tired, lightheaded, lethargic, with very limited energy. The patient kept track of her periods for years which were always regular 4-5 days every 23-28 days. This is the first/only instance of trouble with her menstraul cycle being abnormal. She is in pain and wants medical advice on how to stop the bleeding.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Haemorrhagic ovarian cyst, Heavy menstrual bleeding, Lethargy, Loss of personal independence in daily activities
Clinical narrative: The patient's menstrual cycle began two days after the vaccine and has not stopped. So from April 15 to at least June 1st she has been menstrating and has had severe symptoms such as pain in the ovaries and kidneys. She was given birth control progesterone for one month which did not stop the bleeding entirely. The patient reported mostly heavy days with a few days of light bleeding. In May, the patient had an ultrasound done which showed several hemorrhagic cysts had formed on both ovaries. The patient asked to be removed from the birth control as she felt it was making her even sicker, with more kidney pain, nausea, and moodiness. The patient had significant difficulty doing  her normal work, and quit her full time job because she could not function mentally because of the pain of her menstration. She claims her mind is constantly in anguish from the bleeding and her ovaries feel as if they are experiencing twisting and burning. She has tried to get out of the house and walk but complains she feels very tired, lightheaded, lethargic, with very limited energy. The patient kept track of her periods for years which were always regular 4-5 days every 23-28 days. This is the first/only instance of trouble with her menstraul cycle being abnormal. She is in pain and wants medical advice on how to stop the bleeding.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Menstrual disorder, Renal pain
Clinical narrative: The patient's menstrual cycle began two days after the vaccine and has not stopped. So from April 15 to at least June 1st she has been menstrating and has had severe symptoms such as pain in the ovaries and kidneys. She was given birth control progesterone for one month which did not stop the bleeding entirely. The patient reported mostly heavy days with a few days of light bleeding. In May, the patient had an ultrasound done which showed several hemorrhagic cysts had formed on both ovaries. The patient asked to be removed from the birth control as she felt it was making her even sicker, with more kidney pain, nausea, and moodiness. The patient had significant difficulty doing  her normal work, and quit her full time job because she could not function mentally because of the pain of her menstration. She claims her mind is constantly in anguish from the bleeding and her ovaries feel as if they are experiencing twisting and burning. She has tried to get out of the house and walk but complains she feels very tired, lightheaded, lethargic, with very limited energy. The patient kept track of her periods for years which were always regular 4-5 days every 23-28 days. This is the first/only instance of trouble with her menstraul cycle being abnormal. She is in pain and wants medical advice on how to stop the bleeding.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Condition aggravated, Depression, Diabetic neuropathy, Type 2 diabetes mellitus
Clinical narrative: Diabetes about 1 year later and increase in depression.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Respiratory rate decreased
Clinical narrative: Patient received his 2nd shingles vaccine yesterday.  It was not within the 2-6 month range. The previous was March of 2024.  The patient does have COPD and when he got home , he felt as if his breathing was slowed down.  He did go to the ER and was given a antibiotic and  naproxen.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Brain fog, Dizziness, Fatigue
Clinical narrative: - Day 0?3 post-vaccination:  Onset of symptoms including dizziness, lightheadedness, brain fog, and extreme fatigue. These symptoms were new and sudden, distinct from prior autoimmune flares.  - Day 4?14:  Symptoms gradually improved, returning close to baseline.  - Day 15?30:  Symptoms returned abruptly, now including neck stiffness, increased cognitive dysfunction, and worsened lightheadedness, especially after meals or prolonged standing.  - Present status:  Symptoms are persistent and interfere with daily functioning. Strong suspicion of autonomic nervous system involvement (e.g., POTS, dysautonomia) and/or small fiber neuropathy flare, likely autoimmune in nature.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient had rash down left arm from injection site to wrist, also had rash on right side of neck and chest.  Red itchy rash that looked like hives.
