chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Myocarditis, Pain, Pain in extremity
Clinical narrative: Within 2 weeks of the 2nd dose of the covid vaccine, I entered atrial fibrillation. The afib was severe and was treated with ablation. I also experienced mycarditus. In September 2022 I had another booster of Moderna. Within 4 weeks I was experiencing shooting pain in my arm and the left side of my body
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reactions noted
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Administration site warmth
Clinical narrative: Swolen and warm to the touch on the arm where vaccine administrated from the shoulder down to elbow.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in the arm, especially when raising arm
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second Arexvy vaccine from our location after previously receiving earlier in the year. He does not report any issues but documenting for any needed follow up with patient.
Age: 77.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: Patient stated that he had weakness in legs and hard time standing.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: 5 episodes of recurrent emesis (nonbloody, nonbilious) the evening after the 4mo vaccines
Sex: M
Vaccine: PNC13, PPV
Symptoms: Meningitis pneumococcal, Streptococcus test positive
Clinical narrative: Meningitis; This spontaneous report has been downloaded from Surveillance System, and refers to a child male patient (age group reported as 5-9 years old). There was no information about the patient's concurrent conditions, concomitant medications, drug reactions, allergies or medical history provided.   On unknown dates, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis; and with four doses of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (formulation, exact doses, route of administration, anatomical location, lot number, expiration date and indication were not provided).  On an unknown date in 2019, the patient experienced Streptococcus pneumoniae meningitis (meningitis pneumococcal), and his Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The causal relationship between the event and the suspect vaccines was not provided by the reporter.   Upon internal review, the event of meningitis pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from health authority (agency # not reported) on 12-JAN-2024.  This spontaneous report has been downloaded from database and referring to an elderly male patient (age: 75-79). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 times, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).   On an unknown date in 2021, the patient experienced Streptococcus pneumoniae pneumonia (reported as pneumonia). On an unknown date in 2021, streptococcus pneumoniae serotyping was performed and the result was not available. At the time of reporting, the outcome of the event Streptococcus pneumoniae pneumonia was not known.    The causal relationship between Streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of Streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Regulatory Authority, and refers to an adult male patient (age group reported as 60-64 years old). There was no information about the patient's concurrent conditions, concomitant medications, drug reactions, allergies or medical history provided.   On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (exact dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On an unknown date in 2016, the patient experienced bacteraemia caused by Streptococcus pneumoniae (pneumococcal bacteraemia), and his Streptococcus pneumoniae serotyping result was reported as not available. The outcome of the event was not reported.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided by the reporter.   Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: Clinical category: Bacteremia; This spontaneous report has been downloaded from database on 12-JAN-2024, concerning an elderly (reported as 75-79-year-old) male patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis.  On an unspecified date in 2020, the patient experienced pneumococcal bacteraemia (clinical category: bacteraemia), with a streptococcus pneumoniae serotyping result reported as "not available".  At the time of reporting, the outcome of the event and the causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Hours after receiving COVID vaccine, patient reported an itchy rash under breasts, stomach, legs and arms, worsening over the weekend, and now she has sores on her body from scratching so much; one on her leg, some under her breast (but she can't see it), sores on the thighs.  The patient was advised to send in photo-documentation so that appropriate topicals may be recommended. an antihistamine may also be e-scribed to assist with symptom management.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site swelling
Clinical narrative: Swelling of left arm at the injection site for 3 days. Massaging helped. No pain. No residual effect after that.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pediatric COVID dose was administered past best used by date. Expiration date on vial is 04/2024, but the best used by date (10 weeks after vaccine was removed from freezer for storage in refrigerator) was 1/10/2024. Vaccine was administered on 1/19/2024. Pt parent notified that immediate revaccination recommended.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Hives on torso. Benadryl seemed to improve symptoms. No closing of air way
Age: 78.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Cerebrovascular accident, Musculoskeletal disorder
