chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received First Dose of Heplisav-B May 2023. No Other Doses Have Been Given; Initial report received on 25-Mar-2024.  A pharmacist in the reported that a patient (age, gender, race, and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not receive another dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 27-May-2023, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported).  After having been vaccinated with the first dose of HEPLISAV-B, the patient did not receive a second dose.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Heplisav-B Administered, After It Underwent A Temperature Excursion; Initial report received on 27-Mar-2024.   A pharmacist in the reported that a 30-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had undergone temperature excursion for 24 hours reaching 55-60 degrees Fahrenheit.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 19-Mar-2024, the patient received the first dose of HEPLISAV-B (lot # 944313, expiration date 02-May-2026, and NDC # 43528-003-05; route not specified) in the left arm.  The dose was noted to have underwent a temperature excursion for 24 hours, reaching temperatures of 55-60 degrees Fahrenheit.  No adverse events were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Vertigo positional
Clinical narrative: over all soreness, joint pain, headaches, morning blurred vision, headaches, tiredness, ED, and Vertigo when standing up
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: over all soreness, joint pain, headaches, morning blurred vision, headaches, tiredness, ED, and Vertigo when standing up
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Continuous Muscle and Joint aching, Ibuprofen as needed, since the vaccine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-GAD antibody, Glycosylated haemoglobin, Thirst, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Had extreme thirst and weight loss of 20 pounds. Was subsequently diagnosed with type one diabetes.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Ankle fracture, Autoimmune disorder, Autoimmune thyroiditis, Biopsy
Clinical narrative: December, 2021 Developed chronic hives of unknown origin. Syncope resulting in broken ankle Jan 2022. Hives resolved (unknown reason) mid-2022. August 2023, Diagnosed with autoimmune Hashimoto's Thyroiditis. March 2024, diagnosed with thymoma (cancer). (Multiple medical providers were involved throughout all of these effects).
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Computerised tomogram abnormal, Neoplasm malignant, Positron emission tomogram abnormal, Syncope
Clinical narrative: December, 2021 Developed chronic hives of unknown origin. Syncope resulting in broken ankle Jan 2022. Hives resolved (unknown reason) mid-2022. August 2023, Diagnosed with autoimmune Hashimoto's Thyroiditis. March 2024, diagnosed with thymoma (cancer). (Multiple medical providers were involved throughout all of these effects).
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thymoma, Urticaria, X-ray abnormal
Clinical narrative: December, 2021 Developed chronic hives of unknown origin. Syncope resulting in broken ankle Jan 2022. Hives resolved (unknown reason) mid-2022. August 2023, Diagnosed with autoimmune Hashimoto's Thyroiditis. March 2024, diagnosed with thymoma (cancer). (Multiple medical providers were involved throughout all of these effects).
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain upper, Diarrhoea, Electromyogram, Laboratory test, Limb discomfort
Clinical narrative: Starting on 12/13/23 patient was CO stomach ache and loose bowel movements. This lasted several days. By 12/16 late night he said leg felt funny. On 12/17/23 he said the right leg felt heavy and a little weak. On 12/17/23 there was notable leg  and arm weakness. Which progressed. He was admitted to hospital.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Sensory disturbance
Clinical narrative: Starting on 12/13/23 patient was CO stomach ache and loose bowel movements. This lasted several days. By 12/16 late night he said leg felt funny. On 12/17/23 he said the right leg felt heavy and a little weak. On 12/17/23 there was notable leg  and arm weakness. Which progressed. He was admitted to hospital.
Age: 66.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is experiencing muscle soreness at the site of injection and ocassionally limited range of movement  of shoulder 3 months post vaccination
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Tachycardia the day after she received her immunization. Resolved after taking atenolol.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test normal, Echocardiogram normal, Electrocardiogram ambulatory normal
Clinical narrative: Lone Atrial Fibrillation, admitted to ER, given IV fluids, still in atrial fibrillation at hospital. Released and even lasted for about 13 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Lost menstral cycle for 3 months. More details under 19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Patient reports hearing loss - Dx with sensory neural loss
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Dizziness
Clinical narrative: Unlisted side effect from Pfizer vaccine. This morning, approximately 15 hours after receiving the vaccine, I have had extreme brain fog that is comparable to a side effect I had also experienced from Strattera (which I ceased using). This cannot be explained by any other medication or physiological changes since I do not take any medications. The only thing that changed was the vaccine. I have also been experiencing occasional dizzy episodes that leave me unable to stand properly. I am also properly hydrated.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Foot operation, Gait disturbance, Impaired work ability, Musculoskeletal disorder
Clinical narrative: Two weeks after receiving the third dose of the of the vaccine, I woke up two weeks later for work one morning and I was unable to walk normal on my left foot. I underwent surgery on my left foot in November of 2022. I was out on medical leave from November 4, 2022, until March 31, 2023. I am able to walk in my shoes, but my toes still ball up when I am walking.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Pain, Pain in extremity, Rash pruritic, Skin burning sensation
Clinical narrative: EXTREME PAIN IN ARM, STILL PRESENT 3 MONTHS LATER.  BROKE OUT IN PIMPLY RASH THAT WAS ITCHY AND BURNING FOR 3 WEEKS.  PATIENT FOLLOWING UP WITH ORTHOPEDIC DOCTOR TO HAVE ARM LOOKED AT.  PAIN STILL PRESENT SHOOTING DOWN ARM.