Age: 78.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Patient came to the pharmacy asked if he could get the Twinrix, we gave him the vaccine on 11/7/24 and he came back on 12/14/25 after receiving the text notification that he is due for the 2nd dose, he came back again after 5 months after getting the notification for the 3rd dose but after checking the database, it shows that he already received 2 incomplete doses from pharmacy in 2023. He wanted to get the 3rd dose from another pharmacy but we informed him that he already received total of 4 doses since 2023.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Cough, Rhinorrhoea, Throat clearing
Clinical narrative: Anaphylaxis - coughing, throat clearing, runny nose
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction aprox. 4" around injection site. Swollen, itchy, warm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy, Diarrhoea
Clinical narrative: Patient experiencing Diarrhea for 8 weeks and currently ongoing. Patient is treated with medication to manage adverse event.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site hypersensitivity
Clinical narrative: cellulitis/hypersensitive site reaction
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Patient passed out and also vomited
Age: 78.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Joint swelling, Rash
Clinical narrative: PATIENT EXPERIANCING RASH, ANKLE SWELLING
Age: 65.0
Sex: M
Vaccine: COVID19, FLU3, MMR, PNC21
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported a sore arm off and on since receiving vaccines which is typically worse at night and sometimes makes it hard to pick up objects. Patient states he heard/read that MRNA vaccines just stay in the muscle. No treatment mentioned and has be occurring since 3/18/2025 when vaccines were administered. No follow up has occurred with PCP per patient.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness
Clinical narrative: Unconsolable crying started within twenty-four hours and continued for days without ceasing; fussiness continued for weeks.  Unilateral weakness turning to stiffness down one side of body as if paralysis (arm and leg on same side), change in crying voice.  Corresponded with pediatrician office.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Chills, Hand-foot-and-mouth disease, Malaise, Migraine
Clinical narrative: patient stated that she felt sick after the vaccine with chills, fever, vomit, migraine, weakness, tachycardia, and elevated WBC treated with Vancomycin.  was also given Benadryl in the hospital. She picked up Norco 5mg at pharmacy on 5/1/2025 prescriptions stated for migraine.  Then was seen by her primary care doctor on 5/1/2025 for prescriptions for Ibuprofen, valtrex , triamcinolone, for hand foot mouth disease that she says that she got at the hospital on 4/29/25.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia, Tachycardia, Vomiting, White blood cell count increased
Clinical narrative: patient stated that she felt sick after the vaccine with chills, fever, vomit, migraine, weakness, tachycardia, and elevated WBC treated with Vancomycin.  was also given Benadryl in the hospital. She picked up Norco 5mg at pharmacy on 5/1/2025 prescriptions stated for migraine.  Then was seen by her primary care doctor on 5/1/2025 for prescriptions for Ibuprofen, valtrex , triamcinolone, for hand foot mouth disease that she says that she got at the hospital on 4/29/25.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: NONE
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Amylase normal, Blood calcium, Blood culture, Blood gases normal, C-reactive protein
Clinical narrative: Febrile seizures  Evaluated at ER for febrile seizure, ruled by attending physician to be vaccine-induced. All tests including blood gases and urine were normal; nasal swab not performed. Highest recorded temperature was 101°F, rectal temperature prior to visit was 97.3°F. Mother reports full-body seizure 05/21/2025 at 1900 hours, lasting 1-2 seconds, occurring every minute for 10 minutes for a total of 13 seizures. Patient had bowel movement and urination with each seizure, full diaper after 10 minutes. Transported via ambulance to hospital, where another seizure occurred in the emergency room. Condition improved the following day: more consolable, less irritable, eating and drinking well, normal bowel movements and urination, walking independently today but needed walker assistance day after ER visit, playful, taking two naps instead of one. Mother reports possible minor seizure 5/22/2025, woke up at 0230 hours with heart rate 89 and oxygen saturation 98-99. Patient woke up fine, fell back asleep, back stiffened and arched for a minute, then relaxed. Total 15 seizures between 05/21/2025 and 05/22/2025.