Clinical narrative: My dad had a stroke the day after he got both of these vaccines. I am not sure why he was given the Covid vaccine, when he just had covid.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Lethargy, Muscle spasms, Nausea, Vomiting
Clinical narrative: Spasm, fatigue, lethargy, nausea, and vomiting beginning 5 minutes after HPV vaccine administration. Resolved after vomiting. BP 96/64, BG 107
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: pt reported that 2 days after the vaccine she developed left neck stiffness and pain which then moved to the right back area and has continued to alternate sides.  No fever, activity change, sob, swelling.  Using nsaids to relieve
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A single expired dose of Moderna Spikevax COVID vaccine was administered which had expired on 01/18/2024 (pulled from freezer on 12/19/2023). I went by the box/vial expiration and missed the "pulled from freezer" date. So it was 35 days after it was moved to the fridge; 5 days over.  Employee Health contacted CDC w/recommendations NOT to repeat dose until after 8 weeks from invalid dose.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Chest pain, Echocardiogram normal, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: MODERNA Administration dates 4/22/2021, 5/20/2021, 1/6/2022.  PATIENT DEVELOPED CHEST PAIN EFFORT INTOLERANCE FATIGUE, AND ON OR ABOUT 7/1/2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION, MEDICATIONS, MULTIPLE DIAGNOSTIC TESTS.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Full blood count normal, Laboratory test normal, Thyroid function test normal
Clinical narrative: MODERNA Administration dates 4/22/2021, 5/20/2021, 1/6/2022.  PATIENT DEVELOPED CHEST PAIN EFFORT INTOLERANCE FATIGUE, AND ON OR ABOUT 7/1/2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION, MEDICATIONS, MULTIPLE DIAGNOSTIC TESTS.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: MODERNA Administration dates 4/22/2021, 5/20/2021, 1/6/2022.  PATIENT DEVELOPED CHEST PAIN EFFORT INTOLERANCE FATIGUE, AND ON OR ABOUT 7/1/2023 DEVELOPED PAROXYSMAL ATRIAL FIBRILLATION REQUIRING HOSPITALIZATION, MEDICATIONS, MULTIPLE DIAGNOSTIC TESTS.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: injection site is hot to touch, red, and painful
Age: 16.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Fall, Head injury, Unresponsive to stimuli
Clinical narrative: Patient was dizzy after receiving vaccines (no history of reaction). Patient fell into chair in waiting area, hitting her head on the nearby wall (did not fall out of the chair). After 30-60 seconds, patient become unresponsive to verbal/physical stimuli in a seated position for 30-60 seconds (patient continued breathing/ pulse detectable). Regained consciousness, oriented to person, place, time, situation. EMS called per mother's request, transported to hospital.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Bruise on right arm of injection site, tenderness of area, swollen
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Muscle Spasms in the left arm Deltoid. Muscle Spasms near the injection site continued 2 months after the injection. Sustained minor spasms continue randomly.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Electric shock sensation, Thinking abnormal
Clinical narrative: intermittant chest pain, unable to focus thoughts, electrical shocks through various parts of body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: After second shot developed whooshing, pulsating in left ear. Still a problem until this day.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Agglutination test, Anti-neutrophil cytoplasmic antibody positive vasculitis, Antibody test, Antineutrophil cytoplasmic antibody
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid antibodies, Aspartate aminotransferase, Aspergillus test, Bacterial test, Bartonella test
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Beta-2 glycoprotein antibody, Blood alkaline phosphatase, Blood beta-D-glucan, Blood bilirubin, Blood calcium
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood chloride, Blood cortisol, Blood creatine, Blood creatine phosphokinase, Blood culture
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Blood glucose, Blood immunoglobulin G, Blood immunoglobulin M, Blood lactate dehydrogenase
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, Blood magnesium, Blood potassium, Blood sodium, Blood urea
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Carbon dioxide, Cardiolipin antibody, Chest X-ray, Complement factor C3
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Creatinine urine, Culture
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Drug level, Drug screen, Electrocardiogram, Factor V Leiden mutation
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Fungal test, Gamma-glutamyltransferase, Gram stain, Granulomatosis with polyangiitis
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test, Hepatitis B core antibody, Hepatitis B surface antigen, Hepatitis C antibody, Herpes virus test
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Interleukin level, Laboratory test, Lymphocyte count
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Microbiology test, Microscopic polyangiitis, Microscopy
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mycobacterium tuberculosis complex test, Pathology test, Protein C, Protein S, Protein urine
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time, Red blood cell sedimentation rate, Respiratory syncytial virus test, Respiratory viral panel, Russell's viper venom time
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scan with contrast, Serum ferritin, Skin wound, Transaminases