Age: 65.0
Sex: F
Vaccine: DTAP, PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Pt had no issues until 12pm noon the day after the vaccine was administered.  Site of injection started itching and felt bruised, sensitive to touch. Pt came to pharmacy 7 days post vaccine and there was a 3" diameter red welt where the injection had been given. Upon touch the pt said it was still slightly painful. The pain was less then when the symptoms first occurred, the itching had resolved.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Hearing aid user, Tinnitus
Clinical narrative: Tinnitus in the right ear.  Constant ringing and humming in the right ear. Saw  my primary care they put me on medicine for an ear infection, but I knew that was it, so the next day or two I went to see that your doctor specialist, he said it was tinnitus and he gave me a steroid shot in the ear.. the steroid shot did not help so they set me up with a hearing aid to see if that would help which it did not. I have had several hearing test and hearing in that ear for whispering sounds at a low decibels.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysarthria, Loss of consciousness
Clinical narrative: After gave the patient  shot ,  he passed out and  and was slurring his words for a few minutes until he came to. called ems and they checked him out  and said he should go to hospital and he declined.  he had filled out that he did not have any medical problems or vaccine events on  the vaccine questionaire .
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: skin erythema, tenderness. on his left upper thigh for 3 days.    Precipitating event was injection site s/p vaccine. Symptoms have worsened since it started. Patient denies symptoms of fever, lymphadenopathy, purulent discharge.  Pertinent past medical history includes none. SKIN: Erythema located on the left hip. Positive findings: erythema surrounding area, induration, and tenderness
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site pain, Pruritus, Swelling
Clinical narrative: Swelling, hardening at site, itching, pain at injection sites.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: complaints of lumps, skin erythema, tenderness on his right and left thigh for 2 days.    Precipitating event was vaccine. Symptoms have worsened since it started. Patient denies symptoms of fever, lymphadenopathy, purulent discharge, red streaks.  Pertinent past medical history includes none. History of recent skin infection: No. SKIN: Erythema located on the right and left thigh. Positive findings: erythema surrounding area, induration, and tenderness
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: C-reactive protein increased, Electrocardiogram ST segment elevation, Pericarditis, Troponin normal, White blood cell count normal
Clinical narrative: pericarditis
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Rash macular
Clinical narrative: Bright red blotch and pain and sensitivity at injection site.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Swelling and pain for a week
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Balance disorder, Balance test, Brain fog, Computerised tomogram
Clinical narrative: Developed POTS, unable to stand up for any length of time, severe migraines, brain fog, dizziness, balance issues, hypotension, fatigue, tinnitus, and am still suffering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Electrocardiogram, Fatigue, Hypotension
Clinical narrative: Developed POTS, unable to stand up for any length of time, severe migraines, brain fog, dizziness, balance issues, hypotension, fatigue, tinnitus, and am still suffering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Migraine, Postural orthostatic tachycardia syndrome
Clinical narrative: Developed POTS, unable to stand up for any length of time, severe migraines, brain fog, dizziness, balance issues, hypotension, fatigue, tinnitus, and am still suffering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tilt table test, Tinnitus
Clinical narrative: Developed POTS, unable to stand up for any length of time, severe migraines, brain fog, dizziness, balance issues, hypotension, fatigue, tinnitus, and am still suffering.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Patient called pharmacy on 4/13/2024 @ 10:00 AM stating that a chicken pox-like rash had developed all over her body. The rash was reportedly very itchy, red small bumps. PCP was contacted, afterhours nurse conveyed message. Patient did not present to pharmacy but did state she was worried and would likely seek emergency care. Unknown outcome
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness and swelling in L arm
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient's primary care health facility reported administering 1 dose of Shingrix on 1/11/24 to reporting system but patient states he does not remember getting the shot there.  A dose of Shingrix was administered at Pharmacy on 1/13/2024.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Axillary pain, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: severe redness and swelling entire bicep area, joint and muscle  pain entire body, intestinal pain and bow movement, severe fatigue difficult to get out of bed, no appetite  for days, headache, fever,  dizziness, swollen and pain in armpit,  shortness of breath.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Gastrointestinal pain, Headache, Mobility decreased
Clinical narrative: severe redness and swelling entire bicep area, joint and muscle  pain entire body, intestinal pain and bow movement, severe fatigue difficult to get out of bed, no appetite  for days, headache, fever,  dizziness, swollen and pain in armpit,  shortness of breath.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Myalgia, Oedema peripheral, Peripheral swelling, Pyrexia