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Differential white blood cell count, Febrile convulsion, Full blood count, Irritability, Metabolic function test
Clinical narrative: Febrile seizures  Evaluated at ER for febrile seizure, ruled by attending physician to be vaccine-induced. All tests including blood gases and urine were normal; nasal swab not performed. Highest recorded temperature was 101°F, rectal temperature prior to visit was 97.3°F. Mother reports full-body seizure 05/21/2025 at 1900 hours, lasting 1-2 seconds, occurring every minute for 10 minutes for a total of 13 seizures. Patient had bowel movement and urination with each seizure, full diaper after 10 minutes. Transported via ambulance to hospital, where another seizure occurred in the emergency room. Condition improved the following day: more consolable, less irritable, eating and drinking well, normal bowel movements and urination, walking independently today but needed walker assistance day after ER visit, playful, taking two naps instead of one. Mother reports possible minor seizure 5/22/2025, woke up at 0230 hours with heart rate 89 and oxygen saturation 98-99. Patient woke up fine, fell back asleep, back stiffened and arched for a minute, then relaxed. Total 15 seizures between 05/21/2025 and 05/22/2025.
Age: 1.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Musculoskeletal stiffness, Procalcitonin
Clinical narrative: Febrile seizures  Evaluated at ER for febrile seizure, ruled by attending physician to be vaccine-induced. All tests including blood gases and urine were normal; nasal swab not performed. Highest recorded temperature was 101°F, rectal temperature prior to visit was 97.3°F. Mother reports full-body seizure 05/21/2025 at 1900 hours, lasting 1-2 seconds, occurring every minute for 10 minutes for a total of 13 seizures. Patient had bowel movement and urination with each seizure, full diaper after 10 minutes. Transported via ambulance to hospital, where another seizure occurred in the emergency room. Condition improved the following day: more consolable, less irritable, eating and drinking well, normal bowel movements and urination, walking independently today but needed walker assistance day after ER visit, playful, taking two naps instead of one. Mother reports possible minor seizure 5/22/2025, woke up at 0230 hours with heart rate 89 and oxygen saturation 98-99. Patient woke up fine, fell back asleep, back stiffened and arched for a minute, then relaxed. Total 15 seizures between 05/21/2025 and 05/22/2025.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Crying, Hemiparesis, Infant irritability, Musculoskeletal stiffness
Clinical narrative: Extreme, unconsolable crying for days; fussiness lasted weeks.  One sided weakness that progressed into stiff, board-like paralysis on one full side of body.  This happened after the two month appointment and was discussed with provider.  Provider wished to proceed citing it would confuse office staff to split up the vaccines-the effects were reproduced with the recurrent exposure and lasted longer than the previous encounter, specifically the unilateral, board-like stiffness.  Corresponded effects to provider office.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Herpes zoster, Knee arthroplasty, Ligament sprain, Muscle injury
Clinical narrative: surgical wound infected; Wound dehiscence Right knee surgical wound opened; Knee replacement surgery right knee; diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck; Pain; back twisted; hurt a muscle; This serious case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included retinal detachment. Concurrent medical conditions included hypertension, indigestion and prostate cancer. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), gabapentin, aciclovir (Acyclovir), prednisolone, lisinopril, cyanocobalamin (B 12), famotidine, latanoprost and tamsulosin.   On 23-DEC-2024, the patient received the 2nd dose of Shingrix (left arm) .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sprained back (Verbatim: back twisted) and muscle injury (Verbatim: hurt a muscle). On 02-JAN-2025, the patient experienced knee replacement (Verbatim: Knee replacement surgery right knee) (serious criteria clinically significant/intervention required). In JAN-2025, the patient experienced shingles (Verbatim: diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck) and pain (Verbatim: Pain). On an unknown date, the patient experienced surgical wound infection (Verbatim: surgical wound infected) and wound dehiscence (Verbatim: Wound dehiscence Right knee surgical wound opened). The patient was treated with clobetasol propionate. The outcome of the knee replacement, surgical wound infection, wound dehiscence, sprained back and muscle injury were not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the knee replacement, shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix.     