chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Immediately after receiving the vaccination, patient felt lightheaded and needed to lie down. Shortly after lying down, the patient had a brief loss of consciousness with seizure activity. After about 30 seconds, patient regained consciousness and complained of headache and nausea. Clinic Triage nurses and patient Primary care provider were called in to assist patient. Patient mother agreed to take the patient to the local hospital ER for stabilization and further evaluation.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Patient does not report any adverse reactions. Vaccine was given by one of my staff members in ventrogluteal site, which is not a valid site.
Age: 1.83
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave boostrix instead of infanrix to 1 yr 10 month baby
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Rash
Clinical narrative: Pt reports he was getting COVID vaccine and started feeling "flushed, SOB, and difficulty swallowing". Upon arrival pt has mild rash to chest that he states is new.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: GOT SHOTS LAST WEEK AND NOW SWOLLEN AND RED AND HOT TO TOUCH RIGHT ARM
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Moderate Pain and swelling at injection site.   Headache.   Fatigue,  Muscle and joint pain all over body.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Moderate Pain and swelling at injection site.   Headache.   Fatigue,  Muscle and joint pain all over body.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: PAIN IN THE ARM THAT HAS PERSISTED FOR 2 WEEKS. ADVISED BY PHYSICIAN TO TAKE OTC NSAIDS AND GIVE IT MORE TIME
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Rash, Rash erythematous
Clinical narrative: Quarter sized knot with itchy red rash that is not resolving within a weeks time after vaccination. The area has increased in size since getting the vaccine and the rtash covers the upper part of her arm.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive a Varivax, but received Proquad instead.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Moderna 6M-11yrs instead of Spikevax 12yrs and older. No adverse event symptoms.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient presented today for Heplisav-B #2 reporting that her right deltoid area/upper arm was swollen the next day and she had pain in her arm with movement radiating into her right shoulder for at least 4 days. She verbalized concern due to her autoimmune history, and she has a similar prior adverse reaction to the Moderna mRNA Covid-19 vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Pt experinced a rash on injection site shortly after recieving vaccination
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Like around 8 at night i just got really tired and i went to bed and started feeling a little dizzy and nauseous. I got up and took some medication and it helped and i woke up and still had a little head ache.
Age: 14.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain
Clinical narrative: right upper arm pain after immunizations.  no warmth, swelling or redness.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Disturbance in attention, Lethargy, Vision blurred
Clinical narrative: Blurry vision, lethargy and couldn't focus well for a few hours. Seen at physician office and monitored with no further issues noted.
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: it was broken, the neck of the vial snapped off; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LX4483, Expiration Date: 28Feb2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "it was broken, the neck of the vial snapped off".  Causality for "it was broken, the neck of the vial snapped off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: The nurse stated that she put the needle into vial and it snapped off it was not administered to the patient she used another one. Reporter stated it's 0.5 milliliters vial. NDC number is 0005200001.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine); had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine); This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknon, single (Lot number: LH5978) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine)". Clinical courses: The reporter's oldest brother had it three or four times. He took Pfizer (Pfizer COVID-19 Vaccine). He has had COVID four times and he took the vaccine. He took it and he has had it multiple times and got very sick with COVID.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Confusional state, Dyspnoea, Fatigue
