chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electromyogram abnormal, Nerve injury, Neuropathy peripheral, Sensory disturbance
Clinical narrative: Several months after receiving my 3rd covid 19 shot (or 1st booster), I started feeling strange feelings in my feet. My dr at the time misdiagnosed me as having plantar fasciitis. I changed insurance companies and primary care drs in january of 2023. My new pc sent me to a podiatrist who suggested I see a neurologist which I did. He performed an emg and determined that I had small nerve peripheral nerve damage to my feet and parts of my legs. He performed all the relevant blood tests which all came out negative for anything that might cause it.  I did some research online and discovered that there had been cases of small nerve peripheral neuropathy following the covid 19 vaccine. I believe that is the case for me.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Conjunctivitis, Palpitations, Rash
Clinical narrative: Patient presented to pharmacy and reported heart palpitations, rash on foot and conjunctivitis after receiving the Comirnaty booster. Patient stated they were seen by and are currently under the care of a PCP.
Age: 51.0
Sex: F
Vaccine: TD, VARCEL, TD, VARCEL
Symptoms: Abdominal pain upper, Injection site erythema, Injection site pain, Injection site rash, Periorbital swelling
Clinical narrative: Scratchy, itchy throat, fine red rash over skin, stomach pain, nausea, puffy eyes, headache,  left-sided chest pain, itching all over, soreness and redness at the site of injection (Left arm, deltoid),  moderate vertigo and inability to concentrate.
Age: 51.0
Sex: F
Vaccine: TD, VARCEL, TD, VARCEL
Symptoms: Throat irritation, Urticaria, Vertigo
Clinical narrative: Scratchy, itchy throat, fine red rash over skin, stomach pain, nausea, puffy eyes, headache,  left-sided chest pain, itching all over, soreness and redness at the site of injection (Left arm, deltoid),  moderate vertigo and inability to concentrate.
Age: 51.0
Sex: F
Vaccine: TD, VARCEL, TD, VARCEL
Symptoms: Abdominal pain upper, Chest pain, Disturbance in attention, Headache, Injection site erythema
Clinical narrative: Scratchy, itchy throat, fine red rash over skin, stomach pain, nausea, puffy eyes, headache,  left-sided chest pain, itching all over, soreness and redness at the site of injection (Left arm, deltoid),  moderate vertigo and inability to concentrate.
Age: 51.0
Sex: F
Vaccine: TD, VARCEL, TD, VARCEL
Symptoms: Injection site pain, Nausea, Periorbital swelling, Pruritus, Rash
Clinical narrative: Scratchy, itchy throat, fine red rash over skin, stomach pain, nausea, puffy eyes, headache,  left-sided chest pain, itching all over, soreness and redness at the site of injection (Left arm, deltoid),  moderate vertigo and inability to concentrate.
Age: 51.0
Sex: F
Vaccine: TD, VARCEL, TD, VARCEL
Symptoms: Rash erythematous, Throat irritation, Vertigo
Clinical narrative: Scratchy, itchy throat, fine red rash over skin, stomach pain, nausea, puffy eyes, headache,  left-sided chest pain, itching all over, soreness and redness at the site of injection (Left arm, deltoid),  moderate vertigo and inability to concentrate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody positive, Blood thyroid stimulating hormone, Graves' disease, Thyroxine, Tri-iodothyronine
Clinical narrative: I was diagnosed with Graves? disease 12/21-  I received first dose of Moderna 4/10/21 lot number 037b21a and then a booster 12/18/21 in addition to second dose of backing 5/8
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Muscular weakness, Paraesthesia, Tremor
Clinical narrative: Shakiness in right hand. Lasted for about an hour. Muscle weakness in right arm from shoulder to hand.  Muscle weakness in right leg from hip to foot.  Tingling in right leg from toes to mid though. Tingling in leg returned to normal neuropathy in about a week.   Muscle weakness is still present.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Received the vaccine on 11/20.  I was counseled to avoid pregnancy for 28 days.  I had recently been diagnosed with unexplained infertility and was being worked up by a reproductive endocrinologist.  She recommended I get a repeat MMR before starting IVF because my rubella titers were low.  For the 28 days following the MMR vaccine, we used the withdrawal method.  I had a positive pregnancy test on 12/26, however the first day of my last menstrual cycle was 11/22, there that is considered the first day of pregnancy.  The pregnancy has been uncomplicated thus far.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site swelling, Mental impairment, Pain, Pyrexia
Clinical narrative: Patient reported complete body pain, fever, difficulty thinking clearly. Patient also reported swelling and redness at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Cartilage injury, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: The Shingrix shot I received on 8/11/2023 was extremely painful.  Had pain 1 month later.  Went to PCP who ordered X-Ray and sent me to PT.   6 months later the pain is still there, so I saw PCP again.  She ordered MRI and it showed labral tear, tendon tear and bursitis.  Am in more pain than ever.  Have trouble with every-day things like driving, getting dressed etc.  Need to see an Orthopedic surgeon.  Will see him 3/24/2024.  Just to add, the second dose of Shingrix, in my right arm given by a different pharmacist, was not painful and caused no issues in my right shoulder.  I did nothing to cause the left shoulder injury, other than get the vaccine.  It is clear that the first vaccine administration was wrong by the pharmacist.   This problem is causing me financial and emotional distress!
