chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was due for a Hib vaccine, along with PCV20 and Dtap. I drew hib vaccine without realizing powder needed to be mixed. Vaccine diluent was administered by college, while I administered the other two vaccines. Parents were notified of incident, and verbalize patient is well, and denied having no adverse effects. Attempted to schedule patient for a nursing visit to repeat vaccine, but family has moved. Informed parents they should contact us back once they have a new pcp, to address the incident before new Hib vaccine is administered. Parents agreed with plan.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Myalgia
Clinical narrative: For the last 6-9 months i have been checking in with the pharmacy and no one had Moderna, and i called a pharmacy and they ended up having it, and an hour or  later after getting the shot i started to feel bad. And in the evening i got extreme muscle pain and bone pain. I almost drove myself to the hospital.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia
Clinical narrative: patient began have joint pain in hips the day after vaccination. patient still has joint pain now.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: red rash on patients arm that went down from injection site past the elbow, was not hot, just red rash
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Brief resolved unexplained event, Choking, Cyanosis, Pallor
Clinical narrative: Had a BRUE the evening she received the vaccine.  Acted like she was choking, then skin turned pale, lips turned blue, acted like she was passing out.  Transported by EMS to ER, was back to baseline by the time she was seen in ED.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Pt came to the pharmacy to receive an updated pneumonia vaccine. Pt is immunocompromised and received the vaccine based on recommendations of her MD. Pt completed the appropriate pre-screening which was reviewed by the pharmacist. The vaccine was administered by the graduate intern pharmacist. The vaccine was administered in her right arm. Pt waiting 30 minutes in the pharmacy after administration to ensure no adverse responses. She also shopped for groceries following the 30 minute wait period. Pt when home and noticed a welt at the site of administration. As the night progressed the pt realized that the redness expanded and encompassed an area much larger than the injection site. By the next day the redness covered the majority of the upper arm . She went to urgent care for assistance and was prescribed 7 days of oral steroids. The rash and redness lasted for 7 days. Pt came to the pharmacy about 3 weeks later to discuss the matter with the pharmacist and receive the bandaid used during the vaccine administration. The PT's MD thought it was associated with the bandaid used.
Age: 42.0
Sex: F
Vaccine: CHIK
Symptoms: Arthralgia, Borrelia test, Lymphadenopathy, Tenderness
Clinical narrative: 6/16 developed right supraclavicular adenopathy , tender, followed by arthralgias of the right fingers and wrist, then left fingers and wrist , subsequently cervical and thoracic paraspinal tenderness to the right- all mild , able to conduct her daily activities.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Lethargy, Pyrexia
Clinical narrative: High fevers over one week with no other symptoms other than lethargy. After one week, constant temperature above 99 and below 100.
Age: 69.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC20, RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Transfusion, X-ray
Clinical narrative: Patient is still experiencing pain at the site on both arms. States that she occasionally unable to move her arm.
Age: 65.0
Sex: F
Vaccine: HEPAB, PNC21, TDAP
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Pt received 3 vaccines(capvaxive/boostrix/twinrix) on 5/23, now pt presents to the pharmacy on 6/30 to inform us that she is having excessive pain and weakness in her arm- she is unable to lift her arm fully without feeling pain and unable to hold objects without it falling out of her hand. Injection site reaction was free from redness or swelling
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, VARCEL
Symptoms: Extra dose administered
Clinical narrative: I was preparing to draw up the Varicella vaccine. I had the needle on the diluent. I grabbed the vial on the counter and threw it in the bin. I thought I had thrown the varicella vaccine vial away with the vaccine still inside. I got out another varicella vaccine, put the diluent into the vial. I administered the vaccine to the patient. It wasn't until after the patient left that I discovered I had made an error.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: This was a duplicate vaccination, other dose administered 02/10/2025
Age: 1.17
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Autism spectrum disorder, Developmental regression, Eating disorder, Hyperacusis, Lethargy
Clinical narrative: High fever, extreme lethargy, skin rash, decline of developmental abilities (i.e. all speech, eye contact, pointing, playing, etc) increase in stimming like hand flapping, extreme sensitivity to loud noises, limited eating variety,
Age: 1.17
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Stereotypy
Clinical narrative: High fever, extreme lethargy, skin rash, decline of developmental abilities (i.e. all speech, eye contact, pointing, playing, etc) increase in stimming like hand flapping, extreme sensitivity to loud noises, limited eating variety,