Clinical narrative: severe redness and swelling entire bicep area, joint and muscle  pain entire body, intestinal pain and bow movement, severe fatigue difficult to get out of bed, no appetite  for days, headache, fever,  dizziness, swollen and pain in armpit,  shortness of breath.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Severevertigo
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Gastrointestinal sounds abnormal, Headache, Injection site pain, Muscle fatigue
Clinical narrative: Headache, pain at injeciton site and surrounding area, chills, stomach gurgline, tired muscles,
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: Trigeminal pain on left side of face
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Feeling hot, Pain, Rash, Swelling
Clinical narrative: Patient complains about soreness, redness, rash, feeling hot, and swelling
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness about 8 hours after injection
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea, Nausea, Pharyngeal swelling, Pruritus
Clinical narrative: Hives, itching, chest tightness, throat swelling, trouble breathing, nausea,  Tachycardia , within 20 minutes of injection
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Tachycardia, Urticaria
Clinical narrative: Hives, itching, chest tightness, throat swelling, trouble breathing, nausea,  Tachycardia , within 20 minutes of injection
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain lower, Asthma, Back pain, Condition aggravated, Cough
Clinical narrative: My arm was really sore, and I started getting stiffness within a day or two. It kept happening. I started to get a sore throat and cough on 4-3 and had pain in my back and left side near my waist. The cough was getting progressively worse and my asthma was being triggered with wheezing so I went to the treatment center on 4-12-24.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Pain in extremity, Wheezing
Clinical narrative: My arm was really sore, and I started getting stiffness within a day or two. It kept happening. I started to get a sore throat and cough on 4-3 and had pain in my back and left side near my waist. The cough was getting progressively worse and my asthma was being triggered with wheezing so I went to the treatment center on 4-12-24.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Butterfly rash, Lymphadenopathy, Pain of skin
Clinical narrative: Onset of  areas of rash 3 days after vaccine. Initially they had butterfly-like shape with white ring around them.   Later realized also on low back.  Dx visually at urgent care and started on anti-viral  1 mg TID x 7 days.    also skin tenderness other areas as progressed and 1-2 days with swollen lymph node in left arm pit on 5th day that has shrunk down (8th day).    Finished rx yesterday.   Rash is still present.  I have pictures from most days if not all.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Contusion, Fatigue, Lymph node pain, Pyrexia
Clinical narrative: Larger than normal bruising. Behavioral issues/outbursts. Extreme fatigue. Throat pain in glands. Vomiting. Fever. These symptoms have lasted from the 4th of April until today, the 14th, and have not improved.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Larger than normal bruising. Behavioral issues/outbursts. Extreme fatigue. Throat pain in glands. Vomiting. Fever. These symptoms have lasted from the 4th of April until today, the 14th, and have not improved.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Pain, Pyrexia, Rash
Clinical narrative: Patient started feeling fatigue, aches and swollen glands on 04/07/2024 about 5 days after the vaccine. She later developed high fevers on 4/12/2024 and was seen at urgent care for fever and additional symptoms. A rash began on her face on 4/13/2024. She says it started splotchy on her face and by 4/14/2024 the rash spread to the rest of her body and looks a lot like measles rash he found online.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Rash macular, Rash morbilliform
Clinical narrative: Patient started feeling fatigue, aches and swollen glands on 04/07/2024 about 5 days after the vaccine. She later developed high fevers on 4/12/2024 and was seen at urgent care for fever and additional symptoms. A rash began on her face on 4/13/2024. She says it started splotchy on her face and by 4/14/2024 the rash spread to the rest of her body and looks a lot like measles rash he found online.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Cold, chills, headache, bodyaches, lightheadedness, fatigue, sore shoulder, nausea
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Nausea, Pain
Clinical narrative: Cold, chills, headache, bodyaches, lightheadedness, fatigue, sore shoulder, nausea
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tic
Clinical narrative: Chronic swelling of the entire left lower extremity with significantly enlarged and hardened left inguinal lymph nodes. These symptoms lasted for at least 3 months.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Approximately 3 weeks after the vaccine I developed pain, soreness and swelling at the injection site. I also had a relapse in migraine symptoms; I have not had these symptoms in nearly 2 years.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Condition aggravated, Joint stiffness, Walking aid user
Clinical narrative: Right knee essentially immobile. Before the 27th, my knee was only briefly stiff in morning. After the 27th, I had to begin using a walker. I am unable to leave my home b/c of stairs. Additionally, previously well controlled arrhythmias have increased.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: As you can see I received only the (2) doses of Pfizer Covid vaccines. Developed Bilateral Tinnitus and there isn't a medical cure. I DO EXPECT monetary compensation as I do believe now it is possibly effecting my memory and I NEED to see neurologist!