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging abnormal, Tendon rupture, X-ray limb
Clinical narrative: The Shingrix shot I received on 8/11/2023 was extremely painful.  Had pain 1 month later.  Went to PCP who ordered X-Ray and sent me to PT.   6 months later the pain is still there, so I saw PCP again.  She ordered MRI and it showed labral tear, tendon tear and bursitis.  Am in more pain than ever.  Have trouble with every-day things like driving, getting dressed etc.  Need to see an Orthopedic surgeon.  Will see him 3/24/2024.  Just to add, the second dose of Shingrix, in my right arm given by a different pharmacist, was not painful and caused no issues in my right shoulder.  I did nothing to cause the left shoulder injury, other than get the vaccine.  It is clear that the first vaccine administration was wrong by the pharmacist.   This problem is causing me financial and emotional distress!
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Child noticed the hives and itching symptoms on 3/8/24 the following  night of vaccination but failed to report to us (parents). The following morning the hives located on the chest, back abdomen got worse and the child complained to us already. Child was given benadryl 25mg po at 3:00 and another dose at 9:00 per dosing instructions. Gradually, the symptoms disappeared the following day.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Hyperhidrosis, Syncope
Clinical narrative: POTS like syndrome, with resting HR 60, on standing became 140's with extreme weakness, diaphoresis, collapse.  unable to walk more than 10 feet for 4 weeks, gradually increasing and resolving over the subsequent 4 weeks.  Totally incapacitating.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Angiogram pulmonary abnormal, Atelectasis, Atrial fibrillation, Blood alkaline phosphatase increased
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood glucose normal, Blood sodium decreased, C-reactive protein increased, Cardiac failure congestive
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac tamponade, Cardiomegaly, Chest X-ray abnormal, Discomfort, Dyspnoea
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Feeling abnormal, Fibrin D dimer increased, Haematocrit decreased, Haemoglobin
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Heart sounds abnormal, Hypotension, Inflammation, Intra-abdominal fluid collection
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Lymphocyte percentage decreased, Mean cell haemoglobin decreased, N-terminal prohormone brain natriuretic peptide increased, Neutrophil count increased
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil percentage increased, Pathology test, Pericardial effusion, Pericardial excision, Pericarditis
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Pneumonitis, Pulmonary embolism, Pulmonary oedema, Pulmonary thrombosis
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Respiratory pathogen panel, Splenomegaly, Troponin decreased, White blood cell count increased
Clinical narrative: Pt started to feel poorly with difficulty with deep breathing starting about 12/01/2023. He went to the Emergency Department on our about 12/10/2023 due to dyspnea for 2 hours duration. His CTA of thorax with angiography indicated: Large pericardial effusion, small bilateral pleural effusions, & mild interstitial edema likely on the basis of CHF. Mild splenomegaly, no evidence of pulmonary emboli, mild atelectasis at the right lung base. He was then admitted for 5 days and underwent a pericardial window related to severe pericarditis and cardiac tamponade. After surgery he had atrial fibrillation that has since resolved. Surgical cytopathology report indicated benign pericardial fluid with acute inflammation, blood elements, and mesothelial cells. He was discharge on 12/14/2023. Since he has felt he has had some discomfort with breathing with elevated pulse. An in-office transthoracic ultrasound on 12/21/2024 revealed pericardial effusion fluid of about 1 cm. Accordingly, his pulse was mildly increased from normal to about 92 bpm with somewhat diminished heart sounds. Blood pressure at that time was slighly lower than normal with a normal pulse pressure.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neurodermatitis
Clinical narrative: I developed a severe chronic skin condition known as prurigo nodularis. I have never had a skin condition ever in my life and now I?m taking Dupixent which hasn?t been very effective.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Cognitive disorder, Confusional state, Dementia, Dizziness
Clinical narrative: Frontal Lobe Dementia, Cognitive Decline, Slurred Speech. Balance/Dizzyness/Posture/Confusion.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Magnetic resonance imaging, Posture abnormal, X-ray
Clinical narrative: Frontal Lobe Dementia, Cognitive Decline, Slurred Speech. Balance/Dizzyness/Posture/Confusion.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Lip swelling