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Full blood count, Metabolic function test, Pericarditis
Clinical narrative: Symptoms of chest pain, that worsened with inspiration. Tried OTC GERD medications with no relief. After about 24 hours of symptoms, went to urgent care. EKG had ST elevations in multiple leads so was sent to ER. EKG in ER had resolved to normal and symptoms started subsiding with no intervention. Troponin level was normal. Echo was normal. Dr. thinks it was most likely a mild pericarditis causing the symptoms. Was instructed by Dr. to take ibuprofen 600mg every 6 hours for a week. Symptoms never returned.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: Symptoms of chest pain, that worsened with inspiration. Tried OTC GERD medications with no relief. After about 24 hours of symptoms, went to urgent care. EKG had ST elevations in multiple leads so was sent to ER. EKG in ER had resolved to normal and symptoms started subsiding with no intervention. Troponin level was normal. Echo was normal. Dr. thinks it was most likely a mild pericarditis causing the symptoms. Was instructed by Dr. to take ibuprofen 600mg every 6 hours for a week. Symptoms never returned.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Confusional state, Fall, Loss of consciousness
Clinical narrative: After 13 minutes into administering vaccine, patient accompanied her dad to the counter to get the paperwork. While pharmacist was talking to the dad, pt slowly started to lose control and fell down on the floor. Dad quickly held her by her lap and tried to wake her up. She gained conscoiusness in  about 10 seconds but was still loopy. Callled 911. EMS arrived in  5 minutes. Was taken to ER for further evaluation.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haemorrhage, Radiculitis brachial, Ultrasound Doppler normal, X-ray limb normal
Clinical narrative: I bled from the injection and almost fainted upon receiving the vaccine, and then was diagnosed with brachial neuritis 30 days after receiving vaccine
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Psoriasis, Skin exfoliation
Clinical narrative: Plaque psoriasis.  Scales/ dry patches on various places on my skin. Never had it before the vaccine. Tried creams, and salves.  No change in effects so far.none
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Mass, Rash pruritic
Clinical narrative: Pt stated that her arm was numb the night after receiving the vaccine. The next day it was red and swollen and had quarter sized lump at the injection site. Hives/itchy rash surrounded the lump. Pt took benadryl which helped with the itching for a while, but wore off and the itching started again. Vaccine was given 3 days ago. Pt still has some swelling and itchiness but severity has decreased since day 1.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt stated that her arm was numb the night after receiving the vaccine. The next day it was red and swollen and had quarter sized lump at the injection site. Hives/itchy rash surrounded the lump. Pt took benadryl which helped with the itching for a while, but wore off and the itching started again. Vaccine was given 3 days ago. Pt still has some swelling and itchiness but severity has decreased since day 1.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Anal pruritus, Anger, Anxiety, Apathy
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Brain fog, Contusion, Dandruff, Depression
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Emotional disorder, Emotional distress, Excessive cerumen production, Fatigue
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Gastroenteritis, Hallucination, visual, Headache, Homicidal ideation
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia, Illness, Immunodeficiency, Insomnia
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Loss of libido, Metamorphopsia, Motor dysfunction, Muscle atrophy
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myocarditis, Negative thoughts, Nutritional supplement allergy, Onychoclasis
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Paraesthesia, Pharyngitis streptococcal, Polyp
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Psoriasis, Psychotic disorder, Rash, Retching
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinusitis, Skin atrophy, Squamous cell carcinoma, Tattoo associated skin reaction, Temperature intolerance
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal, Thrombectomy, Thrombosis, Tinnitus, Tremor
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: I am not a doctor, I do not in understand what happened to me, I was only told I may have dizzyness, sore at injection site and may pass out. I had not connected what happened because no one notified me of effects, nor had my government, who supplied the vaccine notified me, I learned years later in 2024. I did nothing and had not seen a doctor, figured I aquired these because ?life happens? and treated these symptoms on my own. All those responsible should burn in hell, if I made any mistakes reporting, deal with it. 2021 Frequent Brain Fog Frequent Thought Disruption Distorted Vision Sudden Adverse Reaction To Vitamins IBS/Diarrhea Sudden Mental Stress Sudden Anxiety Frequent Strep Throat Sudden Loss Motor Skill Sudden Walking Difficulties Diminished Drive/Initiative 2022 Insomnia Peripheral Nerve Tingling Prolonged Skin Rash Tugging Blood Clot Sudden Heart