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 19Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 04Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "eosinophilic esophagitis" (unspecified if ongoing); "known allergies: Sensitivity to gluten" (unspecified if ongoing); "known allergies: Sensitivity to soy" (unspecified if ongoing); "known allergies: penicillin, Vicodin, codeine, metronidazole, Clin-piq" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 01Apr2024 to 06Apr2024.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Arterial stent insertion, COVID-19, Cardiac assistance device user, Catheterisation cardiac
Clinical narrative: JANSSEN #1 10/1/2021 JANSSEN #2 4/27/2022. PATIENT HAD NO PREMONITORATORY SYMPTOMS PRESENTED WITH ACUTE ANTERIOR MYOCARDIAL INFARCTION AND HYPOTENSION RECEIVED CRITICAL CARE AND STENTING OF LAD.  LVEF <30% REQUIRED TREATMENT WITH ASPIRIN, P2Y12 INHIBITOR, ENTRESTO, CARVEDILOL, ROSUVASTATIN, EZETIMIBE.  LVEF PROGRESSIVELY IMPROVED ON MEDICATIONS.  ALSO ADDED PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery disease, Echocardiogram, Ejection fraction decreased, Electrocardiogram, Hypotension
Clinical narrative: JANSSEN #1 10/1/2021 JANSSEN #2 4/27/2022. PATIENT HAD NO PREMONITORATORY SYMPTOMS PRESENTED WITH ACUTE ANTERIOR MYOCARDIAL INFARCTION AND HYPOTENSION RECEIVED CRITICAL CARE AND STENTING OF LAD.  LVEF <30% REQUIRED TREATMENT WITH ASPIRIN, P2Y12 INHIBITOR, ENTRESTO, CARVEDILOL, ROSUVASTATIN, EZETIMIBE.  LVEF PROGRESSIVELY IMPROVED ON MEDICATIONS.  ALSO ADDED PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Percutaneous coronary intervention
Clinical narrative: JANSSEN #1 10/1/2021 JANSSEN #2 4/27/2022. PATIENT HAD NO PREMONITORATORY SYMPTOMS PRESENTED WITH ACUTE ANTERIOR MYOCARDIAL INFARCTION AND HYPOTENSION RECEIVED CRITICAL CARE AND STENTING OF LAD.  LVEF <30% REQUIRED TREATMENT WITH ASPIRIN, P2Y12 INHIBITOR, ENTRESTO, CARVEDILOL, ROSUVASTATIN, EZETIMIBE.  LVEF PROGRESSIVELY IMPROVED ON MEDICATIONS.  ALSO ADDED PROTOCOL BASE SPIKE DETOXIFICATION.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received their initial dose of GARDASIL 9 (2 dose regimen)  and didn't receive the second dose until 16 months later.; No symptomatic events were reported.; This spontaneous report was received from  anurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided). On another unknown date reported as until 16 months later, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml/ series, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) (inappropriate schedule of product administration). No symptomatic events were reported. No additional information was provided.  Lot numbers were being requested and would be updated upon received.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Second dose received 127 days after first dose of HEPLISAV-B; Received Expired Dose; Initial report received on 09-Feb-2024.  A consumer in the country reported that she, a 27-year old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired. The reporter is a nursing student and was receiving the vaccine for nursing school.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 13-Mar-2023, the patient received the first dose of HEPLISAV-B (lot #, route, and NDC # not reported) in the right arm. The expiration date of the dose was 12-Mar-2023.   On 18-Aug-2023, 127 days after receiving the first dose, the patient received the second dose of HEPLISAV-B (lot #, route, and NDC # not reported) in the right arm.  No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Inappropriate schedule of vaccine administered; Received Series With Heplisav-B, and The Second Dose of Engerix-B; Initial report received on 13-Mar-2024.  A nurse in the country reported that a 53-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received ENGERIX-B as the second dose.  No relevant medical history was reported.    No concomitant medications were reported.    On 15-Jun-2022, the patient received the first dose of HEPLISAV-B (lot # 935841, expiration date 17-Sep-2023, and NDC # 43528-002-01) intramuscularly in the left deltoid.   On 19-Sep-2023, 461 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX-B (lot #, expiration date, and NDC # not provided) intramuscularly in the left deltoid as the second dose.   No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 25.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received Series With Heplisav-B, and The Second Dose of Engerix-B; Initial report received on 13-Mar-2024.  