Clinical narrative: Swelling of lips one day after vaccination. Came to pharmacy 5 days later to see if it was related to vaccine, swelling had reduced. Recommended benadryl and contact doctor
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Magnetic resonance imaging abnormal, Rotator cuff syndrome, Tendon disorder
Clinical narrative: shoulder impingement related to vaccine administration. MRI shows some cuff tendinosis
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient was given 1 dose of arexvy on 9/30/2023 and then a second dose on 10/14/2023- this is only a 1 dose series
Age: 27.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Abdominal pain upper, Blood bilirubin increased, Blood triglycerides normal, Computerised tomogram abdomen abnormal, International normalised ratio increased
Clinical narrative: Patient received all 4 vaccines on 3/5/2024 without incident.  He developed abdominal pain (epigastric) on 3/6/24 and presented to the Medical Center Emergency Department of 3/7/2024 and was admitted.  He was found to have an elevated lipase and normal liver function tests.  CT scan of the abdomen was consistent with acute pancreatitis without abscess. The biliary tree was unremarkable.
Age: 27.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Lipase increased, Liver function test normal, Pancreatitis acute, Toxicologic test normal
Clinical narrative: Patient received all 4 vaccines on 3/5/2024 without incident.  He developed abdominal pain (epigastric) on 3/6/24 and presented to the Medical Center Emergency Department of 3/7/2024 and was admitted.  He was found to have an elevated lipase and normal liver function tests.  CT scan of the abdomen was consistent with acute pancreatitis without abscess. The biliary tree was unremarkable.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt states that she has had pain in her arm since the vaccine over 1 month ago. Her arm feels tender and she feels pain when she touches injection site. She said she was putting cold compresses and it helped but it still hurts. I instructed her to follow up with doctor if the symptoms are not relieved in another week.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Cough, Crying, Fluid intake reduced, Food refusal, Irritability
Clinical narrative: High fever, refusing fluids/food, decrease in wet diapers, irritability, unable to be consoled, hard to wake up, snotty nose, and dry cough.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Somnolence, Urine output decreased
Clinical narrative: High fever, refusing fluids/food, decrease in wet diapers, irritability, unable to be consoled, hard to wake up, snotty nose, and dry cough.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient called saying that her arm was sore after receiving the influenza vaccine. Patient said that she was waiting for the pain to subside. She reports that she has been unable to lift her arm (more than 1 inch away from her body) for the past month. Patient was advised to contact her PCP regarding this adverse event.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient reach out to the pharmacy 3/9/24 complaining of symptoms for a gardasil she received 2 days prior. As per the patient she stated that the pharmacist who vaccinated her was rushed, and stabbed her arm fiercely.  Patient was concerned that the band aid applied was not on the area of the actual injection. 2 days after she claims the area is red, inflamed and warm to the touch. I counseled the patient to monitor the area, in addition to a cold compress and NSAID therapy. If area does not go down, patient was counseled to follow up with a prescriber as this may indicate an infection.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: Adverse Event:  Improper Vaccine Given. PT here for 2nd dose of Hep B.  Patient was accidentally given Hep B  Engerix B (pediatric dose). I contacted Patient and explained to her I gave her a pediatric dose 0.5 mL. I also explained to her a 2nd dose of the vaccine is recommended to make up for the adult dose. Patient was understanding and agreed to second dose of Hep B Engerix. Patient tolerated well and no reaction.    ENGERIX-B NDC: 58160-820-43 Lot #: C2L22 EXP:05/22/2024   ENGERIX-B NDC: 58160-820-43 Lot #: YM444 EXP: 05/22/2024
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC15, VARCEL, DTAP, HIBV, IPV, MMR, PNC15, VARCEL
Symptoms: Device leakage, Incorrect dose administered, Product leakage, Underdose