Palpatations Numbness Extremities Sudden Myocarditis Sudden Gastroenteritis Regular Diarrhea Strong Brain Fog 2023 Adverse Reaction To Vitamins Vomiting Adverse Reaction To Brushing Teeth Gagging Occasional Psychosis Intense Acute Homicidal Emotions Intense Acute Genocidal Emotions Halucination Spots Shaking Sensitivity To Heat Sensitivity To Touch Occasional Strep Throat Intense Itching Unbeatable Psoriasis Frequent Hair Loss Sudden IBS 2024 Loss Sex Drive/Interest Prolonged Severe Rash Intense Stinging Sensations Fatigue Multiple Squamous Carcinomas Distorted/Blurring Vision Loss of Drive/Initiative 2025 Sudden Severe Headaches Sudden Blurred Vision Ongoing Depression Sudden Anger Issues Intense Acute Emotional Overreaction Sudden Intense Diarrhea Severe Itching Anus Severe Fatigue No Adverse Reaction To Ivermectin/Mebendazole No Adverse Reaction To Spike Protein Inhibitor No Adverse Reaction To Vitamins Occasional IBS Occasional Gastroenteritis Occasional Brain Fog Mild Depression Occasional Anxiety Occasional Depression Occasional Hallucination Spots Occasional Hair Loss Occasional Numbness Extremities Occasional Diarrhea Occasional Tiredness Occasional Insomnia Mild Skin Rash Mild Depression Slight Loss of Drive/Initiative Slight Loss Sex Drive/Interest Longer Periods Illness Immunity Deficiency Occasional Sinusitis Occasional Insomnia Negative Thoughts Dark External Polyp Severe Tinnitus Severe Ear Wax Severe Dandruff Movement Induced Headaches Mild Tinnitus Sudden Bruising Prolonged Sores Loss of Muscle Mass Joint Pain/Discomfort Brittle Fingernails Thinning of Skin Tattoo immune response (rejection ink)
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Ocular stroke, Sudden death
Clinical narrative: Cardiac arrest - sudden patient death - September 10, 2021 & Ocular stroke March 26, 2022
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient informed that the vaccine facility type was pharmacy. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Prediabetes. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1, batch/lot number: HH7595), administration date: 03Oct2023, when the patient was 66-year-old, for Covid-19 immunization; Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization; Bnt162b2 (dose number unknown (booster)), for Covid-19 immunization; Flu vaccine (about a month prior to that or 6 weeks prior COVID-19 vaccination), administration date: 2024, when the patient was 66 years old, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Her treatment included Paxlovid. Her prescription was filled on 04Jun. She was diagnosed with COVID on 04Jun and she started the five-day course of the medication that evening of the 4th. She took her last dose on the morning of 09Jun. The first time, she have had the body ache, same amount of fever. She did not run a high fever, it was right at a 100.   The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient informed that the vaccine facility type was pharmacy. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Prediabetes. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1, batch/lot number: HH7595), administration date: 03Oct2023, when the patient was 66-year-old, for Covid-19 immunization; Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization; Bnt162b2 (dose number unknown (booster)), for Covid-19 immunization; Flu vaccine (about a month prior to that or 6 weeks prior COVID-19 vaccination), administration date: 2024, when the patient was 66 years old, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Her treatment included Paxlovid. Her prescription was filled on 04Jun. She was diagnosed with COVID on 04Jun and she started the five-day course of the medication that evening of the 4th. She took her last dose on the morning of 09Jun. The first time, she have had the body ache, same amount of fever. She did not run a high fever, it was right at a 100.   The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.
Vaccine: PNC21
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Tenderness
Clinical narrative: Last night (and today) I experienced several of the reactions listed on the information sheet, including: Chills; Muscle Ache; Tenderness; Joint pain; Tiredness; This spontaneous report was received from a consumer or other non-health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine for prophylaxis (dose, lot #, expiration date, route of administration and anatomical site of injection were not reported).  On 26-Jun-2025 (reported as last night and today), the patient experienced muscle ache (myalgia), tenderness, joint pain (arthralgia), chills and tiredness (fatigue).  At the reporting time, the outcome of all the events was unknown.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: unsuitable product administered with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed to temperature excursion for 48 hours with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication: No other vaccines   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site which was exposed to temperature excursion for 48 hours with no reported adverse event (poor quality product administered).  Information regarding batch number corresponding to the one at time of event occurrence was requested.  Reportedly, Nurse stated that she was not sure for the temperature during excursion. There was no human error in this excursion and extended stability data covers this excursion.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.