chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Eye pruritus, Impaired work ability, Injection site discolouration, Injection site erythema
Clinical narrative: Wednesday the 17 of January 2018 Patient received the shot. Thursday the 18 of January 2018 the patient experienced extremely Itchy eyes and "wanted to scratch her eyes out" also compared it to her cat allergies explaining it was that bad along with Asthma like Symptoms. Friday the 19 of January 2018 the itching was still bad did not attend work and reported that the asthma was better. Saturday the 20 of January 2018 reported that both the itching/ asthma were better and was planning on leaving for vacation. The patient experienced at the site of the injection red, tender, swollen skin which by Saturday the 20 of January had changed to purple was still tender but the swelling was reduced. Patient called the pharmacy on the 20 of January 2018 and reported signs and symptoms was recommended to call her primary care provider if the symptoms worsen.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Wednesday the 17 of January 2018 Patient received the shot. Thursday the 18 of January 2018 the patient experienced extremely Itchy eyes and "wanted to scratch her eyes out" also compared it to her cat allergies explaining it was that bad along with Asthma like Symptoms. Friday the 19 of January 2018 the itching was still bad did not attend work and reported that the asthma was better. Saturday the 20 of January 2018 reported that both the itching/ asthma were better and was planning on leaving for vacation. The patient experienced at the site of the injection red, tender, swollen skin which by Saturday the 20 of January had changed to purple was still tender but the swelling was reduced. Patient called the pharmacy on the 20 of January 2018 and reported signs and symptoms was recommended to call her primary care provider if the symptoms worsen.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: PATIENT'S MOTHER CALLED MORNING OF THE 2OTH TO SAY HER DAUGHTER BECAME ILL AFTER RECEIVING THE VACCINATION ON THE 19TH. SHE REPORTED A FEVER, CHILLS, BODY ACHES, AND SORE THROAT. MOTHER WAS GOING TO TREAT PATIENT WITH TYLENOL; PHARMACIST SUGGESTED VISITING AN URGENT CARE CLINIC TO RULE OUT AN ACTIVE INFLUENZA INFECTION BUT TO DATE THEY HAVE NOT SOUGHT ADDITIONAL MEDICAL TREAMENT.
Age: 14.0
Sex: M
Vaccine: FLUR3
Symptoms: Confusional state, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient was fine up until leaving the building at which time he became light headed and then blacked out, falling to elbows and then hit head to floor. He came to immediately and was walked back to the pharmacy with his family. He lied down with feet elevated x20 minutes, was given some water, and continued to be confused with what happened within the last hour or so. Repeated the same question of "what happened" even after being told just a minute ago. Paramedics came and BP and pulse were normal and head seemed otherwise unharmed. He was then taken the hospital though since he remained very pale and kept asking the same question of "what happened". He could remember what happened yesterday and memory was intact for most everything except for the previous few hours.
Age: 14.0
Sex: M
Vaccine: FLUR3
Symptoms: Pallor
Clinical narrative: Patient was fine up until leaving the building at which time he became light headed and then blacked out, falling to elbows and then hit head to floor. He came to immediately and was walked back to the pharmacy with his family. He lied down with feet elevated x20 minutes, was given some water, and continued to be confused with what happened within the last hour or so. Repeated the same question of "what happened" even after being told just a minute ago. Paramedics came and BP and pulse were normal and head seemed otherwise unharmed. He was then taken the hospital though since he remained very pale and kept asking the same question of "what happened". He could remember what happened yesterday and memory was intact for most everything except for the previous few hours.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Barium swallow, Blood pressure fluctuation, Computerised tomogram, Decreased appetite
Clinical narrative: Heart Palpitations, Dysphagia, Dysmotility, Malaise, Fatigue, Cramps, Esophagitis, Weakness, Weight loss, Loss of appetite, Hypersalivation, Inconsistent blood pressure.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphagia, Endoscopy, Fatigue, Full blood count, Lumbar puncture