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Transferrin, Transferrin saturation, Treponema test, Tryptase, Urine analysis
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Varicella virus test, Venogram, Wound
Clinical narrative: severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener s granulomatosis, and microscopic polyangiitis [MPA]).  Possible other conditions TBD.  Wound opened in face, continued to degrade.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Heart rate increased, Tachycardia, Valsalva maneuver
Clinical narrative: Rapid heart beat.  This time it wasn't as bad as after an earlier  vaccine (which I did not know to report)since patient now takes Cardizem as a result. After that  vaccine his heart rate went to 165 and higher and stayed there for about 24 hours until we took him to the emergency room and they did Valsalva maneuvers, which did not keep it down and finally IV Cardizem.  It took about four hours to come down. At that time he also had an abnormal EKG  in addition to the tachycardia. They called it Belhassen. I would very much like to know if he should not take future vaccines. Thank you.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Erythema, Hypoaesthesia, Induration, Pain in extremity
Clinical narrative: Swelling - Fever - Redness - hard in places chills, arm is Numb Feels Like pins & needles - sore - Low grade fever area Red & turn in scabbing within two weeks
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia, Pyrexia, Scab, Swelling
Clinical narrative: Swelling - Fever - Redness - hard in places chills, arm is Numb Feels Like pins & needles - sore - Low grade fever area Red & turn in scabbing within two weeks
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chondropathy, Complex regional pain syndrome, Condition aggravated, Epidural injection, Fear
Clinical narrative: Shot was administered NOT in the deltoid muscle, but towards the back, possibly directly into the shoulder joint or bone.  The shot immediately stung and burned.  I had the first two shots before this, uneventfully with no pain.  This immediately hurt.  I looked back while from a reaction to the pain.  I saw the needle was well outside the deltoid, from my eyesight it looked "low" however, it was mainly back towards the backside of the arm.  The pain was immediate and burned.  It was shocking.  I went home and iced the arm.  Pain only continued to worsen. Throbbing, aching, burning.  At first I just believed it would clear up and stop hurting.  However, it never has, to this day over 2 years later.  Approximately 10 days later I contacted my doctor as my shoulder began to freeze up.  The pain was intense and shooting when I moved the shoulder.  She referred me to Physical Therapy which I went to for many months.  In some time to follow (I don't recall...3 months? 6 months?) I received an MRI which showed a torn labrum.  I previously NEVER had pain in my shoulders, until the day I received this booster shot.  Even having been a pitcher in baseball (right handed).  Following the MRI I had more PT, acupuncture, massage and even received two or three epidural pain injections.  Nothing helped more than temporarily. The pain continues to undulate from moderate to severe- depending on many factors, use/disuse, sleeping position, weather and so forth.  Immediately following the vaccine injection, the pain/trauma of the injury triggered my CRPS and MCAS conditions.  I struggled with severe symptoms for many months.  To this day, if the arm flares up it is likely to flare up my chronic pain conditions.  This injury has robbed me of a lot of rest, enjoyment of life, ability to work and an otherwise normal existence.  I fear that the only option at this point is surgery which comes with its own set of problems and complications.  And, from what I understand has a relatively low success rate.  I am afraid I am stuck with this injury for a lifetime.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal
Clinical narrative: Shot was administered NOT in the deltoid muscle, but towards the back, possibly directly into the shoulder joint or bone.  The shot immediately stung and burned.  I had the first two shots before this, uneventfully with no pain.  This immediately hurt.  I looked back while from a reaction to the pain.  I saw the needle was well outside the deltoid, from my eyesight it looked "low" however, it was mainly back towards the backside of the arm.  The pain was immediate and burned.  It was shocking.  I went home and iced the arm.  Pain only continued to worsen. Throbbing, aching, burning.  At first I just believed it would clear up and stop hurting.  However, it never has, to this day over 2 years later.  Approximately 10 days later I contacted my doctor as my shoulder began to freeze up.  The pain was intense and shooting when I moved the shoulder.  She referred me to Physical Therapy which I went to for many months.  In some time to follow (I don't recall...3 months? 6 months?) I received an MRI which showed a torn labrum.  I previously NEVER had pain in my shoulders, until the day I received this booster shot.  Even having been a pitcher in baseball (right handed).  Following the MRI I had more PT, acupuncture, massage and even received two or three epidural pain injections.  Nothing helped more than temporarily. The pain continues to undulate from moderate to severe- depending on many factors, use/disuse, sleeping position, weather and so forth.  Immediately following the vaccine injection, the pain/trauma of the injury triggered my CRPS and MCAS conditions.  I struggled with severe symptoms for many months.  To this day, if the arm flares up it is likely to flare up my chronic pain conditions.  This injury has robbed me of a lot of rest, enjoyment of life, ability to work and an otherwise normal existence.  I fear that the only option at this point is surgery which comes with its own set of problems and complications.  And, from what I understand has a relatively low success rate.  I am afraid I am stuck with this injury for a lifetime.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Pain, Periarthritis, Product administered at inappropriate site, Restlessness