The company considered the knee replacement to be unrelated to Shingrix. It was unknown if the company considered the shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAY-2025 The reporter is the patient who reports that he received both Shingrix doses as recommended in the prescribing information in 2024. The reporter read on social media that he should report any adverse event concerning Shingrix.  The reporter stated that he twisted his back in December of 2024 and hurt a muscle in his left back.  He stated in the second week of January 2025 he was diagnosed with shingles at the same location he hurt his back in December of 2024.  The shingles spread to his left neck and left groin. The shingles were still ongoing.; Sender's Comments: Knee arthroplasty is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Postoperative wound infection, Wound dehiscence
Clinical narrative: surgical wound infected; Wound dehiscence Right knee surgical wound opened; Knee replacement surgery right knee; diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck; Pain; back twisted; hurt a muscle; This serious case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included retinal detachment. Concurrent medical conditions included hypertension, indigestion and prostate cancer. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), gabapentin, aciclovir (Acyclovir), prednisolone, lisinopril, cyanocobalamin (B 12), famotidine, latanoprost and tamsulosin.   On 23-DEC-2024, the patient received the 2nd dose of Shingrix (left arm) .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sprained back (Verbatim: back twisted) and muscle injury (Verbatim: hurt a muscle). On 02-JAN-2025, the patient experienced knee replacement (Verbatim: Knee replacement surgery right knee) (serious criteria clinically significant/intervention required). In JAN-2025, the patient experienced shingles (Verbatim: diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck) and pain (Verbatim: Pain). On an unknown date, the patient experienced surgical wound infection (Verbatim: surgical wound infected) and wound dehiscence (Verbatim: Wound dehiscence Right knee surgical wound opened). The patient was treated with clobetasol propionate. The outcome of the knee replacement, surgical wound infection, wound dehiscence, sprained back and muscle injury were not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the knee replacement, shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix.     The company considered the knee replacement to be unrelated to Shingrix. It was unknown if the company considered the shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAY-2025 The reporter is the patient who reports that he received both Shingrix doses as recommended in the prescribing information in 2024. The reporter read on social media that he should report any adverse event concerning Shingrix.  The reporter stated that he twisted his back in December of 2024 and hurt a muscle in his left back.  He stated in the second week of January 2025 he was diagnosed with shingles at the same location he hurt his back in December of 2024.  The shingles spread to his left neck and left groin. The shingles were still ongoing.; Sender's Comments: Knee arthroplasty is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: he developed an itchy rash on both of his forearms; few dots on his back and back of his calves, but they are not itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number Y7XG3, expiry date 27-MAR-2027) for prophylaxis.   On 12-MAY-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 19-MAY-2025, 7 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: he developed an itchy rash on both of his forearms) and rash (Verbatim: few dots on his back and back of his calves, but they are not itchy). The outcome of the itchy rash and rash were not resolved.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.     It was unknown if the company considered the itchy rash and rash to be related to Shingrix.   Additional Information: GSK Receipt Date :27-MAY-2025 Reporter reported that patient received his first Shingrix vaccine in the left arm on 12th May 2025.  He reported 1 week later on 19th May 2025 he developed an itchy rash on both of his forearms, and it was still ongoing.  Reporter also reported a few dots on his back and back of his calves, but they were not itchy. Reporter stated his wife had a prescription medication (unknown name) for itching that he put on the itchy rash a couple times.