Clinical narrative: Heart Palpitations, Dysphagia, Dysmotility, Malaise, Fatigue, Cramps, Esophagitis, Weakness, Weight loss, Loss of appetite, Hypersalivation, Inconsistent blood pressure.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Muscle spasms, Nuclear magnetic resonance imaging, Oesophageal manometry, Oesophageal motility disorder
Clinical narrative: Heart Palpitations, Dysphagia, Dysmotility, Malaise, Fatigue, Cramps, Esophagitis, Weakness, Weight loss, Loss of appetite, Hypersalivation, Inconsistent blood pressure.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Oesophagitis, Palpitations, Salivary hypersecretion, Weight decreased
Clinical narrative: Heart Palpitations, Dysphagia, Dysmotility, Malaise, Fatigue, Cramps, Esophagitis, Weakness, Weight loss, Loss of appetite, Hypersalivation, Inconsistent blood pressure.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Headache- 3 hours after injection. Fatigue - 12 hours after injection. Muscle aches/weakness- 12-15 hours after injection. Low Fever/chills - 15-20 hours after injection. Swelling/burning pain at injection site - 24 hours after injection. Stiffness/swelling of shoulder- 24 hours after injection.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Pyrexia, Swelling
Clinical narrative: Headache- 3 hours after injection. Fatigue - 12 hours after injection. Muscle aches/weakness- 12-15 hours after injection. Low Fever/chills - 15-20 hours after injection. Swelling/burning pain at injection site - 24 hours after injection. Stiffness/swelling of shoulder- 24 hours after injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nasal congestion, Pain, Pyrexia
Clinical narrative: Chills, fever of 101.6, body aches, nasal congestion, malaise. Lasted approx 2 days.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Balance disorder, Coordination abnormal, Hypoaesthesia, Nodule
Clinical narrative: Fifteen minutes after receiving the vaccine, the patient's hands felt numb and uncoordinated, she felt unsteady on her feet, and suddenly developed a painful knot in her lower back which cased pain to radiate up her back. A nurse who was nearby in the store steadied her and called an ambulance for her. She did not leave in the ambulance, but an EMT did stay with her until the pain subsided and she regained her balance, which took around 15 minutes. She never had any other issues and did not seek any follow up care.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Mouth swelling, Pharyngeal oedema
Clinical narrative: Anaphylactic reaction. swelling in mouth and throat.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Eczema, Erythema, Laboratory test, Pruritus, Pyrexia
Clinical narrative: On the day of he got a fever of 105 degrees. He also received the PCV13 shot as well. Following the day after the shot he got red itchy blotchy skin and now has eczema.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: On the day of he got a fever of 105 degrees. He also received the PCV13 shot as well. Following the day after the shot he got red itchy blotchy skin and now has eczema.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cold sweat, Dizziness, Dyspnoea, Fall, Fatigue
Clinical narrative: Shortly after receiving the vaccine, the patient experienced swelling and pain. He could not raise his arm. A few hours later he experienced shortness of breath and dizziness. The dizziness caused him to fall and hit his head. He also experience clamminess, sweating and excessive fatigue. He slept most of the day and the next day. Today, 2 days later, he is feeling normal.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Head injury, Hyperhidrosis, Mobility decreased, Pain, Swelling
Clinical narrative: Shortly after receiving the vaccine, the patient experienced swelling and pain. He could not raise his arm. A few hours later he experienced shortness of breath and dizziness. The dizziness caused him to fall and hit his head. He also experience clamminess, sweating and excessive fatigue. He slept most of the day and the next day. Today, 2 days later, he is feeling normal.
Age: 36.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Cough, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Headache, Runny nose, cough, mucus, light fever, body aches, sneezing.
Age: 36.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Secretion discharge, Sneezing
Clinical narrative: Headache, Runny nose, cough, mucus, light fever, body aches, sneezing.