Clinical narrative: Device leakage; Incorrect dose administered; Product leakage; Underdose; Information has been received from the Food and Drug Administration health authority (2729535-1) on 05-MAR-2024.   This spontaneous report refers to a 1-year-old male patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 28-DEC-2023, the patient was vaccinated with the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered intramuscularly (IM) in the left leg (LL) for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number X019197 with expiration date not provided but upon internal validation established as 30-AUG-2025); with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: rHA) (M-M-R II), IM in the LL for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number W028735 with expiration date not provided but upon internal validation established as 08-SEP-2024); with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), IM in the LL for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number X012267 with expiration date not provided but upon internal validation established as 30-APR-2025); with the third dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), IM in the right leg (RL) for prophylaxis (dose, and vaccination scheme frequency were not provided; lot number GG39D with not expiration date provided); with the third dose of hib vaccine conj (tet tox) (ACTHIB), IM in the right leg (RL) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not provided, lot number UJ854AA with not expiration date provided); with third dose of polio vaccine inact 3v (vero) (IPOL) (dose, route of administration, vaccination scheme frequency, anatomical location were not provided, lot number W1C751M with not expiration date provided).  It was reported that on 28-DEC-2023 the dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not administered fully (incorrect dose administered, underdose) as it was coming out of where the prefilled syringe and needle connect (device leakage), so only about half of vaccine was administered and the other spilled out on the table (product leakage).   The causal relationship between the events and the suspect therapies were not reported.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC15, VARCEL, DTAP, HIBV, IPV, MMR, PNC15, VARCEL
Symptoms: Device leakage
Clinical narrative: Device leakage; Incorrect dose administered; Product leakage; Underdose; Information has been received from the Food and Drug Administration health authority (2729535-1) on 05-MAR-2024.   This spontaneous report refers to a 1-year-old male patient. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 28-DEC-2023, the patient was vaccinated with the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered intramuscularly (IM) in the left leg (LL) for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number X019197 with expiration date not provided but upon internal validation established as 30-AUG-2025); with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: rHA) (M-M-R II), IM in the LL for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number W028735 with expiration date not provided but upon internal validation established as 08-SEP-2024); with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), IM in the LL for prophylaxis (dose, and vaccination scheme frequency were not provided; valid lot number X012267 with expiration date not provided but upon internal validation established as 30-APR-2025); with the third dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), IM in the right leg (RL) for prophylaxis (dose, and vaccination scheme frequency were not provided; lot number GG39D with not expiration date provided); with the third dose of hib vaccine conj (tet tox) (ACTHIB), IM in the right leg (RL) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not provided, lot number UJ854AA with not expiration date provided); with third dose of polio vaccine inact 3v (vero) (IPOL) (dose, route of administration, vaccination scheme frequency, anatomical location were not provided, lot number W1C751M with not expiration date provided).  It was reported that on 28-DEC-2023 the dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not administered fully (incorrect dose administered, underdose) as it was coming out of where the prefilled syringe and needle connect (device leakage), so only about half of vaccine was administered and the other spilled out on the table (product leakage).   The causal relationship between the events and the suspect therapies were not reported.
Age: 78.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: PAIN IN ARM; PATIENT SAID "FELT LIKE HIT NERVE". CONTINUOUS PAIN AT INJECTION SITE
Age: 78.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain, Peripheral swelling, Sleep disorder
Clinical narrative: PAIN IN ARM; PATIENT SAID "FELT LIKE HIT NERVE". CONTINUOUS PAIN AT INJECTION SITE
Age: 78.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN IN ARM; PATIENT SAID "FELT LIKE HIT NERVE". CONTINUOUS PAIN AT INJECTION SITE
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait disturbance, Seizure
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Gait inability, Nervous system disorder, Seizure
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Cerebrovascular accident, Coma, Fatigue, Gait inability, Magnetic resonance imaging
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Malaise, Pain, Paraesthesia, Scan brain, Seizure
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Biopsy brain abnormal, Death, Demyelination, Laboratory test, Neurological symptom
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.