Age: 38.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product package associated injury, Skin laceration
Clinical narrative: Product complaint; 0.8cm laceration to the pad of his left index finger; glass vial, it shattered in the patient's hand suddenly; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional and described the occurrence of skin laceration in a 38-year-old male patient who received Herpes zoster (Shingrix) (batch number P5F7T, expiry date 27-APR-2027) for prophylaxis. This case was associated with a product complaint.   On 28-MAY-2025, the patient received Shingrix. On 28-MAY-2025, less than a day after receiving Shingrix, the patient experienced skin laceration (Verbatim: 0.8cm laceration to the pad of his left index finger), glass ampoule associated injury (Verbatim: glass vial, it shattered in the patient's hand suddenly) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint). On 28-MAY-2025, the outcome of the glass ampoule associated injury was resolved. The outcome of the skin laceration was not reported and the outcome of the inappropriate age at vaccine administration was not applicable and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the skin laceration and glass ampoule associated injury to be related to Shingrix.     It was unknown if the company considered the skin laceration and glass ampoule associated injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-MAY-2025 This report was submitted via the online direct entry reporting system. While preparing to remove the plastic cap from the glass vial, it shattered in the patient's hand suddenly. Patient sustained a 0.8 cm laceration to the pad of his left index finger. First aid was given. The 38 year old patient received dose of Shingrix, which led to inappropriate age at vaccine administration.
Vaccine: RVX
Symptoms: Underdose
Clinical narrative: regurgitated dose of Rotarix during or after administration; Accidental underdose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation in a child patient who received Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, immediately after receiving Rotavirus vaccine, the patient experienced regurgitation (Verbatim: regurgitated dose of Rotarix during or after administration) and accidental underdose (Verbatim: Accidental underdose). The outcome of the regurgitation was resolved and the outcome of the accidental underdose was not applicable.   The reporter considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the reporter considered the regurgitation to be related to Rotarix Unspecified Oral Administation Device.     The company considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the company considered the regurgitation to be related to Rotarix Unspecified Oral Administation Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAY-2025 This report was submitted via the online direct entry reporting system. Healthcare professional (HCP) stated that 3 patients recently have regurgitated dose of Rotarix during or after administration, which led to accidental underdose.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash started in back of neck and is now all over body and feet/it is still ongoing; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 2-year-old female patient who received Hepatitis B vaccine for prophylaxis.   In FEB-2025, the patient received Hepatitis B vaccine. In FEB-2025, between 2 and 3 weeks after receiving Hepatitis B vaccine, the patient experienced generalized rash (Verbatim: Rash started in back of neck and is now all over body and feet/it is still ongoing). The outcome of the generalized rash was not resolved.   It was unknown if the reporter considered the generalized rash to be related to Hepatitis B vaccine.     It was unknown if the company considered the generalized rash to be related to Hepatitis B vaccine.   Additional Information: GSK receipt date: 30-MAY-2025 The grandmother of the patient reported the patient received a Hepatitis B vaccine in February 2025 and 2 and a half weeks later she noticed a rash in the back of the neck.  The rash later traveled to face and is now all over her body including feet.  They took her to several doctors.  She did not want to provide heath care professional consent.  The reporter would call back with the name of the vaccine.
Vaccine: RVX, RVX
Symptoms: Dyspnoea, Extra dose administered, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: I am vaccinated and had the booster shots but I got it anyway; had the booster shots; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine and RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I am vaccinated and had the booster shots but I got it anyway) (serious criteria hospitalization) and extra dose administered (Verbatim: had the booster shots). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine and RSV vaccine.     The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 23 -MAY-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated and had the booster shots but he/she got it anyway which led to extra dose administered. And the patient couldn't breathe, he/she had to go to the hospital. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine(Dose 1 & 2) Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine(Dose 1 & 2)
Vaccine: FLUX, VARZOS
Symptoms: Chills
Clinical narrative: SHIVERING; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included influenza vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: SHIVERING). The action taken with influenza vaccine was unknown. The outcome of the shivering was resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.     It was unknown if the company considered the shivering to be related to Shingrix.   Additional Information: GSK receipt date: 24-MAY-2025 The reporter reported that he/she made the mistake of getting my first Shingrix with my flu shot.  Several days under several blankets, shivering.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine 3 years ago  and i now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine 3 years ago  and i now have shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the vaccine 3 years ago and now have shingles.  He /she was in absolute agony. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.