Clinical narrative: Shot was administered NOT in the deltoid muscle, but towards the back, possibly directly into the shoulder joint or bone.  The shot immediately stung and burned.  I had the first two shots before this, uneventfully with no pain.  This immediately hurt.  I looked back while from a reaction to the pain.  I saw the needle was well outside the deltoid, from my eyesight it looked "low" however, it was mainly back towards the backside of the arm.  The pain was immediate and burned.  It was shocking.  I went home and iced the arm.  Pain only continued to worsen. Throbbing, aching, burning.  At first I just believed it would clear up and stop hurting.  However, it never has, to this day over 2 years later.  Approximately 10 days later I contacted my doctor as my shoulder began to freeze up.  The pain was intense and shooting when I moved the shoulder.  She referred me to Physical Therapy which I went to for many months.  In some time to follow (I don't recall...3 months? 6 months?) I received an MRI which showed a torn labrum.  I previously NEVER had pain in my shoulders, until the day I received this booster shot.  Even having been a pitcher in baseball (right handed).  Following the MRI I had more PT, acupuncture, massage and even received two or three epidural pain injections.  Nothing helped more than temporarily. The pain continues to undulate from moderate to severe- depending on many factors, use/disuse, sleeping position, weather and so forth.  Immediately following the vaccine injection, the pain/trauma of the injury triggered my CRPS and MCAS conditions.  I struggled with severe symptoms for many months.  To this day, if the arm flares up it is likely to flare up my chronic pain conditions.  This injury has robbed me of a lot of rest, enjoyment of life, ability to work and an otherwise normal existence.  I fear that the only option at this point is surgery which comes with its own set of problems and complications.  And, from what I understand has a relatively low success rate.  I am afraid I am stuck with this injury for a lifetime.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Shot was administered NOT in the deltoid muscle, but towards the back, possibly directly into the shoulder joint or bone.  The shot immediately stung and burned.  I had the first two shots before this, uneventfully with no pain.  This immediately hurt.  I looked back while from a reaction to the pain.  I saw the needle was well outside the deltoid, from my eyesight it looked "low" however, it was mainly back towards the backside of the arm.  The pain was immediate and burned.  It was shocking.  I went home and iced the arm.  Pain only continued to worsen. Throbbing, aching, burning.  At first I just believed it would clear up and stop hurting.  However, it never has, to this day over 2 years later.  Approximately 10 days later I contacted my doctor as my shoulder began to freeze up.  The pain was intense and shooting when I moved the shoulder.  She referred me to Physical Therapy which I went to for many months.  In some time to follow (I don't recall...3 months? 6 months?) I received an MRI which showed a torn labrum.  I previously NEVER had pain in my shoulders, until the day I received this booster shot.  Even having been a pitcher in baseball (right handed).  Following the MRI I had more PT, acupuncture, massage and even received two or three epidural pain injections.  Nothing helped more than temporarily. The pain continues to undulate from moderate to severe- depending on many factors, use/disuse, sleeping position, weather and so forth.  Immediately following the vaccine injection, the pain/trauma of the injury triggered my CRPS and MCAS conditions.  I struggled with severe symptoms for many months.  To this day, if the arm flares up it is likely to flare up my chronic pain conditions.  This injury has robbed me of a lot of rest, enjoyment of life, ability to work and an otherwise normal existence.  I fear that the only option at this point is surgery which comes with its own set of problems and complications.  And, from what I understand has a relatively low success rate.  I am afraid I am stuck with this injury for a lifetime.
Age: 0.33
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Unevaluable event
Clinical narrative: No side effects reported.; a third dose of PEDVAX HIB given early to a child at age 6 months, after he had already received his first two doses of the vaccine.; a third dose of PEDVAX HIB given early to a child at age 6 months, after he had already received his first two doses of the vaccine.; This spontaneous report was received from a Medical Assistant and refers to a currently 6-month-old male patient.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 06-NOV-2023, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) given early to a child at age 6 months (However, second dose was administered at the age of 4 months), after he had already received his first two doses of the vaccine (Product administered to patient of inappropriate age).  On 10-JAN-2024, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration); no side effects were reported.