Age: 36.0
Sex: M
Vaccine: FLUC4, FLUX
Symptoms: Influenza
Clinical narrative: Headache, Runny nose, cough, mucus, light fever, body aches, sneezing.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pronounced angioedema, swelling, pain, redness, hardness and fever at the injection site >10 cm diameter, from 2 hours post injection, worsening at 12 hours post injection and gradually improving to 72 hours post injection, with rash still visible.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Rash
Clinical narrative: Pronounced angioedema, swelling, pain, redness, hardness and fever at the injection site >10 cm diameter, from 2 hours post injection, worsening at 12 hours post injection and gradually improving to 72 hours post injection, with rash still visible.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient woke up with swelling, redness and soreness at injection site. The site at peak reaction had a diameter of about 6 inches in diameter and hot to the touch. The patient took ibuprofen over the next couple of days for the soreness and swelling and diphenhydramine at night for itching. As of today (1/21/18),  4 days after the vaccination, the swelling has gone down and the pain is significantly reduced. The site is no longer warm to the touch. The area around the injection site is still red but it is shrinking. We will continue to monitor the patient's condition.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Fall, Head injury, Skin discolouration, Syncope
Clinical narrative: Patient has what seems to have been a self-limiting syncopal episode after the shot was administered. Please see narrative: Patient came in and asked for a Flu Shot. Filled out questionnaire. No contraindications. I asked him if he had had a flu shot before. He had not. I asked him if he has ever had a reaction to any vaccinations that he is aware of. He had not. He did offer that he was anxious about needles. I reassured him and told him that it is a very thin needle, and most people don't even feel it. I gave him the injection. I inspected the site, and told him that there was no blood. I asked him if he wanted a Band-Aid. He responded that he would; that it would be good. I asked him if he felt OK- he responded that he did. I asked him to wait for the observation period, told him that I would go into the department to finish the paperwork, and told him that I would check back on him. He responded affirmatively. I returned to the department and had been there for less than a minute, when somebody called from out front saying that the person who just had a shot was having a reaction.  I went out to find him on the floor trying to sit up. As he was trying to sit up, his eyes rolled up and he fell back from a semi-sitting position, banging his head on the wall. I instructed my technician to call EMS. I adjusted him so that his head was flat on the floor and his knees were up, and he became responsive after about a minute (he was unresponsive for a short time). I asked him if he remembered what happened. He said yes, and that it had happened to him once before when he was giving blood. His color at this point was grey. His pulse was 64 bpm, and his blood pressure 106/60. EMS arrived and examined him. He was rapidly improving at this point. They spoke with him for about 20 minutes, he declined to be transported, signed their refusal of treatment and they left. He stayed for about 10 more minutes, then left.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient has what seems to have been a self-limiting syncopal episode after the shot was administered. Please see narrative: Patient came in and asked for a Flu Shot. Filled out questionnaire. No contraindications. I asked him if he had had a flu shot before. He had not. I asked him if he has ever had a reaction to any vaccinations that he is aware of. He had not. He did offer that he was anxious about needles. I reassured him and told him that it is a very thin needle, and most people don't even feel it. I gave him the injection. I inspected the site, and told him that there was no blood. I asked him if he wanted a Band-Aid. He responded that he would; that it would be good. I asked him if he felt OK- he responded that he did. I asked him to wait for the observation period, told him that I would go into the department to finish the paperwork, and told him that I would check back on him. He responded affirmatively. I returned to the department and had been there for less than a minute, when somebody called from out front saying that the person who just had a shot was having a reaction.  I went out to find him on the floor trying to sit up. As he was trying to sit up, his eyes rolled up and he fell back from a semi-sitting position, banging his head on the wall. I instructed my technician to call EMS. I adjusted him so that his head was flat on the floor and his knees were up, and he became responsive after about a minute (he was unresponsive for a short time). I asked him if he remembered what happened. He said yes, and that it had happened to him once before when he was giving blood. His color at this point was grey. His pulse was 64 bpm, and his blood pressure 106/60. EMS arrived and examined him. He was rapidly improving at this point. They spoke with him for about 20 minutes, he declined to be transported, signed their refusal of treatment and they left. He stayed for about 10 more minutes, then left.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site bruising, Pain, Swelling
Clinical narrative: Injection site is bruised on left arm. Below injection site is bruised and red, swollen and painful. Patient thinks the red and bruised area keeps getting bigger. Told patient to go to ER.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Injection site paraesthesia, Paraesthesia, Sensory disturbance
Clinical narrative: 2 days after receiving the vaccine I woke up with a strange sensation in my left arm I thought it was asleep from sleeping in a weird position, but as I make a fist I have a severe weakness unlike anything I have ever felt. It's like the tendons in my hand have no strength and a slight tingling on my arm from the point of injection. I am really scared as I have never felt this kind of weakness in my arm.  I have no strength and I don't know if this is going to get worse it's only 2 days after the shot, I hope this goes away I am really scared.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm is still sore when moving and it has been almost 1 month.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site. Sought no treatment. Pt advised to use OTC NSAIDS, Benedryl, cold compress. Contact physician if effects persist.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Acute stomach pain beginning at 3 am, lasting 8 hours. Severe pain all over body, chills, and low fever entire next day. Acute tiredness. Stomach pain still present 1/21, but recovering and able to have soup and bread. No vomiting.
Age: 60.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Low grade fever 99 degrees F, worst stomach cramps, nausea and vomiting, headache, shoulders and neck ache, dizzy, started at about 7pm (vaccine admin 5:30PM).