Clinical narrative: Prolonged Fatigue/easily exhausted; Feeling cold all the time; Low Energy level; breathing issues; feeling out of breath; confusion; brain fog; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2021 at 01:00 as dose 2, single (Lot number: FA6780) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (lot number: EW0217, dose 1, vaccine location: Left arm), administration date: 07Jun2021, when the patient was 41-year-old, for Covid-19 Immunization. The following information was reported: FEELING COLD (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Feeling cold all the time"; ASTHENIA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Low Energy level"; FATIGUE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Prolonged Fatigue/easily exhausted"; BRAIN FOG (disability, life threatening) with onset 30Jul2021, outcome "not recovered"; RESPIRATORY DISORDER (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "breathing issues"; CONFUSIONAL STATE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "confusion"; DYSPNOEA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "feeling out of breath". Therapeutic measures were taken as a result of fatigue, feeling cold, asthenia, respiratory disorder, dyspnoea, confusional state, brain fog.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Respiratory disorder
Clinical narrative: Prolonged Fatigue/easily exhausted; Feeling cold all the time; Low Energy level; breathing issues; feeling out of breath; confusion; brain fog; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2021 at 01:00 as dose 2, single (Lot number: FA6780) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (lot number: EW0217, dose 1, vaccine location: Left arm), administration date: 07Jun2021, when the patient was 41-year-old, for Covid-19 Immunization. The following information was reported: FEELING COLD (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Feeling cold all the time"; ASTHENIA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Low Energy level"; FATIGUE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Prolonged Fatigue/easily exhausted"; BRAIN FOG (disability, life threatening) with onset 30Jul2021, outcome "not recovered"; RESPIRATORY DISORDER (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "breathing issues"; CONFUSIONAL STATE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "confusion"; DYSPNOEA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "feeling out of breath". Therapeutic measures were taken as a result of fatigue, feeling cold, asthenia, respiratory disorder, dyspnoea, confusional state, brain fog.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I had blood clots right away years ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (COMIRNATY), in 2024 as dose 1, 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: THROMBOSIS (medically significant) with onset 2024, outcome "unknown", described as "I had blood clots right away years ago". The patient took covid 19 one shot in 2 different prisons.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: had a heart attack in prison; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (COMIRNATY), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack in prison". The patient took covid 19 one shot in 2 different prisons. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Primary immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2025, outcome "unknown" and all described as "COVID". Clinical course: The patient stated she received the "Pfizer shot and a lot of, like, boosters." The patient was getting ready to get the next boosters. On the morning of 28Apr2025, the patient had a sore throat, and it turned out that she had COVID. The patient also said that in the morning she went to urgent care, and she was tested. The patient said she tested positive for COVID and was prescribed nirmatrelvir; ritonavir (PAXLOVID).  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2025) Positive.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had received a dose at 2 months and again at 4 months and should not have received another dose at 6 months. There was no adverse reaction. Submitting this report because extra vaccine given.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had received a dose at 2 months and again at 4 months and should not have received another dose at 6 months. There was no adverse reaction. Submitting this report because extra vaccine given.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood magnesium normal, Blood phosphorus, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Dizziness
Clinical narrative: Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with blurred vision, hot and cold changes and itchy rash over her shoulder blade and upper chest; she sought care at ED on same day and was given diphenhydramine and ondansetron and discharged to home after overnight stay in ED. Later in the afternoon on 4/25, patient lost consciousness and was taken to ED--given 1 liter of IV fluids and migraine cocktail and discharged to home. Seen in PCP office on 5/01/2025 and reports persistent migraine headache pains and tenderness to palpation at site of injection
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling of body temperature change, Full blood count normal, Headache, Injection site pain, Loss of consciousness
Clinical narrative: Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with blurred vision, hot and cold changes and itchy rash over her shoulder blade and upper chest; she sought care at ED on same day and was given diphenhydramine and ondansetron and discharged to home after overnight stay in ED. Later in the afternoon on 4/25, patient lost consciousness and was taken to ED--given 1 liter of IV fluids and migraine cocktail and discharged to home. Seen in PCP office on 5/01/2025 and reports persistent migraine headache pains and tenderness to palpation at site of injection