A nurse in the reported that a 25-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B for the second dose of hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-Nov-2023, the patient received the first dose of hepatitis B vaccine, HEPLISAV-B (lot # 943241, expiration date 07-Sep-2025, and NDC # 43528-002-01) intramuscularly in the left deltoid.   On 18-Dec-2023, 43 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot #, expiration date, and NDC # not reported) intramuscularly in the left deltoid. No adverse events were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: Three Day Old Received Heplisav-B; Initial report received on 28-Mar-2024.  A medical assistant in the reported that a 3-day-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 22-Mar-2024, the patient received the first dose of HEPLISAV-B (lot # 943192, expiration dates reported were 30-Sep-2025 and 08-Mar-2026, and NDC # 43528-003-01) intramuscularly in the left thigh from a medical assistant. The patient was 3-days-old at the time of injection.  The parents of the patient have not reported any side effects.  The reporter stated that the incorrect medication was ordered and given to the patient.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it was painful; This non-serious case was reported by a consumer and described the occurrence of pain in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included fluoxetine.   On 07-FEB-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: it was painful). The outcome of the pain was resolved (duration 3 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2024 The reporter reported that the patient received a dose of Shingles vaccine. The patient stated that 1st shot was painful for 3 days The patient was receiving Fluoxetine from 1st January 2022 for anxiety.
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Migraine; Heart racing; Fever; Painful L arm; body ache; This non-serious case was reported by a consumer and described the occurrence of migraine in a 49-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number F4T5L) for prophylaxis.   On 27-MAR-2024, the patient received Boostrix .5 ml. On 27-MAR-2024, less than a day after receiving Boostrix, the patient experienced migraine (Verbatim: Migraine), heart racing (Verbatim: Heart racing), fever (Verbatim: Fever), pain in arm (Verbatim: Painful L arm) and general body pain (Verbatim: body ache). On 28-MAR-2024, the outcome of the migraine, heart racing, fever, pain in arm and general body pain were resolved (duration 1 day).   It was unknown if the reporter considered the migraine, heart racing, fever, pain in arm and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the migraine, heart racing, fever, pain in arm and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe 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: 28-MAR-2024 The patient received Boostrix. The patient had migraine, heart racing, fever, pain in arm and general body pain. The patient did no received treatment for the events The reporter did not consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Adverse event; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 28-MAR-2024, the patient received Kinrix. On 28-MAR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Adverse event). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2024. This report was submitted via the online direct entry reporting system. The patient administered the vaccine beyond the expiry date which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 1st dose of Bexsero on 12th March 2024 and a second dose on 3rd April 2024; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 03-APR-2024, the patient received the 2nd dose of Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Patient was given 1st dose of Bexsero on 12th March 2024 and a second dose on 3rd April 2024). The outcome of the drug dose administration interval too short was unknown.   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: 03-APR-2024 The patient was given 1st dose of Bexsero on 12th March 2024 and a second dose on 3rd April 2024. The director of pharmacy reached out to adult. The adult reached out to the reporter and the reporter then forwarded to medical to reach out to (not specified). It was unknown as there anything he/she would have liked to share about the primary disease and complicating disease.  There were not provided any additional information about this report. The reporter reported that the patient received 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of the vaccine schedule.