Age: 60.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: Low grade fever 99 degrees F, worst stomach cramps, nausea and vomiting, headache, shoulders and neck ache, dizzy, started at about 7pm (vaccine admin 5:30PM).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient felt lightheaded immediately after receiving vaccine. With 3-4 minute, she lost consciousness. She was laid on floor and breathing was monitored. After approximately 1 minute, she regained consciousness. She was able to answer questions such as her name and where she was. EMS was called and they checked vitals and monitored. She refused additional treatment and transport to hospital.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Death, Gait inability, Lung disorder, Musculoskeletal disorder
Clinical narrative: This spontaneous report was received via a company representative from a researcher who obtained the information from the web site and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date (reported as a "few years ago"), the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiration date were not reported) for prophylaxis. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Reported Cause(s) of Death: died from an unknown cause.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aphasia, Central nervous system inflammation, Completed suicide, Death, Dyspnoea
Clinical narrative: This spontaneous report was received via a company representative from a researcher who obtained the information from the web site and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date (reported as a "few years ago"), the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiration date were not reported) for prophylaxis. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Reported Cause(s) of Death: died from an unknown cause.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Endotracheal intubation, Gait inability, Lung disorder, Malaise, Mechanical ventilation
Clinical narrative: This spontaneous report was received via a company representative from a researcher who obtained the information from the web site and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date (reported as a "few years ago"), the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiration date were not reported) for prophylaxis. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Reported Cause(s) of Death: died from an unknown cause.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal disorder, Myelitis transverse, Nausea, Neck pain, Pallor
Clinical narrative: This spontaneous report was received via a company representative from a researcher who obtained the information from the web site and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date (reported as a "few years ago"), the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiration date were not reported) for prophylaxis. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Reported Cause(s) of Death: died from an unknown cause.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paralysis
Clinical narrative: This spontaneous report was received via a company representative from a researcher who obtained the information from the web site and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date (reported as a "few years ago"), the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiration date were not reported) for prophylaxis. It was unspecified how many doses of the vaccine were administered. On an unknown date, the patient was hospitalized due to loss of some bodily functions (adverse event); the patient lost the ability to walk on an unknown date and had to learn to walk again. It was reported, that the patient never regained full function of his lungs, neck and right arm. It was unknown if the patient received any treatment or had any laboratory diagnostic tests performed for the events. On 08-JAN-2018, the patient died from an unknown cause. It was unknown if an autopsy was performed. The outcome of adverse event was unknown, the outcome of gait inability was reported as resolving and the outcome of lung disorder and musculoskeletal disorder was reported as not resolved. The causality between the events and GARDASIL was not reported. The events loss of some bodily functions, musculoskeletal disorder, lung disorder, and gait inability were considered as disability. Upon internal review, the death was considered as medically significant. Reported Cause(s) of Death: died from an unknown cause.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 76 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 28-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N019983 and expiration date of 03-MAR-2019, for prevention of pneumonia. On the same day, the patient's arm was red (injection site erythema) and swollen (injection site swelling); On approximately 30-DEC-2017, the pharmacist observed the inside of the patient's arm was red, swollen and hot from mid-bicep to past the elbow, and redness was travelling towards the wrist and hand. Patient stated that it looked much better then that the swelling went down. The outcome of erythema, injection site erythema, peripheral swelling and feeling hot and the causal relationship between the events erythema, injection site erythema, peripheral swelling, feeling hot and injection site swelling and therapy with PNEUMOVAX 23 were not reported.
Age: 0.92
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Decreased appetite, Fatigue, Insomnia, Ocular hyperaemia, Pallor
Clinical narrative: High fever of 102+ controlled with MOTRIN around the clock. Baby will not sleep longer than 30-45 min at a time. Restless or awake all night. Screams and writhes for up to an hour at a time multiple times during the night. Decreased appetite. Decrease in wet diapers. Pale face. Red around eyes. Looks exhausted. Excrement is tan and soft.