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Metabolic function test normal, Migraine, Pregnancy test urine negative, Rash, Rash pruritic
Clinical narrative: Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with blurred vision, hot and cold changes and itchy rash over her shoulder blade and upper chest; she sought care at ED on same day and was given diphenhydramine and ondansetron and discharged to home after overnight stay in ED. Later in the afternoon on 4/25, patient lost consciousness and was taken to ED--given 1 liter of IV fluids and migraine cocktail and discharged to home. Seen in PCP office on 5/01/2025 and reports persistent migraine headache pains and tenderness to palpation at site of injection
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis normal, Vision blurred
Clinical narrative: Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with blurred vision, hot and cold changes and itchy rash over her shoulder blade and upper chest; she sought care at ED on same day and was given diphenhydramine and ondansetron and discharged to home after overnight stay in ED. Later in the afternoon on 4/25, patient lost consciousness and was taken to ED--given 1 liter of IV fluids and migraine cocktail and discharged to home. Seen in PCP office on 5/01/2025 and reports persistent migraine headache pains and tenderness to palpation at site of injection
Age: 78.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: Pt described a episode of Atrial fibrillation, first since S/P Cardiac ablation.  Pt sought medical treatment and rhythm controlled by Flecainide.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Mobility decreased, Nausea, Neck pain
Clinical narrative: The patient had headache, nausea, body pain, hip pain and neck pain. The following day she had pelvic pain, back pain and was bedridden. The back pain is still ongoing and all other symptoms have resolved. The doctor she is now seeing thinks the back pain with sciatica is unrelated to the vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pelvic pain
Clinical narrative: The patient had headache, nausea, body pain, hip pain and neck pain. The following day she had pelvic pain, back pain and was bedridden. The back pain is still ongoing and all other symptoms have resolved. The doctor she is now seeing thinks the back pain with sciatica is unrelated to the vaccine.
Age: 43.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Back pain, Cough, Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient received a dose of TDaP and hepatitis B (vaccine specifics not available at this time) approximately 3 weeks prior to symptom onset. About 2 weeks prior to symptom onset patient was ill with influenza A for approximately 3 days. Her symptoms included fevers, cough, body aches and fatigue. She recovered from influenza.  Her GBS symptoms started 4/15/25 with neck and back pain. She then developed hand and feet numbness, tingling and pain. She was hospitalized from 4/17-4/19 and diagnosed with Guillain-Barre Syndrome, treated with IVIG and as of 4/28 is making a slow recovery.
Age: 43.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Immunoglobulin therapy, Influenza, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient received a dose of TDaP and hepatitis B (vaccine specifics not available at this time) approximately 3 weeks prior to symptom onset. About 2 weeks prior to symptom onset patient was ill with influenza A for approximately 3 days. Her symptoms included fevers, cough, body aches and fatigue. She recovered from influenza.  Her GBS symptoms started 4/15/25 with neck and back pain. She then developed hand and feet numbness, tingling and pain. She was hospitalized from 4/17-4/19 and diagnosed with Guillain-Barre Syndrome, treated with IVIG and as of 4/28 is making a slow recovery.
Age: 43.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient received a dose of TDaP and hepatitis B (vaccine specifics not available at this time) approximately 3 weeks prior to symptom onset. About 2 weeks prior to symptom onset patient was ill with influenza A for approximately 3 days. Her symptoms included fevers, cough, body aches and fatigue. She recovered from influenza.  Her GBS symptoms started 4/15/25 with neck and back pain. She then developed hand and feet numbness, tingling and pain. She was hospitalized from 4/17-4/19 and diagnosed with Guillain-Barre Syndrome, treated with IVIG and as of 4/28 is making a slow recovery.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: skin reaction near injection site and on back of neck under hairline
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: As per patient, she had a covid vaccine previously and she passed out. Per patient, she had other vaccines after and did not experience any adverse effects or side effects. Patient was consulted before immunization. Patient was accompanied by her mother. Patient received meningitis vaccine and passed out after 10 seconds approx. Patient took about a 30 minutes rest at pharmacy and a sugar drink was given to her. She felt better after and left the pharmacy with her mother.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient says that her arm experienced, redness, rash, and tenderness at injection site, roughly two inches in diameter