Age: 0.33
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported.; a third dose of PEDVAX HIB given early to a child at age 6 months, after he had already received his first two doses of the vaccine.; a third dose of PEDVAX HIB given early to a child at age 6 months, after he had already received his first two doses of the vaccine.; This spontaneous report was received from a Medical Assistant and refers to a currently 6-month-old male patient.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not provided.  On 06-NOV-2023, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) given early to a child at age 6 months (However, second dose was administered at the age of 4 months), after he had already received his first two doses of the vaccine (Product administered to patient of inappropriate age).  On 10-JAN-2024, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration); no side effects were reported.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, DTAP, HIBV, PNC20
Symptoms: Febrile convulsion, Human rhinovirus test positive, Muscle twitching, Pyrexia, Unresponsive to stimuli
Clinical narrative: Patient's mother called on 01/24/2024 to report that the patient was taken to the ER on day of vaccination (01/17/2024) for a febrile seizure at 1630. Patient's mother states the child is well now and is back to normal.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, DTAP, HIBV, PNC20
Symptoms: Febrile convulsion, Human rhinovirus test positive
Clinical narrative: Patient's mother called on 01/24/2024 to report that the patient was taken to the ER on day of vaccination (01/17/2024) for a febrile seizure at 1630. Patient's mother states the child is well now and is back to normal.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Injection site reaction, Malaise, Rash
Clinical narrative: Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy; 12-24 hrs had high fever of 102; itchy rash on lower back, stretched to upper back over next 4-7 days; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Dec-2023, the patient experienced SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days). The patient was treated with HYDROCORTISONE (HYDROCORTIZON [HYDROCORTISONE]) (topical) for Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had 12-24 hrs had high fever of 102, next morning woke up with itchy rash on lower back, stretched to upper back over next 4-7 days. Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines but left pink patches - upper back rash persisted - still extremely itchy -now going on 4 weeks and still being treated, not resolved.  Had 3 prior vaxes with no problems. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication included H2 Blockers Pepcid.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy; 12-24 hrs had high fever of 102; itchy rash on lower back, stretched to upper back over next 4-7 days; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Dec-2023, the patient experienced SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days). The patient was treated with HYDROCORTISONE (HYDROCORTIZON [HYDROCORTISONE]) (topical) for Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had 12-24 hrs had high fever of 102, next morning woke up with itchy rash on lower back, stretched to upper back over next 4-7 days. Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines but left pink patches - upper back rash persisted - still extremely itchy -now going on 4 weeks and still being treated, not resolved.  Had 3 prior vaxes with no problems. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication included H2 Blockers Pepcid.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia, Rash pruritic, Skin discolouration
Clinical narrative: Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy; 12-24 hrs had high fever of 102; itchy rash on lower back, stretched to upper back over next 4-7 days; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with COVID-19 vaccine, COVID-19 vaccine and COVID-19 vaccine.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Dec-2023, the patient experienced SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days). The patient was treated with HYDROCORTISONE (HYDROCORTIZON [HYDROCORTISONE]) (topical) for Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines, but left pink patches - upper back rash persisted - still extremely itchy), PYREXIA (12-24 hrs had high fever of 102) and RASH PRURITIC (itchy rash on lower back, stretched to upper back over next 4-7 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had 12-24 hrs had high fever of 102, next morning woke up with itchy rash on lower back, stretched to upper back over next 4-7 days. Lower back improved with treatment over 2 weeks of hydrocortizone and antihistamines but left pink patches - upper back rash persisted - still extremely itchy -now going on 4 weeks and still being treated, not resolved.  Had 3 prior vaxes with no problems. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication included H2 Blockers Pepcid.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from the National Notifiable Diseases Surveillance System (NNDSS), and regards a female patient between 70 and 74 years of age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2011, the patient experienced bacteraemia (Pneumococcal bacteraemia). At the time of reporting, the outcome of the event was unknown and the action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding the event was not applicable.   The causal relationship between pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from the Surveillance System, and regards a female patient between 80 and 84 years of age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2011, the patient experienced pneumonia (Pneumonia pneumococcal). At the time of reporting, the outcome of the event was unknown and the action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding the event was not applicable.   The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from the Surveillance System, and regards a male patient between 50 and 54 years of age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2020, the patient experienced pneumonia (Pneumonia pneumococcal). At the time of reporting, the outcome of the event was unknown and the action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding the event was not applicable.   The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) via Case Line Listing concerning an elderly (reported as 65-69 years old) male patient. The patient's concurrent condition, medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported were not provided).  On an unknown date in 2014, the patient experienced bacteraemia (pneumococcal bacteraemia). Streptococcus pneumoniae serotyping was not available (vaccination history: vaccine/s given). At the time of reporting, the outcome of the event was not reported.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not applicable.  The causal relationship between Pneumococcal bacteraemia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of Pneumococcal bacteraemia was determined to be medically significant.