Age: 0.92
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Pyrexia, Restlessness, Screaming
Clinical narrative: High fever of 102+ controlled with MOTRIN around the clock. Baby will not sleep longer than 30-45 min at a time. Restless or awake all night. Screams and writhes for up to an hour at a time multiple times during the night. Decreased appetite. Decrease in wet diapers. Pale face. Red around eyes. Looks exhausted. Excrement is tan and soft.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Myopericarditis.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, regarding a 22 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 23-AUG-2017 the patient was vaccinated with the first dose of GARDASIL 9 which had a lot # N021571 with expiration date on 29-APR-2020 (dose, route and site of administration were not reported) for prophylaxis. On 24-OCT-2017, she received the second dose, and subsequently on 22-DEC-2017 the patient was vaccinated with the third dose of GARDASIL 9. However, no adverse effects were reported.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a 12 month old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 21-DEC-2017, the patient was vaccinated with a dose of VARIVAX intramuscularly for prophylaxis, lot # N010108 (dose and expiration date were not reported). The same day, the patient  was vaccinated with a dose of M-M-R II intramuscularly for prophylaxis, lot # N008366 (dose and expiration date were not reported). At the time of vaccination there was not illness or pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was not adverse event involved or product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Mammogram
Clinical narrative: This spontaneous report concerning a female patient of unknown age, was received from the patient herself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 26-DEC-2017, the patient was vaccinated with ZOSTAVAX (dosage, route, lot number and expiration date were not reported) for prophylaxis. On 27-DEC-2017, the patient had scheduled a mammogram. At the reporting time, the outcome of mammogram was unknown. The causal assessment between the event and the suspect therapy with ZOSTAVAX was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: This spontaneous report has been received from a physician referring to a 25 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On 04-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # N026812, expiration date 22-JUN-2017, by intramuscular route for prophylaxis. After vaccination while leaving the physician's office, the patient experienced headache, nausea, stomach pain, diarrhea and felt light headed (dizziness and abdominal pain upper). On 05-JAN-2018, the patient explained to the physician that the adverse effects had resolved, without receiving treatment within 24 hours. The patient sought for medical attention however none laboratory studies were performed. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 76 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. The patient reported that back in "2000-2005" she participated in a clinical trial for what would become known as ZOSTAVAX (lot # and expiry date were not reported) for prophylaxis. She further stated that at first she received the placebo but at the end of the trial received the actual vaccine. However, starting about a week ago, the patient developed a rash. She stated that on the first night, there was some pain associated with the rash but after the first night, she only had the rash. The following information was asked of the patient, however she stated that she could not remember any of the information. Many of the fields in this report are marked, "Unknown by Reporter," because the reporter did not have specific information to provide. The outcome of the adverse events pain and rash was unknown. Causality assessment was not provided by reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a female patient, age not reported. The patient was vaccinated with ZOSTAVAX on or about 19-AUG-2017 at a pharmacy for as recommended for adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2017, only a few days after being vaccinated, the patient was treated at a community health facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which had been present for three days, and was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster and weakened immune symptoms was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a female patient, age not reported. The patient was vaccinated with ZOSTAVAX on or about 01-JAN-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. Beginning on or about 01-MAR-2017, the patient began to break out with blistering vesicular lesions. The patient was treated at a healthcare facility and by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster and weakened immune symptoms was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-DEC-2016 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a patient (gender and age not reported). The patient was inoculated with ZOSTAVAX on or about 10-SEP-2014, administered by a physician (at an unspecified facility/office), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 07-DEC-2015, the patient was treated by a physician (the same physician who administered the vaccine, at an unspecified facility/office) for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. The outcome of the severe herpes zoster, weakened immune symptoms, and vaccine did not prevent shingles was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a male patient, age not reported. The patient was inoculated with ZOSTAVAX on an unknown date, at an outpatient clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. The male patient was subsequently treated by a physician (on an unknown date) at the outpatient clinic and another physician (on an unknown date) at the outpatient clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further and proximate result the patient suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster/shingles, vaccine did not prevent shingles, and weakened immune symptoms was unknown. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-JAN-2018, at the age of 17 year-old, the patient was inadvertently vaccinated with PROQUAD lot # N010246, expiration date on 25-SEP-2018, for prophylaxis. No adverse effects were reported.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 23-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported). On 06-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported). On 17-JAN-2018, the patient returned to the physician's office to receive the third dose of GARDASIL 9. There was no adverse effect reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 12 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JAN-2018, the patient was vaccinated with VARIVAX (lot # N019128, expiration date 22-JUN-2019) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was Confirmed that sterile diluent (lot # M046371, expiration date 05-JUL-2019) used for reconstitution was properly stored. No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 56 hours 11 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 14 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 26-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported  M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 18 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 11-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-1709USA008693.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 9 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. 09-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the Vaccine Coordinator referring to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.