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT COMPLAINED AFTER 3 DAYS, HER ARM SWELLED UP AND VERY RED
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had a vasovagal syncope episode after receiving HPV9 #1, Afluria (flu), Menveo #1, and Boostrix #1 vaccinations. Patient sat on the exam table for a minute after administration then stepped down from the table and took 4-5 steps towards the door to exit the room. Patient stopped at the door and appeared to be dizzy. Patient was helped to the ground without any injury. Patient's legs were elevated, and a cool, wet towel was applied to forehead. Patient was also offered sugar (lollipop).  Patient's blood pressure was taken twice on left arm (1030: BP 110/73, P 91; 1040: BP 107/72, P 80). Patient was asked how was feeling and stated felt better. Patient was also able to answer questions appropriately (correct name as well as mother's name). Patient sat upright then was helped up and helped to a chair. Patient and mother waited while nursing staff reported the incident to the provider patient seen earlier this morning. Provider instructed that patient be monitored for another 20 minutes and if doing well could then leave the clinic. After 20 minutes, patient verbalized doing well. Nursing staff instructed mother that if patient has another lightheaded spell while walking to the car to have patient sit down, then have anyone near by notify our clinic or anyone with a badge to get help. Mother verbalized understanding.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain. Advised to go to ER. Cause undetermined
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Death, Decreased appetite, Infant irritability, Pyrexia, Unresponsive to stimuli
Clinical narrative: Mother of child reports child had fever and fussiness on the evening of 4/9/25. Fever resolved 4/10/25. However, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 4/10/25, her mother reported to me, child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 4/11/25 and they activated EMS. Child was transported to Hospital (redacted). She did not survive and was pronounced dead in the hospital.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy kidney abnormal, IgA nephropathy, Protein urine present, Urine analysis abnormal
Clinical narrative: Contracted IGA Nephrapothy discovered through protein in urine and confirmed through kidney biopsy in August 2023
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood culture, Blood lactic acid, Blood magnesium normal
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Brain natriuretic peptide normal, C-reactive protein increased, Chest pain, Dyspnoea, Electrocardiogram ST segment elevation
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Electrocardiogram ST-T segment elevation, Electrocardiogram T wave abnormal, Hyperhidrosis, Inflammatory marker increased, Injection site erythema
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, International normalised ratio normal, Lacrimation increased, Metabolic function test normal, Myalgia
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Myocardial necrosis marker increased, Nausea, Procalcitonin increased, Prothrombin time normal, Red blood cell sedimentation rate increased
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Sinus tachycardia, Troponin increased, Vomiting, White blood cell count increased
Clinical narrative: Patient came in 5/1/25 due to possible vaccine side effects from pneumonia vaccine that she received 4/28/25.  States that since then she has been having nausea, vomiting, chest pain on and off.  States that chest pain occasionally radiates to her left arm.  She also endorses entire body muscle and joint aches, new onset diaphoresis and lacrimation. States the last time she had chest pain was last night.  States the last time she vomited was this morning.  Also states she had some shortness of breath.  EKG was obtained which showed ST elevation in V1 and V2 and T wave elevation in V4.  When compared to EKG from 4/16/2025 there was T wave inversion on V4. Given different EKG findings on today's EKG when compared to 2 weeks ago with ST elevation and T wave elevation recommended patient go immediately to emergency room for further cardiac workup.  There was some tenderness and mild erythema on the left deltoid and injection site.  In the ER, EKG showed normal sinus tachycardia.  There was concern for myositis vs myocarditis given abnormal EKG and heart enzymes with elevated inflammatory markers. There was also concern for potential lupus flare as a result of the vaccine or at least coinciding with the timing of the vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: Hight Blood Pressure, Head Ache
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling to left upper thigh (administration site) vertical - 10.5 cm width -8.5 cm.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Pain in extremity
Clinical narrative: Pt will moderate / severe leg pain > 30 days post vaccine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Rash (4/17/25), pain. Went to Dr (4/29/25) they diagnosed as shingles.