Sex: U
Vaccine: RVX
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Bruise; Red like; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of contusion in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. In JAN-2024, an unknown time after receiving RSV vaccine, the patient experienced contusion (Verbatim: Bruise) and erythema (Verbatim: Red like). The outcome of the contusion and erythema were not resolved.   It was unknown if the reporter considered the contusion and erythema to be related to RSV vaccine.     It was unknown if the company considered the contusion and erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2024 This case was reported by a patient via interactive digital media. The patient had a red like bruise from the RSV vaccine that would not go away since January. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: cold). The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-APR-2024 The case was received from the patient via interactive digital media. The patient received Arexvy vaccine. The patient reported that he/she experienced cold, and he/she not facing shortness of breath. The follow-up could not be possible as no contact details were available.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: NP gave Infanrix to a 62 year old patient instead of Boostrix and is asking how to proceed.; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received DTPa (Infanrix) (batch number GG39D) for prophylaxis.   On 28-FEB-2024, the patient received Infanrix. On 28-FEB-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: NP gave Infanrix to a 62 year old patient instead of Boostrix and is asking how to proceed.) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   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: 25-MAR-2024 The nurse practitioner gave Infanrix to a 62 year old patient instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.  Upon internal review the case was updated on: 10-APR-2024. Event coded as wrong vaccine administered and inappropriate age at vaccine administration and narrative added. Summary of Changes: suspect, event and narrative updated.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: administered Pediarix and Kinrix on the same day; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21-OCT-2024) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 28-MAR-2024, the patient received Pediarix and Kinrix. On 28-MAR-2024, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered Pediarix and Kinrix on the same day). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAR-2024 The registered nurse (RN) stated that a child (patient) was administered Pediarix and Kinrix on the same day (on the day of reporting) and the patient was supposed to get either/or of the two vaccines and a Proquad which led to overdose. She was asking if there are any safety concerns. The reporter consented to follow up via email.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, Underdose
Clinical narrative: the patient had only received that 1st dose in March 2023; a patient received their first dose of hepatitis vaccine, and they are adult, but they received a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Engerix B pediatric. In MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: the patient had only received that 1st dose in March 2023) and adult use of a child product (Verbatim: a patient received their first dose of hepatitis vaccine, and they are adult, but they received a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-MAR-2024 The reporter reported that to inform that they had a situation where a patient received their first dose of hepatitis vaccine, and they were adult, but they received a pediatric dose which led to underdose and adult use of a child product. The reporter confirmed that the brand name was Engerix-B. Also, reporter confirmed that the patient had only received that 1st dose in March 2023, and didn't receive any more doses. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 11.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: We administered a dtap to an 11 year old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: We administered a dtap to an 11 year old). The outcome of the inappropriate age at vaccine administration was unknown.   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: 02-APR-2024 The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter was ask was there any contraindications for that. The reporter refused to provide patient information. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not get the second dose until 5 months later on 01Apr2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 4th November 2023).   On 01-APR-2024, the patient received the 2nd dose of Twinrix. On 01-APR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: did not get the second dose until 5 months later on 01Apr2024). The outcome of the drug dose administration interval too long was unknown.   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: 03-APR-2024 The reporter reports that a patient received second dose 5 months later first dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient received only diluent portion of Shingrix; patient received only diluent portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number CZ979, expiry date 13-APR-2026) for prophylaxis.   On 29-MAR-2024, the patient received Shingrix. On 29-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only diluent portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only diluent portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2024 The pharmacist reported that the patient received only diluent portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patients details were not available when medical information safety. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 2nd December 2022, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-APR-2024 The reporter called to report that the patient received the first dose of Shingrix and had not receive the second dose yet. The report did not consent to follow-up. Till the time of reporting patient did not receive the second of Shingrix, which led to incomplete course of vaccination. This case was 1 out of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024042176:SAME REPORTER US-GSK-US2024042177:SAME REPORTER
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: have not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine on 8th March 2023.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: have not yet had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The patient reported that he received the first dose of Shingrix vaccine on 8th March 2023 and has not yet had the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked to the case US2024AMR043996 reported by the same reporter (Wife case).; Sender's Comments:  US-GSK-US2024AMR043996:wife case
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Inappropriate Dose Administered; 50 year old patient was given a single pediatric dose of Engerix-B.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis.   On 28-MAR-2024, the patient received the 1st dose of Engerix B pediatric. On 28-MAR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Inappropriate Dose Administered) and adult use of a child product (Verbatim: 50 year old patient was given a single pediatric dose of Engerix-B.). The outcome of the underdose and adult use of a child product were unknown.   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: 04-APR-2024 The pharmacist reported that 50 year old patient received single pediatric dose of Engerix B vaccine, which led to adult use of a child product and underdose. The reporter consent to follow up.