Age: 1.5
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site pain, Pyrexia, Wrong product administered
Clinical narrative: Patient was given the DTAP-IPV combo instead of DTAP and IPV given separately. Mom states patient has had no issues other than sore legs and low  grade fever. Mom  contacted 5/1/2025.
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: chronic fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: FATIGUE (non-serious), outcome "unknown", described as "chronic fatigue".  Additional Information: Reporter was asking for patients who experience debilitating long-term side effects from company Covid-19 vaccine. Patient specific problem was chronic fatigue.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: chronic fatigue; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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: FATIGUE (non-serious), outcome "unknown", described as "chronic fatigue".  Additional Information: Reporter was asking for patients who experience debilitating long-term side effects from company Covid-19 vaccine. Patient specific problem was chronic fatigue.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event (AE)); HCP calling to inquire about a patient who received the first GARDASIL 9 vaccine in 2017 and presents now for a second dose; This spontaneous report was received from a pharmacist and refers to a 24-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On an unknown date in 2017, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, administered as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the patient presented now (on an unknown day in April 2025) for a second dose of the previous mention vaccine (inappropriate schedule of product administration). No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness after administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness after administration). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date : 28-APR-2025 The patient experienced arm soreness after administration of Shingrix. This case was linked with case US2025051115 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025051115:SAME REPORTER
Age: 16.0
Sex: F
Vaccine: MNP
Symptoms: Dizziness, Presyncope
Clinical narrative: The patient had a vasovagal dizziness; This is a spontaneous report received from a Nurse from a sales representative.  A 16-year-old female patient (not pregnant) received meningococcal group abcwy vaccine (PENBRAYA), on 10Mar2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRESYNCOPE (non-serious) with onset 10Mar2025, outcome "recovered" (10Mar2025), described as "The patient had a vasovagal dizziness". Therapeutic measures were taken as a result of presyncope.  Additional Information: The patient did not receive any other vaccines on the same date as the suspect vaccine. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. The patient had a vasovagal dizziness treatment received for event vasovagal dizziness protocol, including lifting patient legs. Patient do not have known allergies.  The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.
Age: 24.0
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported/ no additional AE; VARIVAX was inadvertently administered to a patient on 4/30/2025, with an expiration date of 4/11/2025.; This spontaneous report was received from a Nurse and refers to a 24-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.   On 30-APR-2025, the patient was inadvertently  vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Injection (lot #X010523, expiration date: 11-APR-2025) at a dose of 0.5 mL (route of administration not provided) reconstituted with sterile diluent (BAXTER STERILE DILUENT) (dose description, lot # and expiration date were not reported) for prophylaxis (expired vaccine administered). No adverse effects were reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye discharge, Eyelid function disorder, Nasal ulcer, Ophthalmic herpes zoster
Clinical narrative: high fever; shingles infection in left eye  which has not resolved in over 7 months; convulsing; had chills; sores in mouth; sore in nose; sleeping for an entire day; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles infection in left eye  which has not resolved in over 7 months) (serious criteria GSK medically significant), convulsion (Verbatim: convulsing) (serious criteria GSK medically significant and clinically significant/intervention required), fever (Verbatim: high fever), sleepiness (Verbatim: sleeping for an entire day), chills (Verbatim: had chills), mucosal sores (Verbatim: sores in mouth) and nasal ulcer (Verbatim: sore in nose). In AUG-2024, the outcome of the fever was resolved and the outcome of the sleepiness was resolved (duration 1 day). The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the convulsion, chills, mucosal sores and nasal ulcer were resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, convulsion, fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix.     The company considered the ophthalmic herpes zoster and convulsion to be unrelated to Shingrix. It was unknown if the company considered the fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2025 The patient indicated that she got Shingrix shot 2 at a pharmacy.  She said that less than 12 hours after the shot she began experiencing adverse reactions such as she had a high fever 102.6 for two days.  She remembers sleeping for an entire day.  She had chills and was convulsing such that her husband wanted to take her to hospital. But with extra blankets and changing the house temperature she was able to manage.  She got sores inside her mouth and also inside her nose which she said were gross, horrible.  She indicated that her left eye was running and that she could not even open her eye, so she went to urgent care. She had a shingles infection in her left eye that has persisted for over 7 months, and this was causing sensitivity to light.  She did not had the lot number but she provided the name of the pharmacy and the pharmacy's phone number as the pharmacy should had the lot number on file.  She went to the eye doctor twice a week and was prescribed numerous unspecified medications, but none have worked to clear the infection; Sender's Comments: Ophthalmic herpes zoster and Seizure are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia, Seizure, Somnolence, Stomatitis
Clinical narrative: high fever; shingles infection in left eye  which has not resolved in over 7 months; convulsing; had chills; sores in mouth; sore in nose; sleeping for an entire day; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles infection in left eye  which has not resolved in over 7 months) (serious criteria GSK medically significant), convulsion (Verbatim: convulsing) (serious criteria GSK medically significant and clinically significant/intervention required), fever (Verbatim: high fever), sleepiness (Verbatim: sleeping for an entire day), chills (Verbatim: had chills), mucosal sores (Verbatim: sores in mouth) and nasal ulcer (Verbatim: sore in nose). In AUG-2024, the outcome of the fever was resolved and the outcome of the sleepiness was resolved (duration 1 day). The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the convulsion, chills, mucosal sores and nasal ulcer were resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, convulsion, fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix.     The company considered the ophthalmic herpes zoster and convulsion to be unrelated to Shingrix. It was unknown if the company considered the fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2025 The patient indicated that she got Shingrix shot 2 at a pharmacy.  She said that less than 12 hours after the shot she began experiencing adverse reactions such as she had a high fever 102.6 for two days.  She remembers sleeping for an entire day.  She had chills and was convulsing such that her husband wanted to take her to hospital. But with extra blankets and changing the house temperature she was able to manage.  She got sores inside her mouth and also inside her nose which she said were gross, horrible.  She indicated that her left eye was running and that she could not even open her eye, so she went to urgent care. She had a shingles infection in her left eye that has persisted for over 7 months, and this was causing sensitivity to light.  She did not had the lot number but she provided the name of the pharmacy and the pharmacy's phone number as the pharmacy should had the lot number on file.  She went to the eye doctor twice a week and was prescribed numerous unspecified medications, but none have worked to clear the infection; Sender's Comments: Ophthalmic herpes zoster and Seizure are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Dizziness, Headache, Hepatic enzyme increased, Vomiting
Clinical narrative: Severely elevated liver enzymes; dizziness; Abdominal pain; headache; vomiting; This serious case was reported by a consumer and described the occurrence of elevated liver enzymes in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-APR-2025, the patient received the 1st dose of Shingles vaccine. On 16-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced elevated liver enzymes (Verbatim: Severely elevated liver enzymes) (serious criteria hospitalization), dizziness (Verbatim: dizziness) (serious criteria hospitalization), abdominal pain (Verbatim: Abdominal pain) (serious criteria hospitalization), headache (Verbatim: headache) (serious criteria hospitalization) and vomiting (Verbatim: vomiting) (serious criteria hospitalization). The outcome of the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting were resolving.   It was unknown if the reporter considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2025 The patient took shingles vaccine and was hospitalized with abdomen pain, dizziness, vomiting, nausea, and severely elevated liver enzymes. She also mentioned, she had to have her blood drawn numerous times to make sure but becoming more stable.  Reporter mentioned she was taken off all medications in the hospital due to potential increase in liver enzyme.; Sender's Comments: Hepatic enzyme increased and Dizziness are unlisted events which are considered unrelated to GSK Shingles vaccine.  Abdominal pain, Headache and Vomiting are listed events which, due to the following criteria (insufficient information on  medical history, concurrent conditions, concomitant medications and investigation details) are considered unrelated to GSK Shingles vaccine.